What is Emtricitabine/Tenofovir disoproxil Sandoz?
Emtricitabine/Tenofovir disoproxil Sandoz and Tenofovir (Emtricitabine/Tenofovir disoproxil Sandoz) combination is used with other medicines for the treatment of the infection caused by the human immunodeficiency virus (HIV). HIV is the virus that causes acquired immune deficiency syndrome (AIDS). Emtricitabine/Tenofovir disoproxil Sandoz and Tenofovir (Emtricitabine/Tenofovir disoproxil Sandoz) is also used as part of a complete prevention strategy (Pre-Exposure prophylaxis) to reduce the risk of getting HIV infection in adults that are at high risk.
Emtricitabine/Tenofovir disoproxil Sandoz and Tenofovir (Emtricitabine/Tenofovir disoproxil Sandoz) combination will not cure or prevent HIV infection or the symptoms of AIDS. It helps keep HIV from reproducing, and appears to slow down the destruction of the immune system. This may help delay the development of serious health problems usually related to AIDS or HIV infection. Emtricitabine/Tenofovir disoproxil Sandoz and Tenofovir (Emtricitabine/Tenofovir disoproxil Sandoz) combination will not keep you from spreading HIV to other people. People who receive Emtricitabine/Tenofovir disoproxil Sandoz and Tenofovir (Emtricitabine/Tenofovir disoproxil Sandoz) may continue to have other problems usually related to AIDS or HIV infection.
Emtricitabine/Tenofovir disoproxil Sandoz and Tenofovir (Emtricitabine/Tenofovir disoproxil Sandoz) is available only with your doctor's prescription.
Emtricitabine/Tenofovir disoproxil Sandoz indications
Treatment Of HIV-1 Infection
Emtricitabine/Tenofovir disoproxil Sandoz®, a combination of EMTRIVA® and VIREAD®, is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 17 kg..
The following points should be considered when initiating therapy with Emtricitabine/Tenofovir disoproxil Sandoz for the treatment of HIV-1 infection:
- It is not recommended that Emtricitabine/Tenofovir disoproxil Sandoz be used as a component of a triple nucleoside regimen.
- Emtricitabine/Tenofovir disoproxil Sandoz should not be coadministered with ATRIPLA®, COMPLERA®, EMTRIVA, GENVOYA®, ODEFSEY®, STRIBILD®, VIREAD or lamivudine-containing products.
- In treatment experienced patients, the use of Emtricitabine/Tenofovir disoproxil Sandoz should be guided by laboratory testing and treatment history.
Pre-Exposure Prophylaxis
Emtricitabine/Tenofovir disoproxil Sandoz is indicated in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults at high risk. This indication is based on clinical trials in men who have sex with men (MSM) at high risk for HIV-1 infection and in heterosexual serodiscordant couples.
When considering Emtricitabine/Tenofovir disoproxil Sandoz for pre-exposure prophylaxis the following factors may help to identify individuals at high risk:
- has partner(s) known to be HIV-1 infected, or
- engages in sexual activity within a high prevalence area or social network and one or more of the following:
- 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
When prescribing Emtricitabine/Tenofovir disoproxil Sandoz for pre-exposure prophylaxis, healthcare providers must:
- prescribe Emtricitabine/Tenofovir disoproxil Sandoz as part of a comprehensive prevention strategy because Emtricitabine/Tenofovir disoproxil Sandoz is not always effective in preventing the acquisition of HIV-1 infection;
- counsel all uninfected individuals to strictly adhere to the recommended Emtricitabine/Tenofovir disoproxil Sandoz dosing schedule because the effectiveness of Emtricitabine/Tenofovir disoproxil Sandoz in reducing the risk of acquiring HIV-1 was strongly correlated with adherence as demonstrated by measurable drug levels in clinical trials;
- confirm a negative HIV-1 test immediately prior to initiating Emtricitabine/Tenofovir disoproxil Sandoz for a PrEP indication. 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 approved by the FDA as an aid in the diagnosis of HIV-1 infection, including acute or primary HIV-1 infection.; and
- screen for HIV-1 infection at least once every 3 months while taking Emtricitabine/Tenofovir disoproxil Sandoz for PrEP.
How should I use Emtricitabine/Tenofovir disoproxil Sandoz?
Use Emtricitabine/Tenofovir disoproxil Sandoz as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Emtricitabine/Tenofovir disoproxil Sandoz comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Emtricitabine/Tenofovir disoproxil Sandoz refilled.
