Resources | Rukobia Official HCP Website

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

Access the resources below for additional details about RUKOBIA, including the challenges of people living with multidrug-resistant (MDR) HIV-1 who are failing their current therapy, its mechanism of action, information about the BRIGHTE trial, dosing and drug interactions, and the full Prescribing Information.

BRIGHTE Long-Term Data for RUKOBIA

~5-Year* Efficacy Results

Hear from Dr. Tony Mills on the exciting long-term data for RUKOBIA

*Based on BRIGHTE 240-week data.

BRIGHTE Educational Series

INTRODUCTION TO PEOPLE LIVING WITH MDR HIV-1

Consider challenges faced by people living with multidrug-resistant (MDR) HIV-1 with multidrug resistance and limited antiretroviral (ARV) options

Video player requires JavaScript enabled. You can download this video here: /content/dam/cf-viiv/rukobia-hcp/master/videos/PM-US-FST-VID-200005%20HTE%20HiRes.mp4

NOVEL MECHANISM OF ACTION

Discover a first-in-class attachment inhibitor that prevents HIV-1 from interacting with host immune cells¹

Video player requires JavaScript enabled. You can download this video here: /content/dam/cf-viiv/rukobia-hcp/master/videos/PM-US-FST-VID-200006%20MOA%20HiRes.mp4

DOSING AND DRUG INTERACTIONS

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

Video player requires JavaScript enabled. You can download this video here: /content/dam/cf-viiv/rukobia-hcp/master/videos/PM-US-FST-VID-200008%20Dosing%20HiRes.mp4

Downloadable Resource

See the full Prescribing Information for RUKOBIA

DOWNLOAD

References:

Cahn P, Fink V, Patterson P. Fostemsavir: a new CD4 attachment inhibitor. Curr Opin HIV AIDS. 2018;13(4):341-345.

FSTWCNT230016

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.

FSTWCNT220012

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.

Trademarks are owned by or licensed to the ViiV Healthcare group of companies.

This site is funded and developed by ViiV Healthcare.

This site is intended for US healthcare professionals only.

Trademarks are owned by or licensed to the

ViiV Healthcare group of companies.

This site is funded and developed by

ViiV Healthcare.

This site is intended for US healthcare

professionals only.

June 2023 Produced in USA.

By completing this registration, you are giving ViiV Healthcare, and companies working with ViiV Healthcare, permission to market or advertise to you across multiple channels, e.g, mail, websites, email, online advertising, applications, and services, regarding professional information from ViiV Healthcare. ViiV Healthcare will not sell or share this information with third parties for their marketing purposes and will always provide you with the opportunity to change your advertising preferences.

BRIGHTE Long-Term Data for RUKOBIA

BRIGHTE Educational Series

Downloadable Resource

RUKOBIA PRESCRIBING INFORMATION