Etoposide (injection)

Etoposide (injection)
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]

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Overview

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Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

Refractory Testicular Tumors

Etoposide Injection USP 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 USP in combination with other approved chemotherapeutic agents as first line treatment in patients with small cell lung cancer.

Dosage

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 USP.

• The usual dose of Etoposide Injection USP in testicular cancer in combination with other approved chemotherapeutic agents ranges from 50 to 100 mg/m2/day on days 1 through 5 to 100 mg/m2/day on days 1, 3, and 5.

• In small cell lung cancer, the Etoposide Injection USP dose in combination with other approved chemotherapeutic drugs ranges from 35 mg/m2/day for 4 days to 50 mg/m2/day for 5 days.

• For recommended dosing adjustments in patients with renal impairment see PRECAUTIONS.

• 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.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Etoposide (injection) in adult patients.

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Etoposide (injection) in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding FDA-Labeled Use of Etoposide (injection) in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Etoposide (injection) in pediatric patients.

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Etoposide (injection) in pediatric patients.

Contraindications

• Condition1

Warnings

• Description

Precautions

• Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Etoposide (injection) in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Etoposide (injection) in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

• Drug

• Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Etoposide (injection) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Etoposide (injection) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Etoposide (injection) with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Etoposide (injection) with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Etoposide (injection) with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Etoposide (injection) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Etoposide (injection) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Etoposide (injection) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Etoposide (injection) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Etoposide (injection) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Etoposide (injection) in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

There is limited information regarding Monitoring of Etoposide (injection) in the drug label.

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Etoposide (injection) in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Etoposide (injection) in the drug label.

Pharmacology

There is limited information regarding Etoposide (injection) Pharmacology in the drug label.

Mechanism of Action

Structure

File:Etoposide (injection)01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Etoposide (injection) in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Etoposide (injection) in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Etoposide (injection) in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Etoposide (injection) in the drug label.

How Supplied

Storage

There is limited information regarding Etoposide (injection) Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Etoposide (injection) in the drug label.

Precautions with Alcohol

• Alcohol-Etoposide (injection) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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