What happens if I overdose Tenoviral?
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local, or emergency room immediately.
Proper storage of Tenoviral powder:
Store Tenoviral powder at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Do not use Tenoviral powder if the seal over the bottle opening is broken or missing. Keep Tenoviral powder 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 Do not keep medicine that is out of date or that you no longer need.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 Tenoviral powder out of the reach of children and away from pets.
Overdose of Tenoviral in details
Human experience of acute overdose with Tenoviral is limited. There is no specific antidote for overdose with Tenoviral. Treatment of overdose with Tenoviral consists of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient.
Since darunavir and cobicistat are highly bound to plasma proteins, it is unlikely that they will be significantly removed by hemodialysis or peritoneal dialysis. Hemodialysis treatment removes approximately 30% of the emtricitabine dose over a 3-hour dialysis period starting within 1.5 hours of emtricitabine dosing (blood flow rate of 400 mL/min and a dialysate flow rate of 600 mL/min). Tenoviral is efficiently removed by hemodialysis with an extraction coefficient of approximately 54%. It is not known whether emtricitabine or Tenoviral can be removed by peritoneal dialysis.
What should I avoid while taking Tenoviral?
Avoid drinking alcohol. It may increase your risk of liver damage.
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.
Tenoviral warnings
Exacerbation of Hepatitis after Discontinuation of Treatment
Discontinuation of anti-HBV therapy, including Tenoviral Disoproxil Fumarate, may be associated with severe acute exacerbations of hepatitis. Patients infected with HBV who discontinue Tenoviral Disoproxil Fumarate should be closely monitored with both clinical and laboratory follow-up for at least several months after stopping treatment. If appropriate, resumption of anti-hepatitis B therapy may be warranted.
New Onset or Worsening Renal Impairment
Tenoviral is 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 Tenoviral Disoproxil Fumarate.
It is recommended that estimated creatinine clearance be assessed in all patients prior to initiating therapy and as clinically appropriate during therapy with Tenoviral Disoproxil Fumarate. 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 Tenoviral Disoproxil Fumarate, and periodically during Tenoviral Disoproxil Fumarate therapy.
Dosing interval adjustment of Tenoviral Disoproxil Fumarate and close monitoring of renal function are recommended in all patients with creatinine clearance below 50 mL/min. No safety or efficacy data are available in patients with renal impairment who received Tenoviral Disoproxil Fumarate using these dosing guidelines, so the potential benefit of Tenoviral Disoproxil Fumarate therapy should be assessed against the potential risk of renal toxicity.
Tenoviral Disoproxil Fumarate 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 Tenoviral 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.
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 Tenoviral DF, alone or in combination with other antiretrovirals. Treatment with Tenoviral Disoproxil Fumarate should be suspended in any patient 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).
Coadministration with Other Products
Tenoviral Disoproxil Fumarate should not be used in combination with other drugs containing Tenoviral DF or Tenoviral alafenamide, including ATRIPLA, COMPLERA, DESCOVY, GENVOYA, ODEFSEY, STRIBILD, TRUVADA, or VEMLIDY. Tenoviral Disoproxil Fumarate should not be administered in combination with HEPSERA (adefovir dipivoxil).
Patients Coinfected with HIV-1 and HBV
Due to the risk of development of HIV-1 resistance, Tenoviral Disoproxil Fumarate should only be used in HIV-1 and HBV coinfected patients as part of an appropriate antiretroviral combination regimen.
HIV-1 antibody testing should be offered to all HBV-infected patients before initiating therapy with Tenoviral Disoproxil Fumarate. It is also recommended that all patients with HIV-1 be tested for the presence of chronic hepatitis B before initiating treatment with Tenoviral Disoproxil Fumarate.
Bone Effects
Bone Mineral Density:
In clinical trials in HIV-1 infected adults, Tenoviral Disoproxil Fumarate 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 Tenoviral Disoproxil Fumarate.
Clinical trials evaluating Tenoviral Disoproxil Fumarate 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 Tenoviral Disoproxil Fumarate-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.
The effects of Tenoviral Disoproxil Fumarate-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 adults 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 for all patients. 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 Tenoviral Disoproxil Fumarate. 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 Tenoviral DF.
Immune Reconstitution Syndrome
Immune reconstitution syndrome has been reported in HIV-infected patients treated with combination antiretroviral therapy, including Tenoviral Disoproxil Fumarate. During the initial phase of combination antiretroviral treatment, 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-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.
What should I discuss with my healthcare provider before taking Tenoviral?
- If you have an allergy to darunavir, cobicistat, emtricitabine, and Tenoviral alafenamide or any part of darunavir, cobicistat, emtricitabine, and Tenoviral alafenamide.
- If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
- If you have any of these health problems: Kidney disease or liver disease.
- If you take any drugs (prescription or OTC, natural products, vitamins) that must not be taken with darunavir, cobicistat, emtricitabine, and Tenoviral alafenamide, like certain drugs that are used for high cholesterol, migraines, or mood problems. There are many drugs that must not be taken with darunavir, cobicistat, emtricitabine, and Tenoviral alafenamide.
- If you are taking St. John's wort. Do not take St. John's wort with darunavir, cobicistat, emtricitabine, and Tenoviral alafenamide. This medicine may not work as well.
- If you are taking any other drugs to treat HIV.
- If you are taking any drugs that can raise the chance of kidney problems. There are many drugs that can do this. Ask your doctor or pharmacist if you are not sure.
- If you are pregnant or may be pregnant. Do not take darunavir, cobicistat, emtricitabine, and Tenoviral alafenamide if you are pregnant.
- If you are breast-feeding. Do not breast-feed while you take darunavir, cobicistat, emtricitabine, and Tenoviral alafenamide.
This is not a list of all drugs or health problems that interact with darunavir, cobicistat, emtricitabine, and Tenoviral alafenamide.
Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take darunavir, cobicistat, emtricitabine, and Tenoviral alafenamide with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
Tenoviral precautions
Co-Administration with Other Drugs: Tenoviral should not be administered concurrently with emtricitabine and Tenoviral combination or adefovir dipivoxil.
Lactic Acidosis/Severe Hepatomegaly with Steatosis: Though the risk of occurrence of lactic acidosis is low for Tenoviral, treatment should be suspended in any patient who develops lactic acidosis or hepatotoxicity.
Exacerbation of Hepatitis After Discontinuation of Treatment: Discontinuation of Tenoviral therapy may be associated with severe acute exacerbations of hepatitis. Monitor liver function tests every 3 months, and viral and serological markers of hepatitis B every 3-6 months. Discontinue if deterioration in liver function, hepatic steatosis, progressive hepatomegaly or unexplained lactic acidosis. Recurrent hepatitis may occur on discontinuation.
Use in pregnancy: Pregnancy Category B. There are no adequate and well-controlled studies in pregnant women. Tenoviral should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Use in lactation: It is not known whether it is excreted in human milk. Mothers should be instructed not to breastfeed if they are receiving Tenoviral.
Use in children: The use of Tenoviral is not recommended for pediatric patients.
Use in the
Elderly: In general, dose selection for the elderly patient should be cautious, keeping in mind the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.
What happens if I miss a dose of Tenoviral?
Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.
Get your prescription refilled before you run out of medicine completely.
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Information checked by Dr. Sachin Kumar, MD Pharmacology
