Pembrolizumab

Pembrolizumab is used to treat the following:

• Melanoma
• Non-small cell lung cancer
• Malignant pleural mesothelioma
• Head and neck squamous cell cancer
• Classical Hodgkin lymphoma
• Primary mediastinal large B-cell lymphoma
• Urothelial cancer
• Microsatellite instability-high or mismatch repair deficient cancer
• Colorectal cancer
• Gastric cancer
• Esophageal cancer
• Cervical cancer
• Hepatocellular carcinoma
• Biliary tract cancer
• Merkel cell carcinoma
• Renal cell carcinoma
• Endometrial carcinoma
• Tumor mutational burden-high cancer
• Cutaneous squamous cell carcinoma
• Triple-negative breast cancer
• Ovarian cancer

Pembrolizumab works by blocking a pathway in your body called the PD-1/PD-L1 pathway. This pathway can prevent your immune system from attacking cancer cells. By blocking this pathway, Pembrolizumab helps your immune system find and kill cancer cells.

• Pembrolizumab is available under the following different brand names: Keytruda.

Common side effects of Pembrolizumab include:

• Tiredness
• Muscle or joint pain
• Skin rash
• Diarrhea
• Fever
• Cough
• Loss of appetite
• Itching
• Shortness of breath
• Constipation
• Stomach pain
• Nausea
• Low thyroid hormones
• Mouth sores
• Hair loss
• Weight loss
• Trouble sleeping
• Numbness, tingling, or burning in your arms, feet, or face
• High blood pressure
• Kidney or bladder infection

Serious side effects of Pembrolizumab include:

• Immune System Reactions. Pembrolizumab may cause your immune system to attack healthy tissues or organs, causing inflammation. When tissues or organs become inflamed, they may not work as well as they should. These side effects of immunotherapy can lead to serious or even life-threatening problems. You may be able to prevent these problems from getting more serious if you get medical help right away. Keep all appointments to check your blood work. Tell your health care provider right away if you have any of the following signs or symptoms, even if you are no longer taking this medicine.
• Inflamed lungs (pneumonitis): Chest pain, shortness of breath, or new or worsening cough.
• Inflamed intestines (colitis): Severe stomach pain, diarrhea, blood or mucus in your stool or black, tarry stools.
• Inflamed liver (hepatitis): Severe nausea or vomiting, stomach pain on your right side, yellowish eyes or skin, dark urine (pee), or easy bleeding or bruising.
• Inflamed hormone glands (adrenal insufficiency, thyroiditis, type 1 diabetes): Headache, fast or irregular heartbeat, sweating, tiredness, weight gain or loss, hair loss, changes in mood or behavior, peeing more than usual, feeling cold.
• Inflamed kidneys (nephritis): Peeing less than usual, bloody urine (pee), or swelling in your ankles.
• Skin inflammation (dermatitis): Skin rash, itching, blistering, or peeling or painful sores in your mouth, nose, throat, or genitals.
• Heart or blood vessel inflammation: Chest pain, fast or irregular heartbeat.
• Inflamed nerves: Weakness, numbness, or tingling in your arms or legs.
• Inflamed muscles or joints: Pain, swelling, or stiffness in your muscles or joints.
• Inflamed eye (uveitis): Blurred or double vision, eye pain or redness, sensitivity to light, vision loss.
• Infusion Reactions. Pembrolizumab can cause reactions that can be serious when it is given to you. Your infusion may need to be slowed or stopped if you have these reactions. Tell your health care provider right away if you have fever, chills, joint or muscle pain, redness of your face and neck, trouble breathing, chest pain, hives, nausea, or vomiting when you get your infusion.
• Complications of Stem Cell Transplant. Serious and life-threatening complications can happen if you have a stem cell transplant before or after treatment with Pembrolizumab.
• Reduced Adrenal Function. This medicine can cause your body’s adrenal glands to stop making as much cortisol (the stress hormone). Tell your health care provider if you have nausea, vomiting, weakness, tiredness, or low blood pressure.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Dosage Forms and Strengths

• Injection: 100 mg/4 mL solution in a single-dose vial

Melanoma

Adult Dose: 200 mg every 3 weeks or 400 mg every 6 weeks.

