Teno-Em Uses

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What is Teno-Em?

Teno-Em and Tenofovir (Teno-Em) 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). Teno-Em and Tenofovir (Teno-Em) 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.

Teno-Em and Tenofovir (Teno-Em) 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. Teno-Em and Tenofovir (Teno-Em) combination will not keep you from spreading HIV to other people. People who receive Teno-Em and Tenofovir (Teno-Em) may continue to have other problems usually related to AIDS or HIV infection.

Teno-Em and Tenofovir (Teno-Em) is available only with your doctor's prescription.

Teno-Em indications

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

Teno-Em®, 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 Teno-Em for the treatment of HIV-1 infection:

  • It is not recommended that Teno-Em be used as a component of a triple nucleoside regimen.
  • Teno-Em should not be coadministered with ATRIPLA®, COMPLERA®, EMTRIVA, GENVOYA®, ODEFSEY®, STRIBILD®, VIREAD or lamivudine-containing products.
  • In treatment experienced patients, the use of Teno-Em should be guided by laboratory testing and treatment history.

Pre-Exposure Prophylaxis

Teno-Em 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 Teno-Em 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 Teno-Em for pre-exposure prophylaxis, healthcare providers must:

  • prescribe Teno-Em as part of a comprehensive prevention strategy because Teno-Em is not always effective in preventing the acquisition of HIV-1 infection;
  • counsel all uninfected individuals to strictly adhere to the recommended Teno-Em dosing schedule because the effectiveness of Teno-Em 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 Teno-Em 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 Teno-Em for PrEP.

How should I use Teno-Em?

Use Teno-Em/Tenofovir (Teno-Em) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Teno-Em/Tenofovir (Teno-Em) comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Teno-Em/Tenofovir (Teno-Em) refilled.
  • Take Teno-Em/Tenofovir (Teno-Em) by mouth with or without food.
  • Continue to take Teno-Em/Tenofovir (Teno-Em) even if you feel well. Do not miss any doses.
  • Do not suddenly stop taking Teno-Em/Tenofovir (Teno-Em) without checking with your doctor. Some conditions (eg, hepatitis B) could become worse if you suddenly stop taking Teno-Em/Tenofovir (Teno-Em).
  • Taking Teno-Em/Tenofovir (Teno-Em) at the same time each day will help you remember to take it.
  • If you miss a dose of Teno-Em/Tenofovir (Teno-Em), 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 Teno-Em/Tenofovir (Teno-Em).

Uses of Teno-Em in details

There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
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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, Teno-Em/Tenofovir (Teno-Em) 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, Teno-Em/Tenofovir (Teno-Em) (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, Teno-Em/Tenofovir (Teno-Em) (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, Teno-Em/Tenofovir (Teno-Em) 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.

Teno-Em description

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Teno-Em tablets are fixed dose combination tablets containing Teno-Em and Tenofovir (Teno-Em) disoproxil fumarate. Teno-Em is a synthetic nucleoside analog of cytidine. Tenofovir (Teno-Em) disoproxil fumarate (Tenofovir (Teno-Em) DF) is converted in vivo to Tenofovir (Teno-Em), an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5′-monophosphate. Both Teno-Em and Tenofovir (Teno-Em) exhibit inhibitory activity against HIV-1 reverse transcriptase.

Teno-Em: The chemical name of Teno-Em is 5-fluoro-1-(2R,5S)-[2-(hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine. Teno-Em 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.

Teno-Em 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 Teno-Em is -0.43 and the pKa is 2.65.

Tenofovir (Teno-Em) Disoproxil Fumarate: Tenofovir (Teno-Em) disoproxil fumarate is a fumaric acid salt of the bis-isopropoxycarbonyloxymethyl ester derivative of Tenofovir (Teno-Em). The chemical name of Tenofovir (Teno-Em) 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 (Teno-Em) 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 (Teno-Em) disoproxil is 1.25 and the pKa is 3.75. All dosages are expressed in terms of Tenofovir (Teno-Em) disoproxil fumarate except where otherwise noted.

Teno-Em tablets are for oral administration. Each film-coated tablet contains 200 mg of Teno-Em and 300 mg of Tenofovir (Teno-Em) disoproxil fumarate, (which is equivalent to 245 mg of Tenofovir (Teno-Em) 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.

