Tenemine Overdose

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What happens if I overdose Tenemine?

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local, or emergency room immediately.

Proper storage of Tenemine:

Store Tenemine at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Do not use Tenemine if the seal over the bottle opening is broken or missing. Keep Tenemine in its original container and keep the container tightly closed. Do not keep medicine that is out of date or that you no longer need. If you throw any medicines away, make sure that children or pets cannot find them. Keep Tenemine out of the reach of children and away from pets.

Overdose of Tenemine in details

infoWhen a dose is taken in higher dose than the recommended doses, it is called Overdose. Overdose always needs a clinical supervision. Any medicine or drug when consumed in Overdose produces untoward side effects on one or various organs in the body. A medicine is excreted in the kidney or metabolized in the liver most of the times. This process goes without any hurdles when taken in normal dose, but when taken in an overdose, the body is not able to metabolize it or send it out properly which causes the effects of anoverdose.
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No data are available on overdose of Tenemine in patients. If overdose occurs, monitor the patient for evidence of toxicity. Treatment of overdose with Tenemine consists of general supportive measures including monitoring of vital signs as well as observation of the clinical status of the patient.

Emtricitabine (Tenemine) (FTC)

Limited clinical experience is available at doses higher than the recommended dose of FTC in Tenemine. In one clinical pharmacology study, single doses of FTC 1200 mg (6 times the FTC dose in Tenemine) were administered to 11 subjects. No severe adverse reactions were reported. The effects of higher doses are not known.

Hemodialysis treatment removes approximately 30% of the FTC dose over a 3-hour dialysis period starting within 1.5 hours of FTC dosing (blood flow rate of 400 mL per minute and a dialysate flow rate of 600 mL per minute). It is not known whether FTC can be removed by peritoneal dialysis.

Tenofovir (Tenemine) Alafenamide (TAF)

Limited clinical experience is available at doses higher than the recommended dose of TAF. A single dose of 125 mg TAF (5 times the TAF dose in 200/25 mg Tenemine) was administered to 48 healthy subjects; no serious adverse reactions were reported. The effects of higher doses are unknown. Tenofovir (Tenemine) is efficiently removed by hemodialysis with an extraction coefficient of approximately 54%.

What should I avoid while taking Tenemine?

Taking this medication will not prevent you from passing HIV to other people. Avoid having unprotected sex or sharing razors or toothbrushes. Talk with your doctor about safe ways to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

Tenemine warnings

infoWarnings are a mix of Precautions. Contraindications and interactions and serious harmful effects associated with the medicine intake. A diabetic or Hypertensive patient need to be warned about few drug interactions. A known hypersensitivity patient needs to be careful about the reactions or anaphylactic shock. A pregnant woman or a breastfeeding woman should be warned of certain medications. A Hepatitis [liver disease] patient or a cardiac patient should avoid few drugs.
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Lactic Acidosis/Severe Hepatomegaly with Steatosis

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs, including VIREAD, a component of Tenemine, in combination with other antiretrovirals. A majority of these cases have been in women. Obesity and prolonged nucleoside exposure may be risk factors. Particular caution should be exercised when administering nucleoside analogs to any patient or uninfected individual with known risk factors for liver disease; however, cases have also been reported in HIV-1 infected patients with no known risk factors. Treatment with Tenemine should be suspended in any patient or uninfected individual who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity (which may include hepatomegaly and steatosis even in the absence of marked transaminase elevations).

HBV Infection

It is recommended that all individuals be tested for the presence of chronic hepatitis B virus (HBV) before initiating Tenemine. Tenemine is not approved for the treatment of chronic HBV infection and the safety and efficacy of Tenemine have not been established in patients infected with HBV. Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HBV and HIV-1 and have discontinued Tenemine. In some patients infected with HBV and treated with EMTRIVA, the exacerbations of hepatitis B were associated with liver decompensation and liver failure. Patients who are infected with HBV should be closely monitored with both clinical and laboratory follow-up for at least several months after stopping treatment with Tenemine. If appropriate, initiation of anti-hepatitis B therapy may be warranted. HBV-uninfected individuals should be offered vaccination.

New Onset or Worsening Renal Impairment

Emtricitabine (Tenemine) and Tenofovir (Tenemine) are principally eliminated by the kidney. Renal impairment, including cases of acute renal failure and Fanconi syndrome (renal tubular injury with severe hypophosphatemia), has been reported with the use of VIREAD.

It is recommended that estimated creatinine clearance be assessed in all individuals prior to initiating therapy and as clinically appropriate during therapy with Tenemine. In patients at risk of renal dysfunction, including patients who have previously experienced renal events while receiving HEPSERA®, it is recommended that estimated creatinine clearance, serum phosphorus, urine glucose, and urine protein be assessed prior to initiation of Tenemine, and periodically during Tenemine therapy.

