Cosibelimab
Cosibelimab is a PD-L1 blocking antibody used to treat adults with advanced cutaneous squamous cell carcinoma (a type of skin cancer) that has spread or cannot be cured with surgery or radiation.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
📖 Cosibelimab: Patient Information Guide
A plain-language walkthrough of Cosibelimab — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Cosibelimab (brand name UNLOXCYT) is an immunotherapy antibody approved to treat adults with advanced cutaneous squamous cell carcinoma (CSCC), a type of skin cancer, when curative surgery or radiation is not an option.
- UNLOXCYT is approved for metastatic CSCC (mCSCC) — skin cancer that has spread beyond the original site to other parts of the body
- UNLOXCYT is approved for locally advanced CSCC (laCSCC) — skin cancer that has grown extensively in the local area and cannot be removed or treated with radiation to cure it
⚙️How it works▾
Some cancer cells protect themselves by displaying a protein called PD-L1 on their surface. PD-L1 binds to receptors on immune cells (called PD-1 and B7.1) and essentially tells those cells to stop attacking — shutting down the body's natural cancer-fighting response. Cosibelimab blocks PD-L1 from connecting to those receptors, releasing the immune system's brakes so it can recognize and attack cancer cells again. Cosibelimab has also been shown in lab studies to trigger a process called antibody-dependent cell-mediated cytotoxicity (ADCC), in which immune cells are directed to destroy tumor cells directly.
💊How it's taken▾
UNLOXCYT is given as an intravenous (IV) infusion at a clinic or infusion center — it cannot be taken by mouth or self-administered at home. Each infusion is administered over 60 minutes and is scheduled once every 3 weeks. Treatment continues until the disease progresses or side effects make it unsafe to continue. There are no dose reductions recommended; if a serious side effect occurs, your doctor may pause or permanently stop treatment based on how severe it is.
🤒Side effects — in detail▾
The most common side effects reported in clinical trials include:
- Fatigue
- Musculoskeletal pain (muscle and joint aches)
- Rash
- Diarrhea
- Hypothyroidism (underactive thyroid)
- Constipation
- Nausea
- Headache
- Pruritus (itching)
- Edema (swelling)
- Localized infection
- Urinary tract infection
More serious reactions — including immune-related inflammation of the lungs, liver, colon, kidneys, skin, heart, and hormone glands — can also occur and require prompt medical attention. Tell your care team right away if you develop any new or worsening symptoms.
⚠️Warnings & precautions▾
- Immune-mediated reactions: UNLOXCYT can cause the immune system to attack healthy organs anywhere in the body — including the lungs (pneumonitis), colon (colitis), liver (hepatitis), kidneys (nephritis), skin (including rare severe blistering conditions like Stevens-Johnson syndrome), heart (myocarditis), and hormone glands (thyroid, adrenal, pituitary). These can be severe or fatal and may occur during or after treatment ends.
- Infusion reactions: Some patients experience reactions during the IV infusion such as chills, fever, flushing, or difficulty breathing. Clinic staff will monitor you during each infusion.
- Stem cell transplant complications: Serious and potentially fatal complications have been reported in patients who receive allogeneic hematopoietic stem cell transplants (donor stem cell transplants) before or after treatment with PD-L1 blocking antibodies like UNLOXCYT.
- Embryo-fetal toxicity: UNLOXCYT can harm an unborn baby. Effective contraception is required during treatment and for 4 months after the last dose. Breastfeeding should be avoided during treatment and for 4 months after the last dose.
🔀What it interacts with▾
The FDA label for UNLOXCYT does not list specific drug, food, or supplement interactions. However, because UNLOXCYT affects the immune system, always tell your doctor and pharmacist about all medications, supplements, and recent or planned medical procedures — especially anything related to immune suppression or organ/stem cell transplants.
- Corticosteroids (like prednisone): These are used to treat immune-mediated side effects from UNLOXCYT — your doctor will guide their use carefully
- Other immunosuppressants: May be needed if corticosteroids alone don't control immune side effects — your doctor will manage this
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Pregnancy: UNLOXCYT can cause fetal harm. A pregnancy test is required before starting treatment. Use effective contraception during treatment and for 4 months after the last dose.
- Breastfeeding: Do not breastfeed during treatment or for 4 months after the last dose — potential risk of serious harm to the nursing infant.
