Keytruda

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What Is Keytruda?

Keytruda (pembrolizumab) is a humanised IgG4 monoclonal antibody from Merck (MSD) that targets the programmed cell death protein 1 (PD-1) receptor on T-cells. By blocking PD-1, pembrolizumab releases the immune brakes that cancer cells exploit to evade immune destruction. Approved by the FDA in 2014, Keytruda is now licensed for more cancer indications than any other immunotherapy and has transformed treatment for advanced melanoma, advanced NSCLC, and many other tumour types.

Pembrolizumab is supplied as a concentrated solution for infusion (100 mg/4 mL vial) that is diluted in normal saline or 5% dextrose and administered as a slow IV infusion over 30 minutes in a hospital or oncology day unit. It is niet available in oral form and cannot be self-administered.

How Does Keytruda Work?

Cancer cells frequently express the PD-L1 ligand on their surface. When PD-L1 binds the PD-1 receptor on a tumour-infiltrating T-cell, it signals the T-cell to stand down — effectively switching off the immune response against the tumour. Pembrolizumab is engineered to block this PD-1 / PD-L1 interaction:

• Releases the immune brake — PD-1 blockade allows tumour-specific T-cells to recognise and kill cancer cells.
• Tumour PD-L1 expression often predicts response — tumours with high PD-L1 staining (TPS ≥ 50%) respond more often than PD-L1-negative tumours, particularly in NSCLC. Some indications require PD-L1 testing before treatment.
• MSI-H / dMMR cancers respond independently of PD-L1 — tumours with mismatch-repair deficiency or microsatellite instability are highly responsive to checkpoint blockade regardless of PD-L1 status. Keytruda has a tumour-agnostic indication for MSI-H/dMMR cancers.
• Tumour mutational burden (TMB) — high-TMB tumours generate more neoantigens for the immune system to recognise; some Keytruda indications use TMB ≥ 10 mut/Mb as a biomarker.

Toepassingen en Indicaties

Keytruda is approved by major regulators (FDA, EMA, MHRA, others) across an unusually broad range of cancers. Major adult indications include:

• Melanoma — unresectable advanced or metastatic; adjuvant for stage IIB/IIC/III after complete resection
• Non-small cell lung cancer (NSCLC) — first-line monotherapy for PD-L1 TPS ≥ 50% metastatic NSCLC; first-line combination with chemotherapy regardless of PD-L1; second-line monotherapy for PD-L1 ≥ 1%; adjuvant therapy after resection
• Head and neck squamous cell carcinoma (HNSCC) — first-line metastatic / recurrent (with or without chemotherapy)
• Classical Hodgkin lymphoma — relapsed or refractory after multi-agent chemotherapy
• Urothelial carcinoma — first-line metastatic in cisplatin-ineligible patients; second-line after platinum chemotherapy; high-risk non-muscle-invasive bladder cancer (BCG-unresponsive)
• MSI-H / dMMR cancers — tumour-agnostic indication for any solid tumour with MSI-high or mismatch-repair-deficient status; particularly important in colorectal, endometrial, gastric cancers
• Gastric and gastroesophageal junction cancer — first-line HER2+ (with chemotherapy) and HER2- (with chemotherapy)
• Oesophageal cancer
• Cervical cancer — first-line PD-L1+ persistent, recurrent or metastatic (with chemotherapy ± bevacizumab)
• Hepatocellular carcinoma (liver)
• Renal cell carcinoma — first-line in combination with axitinib or lenvatinib
• Endometrial cancer — pMMR (with lenvatinib) and dMMR/MSI-H (monotherapy)
• Triple-negative breast cancer (TNBC) — high-risk early-stage neoadjuvant (with chemotherapy) and metastatic PD-L1+ (CPS ≥ 10)
• Cutaneous squamous cell carcinoma, Merkel cell carcinoma, primary mediastinal large B-cell lymphoma, and several rare tumour-agnostic indications

The right Keytruda indication and combination depends on tumour type, stage, biomarker status (PD-L1 TPS or CPS, MSI/dMMR, TMB, HER2), and prior therapy. This is a specialist oncologist decision after pathology and biomarker workup is complete.

