avopef
Avopef (Etoposide) is a topoisomerase inhibitor used to treat Urinary Bladder Neoplasms, Brain Neoplasms, Lung Neoplasms, Mycosis Fungoides.
Etoposide · by Avyxa Holdings
Available as a generic: Etoposide
Key facts
- Active ingredient
- Etoposide
- Drug class
- Topoisomerase Inhibitor
- Form
- Injectable
- Strength
- Etoposide 100MG/5ML (20MG/ML) · Etoposide 500MG/25ML (20MG/ML)
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Avyxa Holdings
- FDA application
- NDA220200
- FDA boxed warning
- Yes — see the boxed warning
What is Avopef?
From the FDA label:AVOPEF injection contains etoposide, a topoisomerase inhibitor. The chemical name for etoposide is 4'-Demethylepipodophyllotoxin 9-[4,6-O-( R )-ethylidene-β-D glucopyranoside] and has the following structural formula: Etoposide is a white or off-white crystalline powder with the molecular formula C 29 H 32 O 13 and a molecular weight of 588.56. It is sparingly soluble in acetone, slightly soluble in methanol or in chloroform, very slightly soluble in ethanol and practically insoluble in water. AVOPEF (etoposide) Injection is a sterile, clear, colorless to light yellow liquid available in 100 mg/5 mL and 500 mg/25 mL multiple-dose vials containing 20 mg/mL of etoposide for intravenous administration. Each mL contains 20 mg etoposide, 37.8% v/v (1490 mg) dehydrated alcohol, 600 mg polyethylene glycol 400, and 80 mg polysorbate 80. The pH is adjusted with anhydrous citric acid and is between 3 to 4. Vial headspace contains nitrogen. Image
How to use
Refractory Testicular Cancer : 50 mg/m 2 to 100 mg/m 2 administered intravenously daily on Days 1 to 5, or 100 mg/m 2 administered intravenously daily on Days 1, 3 and 5. ( 2.2 ) Small Cell Lung Cancer : 35 mg/m 2 administered intravenously daily on days 1 to 4, or 50 mg/m 2 administered intravenously daily on days 1 to 5. ( 2.3 ) Dilute AVOPEF prior to intravenous infusion over 30- to 60-minutes. ( 2.5 ) 2.1 Important Dosage and Administration Information Dilute AVOPEF to a final concentration of 0.2 to 0.4 mg/mL prior to administration [see Dosage and Administration (2.5) ]. Administer diluted AVOPEF by intravenous infusion over 30 to 60 minutes to reduce the risk of infusion-related reactions including hypotension [see Dosage and Administration (2.5) ]. Before each AVOPEF administration and at appropriate intervals during and after therapy, monitor complete blood counts with differential and serum albumin [see Warnings and Precautions (5.1, 5.5) ]. If severe reactions occur, reduce the dosage or discontinue AVOPEF and take appropriate corrective measures according to the clinical judgment of the healthcare provider. 2.2 Recommended Dosage for Refractory Testicular Cancer The recommended dosage of AVOPEF is: 50 mg/m 2 to 100 mg/m 2 administered intravenously daily on Days 1 to 5, or 100 mg/m 2 administered intravenously daily on Days 1, 3 and 5 Repeat treatment cycles every…
Side effects
The following clinically significant adverse reactions are discussed in more detail in other sections of the labeling. Severe Myelosuppression [see Warnings and Precautions (5.1) ] Hypersensitivity and Infusion-Related Reactions [see Warnings and Precautions (5.2) ] Extravasation Resulting in Tissue Necrosis [see Warnings and Precautions (5.3) ] Secondary Leukemia [see Warnings and Precautions (5.4) ] Risk of Increased AVOPEF Toxicity with Low Serum Albumin [see Warnings and Precautions (5.5) ] Alcohol Content [see Warnings and Precautions (5.6) ] The most common adverse reactions are myelosuppression, hypersensitivity, nausea/vomiting, and alopecia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Avyxa Pharma, LLC at 1-888-520-0954 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 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 clinical practice. Blood and lymphatic system disorders : acute leukemia, myelosuppression Eye disorders : transient cortical blindness Gastrointestinal disorders : abdominal pain, anorexia, constipation, diarrhea, dysgeusia, dysphagia, esophagitis, mucositis, nausea, stomatitis and vomiting General disorders and…
FDA Boxed Warning (the FDA’s most serious warning)
Boxed (black-box) warning — from the FDA label
