UNLOXCYT cosibelimab 300 mg/5mL Injection, Solution — NDC 70095-130-01 (Billing 70095-0130-01)
This is a package of UNLOXCYT cosibelimab 300 mg/5mL Injection, Solution from Sun Pharmaceutical Industries, Inc., marketed since Dec 2025 and currently FDA-listed. It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 70095-130-01 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 70095 labeler · 130 product · 01 package
- Package marketed since
- Dec 8, 2025
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2027
- Barcode (UPC-A, from the NDC)
- 3 7009513001 3
- FDA record last changed
- Oct 8, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 086896
- GCN: 56693
- HICL (First Databank): 050094
- AHFS class code: 10:00.00.00
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
Clinical
Cosibelimab-ipdl injection is used to treat certain types of cutaneous squamous cell carcinoma (CSCC; skin cancer) that has spread to nearby tissues or to other parts of the body and cannot be treated well with surgery or radiation therapy. Cosibelimab-ipdlis is in a class of medications called monoclonal antibodies. It works by helping your immune system to slow or stop the growth of cancer cells.
Read the full MedlinePlus article ↗- UNLOXCYT is designed for adults with cutaneous squamous cell carcinoma — a type of skin cancer — that has either spread to other parts of the body or grown too extensively to be re...
- What exactly is UNLOXCYT treating in my case?
- No, UNLOXCYT is not a pill. It's given as an IV infusion at a clinic or infusion center. Each session takes about 60 minutes, and you'll receive it once every 3 weeks. You'll be mo...
- How will I receive this medication — do I take a pill at home?
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
| Medicare Part B allowsASP · J9275 | No ASP payment limit on file for J9275 this quarter. | |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 8, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Billing & reimbursement
Where does this data come from?
- CMS ASP NDC-HCPCS crosswalk · refreshed Sep 22, 2026
- DMEPDAC NDC-HCPCS crosswalk
- openFDA NSDE billing units · refreshed Oct 7, 2026
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 70095-0130-01 You're viewing this Main listing | 1 VIAL, GLASS in 1 CARTON / 5 mL in 1 VIAL, GLASS | 2025-12-08 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Unloxcyt 300 mg/5mLthis 70095-0130-01 | Sun | 1 vial | — | — | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Purple Book · refreshed Oct 5, 2026
- CMS NADAC weekly file
Availability & biosimilar status
Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.
Why the date isn’t exact: Biosimilar timing can change because patents may be challenged, settled, licensed, added or removed, and litigation can move the real date earlier or later.
🛈 What do these terms mean?
- Biologic patent
- A patent the reference product’s maker has publicly listed. A biosimilar generally can’t launch until these expire — unless they’re invalidated or resolved in a settlement.
- Reference-product exclusivity
- A flat 12 years of FDA market protection from the biologic’s first licensure (the BPCIA). No biosimilar can be licensed before it ends, regardless of patents.
- Interchangeable exclusivity
- The first interchangeable biosimilar can earn a period as the only interchangeable version (pharmacists can substitute it without the prescriber).
- Earliest biosimilar (LOE)
- The latest of all the dates above — the soonest a biosimilar can realistically reach the market. Litigation and settlements can move it earlier.
Biologics have no small-molecule “generics” — competition comes from FDA-licensed biosimilars, tracked in the FDA Purple Book.
| Code | What it grants | Expires |
|---|---|---|
| RefProduct | Reference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this date | Dec 13, 2036 |
Is there a biosimilar for UNLOXCYT 300 MG/5 ML VIAL?
Why do different websites show different biosimilar dates?
Can a biosimilar launch before the last patent expires?
What does “current Purple Book estimate” mean?
What does “FDA listed” mean?
What does a patent or protection date mean here?
Where does this data come from?
- FDA Purple Book · refreshed Oct 5, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
🧪 Avoiding an ingredient? See Cosibelimab inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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1.2 mg / 5 mL
UNII Q40Q9N063P
Acetic acid is a weak organic acid commonly used in medicines as a buffer and pH adjuster. It helps maintain the proper acidity level to ensure the drug remains stable and effective in its formulation.
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186.8 mg / 5 mL
UNII 3OWL53L36A
A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
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5.5 mg / 5 mL
UNII 6OZP39ZG8H
Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
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6.55 mg / 5 mL
UNII 4550K0SC9B
Sodium acetate is a salt derived from acetic acid. It acts as a buffer to help maintain the medicine's pH stability and may serve as a preservative or solubilizer in liquid formulations.
