Generic Name
Etoposide
Brand Names
Avopef, Etopophos, VePesid
FDA approval date: May 01, 1996
Classification: Topoisomerase Inhibitor
Form: Injection, Capsule
What is Avopef (Etoposide)?
AVOPEF is a topoisomerase inhibitor indicated, in combination with other chemotherapy and/or immunotherapy, for the treatment of adult patients with: Refractory testicular cancer.
Approved To Treat
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Brand Information
Avopef (etoposide)
WARNING: SEVERE MYELOSUPPRESSION
- AVOPEF can cause severe myelosuppression resulting in infection or bleeding
- Do not administer AVOPEF to patients with absolute neutrophil counts of less than 500 cells/mm
- Monitor complete blood cell counts, prior to the administration of AVOPEF and before each subsequent cycle, and at appropriate intervals during and after therapy
1DOSAGE FORMS AND STRENGTHS
Injection: 100 mg/5 mL (20 mg/mL) and 500 mg/25 mL (20 mg/mL) of etoposide as a sterile, clear, colorless to light yellow liquid in a multiple-dose vial.
2CONTRAINDICATIONS
AVOPEF is contraindicated in patients with hypersensitivity to etoposide or any of its excipients.
3ADVERSE REACTIONS
The following clinically significant adverse reactions are discussed in more detail in other sections of the labeling.
- Severe Myelosuppression
- Hypersensitivity and Infusion-Related Reactions
- Extravasation Resulting in Tissue Necrosis
- Secondary Leukemia
- Risk of Increased AVOPEF Toxicity with Low Serum Albumin
- Alcohol Content
3.1Clinical 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: hepatotoxicity, 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 , perivasculitis
4DESCRIPTION
AVOPEF injection contains etoposide, a topoisomerase inhibitor. The chemical name for etoposide is 4'-Demethylepipodophyllotoxin 9-[4,6-O-(
Etoposide is a white or off-white crystalline powder with the molecular formula C
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.
5REFERENCES
- OSHA Hazardous Drugs. OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html
6HOW SUPPLIED/STORAGE AND HANDLING
AVOPEF (etoposide) Injection, 100 mg/5 mL (20 mg/mL) and 500 mg/25 mL (20 mg/mL) is a sterile, clear, colorless to light yellow liquid available in multiple-dose glass vials as follows:
This container closure is not made with natural rubber latex.
Storage and Handling
Store at 20°C to 25° C (68°F to 77° F); excursions permitted to 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature]. After first use, store the partially used multiple-dose vial in the original carton at controlled room temperature, 20°C to 25°C (68°F to 77°F) for up to 28 days
AVOPEF is a hazardous drug. Follow applicable special handling and disposal procedures
7PATIENT COUNSELING INFORMATION
Severe Myelosuppression
Inform patients that AVOPEF can cause severe myelosuppression. Advise patients that periodic monitoring of their blood counts is required during treatment with AVOPEF. Advise patients to contact their healthcare provider for any signs or symptoms of myelosuppression
Hypersensitivity and Infusion-Related Reactions
Inform patients that AVOPEF can cause severe infusion-related reactions, allergic reactions and anaphylaxis. Advise patients to immediately call their healthcare provider to report any signs or symptoms of an infusion-related reaction, allergic reaction or anaphylaxis
Risk of Increased AVOPEF Toxicity with Low Serum Albumin
Inform patients that the risk of AVOPEF toxicity is increased with low serum albumin. Advise patients that periodic monitoring of their serum albumin is required during treatment with AVOPEF. Advise patients to contact their healthcare provider if they experience signs or symptoms of low serum albumin or AVOPEF toxicity
Secondary Leukemia
Inform patients that AVOPEF can cause secondary leukemia. Advise patients that periodic monitoring is recommended during and after treatment with AVOPEF and to contact their healthcare provider if they experience signs or symptoms of leukemia
Alcohol Content
Advise patients of the effects of alcohol in AVOPEF, including possible effects on the central nervous system. Advise patients in whom alcohol should be avoided or minimized to consider the alcohol content of AVOPEF. AVOPEF at 100 mg/m
Embryo-Fetal Toxicity
- Advise pregnant women and females of reproductive potential of the potential risk to a fetus and to inform their healthcare provider with a known or suspected pregnancy
- Advise females 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
Lactation
Advise women not to breastfeed during treatment with AVOPEF and for 1 week after the last dose
Infertility
Advise males and females of reproductive potential that AVOPEF may impair fertility
Manufactured for:
Avyxa Pharma, LLC
New Jersey 07054, USA
Made in China
8PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
