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Important to know about ibrutinib

Ibrutinib inhibits cancer growth.
For certain forms of leukemia (blood cancer), lymphatic cancer and Waldenström’s disease.
Swallow the capsule or tablet whole with a glass of water. Do not chew or break.
Be careful with grapefruit. Do not eat or drink too much grapefruit (juice). Then the chance of side effects is greater. Ask your pharmacy for information. Or read more information here .
You may experience diarrhea and nausea from this medication. Make sure you drink extra if you have diarrhea or vomiting.
Blood abnormalities may occur. You will mainly notice this in infections, such as pneumonia, bladder infections or skin infections, pale skin and bleeding. Then consult your doctor immediately. Also consult your doctor immediately if you have fever, sore throat and blisters in the mouth.
Other side effects: inflamed mucous membranes of the mouth, throat, esophagus, stomach and intestines. Furthermore, muscle pain, headache, rash.
Ask for advice about what you can do about the side effects.
You must not become pregnant during and for 3 months after treatment.

 

What does ibrutinib do and where do I use it?

 

Ibrutinib is a tyrosine kinase inhibitor . It is a targeted anti-cancer substance (‘targeted therapy’). It inhibits the growth and spread of cancer cells.

Doctors prescribe it for certain types of cancer in the blood (leukemia) or lymph nodes .

What are possible side effects?
This medicine has a powerful effect on cell division, not only of cancer cells but also of healthy body cells. This can cause side effects, for example in places where the cells naturally divide quickly. These are the mucous membranes of the mouth, stomach and intestines, the skin, hair and blood.

The list of side effects may make it seem that the medicine is worse than the disease. But the side effects do not affect everyone to the same extent. In addition, the side effects often disappear gradually.

 

The main side effects are the following.

 

Regularly (in more than 30 out of 100 people)
Gastrointestinal complaints , such as diarrhea, stomach pain, heartburn or bloating. Sometimes nausea, vomiting or constipation.

Uncommon (affects 10 to 30 out of 100 people)
Too few white and red blood cells and platelets in the blood. Do you get a fever or symptoms of an infection, such as shortness of breath, shortness of breath and coughing? Always consult your doctor immediately.
Too few red blood cells can be noticed by extreme fatigue and pale skin.
Too few platelets can be noticed by bleeding, such as nosebleeds, easy bruising, and blood in the urine.

Headache , fever .

Pain in muscles and joints , muscle cramps.

Fluid retention (edema). You will notice this by swollen ankles and lower legs or shortness of breath.

Sore mouth, tongue or throat.

Skin rash

Breaking off the nails

Rare (affects 1 to 10 people in 100)
Dizziness , blurred vision.

Skin tumors . Consult your doctor if you notice any unusual spots or bumps on your skin.

Sepsis . You will notice it by a fever or a temperature that is too low, rapid breathing and rapid heart rate.

High bloodpressure

Decreased kidney function . Notify your doctor if you experience decreased urination or shortness of breath.

Too much uric acid in the blood. This can cause you to have a gout attack.

Hypersensitivity to this drug. You will notice this in hives, rashes and red skin.

Cardiac arrhythmias

Very rare (affects less than 1 in 100 people)
Bleeding in stomach or intestines . Notify a doctor if you notice blood in your stool or if your stool is black.

Blood clot in a blood vessel (thrombosis). You will notice this by pain in your calf or sudden shortness of breath.

Stroke . You will notice this in sudden complaints, such as facial paralysis (for example a crooked mouth), confused speech and thinking, paralysis of the arm or leg, loss of parts of the visual field and tingling.

Inflammation under the skin . The fat under your skin can become inflamed and cause painful bumps.

Flare of hepatitis B virus infection . You can notice this by a tender, swollen abdomen or a yellow discoloration of the whites of the eyes or the skin.

Contact your nurse or doctor if any of the above side effects bother you too much. Sometimes it is necessary to adjust the dosage to reduce side effects. Sometimes the doctor will prescribe another medication to combat the side effects.

Also discuss with your doctor or nurse if you are concerned about side effects.
Do you experience side effects other than those listed above? Please report this to your pharmacy and doctor.

Are you experiencing a side effect? Please report this to the Lareb side effects centre. All reports about side effects of medicines in the Netherlands are collected here

 

How do I use this medicine?

How?

Capsules. Swallow whole with half a glass of water. Do not open or chew the capsule.
Tablets. Swallow whole with half a glass of water. Do not chew, crush or break the tablet.
When?
You use this medicine once a day. Always choose the same time of day so that you are less likely to forget a dose.

How long?
You can use ibrutinib for several months or years. Your doctor will test your blood regularly to check whether the treatment is having the desired effect.

 

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What should I do if I miss a dose?

It is important that you use this medication as prescribed by the doctor. Have you forgotten to take the medicine?

Is it less than 8 hours before you need to take the next tablet or capsule? Then skip the forgotten tablet or capsule. You should not take an additional tablet or capsule.
Will it be longer than 8 hours before you need to take the next tablet or capsule? Then take the forgotten tablet or capsule.

Can I drive, drink alcohol, and eat or drink anything while on this medication?
driving?
Yes, that’s possible. This medicine does not affect how well you can drive.

drinking alcohol?
There are no restrictions for this with this medicine.

eat everything?
It is better not to eat too much grapefruit or drink grapefruit juice while taking this medication. Then the chance of side effects is greater.

Would you like to drink grapefruit juice? Do not drink a glass of grapefruit juice more than 2 days a week. And every time you drink grapefruit juice, wait at least 3 days before drinking grapefruit juice again.
So: if you drink grapefruit juice on Monday, wait until Thursday before drinking grapefruit juice again.
Would you like to eat grapefruit? Do not eat 1 or 2 grapefruits more than 2 days a week. And wait at least 3 days after each time you eat grapefruit before eating grapefruit again.
So: if you eat grapefruit on Monday, wait until Thursday before eating grapefruit again.
Are you used to eating a lot of grapefruits or drinking grapefruit juice? Please discuss this with your pharmacist or doctor. Perhaps there is another medicine you can use that goes well with grapefruit (juice). Read more information about grapefruit and medicines here .  Ibrutinib for sale ( Imbruvica )

 

 

Can I use ibrutinib with other medications?

This drug has interactions with other medications. The text below only contains the active ingredients of these medications, not the brand names. You can check whether your medicine contains one of these active substances in your package leaflet under the heading ‘composition’.

The drugs with which the most important interactions occur are the following.

Anticoagulants such as acetylsalicylic acid, clopidogrel, dipyridamole, heparins, prasugrel, acenocoumarol and phenprocoumon. These medications increase your risk of bleeding. Consult with your doctor.
Are you using acenocoumarol or phenprocoumon? Your pharmacy will inform your thrombosis service that you are using ibrutinib the first time you take it. Also tell the thrombosis service yourself when you start or stop taking ibrutinib or if the dosage changes. Your clotting will then need to be measured additionally.
The antidepressant medications citalopram, duloxetine, escitalopram, etoricoxib, fluoxetine, fluvoxamine, paroxetine, sertraline, and venlafaxine. These medications increase your risk of bleeding. Discuss this with your doctor.
NSAID type painkillers such as diclofenac, phenylbutazone, ibuprofen, piroxicam and naproxen. These painkillers can make you more likely to bleed. Discuss this with your doctor.
Vaccines. Consult your doctor if you are going to be vaccinated. You should not use certain vaccines. Ibrutinib reduces the effectiveness of these vaccines and increases the risk of side effects. This includes mumps, measles and rubella vaccine (MMR), yellow fever vaccine, rotavirus vaccine and BCG vaccine.
With other vaccines you may need to receive an extra vaccination or have your blood tested to see if the vaccine has worked properly. This includes influenza vaccine, tetanus vaccine and vaccine against cervical cancer.
Some medications for HIV and hepatitis C. Ask your pharmacist which medicines this concerns.
Some cancer medications . Ask your pharmacist which medicines this concerns. The effects or side effects of these medications may change. Discuss this with your doctor.
Some medications can increase the side effects of ibrutinib. Talk to your doctor if you are taking any of the following medications.

