Tenemine Side effects

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What are the possible side effects of Tenemine?

Get emergency medical help if you have signs of an allergic reaction to Tenemine: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Early symptoms of lactic acidosis may get worse over time and this condition can be fatal. Get emergency medical help if you have even mild symptoms: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, fast or uneven heart rate, dizziness, or feeling very weak or tired.

Call your doctor at once if you have:

  • sudden or unusual bone pain;

  • kidney problems - little or no urination, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath; or

  • liver problems - nausea, upper stomach pain, itching, tiredness, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Tenemine may increase your risk of certain infections or autoimmune disorders by changing the way your immune system works. Symptoms may occur weeks or months after you start treatment with Tenemine. Tell your doctor if you have:

  • signs of a new infection - fever, night sweats, swollen glands, mouth sores, diarrhea, stomach pain, weight loss;

  • chest pain (especially when you breathe), dry cough, wheezing, feeling short of breath;

  • cold sores, sores on your genital or anal area;

  • rapid heart rate, feeling anxious or irritable, weakness or prickly feeling, problems with balance or eye movement;

  • trouble speaking or swallowing, severe lower back pain, loss of bladder or bowel control; or

  • swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence, loss of interest in sex.

Common Tenemine side effects may include:

  • headache, dizziness, feeling depressed or tired;

  • sleep problems (insomnia), strange dreams;

  • stomach pain;

  • weight loss;

  • rash; or

  • changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Side effects of Tenemine in details

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

  • Lactic Acidosis/Severe Hepatomegaly with Steatosis.
  • Severe Acute Exacerbations of hepatitis B.
  • New Onset or Worsening Renal Impairment.
  • Bone Effects of Tenofovir (Tenemine) DF.
  • Immune Reconstitution Syndrome.

Adverse Reactions from Clinical Trials Experience in HIV-1 Infected Subjects

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.

Clinical Trials in Adult Subjects

The most common adverse reactions (incidence greater than or equal to 10%, any severity) occurring in Study 934, an active-controlled clinical trial of efavirenz, Emtricitabine (Tenemine), and Tenofovir (Tenemine) disoproxil fumarate, include diarrhea, nausea, fatigue, headache, dizziness, depression, insomnia, abnormal dreams, and rash. See also Table 3 for the frequency of treatment-emergent adverse reactions (Grades 2–4) occurring in greater than or equal to 5% of subjects treated in any treatment group in this trial.

Skin discoloration, manifested by hyperpigmentation on the palms and/or soles, was generally mild and asymptomatic. The mechanism and clinical significance are unknown.

Study 934 - Treatment Emergent Adverse Reactions: In Study 934, 511 antiretroviral-naïve subjects received either VIREAD + EMTRIVA administered in combination with efavirenz (N=257) or zidovudine/lamivudine administered in combination with efavirenz (N=254) for 144 weeks. Subjects had a mean age of 40 years (range 20 to 73 years) and were predominantly male (88%). Overall, 65% were White, 17% were Black, and 13% were Hispanic. Adverse reactions observed in this trial were generally consistent with those seen in other trials in treatment-experienced or treatment-naïve subjects receiving VIREAD and/or EMTRIVA (Table 3).

Table 3 Selected Treatment-Emergent Adverse Reactions* (Grades 2–4) Reported in ≥5% in Any Treatment Group in Study 934 (0–144 Weeks)
FTC+TDF+EFV† AZT/3TC+EFV
N=257 N=254
*
Frequencies of adverse reactions are based on all treatment-emergent adverse events, regardless of relationship to study drug.
From Weeks 96 to 144 of the trial, subjects received Tenemine with efavirenz in place of VIREAD + EMTRIVA with efavirenz.
Rash event includes rash, exfoliative rash, rash generalized, rash macular, rash maculo-papular, rash pruritic, and rash vesicular.
Gastrointestinal Disorder
Diarrhea 9% 5%
Nausea 9% 7%
Vomiting 2% 5%
General Disorders and Administration Site Condition
Fatigue 9% 8%
Infections and Infestations
Sinusitis 8% 4%
Upper respiratory tract infections 8% 5%
Nasopharyngitis 5% 3%
Nervous System Disorders
Headache 6% 5%
Dizziness 8% 7%
Psychiatric Disorders
Depression 9% 7%
Insomnia 5% 7%
Skin and Subcutaneous Tissue Disorders
Rash event‡ 7% 9%

Laboratory Abnormalities: Laboratory abnormalities observed in this trial were generally consistent with those seen in other trials of VIREAD and/or EMTRIVA (Table 4).

