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

Educational Resources

Access the resources below for additional details about RUKOBIA, including the challenges of heavily treatment-experienced (HTE) adults with HIV-1 and who are failing their current therapy, its mechanism of action, information about the BRIGHTE trial, dosing and drug interactions, and the full Prescribing Information.

RUKOBIA National Broadcast

On the panel are Dr. Bruce Gilliam, Dr. Max Lataillade, Dr. Anthony Mills, and Dr. Charlotte-Paige Rolle.

Virologic Data

See what panelists have to say about efficacy and safety data and what it could mean for HTE patients

Development of RUKOBIA

Hear a story of innovation, in which scientists discover a novel way to treat HIV in HTE patients

HTE PATIENTS

Get an overview of factors that define the HTE patient and what might be causing multidrug resistance

Immunological Response

Watch practicing clinicians talk about CD4+ T-cell recovery in HTE patients with advanced immunosuppression

BRIGHTE Educational Series

INTRODUCTION TO HTE PATIENTS

Consider challenges faced by HTE patients with multidrug resistance and limited antiretroviral (ARV) options

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NOVEL MECHANISM OF ACTION

Discover a first-in-class attachment inhibitor that prevents HIV-1 from interacting with host immune cells^1-3

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BRIGHTE CLINICAL TRIAL

See results from a pivotal Phase 3 trial evaluating the efficacy and safety of RUKOBIA in HTE patients

Video player requires JavaScript enabled. You can download this video here: /content/dam/cf-viiv/rukobia-hcp/master/videos/PM-US-FST-VID-200007%20BRIGHTE%20Trial%20HiRes.mp4

DOSING AND DRUG INTERACTIONS

Review recommended dosing, considerations for coadministration, and contraindications with RUKOBIA

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Downloadable Resources

See the full Prescribing Information for RUKOBIA

DOWNLOAD

ARV=antiretroviral.

References:

Data on file, ViiV Healthcare.
Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in adults and adolescents with HIV. US Department of Health and Human Services. Updated June 3, 2021. Accessed June 7, 2021. https://clinicalinfo.hiv.gov/sites/default/files/guidelines/documents/guidelines-adult-adolescent-arv.pdf
Cahn P, Fink V, Patterson P. Fostemsavir: a new CD4 attachment inhibitor. Curr Opin HIV AIDS. 2018;13(4):341-345.

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ARROW

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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To report SUSPECTED ADVERSE REACTIONS, contact ViiV Healthcare at
1-877-844-8872 or FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch.

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Educational Resources

RUKOBIA National Broadcast

BRIGHTE Educational Series

Downloadable Resources

RUKOBIA PRESCRIBING INFORMATION