Medicine guide

Etoposide

20 mg/mL · Injection, Solution, Concentrate

Prescription only
Topoisomerase Inhibitor

Active substance: Etoposide
Used in: Cancer treatments and immune-system medicines
Made by: Meitheal Pharmaceuticals Inc.
Source: Official label

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2025-12-01

What it is

Topoisomerase Inhibitor

Used for

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,…

The label’s usual adult dose

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.

Full directions ↓

Serious 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.

All warnings ↓

Good to know

Prescription only
FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02

10other products contain Etoposide — compare makers, forms and strengths

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

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.

From the official label · 2025-12-01 · DailyMed

How it works

From this product’s own US prescribing label.

Etoposide Injection has been shown to cause metaphase arrest in chick fibroblasts.
Its main effect, however, appears to be at the G 2 portion of the cell cycle in mammalian cells.

Half-life1.5 h

Mostly cleared after≈ 7.5 hfive half-lives — our arithmetic

How it leaves the body

In children, approximately 55% of the dose is excreted in the urine as etoposide in 24 hours.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2025-12-01

Serious warning

The strongest warning the FDA requires. It is printed in a box at the top of the label.

Quoted from the official label, section “Boxed Warning”.

Do not take it if

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

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

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.
Preparation for Intravenous Administration Etoposide injection must be diluted prior to use with either 5% Dextrose Injection, USP, or 0.9% Sodium Chloride Injection, USP, to give a final concentration of 0.2 to 0.4 mg/mL.
If solutions are prepared at concentrations above 0.4 mg/mL, precipitation may occur.
Hypotension following rapid intravenous administration has been reported, hence, it is recommended that the etoposide injection solution be administered over a 30- to 60-minute period.
A longer duration of administration may be used if the volume of fluid to be infused is a concern.
Etoposide injection should not be given by rapid intravenous injection.
Parenteral drug products should be inspected visually for particulate matter and discoloration (see DESCRIPTION section) prior to administration whenever solution and container permit.
Stability Unopened vials of etoposide injection are stable until the date indicated on the package at room temperature (25°C).
Vials diluted as recommended to a concentration of 0.2 to 0.4 mg/mL are stable for 96 and 24 hours, respectively, at room temperature (25°C) under normal room fluorescent light in both glass and plastic containers.
Procedures for proper handling and disposal of anticancer drugs should be considered.
Several guidelines on this subject have been published. 1-8 There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

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.
For parenteral administration, etoposide injection should be given only by slow intravenous infusion (usually over a 30- to 60-minute period) since hypotension has been reported as a possible side effect of rapid intravenous injection.
Pregnancy Etoposide Injection can cause fetal harm when administered to a pregnant woman.
General In all instances where the use of etoposide injection is considered for chemotherapy, the physician must evaluate the need and usefulness of the drug against the risk of adverse reactions.
Most such adverse reactions are reversible if detected early.
If severe reactions occur, the drug should be reduced in dosage or discontinued and appropriate corrective measures should be taken according to the clinical judgment of the physician.
Reinstitution of etoposide injection therapy should be carried out with caution, and with adequate consideration of the further need for the drug and alertness as to possible recurrence of toxicity.
Patients with low serum albumin may be at an increased risk for etoposide associated toxicities.
Drug Interactions High-dose cyclosporin A resulting in concentrations above 2000 ng/mL administered with oral etoposide has led to an 80% increase in etoposide exposure with a 38% decrease in total body clearance of etoposide compared to etoposide alone.
Laboratory Tests Periodic complete blood counts should be done during the course of etoposide injection treatment.
They should be performed prior to each cycle of therapy and at appropriate intervals during and after therapy.
At least one determination should be done prior to each dose of etoposide injection.
Renal Impairment In patients with impaired renal function, the following initial dose modification should be considered based on measured creatinine clearance:
Measured Creatinine Clearance >50 mL/min 15 to 50 mL/min etoposide 100% of dose 75% of dose Subsequent etoposide injection dosing should be based on patient tolerance and clinical effect.
Data are not available in patients with creatinine clearances <15 mL/min and further dose reduction should be considered in these patients.
Carcinogenesis, Mutagenesis, Impairment of Fertility (see WARNINGS section) Etoposide has been shown to be mutagenic in Ames assay.
Treatment of Swiss-Albino mice with 1.5 mg/kg I.P. of etoposide injection on day 7 of gestation increased the incidence of intrauterine death and fetal malformations as well as significantly decreased the average fetal body weight.
Maternal weight gain was not affected.
Irreversible testicular atrophy was present in rats treated with etoposide intravenously for 30 days at 0.5 mg/kg/day (about 1/16 th of the human dose on a mg/m 2 basis).
Pregnancy Teratogenic Effects Pregnancy "Category D." (See WARNINGS section.) Nursing Mothers It is not known whether this drug is excreted in human milk.
Pediatric Use Safety and effectiveness in pediatric patients have not been established.
Geriatric Use Clinical studies of etoposide injection for the treatment of refractory testicular tumors did not include sufficient numbers of patients aged 65 years and over to determine whether they respond differently from younger patients.
General In all instances where the use of etoposide injection is considered for chemotherapy, the physician must evaluate the need and usefulness of the drug against the risk of adverse reactions.
Most such adverse reactions are reversible if detected early.
If severe reactions occur, the drug should be reduced in dosage or discontinued and appropriate corrective measures should be taken according to the clinical judgment of the physician.
Reinstitution of etoposide injection therapy should be carried out with caution, and with adequate consideration of the further need for the drug and alertness as to possible recurrence of toxicity.
Patients with low serum albumin may be at an increased risk for etoposide associated toxicities.

