Tenozet Uses

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What is Tenozet?

Darunavir, cobicistat, emtricitabine, and Tenozet alafenamide combination is used to treat human immunodeficiency virus (HIV) infection. HIV is the virus that causes acquired immune deficiency syndrome (AIDS). Darunavir, cobicistat, emtricitabine, and Tenozet alafenamide is usually given to patients who have yet not received any medicine for HIV infection.

Darunavir, cobicistat, emtricitabine, and Tenozet alafenamide combination will not cure or prevent HIV infection or AIDS. It helps keep HIV from reproducing and appears to slow down the destruction of the immune system. This may help delay problems that are usually related to AIDS or HIV disease from occurring. Darunavir, cobicistat, emtricitabine, and Tenozet alafenamide will not keep you from spreading HIV to other people. People who receive darunavir, cobicistat, emtricitabine, and Tenozet alafenamide may continue to have other problems usually related to AIDS or HIV disease.

Darunavir, cobicistat, emtricitabine, and Tenozet alafenamide is available only with your doctor's prescription.

Tenozet 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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In combination with other antiretroviral agents for the treatment of HIV-1 infection in adults. The following points should be considered when initiating therapy with Tenozet for the treatment of HIV-1 infection: Tenozet should not be used in combination with (Tenozet 300 mg + emtricitabine 200 mg) or (efavirenz + emtricitabine + Tenozet).

Treatment of chronic hepatitis B in adults. The following points should be considered when initiating therapy with Tenozet for the treatment of HBV infection: This indication is based primarily on data from treatment of nucleoside-treatment-naive subjects, and a smaller number of subjects who had previously received lamivudine or adefovir. Subjects were adults with HBeAg-positive and HBeAg-negative chronic hepatitis B with compensated liver disease.

How should I use Tenozet?

Use Tenozet powder as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Ask your health care provider any questions you may have about how to use Tenozet powder.

Uses of Tenozet 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

Chronic hepatitis B: Treatment of chronic hepatitis B virus (HBV) in patients ≥2 years of age weighing ≥10 kg

HIV-1 infection, treatment: Treatment of HIV-1 infection in patients ≥2 years of age weighing ≥10 kg, in combination with other antiretroviral agents.

Off Label Uses

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, Tenozet is effective and recommended (in conjunction with other antiretrovirals) as postexposure prophylaxis of HIV-1 infection following nonoccupational exposure (nPEP) 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, Tenozet (in combination with emtricitabine and raltegravir) is effective and recommended for postexposure prophylaxis of HIV-1 infection in health care personnel following occupational exposure (oPEP) to blood and/or other body fluids that may contain HIV.

Tenozet description

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Tenozet disoproxil fumarate (a prodrug of Tenozet), marketed by Gilead Sciences under the trade name Viread®, belongs to a class of antiretroviral drugs known as nucleotide analogue reverse transcriptase inhibitors (nRTIs), which block reverse transcriptase, an enzyme crucial to viral production in HIV-infected people. [Wikipedia] In vivo Tenozet disoproxil fumarate is converted to Tenozet, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5'-monophosphate.

Tenozet dosage

Tenozet Dosage

Generic name: Darunavir 800mg, Cobicistat 150mg, Emtricitabine 200mg, Tenozet alafenamide 10mg

Dosage form: tablet, film coated

Medically reviewed on July 27, 2018.

Testing Prior to Initiation of Tenozet

Prior to or when initiating Tenozet, test patients for hepatitis B (HBV) virus infection.

Prior to or when initiating Tenozet, and during treatment with Tenozet, on a clinically appropriate schedule, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all patients. In patients with chronic kidney disease, also assess serum phosphorus.

Recommended Dosage

Tenozet is a four-drug fixed dose combination product containing 800 mg of darunavir (DRV), 150 mg of cobicistat (COBI), 200 mg of emtricitabine (FTC), and 10 mg of Tenozet alafenamide (TAF). The recommended dosage of Tenozet is one tablet taken orally once daily with food in adults. For patients who are unable to swallow the whole tablet, Tenozet may be split into two pieces using a tablet-cutter, and the entire dose should be consumed immediately after splitting.

Not Recommended in Patients with Severe Renal Impairment

Tenozet is not recommended in patients with creatinine clearance below 30 mL per minute.

Not Recommended in Patients with Severe Hepatic Impairment

Tenozet is not recommended for use in patients with severe hepatic impairment (Child-Pugh Class C).

