Xofluza

Xofluza is a prescription medicine used to treat the flu (influenza) in people 12 years of age and older who have had flu symptoms for no more than 48 hours. It is also used to prevent flu infections in people who have come in contact with a person who has the flu.

Xofluza belongs to a group of drugs called antivirals. These work by stopping the flu virus from growing and replicating by inhibiting viral protein production.

This medication comes in tablet form and as an oral solution. Xofluza is taken as a single dose, with or without food.

Common side effects of Xofluza include diarrhea, headache, nausea, and bronchitis.

Xofluza is a prescription medicine used to treat the flu (influenza) in people who have had flu symptoms for no more than 48 hours. Xofluza is also used to prevent the flu following contact with a person who has the flu.

It is not known if Xofluza is safe and effective in children less than 12 years of age.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Xofluza. See the “Xofluza Precautions” section.

Common side effects of Xofluza include the following:

• Diarrhea
• Nausea
• Headache
• Common cold symptoms
• Inflammation of the lung linings (bronchitis)

This is not a complete list of Xofluza side effects. Ask your doctor or pharmacist for more information.Tell your doctor if you have any side effects that bother you or that do not go awayCall your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• Antacids that contain aluminum, calcium, or magnesium like calcium carbonate (TUMs), aluminum hydroxide (Maalox), and aluminum hydroxide and magnesium hydroxide (Mylanta)

• Laxatives that contain magnesium or calcium like magnesium citrate and milk of magnesia (Phillips’)

• Vitamin supplements like calcium, iron, magnesium, zinc, and selenium

• Flu vaccine

This is not a complete list of Xofluza drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Xofluza including the following:

• Bacterial infection risk. Xofluza does not help treat infections caused by bacterial, which also start with flu-like symptoms. Talk to your doctor to determine what type of infection you have.

Do not take Xofluza if you are allergic to Xofluza or to any of its ingredients.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Xofluza, foods that contain calcium, like dairy, has the potential to interact with the drug. Avoid taking Xofluza together with calcium products. Talk to your doctor how to adjust your diet when taking Xofluza.

Before taking Xofluza, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Xofluza or to any of its ingredients
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Talk to your healthcare provider before you receive a live flu vaccine after taking Xofluza.

Tell your doctor if you are pregnant or plan to become pregnant.

There are no well-done studies that have been done in humans with Xofluza. In animal studies, pregnant animals were given this medication and the babies did not show any medical issues related to this medication. Talk to your doctor to see your risks of using Xofluza.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Xofluza crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Xofluza.

Take Xofluza exactly as directed by your healthcare provider or pharmacist.

• Your healthcare provider will either prescribe:

  • Xofluza tablets that you will take at the same time as a single dose, or
  • Xofluza oral suspension provided with a measuring device (an oral syringe or measuring cup) to be given as a single dose.
• Xofluza may be given through a feeding tube. Follow your healthcare provider’s instructions for giving Xofluza through a feeding tube.
• Take Xofluza with or without food.
• Do not take Xofluza with dairy products, calcium-fortified beverages, laxatives, antacids or oral supplements containing iron, zinc, selenium, calcium or magnesium.
• If you take too much Xofluza, go to the nearest emergency room right away.

If you are taking Xofluza for oral suspension:

• The pharmacist will mix Xofluza for oral suspension before it is given to you. If Xofluza is not given to you as a liquid or measuring device was not provided, contact your pharmacist.
• Take Xofluza before the expiration time and date written by the pharmacist on the bottle label. Do not take Xofluza if the expiration time and date have passed. Throw away (discard) the bottle and contact your healthcare provider.
• The total prescribed dose of Xofluza for oral suspension may require more than one bottle of Xofluza.

Giving a dose of Xofluza for oral suspension:

Step 1. Swirl the Xofluza for oral suspension bottle well before each use. Do not shake.

Step 2. Open the bottle by pushing downward on the child resistant bottle cap and twisting it in the direction of the arrow.
Step 3. Measure the oral suspension with the measuring device provided by the pharmacist to be sure you give the prescribed dose.

Step 4. The patient should sit in an upright position when taking Xofluza.

• Do not give Xofluza while the patient is lying down.
• Do not mix Xofluza with soft food or another liquid to give the medicine.

Step 5. Give the full contents of the measuring device. You may need more than one bottle for your prescribed dose.

Step 6. Close the bottle. Throw away any remaining oral suspension and the measuring device.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated

• other medications you are taking

• your weight

The recommended dosage rage of Xofluza (baloxavir marboxil) for the treatment of rapid onset simple, uncomplicated flu infection is 40 mg to 80 mg as a single dose depending on weight. Patients 40 kg to less than 80 kg should receive 40 mg. Patients 80 kg or greater should receive 80 mg.

If you take too much Xofluza , call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store Xofluza at room temperature between 68°F to 77°F (20°C to 25°C).

• Store Xofluza in the blister package that it comes in.

Keep Xofluza and all medicines out of the reach of children.