Etoposide 20 mg/mL
Etoposide · INJECTION · Hikma Pharmaceuticals USA Inc.
Etoposide is a injection containing etoposide at 20 mg/mL, taken intravenous. Manufactured by Hikma Pharmaceuticals USA Inc..
Key Facts
- Brand Name
- Etoposide
- Generic Name
- Etoposide
- NDC Code (Product)
0143-9511- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Strength
- 20 mg/mL
- Dosage Form
- INJECTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA074290
- Drug Class
- Topoisomerase Inhibitor [EPC]
- Marketing Start
- 02/01/1997
Recall History
Infusion Options, Inc.
Lack of Assurance of Sterility
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Teva Pharmaceuticals USA
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Infusion Options, Inc.
Lack of Assurance of Sterility
Infusion Options, 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
INDICATIONS AND USAGE Etoposide Injection is indicated in the management of the following neoplasms: Refractory Testicular Tumors Etoposide Injection in combination therapy with other approved chemotherapeutic agents in patients with refractory testicular tumors who have already received appropriate surgical, chemotherapeutic, and radiotherapeutic therapy. Small Cell Lung Cancer Etoposide Injection and/or capsules in combination with other approved chemotherapeutic agents as first line treatment in patients with small cell lung cancer.
Dosage & Administration
DOSAGE AND ADMINISTRATION Note: Plastic devices made of acrylic or ABS (a polymer composed of acrylonitrile, butadiene, and styrene) have been reported to crack and leak when used with undiluted etoposide injection. Etoposide Injection The usual dose of etoposide injection in testicular cancer in combination with other approved chemotherapeutic agents ranges from 50 to 100 mg/m 2 /day on days 1 through 5 to 100 mg/m 2 /day on days 1, 3, and 5. In small cell lung cancer, the etoposide injection dose in combination with other approved chemotherapeutic drugs ranges from 35 mg/m 2 /day for 4 days to 50 mg/m 2 /day for 5 days. For recommended dosing adjustments in patients with renal impairment see PRECAUTIONS section. Chemotherapy courses are repeated at 3- to 4-week intervals after adequate recovery from any toxicity. The dosage should be modified to take into account the myelosuppressive effects of other drugs in the combination or the effects of prior x-ray therapy or chemotherapy which may have compromised bone marrow reserve. Administration Precautions As with other potentially toxic compounds, caution should be exercised in handling and preparing the solution of etoposide injecti…
Warnings
WARNINGS Patients being treated with etoposide injection must be frequently observed for myelosuppression both during and after therapy. Myelosuppression resulting in death has been reported. Dose-limiting bone marrow suppression is the most significant toxicity associated with etoposide injection therapy. Therefore, the following studies should be obtained at the start of therapy and prior to each subsequent cycle of etoposide injection: platelet count, hemoglobin, white blood cell count, and differential. The occurrence of a platelet count below 50,000/mm 3 or an absolute neutrophil count below 500/mm 3 is an indication to withhold further therapy until the blood counts have sufficiently recovered. Physicians should be aware of the possible occurrence of an anaphylactic reaction manifested by chills, fever, tachycardia, bronchospasm, dyspnea, and hypotension. Higher rates of anaphylactic-like reactions have been reported in children who received infusions at concentrations higher than those recommended. The role that concentration of infusion (or rate of infusion) plays in the development of anaphylactic-like reactions is uncertain (see ADVERSE REACTIONS section). Treatment is sy…
Contraindications
CONTRAINDICATIONS Etoposide injection is contraindicated in patients who have demonstrated a previous hypersensitivity to etoposide or any component of the formulation.
Drug Interactions
Drug Interactions High-dose cyclosporin A resulting in concentrations above 2000 ng/mL administered with oral etoposide has led to an 80% increase in etoposide exposure with a 38% decrease in total body clearance of etoposide compared to etoposide alone.
Adverse Reactions
ADVERSE REACTIONS The following data on adverse reactions are based on both oral and intravenous administration of etoposide injection as a single agent, using several different dose schedules for treatment of a wide variety of malignancies. Hematologic Toxicity Myelosuppression is dose related and dose limiting, with granulocyte nadirs occurring 7 to 14 days after drug administration and platelet nadirs occurring 9 to 16 days after drug administration. Bone marrow recovery is usually complete by day 20, and no cumulative toxicity has been reported. Fever and infection have also been reported in patients with neutropenia. Death associated with myelosuppression has been reported. The occurrence of acute leukemia with or without a preleukemic phase has been reported rarely in patients treated with etoposide injection in association with other antineoplastic agents (see WARNINGS section). Gastrointestinal Toxicity Nausea and vomiting are the major gastrointestinal toxicities. The severity of such nausea and vomiting is generally mild to moderate with treatment discontinuation required in 1% of patients. Nausea and vomiting can usually be controlled with standard antiemetic therapy. Mi…
Frequently Asked Questions
What is Etoposide used for?
Etoposide contains Etoposide. It is a injection taken intravenous. Consult your doctor for specific uses.
Is Etoposide a controlled substance?
Etoposide is not classified as a controlled substance by the DEA.
What is the generic name for Etoposide?
The generic name for Etoposide is Etoposide. There are 4 other brand versions of Etoposide.
What is the NDC code for Etoposide 20 mg/mL?
The NDC (National Drug Code) for Etoposide 20 mg/mL is 0143-9511, listed by Hikma Pharmaceuticals USA Inc..