Indications & Uses
Pemroluma is indicated for:
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
Melanoma: 200 mg every 3 weeks NSCLC: 200 mg every 3 weeks SCLC: 200 mg every 3 weeks HNSCC: 200 mg every 3 weeks cHL or PMBCL: 200 mg every 3 weeks for adults; 2 mg/kg (up to 200 mg) every 3 weeks for pediatrics Urothelial Carcinoma: 200 mg every 3 weeks MSI-H Cancer: 200 mg every 3 weeks for adults and 2 mg/kg (up to 200 mg) every 3 weeks for pediatrics Gastric Cancer: 200 mg every 3 weeks Esophageal Cancer: 200 mg every 3 weeks Cervical Cancer: 200 mg every 3 weeks HCC: 200 mg every 3 weeks MCC: 200 mg every 3 weeks for adults; 2 mg/kg (up to 200 mg) every 3 weeks for pediatrics RCC: 200 mg every 3 weeks with axitinib 5 mg orally twice daily Endometrial Carcinoma: 200 mg every 3 weeks with lenvatinib 20 mg orally once daily for tumors that are not MSI-H or dMMR. Administer Pembrolizumab as an intravenous infusion over 30 minutes.
Side Effects
Most common adverse reactions (reported in ≥20% of patients) were:Pemomab as a single agent: fatigue, musculoskeletal pain, decreased appetite, pruritus, diarrhea, nausea, rash, pyrexia, cough, dyspnea, constipation, pain, and abdominal pain.Pemomab in combination with chemotherapy: fatigue/asthenia, nausea, constipation, diarrhea, decreased appetite, rash, vomiting, cough, dyspnea, pyrexia, alopecia, peripheral neuropathy, mucosal inflammation, and stomatitis.Pemomab in combination with axitinib: diarrhea, fatigue/asthenia, hypertension, hepatotoxicity, hypothyroidism, decreased appetite, palmar-plantar erythrodysesthesia, nausea, stomatitis/mucosal inflammation, dysphonia, rash, cough, and constipation.Pemomab in combination with lenvatinib: fatigue, hypertension, musculoskeletal pain, diarrhea, decreased appetite, hypothyroidism, nausea, stomatitis, vomiting, decreased weight, abdominal pain, headache, constipation, urinary tract infection, dysphonia, hemorrhagic events, hypomagnesemia, palmar-plantar erythrodysesthesia, dyspnea, cough, and rash.
Cautions & Contraindications
Warnings & Precautions
Immune-mediated pneumonitis: Withhold for moderate, and permanently discontinue for severe, life-threatening or recurrent moderate pneumonitis.Immune-mediated colitis: Withhold for moderate or severe, and permanently discontinue for life-threatening colitis.Immune-mediated hepatitis (Pemomab) and hepatotoxicity (Pemomab in combination with axitinib): Monitor for changes in hepatic function. Based on severity of liver enzyme elevations, withhold or discontinue Pemomab, axitinib, or Pemomab and axitinib. Consider corticosteroid therapy.Immune-mediated endocrinopathies: Adrenal insufficiency: Withhold for moderate and withhold or permanently discontinue for severe or life-threatening adrenal insufficiency. Hypophysitis: Withhold for moderate and withhold or permanently discontinue for severe or life-threatening hypophysitis. Thyroid disorders: Monitor for changes in thyroid function. Withhold or permanently discontinue for severe or life-threatening hyperthyroidism. Type 1 diabetes mellitus: Monitor for hyperglycemia. Withhold Pemomab in cases of severe hyperglycemia. Immune-mediated nephritis: Monitor for changes in renal function. Withhold for moderate, and permanently discontinue for severe or life-threatening nephritis.Immune-mediated skin adverse reactions including, Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN): Withhold for severe and permanently discontinue for life-threatening skin reactions.Other immune-mediated adverse reactions: In organ transplant recipients, consider the benefit of treatment with Pemomab versus the risk of possible organ rejection.Infusion-related reactions: Stop infusion and permanently discontinue Pemomab for severe or life-threatening infusion reactions.Complications of allogeneic HSCT: Allogeneic HSCT after treatment with Pemomab: Monitor for hepatic veno-occlusive disease, grade 3-4 acute GVHD including hyperacute GVHD, steroid-requiring febrile syndrome, and other immune-mediated adverse reactions. Transplant-related mortality has occurred. Allogeneic HSCT prior to treatment with Pemomab: In patients with a history of allogeneic HSCT, consider the benefit of treatment with Pemomab versus the risk of GVHD.Treatment of patients with multiple myeloma with a PD-1 or PD-L1 blocking antibody in combination with a thalidomide analogue plus dexamethasone is not recommended outside of controlled clinical trials.Embryo-Fetal toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective method of contraception.
Contraindications
None.