For heavily treatment-experienced adults with HIV-1 failing therapy. See Full Indication.

Safety

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 ~5 years*,1

KEY SAFETY SUMMARY AT WEEK 96 AND 240

ADVERSE REACTIONS AND DISCONTINUATION RATES THROUGH WEEK 96
ADVERSE REACTIONS AND DISCONTINUATION RATES THROUGH WEEK 96
  • At Week 240, the most common AEs leading to discontinuation were related to infections (3%)1
  • The most frequent Grade 2-4 drug-related AEs occurring in ≥2% of participants (N=371) at Week 240 were: nausea (5%), diarrhea (2%), headache (2%), and IRIS (2%)1

*Based on BRIGHTE 240-week data.

IRIS=immune reconstitution inflammatory syndrome;

OBT=optimized background therapy.

Adverse reactions

ADVERSE REACTIONS (GRADES 1-4) REPORTED IN ≥2% OF RANDOMIZED PARTICIPANTS TREATED WITH RUKOBIA + OBT AT WEEK 2402,†

†Adverse reactions in the nonrandomized cohort were similar to those observed in the randomized cohort. The most common adverse reactions reported in nonrandomized patients were nausea (6%), diarrhea (6%), and fatigure (5%). 

‡Of the 272 patients enrolled in the randomized cohort, 1 participant who received placebo withdrew from the trial prior to receiving RUKOBIA in the open-label phase of the trial. 

§Includes pooled terms: fatigue and asthenia.

Reference:

  1. Aberg J, Shephard B, Wang, et al. Efficacy and safety of fostemsavir plus optimized background therapy in heavily treated-experienced adults with HIV-1: Week 240 results of the Phase 3 BRIGHTE study. Poster EPB160. Poster presented at; 24th International AIDS Conference; July 29-August 2, 2022; Montreal, Canada.
  2. Data on file, ViiV Healthcare.

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