Vijayaganesh Kasinathan
Written & Compiled by Pharmacist Vijayaganesh Kasinathan, B.Pharm, M.Pharm
Dr. Simi Paknikar
Medically Reviewed by Dr. Simi Paknikar, MD
Last Updated on Dec 26, 2017
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General Information on Niraparib

Generic Name : Niraparib

Pronunciation : nye-RAP-a-rib

Latest prescription information about Niraparib. Learn how to pronounce the drug's name, its indications, dosage, how to take, when to take, when not to take, side effects, special precautions, its storage instructions and warnings if any when taken during pregnancy. Also listed are the International and Indian trade name(s) of the drug and its price list.
Therapeutic Classification : Chemotherapy

Trade Names/Brand Names of Niraparib

Zejula

Overview of Niraparib

Niraparib is a poly ADP-ribose polymerase inhibitor which was approved by US FDA March 2017 for treating certain recurrent cancers.

Why is Niraparib Prescribed? (Indications)

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.  

When should Niraparib not to be taken? (Contraindications)

Niraparib is not recommended in patients with the following conditions:

Allergy to niraparib
Pregnancy and breastfeeding
Severe kidney or liver disease

What is the dosage of Niraparib?

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.

How should Niraparib be taken?

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.

What are the warnings and precautions for Niraparib?

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.

What are the side effects of Niraparib?

  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

What are the other precautions for Niraparib?

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.

What are the Drug Interactions of Niraparib?

Not known.

What are the storage conditions for Niraparib?

Store niraparib capsules at a room temperature between 20C and 25C.
Keep away from excess moisture and heat.
Keep out of the reach of children.

Last Updated : 12/26/2017

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