Not Recommended During Pregnancy

Tenozet is not recommended during pregnancy because of substantially lower exposures of darunavir and cobicistat during pregnancy.

Tenozet should not be initiated in pregnant individuals. An alternative regimen is recommended for those who become pregnant during therapy with Tenozet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

More about Tenozet (cobicistat / darunavir / emtricitabine / Tenozet alafenamide)

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Related treatment guides

Tenozet interactions

See also:
What other drugs will affect Tenozet?

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Acyclovir-Valacyclovir: May increase the serum concentration of Tenozet Products. Tenozet Products may increase the serum concentration of Acyclovir-Valacyclovir. Monitor therapy

Adefovir: May diminish the therapeutic effect of Tenozet Products. Adefovir may increase the serum concentration of Tenozet Products. Tenozet Products may increase the serum concentration of Adefovir. Avoid combination

Aminoglycosides: May increase the serum concentration of Tenozet Products. Tenozet Products may increase the serum concentration of Aminoglycosides. Monitor therapy

Atazanavir: Tenozet Disoproxil Fumarate may decrease the serum concentration of Atazanavir. Atazanavir may increase the serum concentration of Tenozet Disoproxil Fumarate. Management: Must use boosted atazanavir in adults; give combo (atazanavir/ritonavir or atazanavir/cobicistat with Tenozet) as a single daily dose with food. Pediatric patients, pregnant patients, and users of H2-blockers require other dose changes. Consider therapy modification

Cabozantinib: MRP2 Inhibitors may increase the serum concentration of Cabozantinib. Monitor therapy

Cidofovir: May increase the serum concentration of Tenozet Products. Tenozet Products may increase the serum concentration of Cidofovir. Monitor therapy

Cladribine: Agents that Undergo Intracellular Phosphorylation may diminish the therapeutic effect of Cladribine. Avoid combination

Cobicistat: May enhance the adverse/toxic effect of Tenozet Products. More specifically, cobicistat may impair proper Tenozet monitoring and dosing. Monitor therapy

Darunavir: Tenozet Disoproxil Fumarate may increase the serum concentration of Darunavir. Darunavir may increase the serum concentration of Tenozet Disoproxil Fumarate. Monitor therapy

Diclofenac (Systemic): May enhance the nephrotoxic effect of Tenozet Products. Management: Seek alternatives to this combination whenever possible. Avoid use of Tenozet with multiple NSAIDs or any NSAID given at a high dose. Consider therapy modification

Didanosine: Tenozet Disoproxil Fumarate may diminish the therapeutic effect of Didanosine. Tenozet Disoproxil Fumarate may increase the serum concentration of Didanosine. Management: Avoid use of Tenozet disoproxil fumarate and didanosine when possible. If combined in adults with CrCL greater than 60 mL/min, decrease didanosine to 250 mg daily if 60 kg or more or to 200 mg if less than 60 kg. Avoid if CrCL is less than 60 mL/min. Consider therapy modification

Ganciclovir-Valganciclovir: Tenozet Products may increase the serum concentration of Ganciclovir-Valganciclovir. Ganciclovir-Valganciclovir may increase the serum concentration of Tenozet Products. Monitor therapy

Ledipasvir: May increase the serum concentration of Tenozet Disoproxil Fumarate. Management: Avoidance of this combination is recommended under some circumstances. Refer to full monograph for details. Consider therapy modification

Lopinavir: May enhance the nephrotoxic effect of Tenozet Disoproxil Fumarate. Lopinavir may increase the serum concentration of Tenozet Disoproxil Fumarate. Monitor therapy

Nonsteroidal Anti-Inflammatory Agents: May enhance the nephrotoxic effect of Tenozet Products. Management: Seek alternatives to these combinations whenever possible. Avoid use of Tenozet with multiple NSAIDs or any NSAID given at a high dose. Consider therapy modification

Orlistat: May decrease the serum concentration of Antiretroviral Agents. Monitor therapy

Simeprevir: Tenozet Disoproxil Fumarate may decrease the serum concentration of Simeprevir. Simeprevir may increase the serum concentration of Tenozet Disoproxil Fumarate. Monitor therapy

Tipranavir: Tenozet Disoproxil Fumarate may decrease the serum concentration of Tipranavir. Tipranavir may decrease the serum concentration of Tenozet Disoproxil Fumarate. Monitor therapy

Velpatasvir: May increase the serum concentration of Tenozet Disoproxil Fumarate. Monitor therapy

Voxilaprevir: Tenozet Disoproxil Fumarate may increase the serum concentration of Voxilaprevir. Voxilaprevir may increase the serum concentration of Tenozet Disoproxil Fumarate. Monitor therapy

Tenozet side effects

See also:
What are the possible side effects of Tenozet?