Clarithromycin and erythromycin , antibiotics.
Itraconazole and voriconazole , medications for fungal infections.
Ketoconazole , a drug for Cushing’s disease.
The following medications reduce the effect of ibrutinib. Your doctor may adjust the dosage. Or checks the effect of ibrutinib. Discuss this with your doctor. If you stop taking the drug, it will take a few weeks for this effect on ibrutinib to disappear.

Hypericum (St. John’s wort), a herbal remedy for depressive complaints.
The anti-seizure medications carbamazepine, p

 

 

Can I use this medicine if I am pregnant, planning to become pregnant or breastfeeding?
Pregnancy
You should NOT use this medication if you are pregnant or plan to become pregnant soon. It is not known if this drug is safe during pregnancy. In theory, it can cause birth defects or bleeding in the child. Therefore, use good contraception during and for at least 3 months after treatment. Discuss this with your doctor.

Breastfeeding
DO NOT breastfeed if you must use this medication. It is not known whether this medication passes into breast milk and whether it will cause side effects in the child.

Are you taking prescription or over-the-counter medications? Would you like to help increase knowledge about medication use during pregnancy and breastfeeding? Then report your experience

 

Can I just stop taking this medicine?

Treatment with this drug is heavy and can be difficult to maintain, even if it helps you suppress the disease. If the treatment is too difficult for you, discuss this with your doctor or nurse. Together you can discuss the side effects and see if there are alternatives.  Ibrutinib for sale ( Imbruvica )

Do I need a prescription?

Ibrutinib has been on the international market since 2014. It is available by prescription in capsules and tablets under the brand name Imbruvica.

Would you like to know more about the price and reimbursement of your medicine? Then read further in the theme

 

 

Introduction to Imbruvica

This brochure provides you with the necessary information about your Imbruvica ® therapy.
You can read more about the treatment itself, special guidelines and…
possible side effects of therapy. We give you tips to deal with
these side effects and we list which ones
cases you need to contact your doctor.
How you experience these side effects is very personal. Some
people suffer a lot from side effects, others do not. Leave
Don’t be influenced by other people’s stories. Moreover, it has
the severity of the side effects has nothing to do with the effect of the
therapy. Do not hesitate to contact your treating doctor or nurses
to contact us with your questions, feelings and possible uncertainties.
Adapted help can often alleviate or solve a problem.
How does Imbruvica® work?
Imbruvica® contains the active substance ibrutinib and is a medicine
(capsules) for the treatment of some forms of cancer. It
belongs to a class of drugs called
protein kinase inhibitors. Resources from this group stop the growth of
cancer cells. The active substance in itself is not a cytostatic agent;
only after absorption by the body is it converted into a cytostatic one
dust. This mainly happens in the tumor tissue. The medicine
can be prescribed by doctors, for example, for the treatment of
 mantle cell lymphoma (MCL), a type of cancer of the lymph nodes, as
the disease has come back or has not responded to
therapy.
 chronic lymphocytic leukemia (CLL), a type of cancer
certain white blood cells – the lymphocytes – which also include the
lymph nodes are involved. It is used when the disease is
has returned or has not responded to treatment, or at
patients with high-risk CLL (patients whose cancer cells
have certain DNA changes).
In MCL and CLL, Imbruvica® works by introducing a protein into the body.
to block cancer cells from growing and surviving. Because of this

blocking protein helps Imbruvica® kill cancer cells and thus their
number to reduce. It also slows down the progression of the cancer.
In addition, there may be some other medicines
be prescribed. These serve to support the
treatment, for example to limit side effects.
When should you be extra careful with this medicine?
Talk to your doctor or nurse before taking this medicine
used:
 if you have ever had unusual bruising or bleeding.
 if you ever have an irregular heartbeat or severe heart failure
had.
 if you have liver or kidney problems.
 if you have recently had an operation, especially if
This prevents the absorption of food or medicines from your stomach
or intestine may be affected.
 if you are scheduled for surgery – your doctor will ask you
to stop taking Imbruvica® for a short time.
Are you taking other medicines in addition to Imbruvica®, e.g.
blood thinners, aspirin (acetylsalicylic acid) and other painkillers,
the so-called NSAIDs (non-steroidal anti-inflammatory drugs)
such as ibuprofen or naproxen, or have you done so recently?
Then tell your doctor! This also applies to medicines you take
can be purchased without a prescription, for example herbal remedies such as St. John’s wort and
nutritional supplements that increase the risk of bleeding such as:
fish oil, vitamin E or linseed

 

Course of your therapy

On day 1 you come to the oncology outpatient clinic to collect the medication
start. Afterwards, continue taking the Imbruvica® capsules at home, as shown below
prescribed.
Guidelines for using Imbruvica®
 Imbruvica® is available in hard capsules of 140 mg
 How much should you take?
o Mantle cell lymphoma
The recommended dose of Imbruvica® is four capsules
(560 mg) once per day.
o Chronic lymphocytic leukemia/Waldenstrom’s disease
(macroglobulinemia).
The recommended dose of Imbruvica® is three capsules
(420 mg) once per day.
Exceptionally, a different dosage may be prescribed if:
side effects occur.
 How do you take this medicine?
o Take the capsules through the mouth (orally) with a large
glass of water.
o Take the capsules at approximately the same time every day.
o Swallow the capsules whole. Don’t open them,
do not break or chew them.  Ibrutinib for sale ( Imbruvica )
 If you are taking digoxin, a medicine for heart problems,
you should take it at least 6 hours before or after Imbruvica®.
 During your treatment with Imbruvica® you should not:
eating grapefruit or sour oranges or the juice
do not drink from it at any time. Other citrus fruits are
Allowed. You should also not use supplements where this occurs
possible. The amount of Imbruvica® in your blood can
increase if you do not follow this guideline.

 

 

If you have forgotten a dose of Imbruvica®, you can take it
take it as soon as possible on the same day.
o Do not take a double dose to make up for a forgotten dose.
o If you are not sure what to do, speak to your
doctor about when to take the next dose.
o Simply take the next dose at the scheduled time.
o Report a missed dose at your next hospital visit.

 Imbruvica® should be stored at room temperature in a
safe place out of the reach of children.

 Bring leftover medication back to the hospital.
Never throw them in the trash and never rinse the medication away through it
toilet or sink.

 In case of vomiting shortly after taking Imbruvica®:
o If all tablets are visible, you can take the prescribed
repeat dose.
o If not all tablets are visible, the prescribed one may be taken
dose should no longer be taken. Doctor’s advice is
than necessary.

 Have you taken too much of this medicine?
If you have taken more Imbruvica® than you should
If you take it, consult a doctor or go to a hospital immediately.
Take the capsules and the package leaflet with you.

