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Alimta (pemetrexed) – Package leaflet - L01BA04

Updated on site: 05-Oct-2017

Medication nameAlimta
ATC CodeL01BA04
Substancepemetrexed
ManufacturerEli Lilly Nederland B.V.

Package leaflet: Information for the user

ALIMTA 100 mg powder for concentrate for solution for infusion ALIMTA 500 mg powder for concentrate for solution for infusion pemetrexed

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

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

-If you have further questions, please ask your doctor or pharmacist.

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

What is in this leaflet:

1.What ALIMTA is and what it is used for

2.What you need to know before you use ALIMTA

3.How to use ALIMTA

4.Possible side effects

5.How to store ALIMTA

6.Contents of the pack and other information

1.What ALIMTA is and what it is used for

ALIMTA is a medicine used in the treatment of cancer.

ALIMTA is given in combination with cisplatin, another anti-cancer medicine, as treatment for malignant pleural mesothelioma, a form of cancer that affects the lining of the lung, to patients who have not received prior chemotherapy.

ALIMTA is also given in combination with cisplatin for the initial treatment of patients with advanced stage of lung cancer.

Alimta can be prescribed to you if you have lung cancer at an advanced stage if your disease has responded to treatment or it remains largely unchanged after initial chemotherapy.

ALIMTA is also a treatment for patients with advanced stage of lung cancer whose disease has progressed after other initial chemotherapy has been used.

2. What you need to know before you use ALIMTA

Do not use ALIMTA

-if you are allergic (hypersensitive) to pemetrexed or any of the other ingredients of of this medicine (listed in section 6).

-if you are breast-feeding; you must discontinue breast-feeding during treatment with ALIMTA.

-if you have recently received or are about to receive a vaccine against yellow fever.

Warnings and precautions

Talk to your doctor or hospital pharmacist before receiving ALIMTA.

If you currently have or have previously had problems with your kidneys, talk to your doctor or hospital pharmacist as you may not be able to receive ALIMTA.

Before each infusion you will have samples of your blood taken to evaluate if you have sufficient kidney and liver function and to check that you have enough blood cells to receive ALIMTA. Your doctor may decide to change the dose or delay treating you depending on your general condition and if your blood cell counts are too low. If you are also receiving cisplatin, your doctor will make sure that you are properly hydrated and receive appropriate treatment before and after receiving cisplatin to prevent vomiting.

If you have had or are going to have radiation therapy, please tell your doctor, as there may be an early or late radiation reaction with ALIMTA.

If you have been recently vaccinated, please tell your doctor, as this can possibly cause bad effects with ALIMTA.

If you have heart disease or a history of heart disease, please tell your doctor.

If you have an accumulation of fluid around your lungs, your doctor may decide to remove the fluid before giving you ALIMTA.

Children and adolescents

There is no relevant use of ALIMTA in the paediatric population

Other medicines and ALIMTA

Please tell your doctor if you are taking any medicine for pain or inflammation (swelling), such as medicines called “nonsteroidal anti-inflammatory drugs” (NSAIDs), including medicines purchased without a doctor’s prescription (such as ibuprofen). There are many sorts of NSAIDs with different durations of activity. Based on the planned date of your infusion of ALIMTA and/or on the status of your kidney function, your doctor needs to advise you on which medicines you can take and when you can take them. If you are unsure, ask your doctor or pharmacist if any of your medicines are NSAIDs.

Please tell your doctor or hospital pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy

If you are pregnant, think you may be pregnant or are planning to have a baby, tell your doctor. The use of ALIMTA should be avoided during pregnancy. Your doctor will discuss with you the potential risk of taking ALIMTA during pregnancy. Women must use effective contraception during treatment with ALIMTA.

Breast-feeding

If you are breast-feeding, tell your doctor.

Breast-feeding must be discontinued during ALIMTA treatment.

Fertility

Men are advised not to father a child during and up to 6 months following treatment with ALIMTA and should therefore use effective contraception during treatment with ALIMTA and for up to 6 months afterwards. If you would like to father a child during the treatment or in the 6 months following receipt of treatment, seek advice from your doctor or pharmacist. You may want to seek counselling on sperm storage before starting your therapy.

