Flu Rx Gets New Indication

FDA approves Xofluza (baloxavir marboxil) to prevent flu after exposure

(RxWiki News) The US Food and Drug Administration (FDA) has approved a new indication for a common flu medication.

Xofluza (baloxavir marboxil) is a common flu treatment option. Until now, it only could be given to those who had already been diagnosed with the flu to treat symptoms and shorten duration. Now, this drug is approved to prevent the flu, too.

In 2018, Xofluza was approved to treat uncomplicated flu in those 12 years of age and older who have symptoms. It was only to be given if symptoms had started within 48 hours. If given within 48 hours of symptoms, this medication can reduce flu symptoms and the length of the flu.

Now, baloxavir marboxil is approved to prevent the flu in those 12 years of age and older.

This new indication means this drug can be given to prevent the flu in those who have been exposed to the flu (by coming into contact with someone with the flu).

Available in tablet form and oral suspension, it is taken as a one-time dose.

“This expanded indication for Xofluza will provide an important option to help prevent influenza just in time for a flu season that is anticipated to be unlike any other because it will coincide with the coronavirus pandemic,” said Dr. Debra Birnkrant, director of the FDA's Division of Antiviral Products, in a press release.

Note that this medication does not replace the flu vaccine. The flu vaccine is the best way to protect against the flu, the FDA noted.

Common side effects of Xofluza included nausea and diarrhea, inflammation of the sinuses, bronchitis and headache. A possible serious side effect is a potentially deadly allergic reaction called anaphylaxis. Seek immediate medical care if you or your loved one experiences trouble breathing, swelling of the face, throat, or mouth or dizziness.

Tell your pharmacist about all the medications you take, including prescriptions, over-the-counter medications, and herbal and nutritional supplements. This drug cannot be taken with the following:

  • Laxatives
  • Antacids
  • Supplements containing calcium, iron, magnesium, selenium, aluminum or zinc

Furthermore, dairy products and calcium-fortified beverages are not to be consumed while taking this drug.

This approval was granted to Genentech USA, Inc.