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20.5 mg / 5 mL
UNII 451W47IQ8X
Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
6 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 8, 2026
- FDA openFDA NDC Directory · synced Oct 8, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Sun Pharmaceutical Industries, Inc. labeler code 70095
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- Pomalidomide 3 mg Capsule NDC 70095-059-01
- Pomalidomide 4 mg Capsule NDC 70095-060-01
- ERIBULIN MESYLATE .5 mg/mL Injection NDC 70095-080-01
- Progesterone 100 mg Insert NDC 70095-136-03
- PHYTONADIONE 1 mg/.5mL Injection, Emulsion NDC 70095-154-02
- Vismodegib 25 kg/25kg Powder NDC 70095-210-11
- Sincalide 25 kg/25kg Powder NDC 70095-212-11
- Istradefylline 25 kg/25kg Powder NDC 70095-214-11
- Methylnaltrexone Bromide 25 kg/25kg Powder NDC 70095-218-11
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1. INDICATIONS 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.
⏱️ Dosage and Administration ▾
2. DOSAGE AND ADMINISTRATION The recommended dosage of UNLOXCYT is 1,200 mg as an intravenous infusion over 60 minutes every 3 weeks. ( 2.1 ) 2.1.
Recommended Dosage The recommended dosage of UNLOXCYT is 1,200 mg administered as an intravenous infusion over 60 minutes every 3 weeks until disease progression or unacceptable toxicity. 2.2. Dose Modifications for Adverse Reactions No dose reductions of UNLOXCYT are recommended.
In general, withhold UNLOXCYT for severe (Grade 3) immune-mediated adverse reactions. Permanently discontinue UNLOXCYT for life-threatening (Grade 4) immune-mediated adverse reactions, recurrent severe (Grade 3) immune-mediated reactions that require systemic immunosuppressive treatment, or an inability to reduce corticosteroid dose to a prednisone equivalent of 10 mg or less per day within 12 weeks of initiating steroids. Dosage modifications for UNLOXCYT for adverse reactions that require management different from these general guidelines are summarized in Table 1.
Table 1: Recommended Dose Modifications for Adverse Reactions Adverse Reaction Severity Based on National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), Version 5. UNLOXCYT Dosage Modifications ALT = alanine aminotransferase; AST = aspartate aminotransferase; DRESS: drug rash with eosinophilia and systemic symptoms; SJS: Stevens-Johnson Syndrome; TEN: toxic epidermal necrolysis; ULN: upper limit of normal. Immune-Mediated Adverse Reactions [see Warnings and Precautions (5.1) ] Pneumonitis Grade 2 Withhold Resume in patients with complete or partial resolution (Grade 0 to 1) after corticosteroid taper.
Permanently discontinue if no complete or partial resolution within 12 weeks of initiating steroids or inability to reduce corticosteroid to a prednisone equivalent of 10 mg/day or less within 12 weeks of initiating steroids. Grade 3 or 4 Permanently discontinue Colitis Grade 2 or 3 Withhold Grade 4 Permanently discontinue Hepatitis with no tumor involvement of the liver AST or ALT increases to more than 3 and up to 8 times ULN or Total bilirubin increases to more than 1.5 and up to 3 times ULN Withhold AST or ALT increases to more than 8 times ULN or Total bilirubin increases to more than 3 times ULN Permanently discontinue Hepatitis with tumor involvement of the liver If AST and ALT are less than or equal to ULN at baseline in patients with liver involvement, withhold or permanently discontinue UNLOXCYT based on recommendations for hepatitis with no tumor involvement of the liver.
Baseline AST or ALT is more than 1 and up to 3 times ULN and increases to more than 5 and up to 10 times ULN or Baseline AST or ALT is more than 3 and up to 5 times ULN and increases to more than 8 and up to 10 times ULN Withhold AST or ALT increases to more than 10 times ULN or Total bilirubin increases to more than 3 times ULN Permanently discontinue Endocrinopathies Depending on clinical severity, consider withholding for Grade 2 endocrinopathy until symptom improvement with hormone replacement. Resume once acute symptoms have resolved.
Grade 3 or 4 Withhold until clinically stable or permanently discontinue, depending on severity Nephritis with renal dysfunction Grade 2 or 3 increased blood creatinine Withhold Grade 4 increased blood creatinine Permanently discontinue Exfoliative dermatologic conditions Suspected SJS, TEN, or DRESS Withhold Confirmed SJS, TEN, or DRESS Permanently discontinue Myocarditis Grade 2, 3 or 4 Permanently discontinue Neurological toxicities Grade 2 Withhold Grade 3 or 4 Permanently discontinue Other Adverse Reactions Infusion-related reactions [see Warnings and Precautions (5.2) ] Grade 1 or 2 Interrupt or slow the rate of infusion Grade 3 or 4 Permanently discontinue 2.3.
Preparation and Administration Visually inspect the vial for particulate matter and discoloration. UNLOXCYT is clear to opalescent, colorless to yellow or slightly brown. Discard the vial if visible particles are observed.
Do not shake the via… [Excerpted — this section continues on DailyMed.]
