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Enfuvirtide
Paul A. Pham, Pharm.D. and John G. Bartlett, M.D.
04-25-2008
- Currently not available in Zambia.
- Active against PI-, NNRTI-, and NRTI-resistance virus, but very expensive and requires twice-daily subcutaneous administration.
Zambia Information Author: Paul A. Pham, Pharm. D.
- Enfuvirtide in combination with other antiretroviral agents is indicated for the treatment of HIV-1 infection in treatment-experienced pts with evidence of HIV-1 replication despite ongoing antiretroviral therapy.
brand
name
| generic
| Mfg
| brand
forms
| cost*
|
|
Fuzeon
| Enfuvirtide (ENF< T20) | Roche |
SC
Vial
90 mg | $40.52 |
*Prices represent cost per unit specified and are representative of "Average Wholesale Price" (AWP).
AWP Prices were obtained and gathered by Lakshmi Vasist Pharm D using the Red Book, manufacturer's
information, and the McKesson database.
^Dosage is indicated in mg unless otherwise noted.
- 90 mg (1 mL) SC q12h into upper arm, anterior thigh or abdomen with each injection given at a site different from the preceding injection site. Do not inject where large nerves course close to skin, over a blood vessel, into moles, scar tissue, tattoos, burn sites, or around the navel.
- Prior to administration, reconstitute with 1.1 mL of sterile water, giving a volume of 1.2 mL.
- Once reconstituted it must be refrigerated and used within 24 hrs.
90 mg SC q12h
>35-50 mL/min: No significant change in PK parameters. Usual dose likely.
<35 mL/min: No data, usual dose likely.
No data, usual dose likely.
No data, usual dose likely.
No data.
- Local site reaction (grade 3 or 4) including pain (9%), erythema (32%), pruritus (4%), induration (57%), and nodules or cysts (26%), leading to discontinuation in 3%.
- Eosinophilia
- Bacterial pneumonia (4.68 vs. 0.61 events per 100 pts-yr in treatment and control arms, respectively).
- With use of Biojector needle-free device: nerve pain (neuralgia and/or paresthesia) lasting up to 6 months at anatomical sites where large nerves course close to the skin; bruising; hematomas.
- Not an inhibitor or inducer CYP3A4, CYP2D6, CYP1A2, CYP2C19 or CYP2E1 substrates. As expected, ENF does not interact with SQV, RTV, or rifampin.
- In an observational study, TPV Cmin was increased by approx. 50% with ENF co-administration. Critical factor such as food-effect and adherence were not objectively measured. Limitations of the study design could also have affected results .
- No cross-resistance with NRTIs, NNRTIs, or PIs. In vitro, clinical isolates resistant to NRTI, NNRTI, or PIs retained susceptibility to ENF.
- A 21-fold (range, <1- 422-fold) decrease in susceptibility to ENF has been correlated with genotypic changes in gp41 amino acids 36-45 (36, 38, 40, 42, 43, and 45).
- Pros: Active against PI-, NNRTI-, and NRTI-resistance virus; good response if background regimen includes >2 active ARTs; well studied in ART-experienced pts.
- Cons: SC administration; injection site reactions; time consuming reconstitution process; expensive; requires extensive pt education and training.
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