- Prior or planned stem cell transplant: Tell your doctor if you have had or are planning an allogeneic (donor) stem cell transplant — serious complications including death have been reported.
- Liver impairment: The effect of severe liver disease on how the body handles UNLOXCYT is not known — discuss with your doctor.
- Kidney impairment: No dosage adjustment appears needed for kidney disease at most levels, but your doctor will monitor kidney function throughout treatment.
- Children: Safety and effectiveness in patients under 18 have not been established.
- Older adults: Patients 75 and older were well represented in clinical trials, and no significant differences in safety or effectiveness were found compared to younger patients.
📡Pharmacodynamics — effects in the body▾
The precise relationship between UNLOXCYT exposure levels and the body's response has not been fully characterized. Your care team will monitor for both the desired anti-cancer effects and any immune-related side effects throughout treatment.
🔬Pharmacokinetics — how your body processes it▾
After repeated IV infusions every 3 weeks, UNLOXCYT reaches stable levels in the bloodstream (called steady state) by about 12 weeks (84 days) of treatment. The drug has a half-life of approximately 17.8 days, meaning it takes roughly 2.5 weeks for the body to clear half of the drug. Age, sex, race, ethnicity, and mild-to-moderate kidney impairment do not meaningfully change how the body handles UNLOXCYT. The effect of severe liver disease on the drug's behavior is not yet known.
📦How to store it▾
Store in a refrigerator at 2°C to 8°C (36°F to 46°F) in original carton to protect from light. Do not freeze or shake.
📄 Written from Cosibelimab’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Cosibelimab — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is UNLOXCYT treating in my case? ▾
How will I receive this medication — do I take a pill at home? ▾
What side effects should I actually expect, and which ones should I call about right away? ▾
Why does the doctor keep checking my blood work so often? ▾
Can I get pregnant or breastfeed while on this treatment? ▾
I've heard immunotherapy can cause the immune system to overreact — is that a real concern with this drug? ▾
Is Cosibelimab available over the counter? ▾
When was Cosibelimab first available? ▾
Who makes Cosibelimab? ▾
💬 Answers drafted from Cosibelimab’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Cosibelimab comes
Cosibelimab is available in 2 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Injection
How this form is used
- UNLOXCYT is used to treat adults with metastatic cutaneous squamous cell carcinoma (skin cancer that has spread) who are not candidates for curative surgery or curative radiation
- UNLOXCYT is used to treat adults with locally advanced cutaneous squamous cell carcinoma (extensive local skin cancer) who are not candidates for curative surgery or curative radiation
- UNLOXCYT is administered as an intravenous infusion over 60 minutes, once every 3 weeks
- UNLOXCYT must not be given as an IV push or bolus injection, and no other drugs should be infused through the same IV line at the same time
- UNLOXCYT is prepared by adding the contents of the vial to a 250 mL bag of 0.9% Sodium Chloride and mixing by gentle inversion — do not shake
- UNLOXCYT is given through an IV line with a sterile in-line filter; the prepared solution should be used within 24 hours and must not be frozen
Oral solution
📊 Cosibelimab across the U.S. market
How Cosibelimab appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
🔍 Compare Cosibelimab products
A representative set of FDA-listed product records for Cosibelimab — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Injection | ||||
| 60 mg/mL | — | Samsung BioLogics Co. LTD | DRUG FOR FURTHER PROCESSING | View NDC → |
| 300 mg/5 mL | Intravenous | Sun Pharmaceutical Industries, Inc. × 2 listings | BLA | View NDC → |
| 💊Oral solution | ||||
| 1 kg/kg | — | SAMSUNG BIOLOGICS Co., Ltd. | BULK INGREDIENT | View NDC → |
Showing 4 of 4 products — FDA National Drug Code Directory. See every product, package size and price: browse all 4 Cosibelimab NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Cosibelimab — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Cosibelimab in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Cosibelimab went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 2717511 1 dose form · 1 strength
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Dose form (SCDF) Injection RxCUI 2717515In current FDA listingsClinical drug / strength (SCD) 5 ML cosibelimab-ipdl 60 MG/MLRxCUI 2717518
Look up RxCUI 2717511 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Supply & shortage status
Whether Cosibelimab is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Cosibelimab belongs to the Programmed Death Ligand-1 Blocker class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Sun Pharmaceutical Industries, Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.