Bleomedac

Leaflet accompanying the packaging: information for the user

Bleomedac 15000 IU (according to the European Pharmacopoeia) = 15 U (according to the American Pharmacopoeia)/vial

powder for solution for injection

powder for solution for injection
bleomycin sulfate

Read the leaflet carefully before administering the medicine, as it contains important information for the patient

• •Keep this leaflet, you may need to read it again.
• •If you have any further questions, ask your doctor, pharmacist, or nurse.
• •If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Bleomedac and what is it used for
• 2. Important information before taking Bleomedac
• 3. How to take Bleomedac
• 4. Possible side effects
• 5. How to store Bleomedac
• 6. Contents of the pack and other information

1. What is Bleomedac and what is it used for

The medicine contains bleomycin sulfate. This substance belongs to a group of cytostatic medicines. These are anticancer medicines, sometimes called chemotherapeutics. They attack cancer cells and prevent them from dividing.
Bleomedac is usually used in combination with other anticancer medicines or radiation therapy. It is used to treat:

• •Head and neck tumors, cervical and external genital tumors
• •Hodgkin's disease and non-Hodgkin's lymphoma (tumors of the lymphatic glands)
• •Testicular cancer
• •Fluid accumulation in the lungs caused by tumors

2. Important information before taking Bleomedac

When not to take Bleomedac

• •If the patient is allergic to bleomycin or any other component of this medicine (listed in section 6). An allergic reaction may manifest as a rash, itching, difficulty breathing, or swelling of the face, lips, throat, or tongue.
• •If the patient has pneumonia or other lung problems.
• •If the patient has already experienced lung damage that was (or may have been) caused by bleomycin administration.
• •If the patient has been diagnosed with ataxia-telangiectasia (a very rare hereditary disease that causes movement problems and infection risk).
• •If the patient is breastfeeding.

Warnings and precautions

Before starting treatment with Bleomedac, discuss it with your doctor or pharmacist.
Particular caution should be exercised when administering Bleomedac:

• •If the patient has kidney or liver function disorders.
• •If the patient has lung disease.
• •If the patient has undergone radiation therapy in the chest area or is undergoing radiation therapy while being treated with bleomycin.
• •If the patient is using oxygen.
• •If the patient is over 60 years old.

The patient may be more susceptible to the harmful effects of bleomycin on the lungs if they belong to any of the above patient groups.
The doctor will likely examine the patient more frequently and/or order a chest X-ray.
Patients treated with bleomycin should undergo regular lung function tests to monitor the potential harmful effects of bleomycin on the lungs.
The doctor should be informed immediately if the patient experiences coughing and/or shortness of breath, as this may indicate harmful effects of bleomycin on the lungs.
Like other cytotoxic active substances, bleomycin can cause tumor lysis syndrome in patients with rapidly growing tumors. Appropriate supportive treatment and pharmacological measures can prevent or alleviate such complications.

Bleomedac and other medicines

Tell your doctor or pharmacist about all medicines the patient is taking, has recently taken, or plans to take.
This is especially important for any of the following medicines, as they may interact with Bleomedac:

• •Carmustine, mitomycin C, cyclophosphamide, and methotrexate (a medicine used to treat certain types of cancer, rheumatism, and severe skin diseases). There is an increased risk of lung damage.
• •Vinca alkaloids (vincristine, vinblastine; a group of medicines used to treat certain types of cancer); this combination may cause reduced blood flow to the fingers and toes and the tip of the nose. In very severe cases, this can lead to tissue necrosis in these parts of the body.
• •Cisplatin (an anticancer medicine) and other nephrotoxic medicines, as there is an increased risk of adverse reactions after bleomycin administration.
• •Digoxin (a medicine used to treat heart diseases): the effect of digoxin may be weakened.
• •Phenytoin (used to treat epilepsy).
• •Live vaccines, as this can lead to severe and fatal infections.

The above-mentioned medicinal products may be known to the patient under different names, often their trade names. Always carefully read the information provided on the outer packaging or in the patient information leaflet of the medicinal product to check which active substances it contains. Remember that the above-mentioned products may also apply to medicines taken recently or to be taken in the future.
Also, inform your doctor if:

• •The patient has recently undergone or will undergo radiation therapy in the chest area; the risk of adverse reactions in the lungs and/or skin is increased;
• •The patient will be given oxygen; there is an increased risk of toxic effects on the lungs when oxygen is administered during general anesthesia. It is possible that the patient may still receive Bleomedac. The doctor will decide on the appropriate course of action for the patient.

Pregnancy, breastfeeding, and fertility

Pregnancy
If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
There are insufficient clinical data on Bleomedac to assess its potential harm during pregnancy. However, animal studies have shown a harmful effect of bleomycin on the fetus.
Bleomycin should not be used during pregnancy, especially during the first 3 months.
If the patient becomes pregnant during treatment with Bleomedac, they should discuss the existing risks to the unborn child with their doctor and be closely monitored.
If the patient is considering becoming pregnant after completing therapy, they should consult a genetics specialist beforehand.
Effective contraceptive methods should be used during treatment and for at least 6 months after completing treatment with this medicine.
Breastfeeding
It is not known whether this medicine passes into breast milk, but since there is a possibility of a harmful effect of bleomycin on the child, breastfeeding should not be done during treatment with Bleomedac. It may have a harmful effect on the child.
Fertility
Men should consult about sperm freezing, as there is a possibility of infertility caused by treatment.