Tenemine should be avoided with concurrent or recent use of a nephrotoxic agent (e.g., high-dose or multiple non-steroidal anti-inflammatory drugs (NSAIDs)). Cases of acute renal failure after initiation of high dose or multiple NSAIDs have been reported in HIV-infected patients with risk factors for renal dysfunction who appeared stable on Tenofovir (Tenemine) disoproxil fumarate (Tenofovir (Tenemine) DF). Some patients required hospitalization and renal replacement therapy. Alternatives to NSAIDs should be considered, if needed, in patients at risk for renal dysfunction.

Persistent or worsening bone pain, pain in extremities, fractures and/or muscular pain or weakness may be manifestations of proximal renal tubulopathy and should prompt an evaluation of renal function in at-risk patients.

Treatment of HIV-1 Infection

Dosing interval adjustment of Tenemine and close monitoring of renal function are recommended in all patients with estimated creatinine clearance 30–49 mL/min. No safety or efficacy data are available in patients with renal impairment who received Tenemine using these dosing guidelines, so the potential benefit of Tenemine therapy should be assessed against the potential risk of renal toxicity. Tenemine should not be administered to patients with estimated creatinine clearance below 30 mL/min or patients requiring hemodialysis.

Pre-exposure Prophylaxis

Tenemine for a PrEP indication should not be used if estimated creatinine clearance is less than 60 mL/min. If a decrease in estimated creatinine clearance is observed in uninfected individuals while using Tenemine for PrEP, evaluate potential causes and re-assess potential risks and benefits of continued use.

Coadministration with Other Products

​Tenemine is a fixed-dose combination of Emtricitabine (Tenemine) and Tenofovir (Tenemine) disoproxil fumarate. Do not coadminister Tenemine with other drugs containing Emtricitabine (Tenemine) or Tenofovir (Tenemine) disoproxil fumarate, or containing Tenofovir (Tenemine) alafenamide, including ATRIPLA, COMPLERA, EMTRIVA, GENVOYA, ODEFSEY, STRIBILD, or VIREAD. Due to similarities between Emtricitabine (Tenemine) and lamivudine, do not coadminister Tenemine with other drugs containing lamivudine, including Combivir (lamivudine/zidovudine), Dutrebis (lamivudine/raltegravir), Epivir or Epivir-HBV (lamivudine), Epzicom (abacavir sulfate/lamivudine), Triumeq (abacavir sulfate/dolutegravir/lamivudine), or Trizivir (abacavir sulfate/lamivudine/zidovudine).

Do not coadminister Tenemine with HEPSERA (adefovir dipivoxil).

Bone Effects of Tenofovir (Tenemine) DF

Bone Mineral Density:

In clinical trials in HIV-1 infected adults and in a clinical trial of HIV-1 uninfected individuals, Tenofovir (Tenemine) DF was associated with slightly greater decreases in bone mineral density (BMD) and increases in biochemical markers of bone metabolism, suggesting increased bone turnover relative to comparators. Serum parathyroid hormone levels and 1,25 Vitamin D levels were also higher in subjects receiving Tenofovir (Tenemine) DF.

Clinical trials evaluating Tenofovir (Tenemine) DF in pediatric and adolescent subjects were conducted. Under normal circumstances, BMD increases rapidly in pediatric patients. In HIV-1 infected subjects aged 2 years to less than 18 years, bone effects were similar to those observed in adult subjects and suggest increased bone turnover. Total body BMD gain was less in the Tenofovir (Tenemine) DF treated HIV-1 infected pediatric subjects as compared to the control groups. Similar trends were observed in chronic hepatitis B infected adolescent subjects aged 12 years to less than 18 years. In all pediatric trials, skeletal growth (height) appeared to be unaffected. For more information, consult the VIREAD prescribing information.

The effects of Tenofovir (Tenemine) DF-associated changes in BMD and biochemical markers on long-term bone health and future fracture risk are unknown. Assessment of BMD should be considered for adult and pediatric patients who have a history of pathologic bone fracture or other risk factors for osteoporosis or bone loss. Although the effect of supplementation with calcium and vitamin D was not studied, such supplementation may be beneficial. If bone abnormalities are suspected then appropriate consultation should be obtained.

Mineralization Defects:

Cases of osteomalacia associated with proximal renal tubulopathy, manifested as bone pain or pain in extremities and which may contribute to fractures, have been reported in association with the use of Tenofovir (Tenemine) DF. Arthralgias and muscle pain or weakness have also been reported in cases of proximal renal tubulopathy. Hypophosphatemia and osteomalacia secondary to proximal renal tubulopathy should be considered in patients at risk of renal dysfunction who present with persistent or worsening bone or muscle symptoms while receiving products containing Tenofovir (Tenemine) DF.

Fat Redistribution

Redistribution/accumulation of body fat including central obesity, dorsocervical fat enlargement (buffalo hump), peripheral wasting, facial wasting, breast enlargement, and "cushingoid appearance" have been observed in HIV-1 infected patients receiving antiretroviral therapy. The mechanism and long-term consequences of these events are currently unknown. A causal relationship has not been established.

