Prospect: information for the patient

Farmiblastina 2 mg/ml concentrate for infusion solution

Doxorubicin hydrochloride

Read this prospect carefully before starting to use this medication, as 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 you should not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospect. See section 4.

1.What Farmiblastina is and for what it is used

2.What you need to know before starting to use Farmiblastina

3.How to use Farmiblastina

4.Possible adverse effects

5.Storage of Farmiblastina

6.Contents of the package and additional information

Farmiblastina is an anticancer antibiotic that belongs to the anthracyclines 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 cartilages, muscles, fat, blood vessels, or other tissues.
4. Lung cancer
5. Stomach cancer
6. Lymphomassuch as Non-Hodgkin lymphomas, (diseases that affect white blood cellsor 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 pediatricssuch as rhabdomyosarcoma (cancer that forms in the soft tissue of the muscle), neuroblastoma (cancer of immature cells and primarily affects 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 the white blood cells that produce the 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.

Do not use Farmiblastina

If you are allergic to doxorubicina hydrochloride, 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, that is, 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, as the potential toxicity of the medication. If you want to have children after treatment with Farmiblastina, you must consult your doctor about genetic counseling and fertility preservation options before starting treatment.
• If you need to be vaccinated while taking 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 recently taken 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 are 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 taking Farmiblastina, blood tests and heart function tests will be performed periodically.

Other medications and Farmiblastina

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

Other medications may increase the risk of adverse effects or modify the action of other medications, such as those used to treat heart problems, cancer, 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, breastfeeding 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.

Do not use Farmiblastina during pregnancy unless strictly necessary. Your doctor will inform you of the potential risks of taking Farmiblastina during pregnancy.

Contraception in fertile women

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

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

Inform your doctor if you are breastfeeding.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 fertility preservation 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 your ability to drive (weakness, nausea or vomiting) do not drive vehicles or operate machinery.

Farmiblastina contains sodium

This medication contains 88.5 mg of sodium (main component of table salt/for cooking) in each 25 ml vial. This is equivalent to 4.4% of the maximum daily sodium intake recommended for an adult.

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) include:

• 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.

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

• Heart failure, increase in heart rate originating from the sinoatrial node of the heart.
• Esophagitis (inflammation of the esophagus),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) include:

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

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

• 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) include:

• 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).
• Lesions on the mucous membrane of the mouth, erosions in the stomach, 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 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 discomfort.
• Severe allergic reaction throughout the body (anaphylaxis).
• Absence of menstruation (amenorrhea), 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 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.

Store in the refrigerator (between 2°C and 8°C). Store the vials in the outer packaging to protect them from light.

Do not use this medication after the expiration datethat appears on the outer packaging and the label 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.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and unused medications at the SIGRE collection pointat the pharmacy.If in doubt, ask your pharmacist how to dispose of the containers and unused medications. By doing so, you will help protect the environment.

Composition of Farmiblastina

• The active principle is doxorubicin hydrochloride.
• The other components are water for injection, sodium chloride, and hydrochloric acid (for pH adjustment).

Each milliliter contains 2 mg of doxorubicin hydrochloride.

Each vial of 25 ml contains 50 mg of doxorubicin hydrochloride.

Appearance of the product and contents of the packaging

Red, transparent solution that is practically free of visible particles. The solution is packaged in polypropylene vials containing 25 ml of concentrate for infusion solution.

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

Pfizer Service Company BV

Hoge Wei 10

Zaventem 1930

Belgium.

or

Bridgewest Perth Pharma Pty Ltd

15 Brodie Hall Drive

Technology Park

BENTLEY WA 6102

Australia

Last review date of this leaflet: May 2022

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