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

What is the most important information I should know about PROGRAF?

PROGRAF can cause serious side effects, including:

Increased risk of cancer. People who take PROGRAF have an increased risk of getting some kinds of cancer, including skin and lymph gland cancer (lymphoma).
Increased risk of infection. PROGRAF is a medicine that affects your immune system. PROGRAF can lower the ability of your immune system to fight infections. Serious infections can happen in people receiving PROGRAF that can cause death. Call your healthcare provider right away if you have any symptoms of an infection, including:

fever
sweats or chills
cough or flu-like symptoms

muscle aches
warm, red, or painful areas on your skin

What is PROGRAF?

PROGRAF is a prescription medicine used with other medicines to help prevent organ rejection in people who have had a kidney, liver, heart, or lung transplant.
PROGRAF capsules and PROGRAF GRANULES are types of tacrolimus immediate-release drugs and they are not the same as tacrolimus extended-release tablets or tacrolimus extended-release capsules. Your healthcare provider should decide what medicine is right for you.

Who should not take PROGRAF?

Do not take PROGRAF if you:

are allergic to tacrolimus or any of the ingredients in PROGRAF. See the end of this leaflet for a complete list of ingredients in PROGRAF.

What should I tell my healthcare provider before taking PROGRAF?

Before taking PROGRAF, tell your healthcare provider about all of your medical conditions, including if you:

plan to receive any vaccines. People taking PROGRAF should not receive live vaccines.
have or have had liver, kidney, or heart problems.
are pregnant or plan to become pregnant. PROGRAF can harm your unborn baby.
- If you are able to become pregnant, you should use effective birth control before and during treatment with PROGRAF. Talk to your healthcare provider before starting treatment with PROGRAF about birth control methods that may be right for you.
- Males who have female partners who are able to become pregnant should also use effective birth control before and during treatment with PROGRAF. Talk to your healthcare provider before starting treatment with PROGRAF about birth control methods that may be right for you.
- There is a pregnancy registry for females who become pregnant and males who have fathered a pregnancy during treatment with PROGRAF. The purpose of this registry is to collect information about the health of you and your baby. To enroll in this voluntary registry, call 1-877-955-6877 or go to https://www.transplantpregnancyregistry.org/.
are breastfeeding or plan to breastfeed. PROGRAF passes into your breast milk. You and your healthcare provider should decide if you will breastfeed while taking PROGRAF.
plan to have children. PROGRAF may affect the ability to have children in females and males (fertility problems).

Tell your healthcare provider about all the medicines you take, and when you start a new medicine or stop taking a medicine, including prescription and over-the-counter medicines, vitamins, natural, herbal, or nutritional supplements.

Especially tell your healthcare provider if you take:

sirolimus (RAPAMUNE): You should not take PROGRAF if you take sirolimus
cyclosporine (GENGRAF, NEORAL, and SANDIMMUNE)
medicines called aminoglycosides that are used to treat bacterial infections
ganciclovir (CYTOVENE IV, VALCYTE)
amphotericin B (ABELCET, AMBISOME)
cisplatin
antiviral medicines called nucleoside reverse transcriptase inhibitors
antiviral medicines called protease inhibitors
water pill (diuretic)
medicine to treat high blood pressure
nelfinavir (VIRACEPT)
telaprevir (INCIVEK)
boceprevir
ritonavir (KALETRA, NORVIR, TECHNIVIE, VIEKIRA PAK, VIEKIRA XR)
letermovir (PREVYMIS)
ketoconazole
itraconazole (ONMEL, SPORANOX)
voriconazole (VFEND)
caspofungin (CANCIDAS)
clarithromycin (BIAXIN, BIAXIN XL, PREVPAC)
rifampin (RIFADIN, RIFAMATE, RIFATER, RIMACTANE)
rifabutin (MYCOBUTIN)
amiodarone (NEXTERONE, PACERONE)
cannabidiol (EPIDIOLEX)

Ask your healthcare provider or pharmacist if you are not sure if you take any of the medicines listed above.

PROGRAF may affect the way other medicines work, and other medicines may affect how PROGRAF works.

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

How should I take PROGRAF?

Take PROGRAF exactly as your healthcare provider tells you to take it.
Your healthcare provider will tell you how much PROGRAF to take and when to take it.
Your healthcare provider may change your PROGRAF dose if needed. Do not stop taking or change your dose of PROGRAF without talking to your healthcare provider.
Take PROGRAF with or without food.
Take PROGRAF the same way every day. For example, if you choose to take PROGRAF with food, you should always take PROGRAF with food.
Take PROGRAF at the same time each day, 12 hours apart. For example, if you take your first dose at 7:00 a.m., you should take your second dose at 7:00 p.m.
Taking PROGRAF at the same time each day helps to keep the amount of medicine in your body at a steady level.
If you take too much PROGRAF, call your healthcare provider or go to the nearest hospital emergency room right away.

PROGRAF capsules:

Do not open or crush PROGRAF capsules.

