Keytruda

This medicine has provisional approval in Australia for unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) cancer and endometrial carcinoma. The decision to provisionally register these new uses of the medicine has been made on the basis of promising results from preliminary studies. More evidence is required to be submitted when available to fully confirm the benefit of the medicine for these uses.

pembrolizumab (rch)

Consumer Medicine Information

This leaflet answers some common questions about KEYTRUDA. It does not contain all the available information.

It does not take the place of talking to your doctor.

All medicines have risks and benefits. Your doctor has weighed the risks of you using KEYTRUDA against the benefits they expect it will have for you.

If you have any concerns about being given this medicine, ask your doctor.

Keep this leaflet.

You may need to read it again.

KEYTRUDA is used to treat:

a kind of skin cancer called melanoma in adults.

a kind of lung cancer called non-small cell lung cancer in adults.

a kind of head and neck cancer called head and neck squamous cell carcinoma in adults.

a kind of cancer called classical Hodgkin Lymphoma in adults.

a kind of cancer called primary mediastinal B-cell lymphoma in adults and children.

a kind of cancer called urothelial carcinoma, including bladder cancer in adults.

a kind of cancer in adults and children that can occur in any part of the body and is shown by laboratory tests to be microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR).

a kind of cancer called colon or rectal cancer in adults that is shown by a laboratory test to be MSI-H or dMMR

a kind of uterine cancer called endometrial carcinoma

a kind of kidney cancer called renal cell carcinoma in adults.

It is not known if KEYTRUDA is safe and effective in children with MSI-H or dMMR cancers of the brain or spinal cord (central nervous system cancers).

KEYTRUDA contains the active substance pembrolizumab.

Adults may get KEYTRUDA if their cancer has spread or cannot be taken out by surgery.

Adults get KEYTRUDA after they had surgery to remove melanoma to help prevent their cancer from coming back.

KEYTRUDA may be given in combination with other anti-cancer medicines. It is important that you also read the Consumer Medicine Information for these other medicines. If you have any questions about these specific medicines, please ask your doctor.

This medicine is available only with a doctor’s prescription.

KEYTRUDA works by helping your immune system fight your cancer.

Ask your doctor if you have any questions about why KEYTRUDA has been prescribed for you.

KEYTRUDA can be used in children with primary mediastinal B-cell lymphoma.

Tell your doctor if you:

have a disease of your immune system like Crohn’s, ulcerative colitis or lupus

had an organ transplant (like a kidney transplant) or a bone marrow (stem cell) transplant that used donor stem cells (allogeneic)

have pneumonia or swelling of your lungs (called pneumonitis)

have liver damage

If you are pregnant, think you may be pregnant or are planning to have a baby, tell your doctor.

KEYTRUDA can cause harm or death to your unborn baby.

You must use effective contraception while you are being treated with KEYTRUDA and for at least 4 months after the last dose of KEYTRUDA if you are a woman who could become pregnant.

If you are breastfeeding, tell your doctor.

Do not breastfeed while taking KEYTRUDA.

Tell your doctor if you

are taking any other medicines, including medicines that you buy without a prescription from your pharmacy, supermarket or health food shop

take other medicines that make your immune system weak. Examples of these may include steroids, such as prednisone.

Your doctor will give you KEYTRUDA through an IV for about 30 minutes.

Most people get KEYTRUDA every 3 weeks or every 6 weeks, depending on the dose you are given.

Your doctor will decide how many treatments you need.

Call your doctor right away to reschedule your appointment.

It is very important that you do not miss a dose of this medicine.

Tell any other doctors, dentists, and pharmacists who are treating you that you are being given KEYTRUDA.

If you are about to be started on any new medicine, tell your doctor, dentist or pharmacist that you are being given KEYTRUDA.

Like all medicines, KEYTRUDA can cause side effects, although not everybody gets them. Your doctor will discuss these with you and will explain the risks and benefits of your treatment.

When you get KEYTRUDA, you can have some serious side effects.

These side effects can sometimes become life-threatening and can lead to death. These side effects may happen anytime during treatment or even after your treatment has ended. You may experience more than one side effect at the same time.

If you have any of the following symptoms, call or see your doctor right away.

Signs and symptoms of lung problems

shortness of breath

chest pain

coughing

Signs and symptoms of problems with your intestines

diarrhoea or more bowel movements than usual

your stools are black, tarry, sticky or have blood or mucus

severe stomach pain or tenderness

Signs and symptoms of liver problems

nausea or vomiting

feeling less hungry

pain on the right side of your stomach

your skin looks yellow

the whites of your eyes look yellow

dark urine

you bleed or bruise more easily than normal

Signs and symptoms of kidney problems

changes in the amount or colour of your urine

Signs and symptoms of hormone gland problems (especially the thyroid, pituitary, and adrenal glands)

