keytruda

Keytruda (pembrolizumab) is a cancer medicine that interferes with the growth and spread of cancer cells in the body.

Keytruda is used to treat advanced skin cancer (melanoma) that has spread to other parts of the body or cannot be surgically removed. It is usually given after other cancer medicine has been tried without success.

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

Important information

Keytruda can cause side effects that may cause symptoms in many different parts of your body. Some side effects may need to be treated with other medicine, and your cancer treatments may be delayed. You will need frequent medical tests to help your doctor determine if it is safe for you to keep receiving Keytruda. Do not miss any follow-up visits to your doctor.

Before taking this medicine

To make sure Keytruda is safe for you, tell your doctor if you have:

• a lung disease or a breathing disorder;

• liver or kidney disease;

• an autoimmune disorder such as lupus, Crohn"s disease, or ulcerative colitis; or

• if you have ever had an organ transplant.

FDA pregnancy category D. Do not use Keytruda if you are pregnant. It could harm the unborn baby. Tell your doctor right away if you become pregnant during treatment. Use effective birth control while you are using this medicine and for at least 4 weeks after your treatment ends.

See also: Pregnancy and breastfeeding warnings (in more detail)

It is not known whether pembrolizumab passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using Keytruda.

Keytruda is not approved for use by anyone younger than 18 years old.

How is Keytruda given?

Keytruda is injected into a vein through an IV. A healthcare provider will give you this injection.

Keytruda is usually given once every 3 weeks. Your doctor will determine how long to treat you with this medicine. Follow your doctor"s dosing instructions.

Before you start treatment, your doctor may perform tests to make sure Keytruda is the best treatment for your type of skin cancer.

Keytruda can cause certain side effects by changing the way your immune system works. These side effects can cause symptoms in many different parts of your body. Some side effects may need to be treated with other medicine, and your cancer treatments may be delayed.

You will need frequent medical tests to help your doctor determine if it is safe for you to keep receiving Keytruda. Do not miss any follow-up visits to your doctor.

Keytruda dosing information

Usual Adult Dose for Melanoma - Metastatic:

2 mg/kg IV infusion over 30 minutes

Duration of therapy: Administer every 3 weeks until disease progression or unacceptable toxicity.

Uses: Treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and a BRAF inhibitor if BRAF V600 mutation positive.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your Keytruda injection.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while receiving Keytruda?

Keytruda can pass into body fluids (including urine, feces, vomit, semen, vaginal fluid). 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. Patients and caregivers should wear rubber gloves while cleaning up 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.

Body fluids should not be handled by a woman who is pregnant or who may become pregnant. Use condoms during sexual activity to avoid exposure to body fluids.

Keytruda side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Keytruda: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• new or worsening cough, chest pain, feeling short of breath;

• easy bruising or bleeding;

• severe muscle weakness, severe or ongoing muscle aches, joint pain;

• diarrhea or increased stools, frequent or constant stomach pain, stools that contain mucus, bloody or tarry stools;

• frequent or unusual headaches, dizziness, vision problems;

• signs of overactive thyroid - feeling nervous or irritable, fast or pounding heartbeats, sweating, tremors or shaking, weight loss even with increased appetite, swelling in your neck or throat (enlarged thyroid);

• signs of underactive thyroid - extreme tiredness, constipation, feeling cold, depressed mood, weight gain, changes in your skin or fingernails;

• symptoms of a kidney problem - little or no urinating, pelvic pain, vomiting, swelling in your ankles or feet, pain or burning when you urinate, bloody or cloudy urine; or

• symptoms of liver problems - severe nausea and vomiting, upper stomach pain, jaundice (yellowing of the skin or eyes).

Common Keytruda side effects may include:

• nausea, loss of appetite, diarrhea, constipation;

• itching or rash;

• cough;

• joint pain; or

• feeling tired;

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

What other drugs will affect Keytruda?

Other drugs may interact with pembrolizumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.