An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
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Treatment of HIV-1 Infection
Emtricitabine/tenofovir disoproxil fumarate tablets are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 17 kg.
HIV-1 Pre-Exposure Prophylaxis (PrEP)
Emtricitabine/tenofovir disoproxil fumarate tablets are indicated in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in at-risk adults and adolescents weighing at least 35 kg. Individuals must have a negative HIV-1 test immediately prior to initiating Emtricitabine/tenofovir disoproxil fumarate tablets for HIV-1 PrEP.
If clinical symptoms consistent with acute viral infection are present and recent (<1 month) exposures are suspected, delay starting PrEP for at least one month and reconfirm HIV-1 status or use a test cleared by the FDA as an aid in the diagnosis of HIV-1 infection, including acute or primary HIV-1 infection.
When considering Emtricitabine/tenofovir disoproxil fumarate tablets for HIV-1 PrEP, factors that help to identify individuals at risk may include:
has partner(s) known to be HIV-1 infected, or
engages in sexual activity within a high prevalence area or social network and has additional risk factors for HIV-1 acquisition, such as:
inconsistent or no condom use
diagnosis of sexually transmitted infections
exchange of sex for commodities (such as money, food, shelter, or drugs)
use of illicit drugs or alcohol dependence
incarceration
partner(s) of unknown HIV-1 status with any of the factors listed above
Testing Prior to Initiation of Emtricitabine/tenofovir disoproxil fumarate Tablets for Treatment of HIV-1 Infection or for HIV-1 PrEP
Prior to or when initiating Emtricitabine/tenofovir disoproxil fumarate tablets, test patients for hepatitis B virus infection.
Prior to initiation and during use of Emtricitabine/tenofovir disoproxil fumarate tablets, 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 phosphorus.
HIV-1 Screening for Individuals Receiving Emtricitabine/tenofovir disoproxil fumarate Tablets for HIV-1 PrEP
Screen all patients for HIV-1 infection before initiating Emtricitabine/tenofovir disoproxil fumarate tablets for HIV-1 PrEP and at least once every 3 months while taking Emtricitabine/tenofovir disoproxil fumarate tablets.
Recommended Dosage for Treatment of HIV-1 Infection in Adults and Pediatric Patients Weighing at Least 35 kg
Emtricitabine/tenofovir disoproxil fumarate tablets is a two-drug fixed dose combination product containing Emtricitabine/tenofovir disoproxil fumarate (FTC) and tenofovir disoproxil fumarate (TDF). The recommended dosage of Emtricitabine/tenofovir disoproxil fumarate in adults and in pediatric patients weighing at least 35 kg is one tablet (containing 200 mg of FTC and 300 mg of TDF) once daily taken orally with or without food.
Recommended Dosage for Treatment of HIV-1 Infection in Pediatric Patients Weighing at Least 17 kg and Able to Swallow a Tablet
The recommended oral dosage of Emtricitabine/tenofovir disoproxil fumarate tablets for pediatric patients weighing at least 17 kg and who can swallow a tablet is presented in Table 1. Tablets should be taken once daily with or without food. Weight should be monitored periodically and the Emtricitabine/tenofovir disoproxil fumarate tablets dose adjusted accordingly.
Table 1 Dosing for Treatment of HIV-1 Infection in Pediatric Patients Weighing 17 kg to less than 35 kg
Body Weight (kg)
Dosing of Emtricitabine/tenofovir disoproxil fumarate Tablets (FTC/TDF)
17 to less than 22
one 100 mg /150 mg tablet once daily
22 to less than 28
one 133 mg /200 mg tablet once daily
28 to less than 35
one 167 mg /250 mg tablet once daily
Recommended Dosage for HIV-1 PrEP
The dosage of Emtricitabine/tenofovir disoproxil fumarate tablets in HIV-1 uninfected adults and adolescents weighing at least 35 kg is one tablet (containing 200 mg of FTC and 300 mg of TDF) once daily taken orally with or without food.