- Take Emtricitabine/Tenofovir disoproxil Sandoz by mouth with or without food.
- Continue to take Emtricitabine/Tenofovir disoproxil Sandoz even if you feel well. Do not miss any doses.
- Do not suddenly stop taking Emtricitabine/Tenofovir disoproxil Sandoz without checking with your doctor. Some conditions (eg, hepatitis B) could become worse if you suddenly stop taking Emtricitabine/Tenofovir disoproxil Sandoz.
- Taking Emtricitabine/Tenofovir disoproxil Sandoz at the same time each day will help you remember to take it.
- If you miss a dose of Emtricitabine/Tenofovir disoproxil Sandoz, take it as soon as possible. If you do not remember until the next day, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. Do not take more than 1 dose in the same day.
Ask your health care provider any questions you may have about how to use Emtricitabine/Tenofovir disoproxil Sandoz.
Uses of Emtricitabine/Tenofovir disoproxil Sandoz in details
Use: Labeled Indications
HIV-1 infection, treatment: Treatment of HIV-1 infection in combination with other antiretroviral agents in adults and pediatric patients weighing ≥17 kg
HIV-1 infection, preexposure prophylaxis: Preexposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in at-risk adults and adolescents weighing ≥35 kg, in combination with safer sex practices.
Off Label Uses
HIV-1/hepatitis B co-infection, treatment
Based on the Department of Health and Human Services guidelines for the use of antiretroviral agents in adults and adolescents with HIV, Emtricitabine/Tenofovir disoproxil Sandoz is effective and recommended as the nucleoside reverse transcriptase inhibitor backbone of a fully suppressive antiretroviral regimen in patients with HIV-1 co-infected with hepatitis B.
HIV-1 nonoccupational postexposure prophylaxis
Based on the Centers for Disease Control and Prevention, US Department of Health and Human Services updated guidelines for antiretroviral postexposure prophylaxis after sexual, injection drug use, or other nonoccupational exposure to HIV, Emtricitabine/Tenofovir disoproxil Sandoz (in combination with other antiretrovirals) is effective and recommended for postexposure prophylaxis of HIV-1 infection following nonoccupational exposure in individuals exposed to blood, genital secretions, or other potentially infectious body fluids that may contain HIV when that exposure represents a substantial risk for HIV transmission.
HIV-1 occupational postexposure prophylaxis
Based on the US Public Health Service updated guidelines for the management of occupational exposures to human immunodeficiency virus and recommendations for postexposure prophylaxis, Emtricitabine/Tenofovir disoproxil Sandoz (in combination with raltegravir) is an effective and recommended treatment option for postexposure prophylaxis of HIV-1 infection in healthcare personnel following occupational exposure to blood and/or other body fluids that may contain HIV.
HIV-1 infection, preexposure prophylaxis in injecting drug users
Based on a Centers for Disease Control and Prevention Morbidity and Mortality Weekly Report, Emtricitabine/Tenofovir disoproxil Sandoz is effective and recommended as pre-exposure prophylaxis of HIV-1 infection in injecting drug users who are at risk for parenteral acquisition of HIV but not at risk for sexual acquisition of HIV.
Emtricitabine/Tenofovir disoproxil Sandoz description
Emtricitabine/Tenofovir disoproxil Sandoz tablets are fixed dose combination tablets containing Emtricitabine/Tenofovir disoproxil Sandoz and Tenofovir (Emtricitabine/Tenofovir disoproxil Sandoz) disoproxil fumarate. Emtricitabine/Tenofovir disoproxil Sandoz is a synthetic nucleoside analog of cytidine. Tenofovir (Emtricitabine/Tenofovir disoproxil Sandoz) disoproxil fumarate (Tenofovir (Emtricitabine/Tenofovir disoproxil Sandoz) DF) is converted in vivo to Tenofovir (Emtricitabine/Tenofovir disoproxil Sandoz), an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5′-monophosphate. Both Emtricitabine/Tenofovir disoproxil Sandoz and Tenofovir (Emtricitabine/Tenofovir disoproxil Sandoz) exhibit inhibitory activity against HIV-1 reverse transcriptase.
Emtricitabine/Tenofovir disoproxil Sandoz: The chemical name of Emtricitabine/Tenofovir disoproxil Sandoz is 5-fluoro-1-(2R,5S)-[2-(hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine. Emtricitabine/Tenofovir disoproxil Sandoz is the (-) enantiomer of a thio analog of cytidine, which differs from other cytidine analogs in that it has a fluorine in the 5-position.
