Generic equivalent of TENOFOVIR DISOPROXIL FUMARATE
3 SKUs available · Available to order · NABP accredited · DSCSA compliant
Tenofovir disoproxil fumarate is the generic equivalent of the brand-name drug TENOFOVIR DISOPROXIL FUMARATE. Licensed pharmacies, clinics, doctor's offices, and veterinary practices can source wholesale Tenofovir disoproxil fumarate through Premier Pharma with same-day fulfillment on in-stock SKUs.
WARNING: POSTTREATMENT ACUTE EXACERBATION OF HEPATITIS B Severe acute exacerbations of hepatitis B virus (HBV) have been reported in HBV-infected patients who have discontinued anti-hepatitis B therapy, including tenofovir disoproxil fumarate. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in HBV-infected patients who discontinue anti-hepatitis B therapy, including tenofovir disoproxil fumarate. If appropriate, resumption of anti-hepatitis B therapy may be warranted [see Warnings and Precautions ( 5.1 )]. WARNING: POSTTREATMENT ACUTE EXACERBATION OF HEPATITIS B See full prescribing information for complete boxed warning. Severe acute exacerbations of hepatitis B virus (HBV) have been reported in HBV-infected patients who…
Source: FDA prescribing information. For licensed professionals only.
1 INDICATIONS AND USAGE Tenofovir disoproxil fumarate tablets are a nucleotide analog HIV-1 reverse transcriptase inhibitor and an HBV reverse transcriptase inhibitor and is indicated: • in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 2 years of age and older weighing at least 10 kg. ( 1.1 ) • for the treatment of chronic hepatitis B in adults and pediatric patients 12 years and older. ( 1.2 ) 1.1 HIV-1 Infection Tenofovir disoproxil fumarate tablets are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients 2 yea…
12.1 Mechanism of Action Tenofovir disoproxil fumarate is an antiviral drug [see Microbiology ( 12.4 )].
12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Tenofovir disoproxil fumarate is an antiviral drug [see Microbiology ( 12.4 )]. 12.3 Pharmacokinetics The pharmacokinetics of TDF have been evaluated in healthy volunteers and HIV-1 infected individuals. Tenofovir pharmacokinetics are similar between these populations. Absorption Tenofovir disoproxil fumarate is a water soluble diester prodrug of the active ingredient tenofovir. The oral bioavailability of tenofovir from tenofovir disoproxil fumarate in fasted subjects is approximately 25%. Following oral administration of a single dose of tenofovir disoproxil fumarate 300 mg to HIV-1 infected subjects in the fasted state, maximum serum conce…
4 CONTRAINDICATIONS None. None. ( 4 )
6 ADVERSE REACTIONS The following adverse reactions are discussed in other sections of the labeling: • Severe Acute Exacerbation of Hepatitis B in Patients with HBV Infection [see Warnings and Precautions ( 5.1 )]. • New Onset or Worsening Renal Impairment [see Warnings and Precautions ( 5.2 )]. • Immune Reconstitution Syndrome [see Warnings and Precautions ( 5.4 )]. • Bone Loss and Mineralization Defects [see Warnings and Precautions ( 5.5 )]. • Lactic Acidosis/Severe Hepatomegaly with Steatosi…
7 DRUG INTERACTIONS • Tenofovir disoproxil fumarate increases didanosine concentrations. Dose reduction and close monitoring for didanosine toxicity are warranted. ( 7.2 ) • Coadministration decreases atazanavir concentrations. When coadministered with tenofovir disoproxil fumarate, use atazanavir given with ritonavir. ( 7.2 ) • Coadministration of tenofovir disoproxil fumarate with certain HIV-1 protease inhibitors or certain drugs to treat HCV increases tenofovir concentrations. Monitor for ev…
2 DOSAGE AND ADMINISTRATION • Testing: Prior to or when initiating tenofovir disoproxil fumarate tablets test for hepatitis B virus infection and HIV-1 infection. Prior to initiation and during use of tenofovir disoproxil fumarate, on a clinically appropriate schedule, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all patients. In patients with chronic kidney disease, also assess serum phosphorous. ( 2.1 ) • Recommended tablet dosage in adults and p…
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for use). Severe Acute Exacerbation of Hepatitis B in Patients Infected with HBV Inform patients that severe acute exacerbations of hepatitis B have been reported in patients infected with hepatitis B virus (HBV) and have discontinued tenofovir disoproxil fumarate. Advise patients not to discontinue tenofovir disoproxil fumarate without first informing their healthcare provider. All patients should be tested for HBV infection before or when starting tenofovir dis…
Source: FDA. For professional use only. Not a substitute for prescribing information.
Premier Pharma stocks 3 Tenofovir disoproxil fumarate SKUs — 0 currently in stock — available to licensed pharmacies, clinics, doctor's offices, and veterinary practices. Tenofovir disoproxil fumarate is the generic equivalent of TENOFOVIR DISOPROXIL FUMARATE. Create a free account to see live wholesale pricing and place orders with same-day fulfillment for in-stock items.
Premier Pharma carries Tenofovir disoproxil fumarate in 300 mg/1 and TABLET, TABLET, FILM COATED.
Tenofovir disoproxil fumarate carries an FDA Orange Book TE code of AB. Therapeutically equivalent — meets FDA bioequivalence requirements; may be substituted for the reference listed drug. Always verify substitution with the current Orange Book before dispensing.
12.1 Mechanism of Action Tenofovir disoproxil fumarate is an antiviral drug [see Microbiology ( 12.4 )].
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