Etoposide Phosphate
FDA Drug Information • Also known as: Etopophos
- Brand Names
- Etopophos
- Route
- INTRAVENOUS
- Dosage Form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
11 DESCRIPTION ETOPOPHOS (etoposide phosphate) is a topoisomerase inhibitor. The chemical name for etoposide phosphate is: 4'-Demethylepipodophyllotoxin 9-[4,6-O-(R)-ethylidene-β-D-glucopyranoside], 4' (dihydrogen phosphate). Etoposide phosphate has the following structure: Etoposide phosphate is a phosphate ester of etoposide, a semi-synthetic derivative of podophyllotoxin. ETOPOPHOS is available for intravenous infusion as a sterile lyophilized powder in single-dose vials for reconstitution containing 114 mg etoposide phosphate, equivalent to 100 mg etoposide, 32.7 mg sodium citrate USP, and 300 mg dextran 40. Image Etoposide Phosphate Chemical Structure
What Is Etoposide Phosphate Used For?
1 INDICATIONS AND USAGE ETOPOPHOS is a topoisomerase inhibitor indicated for the treatment of patients with: Refractory testicular tumors, in combination with other chemotherapeutic drugs. ( 1 ) Small cell lung cancer, in combination with cisplatin, as first-line treatment. ( 1 ) 1.1 Refractory Testicular Tumors ETOPOPHOS is indicated, in combination with other chemotherapeutic drugs, for treatment of patients with refractory testicular tumors. 1.2 Small Cell Lung Cancer ETOPOPHOS is indicated, in combination with cisplatin, for first-line treatment of patients with small cell lung cancer.
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Refractory testicular tumors: 50 to 100 mg/m 2 per day administered intravenously over 5 minutes to 3.5 hours on days 1 through 5, or 100 mg/m 2 administered intravenously over 5 minutes to 3.5 hours on days 1, 3, and 5. ( 2.1 ) Small cell lung cancer: 35 mg/m 2 per day administered intravenously over 5 minutes to 3.5 hours for 4 days or 50 mg/m 2 per day administered intravenously over 5 minutes to 3.5 hours for 5 days. ( 2.2 ) Do not give by bolus injection. ( 2.4 ) Renal impairment: Reduce the recommended dose to 75% in patients with creatinine clearance 15 to 50 mL/min. ( 2.3 ) 2.1 Refractory Testicular Tumors The recommended dose of ETOPOPHOS is: 50 to 100 mg/m 2 per day administered intravenously over 5 minutes to 3.5 hours on days 1 through 5 of each 21-day (or 28-day cycle), or 100 mg/m 2 administered intravenously over 5 minutes to 3.5 hours on days 1, 3, and 5 of each 21-day (or 28-day cycle). 2.2 Small Cell Lung Cancer The recommended dose of ETOPOPHOS is:
Side Effects (Adverse Reactions)
6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: Myelosuppression [see Warnings and Precautions (5.1) ] Secondary leukemias [see Warnings and Precautions (5.2) ] Hypersensitivity reactions [see Warnings and Precautions (5.3) ] Most common adverse reaction is neutropenia. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact the Safety Call Center at 1-866-885-0690 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, adverse reaction rates, observed in the clinical trials of a drug, cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. ETOPOPHOS has been used as a single agent in clinical studies involving 206 patients with a variety of malignancies (including one non-Hodgkin’s lymphoma) and in combination with cisplatin in 60 patients with small cell lung cancer. The most common adverse reaction was neutropenia. Other Important Adverse Reactions Gastrointestinal Toxicity Nausea and vomiting are the major gastrointestinal toxicities. The severity of nausea and vomiting is generally mild to moderate, with treatment discontinuation required in 1% of patients. Nausea and vomiting are managed with standard antiemetic therapy. Other Toxicities Other clinically important adverse reactions in clinical trials were: Gastrointestinal: abdominal pain, constipation, dysphagia General: fever Ocular: transient cortical blindness, optic neuritis Respiratory: interstitial pneumonitis/pulmonary fibrosis Skin: pigmentation, radiation recall dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis Neurologic: seizure, aftertaste Hepatobiliary disorder: hepatotoxicity 6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of ETOPOPHOS. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Extravasation Extravasation, resulting in local soft tissue toxicity. Extravasation of ETOPOPHOS can result in swelling, pain, cellulitis, and necrosis, including skin necrosis. Acute Renal Failure Reversible cases of acute renal failure have been reported with administration of high dose (2220 mg/m 2 ) ETOPOPHOS with total body irradiation used for hematopoietic stem cell transplantation. The ETOPOPHOS formulation contains dextran 40, which has been associated with acute renal failure when administered in high doses.
Drug Interactions
7 DRUG INTERACTIONS Warfarin: Co-administration of ETOPOPHOS with warfarin can result in elevated international normalized ratio (INR). Measure INR frequently. Warfarin: Co-administration can result in elevated international normalized ratio (INR). Measure INR frequently. ( 7 )
Contraindications
4 CONTRAINDICATIONS ETOPOPHOS is contraindicated in patients with a history of a severe hypersensitivity reaction to etoposide products [see Warnings and Precautions (5.3) ] . Hypersensitivity to etoposide products. ( 4 , 5.3 )
Overdosage
10 OVERDOSAGE No antidote has been established for ETOPOPHOS overdosage in humans. Based on animal studies, overdosage may result in neurotoxicity.
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied/Storage ETOPOPHOS is supplied as a single-dose vial containing etoposide phosphate equivalent to 100 mg etoposide as a lyophilized powder for reconstitution, individually packaged in a carton: NDC 61269-410-20 Store unopened vials at 2° to 8°C (36°-46°F). Keep vial in outer carton to protect from light. Handling ETOPOPHOS is a cytotoxic drug. Follow applicable special handling and disposal procedures. 1
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.