It has a molecular formula of C8H10FN3O3S and a molecular weight of 247.24.
Emtricitabine/Tenofovir disoproxil Sandoz is a white to off-white crystalline powder with a solubility of approximately 112 mg/mL in water at 25°C. The partition coefficient (log p) for Emtricitabine/Tenofovir disoproxil Sandoz is -0.43 and the pKa is 2.65.
Tenofovir (Emtricitabine/Tenofovir disoproxil Sandoz) Disoproxil Fumarate: Tenofovir (Emtricitabine/Tenofovir disoproxil Sandoz) disoproxil fumarate is a fumaric acid salt of the bis-isopropoxycarbonyloxymethyl ester derivative of Tenofovir (Emtricitabine/Tenofovir disoproxil Sandoz). The chemical name of Tenofovir (Emtricitabine/Tenofovir disoproxil Sandoz) disoproxil fumarate is 9-[(R)-2 [[bis[[(isopropoxycarbonyl)oxy]- methoxy]phosphinyl]methoxy]propyl]adenine fumarate (1:1). It has a molecular formula of C19H30N5O10P·C4H4O4 and a molecular weight of 635.52.
Tenofovir (Emtricitabine/Tenofovir disoproxil Sandoz) disoproxil fumarate is a white to off-white crystalline powder with a solubility of 13.4 mg/mL in water at 25°C. The partition coefficient (log p) for Tenofovir (Emtricitabine/Tenofovir disoproxil Sandoz) disoproxil is 1.25 and the pKa is 3.75. All dosages are expressed in terms of Tenofovir (Emtricitabine/Tenofovir disoproxil Sandoz) disoproxil fumarate except where otherwise noted.
Emtricitabine/Tenofovir disoproxil Sandoz tablets are for oral administration. Each film-coated tablet contains 200 mg of Emtricitabine/Tenofovir disoproxil Sandoz and 300 mg of Tenofovir (Emtricitabine/Tenofovir disoproxil Sandoz) disoproxil fumarate, (which is equivalent to 245 mg of Tenofovir (Emtricitabine/Tenofovir disoproxil Sandoz) disoproxil), as active ingredients.
Excipients/Inactive Ingredients: Croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and pregelatinized starch (gluten free). The tablets are coated with Opadry II Blue Y-30-10701, which contains FD&C Blue #2 aluminum lake, hydroxypropyl methylcellulose 2910, lactose monohydrate, titanium dioxide, and triacetin.
Emtricitabine/Tenofovir disoproxil Sandoz dosage
Emtricitabine/Tenofovir disoproxil Sandoz Dosage
Generic name: Emtricitabine/Tenofovir disoproxil Sandoz 200mg, Tenofovir (Emtricitabine/Tenofovir disoproxil Sandoz) disoproxil fumarate 300mg
Dosage form: tablet, film coated
The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.
Recommended Dose for Treatment of HIV-1 Infection in Adults and Pediatric Patients Weighing 35 Kg or More
The recommended dose of Emtricitabine/Tenofovir disoproxil Sandoz in adults and in pediatric patients with body weight greater than or equal to 35 kg is one tablet (containing 200 mg of Emtricitabine/Tenofovir disoproxil Sandoz and 300 mg of Tenofovir (Emtricitabine/Tenofovir disoproxil Sandoz) disoproxil fumarate) once daily taken orally with or without food.
Recommended Dose for Treatment of HIV-1 Infection in Pediatric Patients Weighing at Least 17 kg and Able to Swallow a Whole Tablet
The recommended oral dose for pediatric patients weighing greater than or equal to 17 kg and who are able to swallow a whole tablet, is one Emtricitabine/Tenofovir disoproxil Sandoz low strength tablet (Emtricitabine/Tenofovir disoproxil Sandoz [FTC]/Tenofovir (Emtricitabine/Tenofovir disoproxil Sandoz) disoproxil fumarate [TDF]) (167 mg/250 mg, 133 mg/200 mg, or 100 mg/150 mg based on body weight) taken orally once daily with or without food.
The recommended oral dosage of Emtricitabine/Tenofovir disoproxil Sandoz low strength tablets is presented in Table 1. Weight should be monitored periodically and the Emtricitabine/Tenofovir disoproxil Sandoz dose adjusted accordingly.
