Imdetrab 1mg (Talazoparib)

Adult dosage

This drug is administered intravenously over 1 hour. In the initial dosing phase on Day 1 of Cycle 1, 1 mg is administered, and on Days 8 and 15 of Cycle 1, 10 mg is given. After the initial dosing phase, 10 mg is administered once every 2 weeks. Following administration, the patient should be monitored for 2 to 8 hours depending on the patient's condition. On Day 1 and Day 8 of Cycle 1, the patient should be closely monitored for 22 to 24 hours from the start of drug infusion.

This drug may cause serious adverse effects such as cytokine release syndrome (CRS). Symptoms may include fever, hypotension, fatigue, rapid heartbeat, headache, hypoxia, nausea, and vomiting, which can escalate to life-threatening complications such as cardiac dysfunction, acute respiratory distress, neurotoxicity, renal and hepatic failure, and coagulopathy. Symptoms of CRS should be closely monitored before and during administration, and if symptoms occur, administration should be stopped immediately and appropriate treatment should be initiated. Immune effector cell-related neurotoxicity syndrome (ICANS) may also occur, so neurological symptoms such as headache, peripheral neuropathy, dizziness, insomnia, muscle weakness, and confusion should be closely monitored. This drug should not be administered to patients with hypersensitivity or allergies to its components. During administration, blood cytopenia may occur, so regular blood tests should be conducted to monitor white blood cells, platelets, and hemoglobin levels. Due to the increased risk of infection, patients should seek medical attention immediately if there are any signs of infection, and liver function abnormalities may also occur, necessitating regular liver enzyme tests. If hypersensitivity reactions occur, treatment should be stopped immediately, and appropriate measures should be taken. Women who are pregnant or may become pregnant should confirm their pregnancy status prior to administration, as this drug may cause harm to the fetus, and effective contraceptive methods should be used during treatment and for at least 2 months following treatment. Breastfeeding women are advised to discontinue breastfeeding during this treatment. The safety and efficacy of this drug have not been established in children under 18 years of age, and while no special dose adjustment is required for the elderly, careful monitoring is necessary. In patients with impaired renal or hepatic function, dose adjustment may not be needed in mild to moderate cases, but studies on severe cases are lacking. This drug is administered as an intravenous injection, and should always be reconstituted with sterile water for injection and should not be stabilized with an intravenous infusion stabilizer. Administration should be conducted in appropriate medical facilities by trained healthcare personnel while closely monitoring the patient.

Serious side effects

• Cytokine release syndrome (CRS): fever, hypotension, fatigue, tachycardia, headache, hypoxia, nausea, vomiting
• Cardiac dysfunction, acute respiratory distress syndrome, neurotoxicity, renal failure and/or liver failure, disseminated intravascular coagulation (DIC)
• Immune effector cell-related neurotoxicity syndrome (ICANS): confusion, decreased level of consciousness, disorientation, drowsiness, lethargy, slowed mental activity
• Hypersensitivity: rash, bronchospasm
• Respiratory distress,

Mild side effects

• Fatigue
• fever
• altered taste
• decreased appetite
• nausea
• constipation
• musculoskeletal pain
• anemia
• cough
• cytopenia

This drug should be stored in a sealed container to prevent exposure to air and kept in a dark place to avoid degradation by light. It is important to store the drug at a refrigerated temperature between 2 to 8 degrees Celsius to maintain its efficacy.

Appearance

Lyophilized vial: A lyophilized mass that is white to pale yellow contained in a clear glass vial of an injection solution (The reconstituted solution from the lyophilized vial: colorless to pale yellow without visible particles

Package unit

1 vial/box ([[vial (1 mg) × 1 piece + IV stabilizer (7 mL) × 2 pieces]/box]