Bleomycin Viatris 15,000 IU (Ph Eur) = 15 U (USP) powder for solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Bleomycin Viatris 15,000 IU (Ph. Eur.) = 15U (USP) powder for solution for injection

Read all of 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Bleomycin belongs to a group of medicines known as cytostatic antibiotics (medicines used to treat cancer). Bleomycin inhibits the process of cell division and the growth of dividing cells (cancer cells), thereby preventing the progression of cancer. However, normal cells are less sensitive to bleomycin than cancer cells. As a result, normal cells survive while cancer cells are destroyed.

Bleomicina Viatris is indicated for the treatment of:

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

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

2. What you need to know before using Bleomycin Viatris

Do not use Bleomycin Viatris:

• If you are allergic to bleomycin or to any of the other ingredients of this medicine (listed in section 6).
• If you have an acute lung infection or significantly reduced lung function.
• If you have previously experienced certain adverse effects in the lungs caused (possibly) by bleomycin.
• If you have a specific hereditary disorder characterized by problems with coordination (such as staggering), rapid rhythmic eye movements, dilation of blood vessels (capillaries), and increased susceptibility to respiratory infections (ataxia telangiectasia).
• During breastfeeding (see also the section “Pregnancy and breastfeeding”).

Warnings and precautions

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

• If you are over 60 years old.
• If your kidneys or liver are not functioning properly.
• If you have/have had a lung disorder.
• If you have undergone lung radiotherapy before treatment with bleomycin, or if you are undergoing radiotherapy 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 harmful effects of bleomycin on the lungs. Your doctor may examine you more frequently and/or perform X-rays. If you are being treated with bleomycin, your lung function should be monitored regularly to detect possible harmful effects of bleomycin on the lungs.

If you develop coughing and/or have difficulty breathing, this may indicate harmful effects of bleomycin on the lungs. In this case, inform your treating doctor as soon as possible.

Cases 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) have been reported in patients treated concomitantly with bleomycin and other cytostatic agents (substances that inhibit cell growth or division).

Other medicines and Bleomycin Viatris

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Please note that these instructions may also apply to medicines taken previously or those that may be used in the future.

An interaction means that medicines used together may influence each other's action and/or side effects. An interaction may occur when bleomycin is used simultaneously with:

• Carmustine, mitomycin C, cyclophosphamide (medicines used for certain types of cancer) and methotrexate (a medicine used for certain types of cancer, rheumatism, and severe skin diseases); increased risk of harmful effects on the lungs.
• Cisplatin (a cancer medicine) and other medicines that damage the kidneys; increased risk of adverse effects due to bleomycin.
• Vinca alkaloids (a group of medicines used for certain types of cancer, e.g., vincristine, vinblastine); circulatory disorders in the extremities (fingers, toes, nose) may occur. In very severe cases, these areas may become necrotic.
• Live vaccines, such as yellow fever vaccine; may cause severe and fatal infections.
• Digoxin (a medicine used for heart disorders); risk of reduced digoxin effect.
• Phenytoin (a medicine used for epilepsy); risk of reduced phenytoin effect.
• Radiotherapy; increased risk of adverse effects in the lungs and/or skin.
• Oxygen; increased risk of pulmonary toxicity when receiving oxygen during anesthesia.
• Cyclosporine, tacrolimus (medicines used in transplant patients); risk of abnormal increase in lymphocytes.
• Vitamins, such as ascorbic acid and riboflavin; may reduce the effect of bleomycin.

Pregnancy and breastfeeding

The use of bleomycin should be avoided during pregnancy.

There is insufficient information on the use of this medicine during pregnancy in humans to determine its potential toxicity. Animal studies suggest that this medicine may be harmful. Both men and women should use adequate contraception to prevent pregnancy during treatment and for up to 3 months after treatment with bleomycin.

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

Men who wish to father children in the future should seek advice about sperm cryopreservation before starting treatment with bleomycin.

You must not use this medicine while breastfeeding.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Bleomycin may sometimes cause nausea, vomiting, and fatigue (see “Possible side effects”). If you are affected by these side effects, do not drive or operate machinery requiring attention.

