CV: peripheral edema.
Derm: stevens-johnson syndrome, toxic epidermal necrolysis, alopecia, night sweats, pruritus, rash, dry skin.
Endo: hyperglycemia.
F and E: KETOACIDOSIS.
GI: bowel obstruction, ENTEROCOLITIS, gi hemorrhage, gi perforation, gi ulcer, ileus, hepatotoxicity, NEUTROPENIC COLITIS, pancreatitis, abdominal pain, constipation, ↓appetite, diarrhea, nausea, vomiting, ulcer.
GU: ↓fertility.
Hemat: neutropenia, thrombocytopenia, anemia.
Metab: weight loss.
MS: arthralgia, back pain, extremity pain, myalgia, muscle spasm.
Neuro: peripheral neuropathy , PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML), anxiety, dizziness, fatigue, headache, insomnia.
Resp: acute respiratory distress syndrome, interstitial lung disease, cough, dyspnea, oropharyngeal pain.
Misc: (INCLUDING ANAPHYLAXIS)INFUSION REACTIONS , TUMOR LYSIS SYNDROME, fever, lymphadenopathy, chills.
Relapsed cHL or Relapsed Systemic Anaplastic Large Cell Lymphoma
- IV (Adults): 1.8 mg/kg (max dose = 180 mg) every 3 wk until disease progression or unacceptable toxicity.
Renal Impairment
- IV (Adults): CCr <30 mL/min — Avoid use.
Hepatic Impairment
- IV (Adults): Mild (Child-Pugh A) — 1.2 mg/kg (max dose = 120 mg) every 3 wk until disease progression or unacceptable toxicity; Moderate (Child-Pugh B) or severe (Child-Pugh C) — Avoid use.
cHL Consolidation
- IV (Adults): 1.8 mg/kg (max dose = 180 mg) every 3 wk until a maximum of 16 cycles completed, disease progression, or unacceptable toxicity. Initiate therapy within 4–6 wk post-auto-HSCT or upon recovery of auto-HSCT.
Renal Impairment
- IV (Adults): CCr <30 mL/min — Avoid use.
Hepatic Impairment
- IV (Adults): Mild (Child-Pugh A) — 1.2 mg/kg (max dose = 120 mg) every 3 wk until a maximum of 16 cycles completed, disease progression or unacceptable toxicity; Moderate (Child-Pugh B) or severe (Child-Pugh C) — Avoid use.
Previously Untreated Stage III or IV cHL
- IV (Adults): 1.2 mg/kg (max dose = 120 mg) every 2 wk until a maximum of 12 doses completed, disease progression or unacceptable toxicity.
Renal Impairment
- IV (Adults): CCr <30 mL/min — Avoid use.
Hepatic Impairment
- IV (Adults): Mild (Child-Pugh A) — 0.9 mg/kg (max dose = 90 mg) every 2 wk until a maximum of 12 doses completed, disease progression or unacceptable toxicity; Moderate (Child-Pugh B) or severe (Child-Pugh C) — Avoid use.
Relapsed Primary Cutaneous Anaplastic Large Cell Lymphoma or CD-30 Expressing Mycosis Fungoides
- IV (Adults): 1.8 mg/kg (max dose = 180 mg) every 3 wk until a maximum of 16 cycles completed, disease progression, or unacceptable toxicity.
Renal Impairment
- IV (Adults): CCr <30 mL/min — Avoid use.
Hepatic Impairment
- IV (Adults): Mild (Child-Pugh A) — 1.2 mg/kg (max dose = 120 mg) every 3 wk until a maximum of 16 cycles completed, disease progression, or unacceptable toxicity; Moderate (Child-Pugh B) or severe (Child-Pugh C) — Avoid use.
Previously Untreated Systemic Anaplastic Large Cell Lymphoma or Other CD-30 Expressing Peripheral T-Cell Lymphomas
- IV (Adults): 1.8 mg/kg (max dose = 180 mg) every 3 wk with each cycle of chemotherapy for 6–8 doses.
Renal Impairment
- IV (Adults): CCr <30 mL/min — Avoid use.
Hepatic Impairment
- IV (Adults): Mild (Child-Pugh A) — 1.2 mg/kg (max dose = 120 mg) every 3 wk with each cycle of chemotherapy for 6–8 doses; Moderate (Child-Pugh B) or severe (Child-Pugh C) — Avoid use.
Therapeutic Classification: antineoplastics
Pharmacologic Classification: drug-antibody conjugates
Absorption: IV administration results in complete bioavailability.
Distribution: Unknown.
Metabolism/Excretion: Small amounts of MMAE that are released are metabolized by the liver and eliminated mostly by the kidneys.
Half-life: ADC — 4–6 days.
2 prior multi-agent chemotherapies and are not candidates for auto-HSCT.