Table 4 Significant Laboratory Abnormalities Reported in ≥1% of Subjects in Any Treatment Group in Study 934 (0–144 Weeks)
FTC+TDF+EFV* AZT/3TC+EFV
N=257 N=254
*
From Weeks 96 to 144 of the trial, subjects received Tenemine with efavirenz in place of VIREAD + EMTRIVA with efavirenz.
Any ≥ Grade 3 Laboratory Abnormality 30% 26%
Fasting Cholesterol (>240 mg/dL) 22% 24%
Creatine Kinase

(M: >990 U/L)

(F: >845 U/L)

9% 7%
Serum Amylase (>175 U/L) 8% 4%
Alkaline Phosphatase (>550 U/L) 1% 0%
AST

(M: >180 U/L)

(F: >170 U/L)

3% 3%
ALT

(M: >215 U/L)

(F: >170 U/L)

2% 3%
Hemoglobin (<8.0 mg/dL) 0% 4%
Hyperglycemia (>250 mg/dL) 2% 1%
Hematuria (>75 RBC/HPF) 3% 2%
Glycosuria (≥3+) <1% 1%
Neutrophils (<750/mm3) 3% 5%
Fasting Triglycerides (>750 mg/dL) 4% 2%

In addition to the events described above for Study 934, other adverse reactions that occurred in at least 5% of subjects receiving EMTRIVA or VIREAD with other antiretroviral agents in clinical trials include anxiety, arthralgia, increased cough, dyspepsia, fever, myalgia, pain, abdominal pain, back pain, paresthesia, peripheral neuropathy (including peripheral neuritis and neuropathy), pneumonia, and rhinitis.

In addition to the laboratory abnormalities described above for Study 934, Grades 3–4 laboratory abnormalities of increased bilirubin (>2.5 × ULN), increased pancreatic amylase (>2.0 × ULN), increased or decreased serum glucose (<40 or >250 mg/dL), and increased serum lipase (>2.0 × ULN) occurred in up to 3% of subjects treated with EMTRIVA or VIREAD with other antiretroviral agents in clinical trials.

Clinical Trials in Pediatric Subjects

Emtricitabine (Tenemine): In addition to the adverse reactions reported in adults, anemia and hyperpigmentation were observed in 7% and 32%, respectively, of pediatric subjects (3 months to less than 18 years of age) who received treatment with EMTRIVA in the larger of two open-label, uncontrolled pediatric trials (N=116). For additional information, consult the EMTRIVA prescribing information.

Tenofovir (Tenemine) Disoproxil Fumarate: In pediatric clinical trials (Studies 352 and 321) conducted in 184 HIV-1 infected subjects 2 to less than 18 years of age, the adverse reactions observed in pediatric subjects who received treatment with VIREAD were consistent with those observed in clinical trials of VIREAD in adults.

Eighty-nine pediatric subjects (2 to less than 12 years of age) received VIREAD in Study 352 for a median exposure of 104 weeks. Of these, 4 subjects discontinued from the trial due to adverse reactions consistent with proximal renal tubulopathy. Three of these 4 subjects presented with hypophosphatemia and also had decreases in total body or spine BMD Z score. For additional information, consult the VIREAD prescribing information.

Adverse Reactions from Clinical Trial Experience in HIV-1 Uninfected Adult Subjects

No new adverse reactions to Tenemine were identified from two randomized placebo-controlled clinical trials (iPrEx, Partners PrEP), in which 2,830 HIV-1 uninfected adults received Tenemine once daily for pre-exposure prophylaxis. Subjects were followed for a median of 71 weeks and 87 weeks, respectively. These trials enrolled HIV-negative individuals ranging in age from 18 to 67 years. The iPrEx trial enrolled only men or transgender women of Hispanic/Latino (72%), White (18%), Black (9%) and Asian (5%) race. The Partners PrEP trial enrolled both men (61–64% across treatment groups) and women in Kenya and Uganda. Table 5 provides a list of all adverse events that occurred in 2% or more of subjects in any treatment group in the iPrEx and Partners PrEP trials.

Laboratory Abnormalities: Table 6 provides a list of laboratory abnormalities observed in both trials. Six subjects in the TDF-containing arms of the Partners PrEP trial discontinued participation in the study due to an increase in blood creatinine compared with no discontinuations in the placebo group. One subject in the Tenemine arm of the iPrEx trial discontinued from the study due to an increase in blood creatinine and another due to low phosphorous.

In addition to the laboratory abnormalities described above, Grade 1 proteinuria (1+) occurred in 6% of subjects receiving Tenemine in the iPrEx trial. Grades 2–3 proteinuria (2–4+) and glycosuria (3+) occurred in less than 1% of subjects treated with Tenemine in the iPrEx trial and Partners PrEP trial.