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

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.
The occurrence of acute leukemia with or without a preleukemic phase has been reported in rare instances in patients treated with etoposide alone or in association with other neoplastic agents.
The risk of development of a preleukemic or leukemic syndrome is unclear.
Carcinogenicity tests with etoposide injection have not been conducted in laboratory animals.
Teratogenic Effects Pregnancy "Category D." (See WARNINGS section.)
It is not known whether this drug is excreted in human milk.
Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from etoposide injection, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

High-dose cyclosporin A resulting in concentrations above 2000 ng/mL administered with oral etoposide has led to an 80% increase in etoposide exposure with a 38% decrease in total body clearance of etoposide compared to etoposide alone.

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

No proven antidotes have been established for etoposide injection overdosage.

Quoted from the official label, section “Overdosage”.

Use in children

Safety and effectiveness in pediatric patients have not been established.
Etoposide injection contains polysorbate 80.
In premature infants, a life-threatening syndrome consisting of liver and renal failure, pulmonary deterioration, thrombocytopenia, and ascites has been associated with an injectable vitamin E product containing polysorbate 80.
Anaphylactic reactions have been reported in pediatric patients (see WARNINGS section).

Quoted from the official label, section “Pediatric Use”.

Use in older people

Clinical studies of etoposide injection for the treatment of refractory testicular tumors did not include sufficient numbers of patients aged 65 years and over to determine whether they respond differently from younger patients.
Of more than 600 patients in four clinical studies in the NDA databases who received etoposide injection or etoposide phosphate in combination with other chemotherapeutic agents for the treatment of small cell lung cancer (SCLC), about one third were older than 65 years.
When advanced age was determined to be a prognostic factor for response or survival in these studies, comparisons between treatment groups were performed for the elderly subset.
In the one study (etoposide in combination with cyclophosphamide and vincristine compared with cyclophosphamide and vincristine or cyclophosphamide, vincristine, and doxorubicin) where age was a significant prognostic factor for survival, a survival benefit for elderly patients was observed for the etoposide regimen compared with the control regimens.
No differences in myelosuppression were seen between elderly and younger patients in these studies except for an increased frequency of WHO Grade III or IV leukopenia among elderly patients in a study of etoposide phosphate or etoposide in combination with cisplatin.
Elderly patients in this study also had more anorexia, mucositis, dehydration, somnolence, and elevated BUN levels than younger patients.
In five single-agent studies of etoposide phosphate in patients with a variety of tumor types, 34% of patients were age 65 years or more.
WHO Grade III or IV leukopenia, granulocytopenia, and asthenia were more frequent among elderly patients.
Postmarketing experience also suggests that elderly patients may be more sensitive to some of the known adverse effects of etoposide, including myelosuppression, gastrointestinal effects, infectious complications, and alopecia.
Although some minor differences in pharmacokinetic parameters between elderly and nonelderly patients have been observed, these differences were not considered clinically significant.
Etoposide and its metabolites are known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function.
Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function (see PRECAUTIONS , Renal Impairment for recommended dosing adjustments in patients with renal impairment).