Teno-Em dosage

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Recommended Dose for Treatment of HIV-1 Infection in Adults and Pediatric Patients Weighing 35 Kg or More

The recommended dose of Teno-Em in adults and in pediatric patients with body weight greater than or equal to 35 kg is one tablet (containing 200 mg of Teno-Em and 300 mg of Tenofovir (Teno-Em) 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 Teno-Em low strength tablet (Teno-Em [FTC]/Tenofovir (Teno-Em) 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 Teno-Em low strength tablets is presented in Table 1. Weight should be monitored periodically and the Teno-Em dose adjusted accordingly.

Table 1 Dosing for Pediatric Patients Weighing 17 kg to less than 35 kg using Teno-Em Low Strength Tablets
​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 Teno-Em in HIV-1 uninfected adults is one tablet (containing 200 mg of Teno-Em and 300 mg of Tenofovir (Teno-Em) 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 Teno-Em 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.

Table 2 Dosage Adjustment for HIV-1 Infected Adult Patients with Altered Creatinine Clearance
Creatinine Clearance (mL/min)*
≥50 30–49 <30

(Including Patients Requiring Hemodialysis)

*
Calculated using ideal (lean) body weight
Recommended Dosing Interval Every 24 hours Every 48 hours Teno-Em 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 Teno-Em 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 Teno-Em for PrEP, evaluate potential causes and re-assess potential risks and benefits of continued use.

Teno-Em interactions

See also:
What other drugs will affect Teno-Em?

Tenofovir (Teno-Em) Disoproxil Fumarate: When Tenofovir (Teno-Em) 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 (Teno-Em) 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 Teno-Em. Data are not available to recommend a dose adjustment of didanosine for patients weighing <60 kg. When co-administered, Teno-Em 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 Teno-Em should be under fasted conditions. Co-administration of Teno-Em 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 (Teno-Em) concentrations. The mechanism of this interaction is unknown. Patients receiving atazanavir and lopinavir/ritonavir and Teno-Em should be monitored for Teno-Em-associated adverse events. Teno-Em should be discontinued in patients who develop Teno-Em-associated adverse events.

Tenofovir (Teno-Em) decreases the AUC and Cmin of atazanavir. When co-administered with Teno-Em, it is recommended that atazanavir 300 mg is given with ritonavir 100 mg. Atazanavir without ritonavir should not be co-administered with Teno-Em.

Teno-Em and Tenofovir (Teno-Em) Disoproxil Fumarate: Since Teno-Em and Tenofovir (Teno-Em) are primarily eliminated by the kidneys, co-administration of Teno-Em with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of Teno-Em, Tenofovir (Teno-Em) and/or other renally eliminated drugs. Some examples include, but are not limited to acyclovir, adefovir dipivoxil, cidofovir, ganciclovir and valganciclovir.

Teno-Em side effects

See also:
What are the possible side effects of Teno-Em?

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 (Teno-Em) 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, Teno-Em, and Tenofovir (Teno-Em) 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).

Table 3 Selected Treatment-Emergent Adverse Reactions* (Grades 2–4) Reported in ≥5% in Any Treatment Group in Study 934 (0–144 Weeks)
FTC+TDF+EFV† AZT/3TC+EFV
N=257 N=254
*
Frequencies of adverse reactions are based on all treatment-emergent adverse events, regardless of relationship to study drug.
From Weeks 96 to 144 of the trial, subjects received Teno-Em with efavirenz in place of VIREAD + EMTRIVA with efavirenz.
Rash event includes rash, exfoliative rash, rash generalized, rash macular, rash maculo-papular, rash pruritic, and rash vesicular.
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).

Table 4 Significant Laboratory Abnormalities Reported in ≥1% of Subjects in Any Treatment Group in Study 934 (0–144 Weeks)
FTC+TDF+EFV* AZT/3TC+EFV
N=257 N=254
*
From Weeks 96 to 144 of the trial, subjects received Teno-Em with efavirenz in place of VIREAD + EMTRIVA with efavirenz.
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

Teno-Em: 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 (Teno-Em) 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 Teno-Em were identified from two randomized placebo-controlled clinical trials (iPrEx, Partners PrEP), in which 2,830 HIV-1 uninfected adults received Teno-Em 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 Teno-Em 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 Teno-Em in the iPrEx trial. Grades 2–3 proteinuria (2–4+) and glycosuria (3+) occurred in less than 1% of subjects treated with Teno-Em in the iPrEx trial and Partners PrEP trial.

