pharmacopeia
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/api/v1/drug/etoposide

Boxed warning

Etoposide injection should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Severe myelosuppression with resulting infection or bleeding may occur.

Mechanism of action

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Mechanism-of-action class: Topoisomerase Inhibitors.

Topoisomerase

Indications

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  • Etoposide Injection is indicated in the management of the following neoplasms: Refractory Testicular Tumors Etoposide Injection 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 and/or capsules in combination with other approved chemotherapeutic agents as first line treatment in patients with small cell lung cancer.ICD-10: C34.90

Contraindications

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  • Etoposide injection is contraindicated in patients who have demonstrated a previous hypersensitivity to etoposide or any component of the formulation.contraindicated

Dosage & administration

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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. Etoposide Injection The usual dose of etoposide injection in testicular cancer in combination with other approved chemotherapeutic agents ranges from 50 to 100 mg/m 2 /day on days 1 through 5 to 100 mg/m 2 /day on days 1, 3, and 5. In small cell lung cancer, the etoposide injection dose in combination with other approved chemotherapeutic drugs ranges from 35 mg/m 2 /day for 4 days to 50 mg/m 2 /day for 5 days. For recommended dosing adjustments in patients with renal impairment see PRECAUTIONS section. 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. Administration Precautions As with other potentially toxic compounds, caution should be exercised in handling and preparing the solution of etoposide injection. Skin reactions associated with accidental exposure to etoposide injection may occur. The use of gloves is recommended. If etoposide injection solution contacts the skin or mucosa, immediately and thoroughly wash the skin with soap and water and flush the mucosa with water.

Warnings & precautions

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Patients being treated with etoposide injection must be frequently observed for myelosuppression both during and after therapy. Myelosuppression resulting in death has been reported. Dose-limiting bone marrow suppression is the most significant toxicity associated with etoposide injection therapy. Therefore, the following studies should be obtained at the start of therapy and prior to each subsequent cycle of etoposide injection: platelet count, hemoglobin, white blood cell count, and differential. The occurrence of a platelet count below 50,000/mm 3 or an absolute neutrophil count below 500/mm 3 is an indication to withhold further therapy until the blood counts have sufficiently recovered. Physicians should be aware of the possible occurrence of an anaphylactic reaction manifested by chills, fever, tachycardia, bronchospasm, dyspnea, and hypotension. Higher rates of anaphylactic-like reactions have been reported in children who received infusions at concentrations higher than those recommended. The role that concentration of infusion (or rate of infusion) plays in the development of anaphylactic-like reactions is uncertain (see ADVERSE REACTIONS section). Treatment is symptomatic. The infusion should be terminated immediately, followed by the administration of pressor agents, corticosteroids, antihistamines, or volume expanders at the discretion of the physician.

Adverse reactions

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The following data on adverse reactions are based on both oral and intravenous administration of etoposide injection as a single agent, using several different dose schedules for treatment of a wide variety of malignancies. Hematologic Toxicity Myelosuppression is dose related and dose limiting, with granulocyte nadirs occurring 7 to 14 days after drug administration and platelet nadirs occurring 9 to 16 days after drug administration. Bone marrow recovery is usually complete by day 20, and no cumulative toxicity has been reported. Fever and infection have also been reported in patients with neutropenia. Death associated with myelosuppression has been reported. The occurrence of acute leukemia with or without a preleukemic phase has been reported rarely in patients treated with etoposide injection in association with other antineoplastic agents (see WARNINGS section). Gastrointestinal Toxicity Nausea and vomiting are the major gastrointestinal toxicities. The severity of such nausea and vomiting is generally mild to moderate with treatment discontinuation required in 1% of patients. Nausea and vomiting can usually be controlled with standard antiemetic therapy. Mild to severe mucositis/esophagitis may occur. Gastrointestinal toxicities are slightly more frequent after oral administration than after intravenous infusion. Hypotension Transient hypotension following rapid intravenous administration has been reported in 1% to 2% of patients. It has not been associated with cardiac toxicity or electrocardiographic changes. No delayed hypotension has been noted.