Driving and using machines

ALIMTA may make you feel tired. Be careful when driving a car or using machines.

ALIMTA contains sodium

ALIMTA 500 mg contains approximately 54 mg sodium per vial. To be taken into consideration by patients on a controlled sodium diet.

ALIMTA 100 mg contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially ‘sodium-free’

3.How to use ALIMTA

The dose of ALIMTA is 500 milligrams for every square metre of your body’s surface area. Your height and weight are measured to work out the surface area of your body. Your doctor will use this body surface area to work out the right dose for you. This dose may be adjusted, or treatment may be delayed depending on your blood cell counts and on your general condition. A hospital pharmacist, nurse or doctor will have mixed the ALIMTA powder with 9 mg/ml (0.9 %) sodium chloride solution for injection before it is given to you.

You will always receive ALIMTA by infusion into one of your veins. The infusion will last approximately 10 minutes.

When using ALIMTA in combination with cisplatin:

The doctor or hospital pharmacist will work out the dose you need based on your height and weight. Cisplatin is also given by infusion into one of your veins, and is given approximately 30 minutes after the infusion of ALIMTA has finished. The infusion of cisplatin will last approximately 2 hours.

You should usually receive your infusion once every 3 weeks.

Additional medicines:

Corticosteriods: your doctor will prescribe you steroid tablets (equivalent to 4 milligram of dexamethasone twice a day) that you will need to take on the day before, on the day of, and the day after ALIMTA treatment. This medicine is given to you to reduce the frequency and severity of skin reactions that you may experience during your anticancer treatment.

Vitamin supplementation: your doctor will prescribe you oral folic acid (vitamin) or a multivitamin containing folic acid (350 to 1000 micrograms) that you must take once a day while you are taking ALIMTA. You must take at least 5 doses during the seven days before the first dose of ALIMTA. You must continue taking the folic acid for 21 days after the last dose of ALIMTA. You will also receive an injection of vitamin B12 (1000 micrograms) in the week before administration of ALIMTA and then approximately every 9 weeks (corresponding to 3 courses of ALIMTA treatment). Vitamin B12 and folic acid are given to you to reduce the possible toxic effects of the anticancer treatment.

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

4.Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

You must contact your doctor immediately if you notice any of the following:

Fever or infection (common): if you have a temperature of 38ºC or greater, sweating or other signs of infection(since you might have less white blood cells than normal which is very common). Infection (sepsis) may be severe and could lead to death.

If you start feeling chest pain (common) or having a fast heart rate (uncommon).

If you have pain, redness, swelling or sores in your mouth (very common).

Allergic reaction: if you develop skin rash (very common) / burning or prickling sensation (common), or fever (common). Rarely, skin reactions may be severe and could lead to death. Contact your doctor if you get a severe rash, or itching, or blistering (Stevens-Johnson Syndrome or Toxic epidermal necrolysis).

If you experience tiredness, feeling faint, becoming easily breathless or if you look pale (since you might have less haemoglobin than normal which is very common).

If you experience bleeding from the gums, nose or mouth or any bleeding that would not stop, reddish or pinkish urine, unexpected bruising (since you might have less platelets than normal which is very common).

If you experience sudden breathlessness, intense chest pain or cough with bloody sputum (uncommon)(may indicate a blood clot in the blood vessels of the lungs)

Side effects with ALIMTA may include:

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

Low white blood cells

Low haemoglobin level (anaemia)

Low platelet count

Diarrhoea

Vomiting

Pain, redness, swelling or sores in your mouth

Nausea

Loss of appetite

Fatigue (tiredness)

Skin rash

Hair loss

Constipation

Loss of sensation

Kidney: abnormal blood tests

Common (may affect up to 1 in 10 people)

Allergic reaction: skin rash / burning or prickling sensation

Infection including sepsis

Fever

Dehydration

Kidney failure

Irritation of the skin and itching

Chest pain

Muscle weakness

Conjunctivitis (inflamed eye)

Upset stomach

Pain in the abdomen

Taste change

Liver: abnormal blood tests

Watery eyes

Uncommon ( may affect up to 1 in 100 people)

Acute renal failure Fast heart rate

Inflammation of the lining of the oesophagus (gullet) has been experienced with ALIMTA/ radiation therapy.

