FARMIBLASTINA 50 mg POWDER FOR INJECTABLE SOLUTION

Introduction

Patient Information Leaflet

Farmiblastina 50 mg powder for injectable solution

doxorubicin hydrochloride

Read this leaflet carefully before starting to use this 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, pharmacist, or nurse.
• This medicine has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What is Farmiblastina and what is it used for
2. What you need to know before taking Farmiblastina
3. How to use Farmiblastina
4. Possible side effects
5. Storage of Farmiblastina
6. Package contents and additional information

1. What is Farmiblastina and what is it used for

Farmiblastina is an anticancer antibiotic that belongs to the anthracycline group and is used to treat different types of cancer, administered either intravenously or, in some cases, intravesically (direct injection into the organ). Farmiblastina works by inhibiting the cell cycle, preventing the proliferation of cancer cells.

Farmiblastina can be used alone or in combination with other medications, in the treatment of children and adults, for the following types of cancer:

1. Breast cancer
2. Bone sarcomas: malignant tumors in the bones.
3. Soft tissue sarcomas: malignant tumors that can affect cartilage, muscles, fat, blood vessels, or other tissues.
4. Lung cancer.
5. Stomach cancer.
6. Lymphomas, such as non-Hodgkin's lymphoma (diseases that affect white blood cells or lymphocytes) and Hodgkin's lymphoma (a disease of the lymphatic system).
7. Thyroid gland cancer.
8. Gynecological and genitourinary tumors: tumors in the ovaries, endometrium, testicles, prostate, or bladder.
9. Solid tumors in pediatrics, such as rhabdomyosarcoma (a cancer that forms in the soft tissue of the muscle), neuroblastoma (a cancer of immature cells that mainly affects infants and children), Wilms tumor (a disease in which malignant cells are found in the kidney), and liver tumors.
10. Leukemias (bone marrow cancer), such as acute lymphocytic leukemia, acute myeloid leukemia, and chronic leukemias.
11. Induction of multiple myeloma: a cancer that begins in the white blood cells that produce antibodies, which are responsible for the body's defense.

Farmiblastina will only be prescribed to you by a doctor with experience in cancer medications.

If you have any questions about how Farmiblastina works or why this medication has been prescribed to you, consult your doctor.

2. What you need to know before taking Farmiblastina

Do not use Farmiblastina

If you are allergic to the active substance or to other anticancer agents of the same group or to any of the other components of this medication (listed in section 6).

Do not use Farmiblastina if administration is by intravenous route:

• If you have a persistent alteration of your immune system (altered ability to fight infections or diseases)
• If you have severe liver problems
• If you have severe heart problems (arrhythmias, infarctions, or insufficiency)

Do not use Farmiblastina if administration is by intravesical route:

• If you have urinary tract infections, bladder inflammation, or blood in the urine.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Farmiblastina.

• If you have or have had heart problems or if you are receiving or have received radiation therapy in areas close to the heart.
• If you have received treatment with other anthracyclines.
• If you are being treated with other medications that can suppress heart contraction.
• If you are being treated with other medications for cancer.
• If your immune system is altered, i.e., you have lost the ability to fight infections or diseases.
• If you have or have had liver problems.
• If you have or have had gout, as doxorubicin can cause elevated uric acid levels.
• If you are pregnant or think you may be pregnant (see details below).
• If you are breastfeeding (see details below).
• If you are a man, you should use effective contraceptive methods during treatment with doxorubicin, given the potential toxicity of the medication. If you wish to have children after treatment with Farmiblastina, you should consult your doctor about genetic counseling and options for preserving fertility before starting treatment.
• If you need to be vaccinated while being treated with this medication, as live or attenuated vaccines should not be administered, and the response to killed or inactivated vaccines may be diminished.
• If you are taking or have recently taken trastuzumab (a medication used to treat certain types of cancer). Trastuzumab can remain in the body for up to 7 months. As trastuzumab can affect the heart, you should not use Farmiblastina until 7 months after stopping trastuzumab. If Farmiblastina is used before this time, your heart function should be carefully monitored.

If you are in any of the above situations, consult your doctor before using Farmiblastina.

Your doctor will regularly check your condition to see if Farmiblastina is having the expected effect.

While being treated with Farmiblastina, you will undergo periodic blood tests and heart function tests.

Other medications and Farmiblastina

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

It is possible that they may increase the side effects or alter the action of other medications, such as those used for heart disorders, cancer treatment, antibiotics, female hormones, medications that alter the immune system, and medications used to treat epilepsy, as well as plant-based medications containing St. John's Wort (Hypericum perforatum). Your doctor should also be informed about vaccine administration.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

You should not use Farmiblastina during pregnancy unless it is strictly necessary. Your doctor will inform you of the potential risks of using Farmiblastina during pregnancy.

Contraception in women of childbearing age

You should always use an effective contraceptive method while receiving Farmiblastina and for at least 6.5 months after the last dose. Consult your doctor about the contraceptive methods that are suitable for you and your partner.

