RUKOBIA Extended-release tablet (2020)

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ViiV Healthcare Company

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1. Indications and Usage

RUKOBIA, in combination with other antiretroviral(s), is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced adults with multidrug-resistant ...

2. Dosage and Administration

The recommended dosage of RUKOBIA is one 600-mg tablet taken orally twice daily with or without food [see Clinical Pharmacology (12.3)]. Swallow tablets whole. Do not chew, crush, or split tablets. ...

3. Dosage Forms and Strengths

Each RUKOBIA extended-release tablet contains 600 mg of fostemsavir (equivalent to 725 mg of fostemsavir tromethamine). The tablets are beige, oval, film-coated, biconvex tablets, debossed with SV 1V7 ...

4. Contraindications

RUKOBIA is contraindicated in patients: with previous hypersensitivity to fostemsavir or any of the components of RUKOBIA. coadministered strong cytochrome P450 (CYP)3A inducers, as significant decreases ...

5. Warnings and Precautions

5.1 Immune Reconstitution Syndrome Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy, including RUKOBIA [see Adverse Reactions (6.1)] ...

6. Adverse Reactions

The following adverse reactions are discussed in greater detail in other sections of the labeling: Immune reconstitution syndrome [see Warnings and Precautions (5.1)]. QTc prolongation [see ...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of ...

7. Drug Interactions

7.1 Potential for RUKOBIA to Affect Other Drugs Temsavir may increase plasma concentrations of grazoprevir or voxilaprevir to a clinically relevant extent due to organic anion transporting polypeptide ...

8.1. Pregnancy

Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in individuals exposed to RUKOBIA during pregnancy. Healthcare providers are encouraged to register patients ...

8.2. Lactation

Risk Summary The Centers for Disease Control and Prevention recommends that HIV‑1–infected mothers in the United States not breastfeed their infants to avoid risking postnatal transmission of HIV-1 infection. ...

8.4. Pediatric Use

The safety and effectiveness of RUKOBIA have not been established in pediatric patients.

8.5. Geriatric Use

Clinical trials of RUKOBIA did not include sufficient numbers of subjects aged 65 and older to determine whether they respond differently from younger subjects. In general, caution should be exercised ...

8.6. Renal Impairment

No dosage adjustment is required for patients with renal impairment or those on hemodialysis [see Clinical Pharmacology (12.3)].

8.7. Hepatic Impairment

No dosage adjustment is required in patients with mild to severe hepatic impairment (Child-Pugh Score A, B, or C) [see Clinical Pharmacology (12.3)].

10. Overdosage

There is no known specific treatment for overdose with RUKOBIA. If overdose occurs, the patient should be monitored and standard supportive treatment applied as required, including monitoring of vital ...

11. Description

Fostemsavir tromethamine is a prodrug of temsavir, an HIV-1 gp120-directed attachment inhibitor. The chemical name of fostemsavir tromethamine is (3-((4-benzoyl-1-piperazinyl)(oxo)acetyl)-4-methoxy-7-(3-methyl-1 ...

12.1. Mechanism of Action

RUKOBIA is an HIV-1 antiretroviral agent [see Microbiology (12.4)].

12.2. Pharmacodynamics

Cardiac Electrophysiology At therapeutic doses, RUKOBIA does not prolong the QT interval to any clinically relevant extent. At 4 times the recommended dose, the mean (upper 90% confidence interval) QTcF ...

12.3. Pharmacokinetics

Fostemsavir is a prodrug of temsavir, its active moiety. Fostemsavir was generally not detectable in plasma following oral administration. However, temsavir was readily absorbed (Table 4). Following oral ...

12.4. Microbiology

Mechanism of Action Fostemsavir is a prodrug without significant biochemical or antiviral activity that is hydrolyzed to the active moiety, temsavir, which is an HIV-1 attachment inhibitor. Temsavir binds ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis In a 2-year carcinogenicity study conducted in rats and a 26-week carcinogenicity study conducted in transgenic mice, fostemsavir produced no statistically significant increases in tumors ...

14. Clinical Studies

The efficacy of RUKOBIA in heavily treatment-experienced adult subjects with HIV-1 infection is based on 96-week data from a Phase 3, partially-randomized, international, double-blind, placebo-controlled ...

16.1. How Supplied

RUKOBIA extended-release tablets, 600 mg, are beige, oval, film-coated, biconvex tablets debossed with SV 1V7 on one side. Bottle of 60 tablets with child-resistant closure. NDC 49702-250-18.

16.2. Storage and Handling

Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [See USP Controlled Room Temperature]. RUKOBIA extended-release tablets may have a slight vinegar-like odor. ...

17. Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Patient Information). Hypersensitivity Reactions Inform patients that if they have had a hypersensitivity reaction to RUKOBIA or any of its ...