💊 Dosage Forms and Strengths ▾
3. DOSAGE FORMS AND STRENGTHS Injection: 300 mg/5 mL (60 mg/mL), clear to opalescent, colorless to yellow or slightly brown solution in a single-dose vial. Injection: 300 mg/5 mL (60 mg/mL) solution in a single-dose vial. ( 3 )
⛔ Contraindications ▾
4. CONTRAINDICATIONS None. None. ( 4 )
⚠️ Warnings and Cautions ▾
5. WARNINGS AND PRECAUTIONS Immune-Mediated Adverse Reactions ( 5.1 ) Immune-mediated adverse reactions can occur in any organ system or tissue, including the following: immune-mediated pneumonitis, immune-mediated colitis, immune-mediated hepatitis, immune-mediated endocrinopathies, immune-mediated dermatologic adverse reactions, immune-mediated nephritis and renal dysfunction, and solid organ transplant rejection. Monitor for early identification and management.
Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. Withhold or permanently discontinue UNLOXCYT based on the severity of reaction. ( 2.2 ) Infusion-Related Reactions: Interrupt, slow the rate of infusion, or permanently discontinue based on severity of reaction.
( 2.2 , 5.2 ) Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT): Fatal and other serious complications can occur in patients who receive allogeneic HSCT before or after being treated with a PD-1/PD-L1 blocking antibody. ( 5.3 ) Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception.
( 5.4 , 8.1 , 8.3 ) 5.1. Severe and Fatal Immune-Mediated Adverse Reactions UNLOXCYT is a monoclonal antibody that belongs to a class of drugs that bind to either the programmed death receptor-1 (PD-1) or PD-ligand 1 (PD-L1), blocking the PD-1/PD-L1 pathway, thereby removing inhibition of the immune response, potentially breaking peripheral tolerance and inducing immune-mediated adverse reactions. Important immune-mediated adverse reactions listed in WARNINGS AND PRECAUTIONS may not include all possible severe and fatal immune-mediated reactions.
Immune-mediated adverse reactions, which can be severe or fatal, can occur in any organ system or tissue. Immune-mediated adverse reactions can occur at any time after starting a PD-1/PD-L1–blocking antibody. While immune-mediated adverse reactions usually manifest during treatment with PD-1/PD-L1–blocking antibodies, they can also manifest after discontinuation of PD-1/PD-L1–blocking antibodies.
Immune-mediated adverse reactions affecting more than one body system can occur simultaneously. Early identification and management of immune-mediated adverse reactions are essential to ensure safe use of PD-1/PD-L1–blocking antibodies. Monitor closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions.
Evaluate liver enzymes, creatinine, and thyroid function tests at baseline and periodically during treatment. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.
Withhold or permanently discontinue UNLOXCYT depending on severity [see Dosage and Administration (2.2) ] . 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. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month.
Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reaction is not controlled with corticosteroids. Toxicity management guidelines for adverse reactions that do not necessarily require systemic steroids (e.g., endocrinopathies, dermatologic reactions) are discussed below. Immune-Mediated Pneumonitis UNLOXCYT can cause immune-mediated pneumonitis.
In patients treated with other PD-1/PD-L1–blocking antibodies, the incidence of pneumonitis is higher in patients who have received prior thoracic radiation. Immune-mediated pneumonitis occurred in 1% (3/223, Grade 2) of patients receiving UNLOXCYT. Pneumonitis led to withholding of UNLOXCYT in 0.4% (1/223) of patients.
All 3 patients required sys… [Excerpted — this section continues on DailyMed.]
🤒 Adverse Reactions ▾
6. ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Severe and fatal immune-mediated adverse reactions [see Warnings and Precautions (5.1) ] Infusion-related reactions [see Warnings and Precautions (5.2) ] Complications of Allogeneic HSCT [see Warnings and Precautions (5.3) ] The most common adverse reactions (≥10%) were fatigue, musculoskeletal pain, rash, diarrhea, hypothyroidism, constipation, nausea, headache, pruritus, edema, localized infection, and urinary tract infection.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1-800- 818-4555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1. Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The pooled safety population described in WARNINGS AND PRECAUTIONS reflects exposure to UNLOXCYT as a single agent in 223 patients in two open-label, single-arm, multicohort studies, including 141 patients with advanced CSCC and 82 patients with other solid tumors and hematologic malignancies. UNLOXCYT was administered intravenously at doses of 800 mg every 2 weeks (n=174), 1,200 mg every 3 weeks (n=35), or other doses (n=14). Among the 223 patients, 54% were exposed for ≥24 weeks and 17% were exposed for ≥72 weeks.
The safety of UNLOXCYT was evaluated in Study CK-301-101 in 141 patients with metastatic or locally advanced disease CSCC [see Clinical Studies (14) ] . Patients received UNLOXCYT 800 mg every 2 weeks (n=115) or 1,200 mg every 3 weeks (n=26) as an intravenous infusion until disease progression or unacceptable toxicity. The median duration of exposure was 36 weeks (2 weeks to 3.7 years).
