TENOFOVIR DISOPROXIL FUMARATE- tenofovir disoproxil fumarate_tablet, film coated

Tenofovir disoproxil fumarate is an antiviral drug [See Microbiology ( 12. 4 The pharmacokinetics of tenofovir DF have been evaluated in healthy volunteers and HIV-1 infected individuals. Tenofovir pharmacokinetics are similar between these populations. Absorption max max Distribution In vitro Metabolism and Elimination In vitro Effects of Food on Oral Absorption 0 to infinity max max max Special Populations Race: Gender: Pediatric Patients 2 Years of Age and Older: Table 12 Mean (+/- SD) Tenofovir Pharmacokinetic Parameters by Age Groups for HIV-1- infected Pediatric Patients Dose and Formulation 300 mg tablet 12 to <18 Years (N=8) C max 0. 13 AUC tau 3. 22 Tenofovir exposures in 52 HBV-infected pediatric subjects (12 to less than 18 years of age) receiving oral once-daily doses of tenofovir disoproxil fumarate 300 mg tablet were comparable to exposures achieved in HIV-1 infected adults and adolescents receiving once-daily doses of 300 mg. Geriatric Patients: Patients with Impaired Renal Function: [See Warnings and Precautions (5. max 0 to infinity [See Dosage and Administration ( 2. Table 13 Pharmacokinetic Parameters (Mean +/- SD) of Tenofovira in Subjects with Varying Degrees of Renal Function Baseline Creatinine Clearance (mL/min) >80 ( N = 3 ) 50-80 (N=10) 30-49 ( N = 8 ) 12-29 (N=11) C max 0. 19 AUC 0 infinity · 2. 22 CL/F (mL/min) 1043. 8 177 +/- 97. 1 CL renal 243. 5 43 +/- 31. 300 mg, single dose of tenofovir disoproxil fumarate tablets Patients with Hepatic Impairment: Assessment of Drug Interactions Table 14 Drug Interactions: Changes in Pharmacokinetic Parameters for Tenofovira in the Presence of the Coadministered Drug Coadministered Drug Dose of Coadministered Drug (mg) N % Change of Tenofovir Pharmacokinetic Parameters b (90% CI) C max AUC C min Atazanavir c 400 once daily × 14 days 33 up arrow 14 up arrow 24 up arrow 22 Atazanavir/ c 300/100 once daily 12 up arrow 34 up arrow 37 up arrow 29 Darunavir/ d 300/100 twice daily 12 up arrow 24 up arrow 22 up arrow 37 Indinavir 800 three times daily × 13 up arrow 14 Û Û Ledipasvir/ Sofosbuvir e,f 90/400 once daily x 24 up arrow 47 up arrow 35 up arrow 47 Ledipasvir/ Sofosbuvir e,g 23 up arrow 64 up arrow 50 up arrow 59 Ledipasvir/ h 90/400 once daily x 15 up arrow 79 up arrow 98 up arrow 163 Lopinavir/ 400/100 twice daily × 24 Û up arrow 32 up arrow 51 Saquinavir/ 1,000/100 twice daily × 14 days 35 Û Û up arrow 23 Sofosbuvir i 400 single dose 16 up arrow 25 Û Û Sofosbuvir/ Velpatasvir j 400/100 once daily 24 up arrow 44 up arrow 40 up arrow 84 Sofosbuvir/ Velpatasvir k 400/100 once daily 30 up arrow 46 up arrow 40 up arrow 70 Sofosbuvir/ l 400/100/100 + Voxilaprevirm 100 once daily 29 up arrow 48 up arrow 39 up arrow 47 Tacrolimus 0. 05 mg/kg twice 21 up arrow 13 Û Û Tipranavir/ n 500/100 twice daily 22 down arrow 23 down arrow 2 up arrow 7 750/200 twice daily 20 down arrow 38 up arrow 2 up arrow 14 a. Subjects received tenofovir disoproxil fumarate tablets 300 mg once daily. registered No effect on the pharmacokinetic parameters of the following coadministered drugs was observed with tenofovir disoproxil fumarate: abacavir, didanosine (buffered tablets), emtricitabine, entecavir, and lamivudine. Table 15 Drug Interactions: Changes in Pharmacokinetic Parameters for Coadministered Drug in the Presence of Tenofovir disoproxil fumarate Tablets Coadministered Drug Dose of Coadministered Drug (mg) N % Change of Coadministered Drug Pharmacokinetic Parameters a (90% CI) C max A UC C min d e f g g h h i a. Increase = up arrow; Decrease = down arrow; No Effect = Û; NA = Not Applicable min min Mechanism of Action Activity against HIV Antiviral Activity 50 50 50 Resistance [See Clinical Studies ( 14. 