Introduction
Talaparib 1 mg Capsule is a potent oral anticancer agent designed to target and exploit DNA repair vulnerabilities in cancer cells. As a PARP (poly ADP-ribose polymerase) inhibitor, Talaparib selectively induces synthetic lethality in tumors harboring BRCA mutations or homologous recombination repair (HRR) deficiencies. Manufactured by Everest Pharmaceuticals Ltd under WHO-GMP standards and globally distributed by Saif Pharma, Talaparib is a reliable and quality-assured option in precision oncology.
This targeted therapy is indicated for the treatment of HER2-negative, BRCA-mutated locally advanced or metastatic breast cancer, and in HRR gene-mutated metastatic castration-resistant prostate cancer (mCRPC) in combination with Enzalutamide. With proven clinical efficacy, manageable toxicity profile, and oral convenience, Talaparib 1 mg plays a vital role in personalized cancer treatment.
Key Indications
- BRCA-mutated (gBRCAm) HER2-Negative Locally Advanced or Metastatic Breast Cancer
- Indicated as monotherapy for adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) HER2-negative breast cancer.
- HRR Gene-Mutated Metastatic Castration-Resistant Prostate Cancer (mCRPC)
- Used in combination with Enzalutamide in adult patients harboring mutations in HRR genes (e.g., BRCA1, BRCA2, ATM, CHEK2, PALB2, RAD51C).
Mechanism of Action
Talazoparib targets PARP1 and PARP2, enzymes essential for single-strand DNA break repair. Inhibition of these enzymes leads to:
- DNA repair disruption
- Accumulation of DNA damage
- Cancer cell apoptosis, especially in BRCA/HRR-deficient cells
Talazoparib not only blocks enzymatic activity but also traps PARP-DNA complexes, amplifying DNA damage in vulnerable cells. This dual action maximizes cytotoxicity in genetically predisposed tumors and enhances therapeutic precision.
Dosage & Administration
For BRCA-mutated HER2-Negative Advanced Breast Cancer:
- Recommended Dose: 1 mg orally once daily.
- Continue treatment until disease progression or intolerable toxicity.
- Dose modifications may be necessary based on hematologic or non-hematologic adverse events.
For HRR Gene-mutated mCRPC:
- Recommended Dose: 0.5 mg orally once daily with Enzalutamide.
- Therapy should be continued until progression or unacceptable toxicity.
Administration Guidelines:
- Capsules should be swallowed whole.
- Can be taken with or without food.
- If a dose is missed or vomiting occurs, resume with the next scheduled dose.
Drug Interactions
P-glycoprotein (P-gp) Inhibitors:
- Coadministration with P-gp inhibitors (e.g., amiodarone, clarithromycin, verapamil) increases Talaparib exposure.
- Management: Reduce Talaparib dose when combined; increase dose upon P-gp inhibitor withdrawal.
BCRP Inhibitors:
- May raise Talaparib plasma levels and increase toxicity.
- Monitor for adverse reactions and adjust dose accordingly.
In mCRPC Therapy:
- Combined use with Enzalutamide and P-gp inhibitors has not been formally studied.
- Caution and close monitoring are advised.
Side Effects
Common adverse effects (>20%) include:
- Hematologic: Anemia, neutropenia, thrombocytopenia, lymphopenia
- GI & Hepatic: Nausea, vomiting, diarrhea, elevated liver enzymes (AST/ALT)
- Other: Fatigue, headache, alopecia, decreased appetite, hypocalcemia, hyperglycemia
Adverse effects often necessitate dose interruption, reduction, or discontinuation. Routine blood monitoring is essential for early detection and management of toxicities.
Warnings & Precautions
- Myelosuppression: Severe anemia, neutropenia, and thrombocytopenia have been observed. Monitor CBC regularly.
- MDS/AML: Rare cases reported; discontinue if suspected and confirm diagnosis via bone marrow biopsy.
- Embryo-Fetal Toxicity: Contraindicated during pregnancy. Females of childbearing potential must use contraception during treatment and for at least 7 months after the last dose.
- Infertility: May impair male fertility based on animal data.
- Lactation: Discontinue breastfeeding during treatment due to unknown risks.
Use in Special Populations
- Pregnancy: Teratogenic; do not use.
- Lactation: Risk to infants unknown; breastfeeding not recommended.
- Pediatrics: Not established.
- Geriatrics: No clinically meaningful differences in safety or efficacy.
- Hepatic Impairment: No dosage adjustment required.
- Renal Impairment:
- Mild (CrCl 60–89 mL/min): No dose change.
- Moderate (CrCl 30–59 mL/min) and Severe (CrCl 15–29 mL/min): Dose reduction recommended.
- End-stage (CrCl <15 mL/min or on dialysis): Not studied.
Therapeutic Class
Cytotoxic Chemotherapy – PARP Inhibitor, Oral Targeted Therapy
Storage Conditions
- Store below 30°C
- Keep in a dry place, protected from light
- Keep out of reach of children
Why Choose Talaparib 1 mg from Saif Pharma?
Saif Pharma is a globally recognized oncology medicine supplier, delivering WHO-GMP compliant, high-efficacy cancer drugs across continents. Through strategic partnerships with manufacturers like Everest Pharmaceuticals Ltd, Saif Pharma ensures:
- Reliable global supply chain
- Authentic, temperature-controlled oncology medications
- Competitive pricing for cancer treatment centers, clinics, and procurement agencies
Trust Saif Pharma for on-time delivery, regulatory adherence, and expert pharmaceutical support.
Clinical Advantages of Talaparib
- Proven survival benefit in gBRCAm breast cancer and mCRPC with HRR mutations
- Superior PARP-trapping potency compared to other PARP inhibitors
- Convenient oral once-daily dosing
- Fewer hospital visits, improving patient compliance
- Strong performance in pivotal studies (e.g., EMBRACA and TALAPRO-2 trials)
Conclusion
Talaparib 1 mg Capsule represents a targeted leap in cancer therapy by exploiting the DNA repair weaknesses in tumor cells. Whether used as a monotherapy in advanced breast cancer or combined with Enzalutamide in mCRPC, it offers precision, efficacy, and tolerability in a compact, oral dosage form.
With Talaparib supplied by Saif Pharma, you get reliable access to globally accepted standards in oncology treatment. Healthcare providers and procurement authorities can depend on Saif Pharma’s excellence in supplying advanced, life-saving cancer medications around the world.