Tenvor Side effects

How long did you take this medication to work?
sponsored

What are the possible side effects of Tenvor?

Tenvor may cause serious side effects, including:

The most common side effects of Tenvor, include:

These are not all of the possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Side effects of Tenvor in details

A side effect of any drug can be defined as the unwanted or undesired effect produced by the drug. The side effect can be major or in few medications minor that can be ignored. Side effects not only vary from drug to drug, but it also depends on the dose of the drug, the individual sensitivity of the person, brand or company which manufactures it. If side effects overweigh the actual effect of the medicine, it may be difficult to convince the patient to take the drug. Few patients get specific side effects to specific drugs; in that case, a doctor replaces the drug with another. If you feel any side effect and it troubles you, do not forget to share with your healthcare practitioner.
sponsored

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 Tenvor 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 Tenvor once daily and 363 subjects received a combination of PREZCOBIX® (fixed-dose combination of darunavir and cobicistat) and fixed-dose combination of emtricitabine and Tenvor disoproxil fumarate (FTC/TDF).

The proportion of subjects who discontinued treatment with Tenvor 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 Tenvor and those receiving PREZCOBIX and F/TDF are presented in Table 3.

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

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

(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 Tenvor 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 Tenvor, and 378 subjects who continued their treatment regimen of a boosted protease inhibitor with FTC and TDF. Overall, the safety profile of Tenvor 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 Tenvor 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 Tenvor, 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 Tenvor

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 Tenvor 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)*
Tenvor

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 Tenvor, 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 Tenvor, 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 Tenvor 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 (Tenvor) and 118 mL/min (PREZCOBIX + FTC/TDF), mean (SD) serum creatinine increased by 0.05 (0.10) mg/dL in the Tenvor 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 (Tenvor) and 0.89 mg/dL (PREZCOBIX + FTC/TDF) at baseline and 0.95 mg/dL (Tenvor) 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 (Tenvor) and 51 mg/g (PREZCOBIX + FTC/TDF) at baseline and 30 mg per gram (Tenvor) 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 (Tenvor) and 103 mL/min (bPI+FTC/TDF) who were randomized to continue their treatment regimen or switch to Tenvor, at Week 48, mean serum creatinine was similar to baseline for both those continuing baseline treatment and those switching to Tenvor. Mean (SD) serum creatinine was 0.98 (0.18) mg/dL (Tenvor) and 0.98 (0.19) mg/dL (bPI+FTC/TDF) at baseline and 0.99 (0.18) mg/dL (Tenvor) and 0.99 (0.21) mg/dL (bPI+FTC/TDF) at Week 48. Median serum creatinine was 0.97 mg/dL (Tenvor) and 0.98 mg/dL (bPI+FTC/TDF) at baseline and 1.0 mg/dL (Tenvor) and 0.97 mg/dL (bPI+FTC/TDF) at Week 48. Median UPCR was 62 mg per gram (Tenvor) and 63 mg/g (bPI+FTC/TDF) at baseline and 37 mg per gram (Tenvor) and 53 mg/g (bPI+FTC/TDF) at Week 48.

Bone Mineral Density

AMBER

The effects of Tenvor 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 Tenvor 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 Tenvor subjects and 22% of PREZCOBIX + FTC/TDF subjects. BMD declines of 7% or greater at the femoral neck were experienced by 2% of Tenvor 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 Tenvor; 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 Tenvor 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 Tenvor subjects and 9% of PREZCOBIX + FTC/TDF subjects. BMD declines of 7% or greater at the femoral neck were experienced by no Tenvor 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.

What is the most important information I should know about Tenvor?

Tenvor contraindications

Contraindication can be described as a special circumstance or a disease or a condition wherein you are not supposed to use the drug or undergo particular treatment as it can harm the patient; at times, it can be dangerous and life threatening as well. When a procedure should not be combined with other procedure or when a medicine cannot be taken with another medicine, it is called Relative contraindication. Contraindications should be taken seriously as they are based on the relative clinical experience of health care providers or from proven research findings.
sponsored

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


sponsored

Reviews

The results of a survey conducted on ndrugs.com for Tenvor 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 Tenvor. 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 side effects

No survey data has been collected yet


Consumer reviews


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


Your name: 
Email: 
Spam protection:  < Type 26 here

Information checked by Dr. Sachin Kumar, MD Pharmacology

| Privacy Policy
This site does not supply any medicines. It contains prices for information purposes only.
© 2003 - 2024 ndrugs.com All Rights Reserved