Fuzeon


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Related to Fuzeon: Rescriptor, Selzentry

enfuvirtide

Fuzeon

Pharmacologic class: Human immunodeficiency-1 (HIV-1) fusion inhibitor

Therapeutic class: Antiretroviral

Pregnancy risk category B

Action

Interferes with entry of HIV-1 into cells by inhibiting fusion of viral and cellular membranes

Availability

Powder for injection: 90 mg/1-ml vial

Indications and dosages

HIV-1 infection in adults in combination with other antiretrovirals

Adults: 90 mg subcutaneously b.i.d. in upper arm, anterior thigh, or abdomen

Children ages 6 to 16: 2 mg/kg subcutaneously b.i.d. in upper arm, anterior thigh, or abdomen. Maximum dosage is 90 mg b.i.d.

Contraindications

• Hypersensitivity to drug or its components

Precautions

Use cautiously in:
• increased risk of pneumonia
• injection site reaction
• concurrent use of anticoagulants
• hemophilia or other coagulant disorders
• elderly patients
• children younger than age 6 (safety and efficacy not established).

Administration

• Rotate injection sites.
• Be aware that preferred injection sites are upper arm, anterior thigh, and abdomen.
• Reconstitute with 1.1 ml of sterile water for injection, and gently tap vial for 10 seconds. Then gently roll vial between hands or allow vial to stand until product dissolves completely (could take up to 45 minutes).
• Know that drug is usually given with other antiretrovirals.
• Use reconstituted solution immediately.

Adverse reactions

CNS: fatigue, asthenia, insomnia, depression, anxiety, peripheral neuropathy

EENT: conjunctivitis, sinusitis

GI: nausea, diarrhea, upper abdominal pain, dry mouth, anorexia, pancreatitis

Hematologic: lymphadenopathy

Musculoskeletal: limb pain, myalgia

Respiratory: cough, pneumonia

Skin: folliculitis

Other: taste disturbance, decreased appetite, weight loss, herpes simplex infection, injection site reactions (erythema, induration, nodules, cysts, mild to moderate pain, infection), flulike illness, hypersensitivity reactions

Interactions

Drug-diagnostic tests.Alanine aminotransferase, amylase, aspartate aminotransferase, creatine kinase, eosinophils, gamma-glutamyltransferase, lipase, triglycerides: increased levels

Hemoglobin: decreased level

Patient monitoring

• Inspect injection sites frequently for adverse reactions.
• Monitor CBC with white cell differential, lipid panel, liver function test results, and gastric enzymes levels.
• Watch for hypersensitivity reactions.
• Monitor nutritional and hydration status in light of GI adverse effects and underlying disease.

Patient teaching

• Teach patient (or caregiver) how to reconstitute and self-administer drug, as appropriate.

Instruct patient not to change dosage or stop taking drug unless prescriber approves.

Tell patient to immediately report signs or symptoms of hypersensitivity reaction (such as rash, fever, nausea and vomiting, and chills).
• Teach patient how to recognize signs and symptoms of injection site reaction. Tell him to contact prescriber if these occur, especially if they last more than 7 days.
• Advise female patient to notify prescriber if she is pregnant or plans to become pregnant.
• Tell HIV-infected patient not to breastfeed.
• If patient misses a dose, instruct him to take it as soon as he remembers. However, if it's almost time for next dose, tell him to skip the missed dose and take next dose on schedule.
• As appropriate, review all other significant adverse reactions and interactions, especially those related to the tests mentioned above.

Fuzeon

(fyo͞o′zē-ŏn)
A trademark for the drug enfuvirtide.

Fuzeon

a trademark for enfuvirtide.

Fuzeon

A brand name for the HIV fusion inhibitor drug ENFUVIRTIDE.
References in periodicals archive ?
5 million for over charges to FUZEON cost of goods sold during the period from 2003 to 2006.
For patients who are starting treatment with FUZEON in combination with an investigational drug in expanded access, FUZEON ASAP will provide up to a 60-day supply of FUZEON at no cost to the patient, which consists of an immediate shipment of a 30-day supply and an additional 30-day supply if reimbursement is still pending.
The data presented at ICAAC emphasize the importance of using FUZEON earlier in treatment, especially as other active partner agents, such as tipranavir, become available in the clinic.
The traditional approval of FUZEON further confirms its importance as a crucial option for treatment-experienced HIV patients," said Steven D.
These findings demonstrate that Fuzeon significantly enhances the treatment response in treatment experienced patients taking an active boosted PI-containing regimen, thus providing a more potent regimen against drug resistant virus.
The increase in revenue between the periods was driven by increased royalty revenue from FUZEON sales outside of North America offset, in part by decreased collaboration income.
It is alarming that many of these patients offered FUZEON are not accepting the offer due to the fear of injection and are missing out on the modern era of HIV therapy," comments Professor Joep Lange, President of the International AIDS Society.
The new data show that the significant virological and immunological benefits of Fuzeon seen in earlier analyses are extended to 96 weeks, an especially notable achievement given the extensive prior drug exposure of patients enrolled in the TORO studies," said Corklin Steinhart M.
The company announced its strategy to focus on Fuzeon and development of the next generation fusion inhibitor in November 2006.
First approved in 2003, FUZEON was co-developed by Roche and Trimeris, Inc.
Eleven states have capped enrollment (which means anyone new will be put on a waiting list) or other restrictions, such as: Fuzeon waiting lists; no coverage for HIV/hepatitis C co-infection treatment; requiring clients to make co-payments and/or re-apply to the program every six months; and narrower definitions of who is eligible for the program.