 When should you not use this medicine?
o You are allergic to any of the ingredients in this
medicine. Stop using Imbruvica® and inform one immediately
doctor if you notice any of the following side effects:
skin rash with itching and bumps, difficulty breathing,
swollen face, lips, tongue or throat – you may have:
have an allergic reaction to this medicine.
o You are using a herbal remedy called St. John’s wort,
used against depression.
o You are taking blood thinners e.g. Marcoumar® (phenprocoumon)
or Sintrom® (acenocoumarol).
o Just before a surgical procedure. The doctor’s advice is then:
necessary. The medication lasts at least 1-2 days
to be stopped.

 

Possible side effects of Imbruvica

Here you will receive a summary of the various side effects
can occur. On the following pages we will go into more detail
most side effects and we provide explanations and tips to deal with them
side effects to deal with. Find more information about side effects
also in the package leaflet. It is important to know which signals to respond to
pay attention.

 Blood in the stool or urine, heavier periods, bleeding
that you cannot stem from a wound, confusion, headache with
slurred speech or feeling light-headed – this
can be symptoms of serious internal bleeding
your stomach, intestines or brain.

 Fast heartbeat, skipping heartbeat, weak or irregular
heart rate (pulse).

 Fever, chills, body aches, fatigue, symptoms
from a cold or flu, shortness of breath – these can be
are symptoms of a (serious) infection.
Immediately contact the hospital for one or more of the
following signs:
o fever above 38°C, chills, sweating
o sore throat, cough with colored phlegm
o pain when urinating, traces of blood in the urine or stool
o any bruising or bleeding without a demonstrable cause
o bleeding that lasts longer than normal
o shortness of breath, chest pain, sudden extreme
fatigue or palpitations
o if it is very difficult for you to urinate

 Other very common side effects
o mouth sores
o headache or dizziness
o constipation
o nausea or vomiting
o diarrhea; your doctor may need to give you fluids and salt
administer or give another medicine
o skin rash
o painful arms or legs
o back pain or joint pain

o muscle cramps or muscle pain
o a low number of cells that help circulate your blood
clotting (platelets), a very low white count
blood cells, low red blood cell count
(anemia) – shown in blood tests
o swollen hands, ankles or feet
Some advice
 Measure your body temperature daily.

 Inspect your mouth regularly for signs of damage.

 Monitor for sore throat and shortness of breath. Check if you have a cough and/or you
have colored fluff.

 Avoid contact with people who have the flu or a cold
are. Also contact with children who are experiencing a childhood illness
is strongly discouraged. Avoid places where there are many people
get together (cinema, public transport, etc.). If you like this
instructions properly, it is not necessary that you fully comply
isolate or avoid all visitors.  Ibrutinib for sale ( Imbruvica )

 Let your dentist know that you are being treated with Imbruvica®, a
dental care easily causes bleeding.
 Consult a doctor if you cannot stop a nosebleed.
Irritation and/or inflammation of the oral mucosa
 Oral mucosal inflammation can occur a few days after administration
performance. This usually starts with a dry or burning sensation
the mouth.
 Afterwards the mouth, tongue or throat may feel and may be sore
painful small ulcers (canker sores) develop. Your mouth is then
hypersensitive to hot, cold, spicy or hard foods. Follow ter
prevention and good oral care. (brochure
‘Oral care’).
Some advice
 Avoid alcohol and other irritants if possible
nutrients such as foods that are too hot, too spicy or too sour.

 Be sure to consult your doctor if pain prevents you from eating or eating
drinks. He/she can then start therapy to cure it
oral mucosa.

 

Nausea and vomiting
Nausea and vomiting may persist for several days after administration
occur, but can be controlled fairly well with medication. Inform your
doctor at the next consultation if anti-emetic medication
has had insufficient effect.
Some advice
 It is important that you drink a lot during therapy (1.5 l to 2 l)
because the extra waste products must be removed from the body
become.
 Take your anti-nausea and vomiting medicines strictly
as prescribed by your doctor.
 Ask for help from the dietitian at the hospital through your doctor or the
nurses. This can give you advice if you have problems
with your diet
Consult your doctor or GP
 If you are losing weight seriously
 If you show signs of dehydration: a feeling of thirst, a
dry and wrinkled skin, dry mouth, overtiredness and
little urination.
Diarrhea
The therapy can act on the cells of the intestines. This causes irritation
of the intestinal mucosa, which can cause diarrhea.
Some advice
 Drink enough (especially salty drinks, e.g. broth).
prevent dehydration.
 Do not take your own anti-diarrheal medication without your knowledge
your doctor.
Consult your doctor
Contact your doctor if the diarrhea occurs more than 4 times a day
occurs and/or lasts longer than two consecutive days. Your
The doctor may therefore decide to adjust the medication
or to stop.

Finally
If you have any questions or comments after reading this brochure, please contact us
you can contact your treating doctor or the nurses. We
We sincerely hope that this brochure has helped you find your way
treatment with Imbruvica®.
Who to contact if you have questions or problems?
The side effects listed above are the most common
side effects for this treatment. How you experience these side effects is
very personal. Some people suffer from side effects,
others not. Do not hesitate to contact your doctor or nurse
Contact us if you have any questions about other side effects you experience or
other questions, feelings and possible insecurities.
If you have any questions or comments after reading this brochure, please contact us
you can contact your treating doctor or the nurses
(Tel. 014 40 69 14). You will find useful information in the ‘Social facilities’ folder
information about interventions for your illness, about discussion groups and
other forms of psychosocial care. Our social nurse
is always ready to listen to your problems. You can her
reachable via social services (Tel. 014 40 68 32).
Personal notes/questions
If you have any questions or comments, please write them here. So you have
always have them at hand when speaking to your doctor or nurse

 

Package leaflet: information for the patient
IMBRUVICA 140 mg hard capsules
ibrutinib
This medicine is subject to additional monitoring. This means new ones can be created quickly
safety information is determined. You can contribute to this by reporting all
side effects you might experience. You can read how to do this at the end of section 4.
Read all of this leaflet carefully before you start using this medicine because it contains important information
information for you.

 Keep this leaflet. Maybe you might need him later on.

 Do you have any questions? Please contact your doctor, pharmacist or nurse

.
 Do not pass this medicine on to others as it has been prescribed only for you. It’s possible
be harmful to others, even if they have the same complaints as you.

 Do you experience any of the side effects listed in section 4? Or do you experience a side effect?
is not included in this leaflet? Please contact your doctor, pharmacist or nurse.
Contents of this leaflet

1. What IMBRUVICA is and what it is used for?
2. When should you not use this medicine or should you be extra careful with it?
3. How do you use this medicine?
4. Possible side effects
5. How to store this medicine
6. Contents of the package and other information
1. What IMBRUVICA is and what it is used for?

What is IMBRUVICA?

IMBRUVICA is an anticancer medicine that contains the active substance ibrutinib. It belongs to one
class of drugs called protein kinase inhibitors.
What is IMBRUVICA used for?
This medicine is used to treat the following types of blood cancer in adults:

 mantle cell lymphoma (MCL), a type of cancer of the lymph nodes, if the disease has come back
or has not responded to treatment.

 chronic lymphocytic leukemia (CLL), a type of cancer of certain white blood cells – the
lymphocytes – also involving the lymph nodes. IMBRUVICA is used for:
patients who have not previously been treated for CLL, or if the disease has come back or not
has responded to treatment.

 Waldenström’s disease (macroglobulinemia) (WM), a type of cancer of certain white
blood cells – the lymphocytes. It is used if the disease has returned or has not
responded to treatment, or in patients for whom chemotherapy is given together with a
antibody is given is not suitable therapy.
How does IMBRUVICA work?
In MCL, CLL and WM, IMBRUVICA works by blocking Bruton’s tyrosine

 

2. When should you not use this medicine or should you be extra careful with it?
When should you not use this medicine?
 You are allergic to any of the ingredients in this medicine. You can find these substances in
section 6.

