Prospect: information for the user

Daunoblastina 20 mg powder and solvent for injectable solution

Daunorubicin hydrochloride

Read this prospect carefully before starting to use this medicine, 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 or pharmacist.
• This medicine has been prescribed only to you, and you must 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 or pharmacist, even if they are not listed in this prospect. See section 4.

1.What Daunoblastina is and for what it is used

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

3.How to use Daunoblastina

4.Possible adverse effects

5.Storage of Daunoblastina

6.Contents of the package and additional information

Daunoblastina is an anticancer antibiotic that belongs to the anthracyclines group and is used for the treatment of various types of cancers. This medication is administered intravenously. Daunoblastina acts by inhibiting the cell cycle, preventing the proliferation of cancerous cells.

Adults:

Daunoblastina may be used alone or in combination with other medications, for the treatment of leukemias (bone marrow cancer) such as acute myeloid leukemia and acute lymphoblastic leukemia.

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

Children:

Daunoblastina in combination with other medications may be used in children with leukemias (blood cancer) such as acute lymphoblastic leukemia and acute myeloid leukemia.

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

No use Daunoblastina

• If you are allergic to hydrochloride daunorubicina or any of the other components of this medication (listed in section 6), or to other anticancer agents of the same group.
• If you have a persistent alteration of your immune system (altered ability to fight infections or diseases).
• If you have a severe infection.
• If you have or have had severe liver or kidney problems.
• If you have severe heart problems (heart failure, arrhythmias) or have had a recent heart attack.
• If you have received high doses of daunorubicina or other medications of the same group.
• If you are pregnant or suspect you may be.
• If you are breastfeeding your child.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Daunoblastina.

• If you have an uncontrolled infection caused by a virus.
• If you have received, are receiving, or will receive radiation therapy, as you have a higher risk of local reactions. Additionally, if you have received radiation therapy in areas close to the heart, the toxic effects of the medication on the heart may increase.
• If you have received previous treatment with a medication to treat cancer and have small ulcers in the mouth (stomatitis), present a decrease in a type of white blood cells (neutropenia), decrease in platelets (thrombocytopenia), or generalized infections.
• If during treatment you present a severe alteration of the bone marrow accompanied by a decrease in white blood cells (leucopenia, neutropenia) and a decrease in platelets (thrombocytopenia).
• If during treatment you present anemia.
• If you have or have had heart problems. Older patients and children are more sensitive to the harmful effects of this medication on the heart.
• If you have received treatment with other anthracyclines or anthracenediones.
• If you are being treated with other medications that can suppress heart contractions or with medications that are harmful to the heart.

-If you have or have had liver problems.

• If you have or have had kidney problems.
• If during treatment, blood uric acid levels increase. Since Daunoblastina can cause an increase in blood uric acid levels, your doctor may take measures to minimize possible complications.
• 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 have nausea and vomiting. Since Daunoblastina can cause nausea and vomiting, your doctor may administer a medication before treatment to prevent them and/or reduce their incidence and intensity.
• If you are being treated or have been treated with Daunoblastina, you should use effective contraceptive methods.
• If you are taking or have recently taken trastuzumab (a medication used to treat certain types of cancer). Trastuzumab can take up to 7 months to be eliminated from the body. Since trastuzumab can affect the heart, you should not use Daunoblastina until 7 months after stopping trastuzumab. If Daunoblastina is used before this time, your heart function should be closely monitored.

If you are in any of the cases described above, consult your doctor before starting to use Daunoblastina. Your doctor will regularly monitor your condition to check if Daunoblastina is having the expected effect.

Daunoblastina can cause complete hair loss (alopecia) including facial hair, armpit hair, and pubic hair. This adverse effect is usually reversible, with hair growing back two to three months after treatment is completed.

Before starting treatment and while taking Daunoblastina, your doctor may perform periodic blood tests and heart function, liver, and/or kidney function tests.

Be especially careful with daunorubicina

A neurological disorder called SEPR has been reported when daunorubicina is used in combination with other cancer treatments. SEPR can cause symptoms such as headache, convulsions, lethargy, confusion, and altered vision. If you experience any of these symptoms, contact your doctor.

Use of Daunoblastina with other medications

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 to treat cancer, heart problems, those that can affect the bone marrow and liver function, medications that alter uric acid elimination, and antiplatelet medications. Certain types of vaccines should not be administered during Daunoblastina treatment.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or suspect you may be, consult your doctor or pharmacist before using this medication.

Your doctor will inform you of the potential risks of using Daunoblastina during pregnancy.

Effective contraceptive methods should be used to avoid pregnancy during Daunoblastina treatment and after it is completed. This applies to patients of both sexes. It is recommended that men treated with Daunoblastina not father children during treatment and for at least 14 weeks after, and that women of childbearing age use effective contraceptive methods during Daunoblastina treatment and for at least 27 weeks after. If patients wish to have children after completing treatment, both men and women should discuss genetic counseling and fertility preservation options with their doctor before starting Daunoblastina treatment.

