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 brand name for the HIV fusion inhibitor drug ENFUVIRTIDE.
References in periodicals archive ?
According to the company, the slight increase in revenue for the quarter was attributable to certain payments and other adjustments recognized in the second quarter as well as declining sales of FUZEON.
The company plans to issue a Dear Healthcare Provider letter to potential prescribers and pharmacists to make them aware of the Triad product recall and the need to discontinue use of the alcohol prep pads packaged with Boniva Injection, Fuzeon, Nutropin A.Q.
Documents involved with the development and testing of Fuzeon remain in the Eastern District of North Carolina.
A major disadvantage of using Fuzeon and related drugs that target N-HR is the rapid emergence of HIV-1 strains resistant to the drugs.
Roche charges $25,000 a year for Fuzeon. It does not offer a discount price for developing countries.
Table 1 Common Antiretroviral Drugs (14-16) Classification Generic Name Trade Name Nucleoside reverse Abacavir sulfate Ziagen transcriptase inhibitors Abacavir sulfate + Trizivir (NRTI) lamivudine + zidovudine Didanosine (ddl) Videx, Videx EC Lamivudine (3TC) Epivir Lamiudine + zidovudine Combivir Stavudine (d4T) Zerit Tenofovir disoproxil Viread fumarate Zalcitabine (ddC) Hivid Zidovudine (AZT, ZDV) Retrovir Non-nucleoside reverse Delavirdine mesylate Rescriptor transcriptase inhibitors Efavirenz Sustiva (NNRTI) Nevirapine Viramune Protease inhibitors (PI) Amprenavir Agenerase Indinavir sulfate Crixivan Lopinavir + ritonavir Kaletra Nelfinavir Viracept Ritonavir Norvir Saquinavir Fortovase Saquinavir mesylate Invirase Fusion inhibitors (FI) Enfuvirtide Fuzeon
For Novartis, excludes Invoelon and Pulminiq decisions as Novartis on longer (Inovelon) or not yet (Pulminiq) owned the project: Merck included Emend (2007); Roche includes Fuzeon (2007) (2) NMEs and non-NMEs (3) Indiplon counted as approvable (received approvable for 5/10mg immediate release and non-approvable for 15mg extended release (4) Accomplia/Zimulti counted as approvable (received approvable for weight management and non-approvable for smoking cessation) Source: Company reports ...
On January 31 the FDA announced that the FUZEON (enfuvirtide) package insert had been changed to include precautions to avoid injection-site reactions, either using a needle, or the Biojector(r) 2000 needlefree injection system.
The T20, also known as the Fuzeon, is a relatively large peptide composed of 36 amino acids.
So far, just one fusion inhibitor has been FDA approved--enfuviritide (Fuzeon)--but more are on the way.
* The FDA approves the first entry inhibitor enfuvirtide Fuzeon, T20).
(199) For example, on February 24, 2003, a pharmaceutical company, Roche, announced that it was setting a European price of fifty-two euros a day, or more than $20,000 a year, for its new AIDS drug, Fuzeon. (200) The drug's cost is abnormally high compared to other AIDS-related medicines.