Ibrutinib

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Generic Name: Ibrutinib Brand Name(s): Generics only. No brands available. Avability: Rx Pregnancy Category: N

Uses

What is Ibrutinib used for?

Ibrutinib is used to treat certain cancers (such as mantle cell lymphoma, chronic lymphocytic leukemia, Waldenstrom’s macroglobulinemia). Ibrutinib belongs to a class of drugs known as kinase inhibitors. It works by slowing or stopping the growth of cancer cells.

Ibrutinib is also used to treat a certain problem that may occur after a stem cell transplant (chronic graft versus host disease). It works by weakening your body’s defense system (immune system).

How should I take Ibrutinib?

Take this medication by mouth with a full glass of water (240 milliliters) as directed by your doctor, usually once daily. Swallow the capsules and tablets whole. Do not open, break, or chew the capsules. Do not cut, crush, or chew the tablets. Drink plenty of fluids while taking ibrutinib unless otherwise directed by your doctor.

The dosage is based on your medical condition, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Do not increase your dose or take this medication more often than prescribed. Your condition will not improve any faster, and your risk of serious side effects will increase.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the capsules.

How do I store Ibrutinib?

Ibrutinib is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Ibrutinib in the bathroom or the freezer. There may be different brands of Ibrutinib that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Ibrutinib down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Ibrutinib?

Before taking ibrutinib, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood/bleeding problems, heart problems (such as fast/irregular heartbeat, previous heart attack), high blood pressure, kidney problems, liver problems, high levels of uric acid in the blood.

Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Your doctor may tell you to temporarily stop treatment with this medication before certain medical, surgical, or dental procedures.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the capsules.

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while you are taking ibrutinib. Ibrutinib may harm an unborn baby. Men and women should ask about reliable forms of birth control while taking this medication and for 1 month after stopping treatment. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Ibrutinib during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Ibrutinib. Ibrutinib is pregnancy risk category N according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Ibrutinib?

Upset stomach, diarrhea, nausea, vomiting, decreased appetite, headache, joint/muscle pain, swelling of ankles/legs/feet, numbness/tingling of arms/legs, anxiety, constipation, dizziness, or tiredness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high. Your doctor may control your blood pressure with medication.

Tell your doctor right away if you have any serious side effects, including: easy bruising/bleeding, dark/tarry/bloody stools, fast/irregular/pounding heartbeat, signs of low red blood cell count (such as rapid breathing, pale skin, shortness of breath).

Ibrutinib sometimes causes side effects due to the rapid destruction of cancer cells (tumor lysis syndrome). To lower your risk, your doctor may add a medication and tell you to drink plenty of fluids. Tell your doctor right away if you have symptoms such as: low back/side pain (flank pain), signs of kidney problems (such as painful urination, pink/bloody urine, change in the amount of urine), muscle spasms/weakness.

This medication may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infection (such as fever, chills, persistent sore throat, cough).

Very rarely, people taking this medication have developed other cancers (including skin cancer). Consult your doctor for more details.

Get medical help right away if you have any very serious side effects, including: chest pain, signs of bleeding in the brain (such as fainting, sudden vision changes, severe nausea, seizures, confusion).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Ibrutinib?

Some products that may interact with this drug are: other drugs that can cause bleeding/bruising (such as antiplatelet drugs like clopidogrel, NSAIDs like ibuprofen/naproxen, “blood thinners” like warfarin/dabigatran).

Aspirin can increase the risk of bleeding when used with this medication. However, if your doctor has directed you to take low-dose aspirin for heart attack or stroke prevention (usually at dosages of 81-325 milligrams a day), you should continue taking it unless your doctor instructs you otherwise. Ask your doctor or pharmacist for more details.

