Palbokin
Generic Name
Palbociclib
Manufacturer
Different manufacturers produce generic Palbociclib. (e.g., Pfizer for Ibrance)
Country
Varies by manufacturer, generally USA/Europe for original, India/Bangladesh for generics.
Loading images...
Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| palbokin 125 mg capsule | ৳ 400.00 | ৳ 2,800.00 |
Description
Overview of the medicine
Palbociclib is an oral medication used in combination with an aromatase inhibitor or fulvestrant to treat hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer.
Uses & Indications
Dosage
Adults
125 mg orally once daily for 21 consecutive days, followed by 7 days off treatment (28-day cycle). This regimen is continued as long as the patient is benefiting from therapy or until unacceptable toxicity occurs. It should be taken with food.
Elderly
No specific dose adjustment is required based on age, but monitor for adverse reactions.
Renal_impairment
No dose adjustment is required for mild or moderate renal impairment. For severe renal impairment, a reduced starting dose may be considered.
How to Take
Take orally once daily with food, preferably at the same time each day. Do not chew, crush, or open the capsules. If a capsule is damaged, do not take it.
Mechanism of Action
Palbociclib is a reversible inhibitor of cyclin-dependent kinases (CDK) 4 and 6. These kinases play a crucial role in cell cycle progression from G1 to S phase. By inhibiting CDK4/6, palbociclib prevents cancer cell proliferation and tumor growth.
Pharmacokinetics
Onset
Not acutely measured; therapeutic effect develops over time with cell cycle arrest.
Excretion
Excreted mainly via feces (74%) with a minor portion via urine (17%).
Half life
Approximately 29 hours.
Absorption
Tmax typically 6-12 hours. Absorption is increased by approximately 21% when taken with food.
Metabolism
Primarily hepatic metabolism by CYP3A and SULT2A1. Forms several metabolites, most are inactive.
Side Effects
Contraindications
- Known hypersensitivity to palbociclib or any component of the formulation.
Drug Interactions
CYP3A substrates (e.g., midazolam, alfentanil, cyclosporine)
Palbociclib may increase exposure to sensitive CYP3A substrates. Exercise caution.
Strong CYP3A inhibitors (e.g., ketoconazole, clarithromycin, ritonavir)
Concomitant use significantly increases palbociclib exposure. Dose reduction of palbociclib is required.
Strong CYP3A inducers (e.g., rifampin, phenytoin, carbamazepine, St. John's Wort)
Concomitant use significantly decreases palbociclib exposure, reducing efficacy. Avoid concomitant use.
Storage
Store at room temperature (20°C to 25°C), away from moisture and heat. Keep out of reach of children.
Overdose
No specific antidote for palbociclib overdose is known. In case of an overdose, discontinue palbociclib and provide general supportive care. Monitor for severe myelosuppression and other toxicities.
Pregnancy & Lactation
Palbociclib can cause fetal harm. Women of reproductive potential should use effective contraception during treatment and for at least 3 weeks after the last dose. Advise against breastfeeding during treatment and for 3 weeks after the last dose.
Side Effects
Contraindications
- Known hypersensitivity to palbociclib or any component of the formulation.
Drug Interactions
CYP3A substrates (e.g., midazolam, alfentanil, cyclosporine)
Palbociclib may increase exposure to sensitive CYP3A substrates. Exercise caution.
Strong CYP3A inhibitors (e.g., ketoconazole, clarithromycin, ritonavir)
Concomitant use significantly increases palbociclib exposure. Dose reduction of palbociclib is required.
Strong CYP3A inducers (e.g., rifampin, phenytoin, carbamazepine, St. John's Wort)
Concomitant use significantly decreases palbociclib exposure, reducing efficacy. Avoid concomitant use.
Storage
Store at room temperature (20°C to 25°C), away from moisture and heat. Keep out of reach of children.
Overdose
No specific antidote for palbociclib overdose is known. In case of an overdose, discontinue palbociclib and provide general supportive care. Monitor for severe myelosuppression and other toxicities.
Pregnancy & Lactation
Palbociclib can cause fetal harm. Women of reproductive potential should use effective contraception during treatment and for at least 3 weeks after the last dose. Advise against breastfeeding during treatment and for 3 weeks after the last dose.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years, check product packaging for exact date.
Availability
Available in pharmacies and specialized oncology centers.
Approval Status
FDA Approved
Patent Status
Patent protected (original molecule by Pfizer, brand Ibrance). Generics may be available after patent expiry or via compulsory licensing.
Clinical Trials
Key trials include PALOMA-1, PALOMA-2, and PALOMA-3, which demonstrated significant improvement in progression-free survival in HR+, HER2- metastatic breast cancer patients.
Lab Monitoring
- Complete Blood Count (CBC) with differential before starting treatment, every 2 weeks for the first 2 cycles, then prior to the beginning of each cycle, and as clinically indicated.
- Monitor liver function tests (LFTs) periodically.
- Monitor renal function tests periodically.
Doctor Notes
- Emphasize strict adherence to the 21-day on, 7-day off schedule.
- Monitor CBCs rigorously, especially during the initial cycles, and manage neutropenia with dose interruptions or reductions as needed.
- Counsel patients on reporting signs of infection, pulmonary symptoms, and potential drug interactions.
Patient Guidelines
- Take palbociclib capsules once daily with food for 21 days, followed by 7 days off, to complete a 28-day cycle. Repeat cycles as prescribed.
- Do not chew, crush, or open capsules. Swallow whole.
- Report any signs of infection (fever, chills), unusual bleeding or bruising, or difficulty breathing immediately to your doctor.
Missed Dose Advice
If a dose is missed or vomiting occurs after taking a dose, do not take an additional dose. The next dose should be taken at the regularly scheduled time.
Driving Precautions
This medicine may cause fatigue, dizziness, or blurred vision. Patients should be cautious when driving or operating machinery until they know how palbociclib affects them.
Lifestyle Advice
- Maintain good hygiene to reduce infection risk due to neutropenia.
- Avoid grapefruit and grapefruit juice while on this medication.
- Use effective contraception if you are a woman of reproductive potential, or if you are a male patient with a female partner of reproductive potential.
Alternative Medicines in Bangladesh
Similar medicines available in the market
Global Brand Names
International brand names for this medicine. Click a brand to search for detailed information.