Ibrutinib
This page provides a quick overview of the drug Ibrutinib, including what it's used for, how to take it, how it works, available brand names with their strengths, important warnings, and common side effects.
Context and Approval Date
The U.S. FDA approved Ibrutinib on November 13, 2013, as the first Bruton tyrosine kinase (BTK) inhibitor for treating several types of blood cancer.
Mechanism of Action of Ibrutinib
Ibrutinib capsule is a type of targeted cancer treatment known as a biological agent. It belongs to a group of medicines called Bruton tyrosine kinase (BTK) inhibitors, which are part of the broader class known as kinase inhibitors. BTK is a protein that plays a key role in the growth and survival of certain B-cell cancers like chronic lymphocytic leukemia. Ibrutinib blocks the activity of BTK, which helps stop the signals that cancer cells need to grow. As a result, the number of cancer cells decreases and the disease progresses more slowly.
All Substitutes
View All| Product | Packaging Size | Manufacturer | Price |
|---|---|---|---|
| Nitib 140mg capsule | 30 capsule | Hetero Helathcare | INR 6200 |
| Tybriva 140mg capsule | 30 capsule | Emcure Pharmaceuticals | INR 8000 |
| Bdbrut 140mg capsule | 30 capsules | BDR Pharmaceuticals | INR 5500 |
| Ibrunat 140mg capsule | 30 tablet | Natco Pharma | INR 7400 |
| Ibrushil 140mg capsule | 30 tablet | Shilpa Medicare | INR 6500 |
Uses of Ibrutinib
Ibrutinib capsules are used to treat several types of blood cancers, including chronic lymphocytic leukemia (CLL), mantle cell lymphoma, Waldenström’s macroglobulinemia, small lymphocytic lymphoma (SLL), and chronic graft-versus-host disease (cGVHD).
Ibrutinib administration guidelines and available dosage options
The usual recommended dose of Ibrutinib is one 140 mg capsule taken once a day. Swallow the capsule whole with water—do not open, chew, or dissolve it. Try to take it at the same time every day, with or without food. Your doctor will decide the exact dose and how often you should take it, depending on your specific medical condition, as it can vary from person to person.
Information about Ibrutinib
Ibrutinib is used to treat certain types of blood cancer, including chronic lymphocytic leukemia (CLL) and mantle cell lymphoma. It is also prescribed for patients with CLL who have already received at least one previous treatment or those with a specific genetic change called 17p deletion.
How Ibrutinib works
Ibrutinib is a Bruton's tyrosine kinase (BTK) inhibitor. It works by blocking a faulty protein that sends signals for cancer cells to grow and multiply. By stopping this signal, Ibrutinib helps slow down or stop the spread of cancer cells.Common side effects of Ibrutinib
Fever, Headache, Fatigue, Musculoskeletal (bone, muscle or joint) pain, Rash, Anemia (low number of red blood cells), Bruising, Muscle spasm, Hemorrhage, Pneumonia, Cough, Diarrhea, Stomatitis (Inflammation of the mouth), Nausea, Low blood platelets, Decreased white blood cell count (neutrophils), Dry eye, High blood pressure, Weight loss, Urinary tract infection, Peripheral edema, Subdural hematoma, Second primary malignanciesWarning, Precautions, and Side Effects Associated with Ibrutinib
Warning
Contact your doctor right away if you notice any bleeding, signs of infection, shortness of breath, or chest discomfort. During Ibrutinib treatment, your doctor will regularly check your blood to help prevent serious side effects. Make sure to inform your doctor if you have a history of heart failure or hepatitis infection. Do not take Ibrutinib before or after surgery, as it may slow down wound healing. Seek immediate medical help if you have trouble breathing or experience any unusual bleeding.Precautions
Talk to your doctor if you are pregnant or planning to become pregnant, as Ibrutinib may harm an unborn baby. Discuss safe birth control options with your healthcare provider and use them during treatment and for at least one month after your last dose. Avoid breastfeeding during treatment and for one week after finishing Ibrutinib, since it’s not known if the medicine passes into breast milk.Side Effects
Common side effects of Ibrutinib may include diarrhea, tiredness, rash, bruising, muscle or bone pain, anemia, fever, mouth sores, headache, stomach pain, and pneumonia. If you experience a fast or irregular heartbeat, dizziness, chest discomfort, or trouble breathing, contact your doctor right away.Word Of Advice
If you feel weak, dizzy, or very tired, avoid driving or using machines. Tell your doctor if you are taking blood-thinning medicines, as Ibrutinib can increase your risk of bleeding. Use sun protection and see a dermatologist regularly to help lower the risk of skin cancer. Drink plenty of water during treatment to stay hydrated.FAQ - Ibrutinib
1Are there any special precautions to follow during or before Ibrutinib treatment?
2Is it safe to undergo surgery during the treatment with Ibrutinib Capsule?
It is generally not safe to have surgery while taking Ibrutinib. This medicine can increase the risk of bleeding and slow down wound healing. Your doctor will likely advise you to stop Ibrutinib before surgery and wait until your body has healed before starting it again. Always talk to your doctor well in advance if you need surgery during your treatment.
3What can you expect from Patient Assistance Program?