Immune Reconstitution Syndrome

Immune reconstitution syndrome has been reported in HIV-1 infected patients treated with combination antiretroviral therapy, including Tenemine. During the initial phase of combination antiretroviral treatment, HIV-1 infected patients whose immune system responds may develop an inflammatory response to indolent or residual opportunistic infections [such as Mycobacterium avium infection, cytomegalovirus, Pneumocystis jirovecii pneumonia (PCP), or tuberculosis], which may necessitate further evaluation and treatment.

Autoimmune disorders (such as Graves' disease, polymyositis, and Guillain-Barré syndrome) have also been reported to occur in the setting of immune reconstitution, however, the time to onset is more variable, and can occur many months after initiation of treatment.

Early Virologic Failure

Clinical trials in HIV-1 infected subjects have demonstrated that certain regimens that only contain three nucleoside reverse transcriptase inhibitors (NRTI) are generally less effective than triple drug regimens containing two NRTIs in combination with either a non-nucleoside reverse transcriptase inhibitor or a HIV-1 protease inhibitor. In particular, early virologic failure and high rates of resistance substitutions have been reported. Triple nucleoside regimens should therefore be used with caution. Patients on a therapy utilizing a triple nucleoside-only regimen should be carefully monitored and considered for treatment modification.

Comprehensive Management to Reduce the Risk of Acquiring HIV-1

Use Tenemine for pre-exposure prophylaxis only as part of a comprehensive prevention strategy that includes other prevention measures, such as safer sex practices, because Tenemine is not always effective in preventing the acquisition of HIV-1.

  • Counsel uninfected individuals about safer sex practices that include consistent and correct use of condoms, knowledge of their HIV-1 status and that of their partner(s), and regular testing for other sexually transmitted infections that can facilitate HIV-1 transmission (such as syphilis and gonorrhea).
  • Inform uninfected individuals about and support their efforts in reducing sexual risk behavior.

Use Tenemine to reduce the risk of acquiring HIV-1 only in individuals confirmed to be HIV-negative. HIV-1 resistance substitutions may emerge in individuals with undetected HIV-1 infection who are taking only Tenemine, because Tenemine alone does not constitute a complete treatment regimen for HIV-1 treatment; therefore, care should be taken to minimize drug exposure in HIV-infected individuals.

  • Many HIV-1 tests, such as rapid tests, detect anti-HIV antibodies and may not identify HIV-1 during the acute stage of infection. Prior to initiating Tenemine for a PrEP indication, evaluate seronegative individuals for current or recent signs or symptoms consistent with acute viral infections (e.g., fever, fatigue, myalgia, skin rash, etc.) and ask about potential exposure events (e.g., unprotected, or condom broke during sex with an HIV-1 infected partner) that may have occurred within the last month.
    • 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.
  • While using Tenemine for a PrEP indication, HIV-1 screening tests should be repeated at least every 3 months. If symptoms consistent with acute HIV-1 infection develop following a potential exposure event, PrEP should be discontinued until negative infection status is confirmed using a test approved by the FDA as an aid in the diagnosis of HIV-1, including acute or primary HIV-1 infection.

Counsel uninfected individuals to strictly adhere to the recommended Tenemine dosing schedule. The effectiveness of Tenemine in reducing the risk of acquiring HIV-1 is strongly correlated with adherence as demonstrated by measurable drug levels in clinical trials.

What should I discuss with my healthcare provider before taking Tenemine?

You should not take Tenemine if you are allergic to Emtricitabine (Tenemine) or Tenofovir (Tenemine). Do not take if you also use other medicines that contain Emtricitabine (Tenemine), Tenofovir (Tenemine), lamivudine, or adefovir (such as Atripla, Combivir, Complera, Dutrebis, Emtriva, Epivir, Epzicom, Genvoya, Hepsera, Odefsey, Stribild, Triumeq, Trizivir, or Viread).

Do not take Tenemine to reduce infection risk if you are HIV-positive, if have been exposed to HIV within the past month, or if you had any symptoms (such as fever, night sweats, swollen glands, diarrhea, body aches).

If you take Tenemine to reduce your risk of HIV infection: You must have a negative HIV test immediately before you start taking the medicine. An HIV test is also required every 3 months during treatment.

To make sure Tenemine is safe for you, tell your doctor if you have:

  • liver or kidney disease;

  • osteopenia (low bone mineral density); or

  • if you also have hepatitis B infection.

Some people taking Tenemine develop a serious condition called lactic acidosis. This may be more likely in women, in people who are overweight or have liver disease, and in people who have taken HIV/AIDS medication for a long time. Talk with your doctor about your risk.

HIV can be passed to your baby if you are not properly treated during pregnancy. Take all of your HIV medicines as directed to control your infection.

You should not breast-feed while you are using Tenemine to treat or prevent HIV. Women with HIV or AIDS should not breast-feed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.

