DAUNOBLASTINA 20 mg POWDER AND SOLVENT FOR INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

Daunoblastina 20 mg powder and solvent for solution for injection

Daunorubicin 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 or pharmacist.
• 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Daunoblastina and what is it used for

Daunoblastina is an anticancer antibiotic that belongs to the group of anthracyclines and is used to treat different types of cancer. This medicine is administered intravenously. Daunoblastina works by inhibiting the cell cycle, preventing the proliferation of cancer cells.

Adults:

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

Daunoblastina will only be prescribed by a doctor with experience in cancer medicines.

Children:

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

If you have any questions about how Daunoblastina works or why this medicine has been prescribed for you, ask your doctor.

2. What you need to know before you use Daunoblastina

Do not use Daunoblastina

• If you are allergic to daunorubicin hydrochloride or any of the other ingredients of this medicine (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 recently had a heart attack.
• If you have received treatment with high doses of daunorubicin or other medicines of the same group.
• If you are pregnant or think you may be pregnant.
• If you are breastfeeding.

Warnings and precautions

Talk to your doctor or pharmacist before you start using Daunoblastina.

• If you have an uncontrolled viral infection.
• If you have received, are receiving, or are going to receive radiotherapy, as you have a higher risk of local reactions. Also, if you have received radiotherapy in areas close to the heart, the toxic effects of the medicine on the heart may increase.
• If you have received previous treatment with any cancer medicine and have small ulcers in the mouth (stomatitis), decreased white blood cell count (neutropenia), decreased platelet count (thrombocytopenia), or generalized infections.
• If during treatment you experience a severe alteration of the bone marrow accompanied by a decrease in white blood cells (leukopenia, neutropenia) and a decrease in platelets (thrombocytopenia).
• If during treatment you experience anemia.
• If you have or have had heart problems. Elderly patients and children are more sensitive to the harmful effects of this medicine on the heart.
• If you have received treatment with other anthracyclines or anthracenediones.
• If you are being treated with other medicines that can suppress heart contraction or with medicines 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, the levels of uric acid in the blood increase. Since Daunoblastina can cause an increase in uric acid levels in the blood, your doctor may take some measures to minimize possible complications.
• If you need to be vaccinated while being treated with this medicine, as live or attenuated vaccines should not be administered, and the response to killed or inactivated vaccines may be reduced.
• If you experience nausea and vomiting. Since Daunoblastina can cause nausea and vomiting, your doctor may administer some medicine 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 medicine used to treat certain types of cancer). Trastuzumab can take up to 7 months to be eliminated from the body. As trastuzumab can affect the heart, you should not use Daunoblastina until 7 months after stopping trastuzumab. If Daunoblastina is used before this time, then your heart function should be carefully monitored.

If you are in any of the above situations, talk to your doctor before you start using Daunoblastina. Your doctor will regularly check your condition to see if Daunoblastina is having the expected effect.

Daunoblastina can cause complete hair loss (alopecia), including beard, armpit, and pubic hair. This side effect is usually reversible, with hair growing back 2 or 3 months after the end of treatment.

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

Be careful with daunorubicin

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

Using Daunoblastina with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines. They may increase the side effects or alter the action of other medicines, such as those used to treat cancer, heart problems, those that can affect the bone marrow and liver function, medicines that alter uric acid elimination, and antiplatelet agents. Certain types of vaccines should not be administered during treatment with Daunoblastina.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

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

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

If you are breastfeeding, tell your doctor. You should not use Daunoblastina if you are breastfeeding, nor for at least 6 days after the last dose.

Driving and using machines

Daunoblastina can cause nausea and vomiting, which in some cases can alter the ability to drive or operate machines.

Daunoblastina contains sodium

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

3. How to use Daunoblastina

Your doctor will determine the most suitable dose and duration of treatment, according to your condition and response to treatment.

Your doctor will indicate 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, side effects of the medicine may appear.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

• Infections, which can sometimes be life-threatening, generalized infection (sepsis/septicemia).
• Alteration of normal bone marrow function, decreased red blood cell count (anemia), decreased white blood cell count (neutropenia and leukopenia), decreased platelet count (thrombocytopenia), decreased granulocyte count (granulocytopenia).
• Alteration of heart muscle (cardiomyopathy) that can manifest as: difficult breathing (dyspnea), bluish discoloration of the skin (cyanosis), fluid accumulation in the ankles, feet, and legs (peripheral edema), increased liver size (hepatomegaly), fluid accumulation in the abdomen (ascites), fluid accumulation in the pleural cavity (pleural effusion), loss of heart's ability to pump blood (congestive heart failure).
• Bleeding.
• Diarrhea, esophagitis, mucositis/stomatitis, nausea/vomiting.
• Hair loss (alopecia), skin redness (erythema), skin rash.
• Fever.
• Pain.
• Increased levels of certain substances in the blood, such as bilirubin, aspartate aminotransferase, and alkaline phosphatase.

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

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

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

• Acute myeloid leukemia, myocardial infarction.

Rare side effects (frequency not known) include:

• Shock caused by a severe infection (septic shock).
• MDS (myelodysplastic syndrome).
• Severe allergic reaction (anaphylaxis), allergic reactions.
• Dehydration, significant increase in uric acid levels in the blood (acute hyperuricemia).
• Inflammation and thickening of the heart tissue (endomyocardial fibrosis), chest pain due to insufficient blood supply to the heart (angina pectoris), inflammation of the membrane surrounding the heart (pericarditis), inflammation of the heart muscle (myocarditis), irregular heart rhythm (supraventricular tachyarrhythmias).
• Facial redness (flushing), shock, presence of blood clots in the veins (thrombophlebitis), thickening of the vein walls (phlebosclerosis).
• Decreased oxygen supply to the tissues (hypoxia).
• Colitis.
• Hepatitis, liver failure.
• Contact dermatitis, increased sensitivity of the irradiated skin area, itching, increased skin and nail pigmentation, urticaria.
• Red color in the urine for 1 or 2 days after administration.
• Lack of menstruation (amenorrhea), lack of sperm in the semen (azoospermia).
• Chills, death, very high fever, leakage of the medicine from the vein where it is being administered, which can cause symptoms such as: immediate local pain/burning sensation, severe inflammation of the cells in the administration area (cellulitis), painful skin ulcers, and tissue death (necrosis).

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects 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 medicine.

5. Storage of Daunoblastina

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

This medicine does not require special storage conditions.

Do not use this medicine after the expiry date which is stated on the outer packaging and label after EXP. The expiry date is the last day of the month shown.

Do not use this medicine if you notice it is damaged or open.

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

The shelf life of the reconstituted solution should not exceed 24 hours at a temperature not above 30°C and 48 hours in the refrigerator (between 2°-8°C).

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

6. Contents of the pack and other information

Composition of Daunoblastina

• The active substance is daunorubicin hydrochloride.
• The other ingredients are:
• • Vial with powder: mannitol.
  • Ampoule of 10 ml solvent (0.9% sodium chloride solution): water for injections and sodium chloride.

Appearance of the product and pack contents

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

Marketing authorization holder

Pfizer, S.L.

Avda. de Europa, 20 B

Parque Empresarial La Moraleja

28108 Alcobendas (Madrid)

Spain

Manufacturer

Latina Pharma S.p.A.

Via Murillo, 7 - 04013 Sermoneta (LT)

Italy

Date of last revision of this leaflet: April 2022

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