The following adverse reactions are discussed in other sections of the labeling:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Adverse Reactions in Adults with No Prior Antiretroviral Treatment History

The safety profile of Tenozet in HIV-1 infected adults with no prior antiretroviral treatment history is based on Week 48 data from the AMBER trial, a randomized, double-blind, active-controlled trial where a total of 362 subjects received Tenozet once daily and 363 subjects received a combination of PREZCOBIX® (fixed-dose combination of darunavir and cobicistat) and fixed-dose combination of emtricitabine and Tenozet disoproxil fumarate (FTC/TDF).

The proportion of subjects who discontinued treatment with Tenozet or PREZCOBIX+FTC/TDF due to adverse events, regardless of severity, were 2% and 4% respectively.

An overview of the most frequent (occurring in at least 2% of subjects) adverse reactions irrespective of severity reported in AMBER are presented in Table 1. An overview of the most frequent laboratory abnormalities of at least Grade 2 severity reported in AMBER are presented in Table 2. Changes from baseline in lipid parameters for patients receiving Tenozet and those receiving PREZCOBIX and F/TDF are presented in Table 3.

Most adverse reactions during treatment with Tenozet were grade 1 or 2 in severity. One grade 3 reaction was reported and no grade 4 adverse reactions were reported during treatment with Tenozet.

Table 1: Adverse Reactions Reported in ≥2% of HIV-1 Infected Adults With No Prior Antiretroviral Treatment History in AMBER (Week 48 Analysis)
Tenozet

(N=362)

PREZCOBIX+FTC/TDF

(N=363)

All Grades At least Grade 2 All Grades At least Grade 2
*
Includes pooled reported terms: dermatitis, dermatitis allergic, erythema, photosensitivity reaction, rash, rash generalized, rash macular, rash maculo-papular, rash morbilliform, rash pruritic, toxic skin eruption, urticaria
Diarrhea 9% 2% 11% 2%
Rash* 8% 4% 7% 5%
Nausea 6% 1% 10% 3%
Fatigue 4% 1% 4% 1%
Headache 3% 1% 2% 1%
Abdominal discomfort 2% - 4% <1%
Flatulence 2% <1% 1% -

Adverse Reactions in Virologically-Suppressed Adults

The safety profile of Tenozet in virologically-suppressed HIV-1 infected adults is based on Week 48 data from 1,141 subjects in the EMERALD trial, a randomized, open-label, active-controlled trial where 763 subjects with a stable antiretroviral regimen consisting of a boosted protease inhibitor [either darunavir once daily or atazanavir (both boosted with ritonavir or cobicistat), or lopinavir with ritonavir] combined with FTC and TDF switched to Tenozet, and 378 subjects who continued their treatment regimen of a boosted protease inhibitor with FTC and TDF. Overall, the safety profile of Tenozet in subjects in this study was similar to that in subjects with no prior antiretroviral treatment history. The proportion of subjects who discontinued treatment with Tenozet due to adverse events, regardless of severity, was 1%.

Less Frequent Adverse Reactions

The following adverse reactions occurred in less than 2% of adults with no antiretroviral treatment history or virologically suppressed subjects receiving Tenozet, or are from studies described in the prescribing information of the individual component PREZISTA (darunavir).

Gastrointestinal Disorders: dyspepsia, pancreatitis (acute), vomiting

Skin and Subcutaneous Tissue Disorders: angioedema, pruritus, Stevens-Johnson syndrome

Metabolism and Nutrition Disorders: anorexia, diabetes mellitus, lipodystrophy

Reproductive system and Breast disorders: gynecomastia

Musculoskeletal and Connective Tissue Disorders: myalgia, osteonecrosis

Psychiatric Disorders: abnormal dreams

Immune System Disorders: (drug) hypersensitivity, immune reconstitution inflammatory syndrome

Hepatobiliary Disorders: acute hepatitis

Laboratory Abnormalities

Table 2: Laboratory Abnormalities (Grade 2–4) Reported in ≥2% of Adults With No Prior Antiretroviral Treatment History in AMBER (Week 48 Analysis)
Laboratory Parameter

