CV: peripheral edema, MYOCARDITIS, pericarditis, vasculitis.
Derm: pruritus, rash, DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (DRESS), STEVENS-JOHNSON SYNDROME, TOXIC EPIDERMAL NECROLYSIS.
EENT: keratitis, uveitis.
Endo: hyperglycemia, immune-mediated adrenal insufficiency, immune-mediated hyperthyroidism, immune-mediated hypophysitis, immune-mediated hypothyroidism, immune-mediated type 1 diabetes mellitus.
F and E: hyperkalemia, hypocalcemia, hyponatremia, hypercalcemia, hypermagnesemia, hypokalemia.
GI: ↓ appetite, abdominal pain, constipation, nausea, gastritis, hypoalbuminemia, immune-mediated colitis, IMMUNE-MEDIATED HEPATITIS, pancreatitis.
GU: immune-mediated nephritis.
Hemat: lymphopenia, anemia, hemolytic anemia, NEUTROPENIA.
MS: pain, myositis, RHABDOMYOLYSIS.
Neuro: Guillain-Barré syndrome, autoimmune neuropathy, ENCEPHALITIS, MENINGITIS, myasthenic syndrome, myelitis.
Resp: cough, dyspnea, IMMUNE-MEDIATED PNEUMONITIS.
Misc: fatigue, fever, infection, INFUSION-RELATED REACTIONS.
Unresectable Stage III Non-Small Cell Lung Cancer
- IV (Adults ≥30 kg): 10 mg/kg every 2 wk or 1500 mg every 4 wk; continue until disease progression, unacceptable toxicity, or a maximum of 12 mo.
- IV (Adults <30 kg): 10 mg/kg every 2 wk until disease progression, unacceptable toxicity, or a maximum of 12 mo.
Metastatic Non-Small Cell Lung Cancer
- IV (Adults ≥30 kg): Non-squamous: Cycles 1–4: 1500 mg on Day 1 every 3 wk (administered prior to platinum-based chemotherapy and following tremelimumab); Cycle 5 (3 wk after previous durvalumab dose): 1500 mg on Day 1 (administered prior to pemetrexed [if being used for maintenance]); Cycle 6 (4 wk after previous durvalumab dose): 1500 mg on Day 1 (administered prior to pemetrexed [if being used for maintenance] and following tremelimumab); Cycle 7 (4 wk after previous durvalumab dose) and beyond: 1500 mg on Day 1 every 4 wk (administered prior to pemetrexed [if being used for maintenance]); continue until disease progression or unacceptable toxicity. Squamous: Cycles 1–4: 1500 mg on Day 1 every 3 wk (administered prior to platinum-based chemotherapy and following tremelimumab); Cycle 5 (3 wk after previous durvalumab dose): 1500 mg on Day 1 (as monotherapy); Cycle 6 (4 wk after previous durvalumab dose): 1500 mg on Day 1 (administered following tremelimumab); Cycle 7 (4 wk after previous durvalumab dose) and beyond: 1500 mg on Day 1 every 4 wk (as monotherapy); continue until disease progression or unacceptable toxicity.
- IV (Adults <30 kg): Non-squamous: Cycles 1–4: 20 mg/kg on Day 1 every 3 wk (administered prior to platinum-based chemotherapy and following tremelimumab); Cycle 5 (3 wk after previous durvalumab dose): 20 mg/kg on Day 1 (administered prior to pemetrexed [if being used for maintenance]); Cycle 6 (4 wk after previous durvalumab dose): 20 mg/kg on Day 1 (administered prior to pemetrexed [if being used for maintenance] and following tremelimumab); Cycle 7 (4 wk after previous durvalumab dose) and beyond: 20 mg/kg on Day 1 every 4 wk (administered prior to pemetrexed [if being used for maintenance]); continue until disease progression or unacceptable toxicity. Squamous: Cycles 1–4: 20 mg/kg on Day 1 every 3 wk (administered prior to platinum-based chemotherapy and following tremelimumab); Cycle 5 (3 wk after previous durvalumab dose): 20 mg/kg on Day 1 (as monotherapy); Cycle 6 (4 wk after previous durvalumab dose): 20 mg/kg on Day 1 (administered following tremelimumab); Cycle 7 (4 wk after previous durvalumab dose) and beyond: 20 mg/kg on Day 1 every 4 wk (as monotherapy); continue until disease progression or unacceptable toxicity.
Small Cell Lung Cancer
- IV (Adults ≥30 kg): 1500 mg every 3 wk for 4 cycles (administered prior to etoposide and either carboplatin or cisplatin on the same day), then 1500 mg every 4 wk (as monotherapy); continue until disease progression or unacceptable toxicity.
- IV (Adults <30 kg): 20 mg/kg every 3 wk for 4 cycles (administered prior to etoposide and either carboplatin or cisplatin on the same day), then 20 mg/kg every 4 wk (as monotherapy); continue until disease progression or unacceptable toxicity.
Biliary Tract Cancer
- IV (Adults ≥30 kg): 1500 mg every 3 wk for up to 8 cycles (administered prior to gemcitabine and cisplatin on the same day), then 1500 mg every 4 wk (as monotherapy); continue until disease progression or unacceptable toxicity.
- IV (Adults <30 kg): 20 mg/kg every 3 wk for up to 8 cycles (administered prior to gemcitabine and cisplatin on the same day), then 20 mg/kg every 4 wk (as monotherapy); continue until disease progression or unacceptable toxicity.
Hepatocellular Carcinoma
- IV (Adults ≥30 kg): 1500 mg administered following a single dose of tremelimumab on Day 1 of Cycle 1, then 1500 mg every 4 wk (as monotherapy); continue until disease progression or unacceptable toxicity.
- IV (Adults <30 kg): 20 mg/kg administered following a single dose of tremelimumab on Day 1 of Cycle 1, then 20 mg/kg every 4 wk (as monotherapy); continue until disease progression or unacceptable toxicity.
Therapeutic Classification: antineoplastics
Pharmacologic Classification: monoclonal antibodies
Absorption: IV administration results in complete bioavailability.
Distribution: Minimally distributed to tissues.
Metabolism/Excretion: Unknown.
Half-life: 18 days.