Use in specific populations

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Pregnancy Etoposide Injection can cause fetal harm when administered to a pregnant woman. Etoposide has been shown to be teratogenic in mice and rats. In rats, an intravenous etoposide dose of 0.4 mg/kg/day (about 1/20 th of the human dose on a mg/m 2 basis) during organogenesis caused maternal toxicity, embryotoxicity, and teratogenicity (skeletal abnormalities, exencephaly, encephalocele, and anophthalmia); higher doses of 1.2 and 3.6 mg/kg/day (about 1/7 th and 1/2 of human dose on a mg/m 2 basis) resulted in 90 and 100% embryonic resorptions. In mice, a single 1 mg/kg (1/16 th of human dose on a mg/m 2 basis) dose of etoposide administered intraperitoneally on days 6, 7, or 8 of gestation caused embryotoxicity, cranial abnormalities, and major skeletal malformations. An I.P. dose of 1.5 mg/kg (about 1/10 th of human dose on a mg/m 2 basis) on day 7 of gestation caused an increase in the incidence of intrauterine death and fetal malformations and a significant decrease in the average fetal body weight. Women of childbearing potential should be advised to avoid becoming pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while receiving this drug, the patient should be warned of the potential hazard to the fetus. Etoposide injection should be considered a potential carcinogen in humans.

Pharmacokinetics

Sourced from openFDA
Metabolism
On intravenous administration, the disposition of etoposide is best described as a biphasic process with a distribution half-life of about 1.5 hours and terminal elimination half-life ranging from 4 to 11 hours. Total body clearance values range from 33 to 48 mL/min or 16 to 36 mL/min/m 2 and, like the terminal elimination half-life, are independent of dose over a range 100 to 600 mg/m 2 .

Overdosage

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No proven antidotes have been established for etoposide injection overdosage.

Approval history

Sourced from openFDA
  • Dec 30, 1986NDANDA019557Onesource Specialty
  • Jul 17, 1995ANDAANDA074290Hikma
  • Mar 14, 1996ANDAANDA074513Accord Hlthcare
  • May 17, 1996NDANDA020457Cheplapharm
  • Jul 24, 1996ANDAANDA074529Meitheal
  • Sep 30, 1998ANDAANDA074983Fresenius Kabi Usa
  • Sep 19, 2001ANDAANDA075635Mylan
  • Feb 13, 2026NDANDA220200Avyxa Holdings

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
73,028 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Off Label Use8,17611%
  2. 2Febrile Neutropenia7,58410%
  3. 3Neutropenia5,0296.9%
  4. 4Drug Ineffective4,6606.4%
  5. 5Disease Progression4,5526.2%
  6. 6Thrombocytopenia4,0655.6%
  7. 7Pyrexia3,4334.7%
  8. 8Anaemia3,3324.6%
  9. 9Product Use In Unapproved Indication3,0264.1%
  10. 10Sepsis3,0264.1%
  11. 11Death2,8603.9%
  12. 12Pancytopenia2,7463.8%
  13. 13Pneumonia2,4903.4%
  14. 14Nausea2,4383.3%
  15. 15Diarrhoea2,3003.1%

Literature

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Recent PubMed references pinned to Etoposide as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 1,987 ClinicalTrials.gov registrations naming Etoposide as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Pharmacogenomics

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CPIC-curated drug–gene pairs for Etoposide. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.

  • DYNC2H1CPIC D (provisional)ClinPGx 3

Frequently asked questions

How does Etoposide work?
Mechanism-of-action class: Topoisomerase Inhibitors.
What is Etoposide used for?
According to FDA labeling, Etoposide carries indications including: Etoposide Injection is indicated in the management of the following neoplasms: Refractory Testicular Tumors Etoposide Injection 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 and/or capsules in combination with other approved chemotherapeutic agents as first line treatment in patients with small cell lung cancer.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Etoposide?
Etoposide is classified as Podophyllotoxin derivatives, Topoisomerase Inhibitor, Topoisomerase Inhibitors, Cellular Proliferation Alteration, Decreased DNA Integrity, Increased Cellular Death.
What are the brand names for Etoposide?
Etoposide is marketed under brand names including Avopef, Etopophos, Toposar, Vepesid.
What are the contraindications for Etoposide?
Etoposide labeling lists contraindications including: Etoposide injection is contraindicated in patients who have demonstrated a previous hypersensitivity to etoposide or any component of the formulation.. Always consult the full prescribing information and a clinician.
Note. Data for etoposide is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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