Zejula 100 mg Tablet (Niraparib tosylate monohydrate)

Adult dose

The recommended starting dose of this medication is 200 mg (2 x 100 mg tablets) administered orally once daily. Patients weighing 77 kg or more and with a platelet count of 150,000/µl or more should receive 300 mg (3 x 100 mg tablets) administered orally once daily. This medication should be taken at approximately the same time every day, and the tablets should not be chewed, crushed, or split. It can be taken with or without food.

This medication can cause serious blood disorders such as myelodysplastic syndrome and acute myeloid leukemia, so blood status should be periodically monitored during treatment. It may harm the fetus during pregnancy, thus women of childbearing age should ensure effective contraception while taking this medication and for 6 months after its discontinuation. This medication should not be used in patients with allergies to its components or specific genetic disorders such as lactose intolerance. During treatment, various side effects such as nausea, thrombocytopenia, anemia, fatigue, constipation, myalgia, and vomiting may occur; if symptoms worsen, patients must promptly notify healthcare professionals. Dosage adjustment or discontinuation may be necessary based on blood test results, especially if platelet counts are low or if severe anemia symptoms occur. Patients with hypertension or cardiovascular diseases should frequently monitor their blood pressure and heart rate while taking this medication and receive appropriate treatment if necessary. Reversible posterior leukoencephalopathy syndrome, a rare neurological effect may occur, requiring immediate hospital visits if there are headaches, vision changes, or changes in mental state. Caution is needed when driving or operating machinery as fatigue or dizziness may occur due to this medication. Pregnant or breastfeeding women should avoid this medication; it is recommended to discontinue breastfeeding while taking this medication. Patients with impaired kidney or liver function may require dosage adjustment based on the physician's instructions. There is no specific antidote for overdose, and treatment will be symptomatic based on the patient's condition. This medication should be kept out of reach of children, and expired medications should not be used.

Serious side effects

Myelodysplastic syndrome/acute myeloid leukemia, severe thrombocytopenia, severe anemia, severe neutropenia, severe allergic reactions (hypersensitivity, anaphylaxis), reversible posterior leukoencephalopathy syndrome (PRES), hypertension and hypertensive crisis, life-threatening bowel perforation and pleural effusion, respiratory distress (breathing difficulties), serious neurological symptoms (including seizure potential)

Mild side effects

• Nausea
• thrombocytopenia
• anemia
• fatigue
• constipation
• myalgia
• abdominal pain
• vomiting
• neutropenia
• decreased appetite

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. It is important to maintain storage temperatures between 15 to 30 degrees Celsius.

Appearance

This medication is a gray oval film-coated tablet engraved with the number '100' on one side and 'Zejula' on the other side.

Package unit

30 tablets/box [10 tablets/PTPX3]