May 23, 2017
Recommended Topic Related To:

Etopophos

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Etopophos




Side Effects
Interactions

SIDE EFFECTS

The following serious adverse reactions are described elsewhere in the labeling:

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

Post-Marketing Experience

The following adverse reactions have been identified during post-approval 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, was identified in postmarketing reports. Extravasation of ETOPOPHOS may result in swelling, pain, cellulitis, and necrosis including skin necrosis.

Read the Etopophos (etoposide phosphate) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

Warfarin: Co-administration of ETOPOPHOS with warfarin may result in elevated international normalized ratio (INR). Measure INR frequently.

Read the Etopophos Drug Interactions Center for a complete guide to possible interactions

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 4/28/2017

Side Effects
Interactions

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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