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Stribild

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Stribild

Stribild

Stribild Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Stribild (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate) is used to treat HIV-1 in adults who have never taken HIV-1 medications before. Side effects from the use of Stribild may include new or worsening kidney problems, including kidney failure. Stribild may also cause bone problems; changes in fat such as an increased amount of fat in the head and neck, and changes in the immune system that may result in a condition called immune reconstitution syndrome.

Stribild is available in tablets of 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine, and 300 mg of tenofovir disoproxil fumarate. The recommended dose for Stribild is one tablet taken once daily with or without food. Stribild may interact with other drugs. Tell your doctor all prescription and OTC medications you are taking. Stribild should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Consult your doctor before breastfeeding.

Our Stribild (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Stribild FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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

Adverse Reactions from 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.

The safety assessment of STRIBILD is based on the Week 96 pooled data from 1408 subjects in two randomized, double-blind, active-controlled clinical trials, Study 102 and Study 103, in antiretroviral treatment-na´ve HIV-1 infected adult subjects [see Clinical Studies]. A total of 701 subjects received STRIBILD once daily for at least 96 weeks.

The proportion of subjects who discontinued treatment with STRIBILD (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir DF 300 mg); ATRIPLA (efavirenz 600 mg/emtricitabine 200 mg/tenofovir DF 300 mg); or atazanavir (ATV) + ritonavir (RTV) + TRUVADA (emtricitabine 200 mg/tenofovir DF 300 mg) due to adverse events, regardless of severity, was 4.6%, 6.8% and 5.9%, respectively. Table 2 displays the frequency of adverse drug reactions greater than or equal to 5% of subjects in any treatment arm.

Table 2 : Adverse Drug Reactionsa (all grades) Reported in ≥ 5% of Subjects in Any Treatment Arm in Studies 102 and 103 (Week 96 analysis).

  STRIBILD
N=701
ATRIPLA
N=352
ATV + RTV + TRUVADA
N=355
EYE DISORDERS
  Ocular icterus < 1% 0% 13%
GASTROINTESTINAL DISORDERS
  Diarrhea 12% 11% 17%
  Flatulence 2% < 1% 8%
  Nausea 16% 9% 14%
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
  Fatigue 4% 8% 6%
HEPATOBILIARY DISORDERS
  Jaundice 0% <1% 9%
NERVOUS SYSTEM DISORDERS
  Somnolence 1% 7% 1%
  Headache 7% 4% 6%
  Dizziness 3% 21% 4%
PSYCHIATRIC DISORDERS
  Insomnia 3% 8% 1%
  Abnormal dreams 9% 26% 4%
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
  Rashb 3% 15% 6%
a Frequencies of adverse reactions are based on all treatment-emergent adverse events, attributed to study drugs.
b Rash event includes dermatitis, drug eruption, eczema, pruritus, pruritus generalized, rash, rash erythematous, rash generalized, rash macular, rash maculo-papular, rash morbilliform, rash papular, rash pruritic, and urticaria.

See WARNINGS AND PRECAUTIONS, for a discussion of renal adverse reactions from clinical trials experience with STRIBILD.

Adverse Reactions from Clinical Trials of the Components of STRIBILD

Emtricitabine and Tenofovir Disoproxil Fumarate: In addition to the adverse reactions observed with STRIBILD, the following adverse reactions occurred in at least 5% of treatment-experienced or treatment-na´ve subjects receiving emtricitabine or tenofovir DF with other antiretroviral agents in other clinical trials: depression, abdominal pain, dyspepsia, vomiting, fever, pain, nasopharyngitis, pneumonia, sinusitis, upper respiratory tract infection, arthralgia, back pain, myalgia, paresthesia, peripheral neuropathy (including peripheral neuritis and neuropathy), anxiety, increased cough, and rhinitis.

Skin discoloration has been reported with higher frequency among emtricitabine-treated subjects; it was manifested by hyperpigmentation on the palms and/or soles and was generally mild and asymptomatic. The mechanism and clinical significance are unknown.

Laboratory Abnormalities

The frequency of laboratory abnormalities (Grades 3-4) occurring in at least 2% of subjects receiving STRIBILD in Studies 102 and 103 are presented in Table 3.

Table 3 : Laboratory Abnormalities (Grades 3-4) Reported in ≥ 2% of Subjects Receiving STRIBILD in Studies 102 and 103 (Week 96 analysis)

Laboratory Parameter Abnormalitya,b STRIBILD
N=701
ATRIPLA
N=352
ATV + RTV + TRUVADA
N=355
AST ( > 5.0 x ULN) 2% 6% 6%
Amylasea ( > 2.0 x ULN) 3% 2% 4%
Creatine Kinase ( ≥ 10.0 x ULN) 7% 14% 10%
Urine RBC (Hematuria) ( > 75 RBC/HPF) 3% 2% 4%
a Frequencies are based on treatment-emergent laboratory abnormalities.
b For subjects with serum amylase > 1.5 x upper limit of normal, lipase test was also performed. The frequency of increased lipase (Grades 3-4) occurring in STRIBILD (N=61), ATRIPLA (N=36), and ATV +RTV + TRUVADA (N=36) was 15%, 17%, and 25%, respectively.

