Alimta 100 mg, 500 mg powder for concentrate for solution for infusion

XPIL (Text-only Patient Information Leaflet)

Source: Alimta_PIL_AT038_Dec24_IE-MT-NI.pdf

Note: This XPIL text version is intended for accessibility (screen readers / large print).

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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 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 

This medicine should not be used in children or adolescents, since there is no experience with this 

medicine in children and adolescents under 18 years of age. 

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 inform your doctor if you are taking medicines called proton pump inhibitors (omeprazole, 

esomeprazole, lansoprazole, pantoprazole and rabeprazole) used to treat heartburn and acid 

regurgitation. 

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 and for 6 months after receiving the last dose. 

Breast-feeding  

If you are breast-feeding, tell your doctor.  

Breast-feeding must be discontinued during treatment with ALIMTA.  

Fertility 

Men are advised not to father a child during and up to 3 months following treatment with ALIMTA 

and should therefore use effective contraception during treatment with ALIMTA and for up to 3 

months afterwards. If you would like to father a child during the treatment or in the 3 months 

following receipt of treatment, seek advice from your doctor or pharmacist. ALIMTA can affect your 

ability to have children. Talk to your doctor to seek advice about 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 100 mg powder for concentrate for solution for infusion  

This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially 

‘sodium-free’. 

ALIMTA 500 mg powder for concentrate for solution for infusion  

This medicine contains 54 mg sodium (main component of cooking/table salt) in each vial. This is 

equivalent to 2.7 % of the recommended maximum daily dietary intake of sodium for an adult. 

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: 

Corticosteroids: your doctor will prescribe you steroid tablets (equivalent to 4 milligrams 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 (respectively, common or very 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 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)  

Infection 

Pharyngitis (a sore throat) 

Low number of neutrophil granulocytes (a type of white blood cell) 

Low white blood cells 

Low haemoglobin level  

Pain, redness, swelling or sores in your mouth 

Loss of appetite 

Vomiting 

Diarrhoea  

Nausea 

Skin rash 

Flaking skin 

Abnormal blood tests showing reduced functionality of kidneys  

Fatigue (tiredness) 

Common (may affect up to 1 in 10 people)  

Blood infection 

Fever with low number of neutrophil granulocytes (a type of white blood cell) 

Low platelet count 

Allergic reaction 

Loss of body fluids 

Taste change 

Damage to the motor nerves which may cause muscle weakness and atrophy (wasting), primarily in the arms and legs) 

Damage to the sensory nerves that may cause loss of sensation, burning pain and unsteady gait 

Dizziness 

Inflammation or swelling of the conjunctiva (the membrane that lines the eyelids and covers the white of the eye) 

Dry eye 

Watery eyes 

Dryness of the conjunctiva (the membrane that lines the eyelids and covers the white of the eye) and cornea (the clear layer in front of the iris and pupil). 

Swelling of the eyelids 

Eye disorder with dryness, tearing, irritation, and/or pain 

Cardiac Failure (Condition that affects the pumping power of your heart muscles) 

Irregular heart rhythm 

Indigestion 

Constipation 

Abdominal pain 

Liver: increases in the chemicals in the blood made by the liver  

Increased skin pigmentation 

Itchy skin 

Rash on the body where each mark resembles a bullseye 

Hair loss 

Hives 

Kidneys stop working 

Reduced functionality of kidney  

Fever 

Pain 

Excess fluid in body tissue, causing swelling 

Chest pain 

Inflammation and ulceration of the mucous membranes lining the digestive tract 

Uncommon (may affect up to 1 in 100 people)  

Reduction in the number of red, white blood cells and platelets 

Stroke 

Type of stroke when an artery to the brain is blocked 

Bleeding inside the skull 

Angina (Chest pain caused by reduced blood flow to the heart) 