Colitis (inflammation of the lining of the large bowel, which may be accompanied by intestinal or rectal bleeding)

Interstitial pneumonitis (scarring of the air sacs of the lung)

Oedema (excess fluid in body tissue, causing swelling)Some patients have experienced a heart attack, stroke or “mini-stroke” while receiving ALIMTA usually in combination with another anticancer therapy.

Pancytopenia- combined low counts of white cells, red cells and platelets

Radiation pneumonitis (scarring of the air sacs of the lung associated with radiation therapy) may occur in patients who are also treated with radiation either before, during or after their ALIMTA therapy.

Extremity pain, low temperature and discolouration have been reported.

Blood clots in the lung blood vessels (pulmonary embolism)

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

Radiation recall (a skin rash like severe sunburn) which can occur on skin that has previously been exposed to radiotherapy, from days to years after the radiation.

Bullous conditions (blistering skin diseases)-including Stevens-Johnson syndrome and Toxic epidermal necrolysis

Immune mediated haemolytic anaemia (antibody-mediated destruction of red blood cells) Hepatitis (inflammation of the liver)

Anaphylactic shock (severe allergic reaction)

Not known: frequency cannot be estimated from the available data

Lower limb swelling with pain and redness

You might have any of these symptoms and/or conditions. You must tell your doctor as soon as possible when you start experiencing any of these side effects.

If you are concerned about any side effects, talk to your doctor.

Reporting side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in the 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 ALIMTA

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 label and carton

This medicine does not require any special storage conditions.

Reconstituted and Infusion Solutions: The product should be used immediately. When prepared as directed, chemical and physical in-use stability of reconstituted and infusion solutions of pemetrexed were demonstrated for 24 hours at refrigerated temperature.

This medicine is for single use only; any unused solution must be disposed of in accordance with local requirement.

6. Contents of the pack and other information

What ALIMTA contains

The active substance is pemetrexed.

ALIMTA 100 mg: Each vial contains 100 milligrams of pemetrexed (as pemetrexed disodium). ALIMTA 500 mg: Each vial contains 500 milligrams of pemetrexed (as pemetrexed disodium).

After reconstitution, the solution contains 25 mg/ml of pemetrexed. Further dilution by a healthcare provider is required prior to administration.

The other ingredients are mannitol, hydrochloric acid and sodium hydroxide

What ALIMTA looks like and contents of the pack

ALIMTA is a powder for concentrate for solution for infusion in a vial. It is a white to either light yellow or green-yellow lyophilised powder.

Each pack of ALIMTA consists of one ALIMTA vial. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht

The Netherlands

Manufacturer

Lilly France S.A.S. rue du Colonel Lilly F-67640 Fegersheim France

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

Belgique/België/Belgien

Lietuva

Eli Lilly Benelux S.A/N.V.

Eli Lilly Holdings Limited atstovybė

Tél/Tel: + 32-(0)2 548 84 84

Tel. +370 (5) 2649600

България

Luxembourg/Luxemburg

ТП "Ели Лили Недерланд" Б.В. - България

Eli Lilly Benelux S.A/N.V.

тел. + 359 2 491 41 40

Tél/Tel: + 32-(0)2 548 84 84

Česká republika

Magyarország

ELI LILLY ČR, s.r.o.

Lilly Hungária Kft.

Tel: + 420 234 664 111

Tel: + 36 1 328 5100

Danmark

Malta

Eli Lilly Danmark A/S

Charles de Giorgio Ltd.

Tlf: +45 45 26 60 00

Tel: + 356 25600 500

Deutschland

Nederland

Lilly Deutschland GmbH

Eli Lilly Nederland B.V.

Tel. + 49-(0) 6172 273 2222

Tel: + 31-(0) 30 60 25 800

Eesti

Norge

Eli Lilly Holdings Limited Eesti filiaal

Eli Lilly Norge A.S.