Serious adverse reactions occurred in 31% of advanced patients with CSCC who received UNLOXCYT. The most frequent serious adverse reactions (≥ 2% of patients) were sepsis (2.8%), pneumonia (2.8%) and pyrexia (2.1%). Permanent discontinuation of UNLOXCYT due to an adverse reaction occurred in 8% of patients.
Adverse reactions resulting in permanent discontinuation of UNLOXCYT were COVID-19, COVID-19 pneumonia, sepsis, ulcerative keratitis, tumor thrombosis, axillary pain, paresthesia, cholestasis, hepatic cytolysis, wound hemorrhage, neck pain, pemphigoid, and eye pain (1 patient each). Dosage interruptions due to an adverse reaction occurred in 36% of patients who received UNLOXCYT. The adverse reaction that required dosage interruption in ≥ 2% of patients who received UNLOXCYT was COVID-19 (2%).
The most common (≥ 10%) adverse reactions were fatigue, musculoskeletal pain, rash, diarrhea, hypothyroidism, constipation, nausea, headache, pruritus, edema, localized infection, and urinary tract infection. Table 2 and Table 3 summarize adverse reactions and laboratory abnormalities, respectively in CK-301-101. Table 2: Adverse Reactions in ≥ 10% of Patients with Metastatic or Locally Advanced CSCC Receiving UNLOXCYT in Study CK-301-101 UNLOXCYT N = 141 % System Organ Class Preferred Term All Grades % Grade 3 or 4 % Toxicity was graded per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v.4.03 (or later version) General disorders and administrative site conditions Fatigue Represents a composite of multiple related terms 33 3 Edema 11 0 Musculoskeletal and connective tissue disorders Musculoskeletal pain 25 3 Skin and subcutaneous tissue disorders Rash 23 1 Pruritus 12 0 Endocrine disorder Hypothyroidism 14 0 Gastrointestinal disorders Diarrhea 14 0 Nausea 13 0 Constipation 13 0 Nervous system disorders Headache 12 0 Infections and infestations Localized infection 10
0.7Urinary tract infection 10 0 Table 3: Laboratory Abnormalities that Worsened from Baseline to Grade 3 or 4 Occurring in ≥ 1% of Patients with Meta… [Excerpted — this section continues on DailyMed.]
👥 Use in Specific Populations ▾
8. USE IN SPECIFIC POPULATIONS Lactation: Advise not to breastfeed. ( 8.2 ) 8.1.
Pregnancy Risk Summary Based on its mechanism of action, UNLOXCYT can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] . There are no available data on the use of UNLOXCYT in pregnant women. Animal studies have demonstrated that inhibition of the PD-1/PD-L1 pathway can lead to increased risk of immune-mediated rejection of the developing fetus resulting in fetal death (see Data ) .
Human IgG1 immunoglobulins (IgG1) are known to cross the placental barrier; therefore, cosibelimab-ipdl has the potential to be transmitted from the mother to the developing fetus. Advise women of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Data Animal Data : Animal reproduction studies have not been conducted with cosibelimab-ipdl to evaluate its effect on reproduction and fetal development. A central function of the PD-1/PD-L1 pathway is to preserve pregnancy by maintaining maternal immune tolerance to the fetus. In murine models of pregnancy, blockade of PD-L1 signaling has been shown to disrupt tolerance to the fetus and to result in an increase in fetal loss; therefore, potential risks of administering UNLOXCYT during pregnancy include increased rates of abortion or stillbirth.
As reported in the literature, there were no malformations related to the blockade of PD-1/PD-L1 signaling in the offspring of these animals; however, immune-mediated disorders occurred in PD-1 and PD-L1 knockout mice. Based on its mechanism of action, fetal exposure to UNLOXCYT may increase the risk of developing immune-mediated disorders or altering the normal immune response. 8.2.
Lactation Risk Summary There is no information regarding the presence of cosibelimab-ipdl in human milk or its effects on the breastfed child or on milk production. Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment and for 4 months after the last dose of UNLOXCYT. 8.3.
Females and Males of Reproductive Potential UNLOXCYT can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1) ] . Pregnancy Testing Verify pregnancy status in females of reproductive potential prior to initiating UNLOXCYT [see Use in Specific Populations (8.1) ] . Contraception Females: Advise females of reproductive potential to use effective contraception during treatment with UNLOXCYT and for 4 months after the last dose.
8.4. Pediatric Use The safety and effectiveness of UNLOXCYT have not been established in pediatric patients. 8.5.
Geriatric Use Of the 141 patients treated with UNLOXCYT as a single agent, 21% (29) were younger than 65 years, 31% (44) were aged 65 through 75 years, and 48% (68) were 75 years or older. No overall differences in safety or effectiveness were observed between these patients and younger patients.
