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Xofluza 40
Radiant Pharmaceuticals Ltd.
Generic: Baloxavir marboxil
Medicine Overview of Xofluza 40mg tablet
বাংলা
English
Indication
Influenza
Administration
Initiate treatment within 48 hr of influenza symptom onset
Take orally as a single dose
May be taken with or without food
Adult Dose
Hepatic impairment
Moderate (Child-Pugh B) to normal: No clinically meaningful pharmacokinetic differences were observed
Severe: Not studied
Child Dose
Influenza
Indicated for treatment of acute uncomplicated influenza in patients who have been symptomatic for ?48 hr
12 years and weight ?40 kg
40 to 80 kg: 80 mg PO as a single dose
Renal Dose
Renal impairment
CrCl >50 mL/min: Pharmacokinetic analysis did not identify a clinically meaningful effect
Severe: Not studied
Contraindication
Hypersensitivity
Mode of Action
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
Precaution
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
Side Effect
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 Category Note
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...
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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
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