ALIMTA^® 100 mg powder for concentrate for solution for infusion

ALIMTA^® 500 mg powder for concentrate for solution for infusion

pemetrexed

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.

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 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.

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) 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 rythm

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 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.

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.

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