Niraparib

What is Niraparib?

• Niraparib (Zejula) is a poly (ADP-ribose) polymerase (PARP) inhibitor used for the treatment of epithelial ovarian, fallopian tube, or primary peritoneal cancer.

What are the uses of this medicine?

Niraparib (Zejula) used for the:

• maintenance treatment of adults with advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. Zejula is used after the cancer has responded (complete or partial response) to treatment with platinum-based chemotherapy.
• maintenance treatment of adults with ovarian cancer, fallopian tube cancer, or primary peritoneal cancer that comes back. Zejula is used after the cancer has responded (complete or partial response) to treatment with platinum-based chemotherapy.

• treatment of adults with advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who have been treated with 3 or more prior types of chemotherapy and who have tumors with:
• a certain BRCA gene mutation, or
• gene mutation problems and who have progressed more than 6 months after their last treatment with platinum-based chemotherapy.

How does this medicine work?

• Niraparib is an inhibitor of PARP enzymes, including PARP-1 and PARP-2, that play a role in DNA repair.
• In vitro studies have shown that niraparib-induced cytotoxicity may involve inhibition of PARP enzymatic activity and increased formation of PARP-DNA complexes resulting in DNA damage, apoptosis, and cell death.
• Increased niraparib‑induced cytotoxicity was observed in tumor cell lines with or without deficiencies in BRCA1/2.
• Niraparib decreased tumor growth in mouse xenograft models of human cancer cell lines with deficiencies in BRCA1/2 and in human patient‑derived xenograft tumor models with HRD that had either mutated or wild-type BRCA1/2.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• No clinically important drug interactions have been observed with Zejula.

Is this medicine FDA approved?

• It was approved for use in the United States in 2017.

How should this medicine be used?

• Select patients for treatment of advanced ovarian cancer after 3 or more chemotherapy regimens associated with HRD positive status based on either deleterious or suspected deleterious BRCA mutation and/or genomic instability score (GIS).

Recommended Dosage:

First-Line Maintenance Treatment of Advanced Ovarian Cancer:

• For patients weighing <77 kg (<170 lbs) OR with a platelet count of <150,000/mcL, the recommended dosage is 200 mg (two 100-mg capsules) taken orally once daily.
• For patients weighing ≥77 kg (≥170 lbs) AND who have a platelet count ≥150,000/mcL, the recommended dosage is 300 mg (three 100-mg capsules) taken orally once daily.
• For the maintenance treatment of advanced ovarian cancer, patients should start treatment with Zejula no later than 12 weeks after their most recent platinum-containing regimen.

Maintenance Treatment of Recurrent Ovarian Cancer:

• The recommended dosage of Zejula is 300 mg (three 100-mg capsules) taken orally once daily.
• For the maintenance treatment of recurrent ovarian cancer, patients should start treatment with Zejula no later than 8 weeks after their most recent platinum-containing regimen.

Treatment of Advanced Ovarian Cancer after 3 or More Chemotherapiesː

• The recommended dosage of Zejula is 300 mg (three 100-mg capsules) taken orally once daily.

Dosage Adjustment for Hepatic Impairmentː

• For patients with moderate hepatic impairment, reduce the starting dosage of Zejula to 200 mg once daily. Monitor patients for hematologic toxicity and reduce the dose further, if needed.

Administration

• Take Zejula exactly as your healthcare provider tells you to.
• Take Zejula 1 time each day, at the same time each day.
• Zejula may be taken with or without food.
• Zejula capsules should be swallowed whole. Do not chew, crush, or split Zejula capsules before swallowing.
• Taking Zejula at bedtime may help relieve any nausea symptoms you may have.
• Do not stop taking Zejula without first talking with your healthcare provider.
• If you miss a dose of Zejula, take your next dose at your scheduled time. Do not take an extra dose to make up for a missed dose.
• If you vomit after taking a dose of Zejula, do not take an extra dose. Take your next dose at your scheduled time.
• If you take too much Zejula, call your healthcare provider or go to the nearest hospital emergency room right away.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Capsules: 100 mg

This medicine is available in fallowing brand namesː

• Zejula

What side effects can this medication cause?

The most common side effects of this medicine include:

• heart not beating regularly
• nausea
• constipation
• vomiting
• pain in the stomach area
• mouth sores
• diarrhea
• indigestion or heartburn
• dry mouth
• tiredness
• loss of appetite
• urinary tract infection
• changes in liver function or other blood tests
• pain in your muscles and back
• headache
• dizziness
• change in the way food tastes
• trouble sleeping
• anxiety
• sore throat
• shortness of breath
• cough
• rash
• changes in the amount or color of your urine

Zejula may cause serious side effects including:

• Bone marrow problems called myelodysplastic syndrome (MDS) or a type of cancer of the blood called acute myeloid leukemia (AML)
• High blood pressure
• Posterior reversible encephalopathy syndrome (PRES)

What special precautions should I follow?

• Myelodysplastic syndrome/acute myeloid leukemia (MDS/AML), including cases with fatal outcome, have been reported in patients who received monotherapy with Zejula. Monitor patients for hematological toxicity and discontinue if MDS/AML is confirmed.
• Hematologic adverse reactions, including thrombocytopenia, anemia, neutropenia, and/or pancytopenia have been reported in patients treated with Zejula. Test complete blood counts weekly for the first month, monthly for the next 11 months and periodically thereafter for clinically significant changes.
• Hypertension and hypertensive crisis have been reported in patients treated with Zejula. Monitor blood pressure and heart rate at least weekly for the first 2 months, then monthly for the first year and periodically thereafter during treatment with Zejula. Manage with antihypertensive medications and adjustment of the dose of Zejula, if necessary.
• Posterior reversible encephalopathy syndrome (PRES) occurred in 0.1% of 2,165 patients treated with Zejula. Discontinue Zejula if PRES is confirmed.
• Zejula can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception.
• Zejula contains FD&C Yellow No. 5 (tartrazine) as a color additive, which may cause allergic‑type reactions (including bronchial asthma) in certain susceptible patients.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Based on its mechanism of action, Zejula can cause fetal harm when administered to pregnant women.

Can this medicine be used in children?

• The safety and effectiveness of Zejula have not been established in pediatric patients.

What are the active and inactive ingredients in this medicine?

Active ingredient: niraparib.

Inactive ingredients:

• Capsule fill: magnesium stearate and lactose monohydrate.
• Capsule shell: titanium dioxide and gelatin in the white capsule body and FD&C Blue No. 1, FD&C Red No. 3, FD&C Yellow No. 5 (tartrazine), and gelatin in the purple capsule cap.
• The black printing ink: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, purified water, strong ammonia solution, potassium hydroxide, and black iron oxide.
• The white printing ink: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, sodium hydroxide, povidone, and titanium dioxide.

Who manufactures and distributes this medicine?

Manufactured for: GlaxoSmithKline, Research Triangle Park, NC ©2021 GSK group of companies or its licensor.

What should I know about storage and disposal of this medication?

• Store at 20°C to 25°C (68°F to 77°F); excursions are permitted between 15°C to 30°C (59°F to 86°F).

• Dailymed label info on Niraparib
• FDA Niraparib

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