What is Keytruda and how is it used?
KEYTRUDA contains the active substance Pembrolizumab, an effective protein (protein), which helps your immune system to fight your cancer.
KEYTRUDA is used in adults to treat a certain type of skin cancer, called melanoma (melanoma), applied when this has spread or can not be surgically removed.
What you need to consider before using it?
KEYTRUDA must not be given to you,
- if you against Pembrolizumab or in Section 6 ( "Content of the pack and other information") are allergic excipients listed this medicine. Talk to your doctor if you are unsure.
Warnings and Precautions
Talk to your doctor or nurse before you are given KEYTRUDA.
Please talk to your doctor before you receive KEYTRUDA if you:
- an autoimmune disease have (a disease in which the body attacks its own cells)
- pneumonia (pneumonia) or inflammation of the lungs (called a pneumonitis) have
- previously ipilimumab, have received another medicinal product for the treatment of melanoma, and severe side effects when taking this medicine had
- have suffered an allergic reaction to treatments with other monoclonal antibodies
- a chronic viral infection of the liver, including hepatitis B (HBV) or hepatitis C (HCV) have or had
- have an infection with the "human immunodeficiency virus" (HIV) or the "Acquired Immunodeficiency Syndrome" suffer (AIDS)
- have a damaged or a transplanted liver
- have damaged kidneys or a transplanted kidney
If you receive KEYTRUDA, some serious side effects occur to you.
If you notice (s) of the following signs or symptoms, contact or seek emergency medical attention. Your doctor may give you other medicines to prevent more severe complications and to relieve your symptoms. Your doctor can move the next dose KEYTRUDA or stopping your treatment with KEYTRUDA.
- Inflammation of the lung: Associated symptoms and complaints thereof may include shortness of breath, chest pain or coughing.
- Inflammation of the intestines: Appropriate signs and symptoms which may include diarrhea or unusually frequent bowel movements, dark colored, tarry, sticky or comprise interspersed with blood or mucus stools, severe stomach pain or pressure pain sensitivity of the stomach, nausea and vomiting.
- Inflammation of the liver: Associated symptoms and complaints which may include nausea or vomiting, decreased hunger, include right-sided stomach pain / abdominal pain, yellowing of the skin or the eyeballs, dark-colored urine or easily be triggered bleeding or bruising.
- Inflammation of the kidneys: Associated symptoms and discomfort it may be changes in amount or color of your urine.
- Inflammation of the endocrine glands (particularly the thyroid, pituitary and adrenal glands): appropriate signs and symptoms of which may include rapid heartbeat, weight loss, increased sweating, weight gain, hair loss, chills, constipation, deeper voice, muscle pain, dizziness or fainting, chronic headache, or unusual headaches.
- Type I diabetes: Appropriate signs and symptoms of which may include increased hunger or thirst than usual, and the need frequent urination or weight loss.
- Eye infections: Appropriate signs and symptoms may include blurred vision for.
- Inflammation of muscles: Appropriate signs and symptoms thereof may include muscle pain or weakness.
- Inflammation of the pancreas: Appropriate signs and symptoms thereof may include abdominal pain, nausea and vomiting
- Inflammation of the skin: Appropriate signs and symptoms thereof may include skin rash.
- Infusion Reactions: Associated symptoms and complaints thereof may include shortness of breath, itching or rash, dizziness or fever.
Children and adolescents
KEYTRUDA should not be used in children and adolescents under 18 years.
Application of KEYTRUDA with other medicines
Tell your doctor if you
- other medicines that weaken their immune systems. These include corticosteroids such. As prednisone. These medicines may affect the action of KEYTRUDA. However, your doctor may give you corticosteroids, if you are already being treated with KEYTRUDA to reduce side effects that you may have.
- other medicines / taking, have recently taken / occupied or intend to apply / take.
- You may KEYTRUDA not get when you are pregnant, except on special recommendation of your doctor.
- If you are pregnant, or if you suspect you may be pregnant or intend to become pregnant, ask before using this medicine your doctor for advice.
- KEYTRUDA can inflict harm her unborn child or cause his death.
- If you are a woman of childbearing age, you must apply during treatment with KEYTRUDA and at least four months after the last dose of KEYTRUDA a reliable method of contraception.
- If you are breastfeeding, talk to your doctor.
- You should not breastfeed while using KEYTRUDA.
- It is not known whether KEYTRUDA passes into breast milk.
Driving and using machines
Run after administration of KEYTRUDA not drive or operate any tools or machines until you are sure that you feel comfortable. Fatigue or weakness are very common side effects of KEYTRUDA. This can affect your ability to drive and your ability to operate machinery
How is it used?