 You are taking a herbal remedy called St. John’s wort, used for depression. If you don’t
are sure, talk to your doctor, pharmacist or nurse before taking this medicine
used.

When should you be extra careful with this medicine?
Talk to your doctor, pharmacist or nurse before taking this medicine:

 if you have ever had unusual bruising or bleeding or if you are taking any medicines or
are taking nutritional supplements that put you at a higher risk of bleeding (see section
section ‘Are you taking any other medicines?’)

 if you have an irregular heartbeat or have had an irregular heartbeat in the past or severely
have had heart failure, or if you have any of the following symptoms: shortness of breath,
weakness, dizziness, light-headedness, fainting or near fainting, pain in the
chest or swollen legs

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 if you have liver or kidney problems

 if you have recently undergone surgery, especially if this affects the absorption of food
or medicines from your stomach or intestines may be affected

 if you are scheduled for surgery – your doctor may ask you to stay for a short period of time (3 to 6 weeks).
7 days) before and after your operation with IMBRUVICA.

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 if you have ever had hepatitis B infection or if you may currently have one. This is
because IMBRUVICA could cause hepatitis B to become active again. Patients
will be carefully checked by their doctor for signs of this infection before having it
the treatment is started.
If any of these apply to you (or you are not sure), talk to your doctor,
pharmacist or nurse before using this medicine.
Tell your doctor immediately if you or anyone else with you are taking IMBRUVICA
notice: memory loss, difficulty thinking, difficulty walking or decrease in brain function
vision ‒ these symptoms may be the result of a very rare but serious
brain infection that can be fatal (progressive multifocal leukoencephalopathy or PML).
Tests and checks before and during treatment
Tumor lysis syndrome (TLS): unusual levels of chemicals – caused by the
rapid breakdown of cancer cells – have occurred in the blood during cancer treatment and
sometimes even without treatment. This can lead to changes in the functioning of the kidneys, a
abnormal heartbeat or seizures. Your doctor or other healthcare provider may recommend a
have blood tests done to test for TLS.
Lymphocytosis: Laboratory tests may indicate an increase in the number of white blood cells
(so-called lymphocytes) in your blood during the first weeks of treatment. This is according to
expectation and may last a few months. It does not necessarily mean that your blood cancer
is getting worse. Your doctor will measure blood cell counts before and during treatment
and in rare cases you may need to be given another medicine. Discuss with
your doctor what the test results mean.
Children and young people up to 18 years old
IMBRUVICA should not be used in children and adolescents under 18 years of age. This is because it is in this
age groups have not been investigated.
Are you taking any other medicines?  Ibrutinib for sale ( Imbruvica )
Are you taking any other medicines besides IMBRUVICA, have you recently done so or are you taking any other medicines?
the possibility that you will use other medicines in the near future? Then tell your

 

doctor or pharmacist. This also applies to medicines that you can buy without a prescription, herbal remedies
and nutritional supplements. This is because IMBRUVICA can influence the effect of some other medicines
to influence. Other substances can also influence the effect of IMBRUVICA.
IMBRUVICA may make it easier for you to bleed. This means you can handle it
your doctor should tell you if you are taking other medicines that increase your risk of bleeding.
These include:

 acetylsalicylic acid (aspirin) and other anti-inflammatory drugs, the so-called NSAIDs (nonsteroidal anti-inflammatory drugs) such as ibuprofen or naproxen
 ‘blood thinners’ such as warfarin, heparin or other medicines against blood clots

 nutritional supplements that increase the risk of bleeding such as fish oil, vitamin E or
flax seed.
If you are taking any of the above (or if you are not sure), talk to your doctor,
pharmacist or nurse before you start using IMBRUVICA.
Also tell your doctor if you are taking any of the following medicines – The
effects of IMBRUVICA or other medicines may be affected if you take IMBRUVICA
used simultaneously with one of the following medicines:

 medicines called antibiotics, to treat infections with bacteria –
clarithromycin, telithromycin, ciprofloxacin, erythromycin or rifampicin

 medicines for fungal infections – posaconazole, ketoconazole, itraconazole, fluconazole or
voriconazole
 drugs for HIV infection – ritonavir, cobicistat, indinavir, nelfinavir, saquinavir, amprenavir,
atazanavir

 

 

Women of childbearing potential should use a highly effective method of contraception
while they receive IMBRUVICA and for three months afterwards, to prevent them from becoming pregnant
while being treated with IMBRUVICA. If you use hormone-based contraception –
such as the pill, or another form – then you must also use a barrier method
(e.g. condoms).

 Tell your doctor immediately if you are pregnant.

 Do not breastfeed your child while you are taking this medicine.
Driving and using machines

You may feel tired or dizzy after taking IMBRUVICA. That can have an influence
affect your ability to drive or use machines.

3. How do you use this medicine IMBRUVICA ?

Always use this medicine exactly as your doctor, pharmacist or nurse has told you
told. Are you unsure about the correct use? Please contact your doctor, pharmacist or
nurse.
How much should you take?
Mantle cell lymphoma (MCL)
The recommended dose of IMBRUVICA is four capsules (560 mg) once a day.
Chronic lymphocytic leukemia (CLL)/Waldenström disease
(macroglobulinemia – WM)
The recommended dose of IMBRUVICA is three capsules (420 mg) once a day.
Your doctor may adjust your dose.
How do you take this medicine?
 Take the capsules through the mouth (orally) with a glass of water.
 Take the capsules at approximately the same time every day.
 Swallow the capsules whole. Do not open, break or chew them.
Have you taken too much of this medicine?
If you have taken more IMBRUVICA than you should, consult a doctor or go
straight to a hospital. Take the capsules and this leaflet with you.
Did you forget to take this medicine?
 If you miss a dose, you can take it as soon as possible on the same day
taking it, returning to your normal schedule the next day.
 Do not take a double dose to make up for a forgotten dose.
 If you are not sure what to do, talk to your doctor, pharmacist or nurse
about when to take the next dose.
If you stop taking this medicine
Do not stop taking this medicine unless your doctor tells you to do so.
Do you have any other questions about the use of this medicine? Please contact your doctor,
pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them
to do with that. The following side effects may occur with this medicine.

 

Stop taking IMBRUVICA and tell a doctor immediately if you experience any of the following side effects
notes:
rash with itching and bumps; difficulty breathing; swollen face, lips, tongue or throat – it is possible
that you are having an allergic reaction to this medicine.
Consult a doctor immediately if you notice any of the following side effects:
Very common (may affect more than 1 in 10 people)
 fever, chills, body aches, fatigue, symptoms of cold or flu,
shortness of breath – these may be symptoms of an infection (with a virus, bacteria or
a fungus). These may include infections of the nose, sinuses or throat (infection of the
upper respiratory tract), or of the lungs or skin.
 bruising or easier bruising.
 Mouth sores
 headache
 constipation
 nausea or vomiting
 diarrhea; your doctor may need to give you fluids and salt or another medicine
 skin rash
 painful arms or legs
 back pain or joint pain
 muscle cramps, pain or contraction of the muscles (spasms)
 a low number of cells that help your blood to clot (platelets), very low
number of white blood cells – shown in blood tests
 swollen hands, ankles or feet.
Common (may affect up to 1 in 10 people)
 serious infections throughout the body (blood poisoning)
 urinary tract infections
 nosebleeds, small red or purple spots caused by bleeding under the nose
skin
 blood in the stool or urine, heavier periods, bleeding that you cannot stop
wound, confusion, headache with slurred speech or feeling light-headed
– these may be symptoms of serious internal bleeding in your stomach, intestines or
brain
 fast heartbeat, skipping heartbeat, weak or irregular heartbeat (pulse), a light
feeling in the head, shortness of breath, discomfort in the chest (these are symptoms
of heart rhythm problems)
 an increase in the number or proportion of white blood cells in blood tests
 a low white blood cell count with fever (febrile neutropenia)
 unusual amounts of chemicals – caused by the rapid breakdown of
cancer cells – have appeared in the blood during cancer treatment and sometimes even
without treatment (tumor lysis syndrome)
 skin cancer that is not melanoma – usually squamous cell cancer or
basal cell cancer
 feeling dizzy
 blurred vision
 high blood pressure
 redness of the skin
 a lot of ‘uric acid’ in the blood (shown in blood tests); this can cause gout
 inflammation in the lungs that can cause permanent damage
 breaking off of the nails
 weakness, numbness, tingling or pain in your hands or feet or other parts of the body
(peripheral neuropathy).

