Instructions for Use

PROGRAF

Granules

(PRO-graf)

(tacrolimus for oral suspension)

Your healthcare provider has prescribed PROGRAF

Granules, which comes in individual packets that will need to be

mixed with water before giving the medicine to your child.

Read this Instructions for Use and the Patient Information for the first time and each time you get a refill of PROGRAF

Granules (tacrolimus for oral suspension). There may be new information.

This Instructions for Use does not take the place of talking to your child’s healthcare provider about their medical

condition or treatment. Ask the healthcare provider if you have any questions about how to mix or give a dose of

PROGRAF Granules the right way.

Important information:

These instructions are for preparing PROGRAF Granules only.

These instructions should not be used for PROGRAF capsules.

• Mix PROGRAF Granules in water to make an oral suspension.

• Give all of the prepared oral suspension to your child right away after preparing. Do not save the prepared oral

suspension for later use.

• Use glass or metal materials to prepare your child’s dose of PROGRAF Granules.

o Do not use any plastic (PVC) materials to prepare PROGRAF Granules. The granules will stick to a

plastic container and your child may not receive their full dose.

• Do not breathe in (inhale) or let the granules in PROGRAF or the prepared oral suspension come in contact with

your skin or eyes.

o If you get the granules or the prepared oral suspension on your skin, wash the area well with soap and

water.

o If you get the granules or the prepared oral suspension in your eyes, rinse with plain water.

If you spill the granules, wipe the surface with a wet paper towel. If you spill the prepared oral suspension, dry the area

with a dry paper towel and then wipe the area with a wet paper towel. Throw away the paper towels in the trash and wash

your hands well with soap and water.

For each dose of PROGRAF Granules mixed with water that will be given using a glass cup, you will need the

following supplies (See Figure A):

• Carton containing PROGRAF Granules packets. Follow the instructions on the carton for the number of

packets your child’s healthcare provider has prescribed for each dose.

• paper towels

• pair of scissors

• metal stirring spoon

• measuring device

• 1 small clean glass cup (plastic containers should not be used)

• container with drinking water

Figure A

Step 1

Choose a clean flat work surface. Place a

clean paper towel on the work surface. Place

the supplies to prepare the dose on the paper

towel.

Step 2

Wash and dry your hands.

Step 3

Remove the prescribed number of PROGRAF

Granules packets from the carton.

Step 4

Using a pair of scissors, cut along the dotted

line on 1 PROGRAF Granules packet to open

it.

Step 5

Empty all of the granules in the packet into

the glass cup. Check for any remaining

granules in the packet and empty these into

the glass cup.

Step 6

If more than 1 packet of PROGRAF Granules

is needed for your child’s prescribed dose,

repeat Steps 4 and 5 using the number of

packets needed for the prescribed dose.

Step 7

Add 1 to 2 tablespoons (15 to 30 milliliters)

of room temperature drinking water to the

glass cup containing the granules.

Step 8

Gently stir the granules and water in the glass

cup with a metal stirring spoon. The granules

will not completely dissolve. You will see

granules that are suspended in the water.

Step 9

Give the granules and water suspension in the

glass cup to your child. Make sure your child

drinks all of the medicine in the cup.

Give all of the medicine to your child right

away after preparing. Do not save the

medicine for later use.

Step 10

To make sure all of the medicine is given to

your child, refill the glass cup with the same

amount of water used in Step 7.

Step 11

Gently swirl the glass cup to mix any

remaining granules.

Step 12

Give all of the medicine in the cup to the

child.

Step 13

Wash the glass cup. Throw away the paper

towel and clean the work surface. Wash your

hands.

For each dose of PROGRAF Granules (tacrolimus for oral suspension) mixed with water that will be drawn up

and given using an oral syringe, you will need the following supplies (See Figure B):

• Carton containing PROGRAF Granules packets. Follow the instructions on the carton for the number of

packets your child’s healthcare provider has prescribed for each dose.

• paper towels

• pair of scissors

• metal stirring spoon

• measuring device

• 1 small clean glass cup (plastic containers should not be used)

• container with drinking water

• 1 non-PVC oral syringe (ask your pharmacist for the oral syringe you should use)

Figure B

Step 1

Choose a clean flat work surface. Place a

clean paper towel on the work surface.

Place the supplies to prepare the dose on the

paper towel.

Step 2

Wash and dry your hands.

Step 3

Remove the prescribed number of

PROGRAF Granules packets from the

carton.

Step 4

Using a pair of scissors, cut along the dotted

line on 1 PROGRAF Granules packet to

open it.

Step 5

Empty all of the granules in the packet into

the glass cup. Check for any remaining

granules in the packet and empty these into

the glass cup.

Step 6

If more than 1 packet of PROGRAF

Granules is needed for your child’s

prescribed dose, repeat Steps 4 and 5 using

the number of packets needed for the

prescribed dose.

Step 7

Add 1 to 2 tablespoons (15 to 30 milliliters)

of room temperature drinking water to the

glass cup containing the granules.

Step 8

Gently stir the granules and drinking water

in the glass cup with a metal stirring spoon.

The granules will not completely dissolve.

You will see granules that are suspended in

the drinking water.

Step 9

Insert the tip of the oral syringe into the

glass cup.

Pull back on the plunger of the oral syringe

to draw up the suspension.

Step 10

Place the tip of the oral syringe in your

child’s mouth along the inner cheek. Slowly

push the plunger all the way down to give

your child all of the medicine in the oral

syringe.

Repeat Steps 9 and 10 until the glass cup is

empty.

Give all of the medicine to your child right

away after preparing. Do not save the

medicine for later use.

Step 11

To make sure all of the medicine is given to

your child, refill the glass cup with the same

amount of drinking water used in Step 7.

Step 12

Gently swirl the glass cup to mix any

remaining granules.

Step 13

Repeat Steps 9 and 10 until the glass cup is

empty.

Step 14

Rinse the plunger and barrel of the syringe

well with drinking water and dry well

before storing the oral syringe.

Step 15

Wash the glass cup. Throw away the paper

towel and clean the work surface. Wash

your hands.

How should I store PROGRAF Granules packets?

Store PROGRAF Granules packets at room temperature between 68°F to 77°F (20°C to 25°C).

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines

you no longer use.

Keep PROGRAF Granules and all medicine out of the reach of children.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Distributed by:

Astellas Pharma US, Inc.

Northbrook, IL 60062

PROGRAF

is a registered trademark of Astellas Pharma Inc.

341124-PRG

Revised: 11/2022