Other medications can affect the removal of ibrutinib from your body, which may affect how ibrutinib works. Examples include azole antifungals (such as itraconazole, ketoconazole), boceprevir, nefazodone, St. John’s wort, telaprevir, HIV protease inhibitors (such as ritonavir, saquinavir), macrolide antibiotics (such as erythromycin, clarithromycin), rifamycins (such as rifampin, rifabutin), certain drugs used to treat seizures (such as carbamazepine, phenytoin), among others.

Ibrutinib may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Ibrutinib?

Ibrutinib may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor or pharmacist says you may do so safely. Also avoid eating Seville oranges (often found in marmalade). Grapefruit and Seville oranges can increase the chance of side effects with this medicine. Ask your doctor or pharmacist for more details.

This drug may make you dizzy. Alcohol or marijuana can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana.

What health conditions may interact with Ibrutinib?

Ibrutinib may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Ibrutinib can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Ibrutinib.

What is the dose of Ibrutinib for an adult?

Usual Adult Dose for Lymphoma

Mantle Cell Lymphoma (MCL) OR Marginal Zone Lymphoma (MZL): 560 mg orally once a day

Duration of Therapy: Until disease progression or unacceptable toxicity

Uses:

-Treatment of MCL patients who have received at least one prior therapy

-Treatment of MZL patients who require systemic therapy and have received at least one prior anti-CD20-based therapy

Usual Adult Dose for Chronic Lymphocytic Leukemia

Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL):

-Monotherapy: 420 mg orally once a day

-In Combination with Bendamustine and Rituximab: 420 mg orally once a day every 28 days for up to 6 cycles

Duration of Therapy: Until disease progression or unacceptable toxicity

Use: Treatment of CLL/SLL patients with or without 17p deletion

Usual Adult Dose for non-Hodgkin’s Lymphoma

Waldenstrom’s Macroglobulinemia (WM) OR Chronic Graft Versus Host Disease (cGVHD): 420 mg orally once a day

Duration of Therapy:

-WM: Until disease progression or unacceptable toxicity

-cGVHD: Until disease progression, recurrence of an underlying malignancy, or unacceptable toxicity

Comments:

-WM: Management of hyperviscosity may include plasmapheresis before and during treatment with this drug, which will not require dosing modifications.

-cGVHD: When a patient no longer requires treatment, discontinue this drug considering the medical assessment of the individual patient

Uses:

-Treatment of WM patients

-Treatment of cGVHD patients after failure of one or more lines of systemic therapy

Usual Adult Dose for Graft Versus Host Disease

Waldenstrom’s Macroglobulinemia (WM) OR Chronic Graft Versus Host Disease (cGVHD): 420 mg orally once a day

Duration of Therapy:

-WM: Until disease progression or unacceptable toxicity

-cGVHD: Until disease progression, recurrence of an underlying malignancy, or unacceptable toxicity

Comments:

-WM: Management of hyperviscosity may include plasmapheresis before and during treatment with this drug, which will not require dosing modifications.

-cGVHD: When a patient no longer requires treatment, discontinue this drug considering the medical assessment of the individual patient

Uses:

-Treatment of WM patients

-Treatment of cGVHD patients after failure of one or more lines of systemic therapy

Renal Dose Adjustments

-Mild and Moderate Renal Impairment (CrCl 25 mL/min or greater): No dose adjustments recommended

-Severe Renal Impairment (CrCl less than 25 mL/min): Data not available

Liver Dose Adjustments

-Mild Hepatic Impairment (Child-Pugh A): Data not available

-Moderate or Severe Hepatic Impairment (Child-Pugh B or C): Not recommended

Dose Adjustments

ADVERSE REACTIONS:

Any Grade 3 or Greater Non-Hematological Toxicity, Grade 3 or Greater Neutropenia with Infection or Fever, OR Grade 4 Hematological Toxicity:

-Toxicity Occurs: Interrupt dosing of this drug.

-Once Toxicity Symptoms Resolve to Grade 1 or Baseline: Reinitiate this drug at the initial dose.

-If Toxicity Recurs: Reduce dose by 140 mg, and consider a second 140 mg dose reduction as needed.