Body Weight (kg) | Dosing of FTC (mg)/TDF (mg) |
---|---|
17 to less than 22 | one 100/150 tablet once daily |
22 to less than 28 | one 133/200 tablet once daily |
28 to less than 35 | one 167/250 tablet once daily |
Recommended Dose for Pre-exposure Prophylaxis
The dose of Emtricitabine/Tenofovir disoproxil Sandoz in HIV-1 uninfected adults is one tablet (containing 200 mg of Emtricitabine/Tenofovir disoproxil Sandoz and 300 mg of Tenofovir (Emtricitabine/Tenofovir disoproxil Sandoz) disoproxil fumarate) once daily taken orally with or without food.
Dose Adjustment for Renal Impairment
Treatment of HIV-1 Infection
Significantly increased drug exposures occurred when EMTRIVA or VIREAD were administered to subjects with moderate to severe renal impairment. Therefore, adjust the dosing interval of Emtricitabine/Tenofovir disoproxil Sandoz in HIV-1 infected adult patients with baseline creatinine clearance 30–49 mL/min using the recommendations in Table 2. These dosing interval recommendations are based on modeling of single-dose pharmacokinetic data in non-HIV infected subjects. The safety and effectiveness of these dosing interval adjustment recommendations have not been clinically evaluated in patients with moderate renal impairment, therefore clinical response to treatment and renal function should be closely monitored in these patients.
No dose adjustment is necessary for HIV-1 infected patients with mild renal impairment (creatinine clearance 50–80 mL/min). No data are available to make dose recommendations in pediatric patients with renal impairment.
Creatinine Clearance (mL/min)* | |||
---|---|---|---|
≥50 | 30–49 | <30 (Including Patients Requiring Hemodialysis) | |
| |||
Recommended Dosing Interval | Every 24 hours | Every 48 hours | Emtricitabine/Tenofovir disoproxil Sandoz should not be administered. |
Routine monitoring of estimated creatinine clearance, serum phosphorus, urine glucose, and urine protein should be performed in all individuals with mild renal impairment.
Pre-exposure Prophylaxis
Do not use Emtricitabine/Tenofovir disoproxil Sandoz for a PrEP indication in HIV-1 uninfected individuals with estimated creatinine clearance below 60 mL/min.
Routine monitoring of estimated creatinine clearance, serum phosphorus, urine glucose, and urine protein should be performed in all individuals with mild renal impairment. If a decrease in estimated creatinine clearance is observed in uninfected individuals while using Emtricitabine/Tenofovir disoproxil Sandoz for PrEP, evaluate potential causes and re-assess potential risks and benefits of continued use.
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Emtricitabine/Tenofovir disoproxil Sandoz interactions
See also:
What other drugs will affect Emtricitabine/Tenofovir disoproxil Sandoz?
Tenofovir (Emtricitabine/Tenofovir disoproxil Sandoz) Disoproxil Fumarate: When Tenofovir (Emtricitabine/Tenofovir disoproxil Sandoz) disoproxil fumarate was administered with didanosine (Videx and Videx EC), the Cmax and AUC of didanosine administered as either the buffered or enteric-coated formulation increased significantly. The mechanism of this interaction is unknown. Higher didanosine concentrations could potentiate didanosine associated adverse events, including pancreatitis and neuropathy. Suppression of CD4+ cell counts has been observed in patients receiving Tenofovir (Emtricitabine/Tenofovir disoproxil Sandoz) DF with didanosine 400 mg daily. In adults weighing >60 kg, the didanosine dose should be reduced to 250 mg when it is co-administered with Emtricitabine/Tenofovir disoproxil Sandoz. Data are not available to recommend a dose adjustment of didanosine for patients weighing <60 kg. When co-administered, Emtricitabine/Tenofovir disoproxil Sandoz and didanosine may be taken under fasted conditions or with a light meal (<400 kcal, 20% fat).
Co-administration of didanosine buffered tablet formulation with Emtricitabine/Tenofovir disoproxil Sandoz should be under fasted conditions. Co-administration of Emtricitabine/Tenofovir disoproxil Sandoz and didanosine should be undertaken with caution and patients receiving this combination should be monitored closely for didanosine-associated adverse events. Didanosine should be discontinued in patients who develop didanosine-associated adverse events.
Atazanavir and lopinavir/ritonavir have been shown to increase Tenofovir (Emtricitabine/Tenofovir disoproxil Sandoz) concentrations. The mechanism of this interaction is unknown. Patients receiving atazanavir and lopinavir/ritonavir and Emtricitabine/Tenofovir disoproxil Sandoz should be monitored for Emtricitabine/Tenofovir disoproxil Sandoz-associated adverse events. Emtricitabine/Tenofovir disoproxil Sandoz should be discontinued in patients who develop Emtricitabine/Tenofovir disoproxil Sandoz-associated adverse events.