🤰 Pregnancy ▾
8.1. Pregnancy Risk Summary Based on its mechanism of action, UNLOXCYT can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] . There are no available data on the use of UNLOXCYT in pregnant women.
Animal studies have demonstrated that inhibition of the PD-1/PD-L1 pathway can lead to increased risk of immune-mediated rejection of the developing fetus resulting in fetal death (see Data ) . Human IgG1 immunoglobulins (IgG1) are known to cross the placental barrier; therefore, cosibelimab-ipdl has the potential to be transmitted from the mother to the developing fetus. Advise women of the potential risk to a fetus.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data : Animal reproduction studies have not been conducted with cosibelimab-ipdl to evaluate its effect on reproduction and fetal development. A central function of the PD-1/PD-L1 pathway is to preserve pregnancy by maintaining maternal immune tolerance to the fetus.
In murine models of pregnancy, blockade of PD-L1 signaling has been shown to disrupt tolerance to the fetus and to result in an increase in fetal loss; therefore, potential risks of administering UNLOXCYT during pregnancy include increased rates of abortion or stillbirth. As reported in the literature, there were no malformations related to the blockade of PD-1/PD-L1 signaling in the offspring of these animals; however, immune-mediated disorders occurred in PD-1 and PD-L1 knockout mice. Based on its mechanism of action, fetal exposure to UNLOXCYT may increase the risk of developing immune-mediated disorders or altering the normal immune response.
🧒 Pediatric Use ▾
8.4. Pediatric Use The safety and effectiveness of UNLOXCYT have not been established in pediatric patients.
🧓 Geriatric Use ▾
8.5. Geriatric Use Of the 141 patients treated with UNLOXCYT as a single agent, 21% (29) were younger than 65 years, 31% (44) were aged 65 through 75 years, and 48% (68) were 75 years or older. No overall differences in safety or effectiveness were observed between these patients and younger patients.
🧬 Clinical Pharmacology ▾
12. CLINICAL PHARMACOLOGY 12.1. Mechanism of Action PD-L1 may be expressed on tumor cells and tumor-infiltrating immune cells and can contribute to the inhibition of the anti-tumor immune response in the tumor microenvironment.
Binding of PD-L1 to the PD-1 and B7.1 receptors found on T cells and antigen presenting cells suppresses cytotoxic T-cell activity, T-cell proliferation, and cytokine production. Cosibelimab-ipdl binds PD-L1 and blocks the interaction between PD-L1 and its receptors PD-1 and B7.1. This interaction releases the inhibitory effects of PD-L1 on the anti-tumor immune response.
Cosibelimab-ipdl has also been shown to induce antibody-dependent cell-mediated cytotoxicity (ADCC) in vitro. 12.2. Pharmacodynamics Cosibelimab-ipdl exposure-response relationships and the time course of pharmacodynamic responses have not been fully characterized.
12.3. Pharmacokinetics Cosibelimab-ipdl pharmacokinetic parameters are presented as geometric mean (coefficient of variation) unless otherwise stated. At the recommended dosage, the cosibelimab-ipdl steady-state maximum plasma concentration (C max ) is 492 µg/mL (24.3%) and area under curve (AUC) is 112000 µg*h/mL (39.6%).
Cosibelimab-ipdl C max and AUC increased proportionally over the dose range of 800 mg to 1,200 mg following single dosing. Steady-state concentrations of cosibelimab-ipdl are reached by 12 weeks. At 1,200 mg every 3 weeks, the mean cosibelimab-ipdl concentrations (coefficient of variation, CV%) at steady-state ranged between a minimum concentration of 120 µg/L (46.3%) and a maximum concentration of 453 µg/L (22.2%).
Steady-state exposure was achieved after 84 days of treatment. In patients with CSCC, cosibelimab-ipdl steady-state exposure at 1,200 mg every 3 weeks (the recommended dosage) was comparable to the exposure at 800 mg every 2 weeks. Distribution Cosibelimab-ipdl steady state volume of distribution is approximately
5.67L (19.7%). Elimination Cosibelimab-ipdl steady state elimination half-life is 17.8 days (43.8%), and the clearance is 0.256 L/day (41%). Specific Populations No clinically significant differences in the pharmacokinetics of cosibelimab-ipdl were observed based on age (24.8 to 95.0 years), sex, race (79.6% White, 10.7% Asian, 0.5% African American, and 1.5% other), ethnicity (76.9% Not Hispanic/Latino and 4.9% Hispanic/Latino), ADA and nAb status, albumin (22 to 51 g/L), tumor type, tumor diameter, and renal impairment (CLcr 15 mL/min and higher).
The effect of severe hepatic impairment (bilirubin > 3 × ULN and any AST) on cosibelimab-ipdl pharmacokinetics is unknown.