Table 5 Selected Adverse Events (All Grades) Reported in ≥2% in Any Treatment Group 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)

*
Not reported or reported below 2%.
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% - -
Table 6 Laboratory Abnormalities (Highest Toxicity Grade) Reported for Each Subject in the iPrEx Trial and Partners PrEP Trial
iPrEx Trial Partners PrEP Trial
Grade* FTC/TDF

(N= 1251)

Placebo

(N= 1248)

FTC/TDF

(N=1579)

Placebo

(N=1584)

*
Grading is per DAIDS criteria.
Grade 1 phosphorus was not reported for the Partners PrEP trial.
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 Teno-Em group compared with the placebo group, which returned toward baseline after discontinuation of treatment. Thirteen percent of subjects receiving Teno-Em 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 Teno-Em 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.

Teno-Em contraindications

See also:
What is the most important information I should know about Teno-Em?

Do not use Teno-Em for pre-exposure prophylaxis in individuals with unknown or positive HIV-1 status. Teno-Em should be used in HIV-infected patients only in combination with other antiretroviral agents.

Active ingredient matches for Teno-Em:

Emtricitabine/Tenofovir in Thailand.

Emtricitabine/Tenofovir/Tenofovir disoproxil fumarate in Thailand.


Unit description / dosage (Manufacturer)Price, USD
Teno-Em film-coated tab 30's (GPO)

List of Teno-Em substitutes (brand and generic names):

Ricovir-Em FC tab 30's (Mylan)
RICOVIR-EM tab 30's (Mylan)$ 32.54
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
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
TENTIDE EM TABLET 1 strip / 30 tablets each (Ranbaxy Laboratories Ltd)$ 31.75
TENVIR EM TABLET 1 strip / 30 tablets each (Cipla Ltd)$ 34.92
30's (Cipla)$ 31.75
Tenvir-EM Tenofovir disoproxil fumarate300 mg, emtricitabine 200 mg. TAB / 30 (Cipla)$ 31.75
TENVIR-EM tab 30's (Cipla)$ 31.75
Tenvir-EM Tenofovir disoproxil fumarate300 mg, emtricitabine 200 mg. TAB / 30 (Cipla)$ 31.75
TOFOCOM 200MG/300MG TABLET 1 strip / 30 tablets each (Alkem Laboratories Ltd)$ 31.29
Tofocom 200 mg/300 mg Tablet (Alkem Laboratories Ltd)$ 1.04
Tablet, Film-Coated; Oral; Emtricitabine 200 mg; Tenofovir Disoproxil Fumarate 300 mg (Gilead)
Tablet; Oral; Emtricitabine 200 mg; Tenofovir Disoproxil Fumarate 300 mg (Gilead)
30 tablet in 1 bottle, plastic (Gilead)
Truvada 30's (Gilead)
TRUVADA 200 MG/300 MG TABLET 1 strip / 30 tablets each (Gilead)$ 39.84
Truvada FC tab 30's (Gilead)
Truvada film-coated tab 30's (Gilead)

References

  1. 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).
  2. 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).
  3. PubChem. "Emtricitabine". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).

Reviews

The results of a survey conducted on ndrugs.com for Teno-Em 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 Teno-Em. 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

Consumer reported useful

No survey data has been collected yet


Consumer reported price estimates

No survey data has been collected yet


3 consumers reported time for results

To what extent do I have to use Teno-Em before I begin to see changes in my health conditions?
As part of the reports released by ndrugs.com website users, it takes 1 month and a few days before you notice an improvement in your health conditions.
Please note, it doesn't mean you will start to notice such health improvement in the same time frame as other users. There are many factors to consider, and we implore you to visit your doctor to know how long before you can see improvements in your health while taking Teno-Em. To get the time effectiveness of using Teno-Em drug by other patients, please click here.
Users%
1 month2
66.7%
3 month1
33.3%


2 consumers reported age

Users%
46-601
50.0%
30-451
50.0%


Consumer reviews


There are no reviews yet. Be the first to write one!


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Information checked by Dr. Sachin Kumar, MD Pharmacology

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