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Emtricitabine
Paul A. Pham, Pharm.D. and John G. Bartlett, M.D.
03-24-2008
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Available formulation in Zambia: Capsule: 200 mg; Oral liquid: 10 mg/ml. TDF 300 mg/FTC 200 mg combination tab EFV 600 mg/TDF 300 mg/FTC 200 mg combination tab
- FTC/TDF plus EFV or NVP is now preferred firstline regimen due to long-term potency and favorable mutation pathway.
- Refrigerate FTC solution. Solution can be kept out at room temperature for 3 months only.
Zambia Information Author: Paul A. Pham, Pharm. D.
- Treatment of HIV infection in combination with other antiretroviral agents.
- Treatment of hepatitis B in HIV-HBV co-infected pts. or in HBV mono-infected patients.
brand
name
| generic
| Mfg
| brand
forms
| cost*
|
|
Emtriva
| Emtricitabine (FTC) | Gilead | Oral
capsule
200 mg | $10.11 per cap |
|
Truvada
| Emtricitabine (FTC)+ Tenofovir DF (TDF) | Gilead | Oral
tablet
FTC200 mg/TDF 300 mg | $27.62 per tab |
| Atripla | Emtricitabine (FTC)+ Tenofovir DF (TDF) + Efavirenz (EFV) | Bristol-Myers Squibb / Gilead | Oral
tablet
FTC200mg/TDF300 mg/EFV 600 mg | $47.95 per tab |
*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.
Pill burden: 1 cap or tab qd
- FTC 200 mg - 1 tab qd with or without food.
- Can be administered as a co-formulated product with tenofovir DF (Truvada) 1 tab PO qd with or without food and TDF/EFV (Atripla) 1 tab qd. Evening dosing on an empty stomach recommended with initial Atripla therapy to decrease EFV-associated side effects.
200 mg q24hrs.
30-49 mL/min: FTC 200 mg q48hrs or TDF/FTC co-formulation (Truvada) 1 tab q48h ;15-29 mL/min: FTC 200 mg q72hrs. EFV/TDF/FTC co-formulation (Atripla) not recommended with GFR <50 ml/min).
<15 mL/min: 200 mg q96hrs. TDF/FTC (Truvada) and EFV/TDF/FTC co-formulation (Atripla) not recommended with GFR <50 ml/min).
200 mg q96hrs post-HD (30% of dose removed with 3-hr HD). EFV/TDF/FTC co-formulation (Atripla) not recommended with GFR <50 ml/min).
No data. Consider dose reduction. TDF/FTC (Truvada) and EFV/TDF/FTC co-formulation (Atripla) not recommended with GFR <50 ml/min).
No data. Consider dose reduction.
- Generally well tolerated. For Atripla, see EFV for EFV-associated side effects and TDF for TDF-associated side effects
- Mild asymptomatic skin hyperpigmentation on the palm and/or soles, with increased frequency in dark-skinned individuals.
- Asymptomatic and transient CPK elevation.
- Headache, diarrhea, nausea, asthenia, and rash that required discontinuation in approx. 1% of pts.
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Lactic acidosis (categorized as NRTI class adverse effect, but not expected to occur frequently with FTC).
Not a substrate, inhibitor, or inducer of any CYP450 isoforms. No clinically significant drug interactions.
| Drug | Effect of Interaction | Recommendations/Comments |
|
AZT
| No significant drug interaction. | Use standard dose. |
|
TDF
| Tenofovir Cmin was increased by 20%; AUC was unchanged. | Interaction not significant. Use standard dose. |
| Food | FTC AUC was not affected by food. | Administer FTC with or without food |
- 184V: High-level resistance.
- T69ins: High-level resistance.
- Q151M complex: Unknown data, but low-level resistance likely.
- TAMs (41L, 210W, 215Y/F, 219Q/E, 44D, 67N, 70R, 118I): high level resistance with multiple TAMs.
- Pros: Activity against HBV; well tolerated; qd dosing; co-formulation with TDF; similar to 3TC with respect to activity, tolerability, and resistance profile
- Cons: Hyperpigmentation in some pts; less clinical data than for 3TC.
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