Talazoparib Capsule 1 mg (Talazoparib Tosylate)

Adult dose

This medicine is administered orally at 1 mg once daily. Continue treatment until disease progression or unacceptable toxicity occurs. If a patient vomits or misses a dose, an additional dose should not be taken. The next prescribed dose should be taken at the scheduled time. Hemoglobin < 8 g/dL: Interrupt treatment with this medicine until recovery to the value below. ≥ 9 g/dL: Resume this medicine at one dose level lower Platelet count < 50,000/μL: Interrupt treatment with this medicine until recovery to the value below. ≥ 75,000/μL: Resume this medicine at one dose level lower Neutrophil count < 1,000/μL: Interrupt treatment with this medicine until recovery to the value below. ≥ 1,500/µL: Resume this medicine at one dose level lower Grade 3 or 4 nonhematologic adverse reactions: Interrupt treatment with this medicine until recovery to the value below. ≤Grade 1: Resume this medicine at one dose level lower or discontinue treatment Recommended starting dose: 1 mg once daily First dose reduction: 0.75 mg once daily Second dose reduction: 0.5 mg once daily Third dose reduction: 0.25 mg once daily If concomitant administration of a strong P-gp inhibitor is unavoidable, reduce the dose of this medicine by one dose level. If the strong P-gp inhibitor is discontinued, increase the dose of this medicine to the dose used before administration of the strong P-gp inhibitor after 3-5 half-lives of the P-gp inhibitor. No dose adjustment is necessary in patients with mild renal impairment (60 mL/min≤creatinine clearance [CrCl]<90 mL/min). The recommended starting dose of this medicine in patients with moderate renal impairment (30 mL/min≤CrCl<60 mL/min) is 0.75 mg once daily. The recommended starting dose of this medicine in patients with severe renal impairment (15mL/min≤CrCL<30mL/min) is 0.5 mg once daily. This medicine has not been studied in patients with CrCL<15 mL/min or in patients requiring hemodialysis. No dose adjustment is necessary in patients with mild hepatic impairment (total bilirubin≤1×upper limit of normal [ULN] and aspartate aminotransferase (AST)>ULN, or total bilirubin>1.0-1.5×ULN and any AST), moderate hepatic impairment (total bilirubin>1.5-3.0×ULN and any AST), or severe hepatic impairment (total bilirubin>3.0×ULN and any AST).

This medication can cause severe blood disorders such as myelodysplastic syndrome or acute myeloid leukemia; therefore, regular blood tests must be conducted before and during treatment to closely monitor the condition. Women of childbearing potential must use highly effective contraception during treatment and should be tested for pregnancy before administration. This medication can be harmful to the fetus when administered to pregnant women; thus, women who are pregnant or planning to become pregnant should not use this drug. Breastfeeding women are advised to avoid breastfeeding during treatment and for at least one month after treatment. This medication may decrease red blood cells, white blood cells, and platelets, leading to symptoms such as fatigue, increased risk of infections, and bleeding; therefore, if any of these symptoms occur, contact medical personnel immediately. During treatment, symptoms such as fatigue, dizziness, and headache may occur, so caution is needed when driving or operating machinery. The blood concentration of this medication can be altered when taken with certain other drugs; therefore, inform your healthcare provider if you are taking other medications. This medication must be used under the management of a physician experienced in the use of chemotherapy agents, and patients should not stop or alter the dose based on personal judgment. In case of overdose, visit a medical institution immediately for appropriate treatment and store the medication out of reach of children.

• Fatigue
• anemia
• nausea
• neutropenia
• thrombocytopenia
• headache
• thrombocytopenia
• anemia
• neutropenia
• leukopenia

This medication may be sensitive to air and moisture; therefore, it must be stored in a tightly sealed container. It is important to maintain a storage temperature between 1 and 30 degrees Celsius to preserve the medication's effectiveness.

Appearance

An opaque hard capsule with a bright red upper part and a white lower part containing a yellowish-white to off-white powder.

Package unit

30 capsules/bottle