Biodribin

Package Leaflet: Information for the Patient

BIODRIBIN, 1 mg/ml, Solution for Infusion

Cladribine

Read the Package Leaflet Carefully Before Using the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse.

Table of Contents of the Leaflet

• 1. What is Biodribin and what is it used for
• 2. Important information before using Biodribin
• 3. How to use Biodribin
• 4. Possible side effects
• 5. How to store Biodribin
• 6. Package contents and other information

1. What is Biodribin and what is it used for

Biodribin is an anticancer medication. The active substance is cladribine, a purine analog (purines are involved in the synthesis of nucleic acids). The medication is administered in the appropriate dose through prolonged intravenous infusions. Cladribine acts toxicly on cancerous white blood cells (lymphocytes). After intravenous administration, the medication quickly penetrates cancer cells and destroys them by inhibiting the activity of many enzymes responsible for cellular metabolism and by inhibiting the cell cycle. Biodribin is intended for the treatment of hematological malignancies: hairy cell leukemia at any stage of the disease, chronic lymphocytic leukemia, and non-Hodgkin's lymphoma with a low degree of malignancy in cases that are primarily or secondarily resistant to treatment with other cytostatic medications.

2. Important information before using Biodribin

When not to use Biodribin

If the patient is allergic to cladribine or any of the other ingredients of this medication (listed in section 6). If the patient is pregnant or breastfeeding.

Warnings and precautions

Before starting treatment, the doctor assesses the patient's overall condition, with particular attention to infections, bleeding disorders characterized by bruising and petechiae, and peripheral neuropathy characterized by tingling, pain, and weakness of the hands and feet. A blood test should be performed, including a white blood cell count, and kidney and liver function should be evaluated. During treatment, especially during the first course, the patient should drink plenty of fluids to increase urine excretion. If necessary, fluids and/or diuretics should be administered intravenously. Due to the strong and long-lasting immunosuppression associated with the use of nucleoside analogs (medications used in cancer treatment) such as Biodribin, there is a risk of secondary tumors. Primary hematological tumors treated with Biodribin (e.g., hairy cell leukemia) may also be a risk factor for secondary tumors. During treatment, very serious side effects may occur that require appropriate action.

• Inhibition of bone marrow function and decreased blood cell count (cytopenia); neutropenia (granulocyte count less than 1.0 G/l) or thrombocytopenia (platelet count less than 50 G/l). Blood transfusion may be necessary.
• Viral, bacterial, or fungal infections; it may be necessary to discontinue Biodribin and use appropriate intensive infection treatment. In patients with granulocytopenia and thrombocytopenia, the doctor may recommend prophylactic anti-infection medications one week before and after the end of cladribine treatment.
• Tumor lysis syndrome; the doctor may recommend the use of medications to counteract the effects of rapid tumor breakdown (especially in patients with a leukocyte count greater than 100 G/l) before starting treatment and two days after the end of the treatment course.
• Severe peripheral neuropathy.

If, at any time during treatment or after its completion, the patient experiences the following symptoms, they should immediately inform their doctor or nurse: blurred vision, loss of vision, or double vision, difficulty speaking, weakness of the hand or foot, change in gait or balance disorders, persistent numbness, weakness, or loss of sensation, memory loss, or confusion. These can all be symptoms of severe and potentially life-threatening brain disease, called progressive multifocal leukoencephalopathy (PML). If these symptoms occurred before treatment with cladribine, the patient should inform their doctorabout any changes in these symptoms. In cases of severe bone marrow disorders, toxic effects on the nervous system, or kidney failure, special caution should be exercised. Based on the patient's condition and test results, the doctor may reduce the dose or discontinue treatment.

Children

The safety and efficacy of Biodribin in children have not been established.