Tel: +372 6 817 280

Tlf: + 47 22 88 18 00

Ελλάδα

Österreich

ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.

Eli Lilly Ges.m.b.H.

Τηλ: +30 210 629 4600

Tel: + 43-(0) 1 711 780

España

Polska

Lilly S.A.

Eli Lilly Polska Sp. z o.o.

Tel: + 34-91-663 50 00

Tel.: +48 22 440 33 00

France

Portugal

Lilly France SAS

Lilly Portugal Produtos Farmacêuticos, Lda

Tél: +33-(0) 1 55 49 34 34

Tel: + 351-21-4126600

Hrvatska

România

Eli Lilly Hrvatska d.o.o.

Eli Lilly România S.R.L.

Tel: +385 1 2350 999

Tel: + 40 21 4023000

Ireland

Slovenija

Eli Lilly and Company (Ireland) Limited

Eli Lilly farmacevtska družba, d.o.o.

Tel: + 353-(0) 1 661 4377

Tel: +386 (0)1 580 00 10

Ísland

Slovenská republika

Icepharma hf.

Eli Lilly Slovakia, s.r.o.

Sími + 354 540 8000

Tel: + 421 220 663 111

Italia

Suomi/Finland

Eli Lilly Italia S.p.A.

Oy Eli Lilly Finland Ab

Tel: + 39- 055 42571

Puh/Tel: + 358-(0) 9 85 45 250

Κύπρος

Sverige

Phadisco Ltd

Eli Lilly Sweden AB

Τηλ: +357 22 715000

Tel: + 46-(0) 8 7378800

Latvija

United Kingdom

Eli Lilly Holdings Limited pārstāvniecība Latvijā

Eli Lilly and Company Limited

Tel: +371 6 7364000

Tel: + 44-(0) 1256 315000

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.

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The following information is intended for medical or healthcare professionals only:

Instructions for use, handling and disposal.

1.Use aseptic techniques during the reconstitution and further dilution of pemetrexed for intravenous infusion administration.

2.Calculate the dose and the number of ALIMTA vials needed. Each vial contains an excess of pemetrexed to facilitate delivery of the label amount.

3.ALIMTA 100 mg:

Reconstitute each 100 mg vial with 4.2 ml of 9 mg/ml (0.9%) sodium chloride solution for injection, without preservative, resulting in a solution containing 25 mg/ml pemetrexed.

ALIMTA 500 mg:

Reconstitute each 500 mg vial with 20 ml of 9 mg/ml (0.9%) sodium chloride solution for injection, without preservative, resulting in a solution containing 25 mg/ml pemetrexed.

Gently swirl each vial until the powder is completely dissolved. The resulting solution is clear and ranges in colour from colourless to yellow or green-yellow without adversely affecting product quality. The pH of the reconstituted solution is between 6.6 and 7.8. Further dilution is required.

4.The appropriate volume of reconstituted pemetrexed solution must be further diluted to 100 ml with 9 mg/ml (0.9 %) sodium chloride solution for injection, without preservative, and administered as an intravenous infusion over 10 minutes.

5.Pemetrexed infusion solutions prepared as directed above are compatible with polyvinyl chloride and polyolefin lined administration sets and infusion bags. Pemetrexed is incompatible with diluents containing calcium, including lactated Ringer’s Injection and Ringer’s Injection.

6.Parenteral medicinal products should be inspected visually for particulate matter and discolouration prior to administration. If particulate matter is observed, do not administer.

7.Pemetrexed solutions are for single use only. Any unused product or waste material should be disposed of in accordance with local requirements.

Preparation and administration precautions: As with other potentially toxic anticancer agents, care should be exercised in the handling and preparation of pemetrexed infusion solutions. The use of gloves is recommended. If a pemetrexed solution contacts the skin, wash the skin immediately and thoroughly with soap and water. If pemetrexed solutions contact the mucous membranes, flush thoroughly with water. Pemetrexed is not a vesicant. There is not a specific antidote for extravasation of pemetrexed. There have been a few reported cases of pemetrexed extravasation, which were not assessed as serious by the investigator. Extravasation should be managed by local standard practice as with other non-vesicants.

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