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 the entire 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 adverse reactions 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 effects

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 using LITAK

Do not use LITAK

• If you are allergic to cladribine or to any of the other components 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

Talk to your doctor or pharmacist before starting to use LITAK.

At any time during or after treatment, inform 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, balance problems, persistent numbness, reduced sensation or loss of sensation, memory loss or confusion. These may be symptoms of a serious and potentially fatal brain disorder 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.

Tell 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.

You must not use LITAK 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, inform your doctor immediately.

You must not breastfeed during treatment with LITAK and for at least six months after receiving the last dose of LITAK.

Driving and using machines

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

3. How to use LITAK

Always follow the instructions for administering LITAK as given 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 adequate training from your doctor or nurse. Detailed instructions for injection can be found 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 cause 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 (e.g., flu-like symptoms).
• Fever.

The possibility of recurrence of malignant disease (cancer) 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 breathing sounds, abnormal chest sounds, cough.
• Nausea, vomiting, constipation, and diarrhea.
• Skin rash, swelling, redness, and pain around 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 (e.g., 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.
• Itchy skin rash (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.
• Abnormal heart rhythm.
• 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 adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system detailed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of LITAK

Keep this medicinal product out of sight and reach of children.

Store below 30°C.

Keep the container tightly closed in order to protect from moisture.

Do not store above 30°C.

Protect from light.

Keep the bottle in the outer carton to protect from light.

Do not use this medicinal substance after the expiry date which is stated on the label and carton after "EXP".

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

Do not use LITAK if you notice any changes in the appearance of the medicine. If you have any doubts, consult your pharmacist.

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

Keep the bottle tightly closed.

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 outer carton following EXP. The expiry date refers to the last day of the month indicated.

From a microbiological standpoint, unless the opening of the product prevents the risk of microbiological contamination, the product should be used immediately. If not used immediately, the storage times and conditions during use are the responsibility of the user.

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

Disposal of unused medicine and of any 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 pack

LITAK is supplied in glass vials containing 5 ml of a clear, colourless injectable solution.

Pack size of 1 or 5 vials. Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Lipomed GmbH

Hegenheimer Strasse 2

D-79576 Weil/Rhein

Germany

For further information about this medicinal product, please contact the Marketing Authorisation Holder.

Date of the most recent review of this leaflet:

Detailed information on this medicinal product is available on the European Medicines Agency website: 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 to do so 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 ask your doctor or nurse.

LITAK is cytotoxic and must therefore be handled with care. When the patient is not self-administering LITAK, it is recommended to wear disposable gloves and protective goggles when handling and administering LITAK. If LITAK comes into contact with the skin or eyes, immediately rinse the affected area thoroughly with large 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-impregnated 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 reach room temperature.

2. Wash your hands thoroughly.

3. Find a comfortable, well-lit place and lay out 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-impregnated 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. 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 tip of the needle is immersed 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.

1. Slightly pull back the plunger to make sure you have not punctured a blood vessel. If you see blood in the syringe, remove 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 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 trash.