Etopophos Drug Information
Generic name: ETOPOSIDE PHOSPHATE
Uses of Etopophos
Refractory Testicular Tumors
ETOPOPHOS is indicated, in combination with other chemotherapeutic drugs, for treatment of patients with refractory testicular tumors.
Small Cell Lung Cancer
ETOPOPHOS is indicated, in combination with cisplatin, for first-line treatment of patients with small cell lung cancer.
Dosage & Administration of Etopophos
| 100 mg | 5 mL |
|---|---|
| 10 mL | 10 mg/mL |
Side Effects of Etopophos
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
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.
Warnings & Cautions for Etopophos
Myelosuppression
ETOPOPHOS causes myelosuppression that results in thrombocytopenia and neutropenia. Fatal infections and bleeding have occurred. Obtain complete blood counts prior to each cycle of ETOPOPHOS and more frequently as clinically indicated .
Secondary Leukemias Secondary leukemias have occurred with long term use of
ETOPOPHOS.
Hypersensitivity Reactions
ETOPOPHOS can cause hypersensitivity reactions, including rash, urticaria, pruritus, and anaphylaxis . If hypersensitivity reactions occur, immediately interrupt ETOPOPHOS and institute supportive management. Permanently discontinue ETOPOPHOS in patients who experience a severe hypersensitivity reaction.
Embryo-Fetal Toxicity
Based on animal studies and its mechanism of action, ETOPOPHOS can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential hazard to the fetus . Advise females of reproductive potential to use effective contraception during treatment with ETOPOPHOS and for at least 6 months after the final dose. Advise males with female partners of reproductive potential to use effective contraception for 4 months after the final dose .
Drug Interactions with Etopophos
- 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.
Contraindications for Etopophos
is contraindicated in patients with a history of a severe hypersensitivity reaction to etoposide products . Hypersensitivity to etoposide products.
Overdosage Information for Etopophos
No antidote has been established for ETOPOPHOS overdosage in humans. Based on animal studies, overdosage may result in neurotoxicity.
Clinical Studies of Etopophos
Study 1 was a multicenter trial in patients, with previously untreated, small cell lung cancer, randomized (1:1) to receive either etoposide phosphate (80 mg/m 2 /day) plus cisplatin (20 mg/m 2 /day) for 5 days, or etoposide (80 mg/m 2 /day) plus cisplatin (20 mg/m 2 /day). The major efficacy outcome measure was objective response rate (ORR). Among the 121 patients enrolled, the median age was 64 years, 65% of patients were male, 89% were White, and ECOG performance score was 0 to 2. Study 1 demonstrated an overall response rate of 61% (95% confidence interval 47, 73) for patients treated with etoposide phosphate plus cisplatin, and 58% (95% CI: 45, 71) for those receiving etoposide plus cisplatin.
Drug information sourced from the FDA. This content is for informational purposes only and does not constitute medical advice. Consult a healthcare professional before making any medication decisions.
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