Tenemine is not approved for anyone younger than 12 years old. The child receiving this medicine must weigh at least 37 pounds.

Tenemine precautions

infoCertain people who are very sick or very old or who are sensitive show an exacerbation of side effect of the drug which can turn dangerous at times. So, it is very important to remember the precautions while taking the medicine. Pregnancy and Breastfeeding are also special categories wherein extra care or precaution is needed when taking a drug. Few patients may have a hypersensitivity reaction to few medications, and that can be life-threatening rarely. Penicillin hypersensitivity is one example. Diarrhea, rashes are few other symptoms which need a watch. A patient with other co-existing diseases like liver disease, heart disease, kidney disease should take special precautions.
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Lactic Acidosis/Severe Hepatomegaly With Steatosis

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs, including VIREAD, a component of Tenemine, in combination with other antiretrovirals. A majority of these cases have been in women. Obesity and prolonged nucleoside exposure may be risk factors. Particular caution should be exercised when administering nucleoside analogs to any patient or uninfected individual with known risk factors for liver disease; however, cases have also been reported in HIV-1 infected patients with no known risk factors. Treatment with Tenemine should be suspended in any patient or uninfected individual who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity (which may include hepatomegaly and steatosis even in the absence of marked transaminase elevations).

HBV Infection

It is recommended that all individuals be tested for the presence of chronic hepatitis B virus (HBV) before initiating Tenemine. Tenemine is not approved for the treatment of chronic HBV infection and the safety and efficacy of Tenemine have not been established in patients infected with HBV. Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HBV and HIV-1 and have discontinued Tenemine. In some patients infected with HBV and treated with EMTRIVA, the exacerbations of hepatitis B were associated with liver decompensation and liver failure. Patients who are infected with HBV should be closely monitored with both clinical and laboratory follow-up for at least several months after stopping treatment with Tenemine. If appropriate, initiation of anti-hepatitis B therapy may be warranted. HBV-uninfected individuals should be offered vaccination.

New Onset Or Worsening Renal Impairment

Emtricitabine (Tenemine) and Tenofovir (Tenemine) are principally eliminated by the kidney. Renal impairment, including cases of acute renal failure and Fanconi syndrome (renal tubular injury with severe hypophosphatemia), has been reported with the use of VIREAD.

It is recommended that estimated creatinine clearance be assessed in all individuals prior to initiating therapy and as clinically appropriate during therapy with Tenemine. In patients at risk of renal dysfunction, including patients who have previously experienced renal events while receiving HEPSERA, it is recommended that estimated creatinine clearance, serum phosphorus, urine glucose, and urine protein be assessed prior to initiation of Tenemine, and periodically during Tenemine therapy.

Tenemine should be avoided with concurrent or recent use of a nephrotoxic agent (e.g., high-dose or multiple non-steroidal anti-inflammatory drugs (NSAIDs)). Cases of acute renal failure after initiation of high dose or multiple NSAIDs have been reported in HIV-infected patients with risk factors for renal dysfunction who appeared stable on Tenofovir (Tenemine) disoproxil fumarate (Tenofovir (Tenemine) DF). Some patients required hospitalization and renal replacement therapy. Alternatives to NSAIDs should be considered, if needed, in patients at risk for renal dysfunction.

Persistent or worsening bone pain, pain in extremities, fractures and/or muscular pain or weakness may be manifestations of proximal renal tubulopathy and should prompt an evaluation of renal function in at-risk patients.

Treatment Of HIV-1 Infection

Dosing interval adjustment of Tenemine and close monitoring of renal function are recommended in all patients with estimated creatinine clearance 30–49 mL/min. No safety or efficacy data are available in patients with renal impairment who received Tenemine using these dosing guidelines, so the potential benefit of Tenemine therapy should be assessed against the potential risk of renal toxicity. Tenemine should not be administered to patients with estimated creatinine clearance below 30 mL/min or patients requiring hemodialysis.

Pre-exposure Prophylaxis

Tenemine for a PrEP indication should not be used if estimated creatinine clearance is less than 60 mL/min. If a decrease in estimated creatinine clearance is observed in uninfected individuals while using Tenemine for PrEP, evaluate potential causes and re-assess potential risks and benefits of continued use.

Coadministration With Other Products

Tenemine is a fixed-dose combination of Emtricitabine (Tenemine) and Tenofovir (Tenemine) disoproxil fumarate. Do not coadminister Tenemine with other drugs containing Emtricitabine (Tenemine) or Tenofovir (Tenemine) disoproxil fumarate, or containing Tenofovir (Tenemine) alafenamide, including ATRIPLA, COMPLERA, EMTRIVA, GENVOYA, ODEFSEY, STRIBILD, or VIREAD. Due to similarities between Emtricitabine (Tenemine) and lamivudine, do not coadminister Tenemine with other drugs containing lamivudine, including Combivir (lamivudine/zidovudine), Dutrebis (lamivudine/raltegravir), Epivir or Epivir-HBV (lamivudine), Epzicom (abacavir sulfate/lamivudine), Triumeq (abacavir sulfate/dolutegravir/lamivudine), or Trizivir (abacavir sulfate/lamivudine/zidovudine).

