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Pembrolizumab (Keytruda)

Trade Name : KEYTRUDA

Merck Sharp & Dohme Corp.

INJECTION, SOLUTION

Strength 25 mg/mL

PEMBROLIZUMAB Programmed Death Receptor-1 Blocking Antibody [EPC],Programmed Death Receptor-1-directed Antibody Interactions [MoA]

Delivery Process

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You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

Product information is meant for

Wholesalers Suppliers Exporters Doctors MOH Tender Supplies Hospitals Brand CROs Comparator Supplies Generic Cooperate Sourcing Individual Patients Indian Institutional Buyers

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Pembrolizumab (Keytruda) which is also known as KEYTRUDA and Manufactured by Merck Sharp & Dohme Corp.. It is available in strength of 25 mg/mL per ml. Read more

Pembrolizumab (Keytruda) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • No data
  • KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated:
  • Melanoma
  • Non-Small Cell Lung Cancer (NSCLC)
  • Small Cell Lung Cancer (SCLC
  • Head and Neck Squamous Cell Cancer (HNSCC)
  • Classical Hodgkin Lymphoma (cHL)
  • Primary Mediastinal Large B-Cell Lymphoma (PMBCL)
  • Urothelial Carcinoma
  • Microsatellite Instability-High Cancer
  • Gastric Cancer
  • Esophageal Cancer
  • Cervical Cancer
  • Hepatocellular Carcinoma (HCC)
  • Merkel Cell Carcinoma (MCC)
  • Renal Cell Carcinoma (RCC)
  • Endometrial Carcinoma
  • 1
  • Administer KEYTRUDA as an intravenous infusion over 30 minutes.
  • 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. ()
  • No data
  • Injection: 100 mg/4 mL (25 mg/mL) solution in a single-dose vial ()
  • None.
  • None. ()
  • No data
  • 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 (KEYTRUDA) and hepatotoxicity (KEYTRUDA in combination with axitinib): Monitor for changes in hepatic function. Based on severity of liver enzyme elevations, withhold or discontinue KEYTRUDA, axitinib, or KEYTRUDA and axitinib. Consider corticosteroid therapy. (, )
  • Immune-mediated endocrinopathies (): n
  • 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 KEYTRUDA versus the risk of possible organ rejection. ()
  • Infusion-related reactions: Stop infusion and permanently discontinue KEYTRUDA for severe or life-threatening infusion reactions. ()
  • Complications of allogeneic HSCT (): n
  • 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. (, , )
  • The following clinically significant adverse reactions are described elsewhere in the labeling.
  • Most common adverse reactions (reported in u226520% of patients) were:
  • To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., at 1-877-888-4231 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • KEYTRUDA as a single agent: fatigue, musculoskeletal pain, decreased appetite, pruritus, diarrhea, nausea, rash, pyrexia, cough, dyspnea, constipation, pain, and abdominal pain. ()
  • KEYTRUDA in combination with chemotherapy: fatigue/asthenia, nausea, constipation, diarrhea, decreased appetite, rash, vomiting, cough, dyspnea, pyrexia, alopecia, peripheral neuropathy, mucosal inflammation, and stomatitis. ()
  • KEYTRUDA in combination with axitinib: diarrhea, fatigue/asthenia, hypertension, hepatotoxicity, hypothyroidism, decreased appetite, palmar-plantar erythrodysesthesia, nausea, stomatitis/mucosal inflammation, dysphonia, rash, cough, and constipation. ()
  • KEYTRUDA 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. ()
  • Lactation: Advise not to breastfeed. ()
  • Pembrolizumab is a programmed death receptor-1 (PD 1)-blocking antibody. Pembrolizumab is a humanized monoclonal IgG4 kappa antibody with an approximate molecular weight of 149 kDa. Pembrolizumab is produced in recombinant Chinese hamster ovary (CHO) cells.
  • KEYTRUDA (pembrolizumab) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution for intravenous use. Each vial contains 100 mg of pembrolizumab in 4 mL of solution. Each 1 mL of solution contains 25 mg of pembrolizumab and is formulated in: L-histidine (1.55 mg), polysorbate 80 (0.2 mg), sucrose (70 mg), and Water for Injection, USP.
  • No data
  • No data
  • No data
  • KEYTRUDA injection (clear to slightly opalescent, colorless to slightly yellow solution):
  • Carton containing one 100 mg/4 mL (25 mg/mL), single-dose vial (NDC 0006-3026-02)
  • Carton containing two 100 mg/4 mL (25 mg/mL), single-dose vials (NDC 0006-3026-04)
  • Store vials under refrigeration at 2u00b0C to 8u00b0C (36u00b0F to 46u00b0F) in original carton to protect from light. Do not freeze. Do not shake.
  • Advise the patient to read the FDA-approved patient labeling (Medication Guide).
  • Manufactured by: Merck Sharp & Dohme Corp., a subsidiary ofn Whitehouse Station, NJ 08889, USAU.S. License No. 0002
  • For KEYTRUDA injection, at:MSD Ireland (Carlow)County Carlow, Ireland
  • For patent information: www.merck.com/product/patent/home.html
  • The trademarks depicted herein are owned by their respective companies.
  • Copyright u00a9 2014-2020 Merck Sharp & Dohme Corp., a subsidiary ofn All rights reserved.
  • uspi-mk3475-iv-2001r032
  • No data
  • NDC 0006-3029-02
  • Keytrudan- (pembrolizumab)for Injection
  • 50 mg / vial
  • For Intravenous Infusion Only
  • Dispense the enclosed Medication Guide to each patient.
  • Sterile lyophilized powder must be reconstituted with Sterile Water forInjection, USP. Reconstituted solution requires further dilution priorto administration.
  • Rx only
  • Single-dose vial. Discard unused portion.
  • NDC 0006-3026-02
  • tttttttKeytrudan ttttttt(pembrolizumab)Injection tttttt
  • ttttttt100 mg/4 mL ttttttt(25 mg/mL)
  • tttttttFor Intravenous Infusion Only tttttt
  • tttttttDispense the enclosed Medication Guide to each patient. tttttt
  • Requires dilution prior to administration.
  • tttttttRx only tttttttSingle-dose vial. Discard unused portion.

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