ALIMTA 500 mg powder for concentrate for solution forinfusion

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 is also a treatment for patients with advanced stage of lung cancer after other chemotherapy has been used.

You should not be given ALIMTA

• if you are allergic (hypersensitive) to pemetrexed or any of the other ingredients of ALIMTA.
• 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.

Take special care with 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 an accumulation of fluid around your lungs, your doctor may decide to remove the fluid before giving you ALIMTA.

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.

Taking other medicines
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, or thinking about becoming pregnant, 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.

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

Important information about some of the ingredients of ALIMTA

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 approximately 11 mg sodium per vial.

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 B 12 (1000 micrograms) in the week before administration of ALIMTA and then approximately every 9 weeks (corresponding to 3 courses of ALIMTA treatment). Vitamin B 12 and folic acid are given to you to reduce the possible toxic effects of the anticancer treatment.

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

Like all medicines, ALIMTA 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 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).

The frequency of possible side effects listed below is defined as follows:
Very common (affects more than 1 patient in 10)
Common (affects 1 to 10 patients in 100)
Uncommon (affects 1 to 10 patients in 1,000)
Rare (affects 1 to 10 patients in 10,000)
Very rare (affects less than 1 patient in 10,000)
Not known (frequency cannot be estimated from the available data)

Side effects with ALIMTA may include:

Very common

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

Allergic reaction: skin rash / burning or prickling sensation
Infection
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

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 stroke or ?mini-stroke? while receiving ALIMTA usually in combination with another anticancer therapy.

Rare

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.

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.

Not known

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.

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

If any of the side effects gets serious, or if you notice any side effects not mentioned in this leaflet, please tell your doctor or pharmacist.

Keep out of the reach and sight of children.

Do not use after the expiry date which is shown on the pack.

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 or 25°C.

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

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.
Grootslag 1-5
NL-3991 RA
Houten
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.

LuxembourgLuxemburg Eli Lilly Benelux S.A TélTel 32-02 548 84 84 Magyarország Lilly Hungária Kft. Tel 36 1 328 5100 Malta Charles de Giorgio Ltd. Tel 356 25600 500 Nederland Eli Lilly Nederland B.V. Tel 31-0 30 60 25 800 Norge Eli Lilly Norge A.S. Tlf 47 22 88 18 00 Österreich Eli Lilly Ges.m.b.H. Tel 43-0 1 711 780 Polska Eli Lilly Polska Sp. z o.o. Tel. 48 0 22 440 33 00 Portugal Lilly Portugal - Produtos Farmacêuticos, Lda Tel 351-21-4126600 România Eli Lilly România S.R.L. Tel 40 21 4023000 Slovenija Eli Lilly farmacevtska druba, d.o.o. Tel 386 01 580 00 10 Slovenská republika Eli Lilly Slovakia, s.r.o. Tel 421 220 663 111 SuomiFinland Oy Eli Lilly Finland Ab PuhTel 358-0 9 85 45 250 Sverige Eli Lilly Sweden AB Tel 46-0 8 7378800 United Kingdom Eli Lilly and Company Limited Tel 44-0 1256 315000 BelgiqueBelgiëBelgien Eli Lilly Benelux S.A TélTel 32-02 548 84 84 .. - . 359 2 491 41 40 eská republika ELI LILLY R, s.r.o. Tel 420 234 664 111 Danmark Eli Lilly Danmark AS Tlf 45 45 26 60 00 Deutschland Lilly Deutschland GmbH Tel. 49-0 6172 273 2222 Eesti Eli Lilly Holdings Limited Eesti filiaal Tel 372 6 817 280 - .... 30 210 629 4600 España Lilly S.A. Tel 34-91-663 50 00 France Lilly France S.A.S Tél 33-0 1 55 49 34 34 Ireland Eli Lilly and Company Ireland Limited Tel 353-0 1 661 4377 Ísland Icepharma hf. Sími 354 540 8000 Italia Eli Lilly Italia S.p.A. Tel 39- 055 42571 Phadisco Ltd 357 22 715000 Latvija Eli Lilly Holdings Limited prstvniecba Latvij Tel 371 6 7364000 Lietuva Eli Lilly Holdings Limited atstovyb Tel. 370 5 2649600

This leaflet was last approved in
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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.