Ibrutinib is the generic name for the trade drug Imbruvica™. In some cases, health care professionals may use the trade name Imbruvica™ when referring to the generic drug name ibrutinib.
Ibrutinib is a targeted therapy. Ibrutinib inhibits the function of Bruton’s tyrosine kinase (BTK). (For more detail, see “How this drug works,” below.)
What Inbrutinib Is Used For
- Chronic graft-versus-host (cGVHD) disease after failure of one or more prior lines of systemic therapy.
- Chronic lymphocytic leukemia (CLL) who have received at least one prior therapy.
- Mantle cell lymphoma (MCL) who have received at least one prior therapy.
- Marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy.
- Waldenstrom’s macroglobulinemia.
Note: If a drug has been approved for one use, physicians may elect to use this same drug for other problems if they believe it may be helpful.
How Ibrutinib Is Given:
- Ibrutinib is a capsule, taken by mouth once daily. You may take 1-4 capsules at once depending on your prescribed dose.
- Take ibrutinib at approximately the same time each day.
- Take ibrutinib exactly as prescribed.
- Swallow ibrutinib capsules whole with at least 8 ounces of water. Do not crush, open, chew or dissolve capsules.
- Do not change your dose or stop ibrutinib unless your health care provider tells you to.
- If you miss a dose of irbrutinib, it should be taken as soon as possible on the same day with return to the normal schedule the following day. Do not take extra capsules of ibrutinib to make up the next dose.
- Do not take more than 1 dose of ibrutinib at one time. Call your health care provider and go to the emergency room right away if you take too much.
- Store at room temperature (68° F to 77° F); keep medication in original bottle; protect from high humidity, moisture and light.
- Keep out of reach from children and pets.
- Safely throw away any ibrutinib that is out of date or unused (ask your provider for directions on how to discard the medication).
- The amount of ibrutinib that you will receive depends on many factors, including your general health or other health problems, and the type of cancer or condition you have. Your doctor will determine your exact ibrutinib dosage and schedule.
Important things to remember about the side effects of ibrutinib:
- Most people will not experience all of the ibrutinib side effects listed.
- Ibrutinib side effects are often predictable in terms of their onset, duration, and severity.
- Ibrutinib side effects are almost always reversible and will go away after therapy is complete.
- Ibrutinib side effects may be quite manageable. There are many options to minimize or prevent the side effects of ibrutinib.
The following side effects are common (occurring in greater than 30%) for patients taking ibrutinib:
- Decreased platelets
- Decreased neutrophils
- Decreased hemaglobin
- Musculoskeletal pain
- Upper respiratory tract infection
These are less common side effects (occurring in 10-29%) for patients receiving ibrutinib:
- Shortness of breath
- Abdominal pain
- Decreased appetite
- Urinary Tract Infection
- Skin infections
- Muscle spasms
Not all side effects are listed above. Some that are rare (occurring in less than about 10 percent of patients) are not listed here. Always inform your health care provider if you experience any unusual symptoms.
When to contact your doctor or health care provider:
Contact your health care provider immediately, day or night, if you should experience any of the following symptoms:
- Fever of 100.4° F (38° C or higher, chills)
- Shortness of breath, cough or trouble breathing
- Any bleeding that won’t stop
The following symptoms require medical attention, but are not an emergency. Contact your doctor or health care provider within 24 hours of noticing any of the following:
- Diarrhea (4-6 episodes in a 24-hour period).
- Blood in your stools or black stools
- Headache that lasts a long time, confusion, change in your speech
- Nausea (interferes with ability to eat and unrelieved with prescribed medication).
- Vomiting (vomiting more than 4-5 times in a 24 hour period).
- Unable to eat or drink for 24 hours or have signs of dehydration: tiredness, thirst, dry mouth, dark and decrease amount of urine, or dizziness.
- Skin or the whites of your eyes turn yellow
- Urine turns dark or brown (tea color)
- Decreased appetite
- Pain on the right side of your stomach
- Bleed or bruise more easily than normal
- Any skin or nail changes (rash, itching, severe dryness, blisters, nail infection, inflammation of the lips, etc.)
- Cough with or without mucus
- Mouth sores
- Pain or burning with urination
- Extreme fatigue (unable to carry on self-care activities)
Always inform your doctor or health care provider if you experience any unusual symptoms.
- Do not drink grapefruit juice, eat grapefruit or eat Seville oranges (often used in marmalades) while you are taking ibrutinib. These products may increase the amount of ibrutinib in your blood.
- Before starting ibrutinib treatment, make sure you tell your doctor about any other medications you are taking (including prescription, over-the-counter, vitamins, herbal remedies, etc.).
- While taking ibrutinib, do not receive any kind of immunization or vaccination without your doctor’s approval.
- Limit your time in the sun. Ibrutinib can make your skin sensitive to sunlight. A severe sunburn, rash or worsening acne can occur with too much exposure. Remember to use sunscreen and wear a hat and clothes that cover as much of your skin as possible while taking ibrutinib.
- Inform your health care professional if you are pregnant or may be pregnant prior to starting this treatment. Pregnancy category D (may be hazardous to the fetus. Women who are pregnant or become pregnant must be advised of the potential hazard to the fetus.)
- For both men and women: Barrier methods of contraception, such as condoms, are recommended during therapy and for at least 2 weeks after treatment is complete. Discuss with your doctor when you may safely become pregnant or conceive a child after therapy.
- Do not breast feed while taking ibrutinib.
- While taking ibrutinib, drink at least two to three quarts of fluid every 24 hours, unless you are instructed otherwise.
- Wash your hands often and after taking each dose of ibrutinib.
- You may be at risk of infection so try to avoid crowds or people with colds, and report fever or any other signs of infection immediately to your health care provider.
