What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 41013/0013 .


Pemetrexed 100 mg/500 mg powder for concentrate for solution for infusion

Package leaflet: Information for the user

Pemetrexed Seacross 100 mg powder for concentrate for solution for infusion

Pemetrexed Seacross 500 mg powder for concentrate for solution for infusion

pemetrexed

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

1. What Pemetrexed Seacross is and what it is used for

Pemetrexed Seacross is a medicine used in the treatment of cancer.

This medicine 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.

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

Pemetrexed Seacross 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.

This medicine 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 use Pemetrexed Seacross

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.

3. How to use Pemetrexed Seacross

Always use this medicine exactly as your doctor or pharmacist has told you.

Check with your doctor or pharmacist if you are not sure.

The recommended dose is 500 milligrams for every square meter 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 Seacross powder with 9 mg/ml (0.9 %) sodium chloride solution for injection before it is given to you.

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

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.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

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 (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 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.

5. How to store Pemetrexed Seacross

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

This medicine does not require any special storage conditions.

Reconstituted and diluted infusion solutions: When prepared as directed, chemical and physical in-use stability of reconstituted and further diluted infusion solutions of pemetrexed were demonstrated for 24 hours at 25°C and at refrigerated temperature (2-8°C). From microbiological point of view, the product should be used immediately.

This medicine is for single use only; any unused solution must be disposed of in accordance with local requirement.

Do not throw away any medicines via wastewater or household waste.

Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

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.

Marketing Authorisation Holder

Seacross Pharmaceuticals Ltd.
Bedford Business Centre
61-63 St. Peters Street
Bedford
MK40 2PR
United Kingdom

Manufacturer

Seacross Pharmaceuticals Ltd
Stanmore Place
Howard Road
Stanmore
HA7 1BT
United Kingdom

This medicinal product Is authorised In the Member States of the EEA under the following names:

Fl Pemetrexed Seacross 100 mg

Kuiva-aine välikonsentraatiksi infuusionestettä varten, liuos

Pemetrexed Seacross 500 mg

Kuiva-aine välikonsentraatiksi infuusionestettä varten, liuos

BG Pemetrexed Novamed 100 mg

Пpax 3a концентрaт 3a ИHФy3ИOHeH pa3TBOp

Pemetrexed Novamed 500 mg

Пpax 3a концентрaт 3a ИHФy3ИOHeH pa3TBOp

DE Pemetrexed Seacross 100 mg

Pulver für ein Konzentrat zur Herstellung einer Infusionslösung

Pemetrexed Seacross 500 mg

Pulver für ein Konzentrat zur Herstellung einer Infusionslösung

FR PEMETREXED SEACROSS 100 mg,

poudre pour solution à diluer pour perfusion

PEMETREXED SEACROSS 500 mg,

poudre pour solution à diluer pour perfusion

IE Pemetrexed Seacross 100 mg

powder for concentrate for solution for infusion

Pemetrexed Seacross 500 mg

powder for concentrate for solution for infusion

RO Pemetrexed Novamed 100 mg

Pulbere pentru concentrat pentru solutie perfuzabilă

Pemetrexed Novamed 500 mg

Pulbere pentru concentrat pentru solutie perfuzabilă

UK Pemetrexed Seacross 100 mg

powder for concentrate for solution for infusion

Pemetrexed Seacross 500 mg

powder for concentrate for solution for infusion

This leaflet was last revised In 04/2017.