Talzenna Capsule 0.1 mg (Talazoparib Tosylate)

Adult dose

This medicine is for oral use. Swallow the capsule whole to avoid contact with its contents; do not open or dissolve the capsule. This medicine may be taken with or without food. Administer this medicine orally at a dose of 1 mg once daily. Continue treatment until disease progression or unacceptable toxicity occurs. The recommended dose of this medicine is 0.5 mg, administered orally once daily with enzalutamide 160mg. Patients should continue treatment until disease progression or unacceptable toxicity occurs. Medical castration with a luteinizing hormone-releasing hormone (LHRH) analog should be continued during treatment in patients who have not undergone surgical castration. If the patient vomits or misses a dose, do not administer an additional dose. Take the next prescribed dose at the scheduled time. Hemoglobin < 8 g/dL: Interrupt treatment with this medicine until recovery to ≥ 9 g/dL, then resume treatment at a reduced dose Platelet count < 50,000/μL: Interrupt treatment with this medicine until recovery to ≥ 75,000/μL, then resume treatment at a reduced dose Neutrophil count < 1,000/μL: Interrupt treatment with this medicine until recovery to ≥ 1,500/µL, then resume treatment at a reduced dose Grade 3 or 4 nonhematologic adverse reaction: Interrupt treatment with this medicine until recovery to ≤ Grade 1, then resume at a reduced dose or discontinue treatment Dose reduction when this medicine is used as monotherapy (breast cancer) 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 Dose reduction when this medicine is administered with enzalutamide (prostate cancer) Recommended starting dose: 0.5 mg once daily First dose reduction: 0.35 mg once daily Second dose reduction: 0.25 mg once daily Third dose reduction: 0.1 mg once daily 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 in patients with severe renal impairment (15 mL/min<CrCl<30 mL/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 (see Pharmacokinetic Properties). No dose adjustment is necessary in patients with mild renal impairment (60 mL/min≤creatinine clearance [CrCL]<90 mL/min). The recommended starting dose in patients with moderate renal impairment (30 mL/min≤CrCL<60 mL/min) is 0.35mg of this medicine orally once daily in combination with enzalutamide. The recommended starting dose in patients with severe renal impairment (15mL/min≤CrCL<30mL/min) is 0.25mg of this medicine once daily in combination with enzalutamide. This medicine has not been studied in patients with CrCL <15 mL/min or in patients requiring hemodialysis (see Pharmacokinetic Properties). 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) (see Pharmacokinetic Properties).

This drug may cause serious blood cancers such as myelodysplastic syndrome or acute myeloid leukemia, so blood tests should be conducted thoroughly before and during administration to monitor blood status. Women of childbearing potential must not become pregnant while taking this medication and must test for pregnancy prior to starting the drug. During and for some time after taking this drug, effective contraception must be used, and for breast cancer patients, it is particularly recommended to use non-hormonal methods rather than hormonal contraception. This medication should not be used by individuals with allergies to any components or excipients and by nursing women. Common side effects may include fatigue, nausea, vomiting, and decreased blood cell counts, so if symptoms are severe or persistent, medical advice should be sought. Bone marrow suppression side effects may frequently result in decreased blood cell counts such as anemia, leukopenia, and thrombocytopenia, making regular blood tests necessary. If these side effects occur, dose adjustments or temporary cessation may be required. Fatigue or dizziness may occur during driving or operating machinery, so caution is advised. This medication may interact with other drugs, so it should be reported to healthcare providers especially when taken with certain antibiotics, antivirals, or medications such as enzalutamide, as dose adjustments may be needed. Pregnant women or those who may become pregnant should not take this medication, and nursing mothers should avoid it as well. Safety for children or the elderly has not been sufficiently verified, however, elderly patients do not require separate dose adjustments. In case of overdose, stop taking the medication immediately and obtain appropriate medical care, which may include emergency treatment such as gastric lavage. This drug must be kept out of reach of children and stored in its original container to prevent misuse or degradation of quality.

• Myelodysplastic syndromes
• acute myeloid leukemia
• fatigue
• anemia
• nausea
• neutropenia
• thrombocytopenia
• headache
• leukopenia
• lymphopenia

This medication may be sensitive to air or moisture, so it must be stored in a tightly sealed container. It is recommended to maintain a storage temperature between 1 and 30 degrees Celsius. This will help retain the drug's efficacy and safety over time.

Appearance

An opaque hard capsule with a white to off-white powder of yellowish hue in the upper part and white in the lower part.

Package unit

30 capsules/bottle