Cemiplimab-rwlc (Intravenous route)
se-MIP-li-mab - rwlc
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 or cannot be cured by surgery or radiation.
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:
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.
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.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of cemiplimab-rwlc injection in the elderly.
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.
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.
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 (swelling of the bowels) or
- Crohn’s disease or
- Diabetic ketoacidosis or
- Hepatitis (swelling of the liver) or
- Hyperthyroidism (high levels of thyroid hormone) or
- Hypophysitis (swelling of the pituitary gland) or
- Hypothyroidism (low levels of thyroid hormone) or
- Lupus or
- Nephritis (swelling of the kidneys) or
- Pneumonitis (swelling of the lungs) or
- Type 1 diabetes or
- Ulcerative colitis—Use with caution. May make these conditions 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.
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.
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. 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 (swelling 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.
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 can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, or fever or chills with this medicine.
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.
Side Effects of This Medicine:
- More common
- itching, skin rash
- lower back or side pain
- painful or difficult urination
- Less common
- Bladder pain
- bloody or cloudy urine
- blurred vision
- chest pain or discomfort
- dark urine
- frequent urge to urinate
- general feeling of discomfort or illness
- general tiredness and weakness
- light-colored stools
- muscle or bone pain
- muscle weakness
- pain, redness, swelling, tenderness, or warmth on the skin
- pale skin
- pounding in the ears
- rapid, shallow breathing
- slow or fast heartbeat
- sore throat
- stiff neck or back
- thickening of bronchial secretions
- tightness in the chest
- trouble breathing
- troubled breathing with exertion
- unusual bleeding or bruising
- unusual tiredness or weakness
- upper right abdominal pain
- yellow eyes and skin
- More common
- decreased appetite
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:
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:
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.
Last Updated: 6/18/2019