DOXIL 2 mg/mL
doxorubicin hydrochloride · INJECTION, SUSPENSION, LIPOSOMAL · Baxter Healthcare Corporation
DOXIL is a injection, suspension, liposomal containing doxorubicin hydrochloride at 2 mg/mL, taken intravenous. Manufactured by Baxter Healthcare Corporation.
Key Facts
- Brand Name
- DOXIL
- Generic Name
- doxorubicin hydrochloride
- NDC Code (Product)
0338-9667- Manufacturer
- Baxter Healthcare Corporation
- Strength
- 2 mg/mL
- Dosage Form
- INJECTION, SUSPENSION, LIPOSOMAL
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- NDA050718
- Marketing Start
- 08/26/2024
Recall History
Baxter Healthcare Corporation
CGMP Deviations: Product was exposed to temperatures exceeding the labeled storage conditions during transportation were released by mistake.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Doxil liposomal infusion is an anthracycline topoisomerase inhibitor indicated for: • Ovarian cancer: After failure of platinum-based chemotherapy ( 1.1 ) • AIDS-related Kaposi’s Sarcoma: After failure of prior systemic chemotherapy or intolerance to such therapy ( 1.2 ) • Multiple Myeloma: In combination with bortezomib in patients who have not previously received bortezomib and have received at least one prior therapy ( 1.3 ) 1.1 Ovarian Cancer DOXIL liposomal infusion is indicated for the treatment of patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy. 1.2 AIDS-Related Kaposi’s Sarcoma DOXIL liposomal infusion is indicated for the treatment of AIDS-related Kaposi's sarcoma in patients after failure of prior systemic chemotherapy or intolerance to such therapy. 1.3 Multiple Myeloma DOXIL liposomal infusion, in combination with bortezomib, is indicated for the treatment of patients with multiple myeloma who have not previously received bortezomib and have received at least one prior therapy.
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Administer DOXIL liposomal infusion at an initial rate of 1 mg/min to minimize the risk of infusion reactions. If no infusion-related reactions occur, increase rate of infusion to complete administration over 1 hour. Do not administer as bolus injection or undiluted solution ( 2 ). • Ovarian cancer: 50 mg/m 2 intravenously every 4 weeks ( 2.2 ) • AIDS-related Kaposi’s Sarcoma: 20 mg/m 2 intravenously every 3 weeks ( 2.3 ) • Multiple Myeloma: 30 mg/m 2 intravenously on day 4 following bortezomib ( 2.4 ) 2.1 Important Use Information Do not substitute DOXIL liposomal infusion for other doxorubicin hydrochloride products. Do not administer as an undiluted suspension or as an intravenous bolus [see Warnings and Precautions (5.2) ] . 2.2 Ovarian Cancer The recommended dose of DOXIL liposomal infusion is 50 mg/m 2 intravenously over 60 minutes every 28 days until disease progression or unacceptable toxicity. 2.3 AIDS-Related Kaposi’s Sarcoma The recommended dose of DOXIL liposomal infusion is 20 mg/m 2 intravenously over 60 minutes every 21 days until disease progression or unacceptable toxicity. 2.4 Multiple Myeloma The recommended dose of DOXIL liposomal inf…
Contraindications
4 CONTRAINDICATIONS DOXIL liposomal infusion is contraindicated in patients who have a history of severe hypersensitivity reactions, including anaphylaxis, to doxorubicin hydrochloride [see Warnings and Precautions (5.2) ]. • Hypersensitivity reactions to doxorubicin hydrochloride or the components of DOXIL liposomal infusion ( 4 , 5.2 )
Drug Interactions
7 DRUG INTERACTIONS No formal drug interaction studies have been conducted with DOXIL liposomal infusion.
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are discussed in more detail in other sections of the labeling. • Cardiomyopathy [see Warnings and Precautions (5.1) ] • Infusion-Related Reactions [see Warnings and Precautions (5.2) ] • Hand-Foot Syndrome [see Warnings and Precautions (5.3) ] • Secondary Oral Neoplasms [see Warnings and Precautions (5.4) ] Most common adverse reactions (>20%) are asthenia, fatigue, fever, anorexia, nausea, vomiting, stomatitis, diarrhea, constipation, hand-foot syndrome, rash, neutropenia, thrombocytopenia, and anemia ( 6 ). To report SUSPECTED ADVERSE REACTIONS contact Baxter Healthcare at 1-866-888-2472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed cannot be directly compared to rates on other clinical trials and may not reflect the rates observed in clinical practice. The safety data reflect exposure to DOXIL liposomal infusion in 1310 patients including: 239 patients with ovarian cancer, 753 patients with AIDS-related Kaposi’s sarcoma, and 318 patients with multiple myeloma. The most common adverse rea…
Frequently Asked Questions
What is DOXIL used for?
DOXIL contains doxorubicin hydrochloride. It is a injection, suspension, liposomal taken intravenous. Consult your doctor for specific uses.
Is DOXIL a controlled substance?
DOXIL is not classified as a controlled substance by the DEA.
What is the generic name for DOXIL?
The generic name for DOXIL is doxorubicin hydrochloride. There are 12 other brand versions of doxorubicin hydrochloride.
What is the NDC code for DOXIL 2 mg/mL?
The NDC (National Drug Code) for DOXIL 2 mg/mL is 0338-9667, listed by Baxter Healthcare Corporation.
Other Doxorubicin Brands
See all →- Doxorubicin Hydrochloride2 mg/mL0143-9084
- Doxorubicin Hydrochloride2 mg/mL0143-9089
- Doxorubicin Hydrochloride2 mg/mL0143-9090
- DOXORUBICIN HYDROCHLORIDE2 mg/mL49315-009
- Doxorubicin Hydrochloride2 mg/mL68083-248
- DOXORUBICIN HYDROCHLORIDE2 mg/mL70710-1531
- Doxorubicin Hydrochloride Liposome2 mg/mL25021-263
- doxorubicin hydrochloride2 mg/mL46708-525
- doxorubicin hydrochloride, Liposomal2 mg/mL0338-9581
- Doxorubicin Hydrochloride2 mg/mL68001-492
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)