Biodribin and other medications

The patient should inform their doctor about all medications they are currently taking or have recently taken, as well as any medications they plan to take. As with other cytotoxic medications, special caution should be exercised when using cladribine with other medications that affect the hematological system and immune function.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, or suspects they may be pregnant, or plans to have a child, they should consult their doctor before using this medication. Pregnancy Biodribin should not be used in pregnant women. Before using the medication, the patient should inform their doctor about any potential pregnancy. Breastfeeding During treatment with Biodribin, breastfeeding should be discontinued. Fertility Patients of childbearing age, both men and women, are advised to avoid pregnancy, as the medication may have a negative impact on fetal development.

Driving and using machines

The patient should consult their doctor. The side effects of the medication may have a negative impact on the ability to drive and operate machines.

Biodribin contains sodium

The medication contains 39.55 mg of sodium (the main component of common salt) in each 10 ml vial. This corresponds to 2% of the maximum recommended daily sodium intake in the diet for adults.

3. How to use Biodribin

This medication should only be used under the supervision of a doctor experienced in chemotherapy for cancer, in a hospital setting that allows for appropriate action in case of side effects. Dosage (adults) Hairy cell leukemia The recommended dose is 0.09 mg/kg body weight per day (3.6 mg/m2 per day) in a 24-hour infusion for 7 days. The dose should not be modified. In case of toxic effects on the nervous system or kidneys, the medication should be temporarily discontinued or permanently stopped. Chronic lymphocytic leukemia and non-Hodgkin's lymphoma The recommended dose is 0.12 mg/kg body weight per day (4.8 mg/m2 per day) in a 2-hour infusion for 5 consecutive days, in cycles every 28 days. Instructions for using the medication The appropriate amount of medication is administered intravenously: using an infusion pump without dilution or in a drip infusion after diluting the appropriate amount of medication in 500 ml of 0.9% sodium chloride solution. In hairy cell leukemia, the infusion lasts 24 hours, and in chronic lymphocytic leukemia and non-Hodgkin's lymphoma, it lasts 2 hours. The principles of working with cytostatics should be followed: wearing protective glasses and gloves, and appropriate protective clothing. If the medication comes into contact with the skin or mucous membranes, the area should be immediately and carefully washed with a large amount of water.

Using a higher dose of Biodribin than recommended

A higher dose than recommended should not be taken. If a higher dose of the medication is used, the doctor should be informed immediately.

Missing a dose of Biodribin

A double dose should not be taken to make up for a missed dose. If a dose is missed, the doctor should be consulted. If there are any further doubts about using this medication, the doctor, pharmacist, or nurse should be consulted.

4. Possible side effects

Like all medications, Biodribin can cause side effects, although not everyone will experience them. Side effects occur only in some patients and to varying degrees. The benefits of using the medication far outweigh the effects of side effects. Side effects are more common at the beginning of treatment. The frequency of some side effects varies depending on the patient's disease. List of possible side effects: Hairy cell leukemia Very common(may affect more than 1 in 10 patients)

• neutropenia, severe anemia, and thrombocytopenia; lymphopenia CD4; prolonged pancytopenia
• nausea
• rash
• fever, decreased appetite, fatigue

Common(may affect up to 1 in 10 patients)

• rapid heart rate, heart murmurs
• petechiae, bruising
• headache, dizziness, insomnia, anxiety
• abnormal breathing sounds, cough, shortness of breath
• vomiting, constipation, diarrhea, abdominal pain, bloating
• muscle pain, joint pain
• itching, pain, redness
• bacterial, viral, or fungal infections; severe infections (sepsis, pneumonia)
• edema
• chills, weakness, excessive sweating, malaise, chest pain; reactions at the injection site: redness, swelling, pain, thrombophlebitis, and inflammation of the vein, which are more related to the infusion and/or catheter exchange, rather than the medication itself

Unknown(frequency cannot be determined based on available data)

• secondary tumors (e.g., lung cancer)

Chronic lymphocytic leukemia Very common(may affect more than 1 in 10 patients)