3. How to use Bleomycin Viatris

Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

If you think the effect of Bleomycin 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 medicines. This may result, for example, in one or two injections per week. Your doctor will determine the dose of bleomycin, the duration of treatment, and the number of treatments. These may vary depending on the patient.

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

Method of administration

Your doctor will administer bleomycin into your veins or arteries, through the skin, into the space surrounding the lungs (intrapleural), or into the muscles by injection or via infusion. Occasionally, it is injected directly into the tumour.

If you use more Bleomycin Viatris than you should

Symptoms that may occur if you have received too much bleomycin include: drop in blood pressure, fever, increased heart rate, and shock. If you suspect an overdose, you must inform your doctor immediately.

Treatment must be stopped immediately.

If you stop using Bleomycin Viatris

If you stop using Bleomycin Viatris suddenly and without medical advice, symptoms that existed before starting treatment may reappear.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The frequency of adverse effects is 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 fewer than 1 in 10,000 patients)

The following adverse effects may occur, among others:

Heart

Rare

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

Blood

Uncommon

Changes in the blood that may manifest as unexpected bleeding and/or bruising. This condition resolves after treatment ends.

Immune system

Common

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

Nervous system

Sensation of tingling, itching, or prickling without cause (paraesthesia), hypersensitivity reactions.

Blood vessels

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

Rare

Damage to blood vessels (e.g., disorders of blood circulation in the brain, inflammation of blood vessels in the brain, and a serious disorder affecting the kidneys and circulation known as haemolytic uraemic syndrome).

Respiratory system

Very common

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

Gastrointestinal system

Very common

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

Nausea, vomiting, loss of appetite, weight loss. Inflammation of the mucous lining of the mouth is rarely severe and usually resolves after treatment ends.

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, nail changes, skin inflammation at pressure points such as the elbows, hair loss, skin problems in the hands and feet such as redness and skin rash, which are rarely severe and usually resolve after treatment ends.

Muscles and bones

Pain in the muscles and limbs.

Genital organs

Abnormal cells may develop in sperm (aneuploid spermatozoa) during and shortly after chemotherapy with bleomycin.

Other

Common

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

Rare

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

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

Reporting of adverse effects:

If you experience any type of 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 via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Bleomycin Viatris

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

Before opening:

Store in a refrigerator (between 2 ºC and 8 ºC).

After reconstitution/dilution:

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

Do not use this medicine after the expiry date stated on the packaging and vial after EXP. The expiry date refers to the last day of the month indicated.

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

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

6. Contents of the container and other information

Composition of Bleomycin Viatris

• The active substance 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 contents of the container

Bleomycin 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 pack contains 1 or 100 vials of powder for injectable solution.

Only certain pack 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 latest revision of this package leaflet: April 2024

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

Information intended exclusively for medical or healthcare professionals:

For single use only. Discard any unused portion.

Preparation of the solution:

• For intramuscular or subcutaneous administration, the required dose is dissolved in 5 ml of 0.9% sodium chloride. If injection site pain occurs, a local anesthetic may be added.
• For intravenous administration, the required dose is dissolved in 5–200 ml of 0.9% sodium chloride if administered by slow injection, or in 200–1,000 ml of 0.9% sodium chloride if administered by continuous infusion.
• For intra-arterial administration, a slow infusion in 0.9% sodium chloride is performed.
• For intracavitary administration, 60,000 IU are 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

Standard precautions must be taken when preparing and administering this and other cytotoxic compounds.

Preparation must be carried out by trained, specialized personnel. Pregnant women should be warned to avoid handling cytotoxic agents. Preparation must be performed under aseptic conditions in a designated area. Eating, drinking, and smoking are prohibited in this area. Protective measures include wearing gloves, masks, protective goggles, and protective clothing. Use of laminar airflow cabinets (LAF) is recommended. Gloves must be worn during administration. Disposal of waste must take into account the cytotoxic nature of this substance. Direct contact with skin, eyes, and mucous membranes must be avoided. In case of direct contact, immediately wash thoroughly with abundant water. Soap may be used for skin cleansing.

Feces and vomit should be handled with caution.

Disposal:

Disposal of unused medication and all materials that have come into contact with it must be carried out in accordance with local regulations for cytotoxic medicinal products.