 

 

Uncommon (may affect up to 1 in 100 people)
 a greatly increased number of white blood cells, which can cause cells to clump together
 allergic reaction, sometimes severe, possibly with swollen face, lip, mouth, tongue or throat,
difficulty swallowing or breathing, itchy skin rash (hives)
 inflammation of the subcutaneous fatty tissue.
Not known (cannot be estimated from the available data)
 liver failure
 severe skin rash with blistering and peeling of the skin, especially around the mouth, nose,
eyes and genitals (Stevens-Johnson syndrome).
Reporting side effects
If you experience side effects, contact your doctor, pharmacist or nurse. This
This also applies to possible side effects not listed in this leaflet. You may experience side effects as well
report directly via the national reporting system listed in Appendix V. Due to adverse reactions
By reporting this, you can help us obtain more information about the safety of this medicine.
5. How to store this medicine
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date. This can be found on the box and
the bottle label after EXP. There is a month and a year. The last day of that month is the latest
expiration date.
This medicine does not require any special storage conditions.
Do not flush medicines down the sink or toilet or throw them in the rubbish bin. Ask your
pharmacist what to do with medicines that you no longer use. They are then placed on one
destroyed in a responsible manner and do not end up in the environment.
6. Contents of the package and other information
what chemicals are there in this product?
 The active substance in this medicine is ibrutinib. Each hard capsule contains 140 mg ibrutinib.
 The other ingredients in this medicine are:
– capsule contents: croscarmellose sodium, magnesium stearate, microcrystalline
cellulose and sodium lauryl sulphate (E487);
– capsule shell: gelatin and titanium dioxide (E171);
– printing ink: shellac, black iron oxide (E172) and propylene glycol (E1520).
What does IMBRUVICA look like and how much does the pack contain?
IMBRUVICA are white, opaque, hard capsules with ‘ibr 140 mg’ written in black ink on one side.
The capsules are contained in a plastic bottle with a child-resistant polypropylene closure. Are in every bottle
90 or 120 capsules. Each box contains one bottle.

Package leaflet: information for the patient
IMBRUVICA 140 mg film-coated tablets
IMBRUVICA 280 mg film-coated tablets
IMBRUVICA 420 mg film-coated tablets
IMBRUVICA 560 mg film-coated tablets
ibrutinib
This medicine is subject to additional monitoring. This means new ones can be created quickly
safety information is determined. You can contribute to this by reporting all
side effects you might experience. You can read how to do this at the end of section 4.
Read all of this leaflet carefully before you start using this medicine because it contains important information
information for you. Ibrutinib for sale ( Imbruvica )
 Keep this leaflet. Maybe you might need him later on.
 Do you have any questions? Please contact your doctor, pharmacist or nurse.
 Do not pass this medicine on to others as it has been prescribed only for you. It’s possible
be harmful to others, even if they have the same complaints as you.
 Do you experience any of the side effects listed in section 4? Or do you experience a side effect?
is not included in this leaflet? Please contact your doctor, pharmacist or nurse.
Contents of this leaflet
1. What IMBRUVICA is and what it is used for?
2. When should you not use this medicine or should you be extra careful with it?
3. How do you use this medicine?
4. Possible side effects
5. How to store this medicine
6. Contents of the package and other information
1. What IMBRUVICA is and what it is used for?
What is IMBRUVICA?
IMBRUVICA is an anticancer medicine that contains the active substance ibrutinib. It belongs to one
class of drugs called protein kinase inhibitors.
What is IMBRUVICA used for?
This medicine is used to treat the following types of blood cancer in adults:
 mantle cell lymphoma (MCL), a type of cancer of the lymph nodes, if the disease has come back
or has not responded to treatment.
 chronic lymphocytic leukemia (CLL), a type of cancer of certain white blood cells – the
lymphocytes – also involving the lymph nodes. IMBRUVICA is used for:
patients who have not previously been treated for CLL, or if the disease has come back or not
has responded to treatment.
 Waldenström’s disease (macroglobulinemia) (WM), a type of cancer of certain white
blood cells – the lymphocytes. It is used if the disease has returned or has not
responded to treatment, or in patients for whom chemotherapy is given together with a
antibody is given is not suitable therapy.

 

How does IMBRUVICA work?

In MCL, CLL and WM, IMBRUVICA works by blocking Bruton’s tyrosine kinase in the body.
This is a protein in the body that helps cancer cells grow and survive. Because of this
blocking protein helps IMBRUVICA kill cancer

 

 

2. When should you not use this medicine or should you be extra careful with it?
When should you not use this medicine?
 You are allergic to any of the ingredients in this medicine. You can find these substances in
section 6.
 You are taking a herbal remedy called St. John’s wort, used for depression. If you don’t
are sure, talk to your doctor, pharmacist or nurse before taking this medicine
used.
When should you be extra careful with this medicine?
Talk to your doctor, pharmacist or nurse before taking this medicine:
 if you have ever had unusual bruising or bleeding or if you are taking any medicines or
are taking nutritional supplements that put you at a higher risk of bleeding (see section
section ‘Are you taking any other medicines?’)
 if you have an irregular heartbeat or have had an irregular heartbeat in the past or severely
have had heart failure, or if you have any of the following symptoms: shortness of breath,
weakness, dizziness, light-headedness, fainting or near fainting, pain in the
chest or swollen legs
 if you have liver or kidney problems
 if you have recently undergone surgery, especially if this affects the absorption of food
or medicines from your stomach or intestines may be affected
 if you are scheduled for surgery – your doctor may ask you to stay for a short period of time (3 to 6 weeks).
7 days) before and after your operation with IMBRUVICA.
 if you have ever had hepatitis B infection or if you may currently have one. This is
because IMBRUVICA could cause hepatitis B to become active again. Patients
will be carefully checked by their doctor for signs of this infection before having it
the treatment is started.
If any of these apply to you (or you are not sure), talk to your doctor,
pharmacist or nurse before using this medicine.
Tell your doctor immediately if you or anyone else with you are taking IMBRUVICA
notice: memory loss, difficulty thinking, difficulty walking or decrease in brain function
vision ‒ these symptoms may be the result of a very rare but serious
brain infection that can be fatal (progressive multifocal leukoencephalopathy or PML).
Tests and checks before and during treatment
Tumor lysis syndrome (TLS): unusual levels of chemicals – caused by the
rapid breakdown of cancer cells – have occurred in the blood during cancer treatment and
sometimes even without treatment. This can lead to changes in the functioning of the kidneys, a
abnormal heartbeat or seizures. Your doctor or other healthcare provider may recommend a
have blood tests done to test for TLS.
Lymphocytosis: Laboratory tests may indicate an increase in the number of white blood cells
(so-called lymphocytes) in your blood during the first weeks of treatment. This is according to
expectation and may last a few months. It does not necessarily mean that your blood cancer
is getting worse. Your doctor will measure blood cell counts before and during treatment
and in rare cases you may need to be given another medicine. Discuss with
your doctor what the test results mean.
Children and young people up to 18 years old
IMBRUVICA should not be used in children and adolescents under 18 years of age. This is because it is in this
age groups have not been investigated.

