Pemetrexed Pfizer (previously known as Pemetrexed Hospira UK Limited) - patient leaflet, side effects, dosage

you need to know before you use Pemetrexed Pfizer

use Pemetrexed Pfizer

if you are allergic 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 Pemetrexed Pfizer.

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 Pemetrexed Pfizer.

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 Pemetrexed Pfizer.

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 Pemetrexed Pfizer. 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 Pemetrexed Pfizer.

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

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 r before giving you Pemetrexed Pfizer.

Children and adolescents

There is no relevant use of pemetrexed in the paediatric population.

Other medicines and Pemetrexed Pfizer

Please tell your doctor if you are taking any medicine for pain o medicines called “nonsteroidal anti-inflammatory drugs” (N without a doctor’s pres­cription (such as ibuprofen). There durations of activity. Based on the planned date of your i your kidney function, your doctor needs to advise you n 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 pemetrexed should be avoided during pregnancy. Your doctor will discuss with you the potential risk of taking pemetrexed during pregnancy. Women must use effective contraception during treatment with pemetrexed.

ing, tell your doctor. Breast-feeding must be discontinued during pemetrexed vised not to father a child during and up to 6 months following treatment with pemetrexed uld therefore use effective contraception during treatment with pemetrexed 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

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

3. How to use Pemetrexed Pfizer

The dose of Pemetrexed Pfizer 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 Pemetrexed Pfizer powder with water for injections and 5% glucose solution for injection before it is given to you.

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

he use of this medicine, ask your doctor or pharmacist.

• 4. Possi

  Like all me

  
  

is medicine can cause side effects, although not everybody gets them.

t your doctor immediately if you notice any of the following:

Fever or infection (common): if you have a temperature of 38°C 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 pemetrexed 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 Increased skin pigmentation

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 pemetrexed / 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 pemetrexed 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 pemetrexed 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

Haemolytic anaemia (anaemia due to 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

Increased urine output

Thirst and increased water consumption

Hypernatraemia – increased sodium in blood

Inflammation of the skin, mainly of the lower limb with swelling, pain and redness

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.

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5. How to store Pemetrexed Pfizer

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 label after EXP. The expiry date refers to the last day of that month.

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Pemetrexed Pfizer 100 mg powder for concentrate for solution for infusion

Store the 100 mg vial below 30°C.

Pemetrexed Pfizer 500 mg powder for concentrate for solution for infusion

The 500 mg vial does not require any special storage conditions.

Pemetrexed Pfizer 1,000 mg powder for concentrate for solution for infusion

The 1,000 mg vial does not require any special storage conditions.

Reconstituted and infusion solutions: When prepared as directed, chemical and physical in-use stability has been demonstrated for 24 hours at refrigerated temperature (2°C to 8°C) and at 25°C.

From a mici obiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would not be longer than 24 hours at 2°C to 8°C.

The reconstituted solution is clear and ranges in colour from colourless to yellow or green-yellow without adversely affecting product quality. Parenteral medicines must be inspected visually for particulate matter and discolouration prior to administration. If particulate matter is observed, do not administer.

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 informationWhat Pemetrexed Pfizer containsThe active substance is pemetrexed.

Pemetrexed Pfizer 100 mg powder for concentrate for solution for infusion

Each vial contains 100 milligrams of pemetrexed (as pemetrexed ditromethamine).

Pemetrexed Pfizer 500 mg powder for concentrate for solution for infusion

Each vial contains 500 milligrams of pemetrexed (as pemetrexed ditromethamine).

Pemetrexed Pfizer 1,000 mg powder for concentrate for solution for infusion

Each vial contains 1,000 milligrams of pemetrexed (as pemetrexed ditromethamine).

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

The other ingredient is mannitol.

What Pemetrexed Pfizer looks like and contents of the pack

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

Pfizer Europe MA EEIG Boulevard de la Plaine 17 1050 Bruxelles

Belgium

Hospira UK Limited Horizon

Honey Lane Hurley Maidenhea SL6 6RJ

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

BE

Pfizer SA/NV

Tél/Tel: + 32 2 554 62 11

LU

Pfizer SA/NV

Tél/Tel: + 32 2 554 62 11

BG

n$aň3ep ^TOKCCMOypr CAP^, Khoh Etnrapua

Ten.: +359 2 970 4333

CZ

Pfizer, spol. s r.o.

Tel: +420–283–004–111

LT

Pfizer Luxembourg SARL filialas Lietuvoje

Tel. + 370 52 51 4000

HU

Pfizer Kft.

Tel: + 36 1 488 37 00

MT

Drugsales Ltd

Tel: + 356 21 419 070/1/2

DE

Pfizer Pharma PFE GmbH

Tel: + 49 (0) 800 8535555

EE

Pfizer Luxembourg SARL Eesti filiaal

Tel: +372 666 7500

EL

Pfizer EAAAZ A.E.

Tql.: +30 210 6785 800

ES

Pfizer, S.L.

Tel: +34 91 490 99 00

IE

Pfizer Healthcare Ire

Tel: 1800 633 36 +44 (0) 1304 6

Laboratórios Pfizer, Lda.

Tel: + 351 21 423 55 00

IT

Pfizer Italia Srl

Tel: +39 06 33 18 21

CY

Pharmaceutical Trading Co Ltd

Tql: 24656165

FI

Pfizer PFE Finland Oy

Puh/Tel: +358 (0)9 430 040

SE

Pfizer AB

Tel: +46 (0)8 550 520 00

LV

Pfizer Luxembourg SARL filiäle Latvijä

Tel.: +371 670 35 775

This leaflet was last revised in month YYYY.

Other sources of information

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

This leaflet is available in all EU/EEA languages on the European Medicines Agency we

The following information is intended for healthcare professionals only:

Instructions for use, handling and disposal

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

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

  
  

• 3. Pemetrexed Pfizer must only be reconstituted with sterile water for injections.

Pemetrexed Pfizer 100mg vial:

Reconstitute each 100 mg vial with 4.2 ml of sterile water for injections, resulting in a solution containing 25 mg/ml pemetrexed.

Pemetrexed Pfizer 500mg vial: Reconstitute each 500 mg vial with containing 25 mg/ml pemetrexed.

Pemetrexed Pfizer 1,000mg vial:

Reconstitute each 1,000 mg vial with 40 ml of sterile water for injections, 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 5.7 and 7.7. Further dilution is required.

etrexed Pfizer must only be further diluted with 5% glucose solution, without preservative. The opriate volume of reconstituted pemetrexed solution must be further diluted to 100 ml with 5% ose 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 must 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.