Doxorubicin Hydrochloride Liposome 2 mg/mL
Doxorubicin Hydrochloride Liposome · INJECTION, SUSPENSION, LIPOSOMAL · Baxter Healthcare Company
Doxorubicin Hydrochloride Liposome is a injection, suspension, liposomal containing doxorubicin hydrochloride liposome at 2 mg/mL, taken intravenous. Manufactured by Baxter Healthcare Company.
Key Facts
- Brand Name
- Doxorubicin Hydrochloride Liposome
- Generic Name
- Doxorubicin Hydrochloride Liposome
- NDC Code (Product)
0338-0080- Manufacturer
- Baxter Healthcare Company
- Strength
- 2 mg/mL
- Dosage Form
- INJECTION, SUSPENSION, LIPOSOMAL
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- NDA050718
- Marketing Start
- 08/15/2019
Recall History
Baxter Healthcare Corporation
CGMP Deviations: Product was exposed to temperatures exceeding the labeled storage conditions during transportation were released by mistake.
Sun Pharmaceutical Industries, Inc.
Lack Of Assurance Of Sterility
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 Doxorubicin hydrochloride liposome injection 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 Doxorubicin hydrochloride liposome injection 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 Doxorubicin hydrochloride liposome injection 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 Doxorubicin hydrochloride liposome injection, 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 doxorubicin hydrochloride liposome injection 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 doxorubicin hydrochloride liposome injection 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 doxorubicin hydrochloride liposome injection 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 doxorubicin hydrochloride liposome injection is 20 mg/m 2 intravenously over 60 minutes every 21 days until disease progression or unacceptable…
Contraindications
4 CONTRAINDICATIONS Doxorubicin hydrochloride liposome injection 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 doxorubicin hydrochloride liposome injection ( 4 , 5.2 )
Drug Interactions
7 DRUG INTERACTIONS No formal drug interaction studies have been conducted with doxorubicin hydrochloride liposome injection.
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 Sagent Pharmaceuticals at 1-866-625-1618 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 doxorubicin hydrochloride liposome injection in 1,310 patients including: 239 patients with ovarian cancer, 753 patients with AIDS-related Kaposi's sarcoma, and 318 patients with multiple myeloma. The …
Frequently Asked Questions
What is Doxorubicin Hydrochloride Liposome used for?
Doxorubicin Hydrochloride Liposome contains Doxorubicin Hydrochloride Liposome. It is a injection, suspension, liposomal taken intravenous. Consult your doctor for specific uses.
Is Doxorubicin Hydrochloride Liposome a controlled substance?
Doxorubicin Hydrochloride Liposome is not classified as a controlled substance by the DEA.
What is the generic name for Doxorubicin Hydrochloride Liposome?
The generic name for Doxorubicin Hydrochloride Liposome is Doxorubicin Hydrochloride Liposome. There are no other listed brand versions of Doxorubicin Hydrochloride Liposome.
What is the NDC code for Doxorubicin Hydrochloride Liposome 2 mg/mL?
The NDC (National Drug Code) for Doxorubicin Hydrochloride Liposome 2 mg/mL is 0338-0080, listed by Baxter Healthcare Company.
Other Doxorubicin Hydrochloride Liposome Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)