Do not coadminister Tenemine with HEPSERA (adefovir dipivoxil).

Bone Effects Of Tenofovir (Tenemine) DF

Bone Mineral Density

In clinical trials in HIV-1 infected adults and in a clinical trial of HIV-1 uninfected individuals, Tenofovir (Tenemine) DF was associated with slightly greater decreases in bone mineral density (BMD) and increases in biochemical markers of bone metabolism, suggesting increased bone turnover relative to comparators. Serum parathyroid hormone levels and 1,25 Vitamin D levels were also higher in subjects receiving Tenofovir (Tenemine) DF.

Clinical trials evaluating Tenofovir (Tenemine) DF in pediatric and adolescent subjects were conducted. Under normal circumstances, BMD increases rapidly in pediatric patients. In HIV-1 infected subjects aged 2 years to less than 18 years, bone effects were similar to those observed in adult subjects and suggest increased bone turnover. Total body BMD gain was less in the Tenofovir (Tenemine) DF treated HIV-1 infected pediatric subjects as compared to the control groups. Similar trends were observed in chronic hepatitis B infected adolescent subjects aged 12 years to less than 18 years. In all pediatric trials, skeletal growth (height) appeared to be unaffected. For more information, please consult the VIREAD prescribing information.

The effects of Tenofovir (Tenemine) DF-associated changes in BMD and biochemical markers on long-term bone health and future fracture risk are unknown. Assessment of BMD should be considered for adult and pediatric patients who have a history of pathologic bone fracture or other risk factors for osteoporosis or bone loss. Although the effect of supplementation with calcium and vitamin D was not studied, such supplementation may be beneficial. If bone abnormalities are suspected then appropriate consultation should be obtained.

Mineralization Defects

Cases of osteomalacia associated with proximal renal tubulopathy, manifested as bone pain or pain in extremities and which may contribute to fractures, have been reported in association with the use of Tenofovir (Tenemine) DF. Arthralgias and muscle pain or weakness have also been reported in cases of proximal renal tubulopathy. Hypophosphatemia and osteomalacia secondary to proximal renal tubulopathy should be considered in patients at risk of renal dysfunction who present with persistent or worsening bone or muscle symptoms while receiving products containing Tenofovir (Tenemine) DF.

Fat Redistribution

Redistribution/accumulation of body fat including central obesity, dorsocervical fat enlargement (buffalo hump), peripheral wasting, facial wasting, breast enlargement, and “cushingoid appearance” have been observed in HIV-1 infected patients receiving antiretroviral therapy. The mechanism and long-term consequences of these events are currently unknown. A causal relationship has not been established.

Immune Reconstitution Syndrome

Immune reconstitution syndrome has been reported in HIV-1 infected patients treated with combination antiretroviral therapy, including Tenemine. During the initial phase of combination antiretroviral treatment, HIV-1 infected patients whose immune system responds may develop an inflammatory response to indolent or residual opportunistic infections [such as Mycobacterium avium infection, cytomegalovirus, Pneumocystis jirovecii pneumonia (PCP), or tuberculosis], which may necessitate further evaluation and treatment.

Autoimmune disorders (such as Graves' disease, polymyositis, and Guillain-Barré syndrome) have also been reported to occur in the setting of immune reconstitution, however, the time to onset is more variable, and can occur many months after initiation of treatment.

Early Virologic Failure

Clinical trials in HIV-1 infected subjects have demonstrated that certain regimens that only contain three nucleoside reverse transcriptase inhibitors (NRTI) are generally less effective than triple drug regimens containing two NRTIs in combination with either a non-nucleoside reverse transcriptase inhibitor or a HIV-1 protease inhibitor. In particular, early virological failure and high rates of resistance substitutions have been reported. Triple nucleoside regimens should therefore be used with caution. Patients on a therapy utilizing a triple nucleoside-only regimen should be carefully monitored and considered for treatment modification.

Comprehensive Management To Reduce The Risk Of Acquiring HIV-1

Use Tenemine for pre-exposure prophylaxis only as part of a comprehensive prevention strategy that includes other prevention measures, such as safer sex practices, because Tenemine is not always effective in preventing the acquisition of HIV-1.

  • Counsel uninfected individuals about safer sex practices that include consistent and correct use of condoms, knowledge of their HIV-1 status and that of their partner(s), and regular testing for other sexually transmitted infections that can facilitate HIV-1 transmission (such as syphilis and gonorrhea).
  • Inform uninfected individuals about and support their efforts in reducing sexual risk behavior.