Grade

Limit Tenozet

N=362

PREZCOBIX+FTC/TDF

N=363

Creatinine
Grade 2 >1.3 to 1.8 × ULN 4% 14%
Grade 4 ≥3.5× ULN <1% 0
Triglycerides
Grade 2 301–500 mg/dL 7% 4%
Grade 3 501–1,000 mg/dL 1% 1%
Grade 4 > 1,000 mg/dL <1%% <1%
Total Cholesterol
Grade 2 240–<300 mg/dL 17% 4%
Grade 3 >= 300 mg/dL 2% 1%
Low-Density Lipoprotein Cholesterol
Grade 2 160–189 mg/dL 9% 4%
Grade 3 ≥ 190 mg/dL 5% 1%
Elevated Glucose Levels
Grade 2 126–250 mg/dL 6% 6%
Grade 3 251–500 mg/dL <1% 0

ALT and/or AST elevations (Grade 2–4 combined) occurred in 2% of adult subjects receiving Tenozet with no antiretroviral treatment history in AMBER (Week 48 Analysis). Results were consistent in subjects receiving PREZCOBIX+FTC/TDF.

Table 3: Lipid Values, Mean Change from Baseline, Reported in Adults With No Prior Antiretroviral Treatment History in AMBER (Week 48 Analysis)*
Tenozet

N=356

PREZCOBIX+FTC/TDF

N=355

Baseline Week 48 Baseline Week 48
Mean† mg/dL Change mg/dL Change
N=304‡ N=290
*
Subjects on lipid-lowering agents at screening/baseline were excluded from the analysis (6 out of 362 subjects on Tenozet, 8 out of 363 subjects on PREZCOBIX+FTC/TDF). Subjects initiating a lipid-lowering agent post-baseline had their last fasted on-treatment value (prior to starting the agent) carried forward (6 on Tenozet, 2 on PREZCOBIX+FTC/TDF).
The change from baseline is the mean of within-subject changes from baseline for subjects with both baseline and Week 48 values, or the last value carried forward prior to initiating lipid-lowering agent post-baseline.
One subject did not have a Week 48 result for LDL cholesterol (n=303).
Total cholesterol 168 +30 164 +11
HDL cholesterol 45 +6 44 +2
LDL cholesterol 199 +19 98 +5
Triglycerides 117 +34 112 +21
Total cholesterol to HDL ratio 4.1 0.2 4.0 0.1

The percentage of subjects starting any lipid lowering drug during treatment in the Tenozet and PREZCOBIX + FTC/TDF arm were 1.7% (n=6) and 0.6% (n=2), respectively.

Renal Laboratory Tests

In the AMBER trial, which had 670 adults with no prior antiretroviral treatment history with a median baseline eGFR of 119 mL/min (Tenozet) and 118 mL/min (PREZCOBIX + FTC/TDF), mean (SD) serum creatinine increased by 0.05 (0.10) mg/dL in the Tenozet group and by 0.09 (0.11) mg/dL in the PREZCOBIX + FTC/TDF group from baseline to Week 48. Median serum creatinine was 0.90 mg/dL (Tenozet) and 0.89 mg/dL (PREZCOBIX + FTC/TDF) at baseline and 0.95 mg/dL (Tenozet) and 0.97 mg/dL (PREZCOBIX +FTC/TDF) at Week 48. Increases in serum creatinine occurred by Week 2 of treatment and remained stable. Median urine protein-to-creatinine ratio (UPCR) was 47 mg per gram (Tenozet) and 51 mg/g (PREZCOBIX + FTC/TDF) at baseline and 30 mg per gram (Tenozet) and 34 mg/g (PREZCOBIX + FTC/TDF) at Week 48.

In the EMERALD trial which had 1,141 virologically-suppressed adults treated with an HIV protease inhibitor and TDF containing regimen with a median baseline eGFR of 104 mL/min (Tenozet) and 103 mL/min (bPI+FTC/TDF) who were randomized to continue their treatment regimen or switch to Tenozet, at Week 48, mean serum creatinine was similar to baseline for both those continuing baseline treatment and those switching to Tenozet. Mean (SD) serum creatinine was 0.98 (0.18) mg/dL (Tenozet) and 0.98 (0.19) mg/dL (bPI+FTC/TDF) at baseline and 0.99 (0.18) mg/dL (Tenozet) and 0.99 (0.21) mg/dL (bPI+FTC/TDF) at Week 48. Median serum creatinine was 0.97 mg/dL (Tenozet) and 0.98 mg/dL (bPI+FTC/TDF) at baseline and 1.0 mg/dL (Tenozet) and 0.97 mg/dL (bPI+FTC/TDF) at Week 48. Median UPCR was 62 mg per gram (Tenozet) and 63 mg/g (bPI+FTC/TDF) at baseline and 37 mg per gram (Tenozet) and 53 mg/g (bPI+FTC/TDF) at Week 48.

