Brolizum

Pack	Price	Details
100 mg vial	৳	100 mg vial: ৳ 60,000.00

• 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.

Most common adverse reactions (reported in ≥20% of patients) were:

Brolizum as a single agent: fatigue, musculoskeletal pain, decreased appetite, pruritus, diarrhea, nausea, rash, pyrexia, cough, dyspnea, constipation, pain, and abdominal pain.

Brolizum in combination with chemotherapy: fatigue/asthenia, nausea, constipation, diarrhea, decreased appetite, rash, vomiting, cough, dyspnea, pyrexia, alopecia, peripheral neuropathy, mucosal inflammation, and stomatitis.

Brolizum in combination with axitinib: diarrhea, fatigue/asthenia, hypertension, hepatotoxicity, hypothyroidism, decreased appetite, palmar-plantar erythrodysesthesia, nausea, stomatitis/mucosal inflammation, dysphonia, rash, cough, and constipation.

Brolizum 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.

Binding of the PD-1 ligands, PD-L1 and PD-L2, to the PD-1 receptor found on T cells, inhibits T cell proliferation and cytokine production. Upregulation of PD-1 ligands occurs in some tumors and signaling through this pathway can contribute to inhibition of active T-cell immune surveillance of tumors. Pembrolizumab is a monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2, releasing PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response. In syngeneic mouse tumor models, blocking PD-1 activity resulted in decreased tumor growth.

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 (Brolizum) and hepatotoxicity (Brolizum in combination with axitinib): Monitor for changes in hepatic function. Based on severity of liver enzyme elevations, withhold or discontinue Brolizum, axitinib, or Brolizum 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 Brolizum 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 Brolizum versus the risk of possible organ rejection.

Infusion-related reactions: Stop infusion and permanently discontinue Brolizum for severe or life-threatening infusion reactions.

Complications of allogeneic HSCT: Allogeneic HSCT after treatment with Brolizum: 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 Brolizum: In patients with a history of allogeneic HSCT, consider the benefit of treatment with Brolizum 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.

Immunological Chemotherapy, Immunosuppressant

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