BLEOMICINA VIATRIS 15,000 IU (PH EUR) = 15 U (USP) POWDER FOR INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

Bleomicina Viatris 15,000UI (Ph. Eur.) = 15U (USP) powder for injectable solution

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Bleomicina Viatris and what is it used for

Bleomicina belongs to a group of medicines called cytostatic antibiotics (products used to treat cancer). Bleomicina inhibits the process of cell division and growth of cells that divide (cancerous) and inhibits the progression of cancer in this way. However, normal cells are less sensitive to bleomicina than cancer cells. Therefore, these cells survive, while cancer cells are destroyed.

Bleomicina is indicated for the treatment of:

• Certain forms of head and neck cancer, external genitalia, and cervical cancer.
• Certain forms of cancer of the lymph nodes (such as Hodgkin's disease and non-Hodgkin's disease).
• Cancer in the testicles.
• Fluid accumulation in the lungs as a result of cancer.

Bleomicina is almost always used in combination with other anticancer medicines and/or in combination with radiotherapy.

2. What you need to know before you use Bleomicina Viatris

Do not useBleomicina Viatris:

• If you are allergic to bleomicina or any of the other components of this medicine (listed in section 6).
• If you have acute pulmonary infection or significantly reduced lung function.
• If you have had certain side effects in the lungs, possibly caused by bleomicina.
• If you have a certain hereditary disorder, in which coordination problems (such as stumbling), rapid and rhythmic eye movements, and dilation of blood vessels (capillaries) and increased susceptibility to respiratory infections (ataxia telangiectasia) occur.
• During breastfeeding (see also the section "Pregnancy and breastfeeding").

Warnings and precautions

Consult your doctor or pharmacist before starting to use Bleomicina Viatris.

• If you are over 60 years old.
• If your kidneys or liver are not functioning properly.
• If you have/had a lung disorder.
• If you have undergone pulmonary radiotherapy before treatment with bleomicina, or if you are undergoing radiotherapy during treatment with bleomicina.
• If you are given oxygen. Inform your doctor that you are using bleomicina.

The patient groups mentioned above are more sensitive to the harmful effects of bleomicina on the lungs. Your doctor will probably examine you more frequently and/or perform an X-ray examination. If you are being treated with bleomicina, you will need to undergo regular lung function tests to monitor possible harmful effects of bleomicina on the lungs.

If you cough and/or experience difficulty breathing, it may be indicative of a harmful effect of bleomicina on the lungs. In this case, inform the doctor treating you as soon as possible.

There have been reports of blood cancer (acute myeloid leukemia) and a syndrome in which the bone marrow does not produce enough healthy blood cells or platelets (myelodysplastic syndrome) in patients treated concomitantly with bleomicina and other cytostatics (substances that inhibit cell growth or division).

Other medicines andBleomicina Viatris

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Note that these instructions may also apply to medicines used before or after.

An interaction means that the medicines used together can influence the action of the other and/or the side effects. An interaction may occur when using bleomicina simultaneously with:

• Carmustine, mitomycin C, cyclophosphamide (medicines used for certain forms of cancer) and methotrexate (a medicine used for certain forms of cancer, rheumatism, and severe skin diseases); there is an increased risk of harmful effects on the lungs.
• Cisplatin (an anticancer medicine) and other medicines that damage the kidneys; the risk of adverse effects due to bleomicina increases.
• Vinca alkaloids (a group of medicines used for certain forms of cancer, e.g., vincristine, vinblastine); circulatory disorders may occur in the extremities (fingers, toes, nose). In severe cases, these parts may become necrotic.
• Live vaccines, such as the yellow fever vaccine; they can cause severe and life-threatening infections.
• Digoxin (a medicine used for heart disorders); there is a risk of decreased digoxin effect.
• Phenytoin (a medicine used for epilepsy); there is a risk of decreased phenytoin effect.
• Radiotherapy; the risk of side effects on the lungs and/or skin increases.
• Oxygen; there is a greater risk of pulmonary toxicity when receiving oxygen during anesthesia.
• Cyclosporin, tacrolimus (medicines used in transplants); there is a risk of abnormally increased lymphocytes.
• Vitamins, such as ascorbic acid and riboflavin; they may decrease the effect of bleomicina.

