Overview
Cemiplimab is an antineoplastic agent that interferes with the growth of cancer cells that the body eventually destroys. It is a monoclonal antibody that belongs to a class of drugs that act by binding to the programmed death receptor-1. The most common side effects include fatigue, rash, diarrhea, musculoskeletal pain, and nausea.
It was approved by the U.S. Food and Drug Administration (FDA) in September 2018 for treating metastatic cutaneous squamous cell carcinoma (CSCC) that cannot be treated through surgery or radiation. The Food and Drug Administration approved its use for patients with locally advanced basal cell carcinoma on February 9, 2021. These patients were previously treated with a hedgehog pathway inhibitor (HHI) and for whom an HHI is inappropriate. A doctor only prescribes this medicine, and is administered under their supervision.
What Are the Indications of Cemiplimab?
Cemiplimab treats basal cell carcinoma and cutaneous squamous cell carcinoma that is locally advanced or has spread to other body parts.
Cemiplimab is also used alone or along with other cancer treatments as a first-line treatment for non-small cell lung cancer that has not metastasized or spread and cannot be removed by surgery or radiation or that has spread in patients whose tumors express high PD-L1 protein and do not show any abnormality in EGFR, ALK, or ROS1 gene.
Precautions:
The risks and benefits of this medication must be evaluated:
Pediatric
The safety and efficacy of this medication have yet to be studied. No proper studies have not been performed on the relationship between age and the effects of Cemiplimab in the pediatric population.
Breastfeeding
There are no proper data on nursing women for determining the risk of using this medication in infants during breastfeeding. The benefits must be weighed against the risks before taking this medication while breastfeeding.
Allergies
The doctor must be informed about any unusual or allergic reaction to this medication or any other medicines. Also, inform the health care professionals of any allergies to foods, preservatives, dyes, or animals. For non-prescription products, the package ingredients must be carefully read correctly.
Geriatric
No authentic studies have been performed to date that show geriatric-specific problems further limiting the use of Cemiplimab in the elderly.
Drug Interactions
Certain medications must not be used together. However, in some cases, two medicines must be administered simultaneously, even if an interaction might occur. The doctor might change the dose or take other necessary precautions in these cases. The healthcare professional must be informed about administering any other prescription or nonprescription (over-the-counter) medicine.
Interactions
Certain medicines must be avoided at or around the time of eating or certain types of food since interactions might occur. The use of alcohol or tobacco with specific drugs may also cause certain interactions. The healthcare provider must be consulted about using this medicine with particular food, alcohol, or tobacco.
Other Medical Problems
The medications must be cautiously administered in patients undergoing allogeneic hematopoietic stem cell transplant (HSCT), which might worsen the side effects. The drug is administered by a nurse or other trained healthcare personnel through a needle intravenously (IV). The presence of other medical problems may alter the effect of this medicine.
The doctor must be informed about the presence of the following other medical problems, especially:
Hepatitis (inflammation of the liver).
Colitis (inflammation of the colon).
Hyperthyroidism (high levels of thyroid hormone).
Adrenal gland problems.
Nephritis (inflammation of the kidneys).
Crohn’s disease.
Hypophysitis (inflammation of the pituitary gland).
Hypothyroidism (low levels of thyroid hormone).
Nervous system problems (Guillain-Barré syndrome, myasthenia gravis).
Organ transplant.
Pneumonitis (inflammation of the lungs).
Ulcerative colitis.
Type 1 diabetes.
The medicine should be administered slowly to keep the needle in place for at least 30 minutes. Drugs that treat cancer are powerful and can cause various side effects. Before this medicine is administered, the risk and benefits must be evaluated carefully. It is important to monitor the patient during the treatment.
For Patients:
What Is Basal Cell Carcinoma (BCC)?
Basal cell carcinoma is the most frequently diagnosed cutaneous malignancy, which affects around one in every five Americans. Basal cell carcinoma can severely damage and destroy local tissues when treatment is delayed, although it is rarely fatal. Basal cell carcinoma (BCC) is also known as basal cell epithelioma. It is considered the most common cancer in humans. BCC occurs mainly on sun-damaged skin and is rarely seen on mucous membranes, palms, and soles. It is usually a slow-growing tumor that rarely spreads to other body organs.
Why Is Cemiplimab Prescribed?
