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Prescribing Information

As a parent of a child dealing with chronic renal insufficiency (CRI), you’re dealing with a whole host of interrelated medical issues. While you should always make it a point to discuss any concerns with your healthcare team, here are answers to some of the basic questions about the treatment of short stature due to CRI, as well as about Nutropin® [somatropin (rDNA origin) for injection] and Nutropin therapy.

Why do children with short stature associated with CRI need to take Nutropin therapy?

A: One reason that children with CRI may suffer from abnormal growth and development is related to natural growth hormone. In these children, natural growth hormone does not work as well as it does in those who are healthy. That’s why Nutropin therapy is sometimes used to help children with CRI get closer to their growth potential before kidney transplant.

What is the goal of Nutropin therapy in CRI?

A: The goal of Nutropin therapy for a child with CRI (up to the time of renal transplantation) is to offset the impact of chronic kidney disease on the growth process and to help the child get closer his or her full adult height potential.

How long will my child have to continue Nutropin therapy?

A: Children with CRI should continue to receive Nutropin treatments up to the time of renal transplantation, subject to their healthcare professional’s medical judgment.

Will my child still have to continue taking other kidney medications, while receiving Nutropin therapy?

A: Yes, children with CRI must continue taking their other kidney medications as prescribed by their healthcare professional in addition to receiving Nutropin therapy. Nutropin merely treats one of the problems of CRI rather than the disease itself. to help the Nutropin therapy work as well as possible, children with CRI must also eat a healthy diet.

Does Nutropin therapy have to be given at any special time of day?

Your healthcare professional will look at your child’s overall treatment plan and determine the best time of day to give your child Nutropin treatment. Many children with CRI are on dialysis to help keep them healthy. Growth hormone is broken down by the kidneys, so the type of dialysis the child receives may affect when the Nutropin injection should be given.

In order to optimize therapy for patients who require dialysis, the following guidelines for injection schedule are recommended:

  • Hemodialysis patients should receive their injection at night just prior to going to sleep or at least 3–4 hours after their hemodialysis to prevent hematoma formation due to the heparin.
  • Chronic Cycling Peritoneal Dialysis (CCPD) patients should receive their injection in the morning after they have completed dialysis.
  • Chronic Ambulatory Peritoneal Dialysis (CAPD) patients should receive their injection in the evening at the time of the overnight exchange.
Does a patient need to rotate their injection sites?

A: To avoid tissue atrophy that may result from subcutaneous administration of GH at the same site over a long period of time, the injection site should be rotated.

Are there any special precautions for CRI patients treated with GH?

A: Children with growth failure secondary to CRI should be examined periodically for evidence of progression of renal osteodystrophy. Slipped capital femoral epiphysis or avascular necrosis of the femoral head may be seen in children with advanced renal osteodystrophy, and it is uncertain whether these problems are affected by GH therapy. X-rays of the hip should be obtained prior to initiating GH therapy for CRI patients. Physicians and parents should be alert to the development of a limp or complaints of hip or knee pain in CRI patients treated with GH.

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WHO IS NUTROPIN FOR?

Nutropin® [somatropin (rDNA origin) for injection] and Nutropin AQ® [somatropin (rDNA origin) injection] are human growth hormone, available by prescription only.

Doctors prescribe Nutropin for children and teenagers with growth failure who:

  • Do not make enough growth hormone on their own
  • Have chronic renal insufficiency—a slow loss of kidney function—and have not had a transplant
  • Have Turner syndrome
  • Are not likely to grow to their potential adult height, as determined by a doctor, and whose bones are still able to grow

Doctors prescribe Nutropin for adults who:

  • Have growth hormone deficiency that started either in childhood or as an adult due to brain surgery, radiation therapy, trauma, or diseases of the pituitary gland or the hypothalamus

Your doctor will test to see if growth hormone is right for you.

IMPORTANT SAFETY INFORMATION

Nutropin and your safety:
Please read this important safety information carefully. Then, if you have any questions, talk with your doctor.

Nutropin is NOT for:

If any of these apply, talk to your doctor before you start taking Nutropin.

If you are about to start taking Nutropin, or are already taking it, be sure to tell the doctor who prescribed it:

What are the possible side effects of Nutropin?
You may experience discomfort, soreness, or redness where Nutropin is injected.

Contact your doctor immediately if you experience:

Be sure to inject Nutropin at a different recommended place on your body each time. Your doctor or nurse should supervise the first injection and provide training and instruction.

Your doctor is your primary source of information about your treatment.

Please see the full Prescribing Information for Nutropin and Nutropin AQ, available from your pharmacy and at www.nutropin.com, for more about Nutropin and safety.

Questions? Call the Nurse Hotline at 1-866-NUTROPIN (1-866-688-7674).

The content available from this website is for informational purposes only. Individual results may vary. You may report side effects to the FDA at 1-800-FDA-1088 or to Genentech Drug Safety/Adverse Events at 1-888-835-2555.

Nutropin and Nutropin AQ are registered trademarks; and NuSpin, growingopportunity, and Nutropin GPS are trademarks of Genentech Inc.

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Related Tools & Resources

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Should Nutropin be your choice for GH therapy?

Important Safety Information

WHO IS NUTROPIN FOR?

Nutropin® [somatropin (rDNA origin) for injection] and Nutropin AQ® [somatropin (rDNA origin) injection] are human growth hormone, available by prescription only.