1)], [See Clinical Studies (14. 1)], Cross Resistance [See Clinical Studies (14. 1)], Studies 902 and 907 Phenotypic Analyses Table 16 HIV-1 RNA Response at Week 24 by Baseline Tenofovir disoproxil fumarate Tablets Susceptibility (Intent-To-Treat) a Baseline Tenofovir disoproxil fumarate Tablets Susceptibility b Change in HIV-1 RNA c <1 -0. Tenofovir susceptibility was determined by recombinant phenotypic Antivirogram assay (Virco). 10 Activity against HBV Antiviral Activity 50 50 Resistance Table 17 Amino Acid Substitutions in Viremic Subjects across HBV Trials of Tenofovir disoproxil fumarate Tablets Compensated Liver Disease Decompensated Liver Disease (N=39) d Nucleotide-Naïve (N=417) a HEPSERA-Experienced (N=247) b Lamivudine-Resistant C f h a. Nucleotide-naïve subjects from Studies 0102 (N=246) and 0103 (N=171) receiving up to 384 weeks of treatment with tenofovir disoproxil fumarate tablets. Cross Resistance.

Tenofovir disoproxil fumarate tablets are a nucleotide analog HIV-1 reverse transcriptase inhibitor and an HBV reverse transcriptase inhibitor. (1) (1) Tenofovir disoproxil fumarate tablets are 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. registered registered registered registered registered registered registered registered registered [See Warnings and Precautions (5. Tenofovir disoproxil fumarate tablets are indicated for the treatment of chronic hepatitis B in adults and pediatric patients 12 years of age and older. [See Clinical Studies (14. [See Adverse Reactions (6. [See Microbiology (12.

Recommended dose for the treatment of HIV-1 or chronic hepatitis B in adults and pediatric patients 12 years of age and older (35 kg or more): 300 mg once daily taken orally without regard to food. 3) For the treatment of HIV-1 or chronic hepatitis B: The dose is one 300 mg tenofovir disoproxil fumarate tablet once daily taken orally, without regard to food. HIV-1 Infection Table 2 Dosing Recommendations for Pediatric Patients 2 Years of Age and Older and Weighing At Least 17 kg Using Tenofovir Disoproxil Fumarate Tablets Body Weight Kilogram (kg) Tablets Once Daily 17 to less than 22 150 mg 22 to less than 28 200 mg 28 to less than 35 250 mg 35 or greater 300 mg Chronic Hepatitis B Significantly increased drug exposures occurred when tenofovir disoproxil fumarate tablets were administered to subjects with moderate to severe renal impairment [See Clinical Pharmacology (12. 3)] [See Warnings and Precautions (5. No dose adjustment of tenofovir disoproxil fumarate tablets 300 mg is necessary for patients with mild renal impairment (creatinine clearance 50 to 80 mL/min). Routine monitoring of estimated creatinine clearance, serum phosphorus, urine glucose, and urine protein should be performed in patients with mild renal impairment [See Warnings and Precautions (5. Table 3 Dosage Adjustment for Patients with Altered Creatinine Clearance Cre atinine Clearan ce (mL/min) a Hemodial ysis Patients 50 or greater 30- 49 10- 29 Recomm en ded 300 mg Dosing Inte r v al Every 24 Every 48 Every 72 to Every 7 days or after a tot al of approximate ly 12 hours of dialysis a. Calculated using ideal (lean) body weight.

