Daunorubicin Liposomal

Daunorubicin liposomal is used to treat advanced HIV-associated kaposi sarcoma. As of July 20, 2016, the Food and Drug Administration (FDA) gave notice of discontinuation. No other daunorubicin liposome products are available.

Daunorubicin liposomal is available under the following different brand names: DaunoXome.

Dosages of Daunorubicin Liposomal:

Dosage Forms and Strengths

Injectable Solution

• 2 mg

Dosage Considerations – Should be Given as Follows:

Advanced HIV-Associated Kaposi Sarcoma

• July 20, 2016: FDA notice of discontinuation; no other daunorubicin liposome product available
• 40 mg/m² IV (infuse over 1 hour) every 2 weeks
• Withhold treatment if ANC less than 750/cu.mm
• Continue treatment until evidence of progressive disease

Hepatic Impairment

• Serum bilirubin 1.2-3 mg/dL [20.5-51.3 micromoles/L]: Give 75% normal dose
• Serum bilirubin or creatinine greater than 3 mg/dL [bili greater than 51.3 micromoles/L; Cr greater than 265 micromoles/L]: Give 50% normal dose

Monitor

• Complete blood count (CBC) before each administration
• Left ventricular ejection fraction (LVEF) before and at every cumulative 160 mg/m2
• Renal and hepatic function

Safety and efficacy not established in pediatric patients.

Common side effects of daunorubicin_liposomal include:

• Nausea
• Fatigue
• Fever
• Diarrhea
• Cough
• Shortness of breath
• Headache
• Nerve pain
• Increased sweating
• Depression
• Back pain
• Feeling unwell (malaise)
• Severe shivering (rigors)
• Triad of back pain, flushing and chest tightness
• Chest pain
• Fluid retention (edema)
• Runny or stuffy nose
• Abdominal pain
• Loss of appetite
• Inflammation of mouth and lips
• Vomiting
• Allergic reactions
• Abnormal vision
• Dizziness
• Insomnia
• Sinusitis
• Constipation
• Flu-like Symptoms
• Muscle pain
• Joint pain
• Hair loss
• Itching
• The feeling of needing to have a bowel movement

Other side effects of daunorubicin liposomal include:

• Cardiotoxicity
• Myelosuppression

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

Daunorubicin liposomal has no listed severe interactions with other drugs.

Serious interactions of daunorubicin liposomal include:

• erdafitinib
• influenza virus vaccine trivalent, adjuvanted
• lasmiditan
• palifermin
• tofacitinib
• trastuzumab

Daunorubicin liposomal has moderate interactions with at least 49 different drugs.

Daunorubicin liposomal has no listed mild interactions with other drugs.

Warnings

This medication contains daunorubicin liposomal. Do not take DaunoXome if you are allergic to daunorubicin liposomal or any ingredients contained in this drug.

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 treatment max dose of doxorubicin, daunorubicin, idarubicin, or other anthracyclines
• Not recommended for less than advanced Kaposi's sarcoma

Effects of Drug Abuse

• No information is available.

Short-Term Effects

• See "What Are Side Effects Associated with Using Daunorubicin Liposomal?"

Long-Term Effects

• See "What Are Side Effects Associated with Using Daunorubicin Liposomal?"

Cautions

• Risk of myelosuppression and cardiotoxicity with congestive heart failure
• Irritant
• Safety not established for pts with renal/hepatic impairment
• Avoid pregnancy

Pregnancy and Lactation

Use daunorubicin liposomal during pregnancy in LIFE-THREATENING emergencies when no safer drug is available. There is positive evidence of human fetal risk.

It is unknown if daunorubicin liposomal is excreted in breast milk. Breastfeeding is not recommended while using daunorubicin liposomal.