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Intelence (etravirine) tablet
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
*Update Table 3 with information regarding coadministration of etravirine with the following drugs:
- dolutegravir, dolutegravir/darunavir/ritonavir, dolutegravir/lopinavir/ritonavir
WARNINGS AND PRECAUTIONS
Severe Skin and Hypersensitivity Reactions
- Severe, potentially life-threatening, and fatal skin reactions have been reported. These include cases of Stevens- Johnson syndrome, toxic epidermal necrolysis and erythema multiforme. Hypersensitivity reactions including Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) have also been reported and were characterized by rash, constitutional findings, and sometimes organ dysfunction...
Clinical Trial Experience: Adults
- The incidence of rash was higher in women compared to men in the Intelence arm in the Phase 3 trials (rash ≥ Grade 2 was reported in 9/60 [15.0%] women versus 51/539 [9.5%] men; discontinuations due to rash were reported in 3/60 [5.0%] women versus 10/539 [1.9%] men).
Clinical Trials Experience: Pediatric Subjects (6 years to less than 18 years of age)
- Rash was reported more frequently in female subjects than in male subjects (rash ≥ Grade 2 was reported in 13/64 [20.3%] females versus 2/37 [5.4%] males); discontinuations due to rash were reported in 4% of subjects (4/64 [6.3%] females versus 0/37 [0%] males). Rash (greater than or equal to Grade 2) occurred in 15% of pediatric subjects. In the majority of cases
- Immune System Disorders: Severe hypersensitivity reactions including DRESS and cases of hepatic failure have been reported.
Table 5 and Table 6 with information regarding coadministration of etravirine with artemether/lumefantrine or telaprevir.
- Antimalarials: artemether/lumefantrine – No change in etravirine exposures. Decrease in artemether, dihydroartemisinin and lumefantrine exposures. Caution is warranted when co-administering Intelence and artemether/lumefantrine as it is unknown whether the decrease in exposure of artemether or its active metabolite, dihydroartemisinin, could result in decreased antimalarial efficacy. No dose adjustment is needed for Intelence.
- Hepatitis C Virus (HCV) Direct-Acting Antivirals:telaprevir – No change in etravirine exposures. Decrease in telaprevir exposures. There are insufficient data to make a dosing recommendation for telaprevir when used with Intelence.
PATIENT PACKAGE INSERT
What should I tell my doctor before taking Intelence?
- update with information regardingartemether/lumefantrine
PATIENT COUNSELING INFORMATION
What are the possible side effects of Intelence?
- Muscle pain or tenderness
- Patients should be advised to seek medical attention if... severe hypersensitivity: fever, generally ill feeling, extreme tiredness, muscle or joint aches, blisters, oral lesions, eye inflammation, facial swelling, swelling of the eyes, lips, mouth, breathing difficulty, and/or signs and symptoms of liver problems (e.g., yellowing of your skin or whites of your eyes, dark or tea colored urine, pale colored stools/bowel movements, nausea, vomiting, loss of appetite, or pain, aching or sensitivity on your right side below your ribs). Patients should understand that if severe rash occurs, they will be closely monitored, laboratory tests will be ordered and appropriate therapy will be initiated.