The following adverse reactions are discussed in other sections of the labeling: [See Boxed Warning, Warnings and Precautions ( 5. 1 [See Warnings and Precautions ( 5. 2 [See Warnings and Precautions ( 5. 3 [See Warnings and Precautions ( 5. 6 [See Warnings and Precautions ( 5. In HIV-infected adult subjects: Most common adverse reactions (incidence greater than or equal to 10%, Grades 2 to 4) are rash, diarrhea, headache, pain, depression, asthenia, and nausea. 1) To report SUSPECTED ADVERSE REACTIONS, contact NorthStar Rx LLC at 1-800-206-7821 or FDA at 1-800-FDA-1088 or www. gov/medwatch Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Clinical Trials in Adult Patients with HIV-1 Infection Treatment-Naïve Patients Study 903 - Treatment-Emergent Adverse-Reactions: Mild adverse reactions (Grade 1) were common with a similar incidence in both arms and included dizziness, diarrhea, and nausea. Selected treatment-emergent moderate to severe adverse reactions are summarized in Table 4. Table 4 Selected Treatment-Emergent Adverse Reactionsa (Grades 2 to 4) Reported in >=5% in Any Treatment Group in Study 903 (0 to 144 Weeks) Tenofovir disoproxil fumarate Tablets +3TC+EFV d4T+3TC+EFV N=299 N=301 Body as a Whole Digestive System Metabolic Disorders b Musculoskeletal Nervous System c Respiratory Skin and Appendages d a. Frequencies of adverse reactions are based on all treatment-emergent adverse events, regardless of relationship to study drug. Laboratory Abnormalities: Table 5 Grades 3 to 4 Laboratory Abnormalities Reported in >=1% of Tenofovir Disoproxil Fumarate-Treated Subjects in Study 903 (0 to 144 Weeks) Tenofovir disoproxil fumarate Tablets+3TC+EFV d4T+3TC+EFV N=299 N = 301 Any >= Grade 3 Laboratory Abnormality 36% 42% Fasting Cholesterol (>240 mg/dL) 19% 40% Creatine Kinase (M: >990 U/L; F: >845 U/L) 12% 12% Serum Amylase (>175 U/L) 9% 8% AST (M: >180 U/L; F: >170 U/L) 5% 7% ALT (M: >215 U/L; F: >170 U/L) 4% 5% Hematuria (>100 RBC/HPF) 7% 7% Neutrophils (<750/mm 3 3% 1% Fasting Triglycerides (>750 mg/dL) 1% 9% Study 934 en dash Treatment-Emergent Adverse Reactions: registered Changes in Bone Mineral Density [See Warnings and Precautions (5. Table 6 Selected Treatment-Emergent Adverse Reactions a Tenofovir disoproxil fumarate Tablets b AZT/3TC+EFV N=257 N=254 Gastrointestinal Disorder General Disorders and Administration Infections and Infestations Nervous System Disorders Psychiatric Disorders Skin and Subcutaneous Tissue c a. Laboratory Abnormalities: Table 7 Significant Laboratory Abnormalities Reported in >=1% of Subjects in Any Treatment Group in Study 934 (0 to 144 Weeks) Tenofovir disoproxil fumarate a AZT/3TC+EFV N=257 N=254 Any >= Grade 3 Laboratory Abnormality 30% 26% Fasting Cholesterol (>240 mg/dL) 22% 24% Creatine Kinase Serum Amylase (>175 U/L) 8% 4% Alkaline Phosphatase (>550 U/L) 1% 0% AST (M: >180 U/L; F: >170 U/L) 3% 3% ALT (M: >215 U/L; F: >170 U/L) 2% Hemoglobin (<8 mg/dL) 0% 4% Hyperglycemia (>250 mg/dL) 2% 1% Hematuria (>75 RBC/HPF) 3% 2% Glycosuria (³3+) <1% 1% Neutrophils (<750/mm 3 3% 5% Fasting Triglycerides (>750 mg/dL) 4% 2% a. From Weeks 96 to 144 of the trial, subjects received TRUVADA with efavirenz in place of tenofovir disoproxil fumarate tablets + EMTRIVA with efavirenz. Treatment-Experienced Patients