ALEXAN 50 mg /Ml Solution

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Alexan, 50 mg/ml, Solution for Infusion
   1. Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
   2. Contents of the pack and other information
3. What Alexan is and what it is used for
4. What you need to know before you use Alexan
   1. When not to use Alexan
   2. Warnings and precautions
   3. Children and adolescents
   4. Alexan and other medicines
   5. Pregnancy, breast-feeding, and fertility
   6. Driving and using machines
   7. Alexan contains sodium
5. How to use Alexan
   1. If you have been given too much Alexan
   2. If you miss a dose of Alexan
6. Possible side effects
   1. Very common side effects (may affect more than 1 in 10 people)
   2. Common side effects (may affect up to 1 in 10 people)
   3. Uncommon side effects (may affect up to 1 in 100 people)
   4. Rare side effects (may affect up to 1 in 1,000 people)
   5. Very rare side effects (may affect up to 1 in 10,000 people)
7. How to store Alexan
8. Contents of the pack and other information
   1. What Alexan contains
   2. What Alexan looks like and contents of the pack
   3. Marketing Authorisation Holder and Manufacturer
   4. Manufacturer
   5. For further information, please contact:
   6. Date of last revision of the leaflet: 06/2021
   7. Information intended for healthcare professionals only
   8. Dosing information
   9. Instructions for preparation and handling
   10. Instructions for disposal
   11. Instructions in case of extravasation
   12. Incompatibilities

Package Leaflet: Information for the User

Alexan, 50 mg/ml, Solution for Infusion

Cytarabine

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

• You should keep this leaflet. You may need to read it again.
• If you have any further questions, 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.

Contents of the pack and other information

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

1. What Alexan is and what it is used for

Alexan is used to treat cancer. It may be used alone or with other anti-cancer medicines to treat:

• acute myeloid leukaemia,
• acute lymphoblastic leukaemia,
• leukaemic infiltrations in the central nervous system,
• non-Hodgkin's lymphoma (a type of cancer that affects the immune system),

High doses of Alexan are used in the treatment of:

• refractory non-Hodgkin's lymphoma,
• refractory acute myeloid leukaemia,
• refractory acute lymphoblastic leukaemia,
• blast crisis in chronic myeloid leukaemia.

2. What you need to know before you use Alexan

When not to use Alexan

• if you are allergic (hypersensitive) to cytarabine or any of the other ingredients of this medicine (listed in section 6),
• if you have bone marrow depression (which can cause anaemia, low white blood cell counts, and low platelet counts) that is not related to cancer,
• if you are pregnant, unless there are compelling reasons and your doctor considers that the benefits of the treatment outweigh the risks to the baby.

Warnings and precautions

Alexan should only be given under the supervision of a doctor who is experienced in the use of anticancer medicines. Before using Alexan, you should tell your doctor:

• if you have liver or kidney problems, as this may affect the dose of Alexan that you are given,
• if you have recently had or are going to have any vaccinations,
• if you are taking any other medicines, including those that you have bought yourself.
• if you have a severe infection,
• if you have a peptic ulcer,
• if you have recently had surgery.

During treatment with Alexan, your doctor will take regular blood tests to check how the medicine is affecting you and to check for any signs of infection or other side effects.

Children and adolescents

The safety and effectiveness of Alexan in infants has not been established.

Alexan and other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those that you have bought yourself. Alexan is often used with other anticancer medicines.

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.

Alexan may cause birth defects. It should not be used during pregnancy unless there are compelling reasons and your doctor considers that the benefits of the treatment outweigh the risks to the baby.

Driving and using machines

Alexan does not affect the ability to drive or use machines, but chemotherapy can affect your ability to drive or use machines.

Alexan contains sodium

This medicine contains 1.28 mg of sodium per ml of solution. This is equivalent to 0.064% of the recommended daily intake of sodium for adults.

3. How to use Alexan

Alexan should only be given by a healthcare professional.

The dose and duration of treatment with Alexan will depend on your individual circumstances and will be decided by your doctor.

If you have been given too much Alexan

If you think that you have been given too much Alexan, you should tell your doctor immediately.

