• Niraparib is a poly ADP-ribose polymerase inhibitor which was approved by US FDA March 2017 for treating certain recurrent cancers.
Niraparib is prescribed as a maintenance treatment in adult patients with recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who show a complete or partial response to platinum-based chemotherapy.
Niraparib works by inhibiting the PARP (poly ADP-ribose polymerase) activity. It results in the formation of PARP-DNA complexes leading to the damage of DNA and tumor cell death.
It benefits by improving the patient's progression-free survival and should be given only by the medical specialist who is an expert in handling anti-cancer medicines.
Niraparib is not recommended in patients with the following conditions:
• Allergy to niraparib
• Pregnancy and breastfeeding
• Severe kidney or liver disease
• The recommended adult dose of niraparib is 300mg once a day which should be taken orally as three 100mg capsules.
Dose adjustments are needed in case of occurrence of some adverse reactions:
Initial dose : 300mg (3 capsules of 100mg) once daily
First dose reduction : 200mg (2 capsules of 100mg) once daily
Second dose reduction : 100mg (1 capsule of 100mg) once daily
• Only two dose reductions are allowed and dose less than 100mg is not advised.
• The dose can be withheld for a maximum of 28 days or until the adverse reactions subside in some cases. In case of severe adverse reactions, the niraparib treatment can be discontinued.
• Niraparib comes as a capsule which should be taken by mouth once a day at the same time each day either with or without food.
• Every capsule should be swallowed as a whole and should not be crushed or chewed. It should be taken with a sufficient quantity of water.
• Niraparib capsules can be taken at bedtime to avoid nausea. In case of vomiting after the administration of the niraparib capsule, the dose should not be repeated.
• It is advised to start the niraparib treatment within 8 weeks of taking platinum-containing chemotherapy regimen.
• Complete blood cell counts should be done during the niraparib treatment weekly for the first month and monthly once after the first month to check for adverse effects on the blood counts.
• The blood pressure and heart rate should be closely monitored as the niraparib therapy can give rise to the hypertensive crisis.
• Effective contraceptive methods must be used and pregnancy should be avoided for at least 6 months after stopping the niraparib treatment.
• Breastfeeding can be resumed after at least 1 month of stopping the last dose of niraparib.
• Niraparib could affect the fertility in men.
• Acute myeloid leukemia or myelodysplastic syndrome may occur in patients who already received the platinum chemotherapy or other DNA damaging agents.
• Common: Fatigue or asthenia, nausea, loss of appetite, insomnia, peripheral edema
• Gastrointestinal: Dry mouth, problems with taste, dyspepsia, diarrhea, constipation, mucosal inflammation, vomiting, abdominal pain
• Central nervous system: Dizziness, headache, anxiety, depression
• Cardiovascular system: Hypertension, palpitations
• Respiratory: Cough, difficulty in breathing, nasopharyngitis, bronchitis, epistaxis
• Musculoskeletal: Back pain, arthralgia, muscle pain
• Blood: Decreased hemoglobin, reduced number of white blood cells or platelets, acute myeloid leukemia
• Others: Rash, urinary tract infection, elevated levels of liver enzymes
• Do not use niraparib capsules prescribed for others or a condition for which it is not prescribed.
• It is necessary to confirm a negative pregnancy test before starting niraparib treatment as the drug may cause harm to the baby.
• In case of a missed dose, the next dose should be taken at the scheduled time.
• Do not take less or double the dose. Take exactly as directed by the treating physician.
• Not known.
• Store niraparib capsules at a room temperature between 20°C and 25°C.
• Keep away from excess moisture and heat.
• Keep out of the reach of children.
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