- To help treat/prevent mouth sores while taking ibrutinib, use a soft toothbrush, and rinse three times a day with 1 teaspoon of baking soda mixed with 8 ounces of water.
- Use an electric razor and a soft toothbrush to minimize bleeding.
- Avoid contact sports or activities that could cause injury.
- To reduce nausea, take anti-nausea medications as prescribed by your doctor, and eat small, frequent meals while taking ibrutinib.
- Eat foods that may help reduce diarrhea-see
- Follow regimen of anti-diarrhea medication as prescribed by your health care professional.
- Managing Side Effects – Diarrhea
- Avoid sun exposure. Wear SPF 15 (or higher) sun block and protective clothing. Ibrutinib may make you more sensitive to the sun and you may sunburn more easily.
- In general, drinking alcoholic beverages should be kept to a minimum or avoided completely while you are taking ibrutinib. You should discuss this with your doctor.
- Get plenty of rest.
- Maintain good nutrition while being treated with ibrutinib.
- If you experience symptoms or side effects while being treated with ibrutinib, be sure to discuss them with your health care team. They can prescribe medications and/or offer other suggestions that are effective in managing such problems.
Monitoring and Testing
You will be checked regularly by your doctor while you are taking ibrutinib to monitor side effects and check your response to therapy. Periodic blood work will be obtained to monitor the function of your organs (such as your kidneys and liver) as well as other side effects.
How Ibrutinib Works:
Ibrutinib is not a chemotherapy drug but one of what are termed “targeted therapies.” Targeted therapy is the result of years of research dedicated to understanding the differences between cancer cells and normal cells. To date, cancer treatment has focused primarily on killing rapidly dividing cells because one feature of cancer cells is that they divide rapidly. Unfortunately, some of our normal cells divide rapidly too, causing multiple side effects.
Targeted therapy is about identifying other features of cancer cells. Scientists look for specific differences in the cancer cells and the normal cells. This information is used to create a targeted therapy to attack the cancer cells without damaging the normal cells, thus leading to fewer side effects. Each type of targeted therapy works a little bit differently but all interfere with the ability of the cancer cell to grow, divide, repair and/or communicate with other cells.
Ibrutinib inhibits the function of Bruton’s tyrosine kinase (BTK). BTK is a key signaling molecule of the B-cell receptor signaling complex that plays an important role in the survival of malignant B cells. Ibrutinib blocks signals that stimulate malignant B cells to grow and divide uncontrollably.
Research continues to identify which cancers may be best treated with targeted therapies and to identify additional targets for more types of cancer.
Note: We strongly encourage you to talk with your health care professional about your specific medical condition and treatments. The information contained in this web site is meant to be helpful and educational, but is not a substitute for medical advice.
Follow the following prescription medicine precautions :
|Ibrutinib may be harmful in pregnancy and there is a potential risk of miscarriage or carrying a child with birth defects if you or your partner becomes pregnant during this time. Take proper medical help in case you are pregnant, may be pregnant or planning to become pregnant in the near future.|
|This medicine is not indicated for use in women. It is not known if Ibrutinib is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from Ibrutinib, a decision should be made to either discontinue nursing, or discontinue the drug taking into account the importance of the drug to the mother.|
|Your health care professional may recommend blood tests to see how your body is working. Blood tests help doctors check for certain diseases and conditions. They also help check the function of your organs and show how well treatments are working.|
|Before taking Ibrutinib, tell your doctor and pharmacist if you are allergic to Ibrutinib, any other medications, or any of the ingredients in Ibrutinib tablets. This medicine is not recommended for use in patients with a known allergy to Ibrutinib 140 mg.|
|If you take Ibrutinib, you must stop drinking alcohol. This is one of the ways to prevent this disease from getting worse. If you are dependent on alcohol and want to stop drinking, your doctor can recommend a therapy that’s tailored for your needs.|
|If you use other prescription drugs or over the counter products at the same time, the effects of Ibrutinib may change. Tell your doctor about all the drugs, vitamins, and herbal supplements you are using, so that your pharmacist can help you prevent or manage drug interactions.|
|Missing a dose of Ibrutinib can upset your treatment plan. If you do miss one of your doses, take it as soon as you remember, unless it’s almost time to take your next dose. In this case, you should just skip the missed dose. Don’t take a double dose to “make up” for the one you missed. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.|
|Do not take Ibrutinib the use by (expiry) date printed on the pack. Do not take it if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.|
|During your treatment with Ibrutinib, it is very important for your doctor to know about your medical history if you have Kidney problems, liver problems, HIV, triglycerides, diabetes or other health problems.|
What are the storage instructions for Ibrutinib 140 mg ?
Patients must properly store the drug to retain its quality and efficacy. Following storage instructions will be helpful in storing the drug in the best of manner.
- Store Ibrutinib at 20°C to 25°C (68°F to 77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F).
- Store it in a cool, dry place, protected from light and refrigerated when necessary. Improper storage can affect the effectiveness and shelf life of your medicine.
- Consider storing your medications separately from your other family members. You can put them on a different shelf, or in a different cabinet or drawer.
- If you’re driving, you may want to have certain medicines at hand, but don’t store them in the glove compartment, where they could be damaged from the heat, cold, or rain outside or from the car’s heater or air conditioner.
- Always remember to store your medication out of sight and reach of children and pets, to prevent accidental ingestion.
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The information provided here is for general educational purposes only and does not constitute medical or pharmaceutical advice which should be sought from qualified medical and pharmaceutical advisers.
Remember, keep this and all other medicines out of the reach of children and away from pets, never share your medicines with others, and use this medication only for the indication prescribed.
The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.