Patient information: uses, side effects, how to take - Xofluza

What is XOFLUZA?

XOFLUZA is a prescription medicine used to:

treat the flu (influenza) 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.
prevent the flu in people 5 years of age and older following contact with a person who has the flu (post-exposure prophylaxis).

XOFLUZA does not treat or prevent illness that is caused by infections other than the influenza virus.

XOFLUZA does not prevent bacterial infections that may happen with the flu.

It is not known if XOFLUZA is safe and effective for the treatment and prevention of the flu in children less than 5 years of age. XOFLUZA is not for use in children less than 5 years of age.

Do not take XOFLUZA if you are allergic to baloxavir marboxil or any of the ingredients in XOFLUZA. See the end of this leaflet for a complete list of ingredients in XOFLUZA.

Before you take XOFLUZA, tell your healthcare provider about all of your medical conditions, including if you:

are pregnant or plan to become pregnant. It is not known if XOFLUZA can harm your unborn baby.
are breastfeeding or plan to breastfeed. It is not known if XOFLUZA passes into your breast milk.

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

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I take or give XOFLUZA?

Take or give XOFLUZA exactly as directed by your healthcare provider or pharmacist.
Your healthcare provider will prescribe XOFLUZA as a single, one-time dose.
Your healthcare provider will prescribe XOFLUZA tablets, or XOFLUZA oral suspension packets or XOFLUZA oral suspension bottles (provided with an oral syringe).
Your healthcare provider will prescribe XOFLUZA based on your or your child's weight.
XOFLUZA may be given through a feeding tube that is 4 French or larger. 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 calcium, iron, magnesium, selenium, or zinc.
If you take too much XOFLUZA, go to the nearest emergency room right away.

If your healthcare provider prescribes you XOFLUZA for oral suspension (packets):

See the detailed Instructions for Use for information about how to prepare and take or give a dose of XOFLUZA for oral suspension (packets).
Your or your child's total prescribed dose of XOFLUZA for oral suspension (packets) may require preparing one or two packets of XOFLUZA.
Disperse the oral granules from the XOFLUZA for oral suspension packets into a small container with 1 tablespoon (about 15 to 20 mL) of room temperature drinking water, and take or give the medicine right away.
Contact your healthcare provider or pharmacist if you have any questions on how to take or give the prescribed dose of XOFLUZA for oral suspension (packets).

If your healthcare provider prescribes you XOFLUZA for oral suspension (bottles):

The pharmacist will prepare XOFLUZA for oral suspension in a bottle and provide you with an oral syringe. If XOFLUZA is not given to you as a liquid medicine or an oral syringe 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.
Your or your child's prescribed dose of XOFLUZA for oral suspension may require less than one bottle, one bottle, or two bottles of XOFLUZA.
The total prescribed dose of XOFLUZA for oral suspension may require more than one withdrawal from the bottle with the oral syringe.
Contact your healthcare provider or pharmacist if you have any questions on how to take or give the prescribed dose of XOFLUZA for oral suspension (bottles).

Taking or giving a dose of XOFLUZA for oral suspension (bottles):

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 XOFLUZA for oral suspension with the oral syringe provided by the pharmacist to be sure you give the prescribed dose. If the prescribed dose requires more than one withdrawal from the bottle, repeat Steps 3 and 4 for each withdrawal until you take or give the full prescribed dose.

Step 4. Take or give the full contents of the oral syringe.

Step 5. Close the bottle. Throw away any remaining XOFLUZA for oral suspension and the oral syringe.

What are the possible side effects of XOFLUZA?

XOFLUZA may cause serious side effects, including:

Allergic reactions. Get emergency medical help right away if you develop any of these signs or symptoms of an allergic reaction:

trouble breathing
skin rash, hives or blisters

swelling of your face, throat or mouth
dizziness or lightheadedness

The most common side effects of XOFLUZA for treatment of the flu in adults and adolescents (12 years of age and older) include:

diarrhea
bronchitis
nausea

sinusitis
headache

The most common side effects of XOFLUZA for treatment of the flu in children (5 years of age to less than 12 years of age) include:

vomiting

diarrhea

XOFLUZA is not effective in treating or preventing infections other than influenza. Other kinds of infections can appear like flu or occur along with flu and may need different kinds of treatment.

