Vitekta
- Generic Name: elvitegravir tablets
- Brand Name: Vitekta
- Drug Class: HIV, Integrase Inhibitors
Vitekta (Elvitegravir Tablets) side effects drug center
Vitekta Side Effects Center
Vitekta (elvitegravir) is a human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor used in combination with an HIV protease inhibitor coadministered with ritonavir and with other antiretroviral drug(s) indicated for the treatment of HIV-1 infection in antiretroviral treatment-experienced adults. Common side effects of Vitekta include diarrhea, nausea, and headache.
Vitekta must be administered once daily with food in combination with a protease inhibitor coadministered with ritonavir and another antiretroviral drug. Vitekta may interact with protease inhibitors (PIs), nucleoside reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), antacids, anticonvulsants, antifungals, antimycobacterials, systemic corticosteroids, endothelin receptor antagonists, HCV protease inhibitors, St. John's wort, and hormonal contraceptives. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant before using Vitekta. Vitekta may affect hormonal contraceptives. Alternative methods of non-hormonal contraception are recommended. Because of both the potential for HIV transmission and the potential for serious adverse reactions in nursing infants, breastfeeding while receiving Vitekta is not recommended.
Our Vitekta (elvitegravir) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Vitekta Professional Information
SIDE EFFECTS
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)a
| VITEKTA N=354 |
Raltegravir N=358 |
|
| Diarrhea | 7% | 5% |
| Nausea | 4% | 3% |
| Headache | 3% | 3% |
| a Frequencies of adverse reactions are based on all adverse events attributed to study drugs. | ||
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 x ULN) | 6% | 9% |
| Hematuria ( > 75 RBC/HPF) | 6% | 7% |
| Serum Amylasea ( > 2.0 x ULN) | 6% | 6% |
| Creatine Kinase ( ≥ 10.0 x 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 x ULN) | 3% | 7% |
| 3 Neutrophils ( < 750/mm ) | 3% | 3% |
| ALT ( > 5.0 x ULN) | 2% | 5% |
| AST ( > 5.0 x ULN) | 2% | 6% |
| a 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 VITEKTA (N=66) and raltegravir (N=58) treatment groups was 14% and 7%, respectively. | ||
Read the entire FDA prescribing information for Vitekta (Elvitegravir Tablets)
&Copy; Vitekta Patient Information is supplied by Cerner Multum, Inc. and Vitekta Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.