Enfuvirtide


Generic Medicine Info
Indications and Dosage
Subcutaneous
HIV-1 infection
Adult: Combination therapy w/ other antiretroviral: 90 mg bid. Inject into the arm, thigh or abdomen as directed, at a different site from the preceding one.
Child: 6-16 yr 2 mg/kg bid. Max: 90 mg bid; >16 yr Same as adult dose.
Reconstitution
Reconstitute w/ 1.1 mL water for inj, gently tap the vial and allow to stand for up to 45 min to dissolve into soln. Do not shake or invert vial.
Contraindications
Hypersensitivity. Lactation.
Special Precautions
Patient w/ coagulation disorders, high initial viral load, low initial CD4 cell count, history of lung disease. Smokers and patients receiving IV drugs. Not intended in antiretroviral therapy-naive individual. Hepatic impairment and moderate to severe renal impairment. Childn. Pregnancy.
Adverse Reactions
Significant: Hypersensitivity reactions (e.g. rash, fever, nausea and vomiting, chills, rigors, hypotension, elevated serum liver transaminases), immune reconstitution syndrome, bacterial pneumonia, inj site reaction (e.g. mild to moderate pain/discomfort, induration, erythema, pruritus, ecchymosis).
Nervous: Anxiety, flu-like symptoms, peripheral neuropathy, weakness, insomnia, depression, nightmare, irritability, hypoaesthesia, tremor, vertigo, asthenia.
GI: Abdominal pain, anorexia, dry mouth, nausea, diarrhoea, constipation, pancreatitis, GERD.
Resp: Cough, sinusitis.
Genitourinary: Nephrolithiasis.
Endocrine: Wt loss, hyperglycaemia, hypertriglyceridaemia, DM.
Haematologic: Lymphadenopathy, eosinophilia, haematuria.
Musculoskeletal: Limb pain, myalgia, osteonecrosis.
Ophthalmologic: Conjunctivitis.
Otic: Ear infection.
Dermatologic: Dry skin, seborrheic eczema, acne.
Potentially Fatal: Guillain-Barre syndrome.
Parenteral/SC: B
MonitoringParameters
Monitor viral load, CD4 count, hypersensitivity and inj site reactions, pediatric wt (periodically). Monitor for signs and symptoms of pneumonia, neuropathy and CNS changes.
Drug Interactions
Increased serum concentration w/ protease inhibitors. Decreased serum concentration w/ orlistat. Increased risk of bleeding w/ anticoagulants.
Lab Interference
May cross react w/ HIV glycoprotein 41(gp41) resulting to false-positive HIV result in ELISA test.
Action
Description: Enfuvirtide, is an HIV fusion protein inhibitor which interferes w/ entry of HIV type 1 (HIV-1) into the host cell by binding to viral glycoprotein gp41 subunit, thereby inhibiting viral and cellular membrane fusion w/ the CD4 cell receptor.
Pharmacokinetics:
Absorption: Almost completely absorbed following SC inj. Bioavailability: 84%. Time to peak plasma concentration: 8 hr.
Distribution: Volume of distribution: 5.5 ± 1.1 L. Plasma protein binding: 92%.
Metabolism: Undergoes catabolism in the liver and kidney by peptidase into amino acids and proteinase via hydrolysis to form deaminated metabolite.
Excretion: Elimination half-life: 3.8 hr.
Storage
Store at 25°C.
Any unused medicinal product should be disposed of in accordance w/ local requirement.
MIMS Class
ATC Classification
J05AX07 - enfuvirtide ; Belongs to the class of other antivirals. Used as a direct acting antiviral in the systemic treatment of viral infections.
References
Anon. Enfuvirtide (Briggs Drugs in Pregnancy and Lactation). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 07/09/2017.

Anon. Enfuvirtide. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 06/09/2017.

Buckingham R (ed). Enfuvirtide. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 06/09/2017.

Joint Formulary Committee. Enfuvirtide. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 06/09/2017.

McEvoy GK, Snow EK, Miller J et al (eds). Enfuvirtide. AHFS Drug Information (AHFS DI) [online]. American Society of Health-System Pharmacists (ASHP). https://www.medicinescomplete.com. Accessed 06/09/2017.

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