rapid heart beat

weight loss

increased sweating

weight gain

hair loss

feeling cold

constipation

your voice gets deeper

muscle aches

dizziness or fainting

headaches that will not go away or unusual headache

Signs and symptoms of blood sugar problems

feeling more hungry or thirsty

needing to urinate more often

weight loss

Signs and symptoms of skin problems

rash

itching

skin blistering, peeling or sores

ulcers in mouth or in lining of nose, throat, or genital area

Signs and symptoms of problems in other organs

muscle pain or weakness

changes in eyesight

stomach area pain with nausea and vomiting (pancreatitis)

confusion, fever, memory problems, or seizures (encephalitis)

swollen lymph nodes, rash or tender lumps on skin, cough, or eye pain (sarcoidosis)

shortness of breath, irregular heartbeat, feeling tired, or chest pain (myocarditis)

inflammation of the heart muscle, which may present as shortness of breath, irregular heartbeat, feeling tired, or chest pain (pericarditis)

inflammation of the covering of the heart and accumulation of fluid around the heart (pericardial effusion)

inflammation of the nerves that may cause pain, weakness, and paralysis in the arms and legs (peripheral neuropathy)

pain, numbness, tingling, or weakness in the arms or legs; bladder or bowel problems including needing to urinate more frequently, urinary incontinence, difficulty urinating and constipation (myelitis)

Signs and symptoms of infusion (IV) reactions

shortness of breath

itching or rash

dizziness

fever

There are possible side effects of treatment with KEYTRUDA in people who have received a transplant

Rejection of a transplanted organ.

People who have had an organ transplant may have an increased risk of organ transplant rejection. Your doctor should tell you what signs and symptoms you should report and monitor you, depending on the type of organ transplant that you have had.

Complications, including graft-versus-host-disease (GVHD), in people with bone marrow (stem cell) transplant that uses donor stem cells (allogeneic).

These complications can be severe and can lead to death. They may occur if you had this kind of transplant in the past or if you get it in the future. Your doctor will monitor you for the following signs and symptoms: skin rash, liver inflammation, abdominal pain, and diarrhoea.

The following side effects have been reported in clinical trials:

Very common (may affect more than 1 in 10 people)

diarrhoea, nausea

itching, rash

joint pain

back pain

feeling tired

cough

patches of skin which have lost colour

stomach pain

decreased sodium levels in the blood

fever

infections of the upper respiratory tract

a decreased number of white blood cells (which are important in fighting infection) in patients with primary mediastinal B-cell lymphoma

The following side effects have been reported in more than 1 in 5 people when KEYTRUDA was given in combination with chemotherapy:

hair loss

feeling tired

diarrhoea

decrease in white blood cell count

joint pain

rash

swelling of the lining of the digestive system (for example mouth, intestines)

mouth sores

decrease in red blood cell count

nausea

constipation

vomiting

Common side effects when KEYTRUDA is given in combination with lenvatinib include:

feeling tired

high blood pressure

joint and muscle pain

diarrhoea

decreased appetite

low levels of thyroid hormone

nausea

mouth sores

vomiting

weight loss

stomach-area (abdominal) pain

headache

constipation

urinary tract infection

hoarseness

bleeding

low magnesium level

blisters or rash on the palms of your hands and soles of your feet

shortness of breath

cough

rash

The most common side effects when KEYTRUDA is given in combination with axitinib are:

diarrhoea

fatigue

high blood pressure

liver problems

low levels of thyroid hormone

decreased appetite

blisters or rash on the palms of your hands and soles of your feet

nausea

mouth sores or swelling of the lining of the mouth, nose, eyes, throat, intestines, or vagina

hoarseness

rash

cough

constipation

The most common side effects when KEYTRUDA is given to children are:

fever

vomiting

fatigue

constipation

stomach pain

nausea

Less common side effects can happen.

Also, your doctor may do blood tests to check for side effects.

KEYTRUDA may cause other side effects that are not listed. For more information, ask your doctor.

If you have any side effect that bothers you or that does not go away, tell your doctor.

Ask your doctor to answer any questions you may have.

It is unlikely that you will be asked to store KEYTRUDA yourself. It will usually be stored in the pharmacy or on the ward.

KEYTRUDA powder for injection comes as a white to off-white powder in a glass vial. KEYTRUDA concentrated injection comes as a clear to slightly opalescent, colourless to slightly yellow solution in a glass vial.

Active ingredient:

pembrolizumab

Inactive ingredients:

Histidine

Histidine hydrochloride monohydrate

Sucrose

Polysorbate 80

Water for Injections

KEYTRUDA is supplied in Australia by:

Merck Sharp & Dohme (Australia) Pty Limited

Level 1, Building A, 26 Talavera Road, Macquarie Park NSW 2113, AUSTRALIA

 

This leaflet was prepared 08 December 2020.

 

Australian Register Numbers:

AUST R 226597 – KEYTRUDA 50mg Powder for injection

AUST R 263932 – KEYTRUDA 100mg/4mL concentrated injection

 

RCN: 000015708-AU; 000018809-AU