Pregnancy and breastfeeding

The use of bleomicina should be avoided during pregnancy.

There is not enough information on the use of this medicine during pregnancy in humans to determine its potential toxicity. In animal studies, this medicine appears to be harmful. Both men and women should take adequate contraceptive measures to avoid pregnancy during and up to 3 months after using bleomicina.

If pregnancy occurs during treatment with bleomicina, genetic counseling is recommended.

Men who wish to become fathers in the future should seek advice on sperm freezing before starting treatment with bleomicina.

Do not use this medicine while breastfeeding.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

The use of bleomicina may sometimes cause nausea, vomiting, and fatigue (see "Possible side effects"). If you are affected by these side effects, do not drive or operate machines that require attention.

3. How to use Bleomicina Viatris

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

If you think the action of Bleomicina Viatris is too strong or too weak, tell your doctor or pharmacist.

The recommended dose (total) depends on the indication, age, renal function, and combination with other anticancer medicines. This may result in, for example, one or two injections per week. Your doctor will determine the dose of bleomicina, the duration of treatment, and the number of treatments. These may vary from patient to patient.

There is a risk of severe hypersensitivity reaction, especially in patients with lymphoma, which can occur directly or some time after administration. Therefore, your doctor will administer a test dose and observe you for 4 hours before starting treatment with bleomicina for the first time.

Method of administration

Your doctor will administer bleomicina into the veins or arteries, through the skin, into the space surrounding the lungs (intrapleural), or into the muscles by injection or with the help of an infusion. Occasionally, it is injected directly into the tumor.

If you use more Bleomicina Viatris than you should

The symptoms that may occur if you have received too much bleomicina are: low blood pressure, fever, increased heart rate, and shock. If you suspect an overdose, inform your doctor immediately.

The medication should be discontinued immediately.

If you stop using Bleomicina Viatris

If you suddenly stop using Bleomicina Viatris without the advice of a doctor, the symptoms that existed before the start of treatment may reappear.

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

4. Possible side effects

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

The frequency of side effects may be classified as follows:

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

Common (may affect between 1 and 10 in 100 patients)

Uncommon (may affect between 1 and 10 in 1,000 patients)

Rare (may affect between 1 and 10 in 10,000 patients)

Very rare (may affect less than 1 in 10,000 patients)

The following side effects may occur, among others:

Heart

Rare

Heart attack, disorders of the blood vessels of the heart.

Blood

Uncommon

Changes in the blood that can manifest as unexpected bleeding and/or bruising. This situation disappears after the end of treatment.

Immune system

Common

Severe hypersensitivity reactions (low blood pressure, mental confusion, fever, chills, and difficulty breathing). These reactions can occur immediately or a few hours after the first or second dose.

Nervous system

Feeling of tingling, itching, or numbness without cause (paresthesia), hypersensitivity effects.

Blood vessels

Low blood pressure, inflammation of the blood vessels (thrombophlebitis), obstruction of a blood vessel, decreased blood flow in the fingers, toes, tip of the nose (Raynaud's phenomenon).

Rare

Damaged blood vessels (e.g., disorders of blood circulation in the brain, inflammation of the blood vessels of the brain, and severe kidney and circulation disorder (hemolytic uremic syndrome)).

Respiratory system

Very common

Approximately 10% of patients develop pneumonia. This can cause permanent damage to the lungs and can be fatal. Consult your doctor as soon as possible if you experience coughing and/or difficulty breathing (see also the section "Warnings and precautions").

Gastrointestinal system

Very common

Inflammation of the mouth mucosa (stomatitis), inflammation or ulceration of the mucous membranes, which can worsen when combined with radiotherapy or other mucous-damaging medicines.

Nausea, vomiting, loss of appetite, weight loss. Inflammation of the mouth mucosa is rarely severe and usually disappears after the end of treatment.

Skin

Very common

Darkening and itching in localized areas of the skin. Thickening and hardening of the skin. Sensitivity and inflammation of the fingertips, stretch marks, blisters, changes in the nails, skin inflammation in sensitive pressure points such as the elbows, hair loss, skin problems on the hands and feet, such as redness and skin rash, which are rarely severe and usually disappear after the end of treatment.

