VIREAD is available as tablets in four dose strengths or as an oral powder.

None.

The following adverse reactions are discussed in other sections of the labeling:

If overdose occurs, the patient must be monitored for evidence of toxicity, and standard supportive treatment applied as necessary.

Tenofovir is efficiently removed by hemodialysis with an extraction coefficient of approximately 54%. Following a single 300 mg dose of VIREAD, a four-hour hemodialysis session removed approximately 10% of the administered tenofovir dose.

VIREAD is the brand name for tenofovir disoproxil fumarate (TDF) (a prodrug of tenofovir) which is a fumaric acid salt of bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. TDF is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5'-monophosphate. Tenofovir exhibits activity against HIV-1 reverse transcriptase.

The chemical name of TDF is 9-[(

Tenofovir disoproxil fumarate is a white to off-white crystalline powder with a solubility of 13.4 mg/mL in distilled water at 25 °C. It has an octanol/phosphate buffer (pH 6.5) partition coefficient (log p) of 1.25 at 25 °C.

VIREAD is available as tablets or as an oral powder.

VIREAD tablets are for oral administration and are available in the following strengths: 150 mg, 200 mg, 250 mg, and 300 mg of TDF (equivalent to 123 mg, 163 mg, 204 mg, and 245 mg of tenofovir disoproxil, respectively).

All strengths of VIREAD tablets contain the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and pregelatinized starch. The 300 mg strength tablets are coated with Opadry II Y-30-10671-A, which contains FD&C blue #2 aluminum lake, hypromellose 2910, lactose monohydrate, titanium dioxide, and triacetin. The 150 mg, 200 mg, and 250 mg strength tablets are coated with Opadry II 32K-18425, which contains hypromellose 2910, lactose monohydrate, titanium dioxide, and triacetin.

VIREAD oral powder is available for oral administration as white, taste-masked, coated granules containing 40 mg of TDF per gram of oral powder (equivalent to 33 mg of tenofovir disoproxil). The oral powder contains the following inactive ingredients: mannitol, hydroxypropyl cellulose, ethylcellulose, and silicon dioxide.

In this insert, all dosages are expressed in terms of TDF except where otherwise noted.

VIREAD tablets are available in bottles containing 30 tablets with child-resistant closure as follows:

VIREAD oral powder consists of white, coated granules containing 40 mg of TDF (equivalent to 33 mg of tenofovir disoproxil) per gram of powder and is available in multi-use bottles containing 60 grams of oral powder, closed with a child-resistant closure, and co-packaged with a dosing scoop. (NDC 61958-0403-1)

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).

VIREAD

Read the Patient Information that comes with VIREAD powder for important information about VIREAD.

Read this Instructions for Use before you give VIREAD for the first time. Be sure you understand and follow the instructions. If you have any questions, ask your healthcare provider or pharmacist.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

NDC 61958-0404-1

Viread

150 mg

30 tablets

R

NDC 61958-0405-1

Viread

200 mg

30 tablets

R

NDC 61958-0406-1

Viread

250 mg

30 tablets

R

NDC 61958-0401-1

Viread

300 mg

30 tablets

R

NDC 61958-0403-1

Viread

60 g per bottle

R