TLPH Olieni Olaparib 50mg

Product Information

• Product name: Olieni Olaparib 50mg
• Manufacturer / brand: Laos TLPH Pharma
• Active ingredient: Olaparib
• Current strength: 50mg
• SKU: AM-ITEM-49
• Site category: BRCA target, general medicines

Product Summary

Olieni Olaparib 50mg is an AISTIKA-listed product supplied by Laos TLPH Pharma. This page summarizes the product identity, strength, SKU, site category, and public medical reference information. Product name, manufacturer, packaging, and strength follow this AISTIKA product page.

Active Ingredient and Reference Data

Olaparib is the active ingredient used for this product page. Public prescribing information for Olaparib was used for the medical reference sections. Medical details are provided for reference and must be interpreted by a qualified healthcare professional.

Mechanism of Action

Olaparib is an inhibitor of poly (ADP-ribose) polymerase (PARP) enzymes, including PARP1, PARP2, and PARP3. PARP enzymes are involved in normal cellular functions, such as DNA transcription and DNA repair. Olaparib has been shown to inhibit growth of select tumor cell lines in vitro and decrease tumor growth in mouse xenograft models of human cancer, both as monotherapy or following platinum-based chemotherapy.

Reference Indications

Olaparib is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated: Ovarian cancer for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA -mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Olaparib.

Reference Dosage and Administration

Recommended dosage is 300 mg taken orally twice daily with or without food.

With this 50mg product, that corresponds to 6 x 50mg tablets when that reference dose is clinically appropriate.

This reference dosage is not an individualized prescription. Dose changes, treatment interruptions, or discontinuation must be directed by a physician.

Important Safety Information

Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML): Occurred in approximately 1.2% of patients with various BRCA m, g BRCA m, HRR gene-mutated or HRD-positive cancers exposed to Olaparib and the majority of events had a fatal outcome. Monitor patients for hematological toxicity at baseline and monthly thereafter. Discontinue if MDS/AML is confirmed. Pneumonitis: Occurred in 1.0% of patients exposed to Olaparib, and some cases were fatal. Interrupt treatment if pneumonitis is suspected. Discontinue if pneumonitis is confirmed. Venous thromboembolism (VTE), including severe or fatal pulmonary embolism (PE), occurred in patients treated with Olaparib. VTE occurred in 8% of patients with mCRPC. Monitor patients for signs and symptoms of VTE and PE and treat as medically appropriate.

Common Adverse Reactions and Monitoring

Additional data reflect exposure to Olaparib as a single agent in 2901 patients; 2135 patients with exposure to 300 mg twice daily tablet dose including five controlled, randomized, trials (SOLO-1, SOLO-2, OlympiAD, POLO, and PROfound) and to 400 mg twice daily capsule dose in 766 patients in other trials that were pooled to conduct safety analyses. First-Line Maintenance Treatment of BRCA -mutated Advanced Ovarian Cancer SOLO-1 The safety of Olaparib for the maintenance treatment of patients with BRCA-mutated advanced ovarian cancer following first-line treatment with platinum-based chemotherapy was investigated in SOLO- 1 .

Drug Interactions and Special Populations

Strong or moderate CYP3A inhibitors: Avoid concomitant use. If concomitant use cannot be avoided, reduce Olaparib dosage. ( 2.4 , 7.2 , 12.3 ) Strong or moderate CYP3A inducers: Avoid concomitant use. ( 7.2 , 12.3 ) 7.1 Use with Anticancer Agents Clinical studies of Olaparib with other myelosuppressive anticancer agents, including DNA damaging agents, indicate a potentiation and prolongation of myelosuppressive toxicity. Avoid coadministration of strong or moderate CYP3A inhibitors. If the strong or moderate inhibitor must be coadministered, reduce the dose of Olaparib . Strong and Moderate CYP3A Inducers Concomitant use with a strong or moderate CYP3A inducer decreased olaparib exposure, which may reduce Olaparib efficacy . Avoid coadministration of strong or moderate CYP3A inducers. Lactation: Advise women not to breastfeed.

Storage and Purchase Notes

Store according to the package or pharmacist instructions and keep out of reach of children. Before ordering, confirm product name, strength, quantity, price, shipping details, and payment method. After receipt, check packaging, batch number, expiration date, and storage conditions.

Sources

Sources: Lynparza public prescribing information; openFDA/DailyMed public label data. These sources are used for public medical reference. Product information follows this AISTIKA product page.

DisclaimerThis page is for product information and public-label reference only. It does not provide diagnosis, prescription, or individualized medical advice. Consult a physician for treatment decisions.