Driving and using machines

Do not drive or operate machines. This medicine can cause nausea and vomiting, which can affect the ability to drive.

3. How to take Bleomedac

This medicine should always be taken according to the doctor's instructions. If you have any doubts, consult your doctor or pharmacist.
If the effect of Bleomedac is too strong or too weak, consult your doctor, pharmacist, or nurse.
Dose
The recommended dose depends on the therapeutic indication, age, kidney function, and combination with other anticancer medicines. As a result, one or two injections per week may be administered. The doctor will determine the dose of bleomycin, the duration of treatment, and the number of therapeutic procedures. These may vary depending on the patient.
There is a risk of severe hypersensitivity reactions, especially in patients with lymphoma, which can occur immediately or a few hours after the first or second dose. Therefore, the doctor will administer a test dose and observe the patient for 4 hours before starting treatment with bleomycin for the first time.
Method of administration
The doctor will administer bleomycin through infusion or injection into the veins or arteries, under the skin, into the space surrounding the lungs (intrapleurally), into the abdominal cavity (intraperitoneally), into the muscles, or directly into the tumor.

Overdose of Bleomedac

Symptoms that may occur if the patient has received too much Bleomedac include: low blood pressure, fever, rapid heartbeat, and shock. If the patient suspects an overdose, they should immediately inform their doctor, and the administration of the medicine should be stopped immediately.

Missed dose of Bleomedac

If the patient misses a dose, they should contact their doctor to determine whether and when they should take the missed dose.

Stopping treatment with Bleomedac

If the patient suddenly stops taking Bleomedac without consulting their doctor, the symptoms that occurred before starting treatment may recur.
If you have any further questions about taking this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

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

Severe side effects

Tell your doctor immediately if you experience any of the following side effects:

• •Cough,
• •Shortness of breath,
• •Crackling or rattling sound while breathing. Treatment may need to be discontinued.

The following side effects have also been reported:
Very common(may occur more often than 1 in 10 people)

• •Pneumonia (inflammation of the lungs). May cause irreversible lung damage and can be fatal. If the patient experiences coughing and/or shortness of breath, they should immediately inform their doctor (see section 2 "Warnings and precautions").
• •Oral mucositis. Inflammation or ulceration of the mucous membranes can worsen with concurrent radiation therapy or other medicines that are harmful to the mucous membranes. Oral mucositis rarely becomes severe and usually resolves after treatment is completed.
• •Nausea, vomiting, loss of appetite, weight loss.
• •Rash, itching, and thickening of the skin. Sensitivity and swelling of the fingertips, stretch marks, hyperpigmentation (increased pigment production), blisters, nail changes, swelling of the skin in areas under pressure (e.g., elbows), hair loss, red and peeling skin, and fever; skin problems on the hands and feet, such as redness and rash, rarely become severe and usually resolve after treatment.

Common(may occur no more often than 1 in 10 people)

• •Severe hypersensitivity reactions. These reactions can occur immediately or a few hours after the first or second dose. Tell your doctor immediately if you suddenly experience wheezing, difficulty breathing, swelling of the eyelids, face, or lips, rash, or itching (especially if it affects the whole body).
• •Allergic reactions.
• •Acute respiratory distress syndrome (ARDS).
• •Pulmonary embolism.
• •Fever (2 to 6 hours after the first injection), pain at the tumor site, and headache.

Uncommon(may occur no more often than 1 in 100 people)

• •Blood changes. These can be observed in the form of unexpected bleeding and/or bruising. These symptoms resolve after treatment is completed.
• •Changes in white blood cell count (can be detected by a test performed by a doctor), called leukopenia (decreased white blood cell count) and neutropenia (decreased granulocyte count in the blood).
• •Bleeding.
• •Diarrhea.

Rare(may occur no more often than 1 in 1,000 people)

• •Neutropenic fever (fever caused by a decrease in white blood cell count).
• •Myocardial infarction, coronary artery disorders.
• •Reports of circulatory failure (shock), elevated body temperature, and death associated with intrapleural administration of bleomycin.
• When using higher than recommended doses, reports of acute reactions accompanied by elevated body temperature and severe cardiovascular and respiratory adverse reactions have been made.
• •Vascular damage (e.g., cerebral blood flow disorders, cerebral vasculitis, and severe kidney and blood disorders, i.e., hemolytic-uremic syndrome), arterial thrombosis.
• •Liver function disorders.

Very rare(may occur no more often than 1 in 10,000 people)

• •Tumor lysis syndrome (a condition after rapid tumor breakdown).