-If Toxicity Persists or Recurs Following 2 Dose Reductions: Discontinue this drug.

CONCOMITANT USE WITH CYP450 3A4 INHIBITORS:

Patients with B-Cell Malignancies:

-Concomitant Administration of Moderate CYP450 3A Inhibitor, Posaconazole 200 mg Twice a Day or Less, OR Voriconazole at Any Dose: Reduce dose to 140 mg orally once a day; interrupt dose as recommended.

-Concomitant Administration of Strong CYP450 3A Inhibitor, Posaconazole at Doses Greater Than 200 mg Twice a Day, OR Voriconazole at Any Dose: Avoid concomitant use OR interrupt dosing of this drug IF concomitant inhibitors will be used short-term (e.g., anti-infectives for 7 days or less).

Patients with Chronic Graft Versus Host Disease:

-Concomitant Administration of Moderate CYP450 3A Inhibitor: Administer usual dose (420 mg orally once a day); modify dose as recommended.

-Concomitant Administration of Posaconazole Immediate-Release (IR) Tablet 200 mg Twice a Day or Posaconazole Delayed-Release (DR) Tablet 300 mg Every Day OR Voriconazole at Any Dose: Reduce dose to 280 mg orally once a day; modify dose as recommended.

-Concomitant Administration of Strong CYP450 3A Inhibitor OR Posaconazole at Doses Greater Than IR Tablet 200 mg Twice a Day/DR Tablet 300 mg Every Day: Avoid concomitant use OR interrupt dosing of this drug IF concomitant inhibitors will be used short-term (e.g., anti-infectives for 7 days or less).

Other Comments

Administration Advice:

-Administer this drug at approximately the same time each day.

-Instruct patients to swallow drug capsules whole with water, and not to open, break, or chew the capsules.

-Administer a missed dose as soon as possible on the same day with a return to the normal dosing schedule the following day; do not administer extra capsules to make up the missed dose.

Storage Requirements:

-Store drug bottles at room temperature (20 to 25 degrees Celsius/68 to 77 degrees Fahrenheit); excursions are permitted between 15 and 30 degrees Celsius/59 to 86 degrees Fahrenheit.

-Retain in original packaging until dispensing.

General:

-Accelerated approval was granted for treatment of mantle cell lymphoma and marginal zone lymphoma based on overall response rate. Continued approval for these treatment indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

Monitoring:

-Cardiovascular: Signs/symptoms of atrial fibrillation, atrial flutter, ventricular tachyarrhythmia, new onset hypertension or uncontrolled hypertension (during treatment)

-Embryofetal toxicity: Pregnancy status of females of reproductive potential (baseline and during treatment)

-General: Signs of bleeding (during treatment)

-Hematologic: Complete blood counts (monthly); signs/symptoms of leukostasis (during treatment)

-Hepatic: Liver function tests (during treatment)

-Infections/infestations: Fever and infections (during treatment)

-Metabolic: Signs/symptoms of tumor lysis syndrome (during treatment)

-Oncologic: Appearance of non-melanoma skin cancer (during treatment)

-Respiratory: Signs/symptoms of interstitial lung disease

Patient Advice:

-Avoid grapefruit, grapefruit juice, and Seville oranges (often used in marmalades) during treatment.

-This drug may cause side effects such as fatigue and dizziness; avoid driving or other potentially dangerous activities such as operating machinery until you know how this drug affects you.

What is the dose of Ibrutinib for a child?

The dosage has not been established in pediatric patients. It may be unsafe for your child. It is always important to fully understand the safety of the drug before using. Please consult with your doctor or pharmacist for more information.

How is Ibrutinib available?

Ibrutinib is available in the following dosage forms and strengths:

  • Oral tablet,
  • Oral capsule.

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Ibrutinib, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

Hello Health Group does not provide medical advice, diagnosis or treatment.

Review Date: August 14, 2018 | Last Modified: August 14, 2018

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