If you are breastfeeding your child, inform your doctor. Do not use Daunoblastina if you are breastfeeding your child or for at least 6 days after the last dose.

Driving and operating machinery
Daunoblastina can cause nausea and vomiting, which in some cases may affect your ability to drive or operate machinery.

Daunoblastina contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per ml of reconstituted solution; it is essentially "sodium-free".

Your doctor will determine the most suitable dose and treatment duration based on your condition and response to treatment.

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

If you receive more Daunoblastina than you should

Although unlikely, if you receive more Daunoblastina than you should, you may experience medication side effects.

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:

• Infections, which can sometimes be fatal, generalized infection (sepsis/septicemia).
• Alteration of normal bone marrow function, decrease in the number of red blood cells (anemia), decrease in the number of white blood cells (neutropenia and leucopenia), decrease in the number of platelets (thrombocytopenia), decrease in the number of granulocytes (granulocytopenia).
• Alteration of heart muscle (cardiomyopathy) that may manifest as: difficult breathing (dyspnea), blue discoloration of the skin (cyanosis), accumulation of fluid in the ankles, feet, and legs (peripheral edema), enlargement of the liver (hepatomegaly), accumulation of fluid in the abdomen (ascitis), accumulation of fluid in the pleural cavity (pleural effusion), loss of the heart's ability to pump blood (congestive heart failure).
• Bleeding.
• Diarrhea, inflammation of the esophagus (esophagitis), inflammation of the mucous membrane of the mouth (mucositis/stomatitis), nausea/vomiting.
• Hair loss (alopecia), redness of the skin (erythema), skin rash.
• Fever.
• Pain.
• Elevations of certain substances in the blood, such as bilirubin, aspartate aminotransferase, and alkaline phosphatase.

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

• Abdominal pain, inflammation of the vein where the medication is administered (phlebitis at the infusion site), alterations in the electrocardiogram.

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

• Acute myeloid leukemia, myocardial infarction.

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

• Septic shock.
• Myleodysplastic syndrome.
• Severe allergic reaction (anaphylaxis), allergic reactions.
• Dehydration, significant increase in uric acid in the blood (acute hyperuricemia).
• Inflammation and thickening of heart tissue (endomyocardial fibrosis), chest pain that occurs when blood flow to the heart is insufficient (angina pectoris), inflammation of the membrane covering the heart (pericarditis), inflammation of the heart muscle (myocarditis), irregular heart rhythm (supraventricular tachyarrhythmias).
• Redness of the face (flushing), shock, presence of blood clots in the veins (thrombophlebitis), thickening of the walls of the veins (phlebosclerosis).
• Decreased oxygen delivery to tissues (hypoxia).
• Colitis.
• Hepatitis, liver failure.
• Skin inflammation caused by direct contact with a substance (contact dermatitis), increased sensitivity of the irradiated skin area, itching, increased skin pigmentation and nail pigmentation, urticaria.
• Red color in the urine for 1 or 2 days after administration.
• Absence of menstruation (amenorrhea), absence of sperm in the semen (azoospermia).
• Chills, death, high fever, leakage of the medication from the vein in which it is being administered, which may cause symptoms such as: immediate local pain/burning sensation, severe inflammation of cells in the administration area (cellulitis), painful ulcers in the skin and tissue death (necrotic tissue).

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.

This medication does not require special storage conditions.

Do not use this medication after the expiration date that appears on the outer packaging and label after CAD. The expiration date is the last day of the month indicated.

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

It is recommended to use immediately after reconstitution or opening of the vial. If not used immediately, storage times and conditions are the responsibility of the user.

The storage time of the reconstituted solution should not exceed24 hours at a temperature not exceeding 30°C and 48 hours in a refrigerator (between 2°-8°C).

The disposal of unused medication and all materials derived from its use will be carried out in accordance with local regulations for cytotoxic agents.

Composition of Daunoblastina

• The active principle is hydrochloride of daunorubicin.
• The other components are:
• • Vial with powder: mannitol.
  • Bottle of solvent of 10 ml of sodium chloride 0.9% (9 mg/ml): water for injectable preparations and sodium chloride.

Appearance of the product and contents of the packaging

The vial contains the lyophilized active principle, which is a red-orange powder. The bottle contains 10 ml of solvent (sodium chloride 0.9% solution).

Holder of the marketing authorization

Pfizer, S.L.

Avda. de Europa, 20 B

Parque Empresarial La Moraleja

28108 Alcobendas (Madrid)

Spain

Responsible for manufacturing

Latina Pharma S.p.A.

Via Murillo, 7 - 04013 Sermoneta (LT)

Italy

Last review date of this leaflet: April 2022

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