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Pembrolizumab

Pembrolizumab

-Pembrolizumab is a monoclonal antibody used in cancer treatment. It belongs to the class of immune checkpoint inhibitors and works by blocking the programmed death receptor-1 (PD-1) pathway, enhancing the body's immune response against cancer cells. -Pembrolizumab is a immune checkpoint inhibitor drug that works by binding to the protein PD-1 on the surface of certain immune cells called T cells, which keeps cancer cells from suppressing the immune system. This allows the immune system to attack the cancer cells.

Indications

Pembrolizumab is a monoclonal antibody used to treat patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. It is also used to treat non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), classical Hodgkin lymphoma cHL), and urothelial carcinoma (UC).


Dosage

Lyophilized powder for reconstitution 50 mg/vial and Solution for injection 100 mg/4mL (25mg/ml) Melanoma Indicated for unresectable or metastatic melanoma 2 mg/kg intravenously (IV) every 3 weeks until disease progression or unacceptable toxicity Infuse IV over 30 minutes. Non-Small Cell Lung Cancer (NSCLC) Indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression [Tumor Proportion Score (TPS) 50% or greater)] as determined by an FDA approved test, with no EGFR or ALK genomic tumor aberrations -Also indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS 1% or greater) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy; patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving pembrolizumab -200 mg intravenously (IV) every 3 weeks until disease progression or unacceptable toxicity, or up to 24 months in patients without disease progression Select patients for treatment of metastatic NSCLC as a single agent based on the presence of positive PD-L1 expression Head and Neck Squamous Cell Carcinoma (HNSCC). Indicated for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinumcontaining chemotherapy. -200 mg intravenously (IV) every 3 weeks infused over 30 minutes until disease progression, unacceptable toxicity,or up to 24 months in patients without disease progression. Classical Hodgkin Lymphoma (cHL) Indicated for adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL) or who have relapsed after 3 or more prior lines of therapy Adult: 200 mg intravenously (IV) every 3 weeks Pediatric: 2 mg/kg IV every 3wk; not to exceed 200 mg/dose Continue until disease progression or unacceptable toxicity, or up to 24 months in patients without disease progression Urothelial Carcinoma Indicated for locally advanced or metastatic urothelial carcinoma (UC) in patients who are not eligible for cisplatin-containing chemotherapy; also indicated for patients with disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy -200 mg intravenously (IV) every 3 weeks until disease progression or unacceptable toxicity, or up to 24 months in patients without disease progression


Contra-Indications

Pembrolizumab is contraindicated in individuals with known hypersensitivity to the drug. Caution is advised in patients with autoimmune disorders, as the medication may exacerbate these conditions.


Special Precautions

Paediatric: Data not sufficient Pregnancy:There is positive evidence of human fetal risk. Women of reproductive potential should use highly effective contraception during treatment and for 4 months after the last dose. Lactation: It is not recommended for use while breastfeeding. Elderly: Data not sufficient.


Side Effects

Fatigue, Anaemia, High blood sugar (hyperglycemia), Hyponatremia, Hypoalbuminemia, Nausea,, Cough, Itching, Rash, Decreased appetite, Hypertriglyceridemia, Increased AST, Constipation, Diarrhea, Joint pain, Pain in extremity, Shortness of breath, Swelling of extremities, Vomiting, Headache, Muscle pain, Chills, Insomnia, Abdominal pain, Back pain, Dizziness, Fever, Upper respiratory tract infection, Loss of skin pigmentation (vitiligo), Sepsis, Immune-mediated hypothyroidism, Immune-mediated pneumonitis, Immune-mediated hyperthyroidism, Immune-mediated colitis.


Drug Interactions

No clinically significant drug interactions have been reported with commonly used medications. However, caution should be exercised when combining pembrolizumab with other immunosuppressive agents.


Other Brands With Same Generic
Brand Name Manufactured by
KEYTRUDA MSD Pharmaceuticals Pvt. Ltd.
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