Cemiplimab treats basal cell carcinoma and cutaneous squamous cell carcinoma that is locally advanced or has spread to other body parts. Cemiplimab can be used alone or in combination with other cancer treatments as a first-line treatment for non-small cell lung cancer that has not spread or metastasized and cannot be removed by surgery or radiation or that has spread in patients whose tumors express high PD-L1 protein and do not show any abnormality in EGFR, ALK, or ROS1 gene.
What Should Be Done in Case of a Missed Dose?
It is important to administer this medication on a fixed schedule. Call the home health caregiver, doctor, or treatment clinic for instructions if a dose is missed.
Precautions
The doctor must check the progress of the medicine closely to ensure that the medicine is working properly. Blood and urine tests must be performed to monitor any unwanted effects.
Pregnancy:
In female patients who can get pregnant, the doctor must perform a test to confirm that the patient is not pregnant before starting the treatment with Cemiplimab; using this medication during pregnancy can harm the fetus.
The patients must be advised to use birth control during the treatment and at least four months after the last dose. If a woman conceives while taking this medication, she must inform the doctor immediately.
Respiratory Problems:
The doctor must be informed immediately if the patient has chest tightness, cough, or breathing problems after taking Cemiplimab. This indicates a serious lung disease.
Stomach and Liver Problems:
This medicine might cause colitis (inflammation of the bowels). The doctor must be informed immediately in case of the following symptoms after receiving the medication:
Pain or tenderness in the stomach.
Bloody or watery diarrhea.
Fever.
Pale stools.
Dark urine.
Loss of appetite.
Nausea.
Unusual tiredness or weakness.
Yellow eyes or skin.
Kidney Problems:
The patient may also notice symptoms of nephritis or inflammation of the kidney that include:
Bloody or cloudy urine.
Unusual tiredness or weakness.
Trouble breathing.
Vomiting.
Swelling of the face, lower legs, or feet.
Unusual weight gain.
Hormonal Problems:
Severe problems involving the pituitary, adrenal, or thyroid glands (hormone glands) might occur while the patient receives this medicine. Inform the doctor of any unusual headaches, changes in irritable or forgetful mood or behavior, dizziness, lightheadedness, unusual sluggishness, fainting, or increased weight. Blood glucose levels might also be affected while using this medication.
Skin Problems:
The following serious skin reactions might occur:
Exfoliative dermatitis.
Stevens-Johnson syndrome.
Drug rash with eosinophilia systemic syndrome (DRESS).
Inform the doctor if the following symptoms appear:
Blistering.
Peeling.
Loosening of the skin.
Chills.
Diarrhea.
Cough.
Itching.
Severe acne or skin rash.
Joint or muscle pain.
Red irritated eyes.
Red skin lesions with a purple center.
Unusual tiredness or weakness with this medicine.
Sores or ulcers on the skin, mouth, or lips, swollen glands.
Unusual bleeding or bruising.
Infusion-Related Reactions:
Cemiplimab might cause infusion-related reactions that can be life-threatening and need immediate medical attention.
Inform the doctor immediately in case of the following symptoms:
Fever.
Chills or shaking.
Dizziness.
Trouble breathing.
Itching or rash.
Lightheadedness.
Fainting.
Muscle Problems:
This medicine may cause inflammation of the heart muscle (myocardium) called myocarditis.
Inform the doctor immediately in case of the following symptoms:
Chest pain or discomfort.
Fever.
Chills.
Fast heartbeat.
Trouble breathing.
Other Problems:
Inform the doctor immediately if there is difficulty swallowing, breathing, or talking, severe tiredness, muscle weakness, or sudden numbness and weakness in the arms or legs. This indicates a serious nervous system problem.
Cemiplimab might increase the risk of possible organ transplant rejection. Inform the doctor if any changes are noticed in the eyesight and persistent muscle or joint pain is experienced.
There might be symptoms of meningitis that include:
Severe headaches.
Drowsiness.
Stiff neck or back.
Confusion.
A general feeling of illness.
For Doctors:
Indications:
Cemiplimab treats certain types of basal cell carcinoma and cutaneous squamous cell carcinoma that are locally advanced or have spread to other body parts.