Heart attack 

Narrowing or blockage of the coronary arteries 

Increased heart rhythm 

Deficient blood distribution to the limbs 

Blockage in one of the pulmonary arteries in your lungs 

Inflammation and scarring of the lining of the lungs with breathing problems 

Passage of bright red blood from the anus 

Bleeding in the gastrointestinal tract 

Ruptured bowel 

Inflammation of the lining of the oesophagus 

Inflammation of the lining of the large bowel, which may be accompanied by intestinal or rectal 

bleeding (seen only in combination with cisplatin) 

Inflammation, oedema, erythema, and erosion of the mucosal surface of the oesophagus caused by 

radiation therapy 

Inflammation of the lung caused by radiation therapy 

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

Destruction of red blood cells 

Anaphylactic shock (severe allergic reaction) 

Inflammatory condition of the liver 

Redness of the skin 

Skin rash that develops throughout a previously irradiated area 

Very rare (affect up to 1 of 10 000 people) 

Infections of skin and soft tissues 

Stevens-Johnson syndrome (a type of severe skin and mucous membranes reaction that may be life 

threatening) 

Toxic epidermal necrolysis (a type of severe skin reaction that may be life threatening) 

Autoimmune disorder that results in skin rashes and blistering on the legs, arms, and abdomen 

Inflammation of the skin characterized by the presence of bullae which are filled with fluid 

Skin fragility, blisters and erosions and skin scarring 

Redness, pain and swelling mainly of the lower limbs 

Inflammation of the skin and fat beneath the skin (pseudocellulitis) 

Inflammation of the skin (dermatitis) 

Skin to become inflamed, itchy, red, cracked, and rough 

Intensely itchy spots  

Not known: frequency cannot be estimated from the available data 

Form of diabetes primarily due to pathology of the kidney 

Disorder of the kidneys involving the death of tubular epithelial cells that form the renal tubules  

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 Ireland: HPRA 

Pharmacovigilance, website: www.hpra.ie, Malta: ADR Reporting, website: 

www.medicinesauthority.gov.mt/adrportal; United Kingdom (Northern Ireland): Yellow Card 

Scheme, website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play 

or Apple App Store. 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 vial 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. 

It is available in packs of 1 vial. 

Not all pack sizes may be marketed. 

Marketing Authorisation Holder  

Eli Lilly Nederland B.V.  

Papendorpseweg 83, 3528 BJ Utrecht  

The Netherlands  

http://www.hpra.ie/

http://www.medicinesauthority.gov.mt/adrportal

http://www.mhra.gov.uk/yellowcard

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. 

Ireland and United Kingdom (Northern Ireland) 

Eli Lilly and Company (Ireland) Limited Tel: +353-(0) 1 661 4377 

Malta 

Charles de Giorgio Ltd. Tel: +356 25600 500 

This leaflet was last revised in December 2024 

Detailed information on this medicine is available on the European Medicines Agency web site: 

https://www.ema.europa.eu. 

AT038 

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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. 

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

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

What is in this leaflet

1. What ALIMTA is and what it is used for

ALIMTA is a medicine used in the treatment of cancer.

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.

2. What you need to know before you use ALIMTA

Do not use ALIMTA

Warnings and precautions

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

Other medicines and ALIMTA

Pregnancy

Breast-feeding

If you are breast-feeding, tell your doctor.

Breast-feeding must be discontinued during treatment with ALIMTA.

Driving and using machines

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

ALIMTA 100 mg powder for concentrate for solution for infusion

ALIMTA 500 mg powder for concentrate for solution for infusion

3. How to use ALIMTA

You should usually receive your infusion once every 3 weeks.

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.

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

Common (may affect up to 1 in 10 people)

Uncommon (may affect up to 1 in 100 people)

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

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

5. How to store ALIMTA

What ALIMTA contains

The other ingredients are mannitol, hydrochloric acid and sodium hydroxide

What ALIMTA looks like and contents of the pack

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

This leaflet was last revised in December 2024

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

Instructions for use, handling and disposal.

<---------------------------------------------------------------------------------------------------------------  

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.