Dosage Adjustment in Patients with Renal Impairment
Treatment of HIV-1 Infection
Table 2 provides dosage interval adjustment for patients with renal impairment. No dosage adjustment is necessary for HIV-1 infected patients with mild renal impairment (creatinine clearance 50 to 80 mL/min). The safety and effectiveness of the dosing interval adjustment recommendations in patients with moderate renal impairment (creatinine clearance 30 to 49 mL/min) have not been clinically evaluated; therefore, clinical response to treatment and renal function should be closely monitored in these patients.
No data are available to make dosage recommendations in pediatric patients with renal impairment.
Table 2 Dosage Interval Adjustment for HIV-1 Infected Adult Patients with Altered Creatinine Clearance
Creatinine Clearance (mL/min)a
> 50
30 to 49
< 30
(Including Patients Requiring Hemodialysis)
Recommended Dosing Interval
Every 24 hours
Every 48 hours
Emtricitabine/tenofovir disoproxil fumarate tablets are not recommended.
a. Calculated using ideal (lean) body weight
HIV-1 PrEP
Emtricitabine/tenofovir disoproxil fumarate tablets for HIV-1 PrEP is not recommended in HIV-1 uninfected individuals with estimated creatinine clearance below 60 mL/min.
If a decrease in estimated creatinine clearance is observed in uninfected individuals while using Emtricitabine/tenofovir disoproxil fumarate tablets for HIV-1 PrEP, evaluate potential causes and re-assess potential risks and benefits of continued use.
Emtricitabine/tenofovir disoproxil fumarate side effects
The following adverse reactions are discussed in other sections of the labeling:
Severe Acute Exacerbations of Hepatitis B in Patients with HBV Infection.
New Onset or Worsening Renal Impairment.
Immune Reconstitution Syndrome.
Bone Loss and Mineralization Defects.
Lactic Acidosis/Severe Hepatomegaly with Steatosis.
Clinical Trials Experience
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.
Adverse Reactions from Clinical Trials Experience in HIV-1 Infected Subjects
Clinical Trials in Adult Subjects
In Study 934, 511 antiretroviral-naïve subjects received efavirenz (EFV) administered in combination with either FTC+TDF (N=257) or zidovudine (AZT)/lamivudine (3TC) (N=254) for 144 weeks. The most common adverse reactions (incidence greater than or equal to 10%, all grades) included diarrhea, nausea, fatigue, headache, dizziness, depression, insomnia, abnormal dreams, and rash. Table 3 provides the treatment-emergent adverse reactions (Grades 2 to 4) occurring in greater than or equal to 5% of subjects treated in any treatment group.
Skin discoloration, manifested by hyperpigmentation, occurred in 3% of subjects taking FTC+TDF, and was generally mild and asymptomatic. The mechanism and clinical significance are unknown.
Table 3 Selected Adverse Reactionsa (Grades 2 to 4) Reported in > 5% in Any Treatment Group in Study 934 (0 to 144 Weeks)
FTC+TDF+EFVb
AZT/3TC+EFV
N=257
N=254
Fatigue
9%
8%
Depression
9%
7%
Nausea
9%
7%
Diarrhea
9%
5%
Dizziness
8%
7%
Upper respiratory tract infections
8%
5%
Sinusitis
8%
4%
Rash eventc
7%
9%
Headache
6%
5%
Insomnia
5%
7%
Nasopharyngitis
5%
3%
Vomiting
2%
5%
a. Frequencies of adverse reactions are based on all treatment-emergent adverse events, regardless of relationship to study drug.
b. From Weeks 96 to 144 of the trial, subjects received Emtricitabine/tenofovir disoproxil fumarate with efavirenz in place of FTC+TDF with efavirenz.
c. Rash event includes rash, exfoliative rash, rash generalized, rash macular, rash maculo-papular, rash pruritic, and rash vesicular.
Laboratory Abnormalities: Laboratory abnormalities observed in this trial were generally consistent with those seen in other trials of TDF and/or FTC (Table 4).
