Baloxavir Marboxil

Baloxavir Marboxil is a prescription medication used for the treatment of influenza.

• Baloxavir Marboxil is available under the following different brand names: Xofluza

Common side effects of Baloxavir Marboxil include:

• cough,
• chest congestion,
• nausea,
• diarrhea,
• headache, and
• runny or stuffy nose

Serious side effects of Baloxavir Marboxil include:

• hives,
• difficulty breathing, and
• swelling of the face, lips, tongue or throat

Rare side effects of Baloxavir Marboxil include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Tablet

• 40 mg
• 80 mg

Granules for oral suspension

• 40 mg/20 mL
• Reconstituted solution 2 mg/mL

Influenza

Adult and pediatric dosage

• Tablet
  • 20 kg to below 80 kg: 40 mg orally as a single dose
  • Above 80 kg: 80 mg orally as a single dose
• Oral suspension
  • Less than 20 kg: 2 mg/kg orally as a single dose
  • 20 kg to below 80 kg: 40 mg (20 mL) orally as a single dose
  • Above 80 kg: 80 mg (40 mL) orally as a single dose

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Baloxavir Marboxil has severe interactions with the following drugs:
  • magnesium supplement
• Baloxavir Marboxil has serious interactions with at least 49 other drugs.
• Baloxavir Marboxil has moderate interactions with the following drug:
  • influenza virus vaccine quadrivalent, intranasal
• Baloxavir Marboxil has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Hypersensitivity

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Baloxavir Marboxil?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Baloxavir Marboxil?”

Cautions

• There is no evidence of efficacy in any illness caused by pathogens other than influenza viruses; serious bacterial infections may begin with influenza-like symptoms, may coexist with, or may occur as a complication of influenza; monitor for secondary bacterial infections and treat appropriately
• Cases of anaphylaxis, urticaria, angioedema and erythema multiforme have been reported in postmarketing experience; institute appropriate treatment if an allergic-like reaction occurs or is suspected
• Not indicated in patients below 5 years of age due to increased incidence of treatment-emergent resistance in this age group; potential for transmission of resistant strains in the community has not been determined

Drug interaction overview

• 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

Pregnancy and Lactation

• Data are not available

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 the milk of lactating rats
• Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug and any potential adverse effects on the breastfed child from the drug or the underlying maternal condition