SEVERE MYELOSUPPRESSION AVOPEF can cause severe myelosuppression resulting in infection or bleeding [see Warnings and Precautions (5.1) ] . Do not administer AVOPEF to patients with absolute neutrophil counts of less than 500 cells/mm 3 or platelets less than 50,000 cells/mm 3 [see Warnings and Precautions (5.1) ] . Monitor complete blood cell counts, prior to the administration of AVOPEF and before each subsequent cycle, and at appropriate intervals during and after therapy [see Warnings and Precautions (5.1) ] . WARNING: SEVERE MYELOSUPPRESSION See full prescribing information for complete boxed warning . AVOPEF can cause severe myelosuppression resulting in infection or bleeding. ( 5.1 ) Do not administer AVOPEF to patients with absolute neutrophil counts of less than 500 cells/mm 3 or platelets less than 50,000 cells/mm 3 . ( 5.1 ) Monitor complete blood cell counts, prior to the administration of AVOPEF and before each subsequent cycle, and at appropriate intervals during and after therapy. ( 5.1 )
Warnings
Important safety information
Severe Myelosuppression : Monitor complete blood counts before each AVOPEF administration and at appropriate intervals during and after therapy. Interrupt AVOPEF for absolute neutrophil counts below 500 cells/mm 3 or platelet counts below 50,000 cells/mm 3 . ( 5.1 ) Hypersensitivity and Infusion-Related Reactions : At the first sign of hypersensitivity, stop the infusion and administer volume expanders, corticosteroids, antihistamines, and pressor agents as appropriate. Permanently discontinue AVOPEF in patients who experience a severe hypersensitivity reaction. Hypotension has occurred after rapid intravenous injection. ( 5.2 ) Extravasation Resulting in Tissue Necrosis : Extravasation of etoposide can result in swelling, pain, cellulitis, and tissue necrosis. ( 5.3 ) Secondary Leukemia : Secondary leukemia has occurred with use of etoposide. ( 5.4 ) Risk of Increased AVOPEF Toxicity with Low Serum Albumin : Monitor serum albumin during treatment with AVOPEF. Patients with low serum albumin may have increased concentrations of unbound etoposide and may be at an increased risk for etoposide associated adverse reactions. ( 5.5 ) Alcohol Content : The alcohol content in a dose of AVOPEF may affect the central nervous system. This may include impairment of a patient's ability to drive or use machines immediately after infusion. ( 5.6 ) Embryo-Fetal Toxicity : AVOPEF can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception. ( 5.7 ) 5.1 Severe Myelosuppression AVOPEF can cause severe and fatal myelosuppression, including neutropenia, febrile neutropenia, anemia, and thrombocytopenia. Monitor complete blood counts with differential before each AVOPEF administration and at appropriate intervals during and after treatment with AVOPEF. Do not administer AVOPEF to patients with absolute neutrophil counts of less than 500 cells/mm 3 or platelets less than 50,000 cells/mm 3 . 5.2 Hypersensitivity and Infusion-Related Reactions AVOPEF can cause severe and fatal infusion-related reactions including anaphylactic reactions characterized by chills, fever, tachycardia, bronchospasm, dyspnea and hypotension [see Adverse Reactions (6.1) ] . Hypertension and flushing have occurred. At the first sign of hypersensitivity, stop the infusion and administer volume expanders, corticosteroids, antihistamines, and pressor agents as appropriate. Permanently discontinue AVOPEF in patients who experience a severe hypersensitivity reaction. Hypotension due to rapid intravenous injection has also occurred. To reduce the risk of hypotension due to an infusion-related reaction, administer AVOPEF by intravenous infusion over 30 to 60 minutes [see Dosage and Administration (2.5) ]. 5.3 Extravasation Resulting in Tissue Necrosis Extravasation of etoposide can result in swelling, pain, cellulitis, and tissue necrosis. 5.4 Secondary Leukemia Secondary leukemia has occurred with use of etoposide. 5.5 Risk of Increased AVOPEF Toxicity with Low Serum Albumin Etoposide is highly protein-bound. Patients with low serum albumin may have increased concentrations of unbound etoposide and may be at an increased risk for etoposide associated adverse reactions. Monitor for increased adverse reactions during treatment with AVOPEF in patients with low serum albumin. 5.6 Alcohol Content The alcohol content in a dose of AVOPEF may affect the central nervous system and should be taken into account for patients in whom alcohol intake should be avoided or minimized. Consideration should be given to the alcohol content in AVOPEF on the ability to drive or use machines immediately after the infusion. Each administration of AVOPEF at 100 mg/m 2 delivers 1.5 g/m 2 of ethanol. For a patient with a BSA of 2.0 m 2 this would deliver 3.0 grams of ethanol [see Description (11) ]. Other etoposide products may have a different amount of alcohol or no alcohol. 