12.6Immunogenicity The observed incidence of anti-drug antibodies is highly dependent on the sensitivity and specificity of the assay. Differences in assay methods preclude meaningful comparisons of the incidence of anti-drug antibodies in the studies described below with the incidence of anti-drug antibodies in other studies, including those of UNLOXCYT or of other cosibelimab products. Anti-drug antibody (ADA) and neutralizing antibody (nAb) responses were monitored throughout the treatment period where the benefit to risk ratio was assessed.
ADAs were detected in 65/133 (49%) of patients treated with UNLOXCYT and nAbs were detected in 2/65 (3.0%) of the patients. UNLOXCYT-treated patients who developed anti-cosibelimab antibodies had reduced UNLOXCYT concentrations (20% lower compared to UNLOXCYT-treated subjects who did not develop anti-cosibelimab-ipdl antibodies). There was no clinically significant effect of anti-cosibelimab-ipdl antibodies on the efficacy or safety of cosibelimab-ipdl.
🧬 Mechanism of Action ▾
12.1. Mechanism of Action PD-L1 may be expressed on tumor cells and tumor-infiltrating immune cells and can contribute to the inhibition of the anti-tumor immune response in the tumor microenvironment. Binding of PD-L1 to the PD-1 and B7.1 receptors found on T cells and antigen presenting cells suppresses cytotoxic T-cell activity, T-cell proliferation, and cytokine production.
Cosibelimab-ipdl binds PD-L1 and blocks the interaction between PD-L1 and its receptors PD-1 and B7.1. This interaction releases the inhibitory effects of PD-L1 on the anti-tumor immune response. Cosibelimab-ipdl has also been shown to induce antibody-dependent cell-mediated cytotoxicity (ADCC) in vitro.
📦 How Supplied / Storage and Handling ▾
16. HOW SUPPLIED/STORAGE AND HANDLING UNLOXCYT (cosibelimab-ipdl) injection is a clear to opalescent, colorless to yellow or slightly brown solution supplied in a carton containing one 300 mg/5 mL (60 mg/mL), single-dose vial (NDC 70095-130-01). 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.
📦 Storage and Handling ▾
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.
📋 Description ▾
11. DESCRIPTION Cosibelimab-ipdl is a human programmed death ligand-1 (PD-L1) blocking antibody. Cosibelimab-ipdl is a human IgG1 lambda monoclonal antibody.
Cosibelimab-ipdl is produced in Chinese hamster ovary (CHO) cells and has a calculated molecular weight of approximately 147 kDa. UNLOXCYT (cosibelimab-ipdl) injection for intravenous use is a sterile, preservative-free, clear to opalescent, colorless to yellow or slightly brown solution. It is supplied in single-dose vials.
Each vial contains 300 mg of UNLOXCYT in 5 mL of solution with a pH of 5.3. Each mL of solution contains 60 mg of cosibelimab-ipdl, acetic acid (0.24 mg), mannitol (37.35 mg), polysorbate 80 (1.1 mg), sodium acetate (1.31 mg), sodium chloride (4.09 mg), and Water for Injection, USP.
💬 Information for Patients ▾
17. PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Immune-Mediated Adverse Reactions Advise patients that UNLOXCYT can cause immune-mediated adverse reactions that may require corticosteroid treatment and interruption or discontinuation of UNLOXCYT including the following [ see Warnings and Precautions (5.1) ]: Pneumonitis: Advise patients to contact their healthcare provider immediately for signs or symptoms of pneumonitis, including new or worsening symptoms of cough, chest pain, or shortness of breath.
Colitis: Advise patients to contact their healthcare provider immediately for signs or symptoms of colitis, including diarrhea, blood or mucus in stools, or severe abdominal pain. Hepatitis: Advise patients to contact their healthcare provider immediately for signs or symptoms of hepatitis. Endocrinopathies: Advise patients to contact their healthcare provider immediately for signs or symptoms of hypothyroidism, hyperthyroidism, adrenal insufficiency, hypophysitis, or type 1 diabetes mellitus.
Nephritis: Advise patients to contact their healthcare provider immediately for signs or symptoms of nephritis. Dermatologic Adverse Reactions: Advise patients to contact their healthcare provider immediately if they develop a new rash. Other Immune-Mediated Adverse Reactions: Advise patients that immune-mediated adverse reactions can occur and may involve any organ system, and to contact their healthcare provider immediately for any new signs or symptoms [see Warnings and Precautions (5.1) ] .
Advise patients of the risk of solid organ transplant rejection and other transplant (including corneal graft) rejection. Advise patients to contact their healthcare provider immediately for signs or symptoms of organ transplant (including corneal graft) rejection [see Warnings and Precautions (5.1) ]. Infusion-Related Reactions Advise patients to contact their healthcare provider immediately for signs or symptoms of infusion-related reactions [ see Warnings and Precautions (5.2) ].
