TOMUDEX 2 MG POWDER FOR SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the Patient

Tomudex 2 mg Powder for Solution for Infusion

Raltitrexed

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the Package Leaflet:

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

1. What is Tomudex and what is it used for

Tomudex is used for the palliative treatment of advanced colorectal cancer, which affects the colon and rectum (parts of your large intestine), when 5FU+LV therapy is unacceptable or inappropriate.

2. What you need to know before you use Tomudex

Do not use Tomudex:

• If you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).
• Before being treated with this medicine, you must inform your doctor if you are, or think you may be, pregnant or if you are breast-feeding, as Tomudex must not be used in these cases.
• This medicine must not be given to children.
• This medicine must not be given to patients with severe kidney disease.
• This medicine must not be given with leucovorin (folinic acid), folic acid, or vitamin preparations containing these compounds.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting treatment with Tomudex.

• If you and your partner wish to have children; it is recommended to avoid pregnancy during treatment and for at least 6 months after the end of treatment, if either partner is being treated with Tomudex.
• If you have or have had any blood, kidney, or liver problems.
• If you have or have had any stomach or bowel (gut) problems.
• If you have previously received radiotherapy (treatment with high doses of X-rays).

Children and adolescents

See “Do not use Tomudex”

Other medicines and Tomudex:

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Especially if you are taking folinic acid or folic acid, vitamins, or vitamin supplements, or if you are taking an anticoagulant (a medicine to prevent blood clots).

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

Before starting treatment with this medicine, any possible pregnancy must be ruled out.

Pregnancy should be avoided if a partner is being treated with this medicine; also, it is recommended to avoid pregnancy for at least 6 months after the end of treatment.

Tomudex must not be used during pregnancy or in women who may become pregnant during treatment with this medicine.

Breast-feeding

This medicine must not be used during breast-feeding.

Fertility

Fertility studies in rats indicate that raltitrexed may cause a decrease in male fertility. Fertility returned to normal 3 months after the end of administration.

Use in elderly patients:

Elderly patients are more vulnerable to the toxic effects of Tomudex. As kidney function tends to deteriorate with age, there is a risk of accumulation of this compound in elderly patients. Great care must be taken to ensure adequate monitoring of adverse reactions.

Driving and using machines:

It is unlikely that this medicine will affect your ability to drive or use machines. However, some patients may experience a flu-like syndrome or a general feeling of being unwell for a short time after being treated with this medicine. If you experience these effects, you should not drive or use machines.

Tomudex contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per vial; this is essentially “sodium-free”.

3. How to use Tomudex

Follow exactly the instructions for administration of this medicine given by your doctor. If you are unsure about any aspect, ask your doctor.

Su médico le indicará la duración de su tratamiento con este medicamento. No suspenda el tratamiento antes de que su médico se lo diga.

• Your injection will be given under the supervision of a specialist doctor experienced in the use of this type of medicine.
• If you are unsure about any specific aspect, ask your doctor.
• The exact dose that will be given to you will be decided by your doctor. This will vary depending on your body size and how you react to treatment. The results of your blood tests will also help your doctor decide the dose you will receive.
• The usual dose is 3 mg/m2 of body surface area (you will be given 3 mg for every square meter of body surface area, calculated from your height and weight).

• The dose you receive may vary between treatments.
• Tomudex will be slowly injected into one of your veins. The injection will usually take 15 minutes to administer.

The medicine is usually given every 3 weeks. This period may be extended depending on the results of your regular blood tests.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some of these need to be treated immediately. If you experience any of the following, contact your doctor (specialist) immediately for treatment if necessary:

The very common side effects (may affect more than 1 in 10 patients) include:

• Diarrhea
• Vomiting
• Fever

The common side effects (may affect up to 1 in 10 patients) include:

Infections

• Mouth ulcers or stomatitis (pain in the mouth)

Other possible side effects are:

The very common side effects (may affect more than 1 in 10 patients) include:

• Loss of appetite
• Leukopenia (low blood cell count)
• Anemia
• Nausea
• Constipation
• Abdominal pain
• Skin effects (red, peeling, or itchy skin)
• Weakness (sometimes similar to flu-like symptoms)
• Mucositis (inflammation of the mouth and intestines that causes pain or ulcers in the mouth or diarrhea)
• Liver changes

The common side effects (may affect up to 1 in 10 patients) include:

• Cellulitis (softness and swelling under the skin)
• Infection
• Flu-like symptoms
• Low platelet count
• Dehydration (feeling thirsty and/or dry skin)
• Headache
• Muscle cramps
• Taste changes
• Conjunctivitis (red, itchy eyes)
• Hair loss
• Itchy skin
• Sweating
• Joint pain
• Swelling, pain, and discomfort at the injection site
• Weight loss

This medicine may also cause changes in your blood due to its effects on your bone marrow or liver. Your doctor will perform regular blood tests to detect any such abnormalities.

