Pronunciation:

koe-si-BEL-i-mab - ipdl

Brand Names:

• Unloxcyt

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Cosibelimab

Uses of This Medicine:

Cosibelimab-ipdl injection is used to treat a type of skin cancer called cutaneous squamous cell carcinoma (CSCC) that has spread (metastatic or locally advanced) or cannot be removed by surgery or radiation.

This medicine is to be given only by or under the supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of cosibelimab-ipdl injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of cosibelimab-ipdl injection in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Bacillus of Calmette and Guerin Vaccine, Live
• Dengue Tetravalent Vaccine, Live
• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Rubella Virus Vaccine, Live
• Smallpox Monkeypox Vaccine
• Typhoid Vaccine
• Varicella Virus Vaccine
• Yellow Fever Vaccine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adenovirus Vaccine Type 4, Live
• Adenovirus Vaccine Type 7, Live
• Cholera Vaccine
• Ebola Zaire Vaccine, Live
• Influenza Virus Vaccine, Live
• Rotavirus Vaccine, Live

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Adrenal gland problem or
• Colitis (inflammation of the colon) or
• Crohn’s disease or
• Diabetic ketoacidosis or
• Hepatitis (inflammation of the liver) or
• Hyperthyroidism (overactive thyroid gland) or
• Hypophysitis (inflammation of the pituitary gland) or
• Hypothyroidism (underactive thyroid gland) or
• Lupus or
• Muscle or nerve problems (eg, Guillain-Barré syndrome, myasthenia gravis) or
• Nephritis (inflammation of the kidneys) or
• Pneumonitis (inflammation of the lungs) or
• Type 1 diabetes or
• Ulcerative colitis—Use with caution. May make these conditions worse.

• Organ transplant or tissue transplant (eg, cornea transplant), recent—Use with caution. May increase risk for organ or tissue transplant rejection.

• Patients who have had allogeneic hematopoietic stem cell transplant (HSCT)—Use with caution. May cause side effects to become worse.

Proper Use of This Medicine:

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.

A nurse or other trained health professional will give you this medicine in a medical facility. It is given through an IV catheter that is placed into a vein. The medicine must be given slowly, so the IV will have to remain in place for at least 60 minutes. It is usually given every 3 weeks.

This medicine comes with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Your doctor will give you other medicines (eg, steroid medicine) before you receive this medicine and during treatment to help prevent unwanted effects.

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.

Precautions While Using This Medicine:

It is very important that your doctor check your progress closely to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Receiving this medicine while you are pregnant can harm your unborn baby. 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 to keep from getting pregnant during treatment with this medicine and for at least 4 months after the last dose. If you think you have become pregnant while using this medicine, tell your doctor right away.

Tell your doctor right away if you have a cough, chest tightness, or any type of breathing problem with this medicine. These could be symptoms of a serious lung problem (eg, pneumonitis).

Colitis (inflammation of the bowels) may occur with this medicine. Tell your doctor right away if you have stomach pain or tenderness, watery or bloody diarrhea, or fever after receiving the medicine.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, a loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Serious problems with the adrenal, pituitary, or thyroid glands may occur while you are receiving this medicine. Tell your doctor if you start having continuing or unusual headaches, changes in mood or behavior (eg, being irritable or forgetful), lightheadedness, dizziness, or fainting, unusual sluggishness, or an increase in weight.

This medicine may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests or if you have any questions, check with your doctor.

Tell your doctor right away if you have bloody or cloudy urine, nausea, vomiting, trouble breathing, swelling of the face, feet, or lower legs, unusual tiredness or weakness, or unusual weight gain. These may be symptoms of a serious kidney problem (eg, nephritis).

Serious skin reactions (eg, bullous or exfoliative dermatitis, Stevens-Johnson syndrome, drug rash with eosinophilia and systemic symptoms (DRESS), or toxic epidermal necrolysis) can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, chills, cough, diarrhea, itching, joint or muscle pain, red irritated eyes, red skin lesions, often with a purple center, severe acne or skin rash, sore throat, sores or ulcers on the skin, mouth, or lips, swollen glands, unusual bleeding or bruising, or unusual tiredness or weakness with this medicine.