Bone Mineral Density

AMBER

The effects of Tenozet compared to PREZCOBIX + FTC/TDF on bone mineral density (BMD) change from baseline to Week 48 were assessed by dual-energy X-ray absorptiometry (DXA). The mean percentage change in BMD from baseline to Week 48 was −0.7% with Tenozet compared to −2.4% with DRV/COBI + FTC/TDF at the lumbar spine and 0.2% compared to −2.7% at the total hip. BMD declines of 5% or greater at the lumbar spine were experienced by 16% of Tenozet subjects and 22% of PREZCOBIX + FTC/TDF subjects. BMD declines of 7% or greater at the femoral neck were experienced by 2% of Tenozet subjects and 15% of PREZCOBIX + FTC/TDF subjects. The long-term clinical significance of these BMD changes is not known.

EMERALD

In EMERALD, boosted Protease Inhibitor (bPI) and TDF-treated subjects were randomized to continue their TDF-based regimen or switch to Tenozet; changes in BMD from baseline to Week 48 were assessed by DXA. The mean percentage change in BMD from baseline to Week 48 was 1.5% with Tenozet compared to −0.6% with PREZCOBIX + FTC/TDF at the lumbar spine and 1.4% compared to -0.3% at the total hip. BMD declines of 5% or greater at the lumbar spine were experienced by 2% of Tenozet subjects and 9% of PREZCOBIX + FTC/TDF subjects. BMD declines of 7% or greater at the femoral neck were experienced by no Tenozet subjects and 2% of PREZCOBIX + FTC/TDF subjects. The long-term clinical significance of these BMD changes is not known.

Postmarketing Experience

The following adverse reactions have been identified during postmarketing experience in patients receiving a darunavir-containing regimen. Because these 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.

Metabolism and Nutrition Disorders

Redistribution of body fat

Musculoskeletal and Connective Tissue Disorders

Rhabdomyolysis (associated with co-administration with HMG-CoA reductase inhibitors)

Skin and Subcutaneous Tissue Disorders

Toxic epidermal necrolysis, acute generalized exanthematous pustulosis, drug rash with eosinophilia and systemic symptoms.

Tenozet contraindications

See also:
What is the most important information I should know about Tenozet?

Tenozet is contraindicated with the following co-administered drugs due to the potential for serious and/or life-threatening events or loss of therapeutic effect.



Active ingredient matches for Tenozet:

Tenofovir in Japan.


List of Tenozet substitutes (brand and generic names)

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Unit description / dosage (Manufacturer)Price, USD
300 mg x 30's (Cipla Limited)$ 23.81
Tenvir 300mg TAB / 30 (Cipla Limited)$ 23.81
Tenvir 300 mg Tablet (Cipla Limited)$ 1.59
TENVIR 300 MG TABLET 1 strip / 30 tablets each (Cipla Limited)$ 21.89
TENVIR tab 300 mg x 30's (Cipla Limited)$ 23.81
Tenvir 300mg TAB / 30 (Cipla Limited)$ 23.81
Tenvir 300mg Tablet (Cipla Limited)$ 0.76
Tenvira FC tab 300 mg 10's (Aristopharma)
Tenvira FC tab 300 mg 20's (Aristopharma)
Tenvira FC tab 300 mg 30's (Aristopharma)
TERAVIR 300MG TABLET 1 strip / 30 tablets each (Natco Pharma Ltd)$ 27.21
Tevir FC tab 300 mg 30's (Sun Pharma)
Valten 300mg Tablet (Wockhardt Ltd)$ 0.76
VALTEN 300 MG TABLET 1 strip / 30 tablets each (Wockhardt Ltd)$ 22.68
Virkil 300 mg x 1 Blister x 10 Tablet
Virkil 300 mg x 3 Blister x 10 Tablet
Zifam Tenovir FC tab 300 mg 6 x 10's (Zifam India)

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