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Yervoy (ipilimumab) – Package leaflet - L01XC11

Updated on site: 11-Oct-2017

Medication nameYervoy
ATC CodeL01XC11
Substanceipilimumab
ManufacturerBristol-Myers Squibb Pharma EEIG

Package leaflet: Information for the user

YERVOY 5 mg/ml concentrate for solution for infusion ipilimumab

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor.

If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.What YERVOY is and what it is used for

2.What you need to know before you use YERVOY

3.How to use YERVOY

4.Possible side effects

5.How to store YERVOY

6.Contents of the pack and other information

1.What YERVOY is and what it is used for

YERVOY contains the active substance ipilimumab, a protein which helps your immune system to attack and destroy cancer cells by your immune cells.

Ipilimumab is used to treat advanced melanoma (a type of skin cancer) in adults.

2. What you need to know before you use YERVOY

You should not be given YERVOY

if you are allergic to ipilimumab or any of the other ingredients of this medicine (listed in Section 6 "Contents of the pack and other information"). Talk to your doctor if you are not sure.

Warnings and precautions

Talk to your doctor before using YERVOY.

-inflammation of the intestines (colitis) which can worsen to bleedings or bowel perforation. Signs and symptoms of colitis may include diarrhoea (watery, loose or soft stools), an increased number of bowel movements than usual, blood in your stools or darker-coloured stools, pain or tenderness in your stomach area.

-inflammation of the liver (hepatitis) that can lead to liver failure. Signs and symptoms of hepatitis may include eye or skin yellowing (jaundice), pain on the right side of your stomach area, tiredness.

-inflammation of the skin that can lead to severe skin reaction (known as toxic epidermal necrolysis and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)). Signs and symptoms of severe skin reaction may include such as skin rash with or without itching, peeling of the skin, dry skin, fever, fatigue, swelling of the face or lymph glands, increase of

eosinophils (type of white blood cells) and effects on liver, kidneys or lungs. Please note that the reaction called DRESS may develop weeks or months after your last dose.

-inflammation of the nerves that can lead to paralysis. Symptoms of nerve problems may include muscle weakness, numbness or tingling in your hands or feet, loss of consciousness or difficulty waking up.

-inflammation of hormone producing glands (especially the pituitary, adrenal and thyroid glands) that may affect how these glands work. Signs and symptoms that your glands are not working properly may include headaches, blurry or double vision, tiredness, decreased sexual drive, behavioral changes.

-inflammation of the eyes. Signs and symptoms may include redness in the eye, pain in the eye, vision problems or blurry vision.

Tell your doctor immediately if you have any of these signs or symptoms or they get worse. Do not try to treat your symptoms with other medicines. Your doctor may give you other medicines in order to prevent more severe complications and reduce your symptoms, withhold the next dose of YERVOY, or stop your treatment with YERVOY altogether.

Please note that these signs and symptoms are sometimes delayed, and may develop weeks or months after your last dose. Before treatment, your doctor will check your general health. You will also have blood tests during treatment.

Check with your doctor or nurse before you are given YERVOY

if you have an autoimmune disease (a condition where the body attacks its own cells);

if you have, or have ever had, chronic viral infection of the liver, including hepatitis B (HBV) or hepatitis C (HCV);

if you have human immunodeficiency virus (HIV) infection or acquired immune deficiency syndrome (AIDS).

if you have previously experienced a severe skin adverse reaction on a prior cancer therapy.

Children and adolescents

YERVOY should not be used in children and adolescents below 18 years of age until more information becomes available.

Other medicines and YERVOY

Before you are given YERVOY, tell your doctor

if you are taking any medicines that suppress your immune system, such as corticosteroids. These medicines may interfere with the effect of YERVOY. However, once you are treated with YERVOY, your doctor may give you corticosteroids to reduce the side-effects that you may have with YERVOY.

if you are taking any medicines that stop your blood from clotting (anticoagulants). These medicines may increase the likelihood of bleeding in the stomach or intestine, which is a side- effect of YERVOY.

Also tell your doctor if you are taking or have recently taken any other medicines.

Do not take any other medicines during your treatment without talking to your doctor first. Based on early data, the combination of YERVOY (ipilimumab) and Zelboraf (vemurafenib, another medicine for the treatment of melanoma) is not recommended due to increased toxicity to the liver.

