PATIENT INFORMATION LEAFLET

LITAK 2 mg/ml injectable solution

cladribina

Read 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, consult your doctor or pharmacist.

• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What you need to know before using LITAK
2. How to use LITAK
3. Possible side effects
4. Storage of LITAK
5. Contents of the pack and additional information

LITAK contains the active ingredient cladribina. Cladribina is a cytostatic agent that affects the growth of malignant white blood cells (cancerous), which play an important role in hairy cell leukemia (tricholeukemia). LITAK is used to treat this disease

Do not use LITAK

• If you are allergic to cladribina or any of the other components of LITAK (listed in section 6).
• If you are pregnant or breastfeeding.
• If you are under 18 years old.
• If you have moderate to severe kidney or liver insufficiency.

• If you use other medications 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, 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 your gait or balance problems, persistent numbness, decreased sensitivity or loss of sensation, memory loss or confusion. All of these may be symptoms of aserious and potentially fatal brain disease known as multifocal leukoencephalopathy (MLP).

If you had any of these symptoms before starting treatment with cladribina, inform your doctor if you notice any change 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 to use 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 the same, regular blood tests will be performed to verify if you can continue treatment without risk. Your doctor may decide that you receive blood transfusions to improve the number of blood cells. Additionally, the liver and kidneys will be checked to see if they are functioning correctly.

Males who wish to have children should inform their doctor before starting treatment with LITAK. Do not conceive during treatment and for at least six months after completing treatment with LITAK. Your doctor may advise you on the possibility of preserving frozen sperm (cryopreservation).

Other medications and LITAK

Inform your doctor if you are taking or have recently taken any other medication, even those purchased without a prescription. In particular, inform your doctor if you are taking any medication that contains:

• Corticosteroids, used frequently to treat inflammation.

• Antivirals, used to treat viral infections.

You must not use LITAK with other medications that affect blood cell production in the bone marrow (myelosuppression).

Pregnancy and lactation

You must not use LITAK if you are pregnant. You must take the necessary 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 while being treated with LITAK and for at least six months after receiving the last dose of LITAK.

Driving and operating machinery

The influence of LITAK on the ability to drive and operate machinery is important. If you feel drowsy, which may occur due to the low red blood cell count caused by treatment with LITAK, or if you experience dizziness, you must not drive or operate machinery.

Always follow the administration instructions for LITAK as indicated by your doctor. In case of doubt, 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, 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 injecting LITAK yourself, you must first receive proper training from your doctor or nurse. You will find detailed injection instructions at the end of this prospectus.

You may also receive an additional medication containing the active ingredient alopurinol to reduce excess uric acid.

If you use more LITAK than you should

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

If you forgot to use LITAK

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

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

Like all medicines, LITAK can cause side effects, although not everyone will experience them.

Inform your doctor immediately if you experience any of the following symptoms or signs during treatment with LITAK or after it:

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

The risk of developing a 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 acute promyelocytic leukemia or the treatments used to treat the disease, including LITAK.

The following side effects may occur:

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

• Infections.
• Fever.
• Low levels of certain white blood cells (neutrophils and lymphocytes) and platelets in blood tests.
• Low levels of red blood cells, which may cause anemia, with symptoms such as fatigue and drowsiness.
• 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 around the injection site, sweating.

Most skin reactions are mild or moderate and usually resolve within a few days.

• Fatigue, chills, decreased appetite.
• Weakness.

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

• Recurrent malignant neoplasm (cancer).
• Low levels of platelets, which may cause unusual bleeding (for example, nosebleeds or skin bleeding).
• Drowsiness, anxiety.
• Increased heart rate, abnormal heart sounds, low blood pressure, decreased blood flow to the heart muscle.
• Difficulty breathing, pulmonary edema due to infection, inflammation of the mouth and tongue.
• Abdominal pain with excessive gas in the stomach or intestines, primarily mild increases in liver function test values (bilirubin, transaminases), which will return to normal when treatment is completed.
• Itchy skin rash, skin redness, and skin pain.
• Swelling of tissues (edema), discomfort, pain (muscle pain, joint pain, and bone pain).

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

• Anemia caused by destruction of red blood cells.
• Drowsiness, numbness, and tingling of the skin, weakness, inactivity, peripheral nerve disorders, confusion, impaired ability to coordinate movements.
• Eye inflammation.
• Sore throat.
• Phlebitis.
• Severe weight loss.