Doctors prescribe Nutropin for children and teenagers with growth failure who:

  • Do not make enough growth hormone on their own
  • Have chronic renal insufficiency—a slow loss of kidney function—and have not had a transplant
  • Have Turner syndrome
  • Are not likely to grow to their potential adult height, as determined by a doctor, and whose bones are still able to grow

Doctors prescribe Nutropin for adults who:

  • Have growth hormone deficiency that started either in childhood or as an adult due to brain surgery, radiation therapy, trauma, or diseases of the pituitary gland or the hypothalamus

Your doctor will test to see if growth hormone is right for you.

IMPORTANT SAFETY INFORMATION

Nutropin and your safety:
Please read this important safety information carefully. Then, if you have any questions, talk with your doctor.

Nutropin is NOT for:

  • Children and teenagers whose bones have finished growing
  • Patients who have certain types of eye disease caused by diabetes
  • Patients who have active cancer or any brain tumors
  • Patients who are critically ill after open heart surgery or abdominal (stomach) surgery, are severely hurt, or have severe breathing problems
  • Children and teenagers who have Prader-Willi syndrome and are very overweight or have trouble breathing
  • Patients with a known sensitivity to benzyl alcohol when using Nutropin reconstituted with Bacteriostatic Water for Injection, USP (benzyl alcohol preserved). For use in newborns, see WARNINGS in full Prescribing Information

If any of these apply, talk to your doctor before you start taking Nutropin.

If you are about to start taking Nutropin, or are already taking it, be sure to tell the doctor who prescribed it:

  • About ALL of the medications you are taking, including supplements
  • If you have or develop a brain tumor
  • If you are given any new medication, especially glucocorticoid steroids like hydrocortisone or prednisone
  • If you are pregnant or if you become pregnant
  • About ANY other condition or illness you have or develop

What are the possible side effects of Nutropin?
You may experience discomfort, soreness, or redness where Nutropin is injected.

Contact your doctor immediately if you experience:

  • Ongoing injection site discomfort
  • Curvature of the spine (scoliosis)
  • Joint pain
  • Puffy hands and/or feet (caused by fluid retention)
  • Changes in vision, a bad headache, or nausea with or without vomiting
  • Hip or knee pain
  • A need to limp when you walk
  • Pain in wrist (carpal tunnel)
  • Allergic reaction

Be sure to inject Nutropin at a different recommended place on your body each time. Your doctor or nurse should supervise the first injection and provide training and instruction.

Your doctor is your primary source of information about your treatment.

Please see the full Prescribing Information for Nutropin and Nutropin AQ, available from your pharmacy and at www.nutropin.com, for more about Nutropin and safety.

Questions? Call the Nurse Hotline at 1-866-NUTROPIN (1-866-688-7674).

View indication and safety information

WHO IS NUTROPIN FOR?

Nutropin® [somatropin (rDNA origin) for injection] and Nutropin AQ® [somatropin (rDNA origin) injection] are human growth hormone, available by prescription only.

Doctors prescribe Nutropin for children and teenagers with growth failure who:

  • Do not make enough growth hormone on their own
  • Have chronic renal insufficiency—a slow loss of kidney function—and have not had a transplant
  • Have Turner syndrome
  • Are not likely to grow to their potential adult height, as determined by a doctor, and whose bones are still able to grow

Doctors prescribe Nutropin for adults who:

  • Have growth hormone deficiency that started either in childhood or as an adult due to brain surgery, radiation therapy, trauma, or diseases of the pituitary gland or the hypothalamus

Your doctor will test to see if growth hormone is right for you.

IMPORTANT SAFETY INFORMATION

Nutropin and your safety:
Please read this important safety information carefully. Then, if you have any questions, talk with your doctor.

Nutropin is NOT for:

  • Children and teenagers whose bones have finished growing
  • Patients who have certain types of eye disease caused by diabetes
  • Patients who have active cancer or any brain tumors
  • Patients who are critically ill after open heart surgery or abdominal (stomach) surgery, are severely hurt, or have severe breathing problems
  • Children and teenagers who have Prader-Willi syndrome and are very overweight or have trouble breathing
  • Patients with a known sensitivity to benzyl alcohol when using Nutropin reconstituted with Bacteriostatic Water for Injection, USP (benzyl alcohol preserved). For use in newborns, see WARNINGS in full Prescribing Information

If any of these apply, talk to your doctor before you start taking Nutropin.

If you are about to start taking Nutropin, or are already taking it, be sure to tell the doctor who prescribed it:

  • About ALL of the medications you are taking, including supplements
  • If you have or develop a brain tumor
  • If you are given any new medication, especially glucocorticoid steroids like hydrocortisone or prednisone
  • If you are pregnant or if you become pregnant
  • About ANY other condition or illness you have or develop

What are the possible side effects of Nutropin?
You may experience discomfort, soreness, or redness where Nutropin is injected.

Contact your doctor immediately if you experience:

  • Ongoing injection site discomfort
  • Curvature of the spine (scoliosis)
  • Joint pain
  • Puffy hands and/or feet (caused by fluid retention)
  • Changes in vision, a bad headache, or nausea with or without vomiting
  • Hip or knee pain
  • A need to limp when you walk
  • Pain in wrist (carpal tunnel)
  • Allergic reaction

Be sure to inject Nutropin at a different recommended place on your body each time. Your doctor or nurse should supervise the first injection and provide training and instruction.

Your doctor is your primary source of information about your treatment.

Please see the full Prescribing Information for Nutropin and Nutropin AQ, available from your pharmacy and at www.nutropin.com, for more about Nutropin and safety.

Questions? Call the Nurse Hotline at 1-866-NUTROPIN (1-866-688-7674).

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