Keytruda

>10%

Fatigue (47%)

Anemia (55%)

Hyperglycemia (40%)

Hyponatremia (35%)

Hypoalbuminemia (34%)

Nausea (30%)

Cough (30%)

Pruritus (30%)

Rash (29%)

Decreased appetite (26%)

Hypertriglyceridemia (25%)

Increased AST (24%)

Constipation (21%)

Diarrhea (20%)

Arthralgia (20%)

Pain in extremity (18%)

Dyspnea (18%)

Peripheral edema (17%)

Vomiting (16%)

Headache (16%)

Myalgia (14%)

Chills (14%)

Insomnia (14%)

Abdominal pain (12%)

Back pain (12%)

Dizziness (11%)

Pyrexia (11%)

Upper respiratory tract infection (11%)

Vitiligo (11%)

1-10%

Sepsis (up to 10%)

Immune-mediated hypothyroidism (8.3%)

Immune-mediated pneumonitis (2.9%)

Immune-mediated hyperthyroidism (1.2%)

Immune-mediated colitis (1%)

<1%

Immune-mediated nephritis (0.7%)

Renal failure (0.5%)

Immune-mediated hepatitis (0.5%)

Immune-mediated hypophysitis (0.5%)

Postmarketing reports

Infusion-related reactions

Exfoliative dermatitis

Bullous pemphigoid

Asthenia

Lymphopenia

Tell your doctor about all prescription, nonprescription, illegal, recreational, herbal, nutritional, or dietary drugs you’re taking while receiving Keytruda.

A doctor or nurse will give you an injection of Keytruda intravenously (into a vein) at a hospital or medical facility.

The medicine is injected over 30 minutes, and the usual dose is 2 milligrams per kilogram of body weight.

Keytruda is typically given once every three weeks for as long as your doctor recommends.

Keytruda Overdose

Keytruda is given in a clinical setting by a trained medical professional, so an overdose isn’t likely.

However, if you suspect an overdose, contact a poison control center or emergency room immediately.

You can get in touch with a poison control center at 800-222-1222.

Missed Dose of Keytruda

Call your doctor if you miss an appointment to receive your dose of Keytruda.

Pembrolizumab is a cancer medicine that interferes with the growth and spread of cancer cells in the body.

Pembrolizumab is used to treat:

• advanced skin cancer (melanoma) that has spread to other parts of the body or cannot be surgically removed;

• a certain type of non-small cell lung cancer, if your tumor has a specific genetic marker for which your doctor will test;

• head and neck cancer that has spread to other parts of the body, or has come back after prior treatment;

• classical Hodgkin lymphoma in adults and children;

• a certain type of bladder and urinary tract cancer that has spread to other parts of the body or cannot be surgically removed; and

• a type of cancer that laboratory testing proves to be a microsatellite instability-high or a mismatch repair deficiency solid tumor.

Pembrolizumab is often given after other cancer medicine has been tried without success.

Pembrolizumab was approved by the US Food and Drug Administration (FDA) on an "accelerated" basis to treat lung cancer or head and neck cancer. In clinical studies, tumors responded to this medicine. However, it has not been shown that pembrolizumab can improve symptoms or lengthen survival time.

Pembrolizumab may also be used for purposes not listed in this medication guide.

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

• If you have an allergy to Keytruda (pembrolizumab) or any part of this medicine.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you are breast-feeding. Do not breast-feed while you take Keytruda or for 4 months after your last dose.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Patient Selection for Treatment of NSCLC

Select patients for treatment of metastatic NSCLC with Keytruda as a single agent based on the presence of positive PD-L1 expression [see Clinical Studies (14.2)]. Information on FDA-approved tests for the detection of PD-L1 expression in NSCLC is available at: http://www.fda.gov/CompanionDiagnostics.

Recommended Dosage for Melanoma

The recommended dose of Keytruda is 200 mg administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression or unacceptable toxicity [see Clinical Studies (14.1)].

Recommended Dosage for NSCLC

The recommended dose of Keytruda is 200 mg administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression [see Clinical Studies (14.2)].

