Prescription medicine
Cosibelimab Brand names: Unloxcyt
Cosibelimab (Unloxcyt) is a prescription medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the cosibelimab FDA label on DailyMed (effective December 8, 2025); every cosibelimab label on DailyMed.
Highlights of the record
FDA label of December 8, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageINDICATIONS AND USAGE UNLOXCYT is indicated for the treatment of adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation.
Forms and strengths
- 300 mg/5ml
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
What is cosibelimab used for?
From the label: indications and usageINDICATIONS AND USAGE UNLOXCYT is indicated for the treatment of adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation. UNLOXCYT is a programmed death ligand-1 (PD-L1) blocking antibody indicated for the treatment of adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation.
FDA pharmacologic class: Programmed Death Ligand-1 Blocker.
Source: FDA drug label (UNLOXCYT), Sun Pharmaceutical Industries, Inc., effective December 8, 2025 (SPL set 06bdadd5-d2db-406f-a3f8-de47f48a52e3), via openFDA; the full label on DailyMed
What does the patient leaflet for cosibelimab 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 UNLOXCYT?UNLOXCYT is a medicine that may treat a type of skin cancer by working with your immune system. UNLOXCYT 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 UNLOXCYT. Call or see your healthcare provider right way for any new or worsening signs or symptoms which may include: chest pain, irregular heartbeat, shortness of breath or swelling of ankles confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight persistent or severe muscle pain or weakness, muscle cramps low red blood cells, bruising Infusion reactions that can sometimes be severe or life-threatening. […]
Source: FDA drug label (UNLOXCYT), Sun Pharmaceutical Industries, Inc., effective December 8, 2025 (SPL set 06bdadd5-d2db-406f-a3f8-de47f48a52e3), via openFDA; the full label on DailyMed
Is there a generic for cosibelimab (Unloxcyt)?
No generic cosibelimab 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 cosibelimab label say about other medicines?
The cosibelimab label names 1 other medicine 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 |
|---|---|---|
| Prednisone | warnings and precautions | In general, if UNLOXCYT requires interruption or discontinuation, administer systemic corticosteroids (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. |
Source: FDA drug label (UNLOXCYT), Sun Pharmaceutical Industries, Inc., effective December 8, 2025 (SPL set 06bdadd5-d2db-406f-a3f8-de47f48a52e3), via openFDA; the full label on DailyMed
What next?
- Other programmed death ligand-1 blockers
- the pharmacologic class, with prices and generics
- Check an interaction
- what two or more labels say about each other