etoposide
Etoposide is a topoisomerase inhibitor used to treat Urinary Bladder Neoplasms, Brain Neoplasms, Lung Neoplasms, Mycosis Fungoides.
Topoisomerase Inhibitor · by Accord Hlthcare
Generic of Avopef
Key facts
- Active ingredient
- Etoposide
- Drug class
- Topoisomerase Inhibitor
- Form
- Capsule
- Strength
- Etoposide 20MG/ML
- Type
- Prescription (Rx)
- Brand or generic
- Generic
- Manufacturer
- Accord Hlthcare
- FDA application
- ANDA074513
- FDA boxed warning
- Yes — see the boxed warning
What is Etoposide?
From the FDA label:Etoposide (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-O-(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. It has a molecular weight of 588.58 and a molecular formula of C 29 H 32 O 13 . Etoposide Injection USP is available for intravenous use as 20 mg/mL solution in 100 mg (5 mL), 500 mg (25 mL), and 1 g (50 mL) sterile, multiple-dose vials. The pH of the clear, colorless to pale yellow liquid is 3 to 4. Each mL contains 20 mg etoposide USP, 2 mg anhydrous citric acid, 30 mg benzyl alcohol, 80 mg polysorbate 80/tween 80, 650 mg polyethylene glycol 300, and 30.5 percent (v/v) dehydrated alcohol. Vial head space contains nitrogen. The structural formula is: Etoposide Structural Formula
How to use
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/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 USP 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 . 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. Skin reactions associated with accidental exposure to Etoposide Injection USP may occur. The use of gloves is recommended. If etoposide solution contacts the skin or mucosa, immediately and thoroughly wash the skin with soap and water and flush…
Side effects
The following data on adverse reactions are based on intravenous administration of etoposide Injection USP 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 USP in association with other antineoplastic agents. (See WARNINGS .) 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…
FDA Boxed Warning (the FDA’s most serious warning)
Boxed (black-box) warning — from the FDA label
Etoposide 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.
Warnings
Important safety information
Patients being treated with etoposide Injection USP 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 USP therapy. Therefore, the following studies should be obtained at the start of therapy and prior to each subsequent cycle of etoposide Injection USP: 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 .) 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 USP 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 Teratogenic Effects: Pregnancy Category D Etoposide Injection USP 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 1/20th 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 1/7th 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 (1/16th 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 IP dose of 1.5 mg/kg (about 1/10th 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 apprised of the potential hazard to the fetus. Etoposide Injection USP 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 USP have not been conducted in laboratory animals.
Who should not take Etoposide
Etoposide Injection USP is contraindicated in patients who have demonstrated a previous hypersensitivity to etoposide or any component of the formulation.
Overdose — what happens if you take too much
No proven antidotes have been established for etoposide Injection USP overdosage.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Drug class
How this class works, per Topoisomerase Inhibitors - LiverTox - NCBI Bookshelf.
May treat (source: NIH RxClass)
- urinary bladder neoplasms
- brain neoplasms
- lung neoplasms
- mycosis fungoides
- neuroblastoma
- prostatic neoplasms
See how Etoposide ranks — best-rated topoisomerase inhibitor for:
Dosage forms
Capsule
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
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Frequently asked questions
- What does Etoposide treat?
- Etoposide (Etoposide) may be used to treat urinary bladder neoplasms, brain neoplasms, lung neoplasms, mycosis fungoides, neuroblastoma, prostatic neoplasms, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How does Etoposide work?
- Etoposide is a topoisomerase inhibitor. Topoisomerase inhibitors target enzymes that cells rely on to cut and rejoin their DNA during cell division. By trapping these enzymes after they cut the DNA but before they can reseal it, the drugs leave the DNA broken, which halts cell division and kills rapidly dividing cancer cells.
- Is there a coupon or discount for Etoposide?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Etoposide. To pay less, Etoposide is already a generic — usually the lowest-cost version — so the main levers are comparing cash prices between pharmacies and using a pharmacy discount-card service. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Etoposide?
- Etoposide is marketed by Accord Hlthcare. You can see Accord Hlthcare's full profile, rating, and other products on pharmaranks.
- Is Etoposide a brand-name or generic drug?
- Etoposide is a generic medication; its active ingredient is Etoposide. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
- Is Etoposide available over the counter?
- No. Etoposide is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Etoposide come in?
- Etoposide is currently marketed as capsule, per the FDA's National Drug Code Directory.
- What class of drug is Etoposide?
- Etoposide is classified as topoisomerase inhibitor, per the FDA's Established Pharmacologic Class.
- Is Etoposide FDA-registered?
- Etoposide is on record with the U.S. FDA under application number ANDA074513. You can verify this on its official FDA label.
- Is Etoposide safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Etoposide. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Etoposide?
- Etoposide's side effects are taken directly from its FDA label. From the label: The following data on adverse reactions are based on intravenous administration of etoposide Injection USP 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,… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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