Complications of Allogeneic HSCT or Solid Organ Transplant Rejection Advise patients to contact their healthcare provider immediately if they develop signs or symptoms of post-allogeneic HSCT complications or of solid organ transplant rejection [ see Warnings and Precautions (5.1 , 5.3) ]. Embryo-Fetal Toxicity Advise females of reproductive potential that UNLOXCYT can cause harm to a fetus and to inform their healthcare provider of a known or suspected pregnancy [ see Warnings and Precautions (5.4) and Use in Specific Populations (8.1 , 8.3) ].
Advise females of reproductive potential to use effective contraception during treatment with UNLOXCYT and for 4 months after the last dose [ see Use in Specific Populations (8.3) ]. Lactation Advise female patients not to breastfeed during treatment with UNLOXCYT and for 4 months after the last dose [ see Use in Specific Populations (8.2) ].
💬 Medication Guide ▾
MEDICATION GUIDE UNLOXCYT (un-LOX-sit) (cosibelimab-ipdl) injection 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.
Call or see your healthcare provider right away if you develop any new or worsening signs or symptoms, including: Lung problems. cough chest pain shortness of breath Intestinal problems. diarrhea (loose stools) or more frequent bowel movements than usual stools that are black, tarry, sticky, or have blood or mucus severe stomach-area (abdomen) pain or tenderness Liver problems . yellowing of your skin or the whites of your eyes severe nausea or vomiting pain on the right side of your stomach area (abdomen) dark urine (tea colored) bleeding or bruising more easily than normal Hormone gland problems. headache that will not go away or unusual headaches eye sensitivity to light eye problems rapid heartbeat increased sweating extreme tiredness weight gain or weight loss feeling more hungry or thirsty than usual urinating more often than usual hair loss feeling cold constipation your voice gets deeper dizziness or fainting changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness Kidney problems : decrease in your amount urine blood in your urine swelling of your ankles loss of appetite Skin problems. rash itching fever or flu-like symptoms skin blistering or peeling painful sores or ulcers in mouth or nose, throat, or genital area swollen lymph nodes Problems can also happen in other organs and tissues.
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.
Signs and symptoms of infusion reactions may include: nausea chills or shaking itching or rash flushing shortness of breath or wheezing dizziness feel like passing out fever back or neck pain Rejection of a transplanted organ. Your healthcare provider should tell you what signs and symptoms you should report and monitor you, depending on the type of organ transplant that you have had. Complications, including graft-versus-host disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic).
These complications can be serious and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with UNLOXCYT. Your healthcare provider will monitor you for these complications.
Getting medical treatment right away may help keep these problems from becoming more serious. Your healthcare provider will check you for these problems during your treatment with UNLOXCYT. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines.
Your healthcare provider may also need to delay or completely stop treatment with UNLOXCYT if you have severe side effects. What is UNLOXCYT? UNLOXCYT is a prescription medicine used to treat adults with a type of skin cancer called cutaneous squamous cell carcinoma (CSCC).
UNLOXCYT may be used to t… [Excerpted — this section continues on DailyMed.]
🧬 Pharmacokinetics ▾
12.3. Pharmacokinetics Cosibelimab-ipdl pharmacokinetic parameters are presented as geometric mean (coefficient of variation) unless otherwise stated. At the recommended dosage, the cosibelimab-ipdl steady-state maximum plasma concentration (C max ) is 492 µg/mL (24.3%) and area under curve (AUC) is 112000 µg*h/mL (39.6%).
Cosibelimab-ipdl C max and AUC increased proportionally over the dose range of 800 mg to 1,200 mg following single dosing. Steady-state concentrations of cosibelimab-ipdl are reached by 12 weeks. At 1,200 mg every 3 weeks, the mean cosibelimab-ipdl concentrations (coefficient of variation, CV%) at steady-state ranged between a minimum concentration of 120 µg/L (46.3%) and a maximum concentration of 453 µg/L (22.2%).
Steady-state exposure was achieved after 84 days of treatment. In patients with CSCC, cosibelimab-ipdl steady-state exposure at 1,200 mg every 3 weeks (the recommended dosage) was comparable to the exposure at 800 mg every 2 weeks. Distribution Cosibelimab-ipdl steady state volume of distribution is approximately
5.67L (19.7%). Elimination Cosibelimab-ipdl steady state elimination half-life is 17.8 days (43.8%), and the clearance is 0.256 L/day (41%). Specific Populations No clinically significant differences in the pharmacokinetics of cosibelimab-ipdl were observed based on age (24.8 to 95.0 years), sex, race (79.6% White, 10.7% Asian, 0.5% African American, and 1.5% other), ethnicity (76.9% Not Hispanic/Latino and 4.9% Hispanic/Latino), ADA and nAb status, albumin (22 to 51 g/L), tumor type, tumor diameter, and renal impairment (CLcr 15 mL/min and higher).
The effect of severe hepatic impairment (bilirubin > 3 × ULN and any AST) on cosibelimab-ipdl pharmacokinetics is unknown.