Table 8 Selected Treatment-Emergent Adverse Reactionsa (Grades 2 to 4) Reported in >=3% in Any Treatment Group in Study 907 (0 to 48 Weeks) Tenofovir disoproxil fumarate Tablets ( N=3 68) (Week 0 -2 4) Placebo ( N=1 82) (Week 0 -2 4) Tenofovir disoproxil fumarate Tablets ( N=3 68) (Week 0 -4 8) Placebo C rosso ver to T enofovir disoproxil fumarate Tablets ( N=1 70) (Week 2 4 -4 8) Body as a Whole Dig estive System R espiratory Ner vous S ys tem b Skin and A ppend age c Musculoskeletal Metabol ic a. Laboratory Abnormalities: Table 9 Grades 3 to 4 Laboratory Abnormalities Reported in >=1% of Tenofovir Disoproxil Fumarate Tablets-Treated Subjects in Study 907 (0 to 48 Weeks) Tenofovir disoproxil fumarate Tablets ( N=3 68) (Week 0-2 4) Placebo ( N=1 82) (Week 0-2 4) Tenofovir disoproxil fumarate Tablets ( N=3 68) (Week 0-4 8) Placebo Cro sso ver to Tenofovir disoproxil fumarate (N=170) (Week 24-48) Any >= Gra de 3 Lab orat ory 25% 38% 35% 34% Triglyceri des (> 750 mg/ dL) 8% 13% 11% 9% Cr eatine Kin ase 7% 14% 12% 12% Serum Amyl a se (>1 75 U/ L) 6% 7% 7% 6% Glycosuria (>= 3+) 3% 3% 3% 2% AST (M: >180 U/L; F: >170 U/L) 3% 3% 4% 5% ALT (M: >215 U/L; F: >170 U/L) 2% 2% 4% 5% Serum Gl u c o se (>2 50 U/ L) 2% 4% 3% 3% Neutrophi ls (<7 50/mm 3 1% 1% 2% 1% Clinical Trials in Pediatric Subjects 2 Years of Age and Older with HIV-1 Infection [See Warnings and Precautions (5. Changes in Bone Mineral Density: [See Warnings and Precautions (5. Clinical Trials in Adult Subjects with Chronic Hepatitis B and Compensated Liver Disease Treatment-Emergent Adverse Reactions: Laboratory Abnormalities: Table 10 Grades 3 to 4 Laboratory Abnormalities Reported in >=1% of Tenofovir disoproxil fumarate -Treated Subjects in Studies 0102 and 0103 (0 to 48 Weeks) Tenofovir disoproxil fumarate Tablets (N=426) HEPSERA (N=215) Any >= Grade 3 Laboratory Abnormality 19% 13% Creatine Kinase (M: >990 U/L; 2% 3% Serum Amylase (>175 U/L) 4% 1% Glycosuria (>=3+) 3% <1% AST (M: >180 U/L; F: >170 U/L) 4% 4% ALT (M: >215 U/L; F: >170 U/L) 10% 6% The overall incidence of on-treatment ALT flares (defined as serum ALT greater than 2 × baseline and greater than 10 × ULN, with or without associated symptoms) was similar between tenofovir disoproxil fumarate tablets (2. 6%) and HEPSERA (2%). ALT flares generally occurred within the first 4 to 8 weeks of treatment and were accompanied by decreases in HBV DNA levels. No subject had evidence of decompensation. ALT flares typically resolved within 4 to 8 weeks without changes in study medication. Clinical Trials in Adult Subjects with Chronic Hepatitis B and Decompensated Liver Disease [See Clinical Studies (14. Clinical Trials in Pediatric Subjects 12 Years of Age and Older with Chronic Hepatitis B [See Warnings and Precautions ( 5. The following adverse reactions have been identified during postapproval use of tenofovir disoproxil fumarate tablets. Because postmarketing reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Immune System Disorders Metabolism and Nutrition Disorders Respiratory, Thoracic, and Mediastinal Disorders Gastrointestinal Disorders Hepatobiliary Disorders Skin and Subcutaneous Tissue Disorders Musculoskeletal and Connective Tissue Disorders Renal and Urinary Disorders General Disorders and Administration Site Conditions.

