Prospect: information for the patient

Farmiblastina 50 mg powder for injectable solution

doxorubicin hydrochloride

Read this prospect carefully before starting to use this medication, because it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor, pharmacist, or nurse.

-This medication has been prescribed only to you and should not be given to other people, even if they have the same symptoms as you, as it may harm them.

-If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this prospect. See section 4.

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Farmiblastina is an anticancer antibiotic that belongs to the anthracycline group and is used for the treatment of various types of cancers, administered either intravenously or in some cases intravesically (direct injection into the organ). Farmiblastina acts by inhibiting the cell cycle, preventing the proliferation of cancerous cells.

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

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 lymphoma (diseases that affect white blood cells or lymphocytes) and Hodgkin lymphoma (disease of the lymphatic system).
7. Thyroid gland cancer.
8. Gynecological and genitourinary tumors: tumors in ovaries, endometrium, testicles, prostate, or bladder.
9. Solid tumors in pediatrics such as rhabdomyosarcoma (cancer that forms in soft tissue of the muscle), neuroblastoma (cancer of immature cells primarily affecting infants and children), Wilms tumor (disease in which malignant cells are found in the kidney) and liver tumors.
10. Leukemias (bone marrow cancer) such as acute lymphoblastic leukemia, acute myeloid leukemia and chronic leukemias.
11. Induction of multiple myeloma: cancer that begins in white blood cells that produce antibodies responsible for the body's defense.

Farmiblastina will only be prescribed by an experienced doctor in cancer medications.

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

No use Farmiblastina

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

Do not use Farmiblastina if administration is intravenous:

• 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, heart attacks, or heart failure)

Do not use Farmiblastina if administration is intravesical:

• 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 contractions.
• If you are being treated with other cancer medications.
• 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 your child (see details below).
• If you are male, you must 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, consult your doctor about genetic counseling and options for preserving fertility before starting treatment
• If you need to be vaccinated while on treatment with this medication, as live or attenuated virus vaccines should not be administered and the response to inactivated or killed vaccines may be reduced.
• If you are taking or have taken recently trastuzumab (a medication used to treat certain types of cancer). Trastuzumab may remain in the body for up to 7 months. As trastuzumab can affect the heart, do not use Farmiblastina until 7 months after stopping trastuzumab. If Farmiblastina is used before this time, your cardiac function should be closely monitored.

If you find yourself in any of the cases listed above, consult your doctor before using Farmiblastina.

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

While on treatment with Farmiblastina, you will undergo periodic blood tests and heart function tests.

Other medications and Farmiblastina

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

They may increase the adverse effects or modify the action of other medications, such as those used for heart conditions, cancer treatment, antibiotics, female hormones, medications that alter the immune system, and medications used to treat epilepsy, as well as herbal medications containing St. John's Wort (Hypericum perforatum).Your doctor should also be informed of vaccine administration.

Pregnancy, lactation, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or intend 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 fertile women

You must always use an effective contraceptive method (contraception) 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 must 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 10days after the last dose, as it is excreted in breast milk.

Farmiblastina may cause amenorrhea and infertility during treatment.

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

Driving and operating machinery
The effect of Farmiblastina on the ability to drive vehicles or operate machinery is unknown. However, if you experience any effect that modifies the ability to drive (weakness, nausea, or vomiting), do not drive vehicles or operate machinery.

Farmiblastina contains parahydroxybenzoate methyl ester (E 218)

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

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

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

If you use more Farmiblastina than you should

Although unlikely, if you receive more Farmiblastina than you should, you may experience some of the known side effects of the medication. Consult your doctor immediately as hospitalization may be required.

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

Frequent 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 mucous membrane 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 (erythrodysthesia plantar palmar), 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.

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

• Heart failure, increase in heart rate originating from the sinoatrial node of the heart.
• Esophagitis, abdominal pain.
• Rash, skin and nail discoloration (hyperpigmentation), urticaria.
• Conjunctivitis (inflammation of the conjunctiva of the eye).
• Generalized infection.
• Reaction at the injection site.

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

• Obstruction of a blood vessel with material transported by the blood.
• Abnormal heart rhythm, heart palpitations, heart failure, which may cause difficulty breathing and may cause swelling of the legs, cardiac arrest.

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

• Blue discoloration of the skin and mucous membranes caused by low oxygen in the blood.
• Thickened skin areas.

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

• Alterations in heart rate (arrhythmias), deterioration of cardiac impulse conduction from the atria to the ventricles (atrioventricular and branch block).
• Keratitis (inflammation of the cornea), excessive tear production (lacrimation).
• Mucous membrane discoloration in the mouth, gastric erosions, gastrointestinal bleeding, colitis (inflammation of the colon).
• Red discoloration 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), headaches, shock.
• General discomfort.
• Severe allergic reaction throughout the body (anaphylaxis).
• Amenorrhea (absence of menstruation), reduction in the number of sperm (oligospermia), absence of sperm (azoospermia).

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, 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 of 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.

This medication does not require special storage conditions.

Nouse this medication after the expiration datethat appears on the label and on the packaging after CAD. The expiration date is the last day of the month indicated.

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

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

Composition of Farmiblastina

- The active ingredient is doxorubicina hydrochloride.

- The other components are methyl parahydroxybenzoate (E 218) and lactose monohydrate.

Appearance of the product and contents of the package

Cada vial contains a lyophilized powder of reddish color.

Cada vial contains 50 mg of doxorubicina hydrochloride.

It is presented in a single format: 1 vial.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Pfizer, S.L.

Avda. de Europa, 20 B

Parque Empresarial La Moraleja

28108 Alcobendas (Madrid)

Responsible for manufacturing

Latina Pharma S.p.A.

Via Murillo, 7

04013 Sermoneta (LT)

Italy

Last review date of this leaflet:May 2022

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