Tenofovir (Emtricitabine/Tenofovir disoproxil Sandoz) decreases the AUC and Cmin of atazanavir. When co-administered with Emtricitabine/Tenofovir disoproxil Sandoz, it is recommended that atazanavir 300 mg is given with ritonavir 100 mg. Atazanavir without ritonavir should not be co-administered with Emtricitabine/Tenofovir disoproxil Sandoz.
Emtricitabine/Tenofovir disoproxil Sandoz and Tenofovir (Emtricitabine/Tenofovir disoproxil Sandoz) Disoproxil Fumarate: Since Emtricitabine/Tenofovir disoproxil Sandoz and Tenofovir (Emtricitabine/Tenofovir disoproxil Sandoz) are primarily eliminated by the kidneys, co-administration of Emtricitabine/Tenofovir disoproxil Sandoz with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of Emtricitabine/Tenofovir disoproxil Sandoz, Tenofovir (Emtricitabine/Tenofovir disoproxil Sandoz) and/or other renally eliminated drugs. Some examples include, but are not limited to acyclovir, adefovir dipivoxil, cidofovir, ganciclovir and valganciclovir.
Emtricitabine/Tenofovir disoproxil Sandoz side effects
See also:
What are the possible side effects of Emtricitabine/Tenofovir disoproxil Sandoz?
The following adverse reactions are discussed in other sections of the labeling:
- Lactic Acidosis/Severe Hepatomegaly with Steatosis.
- Severe Acute Exacerbations of hepatitis B.
- New Onset or Worsening Renal Impairment.
- Bone Effects of Tenofovir (Emtricitabine/Tenofovir disoproxil Sandoz) DF.
- Immune Reconstitution Syndrome.
Adverse Reactions from Clinical Trials Experience in HIV-1 Infected Subjects
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 Subjects
The most common adverse reactions (incidence greater than or equal to 10%, any severity) occurring in Study 934, an active-controlled clinical trial of efavirenz, Emtricitabine/Tenofovir disoproxil Sandoz, and Tenofovir (Emtricitabine/Tenofovir disoproxil Sandoz) disoproxil fumarate, include diarrhea, nausea, fatigue, headache, dizziness, depression, insomnia, abnormal dreams, and rash. See also Table 3 for the frequency of treatment-emergent adverse reactions (Grades 2–4) occurring in greater than or equal to 5% of subjects treated in any treatment group in this trial.
Skin discoloration, manifested by hyperpigmentation on the palms and/or soles, was generally mild and asymptomatic. The mechanism and clinical significance are unknown.
Study 934 - Treatment Emergent Adverse Reactions: In Study 934, 511 antiretroviral-naïve subjects received either VIREAD + EMTRIVA administered in combination with efavirenz (N=257) or zidovudine/lamivudine administered in combination with efavirenz (N=254) for 144 weeks. Subjects had a mean age of 40 years (range 20 to 73 years) and were predominantly male (88%). Overall, 65% were White, 17% were Black, and 13% were Hispanic. Adverse reactions observed in this trial were generally consistent with those seen in other trials in treatment-experienced or treatment-naïve subjects receiving VIREAD and/or EMTRIVA (Table 3).
FTC+TDF+EFV† | AZT/3TC+EFV | |
---|---|---|
N=257 | N=254 | |
| ||
Gastrointestinal Disorder | ||
Diarrhea | 9% | 5% |
Nausea | 9% | 7% |
Vomiting | 2% | 5% |
General Disorders and Administration Site Condition | ||
Fatigue | 9% | 8% |
Infections and Infestations | ||
Sinusitis | 8% | 4% |
Upper respiratory tract infections | 8% | 5% |
Nasopharyngitis | 5% | 3% |
Nervous System Disorders | ||
Headache | 6% | 5% |
Dizziness | 8% | 7% |
Psychiatric Disorders | ||
Depression | 9% | 7% |
Insomnia | 5% | 7% |
Skin and Subcutaneous Tissue Disorders | ||
Rash event‡ | 7% | 9% |
Laboratory Abnormalities: Laboratory abnormalities observed in this trial were generally consistent with those seen in other trials of VIREAD and/or EMTRIVA (Table 4).