Use Tenemine to reduce the risk of acquiring HIV-1 only in individuals confirmed to be HIV-negative. HIV-1 resistance substitutions may emerge in individuals with undetected HIV-1 infection who are taking only Tenemine, because Tenemine alone does not constitute a complete treatment regimen for HIV-1 treatment; therefore, care should be taken to minimize drug exposure in HIV-infected individuals.

  • Many HIV-1 tests, such as rapid tests, detect anti-HIV antibodies and may not identify HIV-1 during the acute stage of infection. Prior to initiating Tenemine for a PrEP indication, evaluate seronegative individuals for current or recent signs or symptoms consistent with acute viral infections (e.g., fever, fatigue, myalgia, skin rash, etc.) and ask about potential exposure events (e.g., unprotected, or condom broke during sex with an HIV-1 infected partner) that may have occurred within the last month.
    • 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.
  • While using Tenemine for a PrEP indication, HIV-1 screening tests should be repeated at least every 3 months. If symptoms consistent with acute HIV-1 infection develop following a potential exposure event, PrEP should be discontinued until negative infection status is confirmed using a test approved by the FDA as an aid in the diagnosis of HIV-1, including acute or primary HIV-1 infection.

Counsel uninfected individuals to strictly adhere to the recommended Tenemine dosing schedule. The effectiveness of Tenemine in reducing the risk of acquiring HIV-1 is strongly correlated with adherence as demonstrated by measurable drug levels in clinical trials.

Patient Counseling Information

As a part of patient counseling, healthcare providers must review the Tenemine Medication Guide with every uninfected individual taking Tenemine to reduce the risk of acquiring HIV.

Advise the patient to read FDA-approved patient labeling (Medication Guide).

Important Information for All Patients and Uninfected Individuals

Advise patients and uninfected individuals that:

  • The long term effects of Tenemine are unknown.
  • Tenemine tablets are for oral ingestion only.
  • Patients and uninfected individuals should not discontinue Tenemine without first informing their physicians.
  • Patients and uninfected individuals should remain under the care of a physician when using Tenemine.
  • It is important to take Tenemine on a regular dosing schedule to avoid missing doses.
  • Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported. Treatment with Tenemine should be suspended in patients or uninfected individuals who develop clinical symptoms suggestive of lactic acidosis or pronounced hepatotoxicity (including nausea, vomiting, unusual or unexpected stomach discomfort, and weakness).
  • Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with hepatitis B virus (HBV) and HIV-1 and have discontinued Tenemine. Before initiating Tenemine, test all patients and uninfected individuals for HBV. All patients who are infected with HBV need close medical follow-up for several months after stopping Tenemine to monitor for exacerbations of hepatitis.
  • Renal impairment, including cases of acute renal failure and Fanconi syndrome, has been reported in association with the use of VIREAD. Tenemine should be avoided with concurrent or recent use of a nephrotoxic agent (e.g., high-dose or multiple NSAIDs). Dosing interval of Tenemine may need adjustment in HIV-1 infected patients with renal impairment. Tenemine for a PrEP indication should not be used in HIV-1 uninfected individuals if estimated creatinine clearance is less than 60 mL/min. If a decrease in estimated creatinine clearance is observed in uninfected individuals while using Tenemine for PrEP, evaluate potential causes and re-assess potential risks and benefits of continued use.
  • Do not administer Tenemine with ATRIPLA, COMPLERA, EMTRIVA, GENVOYA, ODEFSEY, STRIBILD, or VIREAD; or with drugs containing lamivudine, including Combivir (lamivudine/zidovudine), Dutrebis (lamivudine/raltegravir), Epivir or Epivir-HBV (lamivudine), Epzicom (abacavir sulfate/lamivudine), Triumeq (abacavir sulfate/dolutegravir/lamivudine), or Trizivir (abacavir sulfate/lamivudine/zidovudine).
  • Do not administer Tenemine with HEPSERA.
  • Decreases in bone mineral density have been observed with the use of VIREAD or Tenemine. Consider bone monitoring in patients and uninfected individuals who have a history of pathologic bone fracture or at risk for osteopenia.
  • Patients and uninfected individuals should avoid doing things that can spread HIV-1 or HBV infection:
  • Do not share needles or other injection equipment.
  • Do not share personal items that can have blood or body fluids on them, like toothbrushes and razor blades.
  • Do not have any kind of sex without protection. Always practice safer sex by using a latex or polyurethane condom to lower the chance of sexual contact with semen, vaginal secretions, or blood.
  • Patients and uninfected individuals should not breastfeed because the drugs in Tenemine can be passed to the baby in breast milk, and it is not known whether they can harm the baby. HIV-positive women should also not breastfeed because of the risk of passing the HIV-1 virus to the baby.
Treatment of HIV-1 Infection

When Tenemine is used in the treatment of HIV-infection, advise patients that:

