XOFLUZA (baloxavir marboxil) is an oral influenza antiviral. It is an influenza virus polymerase acidic (PA) endonuclease inhibitor: a prodrug that converts to baloxavir, which inhibits the PA endonuclease, an influenza virus-specific enzyme required for viral gene transcription, thereby inhibiting influenza virus replication.¹

XOFLUZA is taken as a single, weight-based oral dose. Please refer to the XOFLUZA Prescribing Information for the most current FDA-approved indications.

XOFLUZA can be taken with or without food.¹

Avoid coadministration of XOFLUZA with dairy products, calcium-fortified beverages, polyvalent cation-containing laxatives, antacids, or oral supplements (e.g., calcium, iron, magnesium, selenium, or zinc).¹

The concurrent use of XOFLUZA with intranasal live attenuated influenza vaccine (LAIV) has not been evaluated. Concurrent administration of antiviral drugs may inhibit viral replication of LAIV and thereby decrease the effectiveness of LAIV vaccination. Interactions between inactivated influenza vaccines and XOFLUZA have not been evaluated.¹

XOFLUZA is contraindicated in patients with a history of hypersensitivity to baloxavir marboxil or any of its ingredients.¹

Serious allergic reactions have included anaphylaxis, angioedema, urticaria, and erythema multiforme. Cases of anaphylaxis, urticaria, angioedema, and erythema multiforme have been reported in postmarketing experience with XOFLUZA. Appropriate treatment should be instituted if an allergic-like reaction occurs or is suspected. The use of XOFLUZA is contraindicated in patients with known hypersensitivity to XOFLUZA. You should review the full Prescribing Information for warnings and precautions before prescribing.¹

The following adverse reactions have been identified during postmarketing use of XOFLUZA. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to XOFLUZA exposure.¹

• Immune System Disorders: Anaphylactic reactions, anaphylactic shock, anaphylactoid reactions, hypersensitivity reactions, angioedema (swelling of face, eyelids, tongue and lips)
• Skin and Subcutaneous Tissue Disorders: Rash, urticaria, erythema multiforme
• Gastrointestinal Disorders: Vomiting, hematochezia, melena, colitis
• Psychiatric Disorders: Delirium, abnormal behavior, hallucinations

You should consult the Prescribing Information for incidence rates and age-specific safety information.

Data on XOFLUZA use in pregnancy are limited. There are no adequate and well-controlled studies with XOFLUZA in pregnant women to inform a drug-associated risk of adverse developmental outcomes.¹

There are risks to the mother and fetus associated with influenza virus infection in pregnancy.¹ Treatment decisions in pregnant patients should weigh the potential benefits and risks, disease severity, and patient risk factors, together with the current Prescribing Information and guidance from the Centers for Disease Control and Prevention (CDC), the American College of Obstetricians and Gynecologists (ACOG), or local public health authorities.

In clinical trials, the incidence of virus with treatment-emergent substitutions associated with reduced susceptibility to baloxavir (resistance) was 16% (19/117) in subjects ≥5 years to <12 years of age, and 7% (60/842) in subjects ≥12 years of age.¹

Because of this, you should consider resistance, adherence/administration issues, reinfection, complications, or alternative diagnoses if a patient has persistent or worsening symptoms after antiviral therapy. Follow CDC surveillance updates, local susceptibility information when available, and the Prescribing Information.

Limitations of Use¹:
Influenza viruses change over time, and factors such as the virus type or subtype, emergence of resistance, or changes in viral virulence could diminish the clinical benefit of antiviral drugs. Consider available information on drug susceptibility patterns for circulating influenza virus strains when deciding whether to use XOFLUZA.

Potential candidates include patients 5 years of age and older with acute uncomplicated influenza whose symptoms began within the 48-hour treatment window, including otherwise healthy patients and patients at high risk for influenza-related complications. It is also indicated for post-exposure prophylaxis of influenza in patients 5 years of age and older following contact with an individual who has influenza.¹

Treatment decisions should consider clinical presentation, timing from symptom onset, influenza activity, patient-specific risk factors, and current CDC or local public health guidance. XOFLUZA is not a substitute for annual influenza vaccination.

Please refer to the XOFLUZA Prescribing Information for the most current FDA-approved indications.

For treatment, XOFLUZA should be initiated as soon as possible and within 48 hours of influenza symptom onset, per the US label.¹

Patients should be managed according to current clinical guidelines and institutional protocols.

XOFLUZA is given as a single weight-based oral dose.¹

The current US Prescribing Information provides specific dose thresholds by body weight.¹ You should confirm the exact tablet dose in the Prescribing Information.

XOFLUZA is taken orally as a single dose and may be taken with or without food.¹

It should not be taken with dairy products, calcium-fortified beverages, polyvalent cation-containing laxatives, antacids, or oral supplements (e.g., calcium, iron, magnesium, selenium, or zinc) because these may reduce baloxavir exposure.¹

Yes. In the US, XOFLUZA is indicated for post-exposure prophylaxis of influenza in patients 5 years of age and older following contact with an individual who has influenza.¹

Post-exposure prophylaxis decisions should consider exposure history, timing, patient-specific risk factors, and current CDC or local public health guidance. Xofluza is not a substitute for annual influenza vaccination.

Unlike oseltamivir, which requires a twice-daily dosing regimen for 5 days (treatment) or once-daily for 10 days (prophylaxis), XOFLUZA is administered as a single, one-time oral dose.^1,2 

XOFLUZA dosing is weight-based (a single 40 mg dose for patients weighing 20 kg to <80 kg, and 80 mg for those ≥80 kg). Oseltamivir dosing is primarily based on age, renal function, and weight tiers. XOFLUZA is used to treat the flu in people 5 years of age and older who have flu symptoms for no more than 48 hours and who are otherwise healthy or at high risk of developing problems from the flu. It is also used to prevent the flu in people 5 years of age and older following contact with a person who has the flu (post-exposure prophylaxis).^1,2

No. XOFLUZA is a prescription medication in the US and requires evaluation by a healthcare provider.¹

Because XOFLUZA is indicated for the treatment of acute uncomplicated influenza in patients who have been symptomatic for no more than 48 hours, patients with suspected influenza (particularly those at high risk of influenza-related complications) should be evaluated promptly.¹ Delayed presentation may place a patient outside the treatment window.

You can direct your patients to the Savings Page of our website where they can learn about the XOFLUZA Coupon, allowing them to pay as little as $35, up to $70 off (Terms and conditions apply). They can also learn about our $50 self-pay option.

Coverage, patient out-of-pocket cost, copay programs, and sample availability can vary by plan, state, institution, and eligibility criteria.

Yes. XOFLUZA is approved for the treatment of acute uncomplicated influenza in patients 5 years of age and older who have been symptomatic for no more than 48 hours. Clinical studies of XOFLUZA for the treatment of influenza included patients with influenza A (predominantly A/H1N1 and A/H3N2) and influenza B.¹

Treatment decisions should weigh the potential benefits and risks, disease severity, and patient risk factors, together with the current Prescribing Information and guidance from the Centers for Disease Control and Prevention (CDC) or local public health authorities.

The complete XOFLUZA prescribing information can be found here. It is also included with the dispensed drug.

You should consult the current FDA-approved US Prescribing Information for complete information on indications, limitations of use, dosing by weight and formulation, contraindications, warnings, adverse reactions, drug or food interactions, use in specific populations, and clinical study data.

Current CDC and local antimicrobial stewardship guidance should also be considered.