openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Warnings sections page 1 of 1 · 1 matching rows.
warnings and cautions
5 WARNINGS AND PRECAUTIONS Do not use with protease inhibitors coadministered with cobicistat. ( 5.2 ) Do not use with other elvitegravir-containing drugs, including STRIBILD. ( 5.2 ) Immune reconstitution syndrome: May necessitate further evaluation and treatment. ( 5.3 ) 5.1 Risk of Adverse Reactions or Loss of Virologic Response Due to Drug Interactions The concomitant use of VITEKTA and other drugs may result in known or potentially significant drug interactions, some of which may lead to [see Drug Interactions (7) ]: Loss of therapeutic effect of VITEKTA and possible development of resistance Possible clinically significant adverse reactions from greater exposures of concomitant drugs or elvitegravir. See Table 4 for steps to prevent or manage these possible and known significant drug interactions, including dosing recommendations [see Drug Interactions (7) ] . Consider the potential for drug interactions prior to and during VITEKTA therapy; review concomitant medications during VITEKTA therapy; and monitor for the adverse reactions associated with the concomitant drugs. 5.2 Use with Other Antiretroviral Agents Use of VITEKTA in combination with the fixed dose combination STRIBILD is not recommended, because elvitegravir is a component of STRIBILD. VITEKTA is indicated for use in combination with a protease inhibitor coadministered with ritonavir and with other antiretroviral drug(s). VITEKTA in combination with a protease inhibitor and cobicistat is not recommended because dosing recommendations for such combinations have not been established and may result in suboptimal plasma concentrations of VITEKTA and/or the protease inhibitor, leading to loss of therapeutic effect and development of resistance. 5.3 Immune Reconstitution Syndrome Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy. During the initial phase of combination antiretroviral treatment, patients whose immune systems respond may develop an inflammatory response to indolent or residual opportunistic infections (such as Mycobacterium avium infection, cytomegalovirus, Pneumocystis jirovecii pneumonia [PCP], or tuberculosis), which may necessitate further evaluation and treatment. Autoimmune disorders (such as Graves' disease, polymyositis, and Guillain-Barré syndrome) have also been reported to occur in the setting of immune reconstitution; however, the time to onset is more variable, and can occur many months after initiation of treatment.
6 ADVERSE REACTIONS The most common adverse drug reaction to VITEKTA (all grades) is diarrhea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Gilead Sciences, Inc. at 1-800-GILEAD-5 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 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 VITEKTA is primarily based on data from a controlled clinical trial, Study 145, in which 712 HIV-1 infected, antiretroviral treatment-experienced adults received VITEKTA (N=354) or raltegravir (N=358), each administered with a background regimen consisting of a fully active protease inhibitor coadministered with ritonavir and with other antiretroviral drug(s) for at least 96 weeks. The proportion of subjects who discontinued study treatment due to adverse events, regardless of severity, was 3% in the VITEKTA group and 4% in the raltegravir group. The most common adverse reaction (all Grades, incidence greater than or equal to 5%) in subjects receiving VITEKTA in Study 145 was diarrhea. See also Table 2 for the frequency of adverse reactions occurring in at least 2% of subjects in any treatment group in Study 145. Table 2 Selected Adverse Reactions (All Grades) Reported in ≥2% of HIV-1 Infected Treatment-Experienced Adults in Either Treatment Group in Study 145 (Week 96 Analysis) Frequencies of adverse reactions are based on all adverse events attributed to study drugs. VITEKTA N=354 Raltegravir N=358 Diarrhea 7% 5% Nausea 4% 3% Headache 3% 3% Less Common Adverse Reactions Observed in Treatment-Experienced Studies: The following adverse reactions occurred in <2% of subjects receiving VITEKTA combined with a protease inhibitor and ritonavir. These reactions have been included because of their seriousness, increased frequency on VITEKTA compared with raltegravir, or investigator's assessment of potential causal relationship. Gastrointestinal Disorders: abdominal pain, dyspepsia, vomiting General Disorders and Administration Site Conditions: fatigue Psychiatric Disorders: depression, insomnia, suicidal ideation and suicide attempt (<1%, most in subjects with a pre-existing history of depression or psychiatric illness) Skin and Subcutaneous Tissue Disorders: rash Laboratory Abnormalities: The frequency of laboratory abnormalities (Grades 3–4), occurring in at least 2% of subjects in either treatment group in Study 145, is presented in Table 3. Table 3 Laboratory Abnormalities (Grades 3–4) Reported in ≥2% of HIV-1 Infected Treatment-Experienced Adults in Either Treatment Group in Study 145 (Week 96 Analysis) Laboratory Parameter Abnormality VITEKTA N=354 Raltegravir N=358 Total Bilirubin (>2.5 × ULN) 6% 9% Hematuria (> 75 RBC/HPF) 6% 7% Serum Amylase For subjects with serum amylase >1.5 × upper limit of normal, lipase test was also performed. The frequency of increased lipase (Grades 3–4) occurring in VITEKTA (N=66) and raltegravir (N=58) treatment groups was 14% and 7%, respectively. (> 2.0 × ULN) 6% 6% Creatine Kinase (≥ 10.0 × ULN) 6% 4% Total Cholesterol (> 300 mg/dL) 5% 5% Total Triglycerides (>750 mg/dL) 5% 4% Hyperglycemia (> 250 mg/dL) 5% 3% Urine Glucose (4 + ) 4% 3% GGT (> 5.0 × ULN) 3% 7% Neutrophils (< 750/mm 3 ) 3% 3% ALT (> 5.0 × ULN) 2% 5% AST (> 5.0 × ULN) 2% 6%
adverse reactions table
<table width="65%" ID="table2"> <caption>Table 2 Selected Adverse Reactions (All Grades) Reported in ≥2% of HIV-1 Infected Treatment-Experienced Adults in Either Treatment Group in Study 145 (Week 96 Analysis) <footnote ID="K1388">Frequencies of adverse reactions are based on all adverse events attributed to study drugs.</footnote> </caption> <col width="50%" valign="top" align="left"/> <col width="25%" valign="top" align="center"/> <col width="25%" valign="top" align="center"/> <thead> <tr> <th styleCode="Lrule Rrule"/> <th styleCode="Rrule">VITEKTA N=354 </th> <th styleCode="Rrule">Raltegravir N=358 </th> </tr> </thead> <tbody> <tr> <td styleCode="Lrule Rrule">Diarrhea</td> <td styleCode="Rrule">7%</td> <td styleCode="Rrule">5%</td> </tr> <tr> <td styleCode="Lrule Rrule">Nausea</td> <td styleCode="Rrule">4%</td> <td styleCode="Rrule">3%</td> </tr> <tr> <td styleCode="Lrule Rrule">Headache</td> <td styleCode="Rrule">3%</td> <td styleCode="Rrule">3%</td> </tr> </tbody> </table>