Astellas Launches PROGRAF® Granules (tacrolimus for oral suspension) in the U.S. for Pediatric Liver, Heart, and Kidney Transplant Patients

By offering this new option, Astellas believes PROGRAF Granules represents an important therapeutic alternative for appropriate pediatric transplant recipients. Astellas is a recognized leader in transplantation and has been committed to the field of transplant immunology for more than 20 years. This milestone is another example of the company's dedication to the transplant community.

 

"More than 1000 pediatric patients receive liver, kidney, and heart transplants annually in the United States," said Walt Johnston, senior vice president of Urology and Hospital, Astellas. "This new granules presentation offers another dosing option for transplant recipients and their caregivers to administer this critical, life-sustaining therapy."

The safety and effectiveness of PROGRAF Granules have been established in pediatric liver, kidney, and heart transplant patients. Use in pediatric de novo liver transplant patients less than 16 years of age are based on evidence from active, controlled studies in adults that included 56 pediatric patients, 31 of whom received PROGRAF, and are supported by two pharmacokinetic and safety studies in 151 children who received PROGRAF. Additionally,122 pediatric patients were studied in an uncontrolled trial of tacrolimus in living related donor liver transplantation.  Dose adjustments were made in the pharmacokinetic studies based on clinical status and whole blood concentrations. 

Use of PROGRAF Capsules and PROGRAF Granules in pediatric kidney and heart transplant patients is supported by adequate and well-controlled studies and pharmacokinetic data in adult kidney and heart transplant patients with additional pharmacokinetic data in pediatric kidney and heart transplant patients and safety data in pediatric liver transplant patients. 

To facilitate precise dosing in pediatric patients, PROGRAF Granules will be sold in standardized 0.2 mg or 1 mg packets in cartons containing 50 units. For conversion of pediatric patients from PROGRAF capsules to PROGRAF Granules, or from the granule formulation to capsules, the total daily dose should remain the same. Following conversion between formulations, therapeutic drug monitoring is recommended and dose adjustments made to ensure that systemic exposure to tacrolimus is maintained.

PROGRAF Granules have been previously approved as MODIGRAF® (tacrolimus) in 29 European countries and in Japanas PROGRAF Granules. It is currently the only pediatric tacrolimus product approved outside of the U.S.  The PROGRAF Granules formulation was approved by the U.S. Food and Drug Administration (FDA) on May 24, 2018. Health professionals, patients and their caregivers can learn more about PROGRAF at https://www.prograf.com/.

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About PROGRAF^® (tacrolimus) 
PROGRAF^® was initially approved by the FDA in 1994. PROGRAF® is a calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in patients receiving allogeneic liver, kidney, or heart transplants, in combination with other immunosuppresants.

For full prescribing information, including boxed warning, please visit www.prograf.com or call Astellas at 1-800-727-7003.

Important Safety Information for PROGRAF^®  (tacrolimus)

PROGRAF can cause serious side effects, including:

1. 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).
2. 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.

Do not take PROGRAF if you are allergic to tacrolimus or any of the ingredients in PROGRAF.

What should I tell my healthcare provider before taking PROGRAF?
Before you take PROGRAF, tell your healthcare provider about all of your medical conditions, including if you:

• plan to receive any live 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.
• 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.

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.

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?

• Do not eat grapefruit or drink grapefruit juice while taking PROGRAF.
• Take PROGRAF exactly as your healthcare provider tells you 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, 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 the Patient Information for detailed instructions about how to mix and give PROGRAF Granules as a liquid.
• 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).

PROGRAF may cause serious side effects, including:

• 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 granulesand cannot be substituted for each other, unless specifically prescribed by your healthcare provider, who will send you to get blood tacrolimus levels at a lab. 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. Call your healthcare provider right away if you have any symptoms of high blood sugar.
• 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.
• 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 symptoms that could be signs of a serious nervous system problem.
• high levels of potassium in your blood. Your healthcare provider may do blood tests to check your potassium level.
• high blood pressure. High blood pressure is a serious and common side effect of PROGRAF. Your healthcare provider will monitor your blood pressure 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 symptoms of heart problems.
• severe low red blood cell count (anemia).

The most common side effects of PROGRAF in people who have received a kidney, liver or heart 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.

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

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

 

Cautionary Notes
In this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management's current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas' intellectual property rights by third parties.

Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice.

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