Leaflet: information for the user

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

Read this leaflet carefully before you start using the medicine, as 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.

-This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section4.

1. What isBleomicin Viatrisand what it is used for

2. What you need to know before startingto use Bleomicin Viatris

3. Howto use Bleomicin Viatris

4. Possible side effects

5. Storage ofBleomicin Viatris

6. Contents of the pack and additional information

Bleomicina belongs to a group of medications called cytostatic antibiotics (cancer treatments). Bleomicina inhibits the process of cell division and the growth of cells that divide (cancerous) and thereby inhibits the progression of cancer. However, normal cells are less sensitive to bleomicina than cancerous cells. Therefore, these cells survive, while cancerous cells are destroyed.

Bleomicina is indicated for the treatment of:

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

Bleomicina is almost always used in combination with other anticancer medications and/or in combination with radiation therapy.

No useBleomicina Viatris:

• If you are allergic to bleomycin or any of the other components of this medication (listed in section6).
• If you have an acute pulmonary infection or significantly reduced lung function.
• If you have experienced certain adverse effects in the lungs, possibly caused by bleomycin.
• If you have a certain hereditary disorder, characterized by coordination problems (such as staggering), rapid and rhythmic eye movements, and includes dilation of blood vessels (capillaries) and increased susceptibility to respiratory infections (ataxia telangiectasia).
• During lactation (also see the section “pregnancy and lactation”).

Warnings and precautions

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

• If you are over 60years old.
• If your kidneys or liver no longer function correctly.
• If you have/have had a lung disorder.
• If you have undergone pulmonary radiation therapy before treatment with bleomycin, or if you are undergoing radiation therapy during treatment with bleomycin.
• If you are receiving oxygen. Inform your doctor that you are using bleomycin.

The patient groups mentioned above are more sensitive to the harmful effects of bleomycin on the lungs. Your doctor may examine you more frequently and/or perform X-ray examinations. If you are being treated with bleomycin, you should have regular pulmonary function tests to monitor possible harmful effects of bleomycin on the lungs.

If you cough and/or experience difficulty breathing, it may be indicative of lung damage caused by bleomycin. Inform your doctor as soon as possible.

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

Other medications andBleomicina Viatris

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

These instructions may also apply to medications that have been used before or may be used afterwards.

An interaction occurs when using two or more medications together, which can influence the action of one another and/or adverse effects. Bleomycin may interact with:

• Carmustine, mitomycin C, cyclophosphamide (medications used for certain types of cancer) and methotrexate (a medication used for certain types of cancer, rheumatism, and severe skin diseases); there is an increased risk of lung damage.
• Cisplatin (a cancer medication) and other medications that damage the kidneys; increases the risk of adverse effects due to bleomycin.
• Vincristine, vinblastine (a group of medications used for certain types of cancer); may cause circulatory disorders in the extremities (fingers of the hands, fingers of the feet, nose). In severe cases, these areas may necrotize.
• Live vaccines, such as the yellow fever vaccine; may cause severe and potentially fatal infections.
• Digoxin (a medication used for heart disorders); there is a risk of reduced digoxin effectiveness.
• Phenytoin (a medication used for epilepsy); there is a risk of reduced phenytoin effectiveness.
• Radiation therapy; increases the risk of lung damage and/or skin damage.
• Oxygen; there is a higher risk of pulmonary toxicity when receiving oxygen during anesthesia.
• Cyclosporine, tacrolimus (medications used in transplants); there is a risk of abnormal lymphocyte increase.
• Vitamins, such as ascorbic acid and riboflavin; may reduce the effectiveness of bleomycin.

Pregnancy and lactation

The use of bleomycin during pregnancy should be avoided.

There is insufficient information on the use of this medication during human pregnancy to determine its possible toxicity. In animal studies, this medication appears to be harmful. Both men and women should take appropriate contraceptive measures to avoid pregnancy during and up to 3months after using bleomycin.

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

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

Do not use this medication during lactation.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

The use of bleomycin may sometimes cause nausea, vomiting, and fatigue (see “Possible adverse effects”). If these adverse effects affect you, do not drive or operate machinery that requires attention.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

If you estimate that the action of bleomicina Viatris is too strong or too weak, inform your doctor or pharmacist.

The recommended total dose depends on the indication, age, renal function, and combination with other anticancer medications. 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, which may vary for each patient.

