ZEJULA 200 mg/1 (Niraparib TABLET, FILM COATED) 200 mg/1

ZEJULA is a PARP inhibitor used in the treatment of ovarian cancer and related conditions. It is indicated for the following uses:

• Recurrent ovarian cancer: Maintenance treatment following response to platinum-based chemotherapy.
• Fallopian tube cancer: Maintenance treatment following response to platinum-based chemotherapy.
• Primary peritoneal cancer: Maintenance treatment following response to platinum-based chemotherapy.
• Advanced ovarian cancer: First-line maintenance therapy for patients with HRD-positive status.

• Niraparib works by inhibiting poly (ADP-ribose) polymerase (PARP) enzymes. This inhibition leads to the accumulation of DNA damage and cell death in tumor cells with deficient homologous recombination repair, thereby targeting cancer cells with specific genetic vulnerabilities.

ZEJULA may cause various side effects, which can be categorized as common or serious.

Common Side Effects

• Fatigue: A common side effect that may affect daily activities.
• Nausea: A feeling of sickness that may or may not lead to vomiting.
• Anemia: A condition characterized by a decrease in red blood cells or hemoglobin.
• Thrombocytopenia: A low platelet count that can affect blood clotting.
• Rash: Skin irritation or inflammation.
• Diarrhea: Frequent, loose, or watery bowel movements.
• Hypertension: Elevated blood pressure.

Serious or Rare Side Effects

• Myelodysplastic syndrome: A rare but serious condition affecting the bone marrow.
• Acute myeloid leukemia: A type of cancer that affects the blood and bone marrow.
• Bone marrow suppression: Reduced production of blood cells, which can lead to infections, anemia, or bleeding.

ZEJULA should be used with caution and certain precautions should be observed. Consult your healthcare provider for personalized advice.

• Monitoring: Regular blood tests are required to monitor blood cell counts and other potential side effects.
• Pregnancy: The safety of ZEJULA during pregnancy is unknown; consult your healthcare provider if you are pregnant or planning to become pregnant.
• Breastfeeding: The safety of ZEJULA during breastfeeding is unknown; consult your healthcare provider if you are breastfeeding.
• Allergies: Inform your healthcare provider if you have any known allergies to niraparib or any of the excipients in ZEJULA.
• Other medications: Inform your healthcare provider about all other medications you are taking to avoid potential interactions.
• Store at 20°C to 25°C: Keep in the original bottle, protect from moisture and light.

ZEJULA may interact with other medications, which can be categorized as major or moderate interactions.

Major Interactions (Avoid)

• Strong CYP3A inducers: May decrease the effectiveness of ZEJULA.
• Strong CYP3A inhibitors: May increase the risk of side effects from ZEJULA.

Moderate Interactions (Monitor Closely)

• Moderate CYP3A inducers: May decrease the effectiveness of ZEJULA.
• Moderate CYP3A inhibitors: May increase the risk of side effects from ZEJULA.
• Anticoagulants: May increase the risk of bleeding.
• Antiplatelet agents: May increase the risk of bleeding.