Etoposide Phosphate
Generic Name: etoposide phosphate
Brand Names:
Etopophos
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.
Overview
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.
Uses
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
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.
Side Effects
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.
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 )
Warnings
5 WARNINGS AND PRECAUTIONS Myelosuppression : Obtain complete blood counts prior to each cycle and more frequently as clinically indicated. ( 5.1 ) Secondary leukemias : Can occur with long-term use. ( 5.2 ) Hypersensitivity reactions : Hypersensitivity reactions including anaphylaxis may occur. ( 5.3 ) Embryo-fetal toxicity : ETOPOPHOS can cause fetal harm. Advise females of potential risk to the fetus and to use effective contraception during treatment with ETOPOPHOS and for 6 months after final dose. Advise males to use effective contraception for 4 months, after the last dose of ETOPOPHOS. ( 5.4 , 8.1 , 8.3 ) 5.1 Myelosuppression ETOPOPHOS causes myelosuppression that results in thrombocytopenia and neutropenia. Fatal infections and bleeding have occurred. 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 )
Storage
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.
Frequently Asked Questions
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.
What are the side effects of Etoposide Phosphate?▼
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.
What are the important warnings for Etoposide Phosphate?▼
5 WARNINGS AND PRECAUTIONS Myelosuppression : Obtain complete blood counts prior to each cycle and more frequently as clinically indicated. ( 5.1 ) Secondary leukemias : Can occur with long-term use. ( 5.2 ) Hypersensitivity reactions : Hypersensitivity reactions including anaphylaxis may occur. ( 5.3 ) Embryo-fetal toxicity : ETOPOPHOS can cause fetal harm. Advise females of potential risk to the fetus and to use effective contraception during treatment with ETOPOPHOS and for 6 months after final dose. Advise males to use effective contraception for 4 months, after the last dose of ETOPOPHOS. ( 5.4 , 8.1 , 8.3 ) 5.1 Myelosuppression ETOPOPHOS causes myelosuppression that results in thrombocytopenia and neutropenia. Fatal infections and bleeding have occurred. 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 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.