• neutropenia, severe anemia, and thrombocytopenia (especially in the 2nd course of treatment); petechiae
• headache
• cough
• local skin reactions at the injection site, fever, fatigue, edema

Common(may affect up to 1 in 10 patients)

• coagulation disorders
• abnormal breathing sounds
• diarrhea, nausea
• inflammation of connective tissue, skin pain
• pneumonia, bacterial infections (e.g., skin), viral skin infections, upper respiratory tract infections, gastrointestinal infections, oral candidiasis, urinary tract infections
• phlebitis
• excessive sweating

Unknown(frequency cannot be determined based on available data)

• secondary tumors (e.g., lung cancer)

Non-Hodgkin's lymphoma Very common(may affect more than 1 in 10 patients)

• neutropenia, anemia, thrombocytopenia
• bacterial infections

Common(may affect up to 1 in 10 patients)

• redness, urticaria
• viral or fungal infections
• fever

Uncommon(may affect up to 1 in 100 patients)

• nausea, vomiting
• severe infections (sepsis, tuberculosis, pneumonia)

If any side effects occur, including any side effects not listed in this leaflet, the patient should consult their doctor, pharmacist, or nurse.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the patient should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Jerozolimskie Avenue 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be gathered on the safety of the medication.

5. How to store Biodribin

The medication should be stored out of sight and reach of children. Do not use this medication after the expiration date stated on the label after the words "Expiration date". The expiration date is the last day of the specified month. Store in a refrigerator (2°C to 8°C). Store in the original packaging to protect from light. After first opening/dilution After first opening, the product should be used immediately. Any unused solution should be destroyed or stored for no longer than 24 hours in a refrigerator (2°C to 8°C). After dilution with 0.9% sodium chloride solution, the prepared infusion solution should be used immediately. Any unused infusion solution should be stored for no longer than 24 hours at a temperature below 25°C. From a microbiological point of view, the medication should be used immediately. If it is not used immediately, the person administering the medication is responsible for the storage conditions during use and before use. Unused solution and infusion equipment should be disposed of in accordance with the principles of proper handling of cytostatics. Medications should not be thrown into the sewage system or household waste. The patient should ask their pharmacist how to dispose of unused medications. This will help protect the environment.

6. Package contents and other information

What Biodribin contains

The active substance of the medication is cladribine (Cladribinum). One milliliter of the solution for infusion contains 1 mg of cladribine. One vial (10 ml) contains 10 mg of cladribine. The other ingredients of the medication are sodium chloride, disodium phosphate dihydrate, phosphoric acid, and water for injections.

What Biodribin looks like and what the package contains

Biodribin is a clear, colorless solution in a colorless glass vial, closed with a bromobutyl rubber stopper and protected with an aluminum cap. The vial is packaged in a cardboard box with a patient information leaflet.

Marketing authorization holder

Łukasiewicz Research Network - Institute of Industrial Chemistry, Professor Ignacy Mościcki, Rydygiera Street 8, 01-793 Warsaw, Tel. +48 22 568 23 93

Manufacturer

Łukasiewicz Research Network - Institute of Industrial Chemistry, Professor Ignacy Mościcki, Starościńska Street 5, 02-516 Warsaw

Date of last update of the leaflet: ---------------------------------------------------------------------------

Information intended only for healthcare professionals: Instructions for using the medication The appropriate amount of medication is administered intravenously: using an infusion pump without dilution or in a drip infusion after diluting the appropriate amount of medication in 500 ml of 0.9% sodium chloride solution. Before administering the medication, the solution should be inspected for contaminants. The medication can only be used if it is clear, colorless, and does not contain insoluble contaminants. In hairy cell leukemia, the infusion lasts 24 hours, and in chronic lymphocytic leukemia and non-Hodgkin's lymphoma, it lasts 2 hours. The principles of working with cytostatics should be followed: wearing protective glasses and gloves, and appropriate protective clothing. If the medication comes into contact with the skin or mucous membranes, the area should be immediately and carefully washed with a large amount of water.