Anaplastic large T-cell systemic malignant lymphoma, After the failure of at least one multi-agent chemotherapy regimen.
Hodgkin's disease, after failure of autologous hematopoietic stem cell transplant (auto-HSCT) or after failure of at least 2 multiagent chemotherapy regimens in patients not eligible for auto-HSCT.
Hodgkin's disease, Consolidation therapy after autologous hematopoietic stem-cell transplantation (auto-HSCT).
藥理
Brentuximab vedotin is a CD30-directed antibody-drug conjugate (ADC) consisting of 3 components: the chimeric IgG1 antibody cAC10 which is specific for human CD30
藥動學
Antibody Drug Conjugate (ADC), Vd: 6 to 10 L; Protein binding, 68% to 82%; Metabolism: hepatic: limited via CYP3A4/5. Excretion: Renal excretion: up to 24%; Elimination Half Life: Antibody Drug Conjugate (ADC), 4 to 6 days.
禁忌症
Concomitant use with bleomycin.
懷孕分類
Based on the mechanism of action and on animal data, brentuximab vedotin may cause fetal harm if administered to a pregnant woman. In women of reproductive potential, verify pregnancy prior to treatment initiation. Women of reproductive potential and men with female partners of reproductive potential should avoid pregnancy during treatment and for at least 6 months after the final dose. Brentuximab vedotin treatment may compromise fertility in males.
哺乳分類
Does not recommend breast-feeding during treatment
副作用
Common:
Cardiovascular: Peripheral edema (4% to 16%)
Central nervous system: Peripheral neuropathy (54% to 67%), peripheral sensory neuropathy (2% to 56%; grade 3: 8% to 10%), fatigue (24% to 49%), pain (7% to 28%), peripheral motor neuropathy (4% to 23%; grade 3: 3% to 6%), headache (11% to 19%), insomnia (14% to 16%), dizziness (11% to 16%), chills (10% to 13%), anxiety (7% to 11%)
Dermatologic: Skin rash (27% to 31%), pruritus (12% to 19%), alopecia (13% to 14%), night sweats (9% to 12%)
Endocrine & metabolic: Weight loss (6% to 19%)
Gastrointestinal: Nausea (2% to 42%), diarrhea (20% to 36%), abdominal pain (3% to 25%), vomiting (3% to 22%), constipation (13% to 19%), decreased appetite (11% to 16%)
Hematologic & oncologic: Neutropenia (54% to 78%; grade 3: 12% to 30%; grade 4: 6% to 9%), anemia (27% to 52%; grade 3: 2% to 8%; grade 4: 4%), thrombocytopenia (16% to 41%; grade 3: 5% to 7%; grade 4: 2% to 5%), lymphadenopathy (10% to 11%)
Immunologic: Antibody development (antibrentuximab; transient: 30%; persistent: 7%)
Neuromuscular & skeletal: Arthralgia (9% to 19%), myalgia (11% to 17%), back pain (10% to 14%), muscle spasm (9% to 11%)
Respiratory: Upper respiratory tract infection (12% to 47%), cough (17% to 25%), dyspnea (13% to 19%), oropharyngeal pain (9% to 11%)
Miscellaneous: Fever (2% to 38%), infusion related reaction (12% to 15%)
劑量和給藥方法
Hodgkin lymphoma, relapsed or refractory: IV: 1.8 mg/kg (maximum dose: 180 mg) every 3 weeks, continue until disease progression or unacceptable toxicities.
Hodgkin lymphoma, consolidation therapy after autologous hematopoietic stem cell transplantation (HSCT): IV: 1.8 mg/kg (maximum dose: 180 mg) every 3 weeks, continue until a maximum of 16 cycles, disease progression, or unacceptable toxicity. Begin therapy within 4 to 6 weeks post HSCT or upon recovery from HSCT.
Systemic anaplastic large cell lymphoma (sALCL), refractory: IV: 1.8 mg/kg (maximum dose: 180 mg) every 3 weeks, continue until disease progression or unacceptable toxicities.
小兒調整劑量
腎功能調整劑量
Renal impairment, mild or moderate (CrCl 30 to 80 mL/min): No dosage adjustment required. Renal impairment, severe (CrCl less than 30 mL/min): Avoid use.
肝功能調整劑量
Hepatic impairment, mild (Child-Pugh A): Reduce dose to 1.2 mg/kg (maximum, 120 mg)
Hepatic impairment, moderate to severe (Child-Pugh B or C): Avoid use.