Baloxavir marboxil is used to treat flu symptoms caused by influenza virus in people who have had symptoms for no more than 48 hours. Baloxavir marboxil will not treat the common cold.

Baloxavir marboxil is also used to prevent flu symptoms in people who have been in contact with someone who has the flu.

Baloxavir marboxil is for adults and children at least 12 years old and weighing at least 88 pounds (40 kilograms).

Baloxavir marboxil should not be used in place of getting a yearly flu shot. The Centers for Disease Control and Prevention recommends an annual flu shot to help protect you each year from new strains of influenza virus.

Baloxavir marboxil may also be used for purposes not listed in this medication guide.

Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

Baloxavir marboxil comes as a tablet and a suspension (liquid) to take by mouth. It is usually taken as a one-time dose with or without food. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take baloxavir marboxil exactly as directed.

Do not take baloxavir marboxil along with dairy products such as milk or yogurt or with calcium-fortified drinks.

If you are taking the suspension, gently swirl the suspension well before use to mix the medication evenly; do not shake the bottle(s). Use an oral syringe provided by your pharmacist to measure the correct amount of liquid needed for your dose. Your total dose may require less than one bottle, one bottle, or 2 bottles of the suspension. Do not take more or less of it other than prescribed by your doctor. Do not mix the suspension with any other liquid or with soft food.

If you feel worse or develop new symptoms while taking baloxavir marboxil or if your flu symptoms do not start to get better, call your doctor.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Baloxavir marboxil is usually given as a single dose to be taken at one time. baloxavir marboxil will be provided either as tablets or a liquid (oral suspension) that is mixed by a healthcare professional.

Baloxavir marboxil doses are based on weight. Follow all dosing instructions carefully, and do not share this medicine with another person.

Take baloxavir marboxil when you first notice flu symptoms (fever, chills, muscle aches, sore throat, runny or stuffy nose). This medicine may not be effective if you have been sick for longer than 48 hours.

If you are taking baloxavir marboxil to prevent flu symptoms, take your dose as soon as possible after you've been in contact with someone who has the flu.

You may take baloxavir marboxil with or without food.

Do not take this medicine with dairy products such as milk or yogurt, or with calcium-fortified juice.

Also avoid taking baloxavir marboxil with a laxative, antacid, or vitamin/mineral supplement that contains aluminum, calcium, magnesium, iron, selenium, or zinc.

Call your doctor if your symptoms do not improve, or if they get worse.

Store tablets in the blister pack at room temperature, away from moisture and heat. You must use the liquid within 10 hours after it was mixed.

You should not use baloxavir marboxil if you are allergic to it.

Tell your doctor if you are pregnant or plan to become pregnant. Having influenza during pregnancy can cause severe complications that could harm both mother and baby. The benefit of treating influenza may outweigh any risks to the baby.

The Centers for Disease Control and Prevention recommends that pregnant women get a flu shot during any trimester of pregnancy to protect themselves and their newborn babies from flu.

Tell your doctor if you are breastfeeding.

Baloxavir marboxil is used as a single dose and does not have a daily dosing schedule.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your normal diet.

Ask your doctor before getting a "live" flu vaccine (such as nasal FluMist). Baloxavir marboxil may interfere with the drug action of FluMist, making the vaccine less effective.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Common side effects of baloxavir marboxil may include:

• cough, chest congestion;

• nausea, diarrhea;

• headache; or

• runny or stuffy nose.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may affect baloxavir marboxil, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

Keep all appointments with your doctor.

Do not let anyone else take your medication.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.