PEMETREXED 500 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION - patient leaflet, side effects, dosage

Patient leaflet - PEMETREXED 500 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Pemetrexed 100 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 or pharmacist.
– If you get any side effects, talk to your doctor or pharmacist. This includes any

possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

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

1. what pemetrexed is and what it is used for

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.

2. what you need to know before you are given pemetrexed do not use pemetrexed

– if you are allergic (hypersensitive) to pemetrexed or any of the other ingredients of Pemetrexed (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

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

Other medicines and Pemetrexed

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 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, breast-feeding and fertility

Pregnancy

If you are pregnant, or thinking about becoming pregnant, 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 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 counseling on 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

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

Pemetrexed 100 mg contains approximately 11 mg sodium per vial.

3. how to use pemetrexed

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 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)

The frequency of possible side effects listed below is defined as follows:

Very common (may affect more than 1 patient in 10) Common (may affect 1 to 10 patients in 100) Uncommon (may affect 1 to 10 patients in 1,000) Rare (may affect 1 to 10 patients in 10,000) Very rare (may affect less than 1 patient in 10,000)

Side effects with Pemetrexed may include:

Very common

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

pcJF	Producto/Product Dosis/Strength Envase/Pack Size	Pemetrexed 100/500 g 1 vial	Control Calidad: Fecha:
	Pa^s/Country	UK
	Material/Material	Leaflet
	Dimensiones/ Dimensions	125 × 300 mm	Registros: Fecha:
	C6digo EAN8/Code EAN8	---
	C6digo/Item Code	---
	Fecha edicion/Date of Issue	14/04/2020
	Tipografia/Fonts	Helvetica Neue (7,2 pt)
Cliente: REIG *£1 JOFRE	Colores/Colours	Black C Troquel/ Die cut
			Marketing: Fecha:
	Programa/Software	Adobe Illustrator CS6

Marketing Authorisation Holder and Manufacturer

Reig Jofre UK Limited

Unit 9A Caddsdown Business Support Centre,

Caddsdown Industrial Park,

Bideford, Devon, EX39 3DX, UK

Manufacturer

Laboratorio Reig Jofre S.A.

c/ Jarama 111 Pol. Ind.

45007 Toledo

Spain

This medicinal product is authorised in the Member States of the EEA under the following names:

Denmark: Pemetrexed Reig Jofre

Iceland: Pemetrexed Reig Jofre 100 mg stofn fyrir innrennslis^ykkni,

lausn

Pemetrexed Reig Jofre 500 mg stofn fyrir innrennslis^ykkni, lausn

Norway: Pemetrexed Reig Jofre

Spain: Pemetrexed Sala 100 mg polvo para concentrado para

solution para perfusion EFG

Pemetrexed Sala 500 mg polvo para concentrado para solucion para perfusion EFG

Sweden: Pemetrexed Reig Jofre

United Kingdom: Pemetrexed 100 mg powder for concentrate for solution for infusion

Pemetrexed 500 mg powder for concentrate for solution for infusion

This leaflet was last approved in: 04/2020.

Detailed information on this medicine is available on the website of United Kingdom/MHRA

The following information is intended for medical or 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 vials needed. Each vial contains an excess of pemetrexed to facilitate delivery of the label amount.
3. Pemetrexed 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 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 waste material should be disposed of in accordance with local requirements.

5. how to store pemetrexed

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 pack.

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 or 25°C.

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

6. contents of the pack and other information what pemetrexed contains

The active substance is pemetrexed.

Pemetrexed 100 mg: Each vial contains 100 milligrams of pemetrexed (as pemetrexed disodium 2.5 H2O).

Pemetrexed 500 mg: Each vial contains 500 milligrams of pemetrexed (as pemetrexed disodium 2.5 H2O).

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 (for pH adjustment) and sodium hydroxide (for pH adjustment).

What Pemetrexed looks like and contents of the pack

Pemetrexed is a powder for concentrate for solution for infusion in a vial. It is a white to faint yellow lyophilised powder.

Each pack of Pemetrexed consists of one Pemetrexed vial. Not all pack sizes may be marketed.