Prescription medicine

Berahyaluronidase alfa and pembrolizumab Brand names: Keytruda

Berahyaluronidase alfa and pembrolizumab (Keytruda) is a prescription medicine. No generic is listed in FDA's NDC Directory.

No generic listed

Check it at the source: the berahyaluronidase alfa and pembrolizumab FDA label on DailyMed (effective July 31, 2026); every berahyaluronidase alfa and pembrolizumab label on DailyMed.

Highlights of the record

FDA label of July 31, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Used for

From the label: indications and usage
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.

Forms and strengths

165 mg/ml

Injection (solution).

On the market

Generic approvals: No generic approved
Labelers listed (NDC): 1 of which 0 under generic applications, 1 under brand applications, repackagers included

Supply and safety

Pharmacy cost (NADAC): Not in the survey
Shortage (FDA): No current entry
Recalls by its makers (FDA): No recall recorded
FAERS reports: 26 through July 30, 2026

What is berahyaluronidase alfa and pembrolizumab used for?

From the label: indications and usage
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. ( 1.1 ) for the adjuvant treatment of adult and pediatric patients 12 years and older with Stage IIB, IIC, or III melanoma following complete resection. ( 1.1 ) Non-Small Cell Lung Cancer (NSCLC) in combination with pemetrexed and platinum chemotherapy, as first-line treatment of adult patients with metastatic nonsquamous NSCLC, with no EGFR or ALK genomic tumor aberrations. […]

Conditions named in the indications of berahyaluronidase alfa and pembrolizumab's FDA labels, with every medicine labeled for each:

From other berahyaluronidase alfa and pembrolizumab labels
Colorectal cancer: … options. ( 1.6 , 2.1 ) Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer (CRC) for the treatment of adult patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC) as determined by an …
Breast cancer: Triple-Negative Breast Cancer KEYTRUDA QLEX is indicated for the treatment of adult patients with high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, and then continued as a …

FDA pharmacologic class: Endoglycosidase and Programmed Death Receptor-1 Blocking Antibody.

Source: FDA drug label (KEYTRUDA QLEX), Merck Sharp & Dohme LLC, effective July 31, 2026 (SPL set 097d166f-b73b-41d3-9b37-7653cd2a0c41), via openFDA; the full label on DailyMed

What does the patient leaflet for berahyaluronidase alfa and pembrolizumab say first?

The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.

From the patient leaflet: What is the most important information I should know about KEYTRUDA QLEX?
KEYTRUDA QLEX is a medicine that may treat certain cancers by working with your immune system. KEYTRUDA QLEX can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen anytime during treatment or even after your treatment has ended. […] These are not all of the signs and symptoms of immune system problems that can happen with KEYTRUDA QLEX. […]

Source: FDA drug label (KEYTRUDA QLEX), Merck Sharp & Dohme LLC, effective July 31, 2026 (SPL set 097d166f-b73b-41d3-9b37-7653cd2a0c41), via openFDA; the full label on DailyMed

Is there a generic for berahyaluronidase alfa and pembrolizumab (Keytruda)?

No generic berahyaluronidase alfa and pembrolizumab is approved (Drugs@FDA, October 8, 2026).

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What does the berahyaluronidase alfa and pembrolizumab label say about other medicines?

The berahyaluronidase alfa and pembrolizumab label names 4 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.

Medicine named	Section	What the label says
Axitinib	warnings and precautions	In Combination with Axitinib KEYTRUDA QLEX in combination with axitinib can cause hepatic toxicity with higher than expected frequencies of Grades 3 and 4 ALT and AST elevations compared to KEYTRUDA QLEX alone.
Dexamethasone	warnings and precautions	… with multiple myeloma with a PD-1 or PD-L1 blocking antibody in combination with a thalidomide analogue plus dexamethasone is not recommended outside of controlled clinical trials. ( 5.4 ) Embryo-Fetal toxicity:
Hyaluronidase	contraindications	CONTRAINDICATIONS KEYTRUDA QLEX is contraindicated in patients with known hypersensitivity to berahyaluronidase alfa, hyaluronidase or to any of its excipients.
Prednisone	warnings and precautions	In general, if KEYTRUDA QLEX requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less.

Check berahyaluronidase alfa and pembrolizumab against other medicines

Source: FDA drug label (KEYTRUDA QLEX), Merck Sharp & Dohme LLC, effective July 31, 2026 (SPL set 097d166f-b73b-41d3-9b37-7653cd2a0c41), via openFDA; the full label on DailyMed

What do FAERS reports show for berahyaluronidase alfa and pembrolizumab?

The FDA Adverse Event Reporting System holds 26 reports that list berahyaluronidase alfa and pembrolizumab among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 3 are coded as a death and 9 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.

The most reported reactions

Rash (named in the label)3
Adrenal Insufficiency (named in the label)2
Autoimmune Disorder2
Dysphagia (named in the label)2
Generalised Oedema2
Hyperglycaemia (named in the label)2
Hyperthyroidism (named in the label)2
Hypertransaminasaemia2

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What else is labeled for the same conditions as berahyaluronidase alfa and pembrolizumab?

5 other medicines are given the same way (subcutaneous) and in the same FDA class as berahyaluronidase alfa and pembrolizumab or labeled mainly for the same use (lung cancer), the same class first. Lung cancer lists all 55 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.

Medicine	Shared indication	Generic labelers (subcutaneous)	Pharmacy cost	Shortage
Amivantamab and hyaluronidase	Lung cancer	none listed	n/a	No current entry
Hyaluronidase and nivolumab	Lung cancer	none listed	n/a	No current entry
Hyaluronidase and pertuzumab and trastuzumab	Breast cancer	none listed	n/a	No current entry
Atezolizumab and hyaluronidase	Lung cancer	none listed	n/a	No current entry
Hyaluronidase and trastuzumab	Breast cancer	none listed	n/a	No current entry

Every medicine labeled for the same conditions as berahyaluronidase alfa and pembrolizumab

Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)

What next?

Alternatives to berahyaluronidase alfa and pembrolizumab: 5 medicines for the same use
Other endoglycosidases: the pharmacologic class, with prices and generics
Berahyaluronidase alfa and pembrolizumab side effects: the label's list beside FAERS reports
Check an interaction: what two or more labels say about each other