Xofluza Film-coated Tablet
Baloxavir marboxil
40 mg
Roche Bangladesh Limited
| Pack size | 2's pack |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 6452.40 AED |
Indications
Xofluza Film-coated Tablet is used for:
Influenza
Adult Dose
Influenza
Indicated for treatment of acute uncomplicated influenza in patients who have been symptomatic for <48 hr and who are otherwise healthy or at high risk of developing influenza-related complications
Indicated for postexposure prophylaxis of influenza following contact with an individual who has influenza
Tablet
Should be taken as a single dose as soon as possible and within 48 hours of influenza symptom onset for treatment of acute uncomplicated influenza or following contact with an individual who has influenza
20 to <80 kg: 40 mg PO as a single dose
>80 kg: 80 mg PO as a single dose
Child Dose
Influenza
Indicated for treatment of acute uncomplicated influenza in patients aged >5 years who have been symptomatic for <48 hr and who are otherwise healthy or 12 years of age and older who are at high risk of developing influenza-related complications
Indicated for postexposure prophylaxis of influenza in children aged >5 years following contact with an individual who has influenza
Tablet
20 kg to <80 kg: 40 mg PO as a single dose
>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
Administration
Initiate treatment within 48 hr of influenza symptom onset
Take orally as a single dose
May be taken with or without food
Contra Indications
Hypersensitivity
Precautions
Hypersensitivity such as anaphylaxis, angioedema, urticaria, and erythema multiforme: Initiate appropriate treatment if an allergic-like reaction occurs or is suspected.
Increased incidence of Treatment-Emergent Resistance in Patients Less Than 5 Years of Age: Baloxavir marboxil is not indicated in patients less than 5 years of age due to increased incidence of treatment-emergent resistance in this age group. In clinical trials, incidence of virus with treatment-emergent substitutions associated with reduced susceptibility to baloxavir (resistance) was higher in pediatric subjects younger than 5 years of age than older subjects.
Risk of bacterial infection: Serious bacterial infections may begin with influenza-like symptoms or may coexist with, or occur as, a complication of influenza. Baloxavir marboxil has not been shown to prevent such complications.
Prescribers should be alert to potential secondary bacterial infections and treat them as appropriate.
Monitoring Parameters
Monitor for secondary bacterial infections and treat appropriately
Pregnancy-Lactation
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
Interactions
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
Contraindicated (1)
magnesium supplement
Adverse Effects
Side effects of Baloxavir marboxil :
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%)
Mechanism 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
Note
Xofluza 40 mg Film-coated Tablet manufactured by Roche Bangladesh Limited. Its generic name is Baloxavir marboxil. Xofluza is availble in Bangladesh.
Farmaco BD drug index information on Xofluza Film-coated Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.