Topoisomerase Inhibitor

Avopef

Approved 13 Feb 2026IntravenousSolution

Indications

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 )

1.1Refractory Testicular Cancer

AVOPEF, in combination with chemotherapy, is indicated for the treatment of refractory testicular cancer in adult patients.

1.2Small 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.

Contraindications

AVOPEF is contraindicated in patients with hypersensitivity to etoposide or any of its excipients. Hypersensitivity to etoposide or any of its excipients. ( 4 )

Warnings and precautions

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.

At a glance

Brand name: Avopef
Active substance: etoposide
Pharmacologic class: Topoisomerase Inhibitor
Route: Intravenous
Dosage form: Solution
Applicant: Avyxa Holdings
Status: Prescription
FDA approval: 13 Feb 2026
Application: NDA220200-001

Indications

1.1Refractory Testicular Cancer

AVOPEF, in combination with chemotherapy, is indicated for the treatment of refractory testicular cancer in adult patients.

1.2Small 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.

Warnings and precautions

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary Based

on findings in animal studies and its mechanism of action [see Clinical Pharmacology (12.1) ], AVOPEF can cause fetal harm when administered to a pregnant woman. There are no available data on the use of AVOPEF in pregnant women to inform a drug-associated risk. AVOPEF contains alcohol which can interfere with neurobehavioral development [see Clinical Considerations] . 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 [see Use in Specific Populations (8.1, 8.3) and Clinical Pharmacology (12.1) ] . In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and of miscarriage is 15% to 20%, respectively.

Clinical Considerations AVOPEF contains alcohol [see Warnings and Precautions (5.6) ] . Published studies have demonstrated that alcohol is associated with fetal harm including central nervous system abnormalities, behavioral disorders, and impaired intellectual development. Data Animal Data In rats, an intravenous etoposide dose of 0.4 mg/kg/day (approximately 0.05 times the human dose of 50 mg/m 2 based on BSA) 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 (approximately 0.14- and 0.5-times the human dose of 50 mg/m 2 based on BSA) resulted in 90% and 100% embryonic resorptions, respectively.

In mice, a single etoposide dose of 1.0 mg/kg (approximately 0.06 times the human dose of 50 mg/m 2 based on BSA) administered intraperitoneally on Days 6, 7, or 8 of gestation caused embryotoxicity, cranial abnormalities, and major skeletal malformations. An intraperitoneal dose of 1.5 mg/kg (approximately 0.10-times the human dose 50 mg/m 2 based on BSA) on Day 7 of gestation caused an increase in the incidence of intrauterine death, fetal malformations, and a significant decrease in the average fetal body weight.

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.

6.1Clinical 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 administration site conditions : fatigue, fever, and infusion site extravasation with necrosis Hepatobiliary disorders : hepatoxicity, metabolic acidosis Immune system disorders : allergic reaction, anaphylactic reaction (including chills, fever, tachycardia, bronchospasm, dyspnea, hypotension, hypertension, flushing, facial swelling, tongue swelling, coughing, diaphoresis, cyanosis, tightness in throat, laryngospasm, back pain, loss of consciousness, hypersensitivity-associated apnea), hypersensitivity, infusion-related reaction.

Infections : febrile neutropenia Nervous system disorders : optic neuritis, peripheral neuropathy and seizure Respiratory, thoracic and mediastinal disorders : interstitial pneumonitis and pulmonary fibrosis Skin and subcutaneous tissue disorders : alopecia, pigmentation changes (including pigmented bands in nails, skin darkening and discoloration of tongue and teeth), pruritic erythematous maculopapular rash, pruritus, radiation recall dermatitis, rash, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and urticaria Vascular disorders : hypotension following rapid intravenous administration [see Dosage and Administration (2.5) ] , perivasculitis

Avopef

Indications

1.1Refractory Testicular Cancer

1.2Small Cell Lung Cancer

Contraindications

Warnings and precautions

At a glance

Two medicines in one question?

Avopef

Indications

1.1Refractory Testicular Cancer

1.2Small Cell Lung Cancer

Contraindications

Warnings and precautions

At a glance

Two medicines in one question?

5.1Severe Myelosuppression

5.2Hypersensitivity and Infusion-Related Reactions

5.3Extravasation Resulting in Tissue Necrosis Extravasation

5.4Secondary Leukemia

5.5Risk of Increased

5.6Alcohol Content

5.7Embryo-Fetal Toxicity Based

Interactions

7.1Effect of Other Drugs on

7.2Effect of

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary Based

Adverse reactions

6.1Clinical Trials Experience

Composition

Official product information