Pembrolizumab (Keytruda) 100mg/4mL | Japan PMDA-Approved PD-1 Inhibitor | GLT

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Product description

Generic Name: Pembrolizumab
Salt Name: Pembrolizumab (recombinant humanized anti-PD-1 monoclonal antibody)
Availability: On Request
Manufacturer: Merck Sharp & Dohme | Japan
Strength: 100mg/4mL injection

What is Pembrolizumab (Keytruda)?

Pembrolizumab is a humanized monoclonal antibody that targets the PD-1 receptor on T-cells. By blocking the PD-1 immune checkpoint, it releases the brake on the immune system and enables T-cells to recognize and attack cancer cells. It is approved by the U.S. FDA, Japan's PMDA, and other regulatory agencies for the treatment of multiple advanced cancers.

What is Keytruda Used For?

Keytruda (pembrolizumab) is approved for a broad range of indications including non-small cell lung cancer (NSCLC), melanoma, head and neck squamous cell carcinoma, classical Hodgkin lymphoma, urothelial carcinoma, gastric cancer, esophageal cancer, cervical cancer, hepatocellular carcinoma, renal cell carcinoma, and microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors.

PMDA-Approved Indications in Japan

The Japan version of Keytruda is approved by the Pharmaceuticals and Medical Devices Agency (PMDA) for multiple indications, including:

  • Non-small cell lung cancer (NSCLC)
  • Melanoma (unresectable)
  • Classical Hodgkin lymphoma
  • Urothelial carcinoma
  • Head and neck squamous cell carcinoma
  • Gastric cancer
  • Esophageal cancer
  • Microsatellite instability-high (MSI-H) solid tumors

How Does Pembrolizumab Work?

PD-1 is a checkpoint protein on T-cells that normally keeps the immune response in check. Cancer cells often exploit PD-1 by expressing PD-L1, which binds to PD-1 and switches off the T-cell attack. Pembrolizumab binds to PD-1, preventing this interaction and restoring the immune system's ability to detect and destroy tumor cells.

Dosage & Administration

The recommended dose is 200 mg every 3 weeks or 400 mg every 6 weeks, administered as an intravenous infusion over 30 minutes. Treatment continues until disease progression or unacceptable toxicity. Dosing must be determined by the treating oncologist.

Common Side Effects

The most common adverse reactions (≥20%) include fatigue, musculoskeletal pain, decreased appetite, pruritus, diarrhea, nausea, rash, and cough. Immune-related adverse events such as pneumonitis, colitis, hepatitis, and endocrinopathies may occur and require prompt medical attention.

Storage

Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze. Do not shake.

Why Choose the GLT?

The Japan version is manufactured by Merck Sharp & Dohme under the same global quality standards as other markets. For patients and institutions in Asia, it offers a locally approved option with full regulatory documentation.

Quality Assurance

All Keytruda supplied by GIVE LIFE TIME LIMITED is sourced from authorized channels with full batch traceability and Certificate of Analysis (COA). Every shipment includes export-ready documentation: commercial invoice, packing list, and Certificate of Origin.

How to Order

To request pricing and place an order, please follow these steps:

  1. Send your prescription or case file via WhatsApp or email — reviewed within 24 hours
  2. Receive a formal quotation with pricing, availability, and shipping options
  3. Confirm and arrange payment via bank transfer or PayPal
  4. Ship globally with full export documentation and tracking

Send your prescription / case file now: WhatsApp: +86 15234153837

Frequently Asked Questions

Is the Japan version of Keytruda the same molecule as the US version?

Yes. The active ingredient pembrolizumab is identical across markets and is manufactured by Merck Sharp & Dohme under the same quality standards. The difference is the regulatory market (Japan, approved by PMDA).

Is a prescription required?

Yes. Keytruda is a prescription-only medicine. A valid prescription from a licensed oncologist is required. Please send your prescription or case file via WhatsApp before ordering.

How long does international shipping take?

Most orders are dispatched within 3-5 business days after payment confirmation, with delivery times of 7-14 business days depending on destination and customs clearance.

Do you ship with cold-chain logistics?

Yes. Keytruda requires temperature-controlled shipping (2-8°C) and is packed in validated cold-chain packaging.

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