Check with your doctor right away if blurred vision, difficulty with reading, eye pain, or any other change in vision occurs while you are receiving this medicine. Your doctor may want your eyes to be checked by an ophthalmologist (eye doctor).

This medicine may cause inflammation of the heart muscle (myocardium) called myocarditis. Check with your doctor right away if you have chest pain or discomfort, fever, chills, a fast heartbeat, or trouble breathing.

Check with your doctor if you have a headache, confusion, seizures, stiff neck, or vomiting while receiving this medicine. These may be symptoms of encephalitis (inflammation of the brain).

Check with your doctor right away if you are having severe muscle pain or cramps, unusual weakness of the arms or legs, or a burning, numbness, tingling, or painful sensation in the arms, hands, legs, or feet. These could be symptoms of a serious muscle or nerve problem.

This medicine may cause infusion-related reactions, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you start to have a fever, chills or shaking, dizziness, trouble breathing, itching or rash, lightheadedness or fainting after receiving this medicine.

This medicine may increase your risk for transplant complications (eg, graft-versus-host-disease [GVHD]) in patients who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic), which can be severe and life-threatening. Check with your doctor right away if you have skin rash, stomach pain, diarrhea, yellow skin or eyes, swelling in the legs or ankles, dark urine, pale stools, nausea, or vomiting.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Black, tarry stools

bladder pain

blistering, peeling, or loosening of the skin

bloody or cloudy urine

bone pain

chest pain or tightness

chills

constipation

cough

cracks in the skin

depressed mood

diarrhea

dry skin and hair

feeling cold

fever or chills

frequent urge to urinate

hair loss

headache

hoarseness or husky voice

itching

joint or muscle pain

loss of heat from the body

loss of taste or smell

lower back or side pain

muscle aches, pains, cramps, and stiffness

nausea and vomiting

painful or difficult urination

red, swollen skin

red irritated eyes

red skin lesions, often with a purple center

scaly skin

slowed heartbeat

sore throat

sores, ulcers, or white spots in the mouth or on the lips

stuffy or runny nose

swelling

swollen glands

trouble breathing

unusual bleeding or bruising

unusual tiredness or weakness

weight gain

Less common

General feeling of discomfort or illness

thickening of bronchial secretions

Rare

Agitation

anxiety

back or leg pain

bleeding gums

bloating

blood in the urine or stools

blue or pale skin

blurred vision or other change in vision

burning, tingling, numbness or pain in the hands, arms, feet, or legs

burning feeling in the chest or stomach

chest discomfort

chest pain, possibly moving to the left arm, neck, or shoulder

coma

confusion

darkening of the skin

dark urine

decreased urine output

difficulty in chewing, swallowing, or talking

difficulty in moving

dizziness

double vision

drooping eyelids

drowsiness

eye pain

fainting

fast heartbeat

inability to move the arms and legs

indigestion

irritability

lethargy

loss of appetite

muscle twitching or weakness

nosebleeds

numbness or tingling in the fingers, face, or feet

pain, swelling, or redness in the joints

pains in stomach, side, or abdomen, possibly radiating to the back

pale skin

pinpoint red spots on the skin

redness of the eye

seeing flashes or sparks of light

seeing floating spots before the eyes, or a veil or curtain appearing across part of vision

seizures

sensation of pins and needles

sensitivity of the eyes to light

stabbing pain

stiff neck or back

stomach cramps, pain, upset, or tenderness

stupor

sudden numbness and weakness in the arms and legs

swelling of the face, ankles, or hands

swollen, painful, or tender lymph glands in the neck, armpit, or groin

tearing

watery or bloody diarrhea

yellow eyes or skin

Incidence not known

Dry mouth

flushed, dry skin

increased hunger

increased thirst

increased urination

light-colored stools

loss of consciousness

sweating

unexplained weight loss

upper right abdominal or stomach pain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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