Frequency not known(frequency cannot be estimated from the available data)

• •Infections, including generalized infections (sepsis).
• •Significant reduction in blood cell count (pancytopenia).
• •Reduction in red blood cell count (anemia).
• •Muscle and limb pain.
• •Abnormal sperm cells (aneuploid sperm) may occur during and immediately after chemotherapy with bleomycin.
• •Skin thickening.
• •Low blood pressure.
• •Vessel closure.
• •Reduced blood flow to the fingers and toes and the tip of the nose (Raynaud's phenomenon).
• •Tingling, itching, or numbness without cause (paresthesia).
• •Abnormal sensitivity to stimuli (hyperesthesia).
• •Pain at the injection site.
• •Vasculitis (thrombophlebitis).

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw, phone: +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.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Bleomedac

Keep the medicine out of the sight and reach of children. The doctor and/or hospital pharmacist are responsible for the proper storage, administration, and disposal of Bleomedac. The medicine should be stored in its original packaging, in the refrigerator, at a temperature of 2°C–8°C.
After reconstitution
After reconstitution in the vial, chemical and physical stability has been demonstrated for 24 hours when stored at a temperature of 2°C to 8°C and for 72 hours at 25°C.
After dilution
After dilution, chemical and physical stability has been demonstrated for 72 hours at 25°C in glass bottles and polypropylene syringes.
From a microbiological point of view, the product should be used immediately. If not used immediately, the user is responsible for the storage conditions prior to administration, and the storage time should not normally exceed 24 hours at 2°C to 8°C, provided that the reconstitution/dilution has taken place in controlled and validated aseptic conditions.
Do not use this medicine after the expiry date stated on the label and carton after:
Expiry date. The expiry date refers to the last day of the month.
Do not administer this medicine if visible signs of product deterioration or vial damage are observed, such as a change in the color of the lyophilized powder cake, vial damage, or damage to the stopper or aluminum cap.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Bleomedac contains

The active substance of the medicine is bleomycin sulfate. The medicine does not contain any other ingredients.
One vial of 10 ml contains 15,000 IU (according to the European Pharmacopoeia) of bleomycin (as bleomycin sulfate).
1 mg of dry powder is equivalent to at least 1,500 IU (according to the European Pharmacopoeia).

What Bleomedac looks like and contents of the pack

Bleomedac is a powder with a color ranging from white to yellowish-white.
Bleomedac is available in a pack containing 1 or 10 vials (of type I glass).
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

medac
Gesellschaft für klinische Spezialpräparate mbH
Theaterstr. 6
22880 Wedel
Germany
Phone: +49 4103 8006-0
Fax: +49 4103 8006-100

This medicine is authorized in the Member States of the European Economic Area under the following names:

Czech Republic
Bleomedac
Estonia
Bleomycin medac 15000 RÜ süstelahuse pulber
Netherlands
Bleomedac, poeder voor oplossing voor injectie 15000 IU en 30000 IU (Ph. Eur.)
Lithuania
Bleomycin medac 15000 TV milteliai injekciniam tirpalui
Latvia
Bleomycin medac 15000 SV pulveris injekciju šķīduma pagatavošanai
Poland
Bleomedac
Slovakia
Bleomedac 15000 IU
Slovenia
Bleomicin medac 15000 i.e. (Ph. Eur.), prašek za raztopino za injiciranje

Date of last revision of the leaflet: 10/2022

---------------------------------------------------------------------------------------------------------------------
Information intended for healthcare professionals only:

Special precautions for disposal and preparation of the medicinal product for administration

Method of administration
Subcutaneous and intramuscular injection: dissolve the required dose in no more than 5 ml of suitable diluent, e.g., sodium chloride 9 mg/ml (0.9%) solution. If pain occurs at the injection site, a local anesthetic suitable for injections (1% lidocaine solution) can be added to the ready-to-use solution.
Intravenous administration: dissolve the required dose in 5–1000 ml of sodium chloride 9 mg/ml (0.9%) solution and slowly inject or add to the ongoing infusion.
Intra-arterial administration: use slow infusion with sodium chloride 9 mg/ml (0.9%) solution.
Intrapleural injection: dissolve 60 x 10^3 IU in 100 ml of sodium chloride 9 mg/ml (0.9%) solution.
Local/intra-tumor injections: bleomycin is dissolved in sodium chloride 9 mg/ml (0.9%) solution to achieve a concentration of 1–3 x 10^3 IU/ml solution.
Precautions are required when handling cytostatic medicines. Regarding safety measures and disposal procedures, follow the applicable guidelines for safe handling of anticancer medicinal products. The product must be prepared by specially trained personnel. Pregnant women should be warned about the need to avoid working with cytotoxic agents. The product should be prepared under aseptic conditions, in a specially designated area. Smoking and eating or drinking are prohibited in this area. Protective measures such as gloves, masks, goggles, and protective clothing should be used. The use of a laminar airflow cabinet (LAF) is recommended. During administration, gloves should be worn. Disposal procedures must take into account the cytotoxic nature of this substance. Avoid direct contact with the skin, eyes, and mucous membranes. In case of direct contact, the affected area should be rinsed immediately with water. Soap can be used to wash the skin. When handling excreta and vomit, exercise caution.
Any unused product or waste materials should be disposed of in accordance with local regulations.