When administering Keytruda in combination with chemotherapy, Keytruda should be administered prior to chemotherapy when given on the same day [see Clinical Studies (14.2)]. See also the Prescribing Information for pemetrexed and carboplatin.

Recommended Dosage for HNSCC

The recommended dose of Keytruda is 200 mg administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression [see Clinical Studies (14.3)].

Recommended Dosage for cHL

The recommended dose of Keytruda in adults is 200 mg administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression or unacceptable toxicity, or up to 24 months in patients without disease progression [see Clinical Studies (14.4)].

The recommended dose of Keytruda in pediatric patients is 2 mg/kg (up to a maximum of 200 mg), administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression or unacceptable toxicity, or up to 24 months in patients without disease progression.

Recommended Dosage for Urothelial Carcinoma

The recommended dose of Keytruda is 200 mg administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression or unacceptable toxicity, or up to 24 months in patients without disease progression [see Clinical Studies (14.5)].

Recommended Dosage for MSI-H Cancer

The recommended dose of Keytruda in adults is 200 mg administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression [see Clinical Studies (14.6)].

The recommended dose of Keytruda in children is 2 mg/kg (up to a maximum of 200 mg), administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression or unacceptable toxicity, or up to 24 months in patients without disease progression.

Dose Modifications

Withhold Keytruda for any of the following:

• Grade 2 pneumonitis [see Warnings and Precautions (5.1)]
• Grade 2 or 3 colitis [see Warnings and Precautions (5.2)]
• Grade 3 or 4 endocrinopathies [see Warnings and Precautions (5.4)]
• Grade 4 hematological toxicity in cHL patients
• Grade 2 nephritis [see Warnings and Precautions (5.5)]
• Grade 3 severe skin reactions or suspected Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN) [see Warnings and Precautions (5.6)]
• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 3 and up to 5 times upper limit of normal (ULN) or total bilirubin greater than 1.5 and up to 3 times ULN
• Any other severe or Grade 3 treatment-related adverse reaction [see Warnings and Precautions (5.7)]

Resume Keytruda in patients whose adverse reactions recover to Grade 0-1.

Permanently discontinue Keytruda for any of the following:

• Any life-threatening adverse reaction (excluding endocrinopathies controlled with hormone replacement therapy, or hematological toxicity in patients with cHL)
• Grade 3 or 4 pneumonitis or recurrent pneumonitis of Grade 2 severity [see Warnings and Precautions (5.1)]
• Grade 3 or 4 nephritis [see Warnings and Precautions (5.5)]
• Grade 4 severe skin reactions or confirmed SJS or TEN [see Warnings and Precautions (5.6)]
• AST or ALT greater than 5 times ULN or total bilirubin greater than 3 times ULN
  • For patients with liver metastasis who begin treatment with Grade 2 AST or ALT, if AST or ALT increases by greater than or equal to 50% relative to baseline and lasts for at least 1 week
• Grade 3 or 4 infusion-related reactions [see Warnings and Precautions (5.8)]
• Inability to reduce corticosteroid dose to 10 mg or less of prednisone or equivalent per day within 12 weeks
• Persistent Grade 2 or 3 adverse reactions (excluding endocrinopathies controlled with hormone replacement therapy) that do not recover to Grade 0-1 within 12 weeks after last dose of Keytruda
• Any severe or Grade 3 treatment-related adverse reaction that recurs [see Warnings and Precautions (5.7)]

Preparation and Administration

Reconstitution of Keytruda for Injection (Lyophilized Powder)

• Add 2.3 mL of Sterile Water for Injection, USP by injecting the water along the walls of the vial and not directly on the lyophilized powder (resulting concentration 25 mg/mL).
• Slowly swirl the vial. Allow up to 5 minutes for the bubbles to clear. Do not shake the vial.