Table 4 Significant Laboratory Abnormalities Reported in > 1% of Subjects in Any Treatment Group in Study 934 (0 to 144 Weeks)
FTC+TDF+EFVa
AZT/3TC+EFV
N=257
N=254
Any > Grade 3 Laboratory Abnormality
30%
26%
Fasting Cholesterol (> 240 mg/dL)
22%
24%
Creatine Kinase
(M: > 990 U/L)
(F: > 845 U/L)
9%
7%
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%
3%
Hemoglobin (< 8.0 mg/dL)
0%
4%
Hyperglycemia (> 250 mg/dL)
2%
1%
Hematuria (> 75 RBC/HPF)
3%
2%
Glycosuria (> 3+)
<1%
1%
Neutrophils (< 750/mm3)
3%
5%
Fasting Triglycerides (> 750 mg/dL)
4%
2%
a. From Weeks 96 to 144 of the trial, subjects received Emtricitabine/tenofovir disoproxil fumarate with efavirenz in place of FTC+TDF with efavirenz.
Clinical Trials in Pediatric Subjects
Emtricitabine/tenofovir disoproxil fumarate: In addition to the adverse reactions reported in adults, anemia and hyperpigmentation were observed in 7% and 32%, respectively, of pediatric subjects (3 months to less than 18 years of age) who received treatment with FTC in the larger of two open-label, uncontrolled pediatric trials (N=116).
Tenofovir Disoproxil Fumarate: In pediatric clinical trials (Studies 352 and 321) conducted in 184 HIV-1 infected subjects 2 to less than 18 years of age, the adverse reactions observed in pediatric subjects who received treatment with TDF were consistent with those observed in clinical trials of TDF in adults.
In Study 352 (2 to less than 12 years of age), 89 pediatric subjects received TDF for a median exposure of 104 weeks. Of these, 4 subjects discontinued from the trial due to adverse reactions consistent with proximal renal tubulopathy. Three of these 4 subjects presented with hypophosphatemia and had decreases in total body or spine BMD Z-score. Total body BMD gain at Week 48 was less in the TDF group compared to the stavudine (d4T) or zidovudine (AZT) treatment groups. The mean rate of BMD gain in lumbar spine was similar between treatment groups. One TDF-treated subject and none of the d4T- or AZT-treated subjects experienced significant (greater than 4%) lumbar spine BMD loss at Week 48. Changes from baseline in BMD Z-scores were −0.012 for lumbar spine and −0.338 for total body in the 64 subjects who were treated with TDF for 96 weeks.
In Study 321 (12 to less than 18 years of age), the mean rate of BMD gain at Week 48 was less in the TDF compared to the placebo treatment group. Six TDF-treated subjects and one placebo-treated subject had significant (greater than 4%) lumbar spine BMD loss at Week 48. Changes from baseline BMD Z-scores were −0.341 for lumbar spine and −0.458 for total body in the 28 subjects who were treated with TDF for 96 weeks.
In both trials, skeletal growth (height) appeared to be unaffected.
Adverse Reactions from Clinical Trial Experience in Uninfected Subjects Taking Emtricitabine/tenofovir disoproxil fumarate for HIV-1 PrEP
Clinical Trials in Adult Subjects
The safety profile of Emtricitabine/tenofovir disoproxil fumarate for HIV-1 PrEP was comparable to that observed in clinical trials of HIV-infected subjects based on two randomized placebo-controlled clinical trials (iPrEx, Partners PrEP) in which 2,830 HIV-1 uninfected adults received Emtricitabine/tenofovir disoproxil fumarate once daily for HIV-1 PrEP. Subjects were followed for a median of 71 weeks and 87 weeks, respectively. Table 5 provides a list of selected adverse events that occurred in 2% or more of subjects in any treatment group in the iPrEx trial, with an incidence greater than placebo.
Table 5 Selected Adverse Events (All Grades) Reported in > 2% in Any Treatment Group in the iPrEx Trial and Greater than Placebo
FTC/TDF
(N=1251)
Placebo
(N=1248)
Headache
7%
6%
Abdominal pain
4%
2%
Weight decreased
3%
2%
In the Partners PrEP trial, the frequency of adverse events in the Emtricitabine/tenofovir disoproxil fumarate treatment group was generally either less than or the same as in the placebo group.