Proteinuria (all grades) occurred in 46% of subjects receiving STRIBILD, 38% of subjects receiving ATRIPLA, and 37% of subjects receiving ATV + RTV + TRUVADA.

The cobicistat component of STRIBILD has been shown to increase serum creatinine and decrease estimated creatinine clearance due to inhibition of tubular secretion of creatinine without affecting renal glomerular function. In Studies 102 and 103, increases in serum creatinine and decreases in estimated creatinine clearance occurred early in treatment with STRIBILD, after which they stabilized. Table 4 displays the mean changes in serum creatinine and eGFR levels at Week 96 and the percentage of subjects with elevations in serum creatinine (All Grades).

Table 4 : Change from Baseline in Serum Creatinine and eGFR and Incidence of Elevated Serum Creatinine (All Grades) at Week 96

  STRIBILD
(N=701)
ATRIPLA
(N=352)
ATV + RTV + TRUVADA
(N=355)
Serum Creatinine (mg/dL)a 0.13 (±0.13) 0.01 (±0.13) 0.08 (±0.14)
eGFR by Cockcroft-Gault (mL/min)a -13.2 (±15.7) -0.9 (±16.1) -8.6 (±17.8)
Subjects with Elevations in Serum Creatinine (All Grades)(%) 10 1 5
a Mean change ±SD

In Study 103, BMD was assessed by DEXA in a non-random subset of 120 subjects. Mean percentage decreases in BMD from baseline to Week 96 in the STRIBILD group (N = 47) were comparable to the ATV + RTV + TRUVADA group (N = 53) at the lumbar spine (-2.0% versus -3.5%, respectively) and at the hip (-3.2% versus -4.2%, respectively). In Studies 102 and 103, bone fractures occurred in 14 subjects (2.0%) in the STRIBILD group, 8 subjects (2.3%) in the ATRIPLA group, and 14 subjects (3.9%) in the ATV + RTV + TRUVADA group. These findings were consistent with data from an earlier 144-week trial of treatment-na´ve subjects receiving tenofovir DF + lamivudine + efavirenz.

Emtricitabine or Tenofovir DF: In addition to the laboratory abnormalities observed with STRIBILD, the following laboratory abnormalities have been previously reported in subjects treated with emtricitabine or tenofovir DF with other antiretroviral agents in other clinical trials: Grade 3 or 4 laboratory abnormalities of ALT (M: greater than 215 U per L; F: greater than 170 U per L), alkaline phosphatase (greater than 550 U per L), bilirubin (greater than 2.5 x ULN), serum glucose (less than 40 or greater than 250 mg per dL), glycosuria (greater than or equal to 3+), neutrophils (less than 750 per mm³), fasting cholesterol (greater than 240 mg per dL), and fasting triglycerides (greater than 750 mg per dL).

Serum Lipids: In the clinical trials of STRIBILD, a similar percentage of subjects receiving STRIBILD, ATRIPLA, and ATV + RTV + TRUVADA were on lipid lowering agents at baseline (11%, 11%, and 12%, respectively). While receiving study drug through Week 96, an additional 8% of STRIBILD subjects were started on lipid lowering agents, compared to 9% of ATRIPLA and 8% of ATV + RTV + TRUVADA subjects.

Changes from baseline in total cholesterol, HDL-cholesterol, LDL-cholesterol, and triglycerides are presented in Table 5.

Table 5 : Lipid Values, Mean Change from Baseline, Reported in Subjects Receiving STRIBILD or Comparator in Studies 102 and 103a. The change from baseline is the mean of within-patient changes from baseline for patients with both baseline and Week 96 values.

  STRIBILD
N=701
ATRIPLA
N=352
ATV + RTV + TRUVADA
N=355
Baseline mg/dL Week 96 Changea Baseline mg/dL Week 96 Changea Baseline mg/dL Week 96 Changea
Total Cholesterol (fasted) 166 [N=675] +12 [N=571] 161 [N=343] +20 [N=288] 168 [N=337] +11 [N=279]
HDL-cholesterol (fasted) 43 [N=675] +7 [N=571] 43 [N=343] +9 [N=288] 42 [N=335] +6 [N=278]
LDL-cholesterol (fasted) 100 [N=675] +12 [N=572] 97 [N=343] +17 [N=287] 101 [N=337] +13 [N=280]
Triglycerides (fasted) 122 [N=675] +8 [N=571] 121 [N=343] +17 [N=288] 132 [N=337] +25 [N=279]

Postmarketing Experience

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. The following adverse reactions have been identified during post approval use of tenofovir DF. No additional postmarketing adverse reactions specific for emtricitabine have been identified.

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.

Read the entire FDA prescribing information for Stribild (Elvitegravir, Cobicistat, Emtricitabine, Tenofovir DF) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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