There is a risk of severe hypersensitivity reaction, especially in patients with lymphoma, which may occur immediately or at 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 Use

Your doctor will administer bleomicina through a vein or artery, into the skin, around the lungs (intrapleural), or into muscles via an injection or perfusion. 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.

Discontinue medication immediately.

If You Discontinue Treatment with Bleomicina Viatris

If you discontinue use of Bleomicina Viatris suddenly and without consulting a doctor, the original symptoms may reappear.

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

Like all medicines,this medicinecan cause side effects, although not everyone will experience them.

The frequency of side effects can be classified in the following way:

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

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

Uncommon(may affect between 1 and 10 in 1000patients)

Rare(may affect between 1 and 10 in 10000patients)

Very rare(may affect fewer than 1 in 10000patients)

The following side effects may occur, among others:

Heart

Rare

Heart attack, heart vessel disorders.

Blood

Uncommon

Blood changes that may manifest as bleeding and/or unexpected bruises. This situation disappears after treatment completion.

Immune system

Common

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

Nervous system

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

Veins

Low blood pressure, vein inflammation (thrombophlebitis), vein obstruction, decreased blood flow in the fingers of the hands, fingers of the feet, tip of the nose (Raynaud's phenomenon).

Rare

Vein damage (e.g., brain circulation disorders, brain vein inflammation, and severe kidney and circulation disorder (denominated hemolytic uremic syndrome)).

Respiratory system

Very common

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

Gastrointestinal system

Very common

Mouth mucosa inflammation (stomatitis), mucosa inflammation or ulceration that may worsen when combined with radiation therapy or other mucosa-harming medications.

Nausea, vomiting, loss of appetite, weight loss. Mouth mucosa inflammation rarely is severe and normally disappears after treatment completion.

Skin

Very common

Darkening and itching in localized areas of the skin. Skin thickening and hardening. Sensitivity and inflammation of the fingertips of the hands, stripes, blisters, nail changes, skin inflammation in sensitive pressure points such as elbows, hair loss, skin problems in the hands and feet, such as redness and skin eruption that rarely are severe and normally disappear after treatment completion.

Muscles and bones

Muscle and limb pain.

Sex organs

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

Others

Common

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

Rare

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

At doses higher than recommended, acute reactions with high fever and severe adverse effects on the heart and breathing have been reported.

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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Before opening:

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

After reconstitution/dilution:

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

Do not use this medication after the expiration date appearing on the packaging and vial after CAD. The expiration date is the last day of the month indicated.

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

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

Composition ofBleomicin Viatris

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

Appearance of the product and contents of the package

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

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

Only some package sizes may be commercially available.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

Manufacturer responsible

Prasfarma, S.L.

C/ Sant Joan, 11-15

08560 – Manlleu (Barcelona)

Spain

Last review date of this leaflet:April 2024

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)https://www.aemps.gob.es/

Information intended exclusively for healthcare professionals:

For single use. Destroy the unused fraction.

Preparation of the solution:

• For intramuscular or subcutaneous administration, the required dose is dissolved in 5ml of sodium chloride 0.9% solution. If pain occurs at the injection site, a local anesthetic may be added.
• For intravenous administration, the required dose is dissolved in 5-200ml of sodium chloride 0.9% solution if injected slowly or in 200-1000ml of sodium chloride 0.9% solution if administered by continuous infusion.
• For intra-arterial administration, a slow infusion in sodium chloride 0.9% solution is performed.
• For intra-cavitary administration, 60,000UI are dissolved in 100ml of sodium chloride 0.9% solution.
• For local administration, bleomycin is dissolved in sodium chloride 0.9% solution at concentrations of 1,000-3,000UI of bleomycin per ml of solution.

Handling

Standard precautions should be taken for the preparation and administration of other cytotoxic compounds.

The preparation should be carried out by trained specialized personnel. Pregnant women should be warned to avoid handling cytotoxic agents. The preparation should be performed in 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 cabins 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 the skin, eyes, and mucous membranes should be avoided. In case of direct contact, wash immediately with abundant water. Soap may be used for skin cleaning.

Heads and vomit should be handled with caution.

Elimination:

The elimination of unused medication and all materials that have come into contact with it will be carried out in accordance with local regulations for cytotoxic drugs.