Pregnancy and breast-feeding

Tell your doctor if you are pregnant, if you are planning to become pregnant, or if you are breast-feeding.

You must not use YERVOY if you are pregnant unless your doctor specifically recommends it. The effects of YERVOY in pregnant women are not known, but it is possible that the active substance, ipilimumab, could harm an unborn baby.

You must use effective contraception while you are being treated with YERVOY if you are a woman who could become pregnant.

If you become pregnant while using YERVOY tell your doctor.

It is not known whether ipilimumab gets into breast milk. However, significant exposure of ipilimumab to the infant through breast milk is not expected and no effects on the breast-fed infant are anticipated. Ask your doctor if you can breast-feed during or after treatment with YERVOY.

Driving and using machines

Do not drive or use machines after you have been given YERVOY unless you are sure you are feeling well. Feeling tired or weak is a very common side effect of YERVOY. This can affect your ability to drive or to use machines.

YERVOY contains sodium

Tell your doctor if you are on a low-sodium (low-salt) diet before you are given YERVOY. It contains 2.3 mg sodium per ml of concentrate.

3.How to use YERVOY

How YERVOY is given

YERVOY will be given to you in a hospital or clinic under the supervision of an experienced doctor.

It will be given to you as an infusion (a drip) into a vein (intravenously) over a period of 90 minutes.

How much YERVOY is given

The recommended dose is 3 mg of ipilimumab per kilogram of your body weight.

The amount of YERVOY you will be given will be calculated based on your body weight. Depending on your dose, some or all of the content of the YERVOY vial may be diluted with sodium

chloride 9 mg/ml (0.9%) solution for injection or 50 mg/ml (5%) glucose solution for injection before use. More than one vial may be necessary to obtain the required dose.

You will be treated with YERVOY once every 3 weeks, for a total of 4 doses. You may notice the appearance of new lesions or growth of existing lesions on your skin, which can be expected when you are being treated with YERVOY. Your doctor will continue giving you YERVOY for a total of 4 doses, depending on your tolerance to the treatment.

If you miss a dose of YERVOY

It is very important for you to keep all your appointments to receive YERVOY. If you miss an appointment, ask your doctor when to schedule your next dose.

If you stop using YERVOY

Stopping your treatment may stop the effect of the medicine. Do not stop treatment with YERVOY unless you have discussed this with your doctor.

If you have any further questions about your treatment or the use of this medicine, ask your doctor.

4.Possible side effects

Like all medicines, this medicine 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.

Be aware of important symptoms of inflammation

YERVOY acts on your immune system and may cause inflammation in parts of your body. Inflammation may cause serious damage to your body and some inflammatory conditions may be life-threatening.

The following side effects have been reported in clinical trials in patients receiving 3 mg/kg ipilimumab:

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

loss of appetite

diarrhoea, vomiting or feeling sick (nausea)

skin rash, itching

feeling tired or weak, reaction at site of injection, fever

Tell your doctor immediately if you get any of these side effects.

Do not try to treat your symptoms with other medicines.

Common (may affect up to 1 in 10 people)

tumour pain

underactive function of the thyroid gland which can cause tiredness or weight gain, underactive function of the pituitary gland

dehydration

confusion

damage to the nerves (causing pain, weakness and cramps), dizziness, headache,

blurred vision, pain in the eye

low blood pressure, temporary redness of the face and neck, feeling of intense heat with sweating and rapid heart beat

shortness of breath, cough

bleeding in the stomach or intestine, inflammation of the intestines (colitis), constipation, heartburn, stomach pain

abnormal function of the liver

inflammation of the inner surface lining of a particular organ

inflammation and redness of the skin, skin colour change in patches (vitiligo), hives (itchy, bumpy rash), hair loss or thinning, excessive sweating at night, dry skin

pain in muscles and joints, muscle spasms

shivering, lack of energy, swelling, pain

flu-like illness

weight loss

Tell your doctor immediately if you get any of these side effects.

Do not try to treat your symptoms with other medicines.

