FARMIBLASTINA 2 mg/ml CONCENTRATE FOR INFUSION SOLUTION

Introduction

Package Leaflet: Information for the Patient

Farmiblastina 2 mg/ml Concentrate for Solution for Infusion

Doxorubicin Hydrochloride

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Farmiblastina and what is it used for
2. What you need to know before you use Farmiblastina
3. How to use Farmiblastina
4. Possible side effects
5. Storage of Farmiblastina
6. Contents of the pack and further information

1. What is Farmiblastina and what is it used for

Farmiblastina is an anticancer antibiotic that belongs to the group of anthracyclines and is used for the treatment of different types of cancer, administered either by intravenous or, in some cases, by intravesical route (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. Osteosarcomas: malignant tumors in the bones.
3. Soft tissue sarcoma: 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 (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 (cancer that forms in the soft tissue of the muscle), neuroblastoma (cancer of immature cells that mainly 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 lymphocytic leukemia, acute myeloid leukemia, and chronic leukemias.
11. Induction of multiple myeloma: cancer that begins in the white blood cells that produce antibodies 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 doubts about how Farmiblastina works or why this medication has been prescribed to you, ask your doctor.

2. What you need to know before you use Farmiblastina

Do not use Farmiblastina

If you are allergic to doxorubicin hydrochloride 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 an increase in uric acid.
• 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 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, 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 for the treatment of 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 you have stopped taking trastuzumab. If Farmiblastina is used before this time, your heart function should be carefully monitored.

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

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

While you are being treated with Farmiblastina, you will have 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 modify 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 in the treatment of epilepsy, as well as herbal medicines that contain St. John's Wort (Hypericum perforatum). Your doctor should also be informed of the administration of vaccines.

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.

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

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 may 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 sodium

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

3. How to use Farmiblastina

Your doctor will determine the dose and duration of treatment, as well as the most suitable route of administration for you, according to 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 gets them.

Very common 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 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) include:

• Loss of the heart's ability to pump blood (congestive heart failure), increased heart rate that originates 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) include:

• Blockage 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 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 (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).
• Red discoloration of the urine for 1 or 2 days after administration.
• Itching, skin changes, increased sensitivity of the skin 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 malaise.
• Severe allergic reaction throughout the body (anaphylaxis).
• Absence of menstruation (amenorrhea), reduced sperm count (oligospermia), absence of sperm (azoospermia).

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es.

By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Farmiblastina

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

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

Do not use this medication after the expiration date that appears on the outer packaging and the label 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. Deposit the packaging and medications you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition of Farmiblastina

• The active ingredient is doxorubicin hydrochloride.
• The other ingredients are water for injectable preparations, sodium chloride, and hydrochloric acid (for pH adjustment).

Each ml contains 2 mg of doxorubicin hydrochloride.

Each 25 ml vial contains 50 mg of doxorubicin hydrochloride.

Appearance of the product and contents of the pack

Red, transparent, and practically particle-free solution. The solution is packaged in vials made of polypropylene, containing 25 ml of concentrate for solution for infusion.

Marketing authorization holder and manufacturer

Marketing authorization holder

Pfizer, S.L.

Avda. de Europa, 20 B.

Parque Empresarial La Moraleja.

28108 Alcobendas (Madrid).

Manufacturer

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

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/