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keytruda pembrolizumab injection 100mg 4ml per vial package

Description

 Indication & Scope

Pembrolizumab Injection (Keytruda®) is a humanized monoclonal antibody targeting PD-1. It blocks the binding between PD-1 and PD-L1/PD-L2, relieves tumor-induced immune suppression and reactivates T cell-mediated anti-tumor immunity to eliminate cancer cells.

  • Mechanism
    Block PD-1/PD-L1 interaction to restore anti-tumor immune function of T lymphocytes
  • Drug class
    Intravenous anti-PD-1 immune checkpoint inhibitor concentrate
  • Clinical use
    Melanoma, non-small cell lung cancer, head and neck carcinoma, urothelial carcinoma, cervical cancer and MSI-H/dMMR pan-solid tumors
Specification
Generic Name Pembrolizumab Injection
Brand Name Keytruda®
Ingredient Pembrolizumab
Dosage Form Injection
Package 100mg/4ml/vial
Conditions Treated Unresectable or metastatic melanoma
Taboos Severe hypersensitivity to pembrolizumab or excipients; active autoimmune disorders, pregnancy and lactation
Place of origin Carlow, Ireland
Priscription Type Prescription Drug, Class B Medicare
Storage Conditions Store at 2℃-8℃, protected from light, sealed
Manufacturer MSD Ireland (Carlow)
Registration Authority National Medical Products Administration (NMPA)
Approval number SJ20180019
Approval Date December 22, 2022
Shelf Life 36 months

How to use ?

Recommended Dose: Most solid tumors: 200mg once every 3 weeks or 400mg once every 6 weeks via intravenous infusion

 

Time: Administer as an intravenous infusion over 30 minutes; do not give as rapid bolus or IV push

 

Interaction: Avoid long-term high-dose systemic corticosteroids and immunosuppressants before treatment, except for managing immune-related adverse events

 

Side effects: Fatigue, pruritus, rash, hypothyroidism, diarrhea, nausea; severe risks: Immune-related pneumonitis, colitis, hepatitis, endocrinopathies, severe infusion reactions

Important Notice

This product shall only be used for post-exposure rabies prophylaxis by professional medical staff. It must be applied combined with rabies vaccine and injected via wound infiltration plus intramuscular routes as specified. Do not administer intravenously or alter the dosage at will. Hypersensitivity monitoring is required throughout the whole injection process.

Packaging & Shipping

Packaging

Original manufacturer’s packaging with secure export carton. Customized export packaging is available upon request.

Shipping Methods

Express Courier (EMS, DHL, FedEx, UPS), Air Freight, and Sea Freight. Cold-chain transportation is available for products requiring temperature-controlled logistics.

Export Support

Certificate of Analysis

GMP Certificate

Commercial Invoice

Packing List & CPP

Cold Chain Logistics

Customs Documentation

Scientific and regulatory sources

1.WHO References
2.NMPA
3.FDA
4.EMA

FAQ

What type of antibody is pembrolizumab?

Humanized IgG4 anti-PD-1 monoclonal antibody.

Why is pembrolizumab not classified as chemotherapy?

It is immunotherapy that activates the body’s own immune system to kill tumor cells.

What special monitoring items are required before and during medication?

Thyroid function, liver and renal function, chest imaging for pneumonia screening.

How to know if pembrolizumab is working?

Imaging scans are the primary method to evaluate Keytruda efficacy. Pseudoprogression, where tumors temporarily enlarge then shrink, is possible, so repeated scans are needed during treatment.

Keytruda® | Pembrolizumab Injection | Metastatic Melanoma | DengYueRX

INN: Pembrolizumab
Indications: Metastatic Melanoma
Dosage Form: Injection
Strength: 100mg/4ml/Vial

Original price was: $4,517.14.Current price is: $3,839.57.

Low MOQ

WHO-GMP

Worldwide Delivery

Compliance and Regulatory Documents

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