FTC+TDF+EFV* | 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% |
In addition to the events described above for Study 934, other adverse reactions that occurred in at least 5% of subjects receiving EMTRIVA or VIREAD with other antiretroviral agents in clinical trials include anxiety, arthralgia, increased cough, dyspepsia, fever, myalgia, pain, abdominal pain, back pain, paresthesia, peripheral neuropathy (including peripheral neuritis and neuropathy), pneumonia, and rhinitis.
In addition to the laboratory abnormalities described above for Study 934, Grades 3–4 laboratory abnormalities of increased bilirubin (>2.5 × ULN), increased pancreatic amylase (>2.0 × ULN), increased or decreased serum glucose (<40 or >250 mg/dL), and increased serum lipase (>2.0 × ULN) occurred in up to 3% of subjects treated with EMTRIVA or VIREAD with other antiretroviral agents in clinical trials.
Clinical Trials in Pediatric Subjects
Emtricitabine/Tenofovir disoproxil Sandoz: 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 EMTRIVA in the larger of two open-label, uncontrolled pediatric trials (N=116). For additional information, consult the EMTRIVA prescribing information.
Tenofovir (Emtricitabine/Tenofovir disoproxil Sandoz) 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 VIREAD were consistent with those observed in clinical trials of VIREAD in adults.
Eighty-nine pediatric subjects (2 to less than 12 years of age) received VIREAD in Study 352 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 also had decreases in total body or spine BMD Z score. For additional information, consult the VIREAD prescribing information.
Adverse Reactions from Clinical Trial Experience in HIV-1 Uninfected Adult Subjects
No new adverse reactions to Emtricitabine/Tenofovir disoproxil Sandoz were identified from two randomized placebo-controlled clinical trials (iPrEx, Partners PrEP), in which 2,830 HIV-1 uninfected adults received Emtricitabine/Tenofovir disoproxil Sandoz once daily for pre-exposure prophylaxis. Subjects were followed for a median of 71 weeks and 87 weeks, respectively. These trials enrolled HIV-negative individuals ranging in age from 18 to 67 years. The iPrEx trial enrolled only men or transgender women of Hispanic/Latino (72%), White (18%), Black (9%) and Asian (5%) race. The Partners PrEP trial enrolled both men (61–64% across treatment groups) and women in Kenya and Uganda. Table 5 provides a list of all adverse events that occurred in 2% or more of subjects in any treatment group in the iPrEx and Partners PrEP trials.
Laboratory Abnormalities: Table 6 provides a list of laboratory abnormalities observed in both trials. Six subjects in the TDF-containing arms of the Partners PrEP trial discontinued participation in the study due to an increase in blood creatinine compared with no discontinuations in the placebo group. One subject in the Emtricitabine/Tenofovir disoproxil Sandoz arm of the iPrEx trial discontinued from the study due to an increase in blood creatinine and another due to low phosphorous.
In addition to the laboratory abnormalities described above, Grade 1 proteinuria (1+) occurred in 6% of subjects receiving Emtricitabine/Tenofovir disoproxil Sandoz in the iPrEx trial. Grades 2–3 proteinuria (2–4+) and glycosuria (3+) occurred in less than 1% of subjects treated with Emtricitabine/Tenofovir disoproxil Sandoz in the iPrEx trial and Partners PrEP trial.
