COMPLERA is a fixed-dose combination tablet containing
emtricitabine, rilpivirine hydrochloride, and tenofovir DF. EMTRIVA is the
brand name for emtricitabine, a synthetic nucleoside analog of cytidine.
EDURANT is the brand name for rilpivirine, a non-nucleoside reverse
transcriptase inhibitor. VIREAD is the brand name for tenofovir DF, which is
converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide)
analog of adenosine 5'-monophosphate.
VIREAD and EMTRIVA are the components of TRUVADA.
COMPLERA tablets are for oral administration. Each tablet
contains 200 mg of emtricitabine, 27.5 mg of rilpivirine hydrochloride
(equivalent to 25 mg of rilpivirine), and 300 mg of tenofovir DF (equivalent to
245 mg of tenofovir disoproxil) as active ingredients. The tablets include the
following inactive ingredients: pregelatinized starch, lactose monohydrate, microcrystalline
cellulose, croscarmellose sodium, magnesium stearate, povidone, polysorbate 20.
The tablets are film-coated with a coating material containing polyethylene
glycol, hypromellose, lactose monohydrate, triacetin, titanium dioxide, iron
oxide red, FD&C Blue #2 aluminum lake, FD&C Yellow #6 aluminum lake.
The chemical name of emtricitabine is 5-fluoro-1-[(2R,5S)-2(hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine.
Emtricitabine is the (-) enantiomer of a thio analog of cytidine, which differs
from other cytidine analogs in that it has a fluorine in the 5-position.
It has a molecular formula of C8H10FN3O3S
and a molecular weight of 247.24. It has the following structural formula:
Emtricitabine is a white to
off-white crystalline powder with a solubility of approximately 112 mg per mL
in water at 25 °C.
Rilpivirine is available as the
hydrochloride salt. The chemical name for rilpivirine hydrochloride is
monohydrochloride. Its molecular formula is C22H18N6 • HCl and its molecular weight is 402.88.
Rilpivirine hydrochloride has the following structural formula:
Rilpivirine hydrochloride is a
white to almost white powder. Rilpivirine hydrochloride is practically
insoluble in water over a wide pH range.
Tenofovir Disoproxil Fumarate
Tenofovir DF is a fumaric acid
salt of the bisisopropoxycarbonyloxymethyl ester derivative of tenofovir. The
chemical name of tenofovir DF is 9-[(R)-2 [[bis[[(isopropoxycarbonyl)oxy]-
methoxy]phosphinyl]methoxy]propyl]adenine fumarate (1:1). It has a molecular
formula of C19H30N5O10P • C4H4O4 and a molecular weight of
635.52. It has the following structural formula:
Tenofovir DF is a white to
off-white crystalline powder with a solubility of 13.4 mg per mL in water at 25
°C. All dosages are expressed in terms
of tenofovir DF except where otherwise noted.
What are the possible side effects of emtricitabine, rilpivirine, and tenofovir (Complera)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
This medication may cause lactic acidosis (a build-up of lactic acid in the body, which can be fatal). Lactic acidosis can start slowly and get worse over time. Get emergency medical help if you have even mild symptoms of lactic acidosis, such as:
- muscle pain or weakness;
- numb or cold feeling in your arms and legs;
- trouble breathing;
- feeling dizzy,...
Read All Potential Side Effects and See Pictures of Complera »
Last reviewed on RxList: 8/27/2012
This monograph has been modified to include the generic and brand name in many instances.