Preparation for Intravenous Infusion

• Visually inspect the solution for particulate matter and discoloration prior to administration. The solution is clear to slightly opalescent, colorless to slightly yellow. Discard the vial if visible particles are observed.
• Dilute Keytruda injection (solution) or reconstituted lyophilized powder prior to intravenous administration.
• Withdraw the required volume from the vial(s) of Keytruda and transfer into an intravenous (IV) bag containing 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP. Mix diluted solution by gentle inversion. The final concentration of the diluted solution should be between 1 mg/mL to 10 mg/mL.
• Discard any unused portion left in the vial.

Storage of Reconstituted and Diluted Solutions

The product does not contain a preservative.

Store the reconstituted and diluted solution from the Keytruda 50 mg vial either:

• At room temperature for no more than 6 hours from the time of reconstitution. This includes room temperature storage of reconstituted vials, storage of the infusion solution in the IV bag, and the duration of infusion.
• Under refrigeration at 2°C to 8°C (36°F to 46°F) for no more than 24 hours from the time of reconstitution. If refrigerated, allow the diluted solution to come to room temperature prior to administration.

Store the diluted solution from the Keytruda 100 mg/4 mL vial either:

• At room temperature for no more than 6 hours from the time of dilution. This includes room temperature storage of the infusion solution in the IV bag, and the duration of infusion.
• Under refrigeration at 2°C to 8°C (36°F to 46°F) for no more than 24 hours from the time of dilution. If refrigerated, allow the diluted solution to come to room temperature prior to administration.

Do not freeze.

Administration

• Administer infusion solution intravenously over 30 minutes through an intravenous line containing a sterile, non-pyrogenic, low-protein binding 0.2 micron to 5 micron in-line or add-on filter.
• Do not co-administer other drugs through the same infusion line.

None.

NDC 0006-3029-02

Keytruda®
(pembrolizumab)
for Injection

50 mg / vial

For Intravenous Infusion Only

Dispense the enclosed Medication Guide to each patient.

Sterile lyophilized powder must be reconstituted with Sterile Water for
Injection, USP. Reconstituted solution requires further dilution prior
to administration.

Rx only

Single-dose vial. Discard unused portion.

Keytruda can pass into body fluids (urine, feces, vomit). For at least 48 hours after you receive a dose, avoid allowing your body fluids to come into contact with your hands or other surfaces. Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

Applies to pembrolizumab: intravenous powder for solution, intravenous solution

Along with its needed effects, pembrolizumab (the active ingredient contained in Keytruda) 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 while taking pembrolizumab:

• Bloating or swelling of the face, arms, hands, lower legs, or feet
• body aches or pain
• chills
• constipation
• cough
• depressed mood
• difficulty with breathing
• difficulty with moving
• dry skin and hair
• ear congestion
• feeling cold
• fever
• hair loss
• headache
• hoarseness or husky voice
• loss of voice
• muscle cramps, pain, and stiffness
• pain in the joints
• pale skin
• rapid weight gain
• runny or stuffy nose
• slowed heartbeat
• sneezing
• sore throat
• tingling of the hands or feet
• trouble breathing
• troubled breathing with exertion
• unusual bleeding or bruising
• unusual tiredness or weakness
• unusual weight gain or loss

• Chest pain
• general feeling of discomfort or illness
• nervousness
• pain
• sensitivity to heat
• stomach cramps
• sweating
• tenderness
• thickening of bronchial secretions
• trouble sleeping
• watery or bloody diarrhea
• weight loss

• Back, leg, or stomach pains
• bleeding gums
• blurred vision or other change in vision
• cracks in the skin
• darkened urine
• difficulty with moving
• drowsiness
• eye pain
• fast heartbeat
• general body swelling
• general tiredness and weakness
• indigestion
• light-colored stools
• loss of appetite
• loss of heat from the body
• nausea or vomiting
• nosebleeds
• pain, swelling, or redness in the joints
• pains in the stomach, side, or abdomen, possibly radiating to the back
• pale skin
• red, swollen skin
• redness of the eye
• scaly skin
• seizures
• sensitivity of the eye to light
• sore throat
• tearing
• upper right abdominal or stomach pain
• yellow eyes and skin

Some side effects of pembrolizumab 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:

• Decreased appetite
• diarrhea
• dizziness
• headache
• rash