Cemiplimab can be used alone or along with other cancer treatments as a first-line treatment for non-small cell lung cancer that has not spread or metastasized and cannot be removed by surgery or radiation or that has spread in patients whose tumors express high PD-L1 protein and do not show any abnormality in EGFR, ALK, or ROS1 gene.
What Are the Side Effects of Cemiplimab?
The medicine might cause some unwanted effects along with its desired effects. The medication might lead to certain side effects that require immediate attention.
Common side effects include:
Chills.
Cough.
Fever.
Diarrhea.
Hoarseness.
Abnormal or decreased touch sensation.
Itching, skin rash.
Lower back or side pain.
Painful or difficult urination.
Decreased appetite.
Trouble sleeping.
Unsteadiness or awkwardness.
Loss or thinning of the hair.
Weakness in the arms, legs, hands, or feet.
Less common side effects include:
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.
A general feeling of discomfort or illness.
Light-colored stools.
Muscle or bone pain.
Lightheadedness.
Loss of voice.
Muscle weakness.
Nausea.
Headache.
Nervousness.
Rapid, shallow breathing.
Pain, swelling, redness, tenderness, or warmth on the skin.
Pale skin.
Pounding in the ears.
Thickening of bronchial secretions.
Runny or stuffy nose.
A slow or fast heartbeat.
Sneezing.
Sore throat.
Stiff neck or back.
Trouble breathing.
Unusual tiredness or weakness.
Unusual bleeding or bruising.
Yellow eyes and skin.
Upper right stomach pain.
Vomiting.
Rare side effects include:
Blistering, peeling, or loosening of the skin.
Difficulty in moving.
Red, irritated eyes.
Joint or muscle pain.
Muscle aches, cramps, or stiffness.
Sores or white spots in the mouth or on the lips.
Red skin lesions with a purple center.
Swollen glands.
Swollen joints.
Clinical Trials:
Efficacy was evaluated in an ongoing multi-center, open-label, non-randomized trial in patients with advanced basal cell carcinoma (BCC) who were receiving hedgehog pathway inhibitor (HHI) therapy and had not responded well after nine months on hedgehog pathway inhibitor (HHI) therapy or was intolerant to a prior hedgehog pathway inhibitor (HHI) therapy. Eligibility requirements involved BCC patients who were not candidates for curative surgery per multidisciplinary assessment. Cemiplimab 350 milligrams was administered every three weeks for up to 93 weeks until planned treatment, unacceptable toxicity, and disease progression were completed.
Pharmacology:
Cemiplimab binds to the protein PD-1 that helps immune cells kill cancer cells; hence, it is used to treat various types of cancer. It can also be used alone or with other medicines for treating non-small cell lung cancer in locally advanced adults or has reached other parts of the body and may have the PD-L1 protein. However, it has no mutation or change in the EGFR, ALK, or ROS1 gene.
It is also being studied in the treatment of other types of cancer. Cemiplimab may block PD-1 and help the immune system kill cancer cells. It is a type of monoclonal antibody and a type of immune checkpoint inhibitor.
What Is the Mechanism of Action of Cemiplimab?
Cemiplimab binds to the PD-1 receptor found on T cells and inhibits cytokine production and T-cell proliferation. PD-1 ligands upregulation occurs in some tumors, further signaling through this pathway to help inhibit active T-cell immune espionage of tumors.
Cemiplimab is a human recombinant immunoglobulin G4 (IgG4) monoclonal antibody that blocks its interaction with PD-L1 and PD-L2, which binds to PD-1, releasing PD-1 pathway-mediated inhibition of the immune response and further includes the anti-tumor immune response. As studied in syngeneic mouse tumor models, blocking PD-1 activity leads to decreased tumor growth.
Pharmacokinetics
The pharmacokinetic data of Cemiplimab was collected from 1062 patients with different solid tumors in a population pharmacokinetic analysis. The pharmacokinetics of Cemiplimab has shown to be dose-proportional and linear in the dosage range of 1 mg/kg to 10 mg/kg.
Distribution
The volume of distribution of Cemiplimab at steady state is 5.3 liter (26%).
Elimination
Cemiplimab clearance after the first dose is 0.29 liter/day (33%) and decreases by 29% over time, resulting in a steady-state clearance of 0.20 liter/day (40%).
The elimination half-life at a steady state is 20.3 days (29%).
