Pronunciation:

se-MIP-li-mab - rwlc

Brand Names:

• Libtayo

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Cemiplimab

Uses of This Medicine:

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

Cemiplimab-rwlc injection is also used to treat a type of skin cancer called basal cell carcinoma (BCC) that cannot be removed by surgery (locally advanced) or that has spread (metastatic) in patients who have received previous treatment with a hedgehog pathway inhibitor (HHI) or who cannot receive treatment with a HHI.

Cemiplimab-rwlc injection is also used alone as a first-line treatment for non-small cell lung cancer (NSCLC) that has not spread and cannot be removed by surgery or radiation (locally advanced), or that has spread (metastatic) in patients whose tumors express high PD-L1 and do not have an abnormal EGFR, ALK , or ROS1 gene. Your doctor will perform a test to check for the PD-L1 tumor before you receive this medicine.

Cemiplimab-rwlc injection is also used in combination with other cancer treatments (eg, platinum-based chemo) as a first-line treatment for non-small cell lung cancer (NSCLC) that has not spread and cannot be removed by surgery or radiation (locally advanced), or that has spread (metastatic) in patients whose tumors do not have an abnormal EGFR, ALK , or ROS1 gene.

Cemiplimab-rwlc is an antineoplastic agent (cancer medicine). It interferes with the growth of cancer cells, which are eventually destroyed by the body.

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 cemiplimab-rwlc 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 cemiplimab-rwlc 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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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 (high levels of thyroid hormone) or
• Hypophysitis (inflammation of the pituitary gland) or
• Hypothyroidism (low levels of thyroid hormone) or
• Lupus or
• Nephritis (inflammation of the kidneys) or
• Nervous system problems (eg, Guillain-Barré syndrome, myasthenia gravis) or
• Organ transplant, recent or
• Pneumonitis (inflammation of the lungs) or
• Type 1 diabetes or
• Ulcerative colitis—Use with caution. May make these conditions worse.

• 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:

A nurse or other trained health professional will give you this medicine in a medical facility. It is given through a needle placed into a vein. The medicine must be given slowly, so the needle will have to remain in place for at least 30 minutes. It is usually given every 3 weeks.

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.

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

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.

Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who 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.

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 (hormone 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 nephritis (inflammation of the kidney).

Tell your doctor right away if you have changes in your eyesight, severe or persistent muscle or joint pain, or severe muscle weakness after receiving this medicine.

Serious skin reactions (eg, exfoliative dermatitis, Stevens-Johnson syndrome, drug rash with eosinophilia and systemic syndrome (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.

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.

Call your doctor right away if you have difficulty with breathing, swallowing, or talking, muscle weakness, severe tiredness, or sudden numbness and weakness in the arms or legs. These could be symptoms of a nervous system problem.

Check with your doctor right away if you have severe headache, drowsiness, confusion, general feeling of illness, or stiff neck or back while you are receiving this medicine. These may be symptoms of meningitis.

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 possible organ transplant rejection. Talk to your doctor about this risk.

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

Chills

cough

diarrhea

fever

hoarseness

itching, skin rash

lower back or side pain

painful or difficult urination

Less common

Bladder pain

bloody or cloudy urine

blurred vision

body aches or pain

chest pain, discomfort, or tightness

confusion

dark urine

dizziness

ear congestion

fainting

frequent urge to urinate

general feeling of discomfort or illness

headache

light-colored stools

lightheadedness

loss of voice

muscle or bone pain

muscle weakness

nausea

nervousness

pain, redness, swelling, tenderness, or warmth on the skin

pale skin

pounding in the ears

rapid, shallow breathing

runny or stuffy nose

slow or fast heartbeat

sneezing

sore throat

stiff neck or back

thickening of bronchial secretions

trouble breathing

unusual bleeding or bruising

unusual tiredness or weakness

upper right stomach pain

vomiting

yellow eyes and skin

Rare

Blistering, peeling, or loosening of the skin

difficulty in moving

joint or muscle pain

muscle aches, cramps, or stiffness

red skin lesions, often with a purple center

red, irritated eyes

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

swollen glands

swollen joints

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Abnormal or decreased touch sensation

burning, crawling, itching, numbness, prickling, "pins and needles", tingling, or painful feelings

constipation

decreased appetite

loss or thinning of the hair

trouble sleeping

unsteadiness or awkwardness

weakness in the arms, hands, legs, or feet

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.