Quoted from the official label, section “Geriatric Use”.

Side effects

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.
To prevent this rare occurrence, it is recommended that etoposide injection be administered by slow intravenous infusion over a 30- to 60-minute period.
If hypotension occurs, it usually responds to cessation of the infusion and administration of fluids or other supportive therapy as appropriate.
When restarting the infusion, a slower administration rate should be used.
Allergic Reactions Anaphylactic-like reactions characterized by chills, fever, tachycardia, bronchospasm, dyspnea, and/or hypotension have been reported to occur in 0.7% to 2% of patients receiving intravenous etoposide injection and in less than 1% of the patients treated with the oral capsules.
These reactions have usually responded promptly to the cessation of the infusion and administration of pressor agents, corticosteroids, antihistamines, or volume expanders as appropriate; however, the reactions can be fatal.
Hypertension and/or flushing have also been reported.
Blood pressure usually normalizes within a few hours after cessation of the infusion.
Anaphylactic-like reactions have occurred during the initial infusion of etoposide injection.
Facial/tongue swelling, coughing, diaphoresis, cyanosis, tightness in throat, laryngospasm, back pain, and/or loss of consciousness have sometimes occurred in association with the above reactions.
In addition, an apparent hypersensitivity-associated apnea has been reported rarely.
Rash, urticaria, and/or pruritus have infrequently been reported at recommended doses.
At investigational doses, a generalized pruritic erythematous maculopapular rash, consistent with perivasculitis, has been reported.
Alopecia Reversible alopecia, sometimes progressing to total baldness, was observed in up to 66% of patients.
Other Toxicities The following adverse reactions have been infrequently reported:
abdominal pain, aftertaste, constipation, dysphagia, asthenia, fatigue, malaise, somnolence, transient cortical blindness, optic neuritis, interstitial pneumonitis/pulmonary fibrosis, fever, seizure (occasionally associated with allergic reactions), Stevens-Johnson syndrome, and toxic epidermal necrolysis, pigmentation, and a single report of radiation recall dermatitis.
Hepatic toxicity, generally in patients receiving higher doses of the drug than those recommended, has been reported with etoposide injection.
Metabolic acidosis has also been reported in patients receiving higher doses.
Reports of extravasation with swelling have been received postmarketing.
Rarely extravasation has been associated with necrosis and venous induration.
The incidences of adverse reactions in the table that follows are derived from multiple data bases from studies in 2,081 patients when etoposide injection was used either orally or by injection as a single agent.
ADVERSE DRUG EFFECT PERCENT RANGE OF REPORTED INCIDENCE Hematologic toxicity Leukopenia (less than 1,000 WBC/mm 3 ) 3 to 17 Leukopenia (less than 4,000 WBC/mm 3 ) 60 to 91 Thrombocytopenia (less than 50,000 platelets/mm 3 ) 1 to 20 Thrombocytopenia (less than 100,000 platelets/mm 3 ) 22 to 41 Anemia 0 to 33 Gastrointestinal toxicity Nausea and vomiting 31 to 43 Abdominal pain 0 to 2 Anorexia 10 to 13 Diarrhea 1 to 13 Stomatitis 1 to 6 Hepatic 0 to 3 Alopecia 8 to 66 Peripheral neurotoxicity 1 to 2 Hypotension 1 to 2 Allergic reaction 1 to 2 To report SUSPECTED ADVERSE REACTIONS, contact Meitheal Pharmaceuticals, Inc. at 1-844-824-8426 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

Quoted from the official label, section “Adverse Reactions”.

