Zejula (Capsules) Instructions for Use

Marketing Authorization Holder

GlaxoSmithKline Trading, JSC (Russia)

Manufactured By

Mayne Pharma, Inc. (USA)

Labeled By

SHARP CORPORATION (USA)

Quality Control Release

GlaxoSmithKline, LLC (USA)

ATC Code

L01XK02 (Niraparib)

Active Substance

Niraparib (Rec.INN registered by WHO)

Dosage Form

Zejula

Capsules 100 mg: 56 pcs.

Dosage Form, Packaging, and Composition

Capsules are hard gelatin, size #0, with a white opaque body and a purple opaque cap; the capsule body is printed with “100 mg” in black ink and the cap is printed with “Niraparib” in white ink; the capsule contents are a white or almost white powder.

Excipients: lactose monohydrate, magnesium stearate, hard gelatin capsule #0 [titanium dioxide, colorant FD&C blue no. 1, colorant FD&C red no. 3, colorant FD&C yellow no. 5, gelatin, black printing ink SW-9049 (shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, concentrated ammonia solution, potassium hydroxide, black iron oxide), white printing ink SB-0007P (shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, sodium hydroxide, povidone, titanium dioxide)].

14 pcs. – blisters (4) – cardboard packs.

Clinical-Pharmacological Group

Antineoplastic drug

Pharmacotherapeutic Group

Antineoplastic agents; other antineoplastic agents; poly(ADP-ribose) polymerase (PARP) inhibitors

Pharmacological Action

Antineoplastic agent, PARP (poly[adenosine diphosphate-ribose] polymerase) inhibitor. PARP helps cells repair damaged DNA, so blocking it means that the DNA of cancer cells will not be repaired. This leads to the death of the cancer cell, which helps control the cancer.

Indications

In adult women over the age of 18 for the maintenance treatment of cancer, in case of: a positive effect (complete or partial response) after the first course of platinum-based chemotherapy; a positive effect (complete or partial response) after a repeated course of platinum-based chemotherapy, after cancer recurrence.

Such types of cancer may include ovarian cancer, fallopian tube cancer, peritoneal cancer.

ICD codes

Dosage Regimen

Take orally once daily.

Swallow capsules whole with water. Do not chew or dissolve.

Take at approximately the same time each day.

You may take Zejula with or without food.

The recommended initial dose is 300 mg (three 100 mg capsules) once daily.

For patients with a body weight below 77 kg (170 lbs) AND a platelet count below 150,000/µL prior to initiation, the recommended initial dose is 200 mg (two 100 mg capsules) once daily.

Continue treatment until disease progression or unacceptable toxicity occurs.

Dose modifications for adverse reactions are based on clinical signs and laboratory findings.

For hematologic toxicities (thrombocytopenia, anemia, neutropenia), interrupt therapy and monitor blood counts weekly.

Resume treatment at a reduced dose of 200 mg or 100 mg once daily after recovery.

For non-hematologic toxicities, interrupt therapy until symptoms resolve.

Restart treatment at a reduced dose or discontinue based on severity.

In cases of moderate hepatic impairment (Child-Pugh class B), reduce the initial dose to 200 mg once daily.

No dose adjustment is required for patients with mild hepatic impairment.

The safety and efficacy of Zejula in patients with severe hepatic impairment have not been established.

Regularly monitor blood pressure and heart rate, especially during the first month of treatment.

Manage elevated blood pressure with appropriate antihypertensive medication as needed.

Adhere to all prescribed laboratory monitoring schedules for blood counts and biochemistry.

Adverse Reactions

Adverse reactions that may require emergency medical care

Very common thrombocytopenia (bruising or bleeding), anemia, neutropenia (may increase the risk of infection), leukopenia.

Common myelodysplastic syndrome, acute myeloid leukemia, allergic reactions (including serious, life-threatening ones).

Rare hypertensive crisis, posterior reversible encephalopathy syndrome (PRES).

Other adverse reactions

Very common abdominal pain, indigestion, stomach and intestinal discomfort, cough, painful and frequent urination (urinary tract infection), headache, asthenia, fatigue, dizziness, arthralgia, back pain, constipation, nausea, vomiting, diarrhea, shortness of breath, nasopharyngitis, insomnia, decreased appetite, palpitations, arrhythmia, arterial hypertension.

Common conjunctivitis, dry mouth, peripheral edema, nosebleed, depression, myalgia, weight loss, hypokalemia (which can cause arrhythmias), bronchitis, mucositis/stomatitis, skin rash, photosensitivity, anxiety, cognitive impairment, tachycardia, which may be accompanied by dizziness, chest pain, or shortness of breath; increased blood creatinine, dysgeusia, abdominal bloating, increased blood levels of liver enzymes.

Uncommon confusion, pneumonia, pneumonitis.

Contraindications

Hypersensitivity to niraparib, pregnancy, breastfeeding period, children and adolescents under 18 years of age.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and breastfeeding.

Use in Hepatic Impairment

In case of liver function impairment, dose adjustment may be required.

Pediatric Use

Contraindicated for use in children and adolescents under 18 years of age.

Special Precautions

Before starting and periodically during treatment, peripheral blood counts should be monitored.

During treatment, regular blood pressure monitoring is required.

If a patient develops headache, visual disturbances, confusion, or seizures, with or without high blood pressure, they should consult a doctor immediately.

Effect on ability to drive vehicles and operate machinery

During treatment, impaired concentration, weakness, fatigue, or dizziness may occur, which may affect the patient’s ability to drive vehicles and operate machinery. Caution is required when performing these activities.

Drug Interactions

The following drugs may affect the efficacy of niraparib: cyclosporine, tacrolimus, irinotecan, methotrexate, rosuvastatin, simvastatin, atorvastatin, quetiapine, pimozide, clozapine, alfentanil, ergotamine, theophylline, halofantrine, ropinirole, metformin.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.