Litak 2 mg/ml solution for injection

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

LITAK 2 mg/ml injection solution

cladribine

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

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What LITAK is and what it is used for

LITAK contains the active substance cladribine. Cladribine is a cytostatic agent that affects the growth of malignant (cancerous) white blood cells, which play a key role in hairy cell leukemia (tricholeukemia). LITAK is used to treat this disease.

2. What you need to know before starting to use LITAK

Do not use LITAK

• If you are allergic to cladribine or to any of the other ingredients of LITAK (listed in section 6).
• If you are pregnant or breastfeeding.
• If you are under 18 years of age.
• If you have moderate to severe kidney or liver impairment.
• If you are taking other medicines that affect blood cell production in the bone marrow (myelosuppression).

Warnings and precautions

Consult your doctor or pharmacist before starting to use LITAK.

At any time during or after treatment, contact your doctor or nurse immediately if you:

experience blurred vision, loss of vision or double vision, difficulty speaking, weakness in one arm or leg, a change in the way you walk or problems with balance, persistent numbness, reduced sensation or loss of sensation, memory loss or confusion. All of these may be symptoms of a serious and potentially life-threatening brain disease known as progressive multifocal leukoencephalopathy (PML).

If you had any of these symptoms before starting treatment with cladribine, inform your doctor if you notice any changes in these symptoms.

Inform your doctor if you have or have had:

• Kidney or liver problems.

• Infections

• If you have an infection, it must be treated before starting LITAK.

• If you notice any signs of infection (e.g., flu-like symptoms or fever) during or after treatment with LITAK, inform your doctor immediately.

• Fever.

Before starting treatment with LITAK, and during treatment, you will have regular blood tests to ensure it is safe for you to continue treatment. Your doctor may decide that you need blood transfusions to improve your blood cell counts. In addition, your liver and kidney function will be monitored.

Men who wish to have children should inform their doctor before starting treatment with LITAK. You must not father a child during treatment and for at least six months after completing treatment with LITAK. Your doctor may advise you about the possibility of storing frozen sperm (cryopreservation).

Other medicines and LITAK

Inform your doctor if you are taking or have recently taken any other medicines, including those obtained without a prescription. In particular, inform your doctor if you are taking any medicine containing:

• Corticosteroids, commonly used to treat inflammation.
• Antivirals, used to treat viral infections.

LITAK must not be used with other medicines that affect blood cell production in the bone marrow (myelosuppression).

Pregnancy and breastfeeding

Do not use LITAK if you are pregnant. You must use appropriate contraceptive precautions during treatment and for at least six months after the last dose of LITAK. If you become pregnant during treatment, you must inform your doctor immediately.

You must not breastfeed while being treated with LITAK and for at least six months after receiving the last dose of LITAK.

Driving and use of machines

LITAK may have a significant influence on the ability to drive and use machines. If you feel drowsy, which may occur due to low red blood cell counts caused by treatment with LITAK, or if you feel dizzy, you should not drive or operate machinery.

3. How to use LITAK

Always follow the administration instructions for LITAK provided by your doctor. If you are unsure, consult your doctor or pharmacist again.

Your doctor will calculate the dose you should receive based on your body weight and will explain the treatment schedule in detail. The recommended daily dose is 0.14 mg per kg of body weight, administered for five consecutive days (single treatment cycle).

LITAK must be injected under the skin (subcutaneous injection), approximately at the same time each day. If you are self-injecting LITAK, you must first receive proper training from your doctor or nurse. Detailed instructions for injection are provided at the end of this leaflet.

You may also receive an additional medicine containing the active substance allopurinol to reduce excess uric acid.

If you use more LITAK than you should

If you accidentally inject an incorrect dose, inform your doctor immediately.

If you forget to use LITAK

Do not inject a double dose to make up for missed doses. If you forget to inject a dose, inform your doctor immediately.

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

4. Possible adverse effects

Like all medicines, LITAK may produce adverse effects, although not everyone experiences them.

Immediately inform your doctor if you experience any of the following symptoms or signs during or after treatment with LITAK:

• Any sign of infection (for example, flu-like symptoms).
• Fever.

The recurrence of a malignant (cancerous) disease cannot be ruled out. This means that the risk of developing a malignant neoplasm in the future is slightly higher than in healthy individuals. This slightly increased risk may be due to hairy cell leukemia or to treatments used for the disease, including LITAK.

The following adverse effects may occur:

Very common adverse effects (may affect more than 1 in 10 patients)

• Infections.
• Fever.
• Low levels of certain white blood cells (neutrophils and lymphocytes) and of platelets in blood tests.
• Low red blood cell count, which may cause anemia, with symptoms such as fatigue and somnolence.
• Decreased function of the body's immune system.
• Headache, dizziness.
• Abnormal respiratory sounds, abnormal chest sounds, cough.
• Nausea, vomiting, constipation, and diarrhea.
• Skin rash, swelling, redness, and pain at the injection site, sweating.
• Skin reactions are mainly mild or moderate and usually resolve within a few days.
• Fatigue, chills, decreased appetite.
• Weakness.

Common adverse effects (may affect up to 1 in 10 patients)

• Recurrence of malignant neoplasm (cancer).
• Low platelet count, which may cause unusual bleeding (for example, nosebleeds or skin bleeding).
• Somnolence, anxiety.
• Increased heart rate, abnormal heart sounds, low blood pressure, reduced blood flow to the heart muscle.
• Difficulty breathing, lung tissue swelling due to infection, inflammation of the mouth and tongue.
• Abdominal pain associated with excessive gas in the stomach or intestines, mainly mild increases in liver test values (bilirubin, transaminases), which will return to normal after treatment ends.
• Skin rash with itching (urticaria), skin redness, and skin pain.
• Tissue swelling (edema), malaise, pain (muscle pain, joint pain, and bone pain).

