Olarigen
Generic Name
Olaparib
Manufacturer
Example Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| olarigen 150 mg tablet | ৳ 833.33 | ৳ 100,000.00 |
Description
Overview of the medicine
Olarigen (Olaparib) is an oral poly (ADP-ribose) polymerase (PARP) inhibitor used for the treatment of certain types of cancer, including ovarian, breast, prostate, and pancreatic cancer, particularly in patients with BRCA gene mutations.
Uses & Indications
Dosage
Adults
300 mg (two 150 mg tablets) orally twice daily. Continue treatment until disease progression or unacceptable toxicity.
Elderly
No specific dosage adjustment required, but monitor for adverse reactions.
Renal_impairment
For moderate renal impairment (creatinine clearance 31-50 mL/min), reduce dosage to 200 mg (two 100 mg tablets) twice daily. Not studied in severe renal impairment (CrCl <30 mL/min).
How to Take
Administer orally, with or without food. Tablets should be swallowed whole and not chewed, crushed, or dissolved.
Mechanism of Action
Olaparib inhibits PARP enzymes, which are involved in DNA damage repair. By inhibiting PARP, Olaparib traps PARP on DNA breaks, leading to accumulation of DNA damage and cell death, particularly in cancer cells with homologous recombination deficiency (e.g., BRCA mutations).
Pharmacokinetics
Onset
Not directly quantifiable for clinical effects; PARP inhibition begins shortly after administration.
Excretion
Eliminated via both renal (approximately 44%) and fecal (approximately 42%) routes.
Half life
Mean terminal half-life is approximately 15-17 hours.
Absorption
Rapidly absorbed after oral administration, with peak plasma concentrations (Cmax) achieved typically within 1-2 hours.
Metabolism
Extensively metabolized, primarily by cytochrome P450 (CYP) 3A4.
Side Effects
Contraindications
- Known hypersensitivity to Olaparib or any of its excipients.
- Pregnancy and breastfeeding (due to potential fetal harm).
Drug Interactions
Moderate CYP3A inhibitors (e.g., erythromycin, diltiazem)
Concomitant use increases Olaparib exposure; reduce Olaparib dose to 150 mg twice daily.
Strong CYP3A inducers (e.g., rifampin, carbamazepine, St. John's wort)
Concomitant use decreases Olaparib exposure; avoid concomitant use.
Strong CYP3A inhibitors (e.g., itraconazole, clarithromycin, grapefruit juice)
Concomitant use increases Olaparib exposure; reduce Olaparib dose to 100 mg twice daily.
Storage
Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Keep in original package to protect from moisture. Do not refrigerate or freeze.
Overdose
There is no specific antidote for Olaparib overdose. In the event of an overdose, treatment should be symptomatic and supportive. Monitor for hematologic and other adverse reactions.
Pregnancy & Lactation
Olaparib can cause fetal harm. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for 6 months after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment and for 3 months after the last dose. It is unknown if Olaparib is excreted in human milk; due to the potential for serious adverse reactions in a breastfed infant, advise women not to breastfeed during treatment and for 1 month after the last dose.
Side Effects
Contraindications
- Known hypersensitivity to Olaparib or any of its excipients.
- Pregnancy and breastfeeding (due to potential fetal harm).
Drug Interactions
Moderate CYP3A inhibitors (e.g., erythromycin, diltiazem)
Concomitant use increases Olaparib exposure; reduce Olaparib dose to 150 mg twice daily.
Strong CYP3A inducers (e.g., rifampin, carbamazepine, St. John's wort)
Concomitant use decreases Olaparib exposure; avoid concomitant use.
Strong CYP3A inhibitors (e.g., itraconazole, clarithromycin, grapefruit juice)
Concomitant use increases Olaparib exposure; reduce Olaparib dose to 100 mg twice daily.
Storage
Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Keep in original package to protect from moisture. Do not refrigerate or freeze.
Overdose
There is no specific antidote for Olaparib overdose. In the event of an overdose, treatment should be symptomatic and supportive. Monitor for hematologic and other adverse reactions.
Pregnancy & Lactation
Olaparib can cause fetal harm. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for 6 months after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment and for 3 months after the last dose. It is unknown if Olaparib is excreted in human milk; due to the potential for serious adverse reactions in a breastfed infant, 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
24-36 months
Availability
Specialized pharmacies, hospitals
Approval Status
FDA approved
Patent Status
Patented
Clinical Trials
Olaparib has been evaluated in numerous Phase 2 and 3 clinical trials, including SOLO1, SOLO2, SOLO3, PAOLA-1, OlympiAD, PROfound, and POLO trials, demonstrating efficacy in different cancer settings with BRCA or HRR mutations.
Lab Monitoring
- Complete blood count (CBC) with differential, including hemoglobin, mean corpuscular volume, platelet count, and neutrophil count, at baseline and monthly thereafter for the first 12 months, and then periodically.
- Renal function (creatinine clearance) at baseline and periodically.
- Liver function tests (ALT, AST, bilirubin) at baseline and periodically.
Doctor Notes
- Closely monitor complete blood counts (CBC) at baseline, monthly for the first year, and periodically thereafter, or more frequently if clinically indicated.
- Educate patients on symptoms of MDS/AML and pneumonitis, and advise them to seek immediate medical attention if these occur.
- Counsel female patients of reproductive potential on the need for effective contraception during and after treatment due to potential genotoxicity.
Patient Guidelines
- Take Olaparib exactly as prescribed by your doctor.
- Do not chew, crush, or dissolve tablets.
- Report any new or worsening symptoms, especially fever, weakness, easy bruising, or bleeding.
- Use effective contraception during treatment and for several months after the last dose.
Missed Dose Advice
If a dose is missed, skip the missed dose and take the next dose at its regularly scheduled time. Do not take two doses at the same time to make up for a missed dose.
Driving Precautions
Olaparib may cause fatigue, asthenia, or dizziness. Patients should be cautioned about driving or operating machinery if they experience these symptoms.
Lifestyle Advice
- Maintain good hydration and a balanced diet.
- Avoid exposure to people with infections, especially during periods of low blood counts.
- Discuss any complementary or alternative therapies with your doctor.
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