Pembrolizumab: uses, dosing, side effects & brands

How pembrolizumab is dosed

From the FDA label for Keytruda (application BLA125514). Other pembrolizumab products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.

Melanoma: 200 mg every 3 weeks or 400 mg every 6 weeks; 2 mg/kg (up to 200 mg) every 3 weeks for pediatrics. ( 2.2 ) NSCLC: 200 mg every 3 weeks or 400 mg every 6 weeks. ( 2.2 ) MPM: 200 mg every 3 weeks or 400 mg every 6 weeks. ( 2.2 ) HNSCC: 200 mg every 3 weeks or 400 mg every 6 weeks. ( 2.2 ) cHL or PMBCL: 200 mg every 3 weeks or 400 mg every 6 weeks for adults; 2 mg/kg (up to 200 mg) every 3 weeks for pediatrics. ( 2.2 ) Urothelial Cancer: 200 mg every 3 weeks or 400 mg every 6 weeks. ( 2.2 ) MSI-H or dMMR Cancer: 200 mg every 3 weeks or 400 mg every 6 weeks for adults; 2 mg/kg (up to 200 mg) every 3 weeks for pediatrics. ( 2.2 ) MSI-H or dMMR CRC: 200 mg every 3 weeks or 400 mg every 6 weeks. ( 2.2 ) Gastric Cancer: 200 mg every 3 weeks or 400 mg every 6 weeks. ( 2.2 ) Esophageal Cancer: 200 mg every 3 weeks or 400 mg every 6 weeks. ( 2.2 ) Cervical Cancer: 200 mg every 3 weeks or 400 mg every 6 weeks. ( 2.2 ) HCC: 200 mg every 3 weeks or 400 mg every 6 weeks. ( 2.2 ) BTC: 200 mg every 3 weeks or 400 mg every 6 weeks. ( 2.2 ) MCC: 200 mg every 3 weeks or 400 mg every 6 weeks for adults; 2 mg/kg (up to 200 mg) every 3 weeks for pediatrics. ( 2.2 ) RCC: 200 mg every 3 weeks or 400 mg every 6 weeks as a single agent in the adjuvant setting, or in the advanced setting with either: axitinib 5 mg orally twice daily or lenvatinib 20 mg orally once daily. ( 2.2 ) ccRCC: 200 mg…

Pembrolizumab side effects

Who shouldn’t take pembrolizumab

Combination products containing pembrolizumab

A combination is a different drug — different dosing, different warnings. It is listed here so you can find it, not so you can substitute it.

• Keytruda Qlex

Pembrolizumab and breastfeeding

From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.

No information is available on the clinical use of pembrolizumab during breastfeeding. Because pembrolizumab is a large protein molecule with a molecular weight of about 149,000 Da, the amount in milk is likely to be very low. It is also likely to be partially destroyed in the infant's gastrointestinal tract and absorption by the infant is probably minimal. Until more data become available, pembrolizumab should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant. The manufacturer recommends that breastfeeding be discontinued during pembrolizumab therapy and for 4 months after the last dose.

National Institute of Child Health and Human Development, record revised November 15, 2023. LactMed states its information is not a substitute for professional judgement.

What people report to the FDA about pembrolizumab

The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 33,812 reports naming pembrolizumab, and the FDA flagged 95% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:

• malignant neoplasm progression2,748 reports
• diarrhoea1,899 reports
• fatigue1,481 reports
• nausea1,322 reports
• pyrexia1,231 reports
• anaemia1,213 reports
• acute kidney injury1,184 reports
• neutropenia1,070 reports

Source: openFDA drug/event (FAERS), retrieved July 25, 2026.

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