PHONIRA Generic name: Niraparib

Niraparib (trade name: Zejula ) is an oral PARP inhibitor mainly used to treat female reproductive system malignancies such as ovarian cancer, fallopian tube cancer and primary peritoneal cancer, especially those patients carrying BRCA gene mutations or with DNA repair defects.

The following is a summary of the Niraparib package insert:

1. Name of drug

• Generic Name : Niraparib
• Product Name : Zejula

2. Drug classification

• Drug category : Anti-tumor drugs
• Drug mechanism : Niraparib is a PARP inhibitor that inhibits the activity of poly(ADP-ribose) polymerase (PARP), preventing cancer cells from repairing DNA damage and inducing cancer cell death.

3. Indications

Niraparib is primarily used to treat:

• Advanced ovarian cancer : including patients with high-risk ovarian cancer who have undergone chemotherapy, and those with BRCA mutations or DNA repair defects.
• Recurrent ovarian cancer : It is suitable for patients with ovarian cancer who have received at least one round of chemotherapy, especially those who have received platinum-based chemotherapy, and whose tumors have DNA repair defects (such as BRCA mutations or homologous recombination repair defects).
• Fallopian tube cancer and primary peritoneal cancer : Treatment for these cancers is usually similar to that for ovarian cancer and follows similar treatment plans as for ovarian cancer.

4. Usage and Dosage

• Dosage form : Oral capsule
• Recommended dose :
  • Initial dose : 300 mg (3 100 mg capsules or 1 300 mg capsule) once daily.
  • Maintenance dose : The dose can be adjusted during the initial treatment period based on the patient's tolerance and clinical response.
  • Duration of treatment : Treatment continued until disease progression or unacceptable toxicity.
• Dosage adjustments :
  • Dose adjustment may be necessary depending on the patient's side effect profile (e.g., hematologic toxicity).
  • If severe adverse reactions occur, the dosage should be adjusted or the medication should be discontinued according to the doctor's advice.

5. Contraindications

• Patients with hypersensitivity to niraparib or any of its ingredients.
• Pregnant and lactating women: Niraparib may be harmful to the fetus and should be avoided during pregnancy. Lactating women should discontinue breastfeeding or discontinue medication.

6. Notes

• Hematologic Monitoring : Niraparib may cause hematologic toxicity, particularly thrombocytopenia , anemia , and leukopenia . Therefore, regular monitoring of complete blood counts (CBC) is required during treatment, especially in the first few months of treatment.

• Renal and liver function : Patients with impaired liver and kidney function should use this drug with caution and adjust the dose accordingly.

• Pregnancy and lactation :

  • Pregnancy : Niraparib is a Category C drug (possibly harmful to the fetus, but there are no adequate clinical studies) and should be avoided during pregnancy.
  • Lactation : Niraparib is excreted in human breast milk; therefore, breastfeeding should be discontinued during treatment.

• Bleeding Risk : Niraparib may increase the risk of bleeding, especially when used in combination with anticoagulants. Monitor for and prevent bleeding events.

• Effects on Fertility : Although there is no sufficient clinical data to suggest that Niraparib has a direct effect on fertility, the drug should be used with caution in women of childbearing age.

7. Adverse Reactions

Common adverse reactions to niraparib include:

• Hematological adverse reactions : The most common ones include anemia, thrombocytopenia, leukopenia, etc.
• Gastrointestinal symptoms : nausea, loss of appetite, vomiting, diarrhea, constipation.
• Fatigue : Niraparib may cause fatigue or weakness, especially at the beginning of treatment.
• Headache , loss of appetite .
• Abnormal liver function : ALT and AST were slightly elevated.
• Hypertension : A small number of patients may develop hypertension.

8. Drug Interactions

The interaction between Niraparib and other drugs is still under study, but studies have shown that the following drugs may interact with Niraparib:

• CYP3A4 inhibitors : such as ketoconazole, may increase the blood concentration of Niraparib and should be used in combination with caution.
• CYP3A4 inducers : Rifampicin and others may reduce the plasma concentration of niraparib and may require dose adjustment.
• Anticoagulants : such as warfarin, may increase the risk of bleeding and should be carefully monitored when used in combination.

9. Storage conditions

• Store in a dry and cool place, the temperature should not exceed 30°C.
• Please keep out of the reach of children.

10. Overtreatment

• In case of overdose, seek medical attention immediately. Treatment should be supportive based on symptoms. Overdose may aggravate adverse reactions, such as hematological toxicity.

Summarize

Niraparib (Zejula) is a PARP inhibitor that is mainly used to treat ovarian cancer and other related cancers, especially patients with BRCA mutations or DNA repair defects. The drug promotes cancer cell death by inhibiting DNA repair mechanisms. Regular monitoring of blood routine, liver and kidney function, etc. is required during treatment to ensure the safety of the patient. When using it, special attention should be paid to hematological side effects and bleeding risks.