PROGRAF Granules:

Children who have trouble swallowing capsules can be given PROGRAF Granules.
Give the dose of PROGRAF Granules right after preparing. Do not save prepared PROGRAF Granules as a liquid to take at a later time.
See the Instructions for Use at the end of this Patient Information for detailed instructions about how to mix and give PROGRAF Granules as a liquid in a glass cup or oral syringe.
If you get the granules or prepared oral suspension on your skin, wash the area well with soap and water.
If you get the granules or prepared oral suspension in your eyes, rinse with plain water.

What should I avoid while taking PROGRAF?

While you take PROGRAF you should not receive any live vaccines.
Limit the amount of time you spend in sunlight and avoid exposure to ultraviolet (UV) light, such as tanning machines. Wear protective clothing and use a sunscreen with a high sun protection factor (SPF).
Do not eat grapefruit or drink grapefruit juice during treatment with PROGRAF.

What are the possible side effects of PROGRAF?

PROGRAF may cause serious side effects, including:

See “What is the most important information I should know about PROGRAF?”
problems from medicine errors. People who take PROGRAF have sometimes been given the wrong type of tacrolimus product. Tacrolimus extended-release medicines are not the same as PROGRAF capsules or granules and cannot be substituted for each other. Check your PROGRAF when you get a new prescription and before you take it to make sure you have received PROGRAF capsules or PROGRAF Granules.
Check with the pharmacist and call your healthcare provider if you think you were given the wrong medicine.
high blood sugar (diabetes). Your healthcare provider may do blood tests to check for diabetes while you take PROGRAF. Call your healthcare provider right away if you have any symptoms of high blood sugar, including:

frequent urination
increased thirst or hunger
blurred vision
confusion

drowsiness
loss of appetite
fruity smell on your breath
nausea, vomiting, or stomach pain

kidney problems. Kidney problems are a serious and common side effect of PROGRAF. Your healthcare provider may do blood tests to check your kidney function while you take PROGRAF.
nervous system problems. Nervous system problems are a serious and common side effect of PROGRAF. Call your healthcare provider right away if you get any of these symptoms while taking PROGRAF. These could be signs of a serious nervous system problem:

headache
confusion
seizures
changes in your vision

changes in behavior
coma
tremors
numbness and tingling

high levels of potassium in your blood. Your healthcare provider may do blood tests to check your potassium level while you take PROGRAF.
high blood pressure. High blood pressure is a serious and common side effect of PROGRAF. Your healthcare provider will monitor your blood pressure while you take PROGRAF and may prescribe blood pressure medicine for you, if needed. Your healthcare provider may instruct you to check your blood pressure at home.
changes in the electrical activity of your heart (QT prolongation).
heart problems (myocardial hypertrophy). Tell your healthcare provider right away if you get any of these symptoms of heart problems while taking PROGRAF:

shortness of breath
chest pain

feel lightheaded
feel faint

severe low red blood cell count (anemia).
blood clotting problems: Tell your healthcare provider right away if you have fever and bruising under the skin that may appear as red dots, with or without unexplained tiredness, confusion, yellowing of the skin or eyes, decreased urination. When taken with sirolimus or everolimus, the risk of developing these symptoms may increase.

The most common side effects of PROGRAF in people who have received a kidney, liver, heart, or lung transplant are:

infections in general, including cytomegalovirus (cmv) infection
tremors (shaking of the body)
constipation
diarrhea
headache
stomach pain
trouble sleeping
nausea
high blood sugar (diabetes)
low levels of magnesium in your blood
low levels of phosphate in your blood

swelling of the hands, legs, ankles, or feet
weakness
pain
high levels of fat in your blood
high levels of potassium in your blood
low red blood cell count (anemia)
low white blood cell count
fever
numbness or tingling in your hands and feet
inflammation of your airway (bronchitis)
fluid around your heart

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of PROGRAF. For more information, ask your healthcare provider or pharmacist.

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 PROGRAF?

PROGRAF capsules

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

PROGRAF Granules

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

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

General information about the safe and effective use of PROGRAF.

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

What are the ingredients in PROGRAF?

Active ingredient: tacrolimus

Inactive ingredients:

PROGRAF capsules: croscarmellose sodium, hypromellose, lactose monohydrate, and magnesium stearate. The 0.5 mg capsule shell contains ferric oxide, gelatin, and titanium dioxide. The 1 mg capsule shell contains gelatin and titanium dioxide. The 5 mg capsule shell contains ferric oxide, gelatin, and titanium dioxide.

PROGRAF Granules: croscarmellose sodium, hypromellose, and lactose monohydrate.

Distributed by: Astellas Pharma US, Inc. Northbrook, IL 60062

PROGRAF^®is a registered trademark of Astellas Pharma Inc. All other trademarks and registered trademarks are the property of their respective owners.

398977-PRG

For more information, go to www.astellas.com/us or call 1-800-727-7003.

This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: 08/2023

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

Prograf (Tacrolimus): Uses, Side Effects and Dosage