Keytruda Dosage and Administration

Standaard dosering voor volwassenen:

• 200 mg IV infusion every 3 weeks (the original schedule) OR
• 400 mg IV infusion every 6 weeks (Q6W flat dosing — equivalent efficacy with less frequent visits)
• Paediatric dose: 2 mg/kg (maximum 200 mg) IV every 3 weeks
• Each infusion is given over 30 minutes via a 0.2–5 µm in-line filter

How Keytruda Is Administered

1. Hospital or oncology day-unit setting only. Keytruda is given by trained nursing or medical staff under specialist oncologist supervision — never self-administered or community-administered.
2. Pre-infusion workup at each cycle: complete blood count, comprehensive metabolic panel (LFTs, renal function), thyroid function (TSH, free T4) every 6 weeks, blood glucose. Symptom screen for new immune-related adverse events.
3. Premedication is generally NOT required — pembrolizumab does not cause typical chemotherapy nausea or hypersensitivity reactions. Antiemetics not needed.
4. Vial preparation: dilute pembrolizumab in normal saline or 5% dextrose to a final concentration of 1–10 mg/mL. Use within 6 hours of preparation if stored at room temperature, or 24 hours if refrigerated.
5. 30-minute IV infusion via a 0.2–5 µm in-line filter. Not for IV push or bolus.
6. Cycle frequency as scheduled (Q3W or Q6W). Continue until disease progression, intolerable toxicity, or completion of planned treatment duration (typically 24 months in adjuvant setting; until progression in metastatic).
7. Verplichte monitoring for immune-related adverse events at every visit: skin (rash, vitiligo, dermatitis), GI (diarrhoea, abdominal pain), respiratory (cough, dyspnoea), endocrine (fatigue, weight change, palpitations from thyroiditis or hypophysitis), liver (jaundice), kidney (creatinine), neurological (weakness, paraesthesiae).
8. Permanent discontinuation for grade 3–4 irAEs of pneumonitis, hepatitis, nephritis, dermatitis, neurotoxicity, myocarditis; recurrent grade 2–3 irAEs of any system; or any grade 4 irAE.

Side Effects of Keytruda

Pembrolizumab has a fundamentally different toxicity profile from cytotoxic chemotherapy. The dominant side-effect category is immune-related adverse events (irAEs) — autoimmune-like reactions caused by un-braked immune activity against normal tissues.

Common (non-irAE): fatigue, decreased appetite, nausea (mild), constipation, diarrhoea, arthralgia, pruritus, rash, mild headache.

Common immune-related adverse events (irAEs):

• Hypothyreoïdie (10–15%) and hyperthyroidism (4–6%) — from immune thyroiditis. Usually requires lifelong levothyroxine. Check TSH every 6 weeks.
• Skin reactions — rash, pruritus, vitiligo, lichenoid eruption. Severe in 1–3%.
• Diarrhoea / colitis — 1–3% severe. Risk of bowel perforation if untreated.
• Pneumonitis (~3% any grade, < 1% severe) — new dyspnoea or cough warrants urgent CT chest.
• Hepatitis (~1% severe) — LFT rise.
• Adrenal insufficiency, hypophysitis — fatigue, hypotension, hyponatraemia. May require lifelong corticosteroid replacement.
• Type 1 diabetes — new-onset ketoacidosis. Mostly irreversible; lifelong insulin.
• Nephritis — rising creatinine.

Less common but important irAEs: myocarditis (rare but high-mortality), peripheral and cranial neuropathies, Guillain-Barré syndrome, myasthenia gravis, encephalitis, polymyalgia, uveitis, severe skin reactions (Stevens-Johnson syndrome, TEN), haemolytic anaemia, cytopenias.