Laboratory Abnormalities: Table 6 provides a list of Grade 2 to 4 laboratory abnormalities observed in the iPrEx and Partners PrEP trials. Six subjects in the TDF-containing arms of the Partners PrEP trial discontinued from the trial due to an increase in serum creatinine compared with no discontinuations in the placebo group. One subject in the Emtricitabine/tenofovir disoproxil fumarate arm of the iPrEx trial discontinued from the trial due to an increase in serum creatinine and another subject discontinued due to low serum phosphorus. Grades 2 to 3 proteinuria (2 to 4+) and/or glycosuria (3+) occurred in less than 1% of subjects treated with Emtricitabine/tenofovir disoproxil fumarate in the iPrEx trial and Partners PrEP trial.
Table 6 Laboratory Abnormalities (Highest Toxicity Grade Reported for Each Subject) in the iPrEx Trial and Partners PrEP Trial
Grade 2 to 4a
iPrEx Trial
Partners PrEP Trial
FTC/TDF
(N=1251)
Placebo
(N=1248)
FTC/TDF
(N=1579)
Placebo
(N=1584)
Creatinine (> 1.4 × ULN)
< 1%
< 1%
< 1%
< 1%
Phosphorus (< 2.0 mg/dL)
10%
8%
9%
9%
AST (> 2.6 × ULN)
5%
5%
<1%
<1%
ALT (> 2.6 × ULN)
7%
7%
< 1%
< 1%
Hemoglobin (< 9.4 mg/dL)
1%
2%
2%
2%
Neutrophils (< 750/mm3)
< 1%
< 1%
5%
3%
a. Grading is per DAIDS criteria.
Changes in Bone Mineral Density: In clinical trials of HIV-1 uninfected individuals, decreases in BMD were observed. In the iPrEx trial, a substudy of 503 subjects found mean changes from baseline in BMD ranging from –0.4% to –1.0% across total hip, spine, femoral neck, and trochanter in the Emtricitabine/tenofovir disoproxil fumarate group compared with the placebo group, which returned toward baseline after discontinuation of treatment. Thirteen percent of Emtricitabine/tenofovir disoproxil fumarate-treated subjects versus 6% of placebo-treated subjects lost at least 5% of BMD at the spine during treatment. Bone fractures were reported in 1.7% of the Emtricitabine/tenofovir disoproxil fumarate group compared with 1.4% in the placebo group. No correlation between BMD and fractures was noted. The Partners PrEP trial found similar fracture rates between the treatment and placebo groups (0.8% and 0.6%, respectively); no BMD evaluations were performed in this trial.
Clinical Trials in Adolescent Subjects
In a single-arm, open-label clinical trial (ATN113), in which 67 HIV-1 uninfected adolescent (15 to 18 years of age) men who have sex with men received Emtricitabine/tenofovir disoproxil fumarate once daily for HIV-1 PrEP, the safety profile of Emtricitabine/tenofovir disoproxil fumarate was similar to that observed in adults. Median duration to exposure of Emtricitabine/tenofovir disoproxil fumarate was 47 weeks.
In the ATN113 trial, median BMD increased from baseline to Week 48, +2.58% for lumbar spine and +0.72% for total body. One subject had significant (greater than or equal to 4%) total body BMD loss at Week 24. Median changes from baseline BMD Z-scores were 0.0 for lumbar spine and −0.2 for total body at Week 48. Three subjects showed a worsening (change from > −2 to ≤ −2) from baseline in their lumbar spine or total body BMD Z-scores at Week 24 or 48. Interpretation of these data, however, may be limited by the low rate of adherence to Emtricitabine/tenofovir disoproxil fumarate by Week 48.
Postmarketing Experience
The following adverse reactions have been identified during postapproval use of TDF. No additional adverse reactions have been identified during postapproval use of FTC. 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.
General Disorders and Administration Site Conditions asthenia
The following adverse reactions, listed under the body system headings above, may occur as a consequence of proximal renal tubulopathy: rhabdomyolysis, osteomalacia, hypokalemia, muscular weakness, myopathy, hypophosphatemia.
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References
DailyMed. "EMTRICITABINE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
DailyMed. "EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
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