 

Are you taking any other medicines?
Are you taking any other medicines besides IMBRUVICA, have you recently done so or are you taking any other medicines?
the possibility that you will use other medicines in the near future? Then tell your
doctor or pharmacist. This also applies to medicines that you can buy without a prescription, herbal remedies
and nutritional supplements. This is because IMBRUVICA can influence the effect of some other medicines
to influence. Other substances can also influence the effect of IMBRUVICA.
IMBRUVICA may make it easier for you to bleed. This means you can handle it
your doctor should tell you if you are taking other medicines that increase your risk of bleeding.
These include:
 acetylsalicylic acid (aspirin) and other anti-inflammatory drugs, the so-called NSAIDs (nonsteroidal anti-inflammatory drugs) such as ibuprofen or naproxen
 ‘blood thinners’ such as warfarin, heparin or other medicines against blood clots
 nutritional supplements that increase the risk of bleeding such as fish oil, vitamin E or
flax seed.
If you are taking any of the above (or if you are not sure), talk to your doctor,
pharmacist or nurse before you start using IMBRUVICA.
Also tell your doctor if you are taking any of the following medicines – The
effects of IMBRUVICA or other medicines may be affected if you take IMBRUVICA
used simultaneously with one of the following medicines:
 medicines called antibiotics, to treat infections with bacteria –
clarithromycin, telithromycin, ciprofloxacin, erythromycin or rifampicin
 medicines for fungal infections – posaconazole, ketoconazole, itraconazole, fluconazole or
voriconazole
 drugs for HIV infection – ritonavir, cobicistat, indinavir, nelfinavir, saquinavir, amprenavir,
atazanavir

 

 

Pregnancy and breastfeeding
Make sure you do not become pregnant while you are taking this medicine. IMBRUVICA is not allowed
are used during pregnancy. There is no information about the safety of IMBRUVICA
in pregnant women.
Women of childbearing potential should use a highly effective method of contraception
while they receive IMBRUVICA and for three months afterwards, to prevent them from becoming pregnant
while being treated with IMBRUVICA. If you use hormone-based contraception –
such as the pill, or another form – then you must also use a barrier method
(e.g. condoms).
 Tell your doctor immediately if you are pregnant.
 Do not breastfeed your child while you are taking this medicine.
Driving and using machines
You may feel tired or dizzy after taking IMBRUVICA. That can have an influence
affect your ability to drive or use machines.
IMBRUVICA contains lactose
IMBRUVICA contains lactose (a type of sugar). If your doctor has informed you that you have certain
intolerance to sugars, contact your doctor before taking this medicine.
3. How do you use this medicine?
Always use this medicine exactly as your doctor, pharmacist or nurse has told you
told. Are you unsure about the correct use? Please contact your doctor, pharmacist or
nurse.
How much should you take?
Mantle cell lymphoma (MCL)
The recommended dose of IMBRUVICA is 560 mg once a day.
Chronic lymphocytic leukemia (CLL)/Waldenström disease
(macroglobulinemia – WM)
The recommended dose of IMBRUVICA is 420 mg once a day.
Your doctor may adjust your dose.
How do you take this medicine?
 Take the tablets through the mouth (orally) with a glass of water.
 Take the tablets at approximately the same time every day.
 Swallow the tablets whole. Do not break or chew them.
Have you taken too much of this medicine?
If you have taken more IMBRUVICA than you should, consult a doctor or go
straight to a hospital. Take the tablets and this leaflet with you.
Did you forget to take this medicine?
 If you miss a dose, you can take it as soon as possible on the same day
taking it, returning to your normal schedule the next day.
 Do not take a double dose to make up for a forgotten dose.
 If you are not sure what to do, talk to your doctor, pharmacist or nurse
about when to take the next dose.
If you stop taking this medicine
Do not stop taking this medicine unless your doctor tells you to do so.

Do you have any other questions about the use of this medicine? Please contact your doctor,
pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them
to do with that. The following side effects may occur with this medicine.
Stop taking IMBRUVICA and tell a doctor immediately if you experience any of the following side effects
notes:
rash with itching and bumps; difficulty breathing; swollen face, lips, tongue or throat – it is possible
that you are having an allergic reaction to this medicine.
Consult a doctor immediately if you notice any of the following side effects:
Very common (may affect more than 1 in 10 people)
 fever, chills, body aches, fatigue, symptoms of cold or flu,
shortness of breath – these may be symptoms of an infection (with a virus, bacteria or
a fungus). These may include infections of the nose, sinuses or throat (infection of the
upper respiratory tract), or of the lungs or skin.
 bruising or easier bruising.
 Mouth sores
 headache
 constipation
 nausea or vomiting
 diarrhea; your doctor may need to give you fluids and salt or another medicine
 skin rash
 painful arms or legs
 back pain or joint pain
 muscle cramps, pain or contraction of the muscles (spasms)
 a low number of cells that help your blood to clot (platelets), very low
number of white blood cells – shown in blood tests
 swollen hands, ankles or feet.
Common (may affect up to 1 in 10 people)
 serious infections throughout the body (blood poisoning)
 urinary tract infections
 nosebleeds, small red or purple spots caused by bleeding under the nose
skin
 blood in the stool or urine, heavier periods, bleeding that you cannot stop
wound, confusion, headache with slurred speech or feeling light-headed
– these may be symptoms of serious internal bleeding in your stomach, intestines or
brain
 fast heartbeat, skipping heartbeat, weak or irregular heartbeat (pulse), a light
feeling in the head, shortness of breath, discomfort in the chest (these are symptoms
of heart rhythm problems)
 an increase in the number or proportion of white blood cells in blood tests
 a low white blood cell count with fever (febrile neutropenia)
 unusual amounts of chemicals – caused by the rapid breakdown of
cancer cells – have appeared in the blood during cancer treatment and sometimes even
without treatment (tumor lysis syndrome)
 skin cancer that is not melanoma – usually squamous cell cancer or
basal cell cancer
 feeling dizzy

 