🧬 Pharmacodynamics ▾
12.2. Pharmacodynamics Cosibelimab-ipdl exposure-response relationships and the time course of pharmacodynamic responses have not been fully characterized.
🔬 Clinical Studies ▾
14. CLINICAL STUDIES 14.1. Cutaneous Squamous Cell Carcinoma (CSCC) The efficacy of UNLOXCYT was evaluated in Study CK-301-101 ( NCT03212404 ), a multicenter, multicohort, open-label study in patients with metastatic CSCC (mCSCC) or locally advanced CSCC (laCSCC) who were not candidates for curative surgery or curative radiation.
Patients were excluded if they had the following: active or suspected autoimmune disease, allogeneic transplant within 6 months prior to treatment, prior treatment with anti–PD-1/PD-L1 blocking antibodies or other immune checkpoint inhibitor therapy, uncontrolled or significant cardiovascular disease, ECOG PS ≥ 2, or infection with HIV, hepatitis B or hepatitis C. Patients received UNLOXCYT 800 mg every 2 weeks until disease progression or unacceptable toxicity. Tumor response assessments were performed every 8 weeks for the first 8 months and every 12 weeks thereafter.
The major efficacy outcomes were objective response rate (ORR) and duration of response (DOR) as assessed by an independent central review committee (ICR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. For patients with laCSCC with externally visible target lesions not assessable by radiologic imaging, ORR was determined by ICR assessments of digital photography (WHO criteria). The efficacy population consisted of 109 patients.
The median age was 75 years (range 37-95); 78% were ≥ 65 years; 72% were male; 85% were White; 6% were Asian; 1% were Black or African American; 7% were race unknown or missing; 34% had ECOG performance status of 0, and 66% had ECOG performance score of 1. Seven percent of patients received at least one prior anti-cancer systemic therapy, 66% of patients had prior surgery, and 69% of patients had prior radiotherapy. Efficacy results are summarized in Table 4.
Table 4: Efficacy Results for Study CK-301-101 Efficacy Endpoints mCSCC N = 78 laCSCC N = 31 Objective Response Rate (ORR) ORR, n (%) (95% CI) 39 (50) (38, 62) 17 (55) (36, 73) Complete response, n (%) 10 (13) 8 (26) Partial response, n (%) 29 (37) 9 (29) Duration of Response (DOR) a Number of responders N=39 N=17 Median DOR in months b (Range) NR (1.4+, 45.3+) NR (8.3, 31.3+) Responders with observed DOR ≥ 6 months, n (%) c 33 (85) 17 (100) Responders with observed DOR ≥ 12 months, n (%) c 26 (67) 15 (88) CI: confidence interval; NR: not reached; +: Denotes ongoing at last assessment. a Median follow up time: mCSCC: 29.3 months; laCSCC: 24.1 months. b Based on Kaplan-Meier estimate. c The numerator includes the number of patients whose observed DOR reached at least the specified times of 6 or 12 months.
Patients who did not have the opportunity to reach the specified timepoint were included in the denominator only.
🧪 Nonclinical Toxicology ▾
13. NONCLINICAL TOXICOLOGY 13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility No studies have been performed to assess the potential of cosibelimab-ipdl for carcinogenicity or genotoxicity.
Fertility studies have not been conducted with cosibelimab-ipdl in animals. In 1- and 3-month repeat-dose toxicology studies in monkeys, there were no notable effects in the male and female reproductive organs up to the highest dose tested of 100 mg/kg/dose; however, many animals in these studies were not sexually mature. 13.2.
Animal Toxicology and/or Pharmacology In animal models, inhibition of PD-L1/PD-1 signaling increased the severity of some infections and enhanced inflammatory responses. Mycobacterium tuberculosis -infected PD-1 knockout mice exhibit markedly decreased survival compared with wild-type controls, which correlated with increased bacterial proliferation and inflammatory responses in these animals. PD-L1 and PD-1 knockout mice and mice receiving PD-L1–blocking antibody have also shown decreased survival following infection with lymphocytic choriomeningitis virus.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility No studies have been performed to assess the potential of cosibelimab-ipdl for carcinogenicity or genotoxicity. Fertility studies have not been conducted with cosibelimab-ipdl in animals.
In 1- and 3-month repeat-dose toxicology studies in monkeys, there were no notable effects in the male and female reproductive organs up to the highest dose tested of 100 mg/kg/dose; however, many animals in these studies were not sexually mature.
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL - 5 mL Vial Carton NDC 70095-130-01 Rx Only UNLOXCYT™ (cosibelimab-ipdl) Injection 300 mg / 5 mL (60 mg/mL) For Intravenous Infusion after Dilution. ATTENTION PHARMACIST: Each patient is required to receive the enclosed Medication Guide. Single-Dose Vial. Discard unused portion. 5 mL Unloxcyt1
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