Cosibelimab-ipdl (By injection)

Cosibelimab-ipdl (koe-si-BEL-i-mab - ipdl)

Treats cutaneous squamous cell carcinoma (skin cancer).

Brand Name(s):

Unloxcyt

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through an IV placed in a vein. The medicine must be given slowly, so the IV will have to remain in place for at least 60 minutes.
• You will receive this medicine while you are in a hospital or cancer treatment center. A nurse or other trained health professional will give you this medicine.
• Your doctor will give you other medicines (including steroid medicine) before you receive this medicine and during treatment to help prevent unwanted effects.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic for instructions.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. If you can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Use an effective form of birth control while you are receiving this medicine and for at least 4 months after your last dose.
• Do not breastfeed while you are receiving this medicine and for 4 months after the last dose.
• Tell your doctor if you have kidney disease, liver disease, diabetes, lung disease, immune system problems (including Crohn disease, ulcerative colitis, lupus), muscle or nerve problems (including Guillain-Barré syndrome, myasthenia gravis), endocrine problems (including adrenal, pituitary, or thyroid gland problems), or any type of infection. Tell your doctor if you have had an organ transplant or other transplant (including cornea transplant).
• This medicine may cause the following problems:
  • Severe inflammation (swelling) or other problems caused by the immune system, including pneumonitis (lungs), colitis (bowels), hepatitis (liver), nephritis (kidneys), myocarditis (heart), encephalitis (brain), or eye or vision problems
  • Adrenal, pituitary, or thyroid gland problems
  • Changes in blood sugar levels
  • Serious skin reactions (including bullous or exfoliative dermatitis, Stevens-Johnson syndrome, drug rash with eosinophilia and systemic symptoms (DRESS), or toxic epidermal necrolysis)
  • Muscle or nerve problems
  • Infusion reactions, which could be severe
  • Increased risk of possible organ transplant rejection
• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, red skin rash
• Bloody or cloudy urine, decrease in how much or how often you urinate
• Blurred vision, trouble seeing, eye pain, or other vision changes
• Confusion, seizures, stiff neck, headache, sleepiness
• Cough, chest tightness, trouble breathing
• Dark urine or pale stools, nausea, vomiting, loss of appetite, yellow skin or eyes
• Diarrhea that may contain blood, severe stomach pain
• Fast or uneven heartbeat, swelling in your face, hands, ankles, feet, or lower legs
• Fever, chills, dizziness, or skin rash while receiving the infusion
• Increased hunger or thirst, dry mouth, sweating
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet
• Severe muscle pain, cramps, or weakness
• Unusual bleeding or bruising
• Weakness, headache, tiredness, weight changes, feeling cold, changes in mood or behavior

If you notice these less serious side effects, talk with your doctor:

• Constipation
• Pain, itching, burning, swelling, or a lump under your skin where the needle is placed

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

Last Updated: 3/4/2025