Tell your healthcare provider if you feel worse or develop new symptoms during or after treatment with XOFLUZA or if your flu symptoms do not start to get better.

These are not all the possible side effects of XOFLUZA.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store XOFLUZA?

XOFLUZA tablets:

Store XOFLUZA tablets at 68°F to 77°F (20°C to 25°C).
Store XOFLUZA tablets in the blister package that it comes in.

XOFLUZA for oral suspension (packets):

Store XOFLUZA for oral suspension at 68°F to 77°F (20°C to 25°C).
Keep XOFLUZA for oral suspension in the original package.
XOFLUZA for oral suspension in packets has no preservative.

XOFLUZA for oral suspension (bottles):

Store XOFLUZA for oral suspension at 68°F to 77°F (20°C to 25°C). Keep XOFLUZA for oral suspension in the original bottle.
XOFLUZA for oral suspension in a bottle has no preservative.
Use XOFLUZA for oral suspension by the expiration time and date written on the bottle label. Throw away any XOFLUZA for oral suspension not used by the time and date on the bottle label, or if it has been stored at a temperature above 77°F (25°C).
XOFLUZA for oral suspension comes in a bottle with a child-resistant cap.

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

General information about the safe and effective use of XOFLUZA.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use XOFLUZA for a condition for which it was not prescribed. Do not give XOFLUZA to other people, even if they have the same symptoms that you have. It may harm them. You can ask pharmacist or your healthcare provider for information about XOFLUZA that is written for health professionals.

What are the ingredients in XOFLUZA?

Active ingredient: baloxavir marboxil

XOFLUZA tablets inactive ingredients: croscarmellose sodium, hypromellose, lactose monohydrate, microcrystalline cellulose, povidone K25, sodium stearyl fumarate, talc and titanium dioxide.

XOFLUZA for oral suspension (packets and bottles) inactive ingredients: hypromellose, maltitol, mannitol, povidone K25, silicon dioxide, sodium chloride, strawberry flavor, sucralose, and talc.

Distributed by: Genentech USA, Inc., A Member of the Roche Group, 1 DNA Way, South San Francisco, CA 94080-4990

For more information, go to www.XOFLUZA.com or call 1-855-XOFLUZA (1-855-963-5892).

INSTRUCTIONS FOR USE

XOFLUZA^®(zoh-FLEW-zuh)

(baloxavir marboxil)

for oral suspension

This Instruction for Use contains information on how to prepare and take or give XOFLUZA for oral suspension in packets.

Read these Instructions for Use before preparing and taking or giving XOFLUZA for oral suspension. These Instructions for Use do not take the place of talking to your or your child's healthcare provider about your or your child's medical condition or treatment.

Important information you need to know before preparing and taking or giving XOFLUZA for oral suspension

XOFLUZA is prescribed as a single, one-time dose.
Wash your hands before and after preparing, taking, or giving XOFLUZA for oral suspension.
XOFLUZA for oral suspension packets must be mixed with 1 tablespoon (about 15 to 20 mL) of room temperature drinking water.
Take or give XOFLUZA for oral suspension right away after mixing.
Check the expiration date and the product for damage before use. Do not use if expired or damaged.
If you are prescribed the 80 mg dose of XOFLUZA for oral suspension, you will need to take two packets of 40 mg XOFLUZA, one at a time, until your full prescribed dose is taken.
XOFLUZA for oral suspension can be taken by mouth or given through a feeding tube. Follow your healthcare provider's instructions for giving XOFLUZA through a feeding tube.

Your healthcare provider will prescribe XOFLUZA packets based on your or your child's weight. See the dosing chart below for the prescribed dose and number of XOFLUZA packets needed based on your or your child's weight.