If you miss a dose of Alexan

If you miss a dose of Alexan, you should tell your doctor as soon as possible.

4. Possible side effects

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

Very common side effects (may affect more than 1 in 10 people)

• bone marrow suppression (which can cause anaemia, low white blood cell counts, and low platelet counts),
• gastrointestinal disorders (such as nausea, vomiting, and diarrhoea),

Common side effects (may affect up to 1 in 10 people)

• fever,
• infection,
• thrombocytopenia (low platelet count),
• anaemia (low red blood cell count),
• leukopenia (low white blood cell count),

Uncommon side effects (may affect up to 1 in 100 people)

• allergic reactions,
• anaphylaxis (a severe allergic reaction),
• seizures,
• confusion,
• comatose state (reduced level of consciousness),

Rare side effects (may affect up to 1 in 1,000 people)

• cardiac problems (such as heart failure and arrhythmias),
• respiratory problems (such as pneumonia and respiratory failure),
• gastrointestinal problems (such as bleeding and perforation),
• hepatic problems (such as liver failure),
• renal problems (such as kidney failure),

Very rare side effects (may affect up to 1 in 10,000 people)

• severe allergic reactions,
• anaphylaxis,
• seizures,
• confusion,
• comatose state (reduced level of consciousness),

5. How to store Alexan

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 after EXP.

The expiry date refers to the last day of that month.

Store in a refrigerator (2°C - 8°C).

6. Contents of the pack and other information

What Alexan contains

The active substance is cytarabine. Each ml of solution contains 50 mg of cytarabine.

What Alexan looks like and contents of the pack

Alexan is a clear and colourless solution.

It is available in vials containing 10 ml, 20 ml, or 40 ml of solution for infusion.

Marketing Authorisation Holder and Manufacturer

EBEWE Pharma Ges.m.b.H. Nfg. KG

Mondseestrasse 11

A-4866 Unterach, Austria

Manufacturer

Fareva Unterach GmbH

Mondseestraße 11

4866 Unterach, Austria

For further information, please contact:

Sandoz Polska Sp. z o.o.

ul. Domaniewska 50 C

02-672 Warszawa

tel. 22 549 15 00

Date of last revision of the leaflet: 06/2021

Information intended for healthcare professionals only

Dosing information

• Induction treatment: The usual dose is 100 to 200 mg of cytarabine per square metre of body surface area per day, given as a continuous intravenous infusion or as a rapid infusion over 5 to 10 days.

The duration of treatment depends on the results of clinical and morphological examinations (bone marrow examinations). Treatment may last for up to 7 days, followed by a 7-9 day break, until remission is achieved in the bone marrow; subsequent cycles of therapy (which are often limited in number) may last until remission is achieved or until toxic effects occur.

Instructions for preparation and handling

Before administration, Alexan should be diluted with 0.9% sodium chloride solution or 5% glucose solution.

Compatibility of Alexan with 0.9% sodium chloride solution and 5% glucose solution has been tested in concentrations of 0.2-3.2 mg/ml in PVC bags, polyethylene infusion bottles, and perfusion syringes.

If cytarabine comes into contact with the skin, the affected area should be rinsed thoroughly with water and then washed with soap and water. If the solution gets into the eyes, they should be rinsed thoroughly with water and medical attention should be sought immediately.

Pregnant women should not handle this medicine.

Instructions for disposal

Bottles and materials used during infusion, including protective gloves, should be disposed of in accordance with the guidelines for cytotoxic medicines.

In the event of spillage or leakage, the solution can be neutralized with 5% sodium hypochlorite solution. All materials used for this purpose should be disposed of as described above.

Instructions in case of extravasation

• 1. Stop the infusion immediately.

• 2. Replace the infusion set or syringe with a new one and slowly aspirate the extravasated drug. NOTE: Do not press on the area of extravasation.
• 3. Withdraw the needle while continuing to aspirate the fluid from the area of extravasation.
• 4. Inform the doctor.

Incompatibilities

Alexan is physically incompatible with heparin, insulin, methotrexate, 5-fluorouracil, nafcillin, oxacillin, benzylpenicillin, and methylprednisolone sodium succinate.