Key treatment principle for irAEs: grade 1 manage with supportive care + monitoring; grade 2 hold treatment + start systemic corticosteroids (prednisone 0.5–1 mg/kg); grade 3–4 hold or permanently discontinue + high-dose corticosteroids (1–2 mg/kg) + endocrine / GI / pulmonology / cardiology specialist review as relevant. Most irAEs improve with timely steroid therapy. Endocrinopathies (thyroid, adrenal, type 1 diabetes) are usually permanent and require lifelong hormone replacement.

Waarschuwingen en voorzorgsmaatregelen

• Immune-related adverse events: can affect any organ system, can occur at any time during treatment (including months after discontinuation). Patient + caregiver education on irAE symptoms is mandatory. Patients must seek same-day care for: severe diarrhoea (> 4 stools above baseline), new shortness of breath, severe fatigue with hypotension, jaundice, severe abdominal pain, chest pain, weakness or numbness, severe skin rash, or new headache + visual change.
• Pre-existing autoimmune disease (e.g. inflammatory bowel disease, lupus, rheumatoid arthritis, psoriasis, MS, type 1 diabetes): Keytruda may flare the underlying disease severely. Risk-benefit decision by oncologist + relevant specialist.
• Solid organ or stem-cell transplant recipients: Keytruda can precipitate transplant rejection or graft-versus-host disease. Specialist supervision required.
• Zwangerschap: contraindicated — pembrolizumab crosses the placenta and could disrupt fetal immune tolerance with stillbirth or autoimmune complications. Reliable contraception throughout treatment + 4 months after the last dose.
• Borstvoeding: avoid — immunoglobulins are excreted in breast milk. Wait 4 months after last dose.
• Live vaccines: contraindicated.
• Active infection: hold during serious infection.
• Severe hepatic / renal impairment: limited data; specialist judgement.
• Cold-chain storage: vials must be refrigerated 2–8°C and not frozen. Cold-chain failure invalidates the vial.
• Cost and reimbursement: Keytruda is one of the most expensive cancer drugs (~$10,000–14,000 USD per dose at originator pricing). Patient access programmes, biosimilar pembrolizumab where available, and source-country generics differ significantly in price.

Contra-indicaties

• Known hypersensitivity to pembrolizumab or any vial excipient
• Pregnancy or planning pregnancy
• Borstvoeding
• Severe pre-existing autoimmune disease (relative; specialist judgement)
• Solid-organ transplant recipients (relative; specialist judgement; transplant rejection risk)
• Active uncontrolled infection

Geneesmiddelinteracties

Bewaaradvies

• Store unopened vials at 2–8°C in the original carton, protected from light. Do NOT freeze.
• Do not shake the vial.
• Diluted infusion solution: stable up to 24 hours under refrigeration or 6 hours at room temperature; do not freeze.
• Cold-chain failure (above 8°C for > 24 hours) invalidates the vial — do not use.
• Buiten bereik van kinderen en huisdieren houden.
• Return unused vials to a pharmacy or oncology unit for proper disposal.

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Veelgestelde vragen

How is Keytruda different from chemotherapy?

Chemotherapy directly kills rapidly-dividing cells (cancer cells, but also bone marrow, hair follicles, GI lining), producing the classic side-effect pattern of myelosuppression, alopecia, mucositis, nausea. Keytruda activates the patient's own immune system to recognise and destroy cancer — it does not directly kill cells. Side effects are therefore fundamentally different: dominated by immune-related adverse events (irAEs) — autoimmune-like reactions in any organ system. Most patients on Keytruda do not experience the typical chemotherapy toxicity profile, though many treatment regimens combine Keytruda with chemotherapy.

What does PD-L1 testing mean for my Keytruda treatment?

PD-L1 is the protein on cancer cells that Keytruda's mechanism interrupts. Tumour PD-L1 expression is measured by immunohistochemistry on the biopsy and reported as TPS (Tumour Proportion Score) of CPS (Combined Positive Score). Higher PD-L1 expression generally predicts better Keytruda response, particularly in NSCLC (TPS ≥ 50% → first-line monotherapy; 1–49% → second-line or with chemotherapy). For some indications (NSCLC, gastric, cervical, TNBC), PD-L1 testing is required before treatment. For others (MSI-H/dMMR cancers, melanoma, Hodgkin lymphoma), Keytruda is used regardless of PD-L1 status.