Uncommon adverse effects (may affect up to 1 in 100 patients)

• Anemia caused by destruction of red blood cells.
• Somnolence, numbness and tingling of the skin, weakness, inactivity, peripheral nerve disorders, confusion, impaired ability to coordinate movements.
• Inflammation of the eyes.
• Sore throat.
• Inflammation of a vein.
• Severe weight loss.

Rare adverse effects (may affect up to 1 in 1,000 patients)

• Decreased liver function.
• Decreased kidney function.
• Complications caused by cancer treatment due to destruction of cancer cells.
• Transfusion reaction (blood transfusion rejection).
• Increased levels of certain white blood cells (eosinophils).
• Stroke.
• Speech and swallowing disorders.
• Heart failure.
• Heart rhythm abnormalities.
• Inability of the heart to maintain adequate blood circulation.
• Intestinal obstruction.
• Severe allergic skin reaction (Stevens-Johnson syndrome or Lyell syndrome).

Very rare adverse effects (may affect up to 1 in 10,000 patients)

• Depression, epileptic seizure.
• Swelling of the eyelids.
• Blood clot in the lung.
• Inflammation of the gallbladder.
• Decreased organ function due to high levels of a specific substance produced by the body (a glycoprotein).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of LITAK

Keep out of sight and reach of children.

Store in a refrigerator (between 2 °C and 8 °C). Do not freeze.

Do not use LITAK after the expiry date stated on the vial label and the outer carton following EXP. The expiry date refers to the last day of the month indicated.

From a microbiological standpoint, unless the way the product is opened eliminates the risk of microbial contamination, the product should be used immediately. If not used immediately, the user is responsible for the duration and conditions of storage during use.

Do not use LITAK if the vial is damaged, or if the solution is not clear or contains particles.

Disposal of unused medicine and of all materials that have come into contact with it should be carried out in accordance with local regulations.

6. Contents of the pack and other information

Composition of LITAK

• The active substance is cladribine. Each ml of solution contains 2 mg of cladribine. Each vial contains 10 mg of cladribine in 5 ml of solution.
• The other components are sodium chloride, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment), and water for injections.

Appearance of the product and contents of the container

LITAK is supplied in glass vials containing 5 ml of a clear, colourless injectable solution. Pack sizes of 1 or 5 vials are available. Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Lipomed GmbH

Hegenheimer Strasse 2

D-79576 Weil/Rhein

Germany

You can request further information about this medicinal product by contacting the Marketing Authorisation Holder.

Date of the most recent revision of this leaflet:

Detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.

INJECTION INSTRUCTIONS

This section contains information on how to administer a LITAK injection. It is important that you do not attempt to self-inject unless instructed by your doctor or nurse. Your doctor will tell you how much LITAK you need and when you should inject it yourself. LITAK must be injected under the skin (subcutaneous injection). If you have any questions about how to administer the injection, please consult your doctor or nurse.

LITAK is cytotoxic and therefore must be handled with care. When the patient does not self-administer LITAK, it is recommended to wear disposable gloves and protective goggles when handling and administering LITAK. If LITAK comes into contact with skin or eyes, immediately rinse the affected area thoroughly with copious amounts of water. Pregnant individuals should avoid contact with LITAK.

What do I need for the injection?

To self-administer a subcutaneous injection, you will need:

• One vial of LITAK (or two vials if you need to inject more than 5 ml).

Do not use vials if they are damaged or if the solution is not clear or contains particles.

• A sterile syringe (e.g., a 10 ml LUER syringe).

• A sterile injection needle (e.g., 0.5 x 19 mm, 25 G x ¾ inch).

• Alcohol-soaked gauze or cotton.

• A sharps-resistant container for the safe disposal of used syringes.

What should I do before injecting LITAK subcutaneously?

1. Before injection, allow the LITAK vial to warm to room temperature.

2. Wash your hands thoroughly.

3. Choose a comfortable, well-lit area and place all necessary materials within easy reach.

How to prepare the injection?

Before injecting LITAK, you should do the following:

1. Remove the red protective cap from the LITAK vial. Do not remove the rubber stopper from the vial. Clean the rubber stopper with an alcohol-soaked gauze. Remove the syringe from its packaging without touching the tip. Remove the injection needle from its packaging and firmly attach it to the syringe tip. Remove the needle cover without touching the needle.

2. Insert the needle through the rubber stopper of the vial and turn the vial and syringe upside down. Ensure the needle tip is submerged in the solution.

3. Draw the exact volume of LITAK into the syringe by pulling back the plunger (your doctor will tell you how many ml of LITAK to inject).

4. Remove the needle from the vial.

5. Ensure there is no air in the syringe: hold the syringe with the needle pointing upwards and expel any air.

6. Check that the volume of solution in the syringe is correct.

7. Inject the solution immediately.

Where should I administer the injection?

How should I administer the injection?

1. Slightly pull back the plunger to make sure you have not punctured a blood vessel. If you see blood in the syringe, withdraw the needle and reinsert it in another location.

2. Inject the liquid slowly and steadily over approximately 1 minute, keeping the skin pinched between your fingers throughout.

3. After injecting the liquid, remove the needle.

4. Dispose of the used syringe in a puncture-resistant container. Use a new syringe and injection needle for each injection. Vials are intended for single use only. Return opened vials containing unused solution to your doctor or pharmacist for proper disposal.

Disposal of used syringes

Place used syringes in a puncture-resistant container and keep it out of the reach and sight of children.

Dispose of the puncture-resistant container according to the instructions provided by your doctor, nurse, or pharmacist.

Do not throw used syringes into your household waste.