Contraception in men

Men should always use effective contraceptive methods while receiving Farmiblastina and for at least 3.5 months after the last dose.

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If you are breastfeeding, inform your doctor. Do not breastfeed during treatment with Farmiblastina or for at least 10 days after the last dose, as it is excreted in breast milk.

Farmiblastina can cause loss of menstruation and infertility during treatment.

Both men and women should seek advice on preserving fertility before treatment.

Driving and using machines

It is not known if Farmiblastina has any effect on the ability to drive vehicles or operate machinery. However, if you experience any effects that alter your ability to drive (weakness, nausea, or vomiting), you should not drive vehicles or use machinery.

Farmiblastina contains methylparahydroxybenzoate (E 218)

It can cause allergic reactions (possibly delayed) and, exceptionally, bronchospasm.

3. How to use Farmiblastina

Your doctor will determine the dose and duration of treatment, as well as the most suitable administration route for you, based on your condition and response to treatment.

Your doctor will indicate the number of treatment cycles you need.

If you use more Farmiblastina than you should

Although it is unlikely, if you receive more Farmiblastina than you should, some of the known side effects of the medication may appear. Consult your doctor immediately, as you may require hospitalization.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

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

• Alterations in the electrocardiogram.
• Reduction in the number of white blood cells, especially neutrophils, red blood cells, and/or platelets in the blood.
• Inflammation of the mucosa of the mouth and/or gums, diarrhea, nausea, and vomiting.
• Redness, sensitivity, and/or peeling of the palms of the hands and soles of the feet (palmar-plantar erythrodysesthesia), hair loss (alopecia).
• Infection.
• Fever, weakness, chills.
• Asymptomatic decrease in the amount of blood pumped by the left ventricle of the heart, alteration of liver enzyme levels (transaminases), weight gain.
• Loss of appetite.

Common side effects (may affect up to 1 in 10 patients):

• Loss of the heart's ability to pump blood (congestive heart failure), increased heart rate originating in the sinus node of the heart.
• Inflammation of the esophagus (esophagitis), abdominal pain.
• Rash, skin and nail spots (hyperpigmentation), urticaria.
• Conjunctivitis (inflammation of the conjunctiva of the eye).
• Generalized infection.
• Reaction at the injection site.

Uncommon side effects (may affect up to 1 in 100 patients):

• Obstruction of a blood vessel with material transported by the blood
• Abnormal heart rhythm, the heartbeat feels fast or irregular (palpitations), heart failure, which can cause difficulty breathing and may cause swelling of the legs, cardiac arrest.

Rare side effects (may affect up to 1 in 1,000 patients):

• Bluish discoloration of the skin and mucous membranes due to low oxygen levels in the blood.
• Thickened skin areas.

Side effects of unknown frequency (cannot be estimated from available data):

• Alterations in heart rate (tachyarrhythmias), deterioration of the conduction of cardiac impulses from the atria to the ventricles (atrioventricular and bundle branch block).
• Keratitis (inflammation of the cornea), excessive tear production (lacrimation).
• Spots on the mucous membranes of the mouth, erosions in the stomach, bleeding in the gastrointestinal tract, inflammation of the colon (colitis).
• Reddish coloration of the urine for 1 or 2 days after administration.
• Itching, skin changes, skin sensitivity to light (photosensitivity), increased sensitivity of the irradiated skin area, dehydration, increased uric acid levels in the blood (hyperuricemia).
• Acute lymphocytic leukemia, acute myeloid leukemia.
• Bleeding, obstruction, and inflammation of a blood vessel (thrombophlebitis), inflammation of blood vessels (phlebitis), hot flashes, shock.
• General malaise.
• Severe allergic reaction throughout the body (anaphylaxis).
• Absence of menstruation (amenorrhea), reduced sperm count (oligospermia), absence of sperm (azoospermia).

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medication Monitoring System for Human Use: https://www.notificaram.es.

By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Farmiblastina

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

This medication does not require special storage conditions.

Do not use this medication after the expiration date shown on the label and packaging after EXP. The expiration date is the last day of the month indicated.

Do not use this medication if you notice that the packaging is damaged or open.

Medications should not be disposed of through wastewater or household waste. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Additional information

Composition of Farmiblastina

• The active substance is doxorubicin hydrochloride.
• The other components are methylparahydroxybenzoate (E 218) and lactose monohydrate.

Appearance of the product and package contents

Each vial contains a reddish-colored lyophilized powder.

Each vial contains 50 mg of doxorubicin hydrochloride.

It is available in a single format: 1 vial.

Marketing authorization holder and manufacturer

Marketing authorization holder

Pfizer, S.L.

Avda. de Europa, 20 B

Parque Empresarial La Moraleja

28108 Alcobendas (Madrid)

Manufacturer

Latina Pharma S.p.A.

Via Murillo, 7

04013 Sermoneta (LT)

Italy

Date of the last revision of this leaflet:May 2022

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