The below information is intended to give healthcare professionals an overview of the potential risks and side effects of RUKOBIA, including warnings and precautions, drug-related adverse events, and discontinuation rates due to adverse events.
WARNINGS AND PRECAUTIONS
Immune Reconstitution Syndrome, including the occurrence of autoimmune disorders with variable time to onset, has been reported with the use of RUKOBIA.
QTc Prolongation with Higher than Recommended Dosages: RUKOBIA at 2,400 mg twice daily has been shown to significantly prolong the QTc interval of the electrocardiogram. Use RUKOBIA with caution in patients with a history of QTc interval prolongation or in patients with relevant pre-existing cardiac disease or who are taking drugs with a known risk of Torsade de Pointes. Elderly patients may be more susceptible to drug-induced QT interval prolongation.
Elevations in Hepatic Transaminases in Patients with Hepatitis B or C Virus Co-infection:
- Monitoring of liver chemistries is recommended in patients with hepatitis B and/or C co-infection.
- Diligence should be applied in initiating or maintaining effective hepatitis B therapy when starting RUKOBIA in patients co-infected with hepatitis B.
Adverse Reactions or Loss of Virologic Response Due to Drug Interactions with concomitant use of RUKOBIA and other drugs may occur (see Contraindications and Drug Interactions).
Safety analysis through Week 96
ADVERSE REACTIONS AND DISCONTINUATION RATES THROUGH WEEK 961
- Overall, most (81%) of the adverse reactions reported with RUKOBIA were mild or moderate in severity
- The most common adverse events leading to discontinuation were related to infections, which occurred in 3% of patients receiving RUKOBIA (2% of randomized patients)1
Of the 271 patients who received RUKOBIA + OBT, the most common adverse reactions (incidence ≥4%, all grades) were nausea (10%) and diarrhea (4%)
ADVERSE REACTIONS (GRADES 1-4) REPORTED IN ≥2% OF RANDOMIZED PATIENTS
TREATED WITH RUKOBIA + OBT THROUGH WEEK 96*
*Adverse reactions in the nonrandomized cohort were similar to those observed in the randomized cohort. The most common adverse reactions reported in patients were fatigue (7%), nausea (6%), and diarrhea (6%). †Of the 272 patients enrolled in the randomized cohort, 1 patient who received placebo withdrew from the trial prior to receiving RUKOBIA in the open-label phase of the trial. ‡Includes pooled terms: abdominal discomfort, abdominal pain, and abdominal pain upper. §Includes pooled terms: fatigue and asthenia. ‖Includes pooled terms: rash, rash generalized, rash maculo-papular, rash pruritic, and dermatitis allergic. ¶Includes pooled terms: insomnia, sleep deficit, sleep disorder, abnormal dreams.
- Adverse reactions (grades 1-4) in the nonrandomized cohort were similar to those observed in the randomized cohort. The most common adverse reactions reported in nonrandomized subjects were fatigue (7%), nausea (6%), and diarrhea (6%)
OBT=optimized background therapy.
- Data on file, ViiV Healthcare.