Niranib 100 mg Capsule

Generic Name: Niraparib
Brand: Niranib
Strength: 100 mg
Form: Capsules
Pack Size: 30 Capsules
Manufacturer: Everest Pharmaceuticals
Distributed by: NP Molecule

Indications:

Niranib (Niraparib) is indicated for:

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

• Also approved for use in patients with BRCA-mutated ovarian cancer regardless of response to prior treatments (based on diagnostic testing).

Pharmacology:

Niraparib is a PARP (Poly ADP-ribose polymerase) inhibitor. It works by blocking PARP enzymes involved in repairing damaged DNA in cancer cells. In BRCA-mutated or DNA repair-deficient tumors, inhibition of PARP leads to cancer cell death, making it a targeted therapy especially effective in ovarian cancer.

Dosage & Administration:

• The recommended dose is 300 mg once daily, with or without food (can be adjusted based on patient weight or platelet count).

• Capsules should be swallowed whole.

• Treatment should be continued until disease progression or unacceptable toxicity occurs.

Interaction:

• May interact with drugs that affect bone marrow or blood counts.

• Caution advised when combined with other myelosuppressive agents.

Contraindications:

• Known hypersensitivity to Niraparib or any of the excipients.

• Severe hepatic impairment (caution required).

Side Effects:

• Common: Fatigue, nausea, anemia, constipation, thrombocytopenia, insomnia.

• Serious: Bone marrow suppression, hypertension, MDS/AML (rare but serious).

Pregnancy & Lactation:

• Not recommended during pregnancy; may cause fetal harm.

• Breastfeeding should be avoided during treatment and for 1 month after the last dose.

Precautions & Warnings:

• Monitor complete blood counts (CBC) weekly during the first month, then monthly.

• Watch for signs of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).

• Blood pressure should be monitored regularly.

Overdose Effects:

• Overdose may increase the risk of hematologic toxicities.

• Supportive treatment and symptomatic care are advised.

Therapeutic Class:

• PARP Inhibitor

• Targeted Therapy in Oncology

Storage Conditions:

• Store below 30°C in a dry place.

• Protect from moisture and light.

• Keep out of reach of children.