5.7 Embryo-Fetal Toxicity Based on findings from animal studies and its mechanism of action, AVOPEF can cause fetal harm when administered to a pregnant woman. In animal reproduction studies, intravenous or intraperitoneal administration of etoposide to pregnant animals during the period of organogenesis caused embryo-fetal mortality and structural abnormalities at doses below the recommended human dose of 50 mg/m 2 based on body surface area (BSA). Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise female patients of reproductive potential to use effective contraception during treatment with AVOPEF and for 6 months after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with AVOPEF and for 4 months after the last dose [see Use in Specific Populations (8.1, 8.3) ].
Who should not take Avopef
AVOPEF is contraindicated in patients with hypersensitivity to etoposide or any of its excipients. Hypersensitivity to etoposide or any of its excipients. ( 4 )
Interactions
CYP3A Inhibitors and CYP3A Inducers : Avoid concomitant use of strong CYP3A inhibitors and strong CYP3A inducers with AVOPEF. ( 7.1 ) Vitamin K Antagonists : Monitor INR more frequently and modify the dosage of the vitamin K antagonists as appropriate. Co-administration of AVOPEF with warfarin can result in elevated international normalized ratio (INR). ( 7.2 ) 7.1 Effect of Other Drugs on AVOPEF CYP3A Inhibitors Avoid concomitant use of strong CYP3A inhibitors. Etoposide is a CYP3A4 substrate. Strong CYP3A inhibitors may increase etoposide exposure, which may increase the risk of AVOPEF-associated adverse reactions [see Clinical Pharmacology (12.3) ]. CYP3A Inducers Avoid concomitant use of strong CYP3A inducers. Etoposide is a CYP3A4 substrate. Strong CYP3A inducers may reduce etoposide exposure, which may decrease the effectiveness of AVOPEF [see Clinical Pharmacology (12.3) ]. 7.2 Effect of AVOPEF on Other Drugs Vitamin K Antagonists Monitor INR more frequently and modify the dosage of the vitamin K antagonists as appropriate. Co-administration of AVOPEF with warfarin can result in elevated international normalized ratio (INR).
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 Avopef ranks — best-rated topoisomerase inhibitor for:
Dosage forms
Injectable
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
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Frequently asked questions
- What does Avopef treat?
- Avopef (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 Avopef work?
- Avopef 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 Avopef?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Avopef. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Avopef?
- Avopef is marketed by Avyxa Holdings. You can see Avyxa Holdings's full profile, rating, and other products on pharmaranks.
- Is Avopef a brand-name or generic drug?
- Avopef is a brand-name product with the active ingredient Etoposide. Lower-cost generic equivalents containing Etoposide are available — ask your pharmacist.
- Is Avopef available over the counter?
- No. Avopef 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 Avopef come in?
- Avopef is currently marketed as injectable, per the FDA's National Drug Code Directory.
- What class of drug is Avopef?
- Avopef is classified as topoisomerase inhibitor, per the FDA's Established Pharmacologic Class.
- Is Avopef FDA-registered?
- Avopef is on record with the U.S. FDA under application number NDA220200. You can verify this on its official FDA label.
- Is Avopef safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Avopef. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Avopef?
- Avopef's side effects are taken directly from its FDA label. From the label: The following clinically significant adverse reactions are discussed in more detail in other sections of the labeling. Severe Myelosuppression [see Warnings and Precautions (5.1) ] Hypersensitivity and Infusion-Related Reactions [see Warnings and Precautions (5.2) ] Extravasation Resulting in Tissue… 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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