Patient leaflet - Pemetrexed Aft, 500 mg powder for concentrate for solution for infusion
1. What Pemetrexed AFT is and what it is used for
Pemetrexed AFT is a medicine used in the treatment of cancer.
Pemetrexed AFT 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.
Pemetrexed AFT is also given in combination with cisplatin for the initial treatment of patients
with advanced stage of lung cancer.
Pemetrexed AFT 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.
Pemetrexed AFT 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 are given Pemetrexed AFT
Do not use Pemetrexed AFT:
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 Pemetrexed AFT.
if you have recently received or are about to receive a vaccine against yellow fever.
Warnings and Precautions
Talk to your doctor, pharmacist or nurse before receiving Pemetrexed AFT:
If you currently have or have previously had problems with your kidneys, talk to your doctor,
pharmacist or nurse, as you may not be able to receive Pemetrexed AFT.
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 AFT.
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 AFT.
If you have been recently vaccinated, please tell your doctor, as this can possibly cause bad
effects with Pemetrexed AFT.
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 Pemetrexed AFT.
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 Pemetrexed AFT
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 Pemetrexed AFT 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, pharmacist or nurse 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 AFT should be avoided during pregnancy. Your doctor will discuss
with you the potential risk of taking Pemetrexed AFT during pregnancy. Women must use
effective contraception during treatment with Pemetrexed AFT 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 Pemetrexed AFT.
Fertility
Men are advised not to father a child during and up to 3 months following treatment with
Pemetrexed AFT and should therefore use effective contraception during treatment with
Pemetrexed AFT 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,
pharmacist or nurse.
Pemetrexed AFT 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
Pemetrexed AFT may make you feel tired. Be careful when driving a car or using machines.
Excipients
Pemetrexed AFT contains sodium
Pemetrexed AFT 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’.
Pemetrexed AFT 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 Pemetrexed AFT is given to you
The dose of Pemetrexed AFT 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 doctor, pharmacist or nurse will have mixed the pemetrexed powder with 9 mg/ml (0.9%)
sodium chloride solution for injection before it is given to you.
You will always receive pemetrexed by infusion into one of your veins. The infusion will last
approximately 10 minutes.
When using pemetrexed in combination with cisplatin:
The doctor, pharmacist or nurse 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 Pemetrexed 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 pemetrexed 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 pemetrexed. You must take at least 5 doses during the seven days before the first dose
of pemetrexed. You must continue taking the folic acid for 21 days after the last dose of
pemetrexed. You will also receive an injection of vitamin B12 (1000 micrograms) in the week
before administration of pemetrexed and then approximately every 9 weeks (corresponding
to 3 courses of pemetrexed 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, pharmacist or nurse.
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 38 º 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 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)
- 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)
The following information is intended for 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 Pemetrexed AFT vials needed. Each vial contains an excess of pemetrexed to facilitate delivery of the label amount.
- 3.
Pemetrexed AFT 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.
Pemetrexed AFT 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 wastematerial 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.
Pemetrexed AFT 100 mg Powder for concentrate for solution for infusion
Pemetrexed AFT 500 mg Powder for concentrate for solution for infusion
Pemetrexed
Pemetrexed AFT 100 mg Powder for concentrate for solution for infusion
Pemetrexed AFT 500 mg Powder for concentrate for solution for infusion
Pemetrexed
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
- Kidney stops 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 (affects 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 of side effects
If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the 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 Pemetrexed AFT
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 requirements.
6. Contents of the pack and other information
What Pemetrexed AFT contains
The active substance is pemetrexed.
Pemetrexed AFT 100 mg: Each vial contains 100 milligrams of pemetrexed (as pemetrexed
disodium).
Pemetrexed AFT 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 Pemetrexed AFT looks like
Pemetrexed AFT is a powder for concentrate for solution for infusion in a vial. It is a white
to off-white lyophilised powder.
It is available in packs of 1 vial.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
AFT Pharma UK Limited
Olympia House,
Unit 13 2nd Floor, Armitage Road,
London, NW11 8RQ
England
Manufacturer
Elara Pharmaservices Limited
5 Garden Court, Lockington Hall,
Main Street, Lockington,
Derby, DE74 2RH,
United Kingdom
This leaflet does not contain the complete information about your medicine. If you have any questions or are not sure about anything, ask your doctor who has access to additional information.
Pemetrexed AFT 100 mg Powder for concentrate for solution for infusion
- PL 57592/0039
Pemetrexed AFT 500 mg Powder for concentrate for solution for infusion
- PL 57592/0040
This leaflet was revised in October 2025