Pediatric Dose (12 years and older): 2 mg/kg (up to 200 mg) every 3 weeks.

Non-Small Cell Lung Cancer

Adult Dose: 200 mg every 3 weeks or 400 mg every 6 weeks.

Malignant Pleural Mesothelioma

Adult Dose: 200 mg every 3 weeks or 400 mg every 6 weeks.

Head and Neck Squamous Cell Cancer

Adult Dose: 200 mg every 3 weeks or 400 mg every 6 weeks.

Classical Hodgkin Lymphoma or Primary Mediastinal Large B-Cell Lymphoma

Adult Dose: 200 mg every 3 weeks or 400 mg every 6 weeks.

Pediatric Dose: 2 mg/kg (up to 200 mg) every 3 weeks.

Urothelial Cancer

Adult Dose: 200 mg every 3 weeks or 400 mg every 6 weeks.

Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Cancer

Adult Dose: 200 mg every 3 weeks or 400 mg every 6 weeks.

Pediatric Dose: 2 mg/kg (up to 200 mg) every 3 weeks.

Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer

Adult Dose: 200 mg every 3 weeks or 400 mg every 6 weeks.

Gastric Cancer

Adult Dose: 200 mg every 3 weeks or 400 mg every 6 weeks.

Esophageal Cancer

Adult Dose: 200 mg every 3 weeks or 400 mg every 6 weeks.

Cervical Cancer

Adult Dose: 200 mg every 3 weeks or 400 mg every 6 weeks.

Hepatocellular Carcinoma

Adult Dose: 200 mg every 3 weeks or 400 mg every 6 weeks.

Biliary Tract Cancer

Adult Dose: 200 mg every 3 weeks or 400 mg every 6 weeks.

Merkel Cell Carcinoma

Adult Dose: 200 mg every 3 weeks or 400 mg every 6 weeks.

Pediatric Dose: 2 mg/kg (up to 200 mg) every 3 weeks.

Renal Cell Carcinoma

Adult Dose: 200 mg every 3 weeks or 400 mg every 6 weeks.

Endometrial Carcinoma

Adult Dose: 200 mg every 3 weeks or 400 mg every 6 weeks.

Tumor Mutational Burden-High Cancer

Adult Dose: 200 mg every 3 weeks or 400 mg every 6 weeks.

Pediatric Dose: 2 mg/kg (up to 200 mg) every 3 weeks.

Cutaneous Squamous Cell Carcinoma

Adult Dose: 200 mg every 3 weeks or 400 mg every 6 weeks.

Triple-Negative Breast Cancer

Adult Dose: 200 mg every 3 weeks or 400 mg every 6 weeks.

Ovarian Cancer

Adult Dose: 200 mg every 3 weeks or 400 mg every 6 weeks.

There are no known drug interactions with pembrolizumab. Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them know if Pembrolizumab is right for you.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications: None.

Cautions:

• Pembrolizumab can cause your immune system to attack normal organs. This can happen during or after treatment and can be fatal.
• Tell your provider if you have ever had an organ transplant or a stem cell transplant.
• If you have a history of chest radiation, you may have a higher risk of lung inflammation.
• If you have a condition that affects your nervous system, like myasthenia gravis, tell your doctor.
• Your doctor will do regular blood tests to check your liver, kidneys, and thyroid.

Pregnancy: Pembrolizumab can cause harm to an unborn baby. Your health care provider will give you a pregnancy test before you start treatment. If you are able to become pregnant, you should use an effective method of birth control during treatment and for 4 months after your last dose. Tell your doctor right away if you think you may be pregnant or if you become pregnant during treatment.

Lactation: It is not known if this medicine passes into breast milk. Because of the risk of serious side effects in a breastfed child, you should not breastfeed during treatment and for 4 months after your last dose.