iPrEx Trial | Partners PrEP Trial | |||
---|---|---|---|---|
FTC/TDF (N=1251) | Placebo (N=1248) | FTC/TDF (N=1579) | Placebo (N=1584) | |
| ||||
Gastrointestinal Disorders | ||||
Diarrhea | 7% | 8% | 2% | 3% |
Abdominal pain | 4% | 2% | -* | - |
Infections and Infestations | ||||
Pharyngitis | 13% | 16% | - | - |
Urethritis | 5% | 7% | - | - |
Urinary tract infection | 2% | 2% | 5% | 7% |
Syphilis | 6% | 5% | - | - |
Secondary syphilis | 6% | 4% | - | - |
Anogenital warts | 2% | 3% | - | - |
Musculoskeletal and Connective Tissue Disorders | ||||
Back pain | 5% | 5% | - | - |
Nervous System Disorders | ||||
Headache | 7% | 6% | - | - |
Psychiatric Disorders | ||||
Depression | 6% | 7% | - | - |
Anxiety | 3% | 3% | - | - |
Reproductive System and Breast Disorders | ||||
Genital ulceration | 2% | 2% | 2% | 2% |
Investigations | ||||
Weight decreased | 3% | 2% | - | - |
iPrEx Trial | Partners PrEP Trial | |||||
---|---|---|---|---|---|---|
Grade* | FTC/TDF (N= 1251) | Placebo (N= 1248) | FTC/TDF (N=1579) | Placebo (N=1584) | ||
| ||||||
Creatinine | 1 | (1.1–1.3 × ULN) | 27 (2%) | 21 (2%) | 18 (1%) | 12 (<1%) |
2–4 | (> 1.4 × ULN) | 5 (<1%) | 3 (<1%) | 2 (<1%) | 1 (<1%) | |
Phosphorus | 1 | (2.5 – <LLN mg/dL) | 81 (7%) | 110 (9%) | NR † | NR † |
2–4 | (<2.0 mg/dL) | 123 (10%) | 101 (8%) | 140 (9%) | 136 (9%) | |
AST | 1 | (1.25–<2.5 × ULN) | 175 (14%) | 175 (14%) | 20 (1%) | 25 (2%) |
2–4 | (> 2.6 × ULN) | 57 (5%) | 61 (5%) | 10 (<1%) | 4 (<1%) | |
ALT | 1 | (1.25–<2.5 × ULN) | 178 (14%) | 194 (16%) | 21 (1%) | 13 (<1%) |
2–4 | (> 2.6 × ULN) | 84 (7%) | 82 (7%) | 4 (<1%) | 6 (<1%) | |
Hemoglobin | 1 | (8.5 – 10 mg/dL) | 49 (4%) | 62 (5%) | 56 (4%) | 39 (2%) |
2–4 | (<9.4 mg/dL) | 13 (1%) | 19 (2%) | 28 (2%) | 39 (2%) | |
Neutrophils | 1 | (1000–1300/mm3) | 23 (2%) | 25 (2%) | 208 (13%) | 163 (10%) |
2–4 | (<750/mm3) | 7 (<1%) | 7 (<1%) | 73 (5%) | 56 (3%) |
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 Sandoz group compared with the placebo group, which returned toward baseline after discontinuation of treatment. Thirteen percent of subjects receiving Emtricitabine/Tenofovir disoproxil Sandoz versus 6% of subjects receiving placebo lost at least 5% of BMD at the spine during treatment. Bone fractures were reported in 1.7% of the Emtricitabine/Tenofovir disoproxil Sandoz 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 treatment and placebo groups (0.8% and 0.6%, respectively). No BMD evaluations were performed during this trial.
Postmarketing Experience
The following adverse reactions have been identified during postapproval use of VIREAD. No additional adverse reactions have been identified during postapproval use of EMTRIVA. 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
allergic reaction, including angioedema
Metabolism and Nutrition Disorders
lactic acidosis, hypokalemia, hypophosphatemia
Respiratory, Thoracic, and Mediastinal Disorders
dyspnea
Gastrointestinal Disorders
pancreatitis, increased amylase, abdominal pain
Hepatobiliary Disorders
hepatic steatosis, hepatitis, increased liver enzymes (most commonly AST, ALT gamma GT)
Skin and Subcutaneous Tissue Disorders
rash
Musculoskeletal and Connective Tissue Disorders
rhabdomyolysis, osteomalacia (manifested as bone pain and which may contribute to fractures), muscular weakness, myopathy
Renal and Urinary Disorders
acute renal failure, renal failure, acute tubular necrosis, Fanconi syndrome, proximal renal tubulopathy, interstitial nephritis (including acute cases), nephrogenic diabetes insipidus, renal insufficiency, increased creatinine, proteinuria, polyuria
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.
Emtricitabine/Tenofovir disoproxil Sandoz contraindications
Do not use Emtricitabine/Tenofovir disoproxil Sandoz for pre-exposure prophylaxis in individuals with unknown or positive HIV-1 status. Emtricitabine/Tenofovir disoproxil Sandoz should be used in HIV-infected patients only in combination with other antiretroviral agents.
Active ingredient matches for Emtricitabine/Tenofovir disoproxil Sandoz:
Emtricitabine/Tenofovir in Estonia, Norway, Romania, Sweden.