What are immune-related adverse events (irAEs) and why are they so important?

irAEs are the dominant Keytruda side-effect category — autoimmune-like reactions caused by the un-braked immune system attacking normal tissues. They can affect any organ: skin, GI tract (colitis), lung (pneumonitis), liver (hepatitis), thyroid, pituitary, adrenal glands, type 1 diabetes pancreas, kidneys, peripheral nerves, heart (rare myocarditis with high mortality). They can occur at any time during treatment, and even months after the last dose. Severity ranges from grade 1 (mild) to grade 4 (life-threatening). Early recognition is critical — most irAEs respond well to systemic corticosteroids if treated promptly. Patients should have a 24-hour oncology contact number and be educated to call same-day for new severe diarrhoea, dyspnoea, jaundice, severe fatigue, weakness, vision change, or chest pain.

Will Keytruda cure my cancer?

For some patients in some indications, Keytruda produces durable responses that may approach functional cure — particularly in advanced melanoma, MSI-H/dMMR cancers, and Hodgkin lymphoma where 5-year survival is now substantial. In NSCLC and other indications, Keytruda extends survival meaningfully in a subset of patients. Response is highly individual and depends on tumour type, PD-L1 expression, MSI/TMB status, prior therapy, performance status, and whether Keytruda is used as monotherapy or combination. Discuss expected outcome specific to your tumour with your oncologist.

When will I see Keytruda working?

Imaging response usually first measurable at 9–12 weeks (after 3–4 cycles). Some patients show pseudoprogression — initial apparent enlargement on first scan caused by immune-cell infiltration of the tumour, followed by genuine response. Specialist judgement is needed before declaring treatment failure on early imaging.

Can I have live vaccines while on Keytruda?

No — live vaccines (MMR, yellow fever, BCG, oral polio, varicella) are contraindicated during Keytruda therapy and for at least 6 months after the last dose. Inactivated vaccines (annual flu shot, pneumococcal, COVID-19, hepatitis B) are not only safe but recommended — cancer patients are at higher infection risk and should be vaccinated proactively.

Can I take steroids on Keytruda?

Brief or short-term steroid courses for irAE management are appropriate and necessary. Chronic high-dose steroids (prednisone > 10 mg/day equivalent for prolonged periods) at baseline may suppress the immune response Keytruda is designed to enhance — oncologists try to wean these before starting Keytruda. If you need steroids for another indication (asthma, autoimmune disease, transplant), discuss with the oncologist.

Is Keytruda safe in pregnancy?

No — absolutely contraindicated. Pembrolizumab crosses the placenta and could disrupt fetal immune tolerance with serious consequences (stillbirth, fetal autoimmune disease). Reliable contraception is mandatory throughout treatment AND for at least 4 months after the last dose. Avoid breastfeeding during treatment and for 4 months after.

Why is Keytruda so expensive?

Pembrolizumab is one of the most expensive cancer drugs globally — a single 200 mg dose at originator pricing can cost USD $10,000–14,000 in high-income markets, before discounts. Reasons: complex monoclonal antibody manufacturing, originator patent monopoly until 2028, high R&D recoupment, premium pricing. Patient assistance programmes (Merck's ACT programme in the US, charity programmes in many countries), source-country generics where available, and emerging biosimilar pembrolizumab in some markets significantly reduce cost. Discuss financial assistance with your oncology social worker or pharmacy.

How long do I stay on Keytruda?

Depends on indication. Adjuvant therapy (after curative-intent surgery in melanoma, NSCLC etc.): typically 1 year (17 cycles of Q3W or 9 cycles of Q6W). Metastatic disease: until disease progression, intolerable toxicity, or completion of 2 years of therapy in patients with sustained complete response. The original trials capped duration at 2 years; durability of response after stopping at 2 years has been reassuring in melanoma and NSCLC, less established in other indications.

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