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

• Liver dysfunction.
• Kidney dysfunction.
• Complications caused by cancer treatment due to destruction of cancer cells.
• Transfusion reaction.
• Increased levels of certain white blood cells (eosinophils).
• Stroke.
• Speech and swallowing disorders.
• Heart failure.
• Arrhythmia.
• Inadequate heart function to maintain adequate blood circulation.
• Intestinal obstruction.
• Severe allergic skin reaction (Stevens-Johnson syndrome or Lyell syndrome).

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

• Depression, epileptic seizure.
• Swelling of the eyelids.
• Pulmonary embolism.
• Cholecystitis.
• Organ dysfunction due to high levels of a specific substance produced by the body (a glucoprotein).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through thenational notification system included in theAppendix V.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of sight and reach of children.

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

Do not use LITAK after the expiration date that appears on the vial label and on the outer box after CAD. The expiration date is the last day of the month indicated.

From a microbiological point of view, unless the product opening prevents microbiological contamination risk, the product must be used immediately. If not used immediately, the usage times and conservation conditions are the responsibility of the user.

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

The disposal of unused medication and all materials that have been in contact with it will be carried out in accordance with local regulations.

Composition of LITAK

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

Aspect of the product and content of the packaging

LITAK is marketed in glass vials containing 5 ml of crystal-clear and colorless injectable solution.

Packaging of 1 or 5 vials. Some packaging sizes may only be marketed.

Holder of the marketing authorization and responsible for manufacturing

Lipomed GmbH

Hegenheimer Strasse 2

D-79576 Weil/Rhein

Germany

You can request more information about this medication by contacting the holder of the marketing authorization.

Last review date of this leaflet:

The detailed information about this medication is available on the website of the European Medicines Agency:http://www.ema.europa.eu.

INSTRUCTIONS FOR INJECTION

This section contains information about how to administer a LITAK injection. It is essential that you do not attempt to administer the injection yourself unless the doctor or nurse has given you instructions. Your doctor will tell you how much LITAK you need and when to inject it yourself. LITAK must be injected under the skin (subcutaneous injection). If you have any questions about administering the injection, ask your doctor or nurse.

LITAK is cytotoxic and must be handled with caution. When the patient does not self-administer LITAK, it is recommended to use disposable gloves and protective glasses when handling and administering LITAK. If LITAK comes into contact with the skin or eyes, rinse the affected area immediately with abundant water. Pregnant women should avoid contact with LITAK.

What do I need for the injection?

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

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

Do not use the vials if they are damaged or if the solution is not transparent 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 cotton balls or gauze.

• A puncture-proof container for safe disposal of used syringes.

What should I do before injecting LITAK subcutaneously?

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

1. Wash your hands thoroughly.

1. Find a comfortable and well-lit place, and put all the necessary material within reach.

How to prepare the injection?

Before injecting LITAK, you must 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 cotton ball. Remove the syringe from its packaging without touching the tip. Remove the injection needle from its packaging and insert it firmly into the syringe tip. Remove the needle protection without touching the needle.

1. Insert the needle through the rubber stopper of the vial and turn the vial and syringe. Make sure the needle tip remains submerged in the solution.

1. Aspirate the exact volume of LITAK in the syringe by pulling back the plunger (your doctor will tell you how many ml of LITAK to inject).

1. Remove the needle from the vial.

1. Make sure there is no air in the syringe: lift the needle and expel the air.

1. Check that the volume of solution contained in the syringe is correct.

1. Inject the solution immediately.

1. Withdraw the plunger slightly to ensure you have not punctured a blood vessel. If you see blood in the syringe, remove the needle and reinsert it in another place.

1. Inject the liquid slowly and regularly for about 1 minute, keeping the skin pinched between your fingers.

1. After injecting the liquid, remove the needle.

1. Dispose of the used syringe in a puncture-proof container. Use a new syringe and needle for each injection. The vials are for single use. Return the opened vials with unused solution to your doctor or pharmacist for proper disposal.

Disposal of used syringes

Dispose of used syringes in a puncture-proof container and keep it out of reach and sight of children.

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

Do not dispose of used syringes in your household trash.