List of Emtricitabine/Tenofovir disoproxil Sandoz substitutes (brand and generic names) | Sort by popularity |
Unit description / dosage (Manufacturer) | Price, USD |
Emtricitabine/Tenofovir Zentiva (Estonia) | |
Emtricitabine/Tenofovirdisoproxil Accord (Netherlands) | |
Emtricitabine/Tenofovirdisoproxil Aristo (Netherlands) | |
Emtricitabine/Tenofovirdisoproxil CF (Netherlands) | |
Emtricitabine/Tenofovirdisoproxil DOC Generici (Netherlands) | |
Emtricitabine/Tenofovirdisoproxil Glenmark (Netherlands) | |
Emtricitabine/Tenofovirdisoproxil Hetero (Netherlands) | |
Emtricitabine/Tenofovirdisoproxil Hormosan (Netherlands) | |
Emtricitabine/Tenofovirdisoproxil Lupin (Netherlands) | |
Emtricitabine/Tenofovirdisoproxil Sandoz (Netherlands) | |
Emtricitabine/Tenofovirdisoproxil Teva (Netherlands) | |
Emtricitabine; Tenofovir | |
Tablet; Oral; Emtricitabine 200 mg; Tenofovir Disoproxil Fumarate 300 mg | |
Emtrifovir (Colombia) | |
Emtrivir Teva (Israel) | |
Ictastan (Estonia, Malta, Netherlands, Sweden) | |
Mylan-Emtricitabine/Tenofovir (Canada) | |
Remivir (Argentina) | |
RICOVIR EM | |
RICOVIR EM 200 MG/300 MG TABLET 1 strip / 30 tablets each (Mylan Pharmaceuticals Pvt Ltd) | $ 30.99 |
Ricovir-Em (India, Thailand) | |
Ricovir-Em 30's (Mylan) | |
Ricovir-Em FC tab 30's (Mylan) | |
RICOVIR-EM tab 30's (Mylan) | $ 32.54 |
Sidatria (Turkey) | |
TAVIN-EM (India) | |
30's (Emcure (ARV)) | $ 31.75 |
Tavin-EM Tenofovir 300 mg, emtricitabine 200 mg. TAB / 30 (Emcure (ARV)) | $ 31.75 |
Tavin-EM Tenofovir 300mg, Emtricitabine200mg TAB / 30 (Emcure (ARV)) | $ 31.75 |
TAVIN-EM tab 30's (Emcure (ARV)) | $ 31.75 |
Tavin-EM Tenofovir 300mg, Emtricitabine200mg TAB / 30 (Emcure (ARV)) | $ 31.75 |
Tavin-EM Tenofovir 300 mg, emtricitabine 200 mg. TAB / 30 (Emcure (ARV)) | $ 31.75 |
Tencitab (South Africa) | |
Tenemine (South Africa) | |
Teno-Em (Thailand) | |
Teno-Em film-coated tab 30's (GPO) | |
TENOF-EM (India) | |
30's (Hetero HC (GenX)) | $ 22.22 |
Tenof-EM Tenofovir disoproxil fumarate300 mg, emtricitabine 200 mg. FC-TAB / 30 (Hetero HC (GenX)) | $ 22.22 |
Tenof-EM Tenofovir Disproxil Fumerate300mg, Emtricitabine 200mg TAB / 30 (Hetero HC (GenX)) | $ 30.16 |
TENOF-EM film-coated tab 30's (Hetero HC (GenX)) | $ 22.22 |
Tenof-EM Tenofovir disoproxil fumarate300 mg, emtricitabine 200 mg. FC-TAB / 30 (Hetero HC (GenX)) | $ 22.22 |
Tenof-EM Tenofovir Disproxil Fumerate300mg, Emtricitabine 200mg TAB / 30 (Hetero HC (GenX)) | $ 30.16 |
Tenofovir Disoproxil Emtricitabine Mylan 300/200 (Australia) | |
Tenofovir EMT GH (Australia) | |
TENTIDE EM | |
TENTIDE EM TABLET 1 strip / 30 tablets each (Ranbaxy Laboratories Ltd) | $ 31.75 |
TENVIR EM | |
TENVIR EM TABLET 1 strip / 30 tablets each (Cipla Ltd) | $ 34.92 |
TENVIR-EM (Uruguay) | |
30's (Cipla) | $ 31.75 |
See 106 substitutes for Emtricitabine/Tenofovir disoproxil Sandoz |
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).
- PubChem. "Emtricitabine". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
- DrugBank. "Emtricitabine". http://www.drugbank.ca/drugs/DB00879 (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Emtricitabine/Tenofovir disoproxil Sandoz are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Emtricitabine/Tenofovir disoproxil Sandoz. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.User reports
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Information checked by Dr. Sachin Kumar, MD Pharmacology