Body weight	Prescribed dose and number of XOFLUZA packets needed
33 lbs (15 kg) to less than 44 lbs (20 kg)	30 mg (One 30 mg packet)
44 lbs (20 kg) to less than 176 lbs (80 kg)	40 mg (One 40 mg packet)
At least 176 lbs (80 kg) and above	80 mg (two 40 mg packets)

Supplies needed to prepare and take or give XOFLUZA for oral suspension:

your prescribed dose of XOFLUZA packets
a tablespoon (about 15 to 20 mL) of room temperature drinking water in a container
an enteral syringe (if giving XOFLUZA for oral suspension through a feeding tube).

Preparing XOFLUZA for oral suspension
Step 1. Wash and dry your hands.
Step 2: Check your dose Your healthcare provider will prescribe: One 30 mg packet, or One 40 mg packet, or Two 40 mg packets for a dose of 80 mg. For the 80 mg dose, you will use two 40 mg packets. Take the packets separately. Follow steps 3 to 7 to take the first packet, then repeat steps 3 to 7 to take the second packet.
Step 3. Tap the packet to make sure the granules are on one side of the packet. Open the packet by hand or with scissors. (Figure A) Do not cut the granules with the scissor.
	Figure A
Step 4. Add the granules to a small container containing 1 tablespoon (about 15 to 20 mL) of room temperature drinking water. ( Figure B ) Tap the packet to make sure all granules have been removed.
	Figure B
Step 5. Gently swirl the cup for 1 minute, or until the granules have fully dispersed. ( Figure C ) Go to Step 6 for taking XOFLUZA for oral suspension by mouth, or Go to Step 10 for giving XOFLUZA for oral suspension through a feeding tube.
	Figure C
Taking XOFLUZA for oral suspension by mouth
Step 6. Drink the mixture right away. ( Figure D )
	Figure D
Step 7. Refill the container with 1 tablespoon (about 15 to 20 mL) of drinking water and swirl to get any remaining granules. ( Figure E ) Drink right away. Repeat this step one more time if there are still granules left in the container. If your prescribed dose requires two XOFLUZA packets, repeat Steps 2 through 7.
	Figure E
Step 8. Wash your hands and all supplies used to take XOFLUZA for oral suspension. ( Figure F )
	Figure F
Step 9. Throw away the empty packet and clean the container with soap and water.
Giving XOFLUZA for oral suspension through a feeding tube
To take or give XOFLUZA for oral suspension through a feeding tube, review the manufacturer's instructions and consult your healthcare provider. Give XOFLUZA for oral suspension through a tube that is 4 French or larger. Follow Steps 2 through 5 to prepare XOFLUZA for oral suspension. Flush the feeding tube with 1 mL of water before and after feeding tube administration.
Step 10 Place the enteral syringe tip right away into the container and slowly pull up the plunger to draw up all the oral suspension. ( Figure G ) Do not wait to draw up the oral suspension. If the mixture sits for too long, it may settle to the bottom, and you may not get the full dose.
	Figure G
Step 11 Place the enteral syringe tip into the feeding tube. Slowly push the plunger all the way down to give XOFLUZA. ( Figure H )
	Figure H
Step 12 Refill the container with 1 tablespoon (about 15 to 20 mL) of drinking water and swirl to get any remaining granules left in the container. ( Figure I ) Use this water to flush the feeding tube. Repeat this step one more time if there are still granules left in the container. If your prescribed dose requires 2 XOFLUZA packets, repeat Steps 2 through 5 to prepare the XOFLUZA for oral suspension, then repeat Steps 10 through 12.
	Figure I
Step 13 Wash your hands with soap and water. Follow the manufacturer's instructions to clean your enteral syringe.

Storing XOFLUZA for oral suspension in packets
Store XOFLUZA for oral suspension at 68°F to 77°F (20°C to 25°C). Keep XOFLUZA for oral suspension in the original package. XOFLUZA for oral suspension in packets has no preservative. Keep XOFLUZA and all medicines out of reach of children.