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NORTHBROOK, Ill., March 18, 2019 /PRNewswire/ -- Astellas announced today that PROGRAF® Granules (tacrolimus for oral suspension) is now available for prescription in the United States. PROGRAF is used in combination with other immunosuppressants to help prevent organ rejection in people who have had a liver, heart, or kidney transplant. Children who have trouble swallowing capsules can be given PROGRAF Granules.
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 Japan as 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/.
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:
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:
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?
What should I avoid while taking PROGRAF?
PROGRAF may cause serious side effects, including:
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.
Astellas is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. For more information on Astellas, please visit our website at http://www.astellas.us. You can also follow us on Twitter at @AstellasUS, Facebook at http://www.facebook.com/AstellasUS or LinkedIn at www.linkedin.com/company/astellas-pharma.
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.
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SOURCE Astellas Pharma US, Inc.
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