🟩 Niraparix 100 mg

Generic Name: Niraparib
Brand Name: Niraparix
Manufacturer: Beacon Pharmaceuticals Ltd.
Dosage Form & Strength: Capsule, 100 mg
Therapeutic Class: Anticancer | PARP (Poly ADP-Ribose Polymerase) Inhibitor

📌 Indications:

Niraparix (Niraparib) is indicated for the treatment of:

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

• Maintenance Therapy in newly diagnosed advanced ovarian cancer with HRD-positive status after first-line platinum-based chemotherapy.

• Other solid tumors with specific BRCA1/BRCA2 mutations (as per oncologist’s guidance).

💊 Pharmacology:

Niraparib is a selective PARP-1 and PARP-2 inhibitor.

• Mechanism: It blocks the PARP enzymes involved in DNA repair.

• Cancer cells with BRCA mutations rely heavily on PARP for survival; by inhibiting PARP, Niraparib causes accumulation of DNA damage, leading to cell death (synthetic lethality).

• Unlike some PARP inhibitors, Niraparib does not require BRCA mutation exclusively for activity, making it effective in a broader patient population.

💉 Dosage & Administration:

• Starting Dose: 200–300 mg orally once daily, with or without food.

• Dose may be adjusted based on body weight, platelet count, or tolerability.

• Capsules should be swallowed whole — do not open or crush.

• Continue until disease progression or unacceptable toxicity.

⚠️ Precautions & Warnings:

• Monitor complete blood counts (CBC) weekly for the first month, monthly thereafter.

• Risk of myelosuppression — may cause anemia, thrombocytopenia, or neutropenia.

• May cause hypertension — monitor blood pressure regularly.

• Use with caution in patients with cardiovascular risk factors.

• Discontinue if signs of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) occur.

❌ Contraindications:

• Hypersensitivity to Niraparib or any component of the formulation.

• Pregnancy and breastfeeding (due to potential harm to the fetus/infant).

🤰 Pregnancy & Lactation:

• Pregnancy: May cause fetal harm — effective contraception required during and for at least 6 months after treatment.

• Lactation: Avoid breastfeeding during therapy and for 1 month after the last dose.

⚕️ Side Effects:

Common:

• Fatigue

• Nausea, vomiting, constipation

• Decreased appetite

• Anemia, thrombocytopenia, neutropenia

• Headache, insomnia

• Hypertension

Serious:

• Bone marrow suppression

• Secondary malignancies (MDS/AML)

• Severe hypertension

🧊 Storage Conditions:

• Store below 30°C, in a dry place away from moisture and direct light.

• Keep out of reach of children.