Pemetrexed Seacross 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.

• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask your doctor, pharmacist or nurse.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1. What Pemetrexed Seacross is and what it is used for
2. What you need to know before you use Pemetrexed Seacross
3. How to use Pemetrexed Seacross
4. Possible side effects
5. How to store Pemetrexed Seacross
6. Contents of the pack and other information

Do not use Pemetrexed Seacross

• 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.
• if you have recently received or are about to receive a vaccine against yellow fever.

Warnings and Precautions

Talk to your doctor, hospital pharmacist or nurse before using Pemetrexed Seacross.

• 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 this medicine.
  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 property 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 this medicine.
• 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

There is no relevant use of Pemetrexed Seacross in the paediatric population.

Other medicines and Pemetrexed Seacross

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Especially 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 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.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy

The use of Pemetrexed Seacross should be avoided during pregnancy.

Your doctor will discuss with you the potential risk of taking this medicine during pregnancy. Women must use effective contraception during treatment with pemetrexed.

Breast-feeding

Breast-feeding must be discontinued during pemetrexed treatment.

Fertility

Men are advised not to father a child during and up to 6 months following treatment with pemetrexed and should 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 Seacross may make you feel tired. Be careful when driving a car or using machines.

Pemetrexed Seacross contains sodium

Pemetrexed Seacross 100 mg contains less than 1 mmol (11 mg) sodium per vial and is therefore considered essentially "sodium-free".

Pemetrexed Seacross 500 mg contains approximately 2.35 mmol (54 mg) sodium per vial. To be taken into consideration by patients on a controlled sodium diet.

When using Pemetrexed Seacross 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 milligram 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.

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 I 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

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
• Immune mediated haemolytic anaemia (antibody-mediated destruction of red blood cells)
• Hepatitis (inflammation of the liver)
• Anaphylactic shock (severe allergic reaction)

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 or pharmacist. This includes any possible side effects not listed in the leaflet.

You can also report side effects directly via Yellow Card Scheme: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

What Pemetrexed Seacross contains

• The active substance is pemetrexed.
  Each vial contains 100 milligrams of pemetrexed (as pemetrexed disodium).
  Each vial contains 500 milligrams of pemetrexed (as pemetrexed disodium).
• The other ingredients are mannitol, hydrochloric acid and sodium hydroxide.

After reconstitution, the solution contains 25 mg/ml of pemetrexed.

Further dilution by a healthcare provider is required prior to administration.

What Pemetrexed Seacross looks like and contents of the pack

Pemetrexed Seacross 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; a clear, colorless to yellow or yellow-green colored solution, once reconstituted.

Each pack of Pemetrexed Seacross consists of one vial.

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