 

blurred vision
 high blood pressure
 redness of the skin
 a lot of ‘uric acid’ in the blood (shown in blood tests); this can cause gout
 inflammation in the lungs that can cause permanent damage
 breaking off of the nails
 weakness, numbness, tingling or pain in your hands or feet or other parts of the body
(peripheral neuropathy).
Uncommon (may affect up to 1 in 100 people)
 a greatly increased number of white blood cells, which can cause cells to clump together
 allergic reaction, sometimes severe, possibly with swollen face, lip, mouth, tongue or throat,
difficulty swallowing or breathing, itchy skin rash (hives)
 inflammation of the subcutaneous fatty tissue.
Not known (cannot be estimated from the available data)
 liver failure
 severe skin rash with blistering and peeling of the skin, especially around the mouth, nose,
eyes and genitals (Stevens-Johnson syndrome). Ibrutinib for sale ( Imbruvica )
Reporting side effects
If you experience side effects, contact your doctor, pharmacist or nurse. This
This also applies to possible side effects not listed in this leaflet. You may experience side effects as well
report directly via the national reporting system listed in Appendix V. Due to adverse reactions
By reporting this, you can help us obtain more information about the safety of this medicine.
5. How to store this medicine
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date. This can be found on the box
EXP. There is a month and a year. The last day of that month is the latest
expiration date.
This medicine does not require any special storage conditions.
Do not flush medicines down the sink or toilet or throw them in the rubbish bin. Ask your
pharmacist what to do with medicines that you no longer use. They are then placed on one
destroyed in a responsible manner and do not end up in the environment.
6. Contents of the package and other information
what chemicals are there in this product?
 The active substance in this medicine is ibrutinib.
– IMBRUVICA 140 mg film-coated tablets: each tablet contains 140 mg ibrutinib.
– IMBRUVICA 280 mg film-coated tablets: each tablet contains 280 mg ibrutinib.
– IMBRUVICA 420 mg film-coated tablets: each tablet contains 420 mg ibrutinib.
– IMBRUVICA 560 mg film-coated tablets: each tablet contains 560 mg ibrutinib.
 The other ingredients in this medicine are:
 Tablet core: colloidal anhydrous silica, croscarmellose sodium, lactose monohydrate,
magnesium stearate, microcrystalline cellulose, povidone, sodium lauryl sulphate (E487).
 Tablet coating: polyvinyl alcohol, macrogol, talc, titanium dioxide (E171);
IMBRUVICA 140 mg and IMBRUVICA 420 mg film-coated tablets also contain black
iron oxide (E172) and yellow iron oxide (E172);

Brochure
What is this medicine used for?
What is IMBRUVICA?
IMBRUVICA is an anticancer medicine that contains the active substance ibrutinib. It belongs to a class of drugs called protein kinase inhibitors.

What is IMBRUVICA used for?
This medicine is used to treat the following types of blood cancer in adults:

mantle cell lymphoma (MCL), a type of cancer of the lymph nodes, if the disease has come back or has not responded to treatment.
chronic lymphocytic leukemia (CLL), a type of cancer of certain white blood cells – the lymphocytes – that also involves the lymph nodes. IMBRUVICA is used in patients who have not previously been treated for CLL, or if the disease has come back or has not responded to treatment.
Waldenström’s disease (macroglobulinemia) (WM), a type of cancer of certain white blood cells – the lymphocytes. It is used in patients who have not previously been treated for WM or if the disease has come back or has not responded to treatment, or in patients for whom chemotherapy given together with an antibody is not suitable therapy.

How does IMBRUVICA work?
In MCL, CLL and WM, IMBRUVICA works by blocking Bruton’s tyrosine kinase in the body. This is a protein in the body that helps cancer cells grow and survive. By blocking this protein, IMBRUVICA helps kill cancer cells and thus reduce their number. It also slows down the progression of the cancer.

 

 

 

When should you not use this medicine or should you be extra careful with it?
When should you not use this medicine?
You are allergic to any of the ingredients of this medicine. You can find these substances in section 6.
You are taking a herbal remedy called St. John’s wort, used for depression . If you are not sure, talk to your doctor, pharmacist or nurse before taking this medicine.
When should you be extra careful with this medicine?
Talk to your doctor, pharmacist or nurse before taking this medicine:

if you have ever had unusual bruising or bleeding or if you are taking medicines or nutritional supplements that may increase your risk of bleeding (see the section ‘Are you taking other medicines?’)
if you have an irregular heartbeat or have had an irregular heartbeat or severe heart failure in the past , or if you have any of the following symptoms: shortness of breath, weakness, dizziness , light-headedness, fainting or near fainting , pain in the chest or swollen legs
if you have liver problems. This also applies if you have a hepatitis B infection (an infection of the liver). Or if you’ve ever had one.
if you have high blood pressure
if you have recently had surgery, especially if this may affect the absorption of food or medicines from your stomach or intestines
if you are scheduled for surgery – your doctor may ask you to stop taking IMBRUVICA for a short time (3 to 7 days) before and after your surgery.
if you have kidney problems.
If any of these apply to you (or you are not sure?), talk to your doctor, pharmacist or nurse before or while using this medicine (see section
‘Possible side effects’).

Tell your doctor immediately if you or anyone else with you notice any of the following while taking IMBRUVICA: loss of memory, difficulty thinking, difficulty walking or vision loss ‒ these symptoms may be due to a very rare but serious brain infection called can be fatal (progressive multifocal leukoencephalopathy or PML).

Tell your doctor immediately if you experience or if someone sees that you experience: loss of feeling or strength in your arm or leg (especially on one side of the body), sudden confusion, slurred or confused speech, loss of vision , difficulty walking, problems with your balance or coordination, very bad headaches . These may be characteristics of a stroke .

Tell your doctor immediately if you develop pain in your left upper abdomen, left lower chest, or left shoulder tip (this may indicate that your spleen has ruptured) after you stop taking IMBRUVICA.

Effects on your heart
Treatment with IMBRUVICA can be bad for your heart. This especially happens if you already have heart disease, such as problems with your heart rate, heart failure or high blood pressure . Or if you have diabetes or if you are older. The effects can be serious and may lead to death. Sometimes to sudden death. Your doctor will check your heart before and during treatment with IMBRUVICA. Tell your doctor straight away if during your treatment with IMBRUVICA you feel short of breath, have difficulty breathing when lying down, if your feet, ankles or legs are swelling and if you experience weakness or tiredness – these may be signs are from heart failure .

During treatment with IMBRUVICA you may suffer from viral, bacterial or fungal infections. Contact your doctor if you experience fever , chills, weakness,

128

confusion, body aches, cold or flu symptoms, tiredness or shortness of breath, yellowing of the skin or eyes (jaundice). These could be signs of an infection.

Hemophagocytic lymphohistiocytosis
Cases of excessive activation of white blood cells causing inflammation have been reported (called hemophagocytic lymphohistiocytosis). It can be fatal if not recognized and treated early. If you experience multiple symptoms such as fever , swollen lymph nodes, bruises or rash, contact your doctor immediately.

Tests and checks before and during treatment

Tumor lysis syndrome (TLS): Unusual levels of chemicals – caused by the rapid breakdown of cancer cells – have occurred in the blood during cancer treatment and sometimes even without treatment. This can lead to changes in kidney function, abnormal heartbeat, or seizures. Your doctor or other healthcare provider may order a blood test to test for TLS.

Lymphocytosis: laboratory tests may show an increase in the number of white blood cells (so-called lymphocytes) in your blood during the first weeks of treatment. This is as expected and may take a few months. It doesn’t necessarily mean that your blood cancer is getting worse. Your doctor will check your blood cell counts before and during treatment and in rare cases you may need to be given a different medicine. Discuss with your doctor what the test results mean.

Liver problems: your doctor will do some blood tests. The doctor uses this to check whether your liver is working properly and you do not have a liver infection. This infection is called viral hepatitis . The doctor also uses blood tests to che

 

How do you use this product?
Always use this medicine exactly as your doctor, pharmacist or nurse has told you. Are you unsure about the correct use? Please contact your doctor, pharmacist or nurse.
How much should you take?
Mantle cell lymphoma (MCL)

The recommended dose of IMBRUVICA is 560 mg once a day.

Chronic lymphocytic leukemia (CLL)/Waldenström disease (macroglobulinemia – WM)

The recommended dose of IMBRUVICA is 420 mg once a day.

Your doctor may adjust your dose.

