When This Medicine Should Not Be Used:
This medicine is not right for everyone. You should not receive it if you had an allergic reaction to pembrolizumab, or if you are pregnant or breastfeeding.

How to Use This Medicine:
Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through a needle placed in a vein.
• You will receive this medicine while you are in a hospital or cancer treatment center. A nurse or other trained health professional will give you this medicine.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• 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.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• This medicine may cause birth defects if either partner is using it during conception or pregnancy. Tell your doctor right away if you or your partner becomes pregnant. Use an effective form of birth control while you receive this medicine and for 4 months after your last dose.
• Tell your doctor if you have liver disease, diabetes, lung disease, or immune system problems.
• This medicine may cause the following problems:
  
  • Pneumonitis (lung problems)
  • Colitis (inflammation of the colon), which might damage your digestive system
  • Hepatitis
  • Adrenal, pituitary, or thyroid gland problems
  • Changes in blood sugar levels
  • Kidney problems, which could lead to kidney failure
  • Infusion reactions, which could be severe
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Bloody or black, tarry stools, diarrhea, severe stomach pain
• Bloody or cloudy urine, swelling of your face, feet, or lower legs
• Blurred vision or vision changes
• Cough, chest tightness, trouble breathing
• Dark urine or pale stools, nausea, vomiting, loss of appetite, yellow skin or eyes
• Fever, chills, shaking, rash, itchy skin
• Increased hunger or thirst, dry mouth, sweating, changes in how much or how often you urinate
• Joint or muscle pain
• Lightheadedness, dizziness, fainting
• Weakness, unusual headaches, tiredness, weight changes, feeling cold

If you notice these less serious side effects, talk with your doctor:

• Constipation
• Pain, itching, burning, swelling, or a lump under your skin where the needle is placed

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088