Balovir 40

Influenza

Initiate treatment within 48 hr of influenza symptom onset Take orally as a single dose May be taken with or without food

Hepatic impairment Moderate (Child-Pugh B) to normal: No clinically meaningful pharmacokinetic differences were observed Severe: Not studied

Influenza Indicated for treatment of acute uncomplicated influenza in patients who have been symptomatic for ?48 hr <12 years: Safety and efficacy not established >12 years and weight ?40 kg 40 to <80 kg: 40 mg PO as a single dose >80 kg: 80 mg PO as a single dose

Renal impairment CrCl >50 mL/min: Pharmacokinetic analysis did not identify a clinically meaningful effect Severe: Not studied

Hypersensitivity

Inhibits cap-dependent endonuclease; it is thought to inhibit viral replication activity of the viral polymerase Inhibition accomplished by a method called cap snatching, where viruses hijack the host mRNA transcription system to allow viral RNA synthesis

There is no evidence of efficacy in any illness caused by pathogens other than influenza viruses; serious bacterial infections may begin with influenzalike symptoms, may coexist with, or may occur as a complication of influenza; monitor for secondary bacterial infections and treat appropriately

1-10% Frequency of adverse effects listed below are less than or equal to those reported with placebo Diarrhea (3%) Bronchitis (2%) Nausea (1%) Nasopharyngitis (1%) Headache (1%)

Pregnancy Data are not available Animal studies No adverse developmental effects observed in rats or rabbits with PO administration at exposures approximately 5 (rats) and 7 (rabbits) times the systemic baloxavir exposure at the maximum recommended human dose (MRHD) Clinical considerations Pregnant women are at higher risk of severe complications from influenza, which may lead to adverse pregnancy and/or fetal outcomes, including maternal death, stillbirth, birth defects, preterm delivery, low birth weight, and small for gestational age Lactation Data are not available for excretion in human milk Baloxavir and its related metabolites were present in milk of lactating rats Consider developmental and health benefits of breastfeeding along with the mother’s clinical need the drug and any potential adverse effects on the breastfed child from the drug or from the underlying maternal condition

Polyvalent cations Baloxavir (active metabolite) may form a chelate with polyvalent cations, such as calcium, aluminum, or magnesium, in food or medications Avoid coadministration with dairy products, calcium-fortified beverages, polyvalent cation-containing laxatives, antacids, or oral supplements (eg, calcium, iron, magnesium, selenium, zinc) Vaccines Concurrent use with intranasal live attenuated influenza vaccine (LAIV) not evaluated Coadministration may inhibit viral replication of LAIV, resulting in decreased LAIV vaccine effectiveness