What it looks like and how it is packed

Etoposide Injection, USP, 20 mg per mL is supplied as follows:
NDC Etoposide Injection, USP (20 mg per mL) Package Factor 71288- 175 -05 100 mg per 5 mL Multi-Dose Vial 1 vial per carton 71288- 176 -25 500 mg per 25 mL Multi-Dose Vial 1 vial per carton 71288- 177 -50 1 gram per 50 mL Multi-Dose Vial 1 vial per carton All are available individually packaged.
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] DO NOT FREEZE.
Protect from light.
Sterile, Nonpyrogenic, Preservative-free.
The container closure is not made with natural rubber latex.

Quoted from the official label, section “How Supplied”.

What is in it

Etoposide Injection, USP (also commonly known as VP-16) is a semisynthetic derivative of podophyllotoxin used in the treatment of certain neoplastic diseases.
It is 4'-demethylepipodophyllotoxin 9-[4,6-0-(R)-ethylidene-β-D-glucopyranoside].
It is very soluble in methanol and chloroform, slightly soluble in ethanol, and sparingly soluble in water and ether.
It is made more miscible with water by means of organic solvents.
Etoposide Injection, USP is available for intravenous use as a sterile 20 mg per mL solution in 100 mg (5 mL), 500 mg (25 mL), or 1 g (50 mL) sterile, multiple dose vials.
The pH of the clear, colorless to yellow solution is 3.0 to 4.0.
Each mL contains:
20 mg etoposide, USP, 2 mg citric acid anhydrous, 80 mg polysorbate 80, 650 mg polyethylene glycol 300 (57.5% v/v and 65.0% w/v), and 262 mg dehydrated alcohol (33.2% v/v and 26.2% w/v).
The structural formula is: Structural Formula

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

The stored label for this product has no list of inactive ingredients. The list on the pack is the one to check.

Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.

Every version of this medicine (6)

The same active substance, strength and kind of form, from every company that sells it — with what each label lists.

Showing 6 of 6

Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

Medicine passport: one printable page to show a pharmacist abroad

CanadaNo exact match for this strength and form

Every strength and form (5)

NetherlandsNo exact match for this strength and form

Every strength and form (9)

Details

Made by	Meitheal Pharmaceuticals Inc.
Active substance	Etoposide
Used in	Cancer treatments and immune-system medicines
Strength	20 mg/mL
Form	Injection, Solution, Concentrate
Route	Intravenous
Packs	1 VIAL, MULTI-DOSE in 1 CARTON / 5 mL in 1 VIAL, MULTI-DOSE · 1 VIAL, MULTI-DOSE in 1 CARTON / 25 mL in 1 VIAL, MULTI-DOSE · 1 VIAL, MULTI-DOSE in 1 CARTON / 50 mL in 1 VIAL, MULTI-DOSE
NDC	71288-175
NDC	71288-176

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

8 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Injection3 products
- 20 mg/mL3
  20 mg/mL · 3 companies
Injection, Solution, Concentrate2 products
- 20 mg/mL2
  20 mg/mL · 2 companies
  - BluePoint Laboratories
  - Meitheal Pharmaceuticals Inc. · this page
Capsule2 products
- 50 mg2
  50 mg · 2 companies
  - Mylan Pharmaceuticals Inc.
  - Onesource Specialty Pharma Limited
Injection, Solution1 products
- 20 mg/mL

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

Avopef100 mg/5mLPrescription onlyInjection Avyxa Pharma, LLC · Etoposide Avopef500 mg/25mLPrescription onlyInjection Avyxa Pharma, LLC · Etoposide Etoposide20 mg/mLPrescription onlyInjection Hikma Pharmaceuticals USA Inc. · Etoposide Etoposide50 mgPrescription onlyCapsule Mylan Pharmaceuticals Inc. · Etoposide Etoposide20 mg/mLPrescription onlyInjection Accord Healthcare Inc. · Etoposide Etoposide20 mg/mLPrescription onlyInjection, Solution Fresenius Kabi USA, LLC · Etoposide

See every product with Etoposide