Nursing mothers: Women infected with HIV should be instructed not to breastfeed. 3) Pregnancy Category B Risk Summary Animal Data Nursing Mothers: The Centers for Disease Control and Prevention recommend that HIV-1 infected mothers not breastfeed their infants to avoid risking postnatal transmission of HIV-1. Samples of breast milk obtained from five HIV-1 infected mothers in the first post-partum week show that tenofovir is secreted in human milk. The impact of this exposure in breastfed infants is unknown. Because of both the potential for HIV-1 transmission and the potential for serious adverse reactions in nursing infants, mothers should be instructed not to breastfeed if they are receiving tenofovir disoproxil fumarate tablets. Pediatric Patients 2 Years of Age and Older with HIV-1 infection [See Clinical Pharmacology ( 12. 3 10 [See Warnings and Precautions (5. Pediatric Patients 12 Years of Age and Older with Chronic Hepatitis B Clinical trials of tenofovir disoproxil fumarate tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for the elderly patient should be cautious, keeping in mind the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. It is recommended that the dosing interval for tenofovir disoproxil fumarate tablets be modified in patients with estimated creatinine clearance below 50 mL/min or in patients with ESRD who require dialysis [See Dosage and Administration (2.

This section describes clinically relevant drug interactions with tenofovir disoproxil fumarate tablets. Drug interactions trials are described elsewhere in the labeling [See Clinical Pharmacology ( 12. 3 Tenofovir disoproxil fumarate increases didanosine concentrations. Dose reduction and close monitoring for didanosine toxicity are warranted. 2) Tenofovir is primarily eliminated by the kidneys [see Clinical Pharmacology ( 12. [see Warnings and Precautions ( 5. Table 11 provides a listing of established or clinically significant drug interactions. The drug interactions described are based on studies conducted with tenofovir DF [see Clinical Pharmacology (12. Table 11 Established and Significanta Drug Interactions: Alteration in Dose or Regimen May Be Recommended Based on Drug Interaction Trials Concomitant Drug Class: Drug Name Effect on Concentration b Clinical Comment NRTI: up arrow didanosine Patients receiving tenofovir disoproxil fumarate tablets and didanosine should be monitored closely for didanosine-associated adverse reactions. Discontinue didanosine in patients who develop didanosine-associated adverse reactions. Higher didanosine concentrations could potentiate didanosine-associated adverse reactions, including pancreatitis, and neuropathy. Suppression of CD4+ cell counts has been observed in patients receiving tenofovir disoproxil fumarate tablets with didanosine 400 mg daily. HIV-1 Protease Inhibitors down arrow atazanavir When coadministered with tenofovir disoproxil fumarate tablets, atazanavir 300 mg should be given with ritonavir 100 mg. Hepatitis C Antiviral Agents: up arrow tenofovir Monitor patients receiving tenofovir disoproxil fumarate tablets concomitantly with EPCLUSA registered registered registered a. This table is not all inclusive. up arrow=Increase, down arrow=Decrease.

OVERDOSAGE
Limited clinical experience at doses higher than the therapeutic dose of tenofovir disoproxil fumarate tablets 300 mg are available. In Study 901, 600 mg tenofovir DF was administered to 8 subjects orally for 28 days. No severe adverse reactions were reported. The effects of higher doses are not known.
NONCLINICAL TOXICOLOGY
Carcinogenesis Mutagenesis in vitro in vitro in vivo Impairment of Fertility Tenofovir and tenofovir DF administered in toxicology studies to rats, dogs, and monkeys at exposures (based on AUC s s.