Table 5 Selected Adverse Events (All Grades) Reported in ≥2% in Any Treatment Group in the iPrEx Trial and Partners PrEP Trial
iPrEx Trial Partners PrEP Trial
FTC/TDF

(N=1251)

Placebo

(N=1248)

FTC/TDF

(N=1579)

Placebo

(N=1584)

*
Not reported or reported below 2%.
Gastrointestinal Disorders
Diarrhea 7% 8% 2% 3%
Abdominal pain 4% 2% -* -
Infections and Infestations
Pharyngitis 13% 16% - -
Urethritis 5% 7% - -
Urinary tract infection 2% 2% 5% 7%
Syphilis 6% 5% - -
Secondary syphilis 6% 4% - -
Anogenital warts 2% 3% - -
Musculoskeletal and Connective Tissue Disorders
Back pain 5% 5% - -
Nervous System Disorders
Headache 7% 6% - -
Psychiatric Disorders
Depression 6% 7% - -
Anxiety 3% 3% - -
Reproductive System and Breast Disorders
Genital ulceration 2% 2% 2% 2%
Investigations
Weight decreased 3% 2% - -
Table 6 Laboratory Abnormalities (Highest Toxicity Grade) Reported for Each Subject in the iPrEx Trial and Partners PrEP Trial
iPrEx Trial Partners PrEP Trial
Grade* FTC/TDF

(N= 1251)

Placebo

(N= 1248)

FTC/TDF

(N=1579)

Placebo

(N=1584)

*
Grading is per DAIDS criteria.
Grade 1 phosphorus was not reported for the Partners PrEP trial.
Creatinine 1 (1.1–1.3 × ULN) 27 (2%) 21 (2%) 18 (1%) 12 (<1%)
2–4 (> 1.4 × ULN) 5 (<1%) 3 (<1%) 2 (<1%) 1 (<1%)
Phosphorus 1 (2.5 – <LLN mg/dL) 81 (7%) 110 (9%) NR † NR †
2–4 (<2.0 mg/dL) 123 (10%) 101 (8%) 140 (9%) 136 (9%)
AST 1 (1.25–<2.5 × ULN) 175 (14%) 175 (14%) 20 (1%) 25 (2%)
2–4 (> 2.6 × ULN) 57 (5%) 61 (5%) 10 (<1%) 4 (<1%)
ALT 1 (1.25–<2.5 × ULN) 178 (14%) 194 (16%) 21 (1%) 13 (<1%)
2–4 (> 2.6 × ULN) 84 (7%) 82 (7%) 4 (<1%) 6 (<1%)
Hemoglobin 1 (8.5 – 10 mg/dL) 49 (4%) 62 (5%) 56 (4%) 39 (2%)
2–4 (<9.4 mg/dL) 13 (1%) 19 (2%) 28 (2%) 39 (2%)
Neutrophils 1 (1000–1300/mm3) 23 (2%) 25 (2%) 208 (13%) 163 (10%)
2–4 (<750/mm3) 7 (<1%) 7 (<1%) 73 (5%) 56 (3%)

Changes in Bone Mineral Density:

In clinical trials of HIV-1 uninfected individuals, decreases in BMD were observed. In the iPrEx trial, a substudy of 503 subjects found mean changes from baseline in BMD ranging from –0.4% to –1.0% across total hip, spine, femoral neck, and trochanter in the Tenemine group compared with the placebo group, which returned toward baseline after discontinuation of treatment. Thirteen percent of subjects receiving Tenemine versus 6% of subjects receiving placebo lost at least 5% of BMD at the spine during treatment. Bone fractures were reported in 1.7% of the Tenemine group compared with 1.4% in the placebo group. No correlation between BMD and fractures was noted. The Partners PrEP trial found similar fracture rates between treatment and placebo groups (0.8% and 0.6%, respectively). No BMD evaluations were performed during this trial.

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of VIREAD. No additional adverse reactions have been identified during postapproval use of EMTRIVA. Because postmarketing 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.

