Daunorubicin (Liposomal)

Black Box Warnings

Monitor cardiac function, especially in patients who have received prior anthracyclines, have had preexisting cardiac disease, or who have had prior radiotherapy encompassing the heart. Severe myelosuppression may occur.

The drug should be administered under the supervision of an experienced chemotherapy physician

Reduce dose in patients with impaired hepatic function

A triad of back pain, flushing, and chest tightness may occur during the first 5 minutes of the infusion. It subsides with interruption of the infusion and generally does not recur when resumed at a slower rate.

Contraindications

Hypersensitivity

Prior tx max dose of doxorubicin, daunorubicin, idarubicin, or other anthracyclines

Not recommended for less than advanced Kaposi's sarcoma

Cautions

Risk of myelosuppression & cardiotoxicity with CHF

Irritant

Safety not established for pts with renal/hepatic impairment

Avoid pregnancy

• If you have an allergy to daunorubicin or any other part of this medicine.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take daunorubicin with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
• You may have more chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu.
• If you have upset stomach, throwing up, loose stools (diarrhea), or are not hungry, talk with your doctor. There may be ways to lower these side effects.
• If you have had daunorubicin, doxorubicin, epirubicin, idarubicin, or mitoxantrone before, talk with your doctor.
• To help with mouth sores, use a soft toothbrush or cotton swabs and rinse the mouth. Do not use mouth rinses that have alcohol in them.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• You will need to have heart function tests while taking daunorubicin. Talk with the doctor.
• Talk with your doctor before getting any vaccines. Use with this medicine may either raise the chance of an infection or make the vaccine not work as well.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant.
• Use birth control that you can trust to prevent pregnancy while taking daunorubicin.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Use daunorubicin as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot into a vein over a period of time.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

• DAUNOrubicin Citrate
• DAUNOrubicin Citrate (Liposomal)
• DAUNOrubicin Citrate Liposome
• Liposomal DAUNOrubicin

Refer to adult dosing.

Adverse events were observed in animal reproduction studies. May cause fetal harm if administered during pregnancy. Women of childbearing potential should avoid becoming pregnant while receiving treatment.

Daunorubicin liposomal may cause dangerous effects on your heart. Call your doctor at once if you have chest pain, shortness of breath (even with mild exertion), swelling, or rapid weight gain.

Some side effects may occur during the injection. Tell your caregiver right away if you feel dizzy, nauseated, light-headed, sweaty, or have back pain and chest tightness.

Daunorubicin liposomal can lower blood cells that help your body fight infections and help your blood to clot. You may get an infection or bleed more easily. Call your doctor if you have unusual bruising or bleeding, or signs of infection (fever, chills, body aches).

You should not use daunorubicin liposomal if you are allergic to it.

To make sure daunorubicin liposomal is safe for you, tell your doctor if you have:

• heart disease;

• kidney disease;

• liver disease;

• a weak immune system (caused by disease or using certain medicines); or

• if you have ever been treated with doxorubicin, epirubicin, idarubicin, mitoxantrone, or non-liposomal daunorubicin (Cerubidine).

Do not use daunorubicin liposomal if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

Daunorubicin liposomal may pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects may occur during the injection. Tell your caregiver right away if you feel dizzy, nauseated, light-headed, sweaty, or have back pain and chest tightness.

Call your doctor at once if you have:

• chest pain, shortness of breath (even with mild exertion), swelling, rapid weight gain;

• fever, chills, body aches, flu symptoms, sores in your mouth and throat;

• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum);

• nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

• pain, burning, irritation, or skin changes where the injection was given.

Common side effects may include:

• mild nausea, vomiting, diarrhea, stomach pain;

• cough;

• headache;

• temporary hair loss, mild itching or rash; or

• red colored urine for 1 or 2 days following a dose.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.