Uncommon (may affect up to 1 in 100 people)

serious bacterial infection of the blood (sepsis, septic shock), inflammation around the brain or spinal cord, inflammation of the stomach and intestines, inflammation of bowel wall (causing fever, vomiting and stomach pain), urinary tract infection, infection of the respiratory tract

a group of symptoms due to cancer in the body such as high blood levels of calcium and cholesterol, and low blood levels of sugar (paraneoplastic syndrome)

allergic reaction

underactive function of the adrenal glands, overactive function of the thyroid gland, which can cause rapid heart rate, sweating and weight loss, defect of the glands producing sex hormones

decreased function of the adrenal glands caused by an underactive hypothalamus (part of the brain)

a group of metabolic complications occurring after cancer treatment characterised by high blood levels of potassium and phosphate, and low blood levels of calcium (tumour lysis syndrome).

changes in mental health, depression, lowered sex drive

severe and possibly fatal inflammation of the nerves causing pain, weakness or paralysis in the extremities (Guillain-Barré syndrome), fainting, inflammation of the nerves within the brain, excessive accumulation of fluid in the brain,difficulty in coordinating movements (ataxia), shaking, brief involuntary muscle contraction, difficulty in speaking

inflammation of the eye which causes redness or pain, bleeding in the eye, inflammation of the coloured part of the eye, reduced vision, a foreign body sensation in the eyes, swollen runny eyes, swelling of the eye, inflammation of the eyelids

irregular or abnormal heart beat

inflammation of the blood vessels, disease of the blood vessels, restriction in the blood supply to the extremities, low blood pressure when standing up

extreme difficulty in breathing, fluid accumulation in the lungs, inflammation of the lungs, hay fever

bowel perforation, inflammation of the membrane of the stomach wall, inflammation of the small intestine, inflammation of the bowel or the pancreas, peptic ulcer, inflammation of the food pipe, blockage of the intestines

liver failure, inflammation of the liver, enlarged liver, yellowing of the skin or eyes (jaundice)

severe and possibly fatal peeling of the skin (toxic epidermal necrolysis)

inflammation of the muscles causing pain or stiffness in the hip and shoulder, painful joints

inflammation of the thyroid gland, the kidney, or the central nervous system

multi organ inflammation

inflammation of skeletal muscles

muscle weakness

kidney function failure, kidney disease

absence of menstrual periods

multi organ dysfunction, reaction related to infusion of the medicine

change in hair colour

Tell your doctor immediately if you get any of these side effects.

Do not try to treat your symptoms with other medicines.

Rare (may affect up to 1 in 1,000 people)

inflammatory disease of blood vessels (most commonly head arteries)

inflammation of the anus and the rectal wall (marked by bloody stools and a frequent urge to defecate)

skin disease characterized by dry red patches covered with scales (psoriasis)

inflammation and redness of the skin (erythema multiforme)

a type of severe skin reaction characterized by rash accompanied by one or more of the following features: fever, swelling of the face or lymph glands, increase of eosinophils (type of white blood cells), effects on liver, kidneys or lungs (a reaction called DRESS).

Tell your doctor immediately if you get any of these side effects.

Do not try to treat your symptoms with other medicines.

Very rare (may affect up to 1 in 10,000 people)

Serious, potential life-threatening allergic reaction

Tell your doctor immediately if you get any of these side effects.

Do not try to treat your symptoms with other medicines.

In addition, the following uncommon (may affect up to 1 in 100 people) side effects have been reported in patients who received doses other than 3mg/kg of YERVOY in clinical trials:

triad of symptoms (meningism): neck stiffness, intolerance of bright light and headache, flu-like discomfort

inflammation of the heart muscle, weakness of the heart muscle, fluid around the heart

inflammation of the liver or the pancreas, nodules of inflammatory cells in various organs of your body

infection within the abdomen

painful skin lesions of the arms and legs and face (erythema nodosum)

overactive pituitary gland

decreased function of the parathyroid gland

inflammation of the eye, eye muscle inflammation

decreased hearing

poor blood circulation which makes toes and fingers numb or pale

damage to the tissues of the hands and feet resulting in redness, swelling and blisters

Tell your doctor immediately if you get any of these side effects.

Do not try to treat your symptoms with other medicines.

Changes in test results

YERVOY may cause changes in the results of tests carried out by your doctor. These include:

a variation in the number of red blood cells (which carry oxygen), white blood cells (which are important in fighting infection) or platelets (cells which help the blood to clot)

an abnormal variation of hormones and liver enzyme levels in the blood

abnormal liver function test

abnormal levels of calcium, sodium, phosphate or potassium in the blood

presence of blood or proteins in the urine

an abnormally high alkalinity of the blood and other body tissues

kidneys unable to remove acids from blood normally

presence of antibodies in the blood against some of your own cells

Reporting of side effects

If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5.How to store YERVOY

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and the vial label after EXP. The expiry date refers to the last day of that month.

