Ibrunib
Generic Name
Ibrutinib
Manufacturer
Janssen Biotech, Inc. / Pharmacyclics LLC (an AbbVie company)
Country
United States
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
ibrunib 140 mg capsule | ৳ 320.00 | ৳ 19,200.00 |
Description
Overview of the medicine
Ibrutinib is an oral, small-molecule inhibitor of Bruton's tyrosine kinase (BTK). It is used to treat certain B-cell malignancies by blocking the signaling pathways essential for B-cell survival and proliferation.
Uses & Indications
Dosage
Adults
CLL/SLL, WM, cGVHD: 420 mg (3 x 140 mg capsules) orally once daily. MCL: 560 mg (4 x 140 mg capsules) orally once daily. Administer at approximately the same time each day.
Elderly
No specific dose adjustment required based on age; monitor for tolerability.
Renal_impairment
No dose adjustment for mild to moderate renal impairment. Data limited for severe renal impairment or end-stage renal disease (ESRD) requiring dialysis.
How to Take
Take orally once daily with a glass of water, at approximately the same time each day, with or without food. Do NOT open, break, or chew the capsules.
Mechanism of Action
Ibrutinib is a potent, selective, irreversible inhibitor of Bruton's tyrosine kinase (BTK). BTK is a key signaling molecule of the B-cell antigen receptor (BCR) and cytokine receptor pathways. By forming a covalent bond with a cysteine residue in the BTK active site, ibrutinib inhibits BTK enzymatic activity, leading to inhibition of B-cell proliferation and survival.
Pharmacokinetics
Onset
Not immediately defined; therapeutic effects are observed over weeks to months.
Excretion
Primarily excreted in feces (80%), with a small amount excreted in urine (10%).
Half life
Approximately 4-6 hours (effective half-life due to irreversible binding).
Absorption
Rapidly absorbed with peak plasma concentrations occurring 1-2 hours after oral administration. Bioavailability is approximately 2.9% (low due to first-pass metabolism).
Metabolism
Primarily metabolized by cytochrome P450 3A (CYP3A) in the liver. Major metabolites are less active than the parent drug.
Side Effects
Contraindications
- Known hypersensitivity to Ibrutinib or any excipients.
- Co-administration with strong CYP3A inhibitors (e.g., ketoconazole, clarithromycin, ritonavir) is contraindicated due to increased exposure to Ibrutinib. If moderate CYP3A inhibitors are used, dose reduction is recommended.
Drug Interactions
Anticoagulants/Antiplatelets
Increased risk of bleeding; monitor closely.
Moderate CYP3A Inhibitors (e.g., erythromycin, diltiazem, verapamil)
Reduce Ibrutinib dose by 50%.
Strong CYP3A Inducers (e.g., rifampin, carbamazepine, St. John's Wort)
Avoid concomitant use as it may decrease Ibrutinib exposure and efficacy.
Strong CYP3A Inhibitors (e.g., ketoconazole, clarithromycin, ritonavir)
Concomitant use is contraindicated. Avoid grapefruit and Seville oranges.
Storage
Store at room temperature (20°C to 25°C), excursions permitted to 15°C to 30°C. Keep in the original container to protect from moisture. Do not remove desiccant.
Overdose
There is no specific antidote for Ibrutinib overdose. Management should consist of general supportive measures, including monitoring for adverse reactions and providing appropriate symptomatic treatment.
Pregnancy & Lactation
Pregnancy: May cause fetal harm. Advise pregnant women of potential risk to a fetus. Lactation: Unknown if Ibrutinib is excreted in human milk. Due to potential for serious adverse reactions in breastfed infants, advise women not to breastfeed during treatment and for 1 month after the last dose.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24-36 months from manufacture date; check specific packaging.
Availability
Hospital pharmacies, specialized oncology pharmacies
Approval Status
FDA approved (initially in 2013)
Patent Status
Patent protected
Clinical Trials
Extensive clinical trials (e.g., RESONATE, RESONATE-2, HELIOS, PCYC-1104, PCYC-1115) have demonstrated Ibrutinib's efficacy and safety across multiple indications, leading to its global approvals.
Lab Monitoring
- Complete Blood Count (CBC) with differential (monthly or more frequently if clinically indicated).
- Liver function tests (LFTs) periodically.
- Renal function tests periodically.
Doctor Notes
- Counsel patients on potential bleeding events and signs of infection.
- Monitor CBC, LFTs, and renal function regularly.
- Review concomitant medications for potential drug interactions, especially CYP3A inhibitors/inducers.
- Advise patients to report any new onset atrial fibrillation or symptoms of cardiac events.
Patient Guidelines
- Take Ibrutinib exactly as prescribed by your doctor.
- Do not open, crush, or chew the capsules.
- Report any signs of bleeding, infection, or cardiac events immediately.
- Avoid grapefruit and Seville oranges.
- Inform your doctor about all other medications, supplements, and herbal products you are taking.
Missed Dose Advice
If a dose is missed, take it as soon as you remember on the same day. Do not take two doses to make up for a missed dose. Return to your regular dosing schedule the next day.
Driving Precautions
Ibrutinib may cause fatigue, dizziness, or blurred vision. Patients should exercise caution when driving or operating machinery until they know how the medication affects them.
Lifestyle Advice
- Maintain good hydration.
- Practice good hygiene to reduce infection risk.
- Avoid activities that may increase bleeding risk.
- Monitor blood pressure regularly if advised.
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International brand names for this medicine
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