Fostemsavir Tromethamine (1 brand name, 1 dosage form, 1 route)
Available dosage forms: TABLET, EXTENDED RELEASE.
Routes of administration: ORAL.
Brand Names
- RUKOBIA
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 HIV-1 infection failing their current antiretroviral regimen due to resistance, intolerance, or safety considerations [see Clinical Studies (14)].
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.
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 in temsavir (the active moiety of fostemsavir) plasma concentrations may occur which may result in loss of virologic response. These drugs include, but are not limited to [see Drug Interactions (7), Clinical Pharmacology (12.3)]: oAndrogen receptor inhibitor: Enzalutamide oAnticonvulsants: Carbamazepine, phenytoin oAntimycobacterial: Rifampin oAntineoplastic: Mitotane oHerbal product: St John’s wort (Hypericum perforatum)
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 Warnings and Precautions (5.2)]. •Elevations in hepatic transaminases in patients with hepatitis B or C virus co-infection [see Warnings and Precautions (5.3)].
Mechanism of Action
RUKOBIA is an HIV-1 antiretroviral agent [see Microbiology (12.4)].
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 signs and ECG (QT interval), as well as observation of the clinical status of the patient. As fostemsavir is highly bound to plasma proteins, it is unlikely that it will be significantly removed by dialysis.