How do you take this medicine?
Take the tablets by mouth (orally) with a glass of water.
Take the tablets at approximately the same time every day.
Swallow the tablets whole. Do not break or chew them.
Have you taken too much of this medicine?
If you take more IMBRUVICA than you should, see a doctor or go to a hospital straight away. Take the tablets and this leaflet with you.

Did you forget to take this medicine?
If you miss a dose, you can take it as soon as possible on the same day, returning to your normal schedule the next day.
Do not take a double dose to make up for a forgotten dose.
If you are not sure what to do, talk to your doctor, pharmacist or nurse about when to take your next dose.
If you stop taking this medicine

Do not stop taking this medicine unless your doctor tells you to do so.

Do you have any other questions about the use of this medicine? Please contact your doctor, pharmacist or nurse.

imbruvica for sale
imbruvica for sale

 

Possible side effects?
Like all medicines, this medicine can cause side effects, although not everyone gets them. The following side effects may occur with this medicine.

Stop taking IMBRUVICA and tell a doctor immediately if you notice any of the following side effects:

rash with itching and bumps; difficulty breathing; swollen face, lips, tongue or throat – you may be having an allergic reaction to this medicine.

Consult a doctor immediately if you notice any of the following side effects:

Very common (may affect more than 1 in 10 people)

fever , chills, body aches, fatigue, symptoms of a cold or flu , shortness of breath – these may be symptoms of an infection (with a virus, bacteria or fungus). These may include infections of the nose, sinuses or throat (upper respiratory tract infection), or of the lungs or skin
bruising or easier bruising
131

sores in the mouth
feeling dizzy
headache
blockage ( constipation )
nausea or vomiting
disturbed digestion (indigestion)
diarrhea ; your doctor may need to give you fluids and salt or another medicine
skin rash
painful arms or legs
back pain or joint pain
muscle cramps, pain or contraction of the muscles (spasms)
a low number of cells that help your blood to clot (platelets), a very low number of white blood cells – shown in blood tests
an increase in the number or proportion of white blood cells in blood tests
swollen hands, ankles or feet
high bloodpressure
more ‘creatinine’ in the blood.
Common (may affect up to 1 in 10 people)

serious infections throughout the body (blood poisoning)
urinary tract infections
nosebleeds, small red or purple spots caused by bleeding under the skin
blood in the stomach, intestines, stool or urine , heavier periods, or bleeding that you cannot stop from a wound
heart failure
skipping heartbeat, weak or irregular heartbeat (pulse), light-headedness, shortness of breath, chest discomfort (these are symptoms of heart rhythm problems)
a low white blood cell count with fever (febrile neutropenia)
skin cancer that is not melanoma – usually squamous cell or basal cell cancer
blurred vision
redness of the skin
inflammation in the lungs that can cause permanent damage
high levels of ‘uric acid’ in the blood (shown in blood tests); this can cause gout
breaking off the nails
weakness, numbness, tingling or pain in your hands or feet or other parts of the body (peripheral neuropathy).
Uncommon (may affect up to 1 in 100 people)

liver failure, including fatal cases
serious fungal infections
confusion, headache with slurred speech or feeling light-headed – these could be signs of serious internal bleeding in your brain
unusual levels of chemicals – caused by the rapid breakdown of cancer cells – have appeared in the blood during cancer treatment and sometimes even without treatment (tumor lysis syndrome)
allergic reaction, sometimes severe, possibly with swollen face, lip, mouth, tongue or throat, difficulty swallowing or breathing, itchy skin rash (hives)
inflammation of the subcutaneous fatty tissue
temporary loss of the brain or nerves (a mild stroke or TIA). This is because the blood flow in the brain is blocked by a blood clot
bleeding in the eye (in some cases also loss of vision)
cardiac arrest (the heart stops beating)
132 Ibrutinib for sale ( Imbruvica )

abnormally fast heart rate
painful skin ulcers (pyoderma gangrenosum) or red, painful, raised spots on the skin, fever and an increase in white blood cells (these may be signs of acute febrile neutrophilic dermatosis or Sweet’s syndrome).
Rare (may affect up to 1 in 1,000 people)

a greatly increased number of white blood cells that can cause cells to clump together
severe skin rash with blistering and peeling of the skin, especially around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome).
Reporting side effects
If you experience side effects, contact your doctor, pharmacist or nurse. This also applies to possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

 

 

 

How do you store this medicine?
Keep out of the sight and reach of children.

Do not use this medicine after the expiry date. which is stated on the carton after EXP. There is a month and a year. The last day of that month is the expiration date.

This medicine does not require any special storage conditions.

Do not flush medicines down the sink or toilet or throw them in the rubbish bin. Ask your pharmacist what to do with medicines you no longer use. If you dispose of medicines correctly, they are destroyed responsibly and do not end up in the environment.

Additional Information
what chemicals are there in this product?
The active substance in this medicine is ibrutinib.
IMBRUVICA 140 mg film-coated tablets: Each tablet contains 140 mg ibrutinib.
IMBRUVICA 280 mg film-coated tablets: Each tablet contains 280 mg ibrutinib.
IMBRUVICA 420 mg film-coated tablets: Each tablet contains 420 mg ibrutinib.
IMBRUVICA 560 mg film-coated tablets: Each tablet contains 560 mg ibrutinib.
The other ingredients in this medicine are:
Tablet core: colloidal anhydrous silica, croscarmellose sodium, lactose monohydrate (see section 2 ‘IMBRUVICA contains lactose’), magnesium stearate, microcrystalline cellulose, povidone, sodium lauryl sulphate (E487).
Tablet coating: polyvinyl alcohol, macrogol, talc, titanium dioxide (E171); IMBRUVICA 140 mg and IMBRUVICA 420 mg film-coated tablets also contain black iron oxide (E172) and yellow iron oxide (E172);
IMBRUVICA 280 mg film-coated tablets also contain black iron oxide (E172) and red iron oxide (E172);
IMBRUVICA 560 mg film-coated tablets also contain red iron oxide (E172) and yellow iron oxide (E172).
What does IMBRUVICA look like and how much does the pack contain?
IMBRUVICA 140 mg film-coated tablets
Yellow-green to green round tablets (9 mm), with ‘ibr’ on one side and ‘140’ on the other side. Each 28 day carton contains 28 film-coated tablets in 2 cardboard wallets of each

133

14 film-coated tablets. Each 30 day carton contains 30 film-coated tablets in 3 cardboard wallets of 10 film-coated tablets each.

IMBRUVICA 280 mg film-coated tablets
Purple oblong tablets (15 mm long and 7 mm wide), debossed with ‘ibr’ on one side and ‘280’ on the other side. Each 28 day carton contains 28 film-coated tablets in 2 cardboard wallets of 14 film-coated tablets each. Each 30 day carton contains 30 film-coated tablets in 3 cardboard wallets of 10 film-coated tablets each.

IMBRUVICA 420 mg film-coated tablets
Yellow-green to green oblong tablets (17.5 mm long and 7.4 mm wide), debossed with ‘ibr’ on one side and ‘420’ on the other side. Each 28 day carton contains 28 film-coated tablets

2 cardboard wallets of 14 film-coated tablets each. Each 30 day carton contains 30 film-coated tablets in 3 cardboard wallets of 10 film-coated tablets each.

IMBRUVICA 560 mg film-coated tablets
Yellow to orange oblong tablets (19 mm long and 8.1 mm wide), debossed with ‘ibr’ on one side and ‘560’ on the other side. Each 28 day carton contains 28 film-coated tablets in 2 cardboard wallets of 14 film-coated tablets each. Each 30 day carton contains 30 film-coated tablets

 

 

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