Avopef 100 mg/5mL
etoposide · INJECTION · Avyxa Pharma, LLC
Avopef is a injection containing etoposide at 100 mg/5mL, taken intravenous. Manufactured by Avyxa Pharma, LLC.
Key Facts
- Brand Name
- Avopef
- Generic Name
- etoposide
- NDC Code (Product)
83831-144- Manufacturer
- Avyxa Pharma, LLC
- Strength
- 100 mg/5mL
- Dosage Form
- INJECTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- NDA220200
- Drug Class
- Topoisomerase Inhibitor [EPC]
- Marketing Start
- 04/01/2026
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE AVOPEF is a topoisomerase inhibitor indicated, in combination with other chemotherapy and/or immunotherapy, for the treatment of adult patients with: Refractory testicular cancer ( 1.1 ) Small cell lung cancer ( 1.2 ) 1.1 Refractory Testicular Cancer AVOPEF, in combination with chemotherapy, is indicated for the treatment of refractory testicular cancer in adult patients. 1.2 Small Cell Lung Cancer AVOPEF, in combination with chemotherapy and immunotherapy, is indicated for the first-line treatment of small cell lung cancer (SCLC) in adult patients.
Dosage & Administration
2 DOSAGE AND ADMINISTRATION 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 Refracto…
Contraindications
4 CONTRAINDICATIONS AVOPEF is contraindicated in patients with hypersensitivity to etoposide or any of its excipients. Hypersensitivity to etoposide or any of its excipients. ( 4 )
Drug Interactions
7 DRUG 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 AVOEPF 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 AVOEPF with warfarin can result in elevated international normalized ratio (INR).
Adverse Reactions
6 ADVERSE REACTIONS 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 …
Frequently Asked Questions
What is Avopef used for?
Avopef contains etoposide. It is a injection taken intravenous. Consult your doctor for specific uses.
Is Avopef a controlled substance?
Avopef is not classified as a controlled substance by the DEA.
What is the generic name for Avopef?
The generic name for Avopef is etoposide. There are 11 other brand versions of etoposide.
What is the NDC code for Avopef 100 mg/5mL?
The NDC (National Drug Code) for Avopef 100 mg/5mL is 83831-144, listed by Avyxa Pharma, LLC.