Zejula Capsules 100 mg (Niraparib Tosylate Monohydrate)

Adult dose

The recommended starting dose of this medication is 200 mg (2 capsules of 100 mg) taken orally once daily. Patients weighing over 77 kg and with a platelet count of 150,000/µl or higher should take 300 mg (3 capsules of 100 mg) orally once daily. The medication should be administered at approximately the same time every day, and the capsules should be swallowed whole without chewing or breaking. This medication can be taken with or without food.

This medication may cause serious blood disorders such as myelodysplastic syndrome and acute myeloid leukemia; therefore, regular blood status checks should be performed during treatment. This medication may harm the fetus during pregnancy; thus, women who are pregnant or may become pregnant should avoid use and employ effective contraception during treatment and for 6 months afterward. Individuals with known allergies to any ingredient of this medication or specific inherited disorders like lactose intolerance should not take it. Patients hypersensitive to Yellow No. 4 (Tartrazine) should use this medication cautiously. Various side effects may commonly occur, including nausea, thrombocytopenia, anemia, fatigue, constipation, myalgia, vomiting, neutropenia, and others, hence symptoms should be closely monitored. Hematological toxicity may occur; routine blood tests should be done before and during treatment, and consultation with a specialist is required for any abnormal findings. Patients with hypertension or cardiovascular disease should frequently monitor their blood pressure and heart rate during treatment, seeking appropriate treatment if necessary. Reversible posterior leukoencephalopathy syndrome, a neurological side effect, may rarely occur; therefore, immediately inform medical personnel of symptoms like headache, seizures, or visual disturbances. While taking this medication, weakness, fatigue, or dizziness may occur; caution is needed when driving or operating machinery. Patients with renal or hepatic impairment may need dose adjustments, thus should take it according to their doctor's instructions. Pregnant or breastfeeding women should avoid using this medication, and it is recommended to discontinue breastfeeding for a certain period during and after treatment. In case of overdose, there is no specific antidote, so symptomatic treatment should be sought promptly, along with immediate consultation with medical staff. This medication should be kept out of reach of children, and expired medications should not be taken.

Serious side effects

Myelodysplastic syndrome/acute myeloid leukemia (MDS/AML), severe allergic reactions (including hypersensitivity, anaphylaxis), severe skin reactions (such as rash, blistering, peeling skin, pain in mouth/eye mucosa), respiratory issues (such as difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever), liver dysfunction (such as jaundice, yellowing of the skin or eyes, general lethargy), serious neurological symptoms (sudden and severe).

Mild side effects

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

This medication should be kept tightly closed in a container to prevent exposure to air or moisture. It is best to store at room temperature between 1 to 30 degrees Celsius. Proper storage will help preserve the medication's effectiveness for a longer period.

Appearance

A hard capsule with a white to off-white powder in a purple upper and white lower part.

Package unit

30 capsules per bottle