Quick answers
- What is Pembrolizumab and berahyaluronidase alfa-pmph used for?
- The FDA-approved label (Keytruda Qlex, Merck Sharp & Dohme LLC, July 31, 2026) says: “KEYTRUDA QLEX is a combination of pembrolizumab, a programmed death receptor-1 (PD-1)-blocking antibody, and berahyaluronidase alfa, an endoglycosidase, indicated: Melanoma for the treatment of adult patients with unresectable or metastatic melanoma. for the adjuvant treatment of adult and pediatric patients 12 years and older with Stage IIB, IIC, or III melanoma following complete resection. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Pembrolizumab and berahyaluronidase alfa-pmph have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Pembrolizumab and berahyaluronidase alfa-pmph?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Pembrolizumab and berahyaluronidase alfa-pmph been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Pembrolizumab and berahyaluronidase alfa-pmph?
- 1 company lists prescription products of Pembrolizumab and berahyaluronidase alfa-pmph in the FDA NDC Directory, including Merck Sharp & Dohme LLC.
What Pembrolizumab and berahyaluronidase alfa-pmph is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
KEYTRUDA QLEX is a combination of pembrolizumab, a programmed death receptor-1 (PD-1)-blocking antibody, and berahyaluronidase alfa, an endoglycosidase, indicated: Melanoma for the treatment of adult patients with unresectable or metastatic melanoma. for the adjuvant treatment of adult and pediatric patients 12 years and older with Stage IIB, IIC, or III melanoma following complete resection. …
— FDA label: Keytruda Qlex, Merck Sharp & Dohme LLC, effective July 31, 2026. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution |
|---|---|
| Route | Subcutaneous |
| Prescription products | 2 in the FDA NDC Directory |
| Brand names | Keytruda Qlex |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Merck Sharp & Dohme LLC2 products
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA761467 KEYTRUDA QLEX | Merck Sharp Dohme | September 19, 2025 | 10, latest October 16, 2026 2026: Efficacy · 2026: Labeling · 2026: Efficacy |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 2723762, 2723769, 2723771, 2723772 |
|---|---|
| SPL set ID of the quoted label | 097d166f-b73b-41d3-9b37-7653cd2a0c41 |
| FDA labels (SPL) | 1 |
| FDA applications | BLA761467 |
| Active ingredients (FDA) | BERAHYALURONIDASE ALFA / PEMBROLIZUMAB |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Keytruda Qlex, Merck Sharp & Dohme LLC, effective July 31, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →