Pemetrexed is a medicine used in the treatment of cancer.

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

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

 Do not use Pemetrexed

- if you are allergic (hypersensitive) to Pemetrexed disodium heptahydrate 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.

- 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.

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. 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. 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.

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

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.

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

Please tell your doctor if you are taking any medicine for pain or inflammation (swelling), such as medicines called “non-steroidal 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 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 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.

Breast-feeding

If you are breast-feeding, tell your doctor. Breast-feeding must be discontinued during treatment with Pemetrexed.

Fertility

Men are advised not to father a child during and up to 3 months following treatment with Pemetrexed and should therefore use effective contraception during treatment with Pemetrexed 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. Pemetrexed 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 may make you feel tired. Be careful when driving a car or using machines.

Pemetrexed contains sodium 

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.

The dose of Pemetrexed 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 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 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 Pemetrexed 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 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 or pharmacist.

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 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)

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) primary in the arms and legs) 

Damage to the sensory nerves that may cause lost 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 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, edema, erythema, and erosion of the mucosal surface of the esophagus 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 membrane’s 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

Store below 30℃. 

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.

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.