Palbocent
Generic Name
Palbociclib
Manufacturer
Bicon Biotechnology (India)
Country
India
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| palbocent 125 mg capsule | ৳ 400.00 | ৳ 2,800.00 |
Description
Overview of the medicine
Palbocent is a brand name for Palbociclib, an oral selective inhibitor of cyclin-dependent kinases (CDK) 4 and 6, indicated for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant.
Uses & Indications
Dosage
Adults
125 mg orally once daily for 21 consecutive days, followed by 7 days off, constituting a complete 28-day cycle. Continue treatment as long as the patient is deriving clinical benefit or until unacceptable toxicity occurs.
Elderly
No dose adjustment is required for elderly patients (≥65 years).
Renal_impairment
Mild to moderate renal impairment: No dose adjustment. Severe renal impairment: Reduce dose to 75 mg once daily for 21 days on, 7 days off.
How to Take
Take orally once daily with food, ideally at the same time each day. Swallow capsules whole. Do not chew, crush, or open capsules.
Mechanism of Action
Palbociclib inhibits cyclin-dependent kinases (CDK) 4 and 6, which are involved in cell cycle progression. By inhibiting CDK4/6, palbociclib prevents the phosphorylation of retinoblastoma protein (Rb), leading to a cell cycle arrest in the G1 phase and reducing cell proliferation.
Pharmacokinetics
Onset
Pharmacodynamic effects (Rb phosphorylation inhibition) can be observed within hours, but clinical anti-tumor activity onset varies.
Excretion
Mainly excreted in feces (74% of dose) and urine (17% of dose), predominantly as metabolites.
Half life
Approximately 29 hours
Absorption
Rapidly absorbed, with peak plasma concentrations (Tmax) generally reached 6 to 12 hours post-dose. High-fat, high-calorie food increases exposure.
Metabolism
Extensively metabolized, primarily by cytochrome P450 (CYP) 3A and sulfotransferase (SULT) 2A1.
Side Effects
Contraindications
- •Known hypersensitivity to palbociclib or any excipient.
- •Severe hepatic impairment or end-stage renal disease without dose adjustment.
Drug Interactions
Strong CYP3A inducers (e.g., rifampin, phenytoin, St. John's wort)
Avoid concomitant use.
Strong CYP3A inhibitors (e.g., ketoconazole, itraconazole, clarithromycin)
Avoid concomitant use, or reduce palbociclib dose.
Storage
Store at controlled room temperature (20°C to 25°C), excursions permitted to 15°C to 30°C. Protect from moisture.
Overdose
There is no specific antidote for palbociclib overdose. In the event of an overdose, symptomatic and supportive treatment should be initiated. Monitor for neutropenia and other adverse reactions.
Pregnancy & Lactation
Based on animal studies and its mechanism of action, palbociclib can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to the fetus. It is unknown if palbociclib is excreted in human milk; advise women not to breastfeed during treatment.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 months
Availability
Available in specialty pharmacies and hospitals
Approval Status
FDA Approved
Patent Status
Patented (original innovator)
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