Do not be alarmed by this list of possible side effects; you may not experience any of them.

Tell your doctor if you think you have any of these or any other problems with your treatment.

If you notice any other reaction not mentioned in this leaflet, please tell your doctor or pharmacist.

Reporting of side effects:

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Tomudex

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 label and carton after EXP. The expiry date is the last day of the month stated.

Store below 25°C. Store the vial in the outer packaging.

The injection will normally be stored in the hospital. The hospital staff is responsible for the correct storage, use, and disposal of the medicine.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

After reconstitution, see the section INFORMATION FOR HEALTHCARE PROFESSIONALSat the end of this leaflet.

6. Contents of the pack and further information

Composition of Tomudex

• The active substance is raltitrexed. Each vial of powder contains 2 mg of raltitrexed.
• The other ingredients are: mannitol, disodium phosphate (heptahydrate), and sodium hydroxide.

Appearance of the product and pack contents

Tomudex is a white to off-white powder.

Each pack contains a glass vial with 2 mg of powder, with a rubber stopper and an aluminum seal.

Marketing authorization holder and manufacturer

The marketing authorization holder is:

HOSPIRA INVICTA, S.A.

Avda. de Europa 20-B - Parque Empresarial La Moraleja

28108-Alcobendas (Madrid)

Spain

The manufacturer is:

Pfizer Service Company BV

Hoge Wei 10,

1930 Zaventem,

Belgium

Date of last revision of this leaflet: November 2021

Detailed and up-to-date information on this medicine is available on the website of the Spanish Medicines and Healthcare Products Agency (AEMPS) http://www.aemps.gob.es/

The following information is intended for healthcare professionals only.

INFORMATION FOR HEALTHCARE PROFESSIONALS.

INSTRUCTIONS FOR CORRECT ADMINISTRATION

Each vial, containing 2 mg of raltitrexed, should be reconstituted with 4 ml of water for injections to provide a solution of 0.5 mg/ml of raltitrexed. The appropriate dose of the solution should be prepared by diluting in 50-250 ml of sodium chloride 9 mg/ml (0.9%) solution or glucose (dextrose) 50 mg/ml (5%) solution and administered by short intravenous infusion over a period of 15 minutes.

Tomudex or the solutions specified for reconstitution or dilution do not contain bacteriostatic agents or preservatives, and therefore should be reconstituted and diluted under aseptic conditions. It is recommended that Tomudex solutions be used as soon as possible. The reconstituted solution should be stored in the refrigerator (2-8°C) for up to 24 hours.

In accordance with established guidelines, when the medicine is diluted in sodium chloride 9 mg/ml (0.9%) solution or glucose (dextrose) 50 mg/ml (5%) solution, it is recommended to administer the reconstituted solution as soon as possible. The reconstituted solution should be used completely or discarded within 24 hours of reconstitution of the intravenous infusion.

The reconstituted and diluted solutions do not need to be protected from light.

Do not store, partially used vials or reconstituted solutions, for future administrations. Any unused injection or reconstituted solution should be discarded, as recommended for cytotoxic products.

The injection of Tomudex should be reconstituted by trained personnel in a designated area for the reconstitution of cytotoxic products. These preparations should not be handled by pregnant women.

Reconstitution should be performed in an area with extraction, such as a laminar flow cabinet, and work surfaces should be protected with disposable, absorbent paper with a plastic backing.

Appropriate protective clothing, including surgical gloves and goggles, should be worn. In case of skin contact, wash immediately and thoroughly with water, and in case of splashes in the eyes, wash with clean water for at least 10 minutes, separating the eyelids, and consult a doctor.

If spilled, it should be cleaned up using standard procedures.

Waste material should be disposed of by incineration, in accordance with guidelines for the handling of cytotoxic agents.