KEYTRUDA is given to you in a hospital or outpatient practice under the supervision of an experienced physician.
- Your doctor will give you KEYTRUDA every 3 weeks for a 30-minute infusion into a vein (IV).
- Your doctor will decide how many treatments you need.
How much KEYTRUDA is given to you?
The recommended dose is 2 mg per kilogram of your body weight Pembrolizumab.
If you miss a treatment with KEYTRUDA
- Contact your doctor immediately to make up for the missed treatment.
- It is very important that you do not miss a treatment with this medicine.
If you stop using KEYTRUDA
Following treatment discontinuation, may reverse the effects of this drug.Do not stop treatment with KEYTRUDA before you have talked to your doctor.
If you have any further questions on the use of this medicine, contact your doctor.
You will also find this information in the patient card that was handed out by your doctor. It is important that you keep this patient card with you and show your partner or caregiver
What are the possible side effects?
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you receive KEYTRUDA, some serious side effects occur to you. See Section 2 below.
Side effects reported in clinical trials:
Very common (may affect more than 1 in 10 people)
- Diarrhea; nausea
- Itching; Skin rash; patchy discoloration of the skin (vitiligo)
- joint pain
- feeling tired
Common (may affect up to 1 in 10 people)
- Reduction in red blood cells
- Thyroid problems; hot flashes
- Decreased hunger
- sleep disorders
- A headache; Taste changes; Inflammation of the nerves, causing numbness, feelings of weakness, tingling, or burning pain in the arms and legs; giddiness
- Pneumonia; Shortness of breath; to cough
- Inflammation of the bowel; dry mouth
- Inflammation of the liver
- Dry eyes
- Stomach pain; Constipation; Vomit
- Red raised skin rash, sometimes with blisters; dry, itchy skin; Changes in hair color; hair loss
- Muscle pain or tenderness of the muscles; Pain in muscles and bones;Pain in arms or legs; Joint pain with swelling
- swelling; unusual tiredness or weakness; Chills; flu-like illness; fever
- Elevated liver function tests in the blood
- Reactions in conjunction with Annex infusion of the drug
Uncommon (may affect up to 1 in 100 people)
- Decreased number of blood platelets (easy to be triggered bruising or bleeding); decreased number of white blood cells (neutrophils, lymphocytes, leukocytes and eosinophils)
- Inflammations located at the base of the diencephalon pituitary gland, decreasing hormone adrenal; Inflammation of the thyroid
- Type I diabetes, decreased potassium, sodium and calcium in the blood
- Seizures; Lack of energy (lethargy)
- Ocular inflammation; Eye pain, eye irritation, Itching, or redness;unpleasant photosensitivity; Seeing "flying gnats"
- heat intolerance
- High blood pressure
- Inflammation of the pancreas
- A thickened, sometimes scaly skin growth; acneiform skin problems;Inflammation of the skin; small skin bumps and nodes or -wunden;sensitive, red bumps under the skin
- Inflammation of the kidneys
- Increased levels of amylase (a starch-degrading enzyme); pathologically altered values in renal function tests; elevated blood calcium levels
Rare (may affect up to 1 in 1,000)
- Inflammatory response that is directed against platelets or red blood cells
- A temporary inflammation of the nerves causing pain, weakness and paralysis of the extremities caused; a disease in which the muscles are weak and easily fatigued
- A hole in the small intestine (small intestine breakdown)
Reporting of adverse reactions
If you notice any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You may experience side effects directly via the in Annex V show listed national reporting system. By reporting side effects, you can help ensure that more information is provided about the safety of this product available
How should it be stored?
Keep this medicine out of reach of children.
Do this medicine after the on the carton and vial label after "EXP" (EXP;. EXP) stated expiration date no longer use. The expiry date refers to the last day of that month.
Store in a refrigerator (2 ° C to 8 ° C).
Chemical and physical in-use stability of the reconstituted and diluted solution for 24 hours at room temperature detected (at or below 25 ° C).From a microbiological point of view, the product must be used immediately. Do not freeze the reconstituted or diluted solution. If the product is not used immediately, in-use storage times and conditions after opening before use are the responsibility of the user, the storage period may not exceed a total time of 24 hours. The retention period of 24 hours may include up to 6 hours at room temperature (at or below 25 ° C), moreover, the solution in the refrigerator at 2 ° C must be kept to 8 ° C.
not store the remains of the infusion solution for reuse. Not product or waste material should be disposed of in accordance with local requirements.