CLINICAL STUDIES
Treatment-Naïve Adult Patients + 3 + + 3 Table 18 Outcomes of Randomized Treatment at Week 48 and 144 (Study 903) Outcomes At Week 48 At Week 144 Tenofovir disoproxil fumarate Tablets+ 3TC+EFV (N=299) d4T+ 3TC+EFV (N=301) Tenofovir disoproxil fumarate Tablets+ 3TC+EFV (N=299) d4T+3TC +EFV (N=301) Responder a 79% 82% 68% 62% Virologic failure b 6% 4% 10% 8% Rebound 5% 3% 8% 7% Never suppressed 0% 1% 0% 0% Added an antiretroviral agent 1% 1% 2% 1% Death <1% 1% <1% 2% Discontinued due to adverse event 6% 6% 8% 13% Discontinued for other reasons c 8% 7% 14% 15% a. Subjects achieved and maintained confirmed HIV-1 RNA <400 copies/mL through Week 48 and 144. + 3 + Study 934 3 + 3 + 3 Table 19 Outcomes of Randomized Treatment at Week 48 and 144 (Study 934) Outcomes At Week 48 At Week 144 FTC + Tenofovir disoproxil fumarate Tablets+ EFV (N=244) AZT/3TC +EFV (N=243) FTC+T enofovir disoproxil fumarate Tablets+EFV (N=227) a AZT/3TC +EFV (N=229) a Responder b 84% 73% 71% 58% Virologic failure c 2% 4% 3% 6% Rebound 1% 3% 2% 5% Never suppressed 0% 0% 0% 0% Change in antiretroviral 1% 1% 1% 1% Death <1% 1% 1% 1% Discontinued due to 4% 9% 5% 12% Discontinued for other d 10% 14% 20% 22% a. Subjects who were responders at Week 48 or Week 96 (HIV-1 RNA <400 copies/mL) but did not consent to continue the trial after Week 48 or Week 96 were excluded from analysis. + 3 3 3 Treatment-Experienced Adult Patients Table 20 Outcomes of Randomized Treatment (Study 907) Outcomes 0en dash24 weeks 0en dash48 weeks 24en dash48 weeks Tenofovir disoproxil fumarate Tablets (N=368) Placebo (N=182) Tenofovir disoproxil fumarate Tablets (N=368) Placebo Crossover to Tenofovir disoproxil fumarate Tablets (N=170) HIV-1 RNA <400 copies/mL a 40% 11% 28% 30% Virologic failure b 53% 84% 61% 64% Discontinued due to adverse event 3% 3% 5% 5% Discontinued for other reasons c 3% 3% 5% 1% a. Subjects with HIV-1 RNA <400 copies/mL and no prior study drug discontinuation at Week 24 and 48, respectively. + 3 + 3 HBeAg-Negative Chronic Hepatitis B + 10 HBeAg-Positive Chronic Hepatitis B 10 Table 21 Histological, Virological, Biochemical, and Serological Response at Week 48 0102 (HBeAg-) 0103 (HBeAg+) Tenofovir disoproxil fumarate Tablets (N=250) HEPSERA (N=125) Tenofovir disoproxil fumarate Tablets(N=176) HEPSERA (N=90) Complete Response 71% 49% 67% 12% Histology a 72% 69% 74% 68% HBV DNA 93% 63% 76% 13% ALT b 76% 77% 68% 54% Serology NA c NA c 20%/19% 16%/16% HBsAg Loss/ 0/0 0/0 3%/1% 0/0 a. Knodell necroinflammatory score improvement of at least 2 points without worsening in Knodell fibrosis. Treatment Beyond 48 Weeks Patients with Lamivudine-Resistant Chronic Hepatitis B Patients with Chronic Hepatitis B and Decompensated Liver Disease [See Adverse Reactions (6.
PATIENT INFORMATION
Patient Information What is the most important information I should know about tenofovir disoproxil fumarate tablets? Worsening of your Hepatitis B infection. Do not Do not Talk to your doctor about taking an HIV test before starting treatment with tenofovir disoproxil fumarate tablets for chronic hepatitis B. You should also get a test for HBV if you are taking tenofovir disoproxil fumarate tablets for treatment of HIV. Tenofovir disoproxil fumarate tablets does not cure HIV infection or AIDS. What should I tell my healthcare provider before taking tenofovir disoproxil fumarate tablets? Before you take tenofovir disoproxil fumarate tablets, tell your healthcare provider if you: Pregnancy Registry. Do not breastfeed if you are taking tenofovir disoproxil fumarate tablets. Tell your healthcare provider about all the medicines you take, Do not start a new medicine without telling your healthcare provider. How should I take tenofovir disoproxil fumarate tablets? What are the possible side effects of tenofovir disoproxil fumarate tablets? Too much lactic acid in your blood (lactic acidosis). Severe liver problems. Bone problems Changes in your immune system (Immune Reconstitution Syndrome) How should I store tenofovir disoproxil fumarate tablets? Keep tenofovir disoproxil fumarate tablets and all medicines out of the reach of children. Do not share or re-use needles or other injection equipment. What are the ingredients in tenofovir disoproxil fumarate tablets? Inactive Ingredients: Tablet Coating: Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

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TENOFOVIR DISOPROXIL FUMARATE- tenofovir disoproxil fumarate_tablet, film coated Product manual source documgent