Keytruda (pembrolizumab) supply for hospitals & distributors

Product facts

Strengths and presentation

• 100 mg/4 mL (25 mg/mL) concentrate for solution for infusion, single-use vial

Approved indications (EMA / FDA label summary)

• Melanoma (advanced and adjuvant)
• Non-small cell lung cancer (first-line, perioperative and later lines)
• Head and neck squamous cell carcinoma
• Classical Hodgkin lymphoma
• Urothelial, renal cell, cervical and endometrial carcinoma
• MSI-H / dMMR tumours, triple-negative breast cancer, gastric and oesophageal cancer (label-dependent)

Short label summary only. Approved indications differ by country and line of therapy; the national label in the destination country governs.

Storage and cold chain

• Store refrigerated at 2–8 °C in the original carton to protect from light
• Do not freeze; do not shake
• Shipped in validated cold-chain packaging with temperature data logging

How we supply

• Original manufacturer packs only — sourced from licensed wholesalers in Türkiye and Europe, never repackaged or relabelled.
• Batch number and expiry confirmed in writing before dispatch; every pack is traceable to its batch.
• Documents with every consignment: commercial invoice, batch / CoA information from the source, and packing list.
• Validated 2–8 °C cold-chain shipping with a temperature data logger from origin to handover.
• Named-patient and special-import support: we prepare the paperwork your hospital or importer needs for the local regulator.

Procurement notes

Keytruda is usually ordered in multiples of 100 mg vials against a 200 mg every-3-weeks or 400 mg every-6-weeks protocol. Hospitals typically ask us for a rolling supply plan per patient cycle so that each consignment arrives inside its infusion window with matching batch documents.

Who we supply

• Hospital pharmacy and procurement departments
• Licensed pharmaceutical distributors and importers
• Oncology and haematology centres
• Treating physicians arranging named-patient supply

Markets served

United Arab Emirates, Saudi Arabia, Qatar, Kuwait, Oman, Bahrain and Iraq. Import into each country follows that country's regulator (for example MOHAP / DoH / DHA, SFDA, MoPH, Kuwait MOH, Oman MOH, NHRA) — we work with the receiving institution's import route.

Clinical reference

Administration (per label)

The approved EU SmPC and FDA prescribing information describe pembrolizumab as an intravenous infusion administered over approximately 30 minutes, given every 3 weeks (200 mg) or every 6 weeks (400 mg), depending on indication and treating physician's choice, until disease progression, unacceptable toxicity, or completion of the approved treatment duration (which may be up to 24 months in certain indications).

The labelled information describes dose modification and interruption criteria for immune-related adverse reactions, such as pneumonitis, colitis, hepatitis, endocrinopathies, nephritis and skin reactions, graded by severity. The SmPC and prescribing information should be consulted directly by the treating clinician for the applicable modification schedule; this content is descriptive only and is not a treatment recommendation.

Pembrolizumab is prepared and diluted by trained personnel using aseptic technique, typically diluted in sodium chloride or dextrose solution as specified in the product information, and administered via an in-line filter. Premedication is not routinely required. Patients are typically monitored during and after infusion for hypersensitivity or infusion-related reactions.

Serious adverse reactions listed in the label

• Immune-mediated pneumonitis
• Immune-mediated colitis
• Immune-mediated hepatitis
• Immune-mediated endocrinopathies (thyroid disorders, adrenal insufficiency, type 1 diabetes, hypophysitis)
• Immune-mediated nephritis
• Severe skin reactions, including Stevens-Johnson syndrome
• Infusion-related reactions
• Solid organ transplant rejection (reported post-marketing)

Keytruda (pembrolizumab) vs Opdivo (nivolumab)

Keytruda and Opdivo are both PD-1 immune checkpoint inhibitors, sharing the same general mechanism of action, and both received initial regulatory approval in 2014. They differ in their approved indications, dosing regimens and typical combination strategies. Choice between the two agents for a given patient is a clinical decision made by the treating oncologist based on tumour type, biomarker status, prior therapy and the specific approved label in the relevant jurisdiction.

Pembrolizumab is most often used as monotherapy or combined with chemotherapy or targeted agents such as lenvatinib. Nivolumab is frequently paired with ipilimumab (a CTLA-4 inhibitor) for dual checkpoint blockade in indications including melanoma, renal cell carcinoma, hepatocellular carcinoma and mesothelioma; this combination is associated with a higher rate of immune-related adverse events than either agent used alone, reflecting the additive immune activation of blocking two distinct checkpoints.

Neither agent is interchangeable with the other once treatment has begun, since both target the same PD-1 pathway; if a patient does not respond to one, the other is not typically expected to succeed via the same mechanism. Selecting between them, or moving to an alternative therapeutic class, is a matter for the treating multidisciplinary oncology team with reference to the applicable regulatory label.

Frequently asked questions

Other medicines we supply to the Gulf

• Opdivo (nivolumab)
• Enhertu (trastuzumab deruxtecan)
• Tagrisso (osimertinib)
• Darzalex (daratumumab)
• Imfinzi (durvalumab)
• Tecentriq (atezolizumab)
• Perjeta (pertuzumab)
• Kadcyla (trastuzumab emtansine)
• Lynparza (olaparib)
• Revlimid (lenalidomide)
• Imbruvica (ibrutinib)
• Venclyxto (venetoclax)
• Xtandi (enzalutamide)
• Adcetris (brentuximab vedotin)

Sources

• EMA — Keytruda EPAR / SmPC
• FDA — Keytruda prescribing information