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Prescribing Information

When a child or a teenager is growing poorly, but his or her body appears to be making normal amounts of growth hormone, he or she is said to have idiopathic short stature.

Children and teenagers with ISS do not have hGH deficiencies.

Children with Idiopathic Short Stature (ISS) have:

Doctors may prescribe Nutropin AQ® [somatropin (rDNA origin) injection] and Nutropin® [somatropin (rDNA origin) for injection] to treat ISS and help your child grow.

How human growth hormone (hGH) works in your body

Made by the pituitary gland in the brain, growth hormone helps the body produce muscle and break down fats. It also plays a critical role in helping young bodies grow and develop.

When levels of growth hormone are too low, there’s an impact on many things the body does—including development and growth.

How ISS is diagnosed

ISS (also called non-growth hormone-deficient short stature) is typically diagnosed in two stages:

  • First, your child or teenager is found to have a height in the lowest 1.2% of all US children of the same age and sex, with growth rates that indicate a low chance of reaching a normal adult height
  • Second, other conditions that might slow growth, such as Turner Syndrome, chronic illness, or chronic renal insufficiency, are ruled out
How ISS may be treated

For children and teenagers who:

  • Are not likely to grow to their potential adult height, as determined by a doctor
  • Have bones that are still able to grow

ISS may be treated with growth hormone therapy.

If you have ISS, GH therapy means taking regular injections of growth hormone (such as Nutropin) until you reach your growth potential (as determined by your doctor), until the growing ends of your bones fuse, or as your doctor recommends.

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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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, an ingredient in the liquid used to mix Nutropin Injection. Sterile water should be used when mixing Nutropin for newborns.

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, an ingredient in the liquid used to mix Nutropin Injection. Sterile water should be used when mixing Nutropin for newborns.

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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