Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV-1 medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider right away if you start having new symptoms after starting your HIV-1 medicine.
New or worse kidney problems, including kidney failure. Your healthcare provider should do blood and urine tests to check your kidneys before you start and during treatment. Your healthcare provider may tell you to stop treatment if you develop new or worse kidney problems.
Too much lactic acid in your blood (lactic acidosis). Too much lactic acid is a serious but rare medical emergency that can lead to death. Tell your healthcare provider right away if you get these symptoms: weakness or being more tired than usual, unusual muscle pain, being short of breath or fast breathing, stomach pain with nausea and vomiting, cold or blue hands and feet, feel dizzy or lightheaded, or a fast or abnormal heartbeat.
Diabetes and high blood sugar (hyperglycemia). Some people who take protease inhibitors including Tenvor can get high blood sugar, develop diabetes, or your diabetes can get worse. Tell your healthcare provider if you notice an increase in thirst or if you start urinating more often during treatment.
Changes in body fat can happen in people who take HIV-1 medicines. The changes may include an increased amount of fat in the upper back and neck (“buffalo hump”), breast, and around the middle of your body (trunk). Loss of fat from the legs, arms, and face may also happen. The exact cause and long-term health effects of these conditions are not known.
Increased bleeding for hemophiliacs. Some people with hemophilia have increased bleeding with protease inhibitors.
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.
The following adverse reactions are discussed in other sections of the labeling:
Severe acute exacerbations of hepatitis B
Severe skin reactions
Immune reconstitution syndrome
New onset or worsening renal impairment
Lactic acidosis/severe hepatomegaly with steatosis
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)
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).
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
Table 2: Laboratory Abnormalities (Grade 2–4) Reported in ≥2% of Adults With No Prior Antiretroviral Treatment History in AMBER (Week 48 Analysis)
>1.3 to 1.8 × ULN
> 1,000 mg/dL
>= 300 mg/dL
Low-Density Lipoprotein Cholesterol
≥ 190 mg/dL
Elevated Glucose Levels
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)*
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 to HDL ratio
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
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.
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.
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 powder may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Tenvor powder with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
If you have HIV infection, you should be tested for HBV infection before you start to take Tenvor powder. If you have HBV infection, you should be tested for HIV infection before you start to take Tenvor powder.
Do NOT take more than the recommended dose, change your dose, or stop taking Tenvor powder or any of your medicines without checking with your doctor.
Keep a list of all the medicines that you take. Make a new list each time medicines are added or stopped. Find out about medicines that should not be taken while you are using Tenvor powder. Be sure that each of your health care providers knows all the medicines that you are taking.
When your medicine supply is low, get more from your doctor or pharmacist as soon as you can. Do not stop taking Tenvor powder, even for a short period of time. If you do, the virus may grow resistant to the medicine and become harder to treat.
Tenvor powder is not a cure for HIV or HBV infection. Patients infected with HIV may still get illnesses and infections associated with the disease. Remain under the care of your doctor.
Tenvor powder does not stop the spread of HIV or HBV to others through blood or sexual contact. Do not have any kind of sex without protection (eg, latex or polyurethane condoms) if you have HIV or HBV infection. Do not share needles, injection supplies, or items like toothbrushes or razors. Talk with your health care provider about ways to prevent the spread of HIV or HBV to others.
If you have HBV infection, you will need close medical follow-up for several months after stopping treatment with Tenvor powder. Follow-up includes medical exams and blood tests to check for HBV infection that could be getting worse.
Tenvor powder may improve immune system function. This may reveal hidden infections in some patients. Tell your doctor right away if you notice symptoms of infection (eg, fever, sore throat, weakness, cough, shortness of breath) after you start Tenvor powder.
Check with your doctor to see if you should take a calcium and vitamin D supplement while you are taking Tenvor powder.
The risk of severe side effects (eg, lactic acidosis, severe liver problems) may be greater in women, patients who are very overweight (obese), and patients who have taken nucleoside medicines (eg, emtricitabine, Tenvor) for a long time. Talk with your doctor if you have questions about your risk for severe side effects from Tenvor powder.
Changes in body fat (eg, an increased amount of fat in the upper back, neck, breast, and trunk, and loss of fat from the legs, arms, and face) may occur in some patients taking Tenvor powder. The cause and long-term effects of these changes are unknown. Discuss any concerns with your doctor.
Tell your doctor or dentist that you take Tenvor powder before you receive any medical or dental care, emergency care, or surgery.
Lab tests, including liver and kidney function and bone mineral density, may be performed while you use Tenvor powder. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
Use Tenvor powder with extreme caution in CHILDREN younger than 2 years old; safety and effectiveness in these children have not been confirmed.
The dose of Tenvor powder in CHILDREN is determined based on body weight; they will need to have regular weight checks while they take Tenvor powder.
PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Tenvor powder while you are pregnant. It is not known if Tenvor powder is found in breast milk. Mothers infected with HIV should not breast-feed. There is a risk of passing the HIV infection or Tenvor powder to the baby. Do not breast-feed while taking Tenvor powder.
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.
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.
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.
Consumer reported side effects
No survey data has been collected yet
There are no reviews yet. Be the first to write one!