INDICATION
RUKOBIA, in combination with other antiretrovirals (ARVs), is indicated to treat HIV-1 infection in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection failing their current ARV regimen due to resistance, intolerance, or safety considerations.

*Prevents HIV-1 from interacting with host immune cells by binding gp120, leaving CD4⁺ T-cells untouched.

^†Based on BRIGHTE 240-week data.

HIV-1=human immunodeficiency virus type-1; gp120=glycoprotein 120.

RUKOBIA, as part of an optimized antiretroviral regimen,
is the only antiretroviral therapy specifically developed for people
living with multidrug-resistant HIV-1 clinically proven to offer
virologic suppression and
CD4⁺ T-cell recovery through ~5 years.

The primary endpoint was the adjusted mean decline in HIV-1 RNA at Day 8: 0.79 log ₁₀ copies/mL (RUKOBIA 600-mg BID + failing regimen, n=201) vs 0.17 log ₁₀ copies/mL (placebo + failing regimen, n=69); difference: -0.625 (95% CI: -0.810, -0.441); P<0.0001. At Week 240, 45% of participants in the Snapshot Analysis and 82% in the Observed Analysis were virologically suppressed vs 53% and 57% at Week 24. The mean increase in CD4 ⁺ T-cell counts from baseline at Week 240 was 296 cells/mm ³. The most adverse reaction (all grades) observed in ≥2% or randomized participants was nausea (11%). ^1,2

~5-Year Data is Here^†

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References:

Ackerman P, Thompson M, Molina J M, et al. Long-term efficacy and safety of fostemsavir among subgroups of heavily treatment-experienced adults with HIV-1. AIDS. 2021;35(7):1061-1072.
Lataillade M, Lalezari JP, Kozal M, et al. Safety and efficacy of the HIV-1 attachment inhibitor prodrug fostemsavir in heavily treatment-experienced individuals: week 96 results of the phase 3 BRIGHTE study. Lancet HIV. 2020;7(11):7 40-751.

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IMPORTANT
SAFETY INFORMATION

Contraindications

Do not use in patients with previous hypersensitivity to fostemsavir or any of the components of RUKOBIA.

Do not use RUKOBIA in patients receiving strong cytochrome P450 (CYP)3A inducers, including but not limited to enzalutamide, carbamazepine, phenytoin, rifampin, mitotane, and St John’s wort (Hypericum perforatum).

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).

Adverse reactions

The most common adverse reaction (all grades, randomized cohort) observed in ≥5% of subjects was nausea (10%).

81% of adverse reactions reported with RUKOBIA were mild or moderate in severity.

Drug interactions

See the full Prescribing Information for RUKOBIA for a complete list of significant drug interactions.

Temsavir may increase plasma concentrations of grazoprevir and voxilaprevir. Use an alternative hepatitis C virus regimen if possible.

Use the lowest possible starting dose for statins and monitor for statin-associated adverse events.

Patients receiving RUKOBIA should not take doses of estrogen-based therapies, including oral contraceptives, that contain more than 30 mcg/day of ethinyl estradiol. Caution is advised particularly in patients with additional risk factors for thromboembolic events.

Use in specific populations

Pregnancy: There are insufficient human data on the use of RUKOBIA during pregnancy to definitively assess a drug-associated risk for birth defects and miscarriage. An Antiretroviral Pregnancy Registry has been established.

Lactation: Breastfeeding is not recommended due to the potential for HIV-1 transmission, developing viral resistance, and adverse reactions in a breastfed infant.

INDICATION

RUKOBIA, in combination with other antiretrovirals (ARVs), is indicated to treat HIV-1 infection in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection failing their current ARV regimen due to resistance, intolerance, or safety considerations.

Please see full Prescribing Information for RUKOBIA.

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1-877-844-8872 or FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch.

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