  • Tenemine is not a cure for HIV-1 infection and patients may continue to experience illnesses associated with HIV-1 infection, including opportunistic infections.
  • It is important to take Tenemine in a regular dosing schedule with combination therapy to avoid missing doses.
  • All patients with HIV-1 should be tested for hepatitis B virus (HBV) before initiating and monitored after discontinuing taking Tenemine.
Pre-Exposure Prophylaxis

When Tenemine is used to reduce the risk of acquiring HIV-1, advise uninfected individuals about the importance of the following:

  • Confirming that they are HIV-negative before starting to take Tenemine to reduce the risk of acquiring HIV-1.
  • Tenemine should only be used as part of a complete prevention strategy including other prevention measures. In clinical trials, Tenemine only protected some subjects from acquiring HIV-1.
  • Using condoms consistently and correctly to lower the chance of sexual contact with any body fluids such as semen, vaginal secretions, or blood.
  • Knowing their HIV status and the status of their partner(s).
  • Getting tested regularly (at least every 3 months) for HIV-1 and ask their partner(s) to get tested as well.
  • HIV-1 resistance substitutions may emerge in individuals with undetected HIV-1 infection who are taking Tenemine, because Tenemine alone does not constitute a complete regimen for HIV-1 treatment
  • Reporting any symptoms of acute HIV-1 infection (flu-like symptoms) to their healthcare provider immediately.
  • Signs and symptoms of acute infection include: fever, headache, fatigue, arthralgia, vomiting, myalgia, diarrhea, pharyngitis, rash, night sweats, and adenopathy (cervical and inguinal).
  • Getting tested for other sexually transmitted infections such as syphilis and gonorrhea that may facilitate HIV-1 transmission.
  • Learning about sexual risk behavior and getting support to help reduce sexual risk behavior.
  • Taking Tenemine on a regular dosing schedule and strictly adhere to the recommended dosing schedule to reduce the risk of acquiring HIV-1. Uninfected individuals who miss doses are at greater risk of acquiring HIV-1 than those who do not miss doses..
  • Women who are pregnant should learn about the risks and benefits of Tenemine to reduce the risk of acquiring HIV-1 during their pregnancy.
  • Encourage use of the Agreement Form for Initiating Tenemine for PrEP of Sexually Acquired HIV-1 Infection.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Emtricitabine (Tenemine): In long-term oral carcinogenicity studies of Emtricitabine (Tenemine), no drug-related increases in tumor incidence were found in mice at doses up to 750 mg/kg/day (26 times the human systemic exposure at the therapeutic dose of 200 mg/day) or in rats at doses up to 600 mg/kg/day (31 times the human systemic exposure at the therapeutic dose).

Emtricitabine (Tenemine) was not genotoxic in the reverse mutation bacterial test (Ames test), mouse lymphoma or mouse micronucleus assays.

Emtricitabine (Tenemine) did not affect fertility in male rats at approximately 140-fold or in male and female mice at approximately 60-fold higher exposures (AUC) than in humans given the recommended 200 mg daily dose. Fertility was normal in the offspring of mice exposed daily from before birth (in utero) through sexual maturity at daily exposures (AUC) of approximately 60-fold higher than human exposures at the recommended 200 mg daily dose.

Tenofovir (Tenemine) Disoproxil Fumarate: Long-term oral carcinogenicity studies of Tenofovir (Tenemine) disoproxil fumarate in mice and rats were carried out at exposures up to approximately 16 times (mice) and 5 times (rats) those observed in humans at the therapeutic dose for HIV-1 infection. At the high dose in female mice, liver adenomas were increased at exposures 16 times that in humans. In rats, the study was negative for carcinogenic findings at exposures up to 5 times that observed in humans at the therapeutic dose.

Tenofovir (Tenemine) disoproxil fumarate was mutagenic in the in vitro mouse lymphoma assay and negative in an in vitro bacterial mutagenicity test (Ames test). In an in vivo mouse micronucleus assay, Tenofovir (Tenemine) disoproxil fumarate was negative when administered to male mice.

There were no effects on fertility, mating performance or early embryonic development when Tenofovir (Tenemine) disoproxil fumarate was administered to male rats at a dose equivalent to 10 times the human dose based on body surface area comparisons for 28 days prior to mating and to female rats for 15 days prior to mating through day seven of gestation. There was, however, an alteration of the estrous cycle in female rats.

Use In Specific Populations

Pregnancy

Pregnancy Category B

Antiretroviral Pregnancy Registry: To monitor fetal outcomes of pregnant women exposed to Tenemine, an Antiretroviral Pregnancy Registry (APR) has been established. Healthcare providers are encouraged to register patients by calling 1-800258-4263.

Risk Summary

Tenemine has been evaluated in a limited number of women during pregnancy and postpartum. Available human and animal data suggest that Tenemine does not increase the risk of major birth defects overall compared to the background rate. There are, however, no adequate and well-controlled trials in pregnant women. Because the studies in humans cannot rule out the possibility of harm, Tenemine should be used during pregnancy only if clearly needed. If an uninfected individual becomes pregnant while taking Tenemine for a PrEP indication, careful consideration should be given to whether use of Tenemine should be continued, taking into account the potential increased risk of HIV-1 infection during pregnancy.

