Brand Name: Viread
Generic Name: Tenofovir disoproxil fumarate, TDF, tenofovir DF
Viread is a medication prescribed to treat HIV, in combination with other antiretroviral drugs. The U.S. Food and Drug Administration (FDA) has approved the medication for use in adults and children ages 2 and older for use in treating HIV infection. Viread is used in combination therapy, meaning the medication is often taken with other medications.
Tenofovir is also used to treat chronic hepatitis B in patients who are at least 12 years of age.
Read the FDA description of Viread.
Viread is not a cure for HIV. Viread belongs to a class of medications known as nucleoside reverse transcriptase inhibitors (NRTIs). These medications block the effectiveness of reverse transcriptase, an enzyme present in HIV. As a result, HIV has difficulty replicating. This can reduce the amount of the virus in the blood. Treatment with this medication can result in an increase in the number of CD4 or immune system cells in the body.
The adult dose of Viread is one 300 milligrams (mg) tablet daily (taken in combination with other antiretroviral drugs). The medication can be taken with or without food. Fatty meals may increase the absorption of Viread. The dose is adjusted for patients with kidney disease, according to how well the kidneys are working. The children’s dose is based on age and body weight. Children 12 years of age and who weigh 77 pounds or more should be dosed like adults. The oral powder can be mixed with applesauce, baby food, or yogurt. Do not mix the oral powder with liquid. Take Viread at the same time every day.
Viread is available as an oral powder or a tablet.
This information is a summary. Before starting this medication, discuss questions with your healthcare provider and make sure you understand dosage instructions.
Tell your doctor before taking Viread if you:
- are breastfeeding or planning on breastfeeding
- have end-stage renal disease (ESRD) that requires dialysis
- have impaired renal function with a creatinine clearance of less than 50 milliliters per minute (mL/min)
- taking the chemotherapy drug Vincristine
Always tell your physician about any prescription medications or herbal remedies you are taking. Some of the medications that can adversely interact with Viread include:
- atazanavir (Reyataz)
- didanosine (Videx and Videx EC)
- lopinavir with ritonavir (Kaletra)
- other medications prescribed to treat HIV that include tenofovir disoproxil fumarate, including Atripla, Complera, Stribild, and Truvada
- doxorubicin (chemotherapy drug)
- vincristine (chemotherapy drug)
- diclofenac and other non-steroidal anti-inflammatory drugs (like ibuprofen, naproxen and others) may increase the drug levels and effects of Viread in the body
- aminoglycosides, which are antibiotics usually given in the hospital
Possible Adverse and Emergency Side Effects
The following are severe and emergent side effects of Viread. Contact your medical provider immediately if you experience any of the following:
- hepatotoxicity, such as hepatomegaly with steatosis, which affects your liver functioning. Symptoms of this condition include dark urine, decrease in appetite, fatigue, yellowing skin, nausea, and tenderness over the liver.
- immune reconstitution syndrome, a condition that causes an inflammatory response in viruses in the blood, such as pneumonia or tuberculosis
- lactic acidosis, a condition that causes excess amounts of acid to build up in your blood. This causes symptoms such as weakness, tiredness, difficulty breathing, stomach pain, feeling cold, or feeling dizzy
- a decline in kidney function, which may be slow and progressive, occurs in some patients. In rare cases, people taking Viread can experience kidney damage, such as acute renal failure or Fanconi syndrome. Your doctor should monitor kidney function.
- reduction in bone mineral density. Your doctor should monitor your bone density and discuss calcium and vitamin D intake when you start Viread.
Possible Nonemergency Side Effects
The following side effects may occur but don’t usually represent an emergency. Discuss with your doctor if they continue or are bothersome.
- abdominal pain
- changes in the distribution of body fat, such as an increasing amount of fat on the neck
This list may not describe all possible side effects. Call your doctor or healthcare provider for advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Viread and Kidney Impairment
Viread (tenofovir) is principally eliminated by the kidney. Renal impairment, including cases of acute kidney failure and Fanconi syndrome, has been reported with the use of Viread.
It’s recommended that the estimated creatinine clearance be evaluated in all patients before starting Viread treatment and as clinically appropriate during therapy with Viread. Patients at risk of kidney disease or reduced kidney function or whose kidney function has been decreased while taking Hepsera (a treatment for Hepatitis B), are recommended to have estimated creatinine clearance, serum phosphorus, urine glucose, and urine protein before starting Viread and be regularly monitored during Viread treatment.
Viread should not be used in patients who are currently being treated with a drug known to be potentially damaging to the kidney or who recently used such a drug (for example, high-dose or more than one nonsteroidal anti-inflammatory drugs (NSAIDs). Some who had risk for kidney disease but appeared to be stable on Viread and were then started on high dose or multiple NSAIDs, have had acute kidney failure. Some patients required hospitalization and dialysis. Alternatives to NSAIDs should be considered in patients at risk for renal dysfunction if needed.
Persistent or worsening bone pain, pain in extremities, fractures, muscular pain, or weakness may be symptoms of kidney damage and require an immediate evaluation of kidney function.
Viread and Hepatitis B
Doctors also prescribe Viread to treat hepatitis B. Patients with hepatitis B and HIV can take Viread as part of an antiretroviral combination medication treatment.
Viread tablets and oral powder should be stored at room temperature at 77 degrees Fahrenheit (25 degrees Celsius). The medication should be kept in its original container at all times.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
LACTIC ACIDOSIS/SEVERE HEPATOMEGALY
LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY W/ STEATOSIS, INCL. FATAL CASES, ASSOCIATED W/ NUCLEOSIDE ANALOGUE USE ALONE OR IN COMBINATION; SUSPEND TX IF CLINICAL OR LABORATORY FINDINGS SUGGEST LACTIC ACIDOSIS OR HEPATOTOXICITY.
HEPATITIS B EXACERBATION
SEVERE ACUTE EXACERBATIONS OF HEPATITIS MAY OCCUR IN HBV-INFECTED PATIENTS WHEN D/C TENOFOVIR; MONITOR HEPATIC FXN CLOSELY FOR AT LEAST SEVERAL MONTHS AFTER D/C TENOFOVIR; INITIATE ANTI-HBV TX IF NEEDED.
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