Store in a refrigerator (2°C to 8°C).

Do not freeze.

Store in the original package in order to protect from light.

Do not store any unused portion of the infusion solution for reuse. Any unused medicine or waste material should be disposed of in accordance with local requirements.

6. Contents of the pack and other information

What YERVOY contains

The active substance is ipilimumab.

Each ml of concentrate contains 5 mg of ipilimumab. Each 10 ml vial contains 50 mg of ipilimumab. Each 40 ml vial contains 200 mg of ipilimumab.

The other ingredients are Tris-hydrochloride, sodium chloride (see section 2 "YERVOY contains sodium"), mannitol (E421), pentetic acid, polysorbate 80, sodium hydroxide, hydrochloric acid and water for injections.

What YERVOY looks like and contents of the pack

YERVOY concentrate for solution for infusion is clear to slightly opalescent, colourless to pale yellow and may contain light (few) particulates.

It is available in packs containing either 1 glass vial of 10 ml or 1 glass vial of 40 ml.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge UB8 1DH

United Kingdom

Manufacturer

Bristol-Myers Squibb S.r.l. Contrada Fontana del Ceraso 03012 Anagni (FR)

Italy

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgique/België/Belgien

Lietuva

N.V. Bristol-Myers Squibb Belgium S.A.

Bristol-Myers Squibb Gyógyszerkereskedelmi Kft.

Tél/Tel: + 32 2 352 76 11

Tel: +370 52 369140

България

Luxembourg/Luxemburg

Bristol-Myers Squibb Gyógyszerkereskedelmi Kft. N.V. Bristol-Myers Squibb Belgium S.A.

Teл.: + 359 800 12 400

Tél/Tel: + 32 2 352 76 11

Česká republika

Magyarország

Bristol-Myers Squibb spol. s r.o.

Bristol-Myers Squibb Gyógyszerkereskedelmi Kft.

Tel: + 420 221 016 111

Tel.: + 36 1 301 9700

Danmark

Malta

Bristol-Myers Squibb

BRISTOL-MYERS SQUIBB S.R.L.

Tlf: + 45 45 93 05 06

Tel: + 39 06 50 39 61

Deutschland

Nederland

Bristol-Myers Squibb GmbH & Co. KGaA

Bristol-Myers Squibb B.V.

Tel: + 31 (0)30 300 2222

Eesti

Norge

Bristol-Myers Squibb Gyógyszerkereskedelmi Kft. Bristol-Myers Squibb Norway Ltd

Tel: +372 640 1030

Tlf: + 47 67 55 53 50

Ελλάδα

Österreich

BRISTOL-MYERS SQUIBB A.E.

Bristol-Myers Squibb GesmbH

Τηλ: + 30 210 6074300

Tel: + 43 1 60 14 30

España

Polska

BRISTOL-MYERS SQUIBB, S.A.

BRISTOL-MYERS SQUIBB POLSKA SP. Z O.O.

Tel: + 34 91 456 53 00

Tel.: + 48 22 5796666

 

France

Portugal

Bristol-Myers Squibb SARL

Bristol-Myers Squibb Farmacêutica Portuguesa,

Tél: + 33 (0)1 58 83 84 96

S.A.

 

Tel: + 351 21 440 70 00

Hrvatska

România

Bristol-Myers Squibb spol. s r.o.

Bristol-Myers Squibb Gyógyszerkereskedelmi Kft.

Tel: +385 1 7100 030

Tel: + 40 (0)21 272 16 00

Ireland

Slovenija

Bristol-Myers Squibb Pharmaceuticals Ltd

Bristol-Myers Squibb spol. s r.o.

Tel: + 353 (1 800) 749 749

Tel: +386 1 2355 100

Ísland

Slovenská republika

Vistor hf.

Bristol-Myers Squibb spol. s r.o.

Sími: + 354 535 7000

Tel: + 421 2 59298411

Italia

Suomi/Finland

BRISTOL-MYERS SQUIBB S.R.L.

Oy Bristol-Myers Squibb (Finland) Ab

Tel: + 39 06 50 39 61

Puh/Tel: + 358 9 251 21 230

Κύπρος

Sverige

BRISTOL-MYERS SQUIBB A.E.