A Patient Assistance Program helps patients get access to medicines like Ibrutinib, especially if they have trouble affording the cost. Through the program, you may receive:
Free or discounted medication
Support with insurance paperwork and approvals
Guidance on how to use the medicine safely
Help with managing side effects and treatment questions
Access to educational resources and counseling
These programs aim to make treatment easier and more affordable for patients. If you want, I can help you find out if you qualify for a specific Patient Assistance Program.
4Should you stop taking Ibrutinib once your blood reports are normal?
No, you should not stop taking Ibrutinib just because your blood tests look normal. Always follow your doctor’s advice about how long to continue the treatment. Even if your blood reports improve, stopping the medication early can allow the cancer to come back or get worse. Your doctor will decide the right time to stop or adjust your treatment based on your overall health and progress.
5What are the common side effects of Ibrutinib?
Common side effects of Ibrutinib include:
Diarrhea
Tiredness or fatigue
Rash
Bruising
Muscle and bone pain
Anemia (low red blood cells)
Fever
Mouth sores
Headache
Stomach pain
Pneumonia
If you notice any serious symptoms like a fast or irregular heartbeat, dizziness, chest pain, or difficulty breathing, contact your doctor immediately.
6What foods should you avoid during treatment with Ibrutinib?
During treatment with Ibrutinib, it’s best to avoid:
Grapefruit and grapefruit juice — they can affect how the medicine works in your body.
Seville oranges, pomelos, and other citrus fruits similar to grapefruit for the same reason.
Alcohol, or limit it, as it may increase side effects or affect your liver.
Foods that increase bleeding risk, like excessive garlic or ginger supplements, especially if you’re taking blood thinners.
7Ibrutinib package insert
1. Indications and Usage
Lists the diseases ibrutinib is approved to treat, such as:
Chronic lymphocytic leukemia (CLL)
Mantle cell lymphoma (MCL)
Waldenström's macroglobulinemia (WM)
Marginal zone lymphoma (MZL)
Chronic graft-versus-host disease (cGVHD)
2. Dosage and Administration
Recommended dose and frequency
Special instructions for missed doses
Dose adjustments for liver impairment or side effects
3. Dosage Forms and Strengths
Available as capsules or tablets (commonly 140 mg, 280 mg, etc.)
4. Contraindications
Situations where ibrutinib should not be used (e.g., known allergy)
Warnings and Precautions
Risk of bleeding, infections, atrial fibrillation, hypertension, second primary malignancies
6. Adverse Reactions (Side Effects)
Most common side effects: diarrhea, fatigue, musculoskeletal pain, rash
Serious side effects: bleeding, infections, heart rhythm problems
7. Drug Interactions
Interactions with CYP3A inhibitors/inducers (like ketoconazole or rifampin)
8. Use in Specific Populations
Pregnancy, breastfeeding, pediatric, and geriatric use
9. Clinical Pharmacology
How the drug works (mechanism of action as a BTK inhibitor)
Absorption, metabolism, and excretion details
10. Clinical Studies
Summary of key clinical trials supporting approval
11. Storage and Handling
Recommended storage conditions and packaging
8ibrutinib cll
Ibrutinib is a targeted therapy used to treat Chronic Lymphocytic Leukemia (CLL), including CLL with 17p deletion, which is a high-risk genetic subtype.
How Ibrutinib Works in CLL
Ibrutinib is a Bruton’s tyrosine kinase (BTK) inhibitor. It blocks BTK, a protein that plays a crucial role in the survival and proliferation of B-cells — the type of cells that become cancerous in CLL.
By inhibiting BTK:It disrupts cancer cell signaling
Slows or stops the growth of CLL cells
Promotes apoptosis (cell death)
✅ FDA-Approved Uses in CLL
1. First-line treatment for CLL/SLL (small lymphocytic lymphoma)
2. Treatment of CLL with 17p deletion
3. Used alone or in combination with other drugs such as:Obinutuzumab (anti-CD20 antibody)
Rituximab (another anti-CD20 antibody)
💊 Typical Dosing for CLL
420 mg orally once daily
Taken until disease progression or unacceptable toxicity
Should be taken at the same time every day with a glass of water (do not crush/chew)
⚠️ Common Side Effects
Diarrhea
Fatigue
Muscle and joint pain
Bruising and bleeding
Infections (especially upper respiratory)
Atrial fibrillation
Hypertension
Rash
🔄 Monitoring During Treatment
Doctors monitor:
Blood counts
ECG (for heart rhythm)
Signs of infection or bleeding
Blood pressure
🧬 CLL with 17p Deletion
Patients with del(17p) often respond poorly to chemotherapy
Ibrutinib is especially effective in this group, making it a preferred first-line treatment
By inhibiting BTK:
2. Treatment of CLL with 17p deletion
3. Used alone or in combination with other drugs such as:
9ibrutinib side effects
Ibrutinib has a well-known side effect profile that healthcare providers monitor closely. It’s important to understand that while some side effects are mild and manageable, others can be serious and require medical attention.
Common Side Effects These occur in many patients but are often manageable:
Diarrhea
Fatigue
Muscle/bone pain
Nausea
Bruising
Rash
Decreased appetite
Cough or URTI
Common Side Effects These occur in many patients but are often manageable:
10ibrutinib cost
ibrutinib cost
ibrutinib cost is INR 620011ibrutinib brand name
ibrutinib brand name
References
pil.10040.pdf
PMC4103574/pdf/ptj3907483.pdf