Muscles and bones

Pain in the muscles and limbs.

Genital organs

During and just after chemotherapy with bleomicina, abnormal cells may develop in the sperm (aneuploid spermatozoa).

Others

Common

Fever (2 to 6 hours after the first injection), pain in the tumor area, pain at the injection site.

Rare

Low blood pressure, high fever, and death related to the administration of bleomicina within the space surrounding the lungs (intrapleural administration) have been reported.

At higher doses than recommended, acute reactions with high fever and severe heart and respiratory side effects have been reported.

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Bleomicina Viatris

Keep this medicine out of the sight and reach of children.

Before opening:

Store in a refrigerator (between 2°C and 8°C).

After reconstitution/dilution:

From a microbiological point of view, the product should be used immediately. If not used immediately, the storage times and conditions before use are the responsibility of the user and normally should not exceed 24 hours between 2°C and 8°C, unless the reconstitution and dilution have taken place in controlled and validated aseptic conditions.

Do not use this medicine after the expiry date which is stated on the packaging and on the vial after EXP. The expiry date is the last day of the month shown.

Do not use this medicine if you notice visible signs of deterioration of the product or the vial, such as a different color of the tablet, deterioration of the vial, the stopper, or the cap.

All materials used for preparation and administration, or those that have come into contact with bleomicina in any way, should be disposed of in accordance with local requirements for cytotoxic medicines.

6. Container contents and additional information

Composition ofBleomicina Viatris

• The active ingredient is bleomycin (as bleomycin sulfate). A 10 ml vial contains 15,000 IU (Ph. Eur.) = 15 U (USP) of bleomycin (as bleomycin sulfate). 1 ml of reconstituted solution contains 1,500 IU of bleomycin.

Appearance of the product and container contents

Bleomicina Viatris is a white powder for injectable solution, packaged in 10 ml glass vials for injection. Each vial contains 15,000 IU (Ph. Eur.) = 15 U (USP) of bleomycin (as bleomycin sulfate).

Each package contains 1 or 100 vials with powder for injectable solution.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

Manufacturer

Prasfarma, S.L.

C/ Sant Joan, 11-15

08560 – Manlleu (Barcelona)

Spain

Date of last revision of this prospectus:April 2024

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) https://www.aemps.gob.es/

Information intended exclusively for medical or healthcare professionals:

For single use. Destroy the unused fraction.

Preparation of the solution:

• For intramuscular or subcutaneous administration, the required dose is dissolved in 5 ml of 0.9% sodium chloride. If pain occurs at the injection site, a local anesthetic may be added.
• For intravenous administration, the required dose is dissolved in 5-200 ml of 0.9% sodium chloride if injected slowly or in 200-1,000 ml of 0.9% sodium chloride if administered by continuous perfusion.
• For intra-arterial administration, a slow perfusion is performed in 0.9% sodium chloride.
• For intra-cavitary administration, 60,000 IU is dissolved in 100 ml of 0.9% sodium chloride.
• For local administration, bleomycin is dissolved in 0.9% sodium chloride at concentrations of 1,000-3,000 IU of bleomycin per ml of solution.

Handling

Usual precautions for the preparation and administration of other cytostatic compounds should be taken.

Preparation should be carried out by specialized trained personnel. Pregnant women should be warned to avoid handling cytotoxic effects. Preparation should be performed under aseptic conditions. It should be performed in a designated area. Smoking, eating, or drinking is prohibited in this area. Protective measures include the use of gloves, masks, protective glasses, and protective clothing. The use of laboratory cabinets with laminar flow (LAF) is recommended. During administration, gloves should be used. When processing waste, the cytotoxic nature of this substance should be taken into account. Direct contact with skin, eyes, and mucous membranes should be avoided. In case of direct contact, wash immediately with plenty of water. For skin cleaning, soap can be used.

Feces and vomit should be handled with caution.

Elimination:

Elimination of unused medicinal products and all materials that have come into contact with them will be carried out in accordance with local regulations for cytotoxic medicinal products.