Immune System Disorders

allergic reaction, including angioedema

Metabolism and Nutrition Disorders

lactic acidosis, hypokalemia, hypophosphatemia

Respiratory, Thoracic, and Mediastinal Disorders

dyspnea

Gastrointestinal Disorders

pancreatitis, increased amylase, abdominal pain

Hepatobiliary Disorders

hepatic steatosis, hepatitis, increased liver enzymes (most commonly AST, ALT gamma GT)

Skin and Subcutaneous Tissue Disorders

rash

Musculoskeletal and Connective Tissue Disorders

rhabdomyolysis, osteomalacia (manifested as bone pain and which may contribute to fractures), muscular weakness, myopathy

Renal and Urinary Disorders

acute renal failure, renal failure, acute tubular necrosis, Fanconi syndrome, proximal renal tubulopathy, interstitial nephritis (including acute cases), nephrogenic diabetes insipidus, renal insufficiency, increased creatinine, proteinuria, polyuria

General Disorders and Administration Site Conditions

asthenia

The following adverse reactions, listed under the body system headings above, may occur as a consequence of proximal renal tubulopathy: rhabdomyolysis, osteomalacia, hypokalemia, muscular weakness, myopathy, hypophosphatemia.

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

  • Tenemine may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Tenemine with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • 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 Tenemine. Be sure that each of your health care providers knows all the medicines that you are taking.
  • You must always practice safer sex at all times. Do not have any kind of sex without protection (eg, latex or polyurethane condoms). Do not share needles, injection supplies, or items like toothbrushes or razors.
  • Tenemine is not for the treatment of HBV. You should be tested for HBV infection before you start to take Tenemine. If you have HBV, you will need close medical follow-up for several months after stopping treatment with Tenemine. Follow-up includes medical exams and blood tests to check for HBV infection that could be getting worse.
  • 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 (Tenemine), Tenofovir (Tenemine)) for a long time. Talk with your doctor if you have questions about your risk for severe side effects from Tenemine.
  • 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 Tenemine. The cause and long-term effects of these changes are unknown. Discuss any concerns with your doctor.
  • Ask your doctor if you should take a calcium and vitamin D supplement while you are taking Tenemine.
  • If you are taking Tenemine to treat HIV:
    • Do not stop taking Tenemine, even for a short period of time. If you do, the virus may grow resistant to the medicine and become harder to treat.
    • Tenemine is not a cure for HIV infection or AIDS. Patients may still get illnesses and infections associated with HIV. Remain under the care of your doctor.
    • Tenemine does not stop the spread of the HIV virus from HIV-infected patients to others through blood or sexual contact. Talk with your health care provider about ways to prevent the spread of HIV to others.
    • Tenemine 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 Tenemine.
  • If you are taking Tenemine to reduce the risk of getting HIV:
    • Do not stop taking Tenemine without checking with your doctor. If you do, you may be at greater risk of getting HIV. Discuss any questions or concerns with your doctor.
    • Tenemine does not always prevent HIV. It should be used as a part of a prevention program that includes other measures (eg, safer sex practices, testing for other sexually transmitted infections). Discuss any questions or concerns with your doctor.
  • Lab tests, including liver function, kidney function, and bone mineral density, may be performed while you use Tenemine. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Tenemine should be used with extreme caution in CHILDREN younger than 12 years old, in children weighing less than 77 lb (35 kg), and in ELDERLY patients older than 65 years old; safety and effectiveness in these patients have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Tenemine while you are pregnant. Tenemine is found in breast milk. Do not breast-feed while taking Tenemine. Mothers infected with HIV should not breast-feed. There is a risk of passing the HIV infection to the baby.

Tenemine contraindications

infoContraindication 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.
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Do not use Tenemine for pre-exposure prophylaxis in individuals with unknown or positive HIV-1 status. Tenemine should be used in HIV-infected patients only in combination with other antiretroviral agents.

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. European Chemicals Agency - ECHA. "2(1H)-Pyrimidinone, 4-amino-5-fluoro-1-[(2R,5S)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl]: The European Chemicals Agency (ECHA) is an agency of the European Union which is the driving force among regulatory authorities in implementing the EU's groundbreaking chemicals legislation for the benefit of human health and the environment as well as for innovation and competitiveness.". https://echa.europa.eu/ (accessed September 17, 2018).
  3. HSDB. "EMTRICITABINE". https://toxnet.nlm.nih.gov/cgi-bin/s... (accessed September 17, 2018).

Reviews

The results of a survey conducted on ndrugs.com for Tenemine 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 Tenemine. 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

5 consumers reported side effects

Did you experience side effects while taking Tenemine drug?
According to the report by ndrugs.com, the below mentioned statistics discuss the number of people who experienced side effects after taking Tenemine drug. Every drug produces at least minor unwanted effects, which we call side effects. The side effects can be bothersome, or they can be minor so patients do not know they are experiencing them. The side effects of the drug depend on the individual, severity of disease, symptom, and associated conditions in the patient. The most deciding factor is the drug dosage. The higher the dosage, the higher the therapeutic result, and the more side effects. Every patient need not have the same intensity of side effect. When the side effects are greater, immediately consult your health care provider.
Users%
No side effects4
80.0%
It has side effects1
20.0%


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