Olakin 150 mg, containing the active ingredient Olaparib, is a targeted cancer therapy used for the treatment of patients with specific BRCA-mutated cancers. It is indicated for:

• Ovarian Cancer: Maintenance treatment in patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy.

• Breast Cancer: Treatment of HER2-negative, locally advanced or metastatic breast cancer in patients with a germline BRCA mutation who have previously received chemotherapy.

• Pancreatic Cancer: Maintenance treatment for germline BRCA-mutated metastatic pancreatic cancer whose disease has not progressed on at least 16 weeks of first-line platinum-based chemotherapy.

• Prostate Cancer: Treatment of metastatic castration-resistant prostate cancer (mCRPC) in patients with BRCA1/2 or ATM gene mutations following progression on prior therapy.

Olakin is designed to exploit defects in tumor DNA repair mechanisms, providing a precision therapy that targets cancer cells while sparing normal tissue.

Description

Olakin 150 mg is an oral poly (ADP-ribose) polymerase (PARP) inhibitor. PARP enzymes are involved in repairing DNA single-strand breaks. By inhibiting PARP, Olakin causes the accumulation of DNA damage in cancer cells that are already deficient in homologous recombination repair (such as BRCA-mutated tumors), leading to cancer cell death—a concept known as synthetic lethality.

Pharmacology

• Mechanism of Action: Olaparib binds to PARP1, PARP2, and PARP3, preventing DNA repair and promoting cancer cell apoptosis.

• Absorption: Rapidly absorbed with peak plasma concentrations typically 1–3 hours after oral administration.

• Distribution: High plasma protein binding (~94%) and widespread tissue distribution.

• Metabolism: Predominantly metabolized via CYP3A4 in the liver.

• Excretion: Eliminated primarily via feces (~44%) and urine (~42%). Terminal half-life is approximately 12 hours.

Dosage & Administration

• Recommended Dose: 300 mg twice daily (two 150 mg capsules each time) for adults, unless otherwise specified by a healthcare provider.

• Administration: Swallow capsules whole with water; can be taken with or without food. Do not crush or chew.

• Dose adjustment is required for moderate renal or hepatic impairment, and for patients taking strong CYP3A inhibitors or inducers.

Drug Interactions

• CYP3A inhibitors: May increase Olakin levels; dose adjustment is recommended.

• CYP3A inducers: May decrease efficacy; avoid co-administration.

• Caution with drugs that affect DNA repair or bone marrow function, as overlapping toxicity may occur.

Contraindications

• Hypersensitivity to Olaparib or any of its excipients.

Side Effects

Common adverse reactions include:

• Fatigue, nausea, vomiting, diarrhea, constipation, and decreased appetite.

• Hematologic toxicities: anemia, neutropenia, thrombocytopenia.

• Rare but serious: myelodysplastic syndrome/acute myeloid leukemia, pneumonitis.

Patients should have regular blood counts and liver function monitoring during treatment. Dose interruptions or reductions may be necessary for severe adverse events.

Pregnancy & Lactation

• Pregnancy: Olakin may cause fetal harm; effective contraception is required during treatment and for 6 months after the last dose.

• Lactation: Unknown if excreted in human milk; breastfeeding is not recommended during therapy.

Special Populations

• Pediatric Use: Safety and efficacy not established.

• Geriatric Use: No dose adjustment required, but monitor for adverse effects.

• Renal or Hepatic Impairment: Dose adjustment may be necessary based on severity.

Therapeutic Class

Targeted Cancer Therapy – PARP Inhibitor

Storage Conditions

Store in a dry place below 30°C, protected from light. Keep out of reach of children.