Bristol-Myers Squibb AB

Τηλ: + 357 800 92666

Tel: + 46 8 704 71 00

Latvija

United Kingdom

Bristol-Myers Squibb Gyógyszerkereskedelmi Kft. Bristol-Myers Squibb Pharmaceuticals Ltd

Tel: +371 67708347

Tel: + 44 (0800) 731 1736

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu

-------------------------------------------------------------------------------------------------------------------------

The following information is intended for healthcare professionals only:

Preparation should be performed by trained personnel in accordance with good practices rules, especially with respect to asepsis.

Calculating the dose:

The prescribed dose for the patient is given in mg/kg. Based on this prescribed dose, calculate the total dose to be given. More than one vial of YERVOY concentrate may be needed to give the total dose for the patient.

Each 10 ml vial of YERVOY concentrate provides 50 mg of ipilimumab; each 40 ml vial provides 200 mg of ipilimumab.

The total ipilimumab dose in mg = the patient’s weight in kg × the prescribed dose in mg/kg.

The volume of YERVOY concentrate to prepare the dose (ml) = the total dose in mg, divided by 5 (the YERVOY concentrate strength is 5 mg/ml).

Preparing the infusion:

Take care to ensure aseptic handling when you prepare the infusion. The infusion should be prepared in a laminar flow hood or safety cabinet using standard precautions for the safe handling of intravenous agents.

YERVOY can be used for intravenous administration either:

without dilution, after transfer to an infusion container using an appropriate sterile syringe; or

after diluting to up to 5 times the original volume of concentrate (up to 4 parts of diluent

to 1 part of concentrate). The final concentration should range from 1 to 4 mg/ml. To dilute the YERVOY concentrate, you can use either:

sodium chloride 9 mg/ml (0.9%) solution for injection; or

50 mg/ml (5%) glucose solution for injection

STEP 1

Allow the appropriate number of vials of YERVOY to stand at room temperature for approximately 5 minutes.

Inspect the YERVOY concentrate for particulate matter or discoloration. YERVOY concentrate is a clear to slightly opalescent, colourless to pale yellow liquid that may contain light (few) particulates. Do not use if unusual amount of particles and signs of discoloration are present.

Withdraw the required volume of YERVOY concentrate using an appropriate sterile syringe.

STEP 2

Transfer the concentrate into a sterile, evacuated glass bottle or IV bag (PVC or non-PVC).

If applicable, dilute with the required volume of sodium chloride 9 mg/ml (0.9%) solution for injection or 50 mg/ml (5%) glucose solution for injection. Gently mix the infusion by manual rotation.

Administration:

The YERVOY infusion must not be administered as an intravenous push or bolus injection. Administer the YERVOY infusion intravenously over a period of 90 minutes.

The YERVOY infusion should not be infused at the same time in the same intravenous line with other agents. Use a separate infusion line for the infusion.

Use an infusion set and an in-line, sterile, non-pyrogenic, low protein binding filter (pore size of 0.2 μm to 1.2 μm).

The YERVOY infusion is compatible with:

PVC infusion sets

Polyethersulfone (0.2 μm to 1.2 μm) and nylon (0.2 μm) in-line filters

Flush the line with sodium chloride 9 mg/ml (0.9%) solution for injection or 50 mg/ml (5%) glucose solution for injection at the end of the infusion.

Storage conditions and shelf life:

Unopened vial

YERVOY must be stored in a refrigerator (2°C to 8°C). The vials must be kept in the original package in order to protect from light. YERVOY should not be frozen.

Do not use YERVOY after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month.

YERVOY infusion

From a microbiological point of view, once opened, the medicine should be infused or diluted and infused immediately. The chemical and physical in-use stability of the undiluted or diluted infusion solution (between 1 and 4 mg/ml) has been demonstrated for 24 hours at room temperature (20°C

to 25°C) or when refrigerated (2°C to 8°C). If not used immediately, the infusion solution (undiluted or diluted) must be used within 24 hours when stored either under refrigeration (2°C to 8°C) or at room temperature (20°C to 25°C). Other in-use storage time and conditions are the responsibility of the user.

Disposal:

Do not store any unused portion of the infusion solution for reuse. Any unused medicine or waste material should be disposed of in accordance with local requirements.

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