Clinical Considerations

As of July 2011, the APR has received prospective reports of 764 and 1219 exposures to Emtricitabine (Tenemine)- and Tenofovir (Tenemine)- containing regimens, respectively in the first trimester, 321 and 455 exposures, respectively, in second trimester, and 140 and 257 exposures, respectively, in the third trimester. Birth defects occurred in 18 of 764 (2.4%) live births for Emtricitabine (Tenemine)-containing regimens and 27 of 1219 (2.2%) live births for tenofovircontaining regimens (first trimester exposure) and 10 of 461 (2.2%) live births for Emtricitabine (Tenemine)-containing regimens and 15 of 714 (2.1%) live births for tenofovircontaining regimens (second/third trimester exposure). Among pregnant women in the U.S. reference population, the background rate of birth defects is 2.7%. There was no association between Emtricitabine (Tenemine) or Tenofovir (Tenemine) and overall birth defects observed in the APR.

Animal Data

Emtricitabine (Tenemine)

The incidence of fetal variations and malformations was not increased in embryofetal toxicity studies performed with Emtricitabine (Tenemine) in mice at exposures (AUC) approximately 60-fold higher and in rabbits at approximately 120-fold higher than human exposures at the recommended daily dose.

Tenofovir (Tenemine) Disoproxil Fumarate

Reproduction studies have been performed in rats and rabbits at doses up to 14 and 19 times the human dose based on body surface area comparisons and revealed no evidence of impaired fertility or harm to the fetus due to Tenofovir (Tenemine).

Nursing Mothers

The Centers for Disease Control and Prevention recommend that HIV-1 infected mothers not breast-feed their infants to avoid risking postnatal transmission of HIV-1.

Studies in humans have shown that both Tenofovir (Tenemine) and Emtricitabine (Tenemine) are excreted in human milk. Because the risks of low level exposure to Emtricitabine (Tenemine) and Tenofovir (Tenemine) to infants are unknown, mothers should be instructed not to breast-feed if they are receiving Tenemine, whether they are taking Tenemine for treatment or to reduce the risk of acquiring HIV-1.

Emtricitabine (Tenemine)

Samples of breast milk obtained from five HIV-1 infected mothers show that Emtricitabine (Tenemine) is secreted in human milk. Breastfeeding infants whose mothers are being treated with Emtricitabine (Tenemine) may be at risk for developing viral resistance to Emtricitabine (Tenemine). Other Emtricitabine (Tenemine)-associated risks in infants breastfed by mothers being treated with Emtricitabine (Tenemine) are unknown.

Tenofovir (Tenemine) Disoproxil Fumarate

Samples of breast milk obtained from five HIV-1 infected mothers show that Tenofovir (Tenemine) is secreted in human milk. Tenofovir (Tenemine)-associated risks, including the risk of viral resistance to Tenofovir (Tenemine), in infants breastfed by mothers being treated with Tenofovir (Tenemine) disoproxil fumarate are unknown.

Pediatric Use

No pediatric clinical trial was conducted to evaluate the safety and efficacy of Tenemine. Data from previously conducted trials with the individual drug products, EMTRIVA and VIREAD, were relied upon to support dosing recommendations for Tenemine. For additional information, please consult the prescribing information for EMTRIVA and VIREAD.

Tenemine should only be administered to HIV-1 infected pediatric patients with body weight greater than or equal to 17 kg and who are able to swallow a whole tablet. Because it is a fixed-dose combination tablet, Tenemine cannot be adjusted for patients of lower weight. Tenemine has not been evaluated for use in pediatric patients weighing less than 17 kg.

Geriatric Use

Clinical trials of EMTRIVA or VIREAD 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 patients should be cautious, keeping in mind the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Patients With Impaired Renal Function

Treatment of HIV-1 Infection

The dosing interval for Tenemine should be modified in HIV-infected adult patients with estimated creatinine clearance of 30–49 mL/min. Tenemine should not be used in patients with estimated creatinine clearance below 30 mL/min and in patients with end-stage renal disease requiring dialysis..

Pre-exposure Prophylaxis

Tenemine for a PrEP indication should not be used 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 Tenemine for PrEP, evaluate potential causes and re-assess potential risks and benefits of continued use.

What happens if I miss a dose of Tenemine?

infoWhen you miss a dose, you should take it as soon as you remember, but you should take care that it should be well spaced from the next dose. You should not take an extra dose at the time of the second dose as it will become a double dose. The double dose can give unwanted side effects, so be careful. In chronic conditions or when you have a serious health issue, if you miss a dose, you should inform your health care provider and ask his suggestion.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.



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. DrugBank. "Emtricitabine". http://www.drugbank.ca/drugs/DB00879 (accessed September 17, 2018).

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