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Prescribing Information

As a parent of a daughter with Turner Syndrome, you may be 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 TS, as well as about Nutropin® [somatropin (rDNA origin) for injection] and Nutropin therapy.

What is Turner Syndrome?

A: Turner Syndrome (TS) is a genetic disease that affects about 1 of every 2,500 live female births. TS is the most common condition affecting the female sex chromosome. Normally, most cells in a girl’s or woman’s body contain two X chromosomes, whereas those of males have one X chromosome and one Y chromosome. These chromosomes are often referred to as sex chromosomes because the genes on these chromosomes determine the sex of a person. TS occurs when a female is missing all or part of one of her X chromosomes. This leads to many different symptoms; some of which include:

  • Short stature
  • Slowed development of the ovaries
  • A webbed neck
  • Increased possibility of cardiovascular, kidney, and thyroid problems
  • Potential for skeletal disorders and hearing problems
Why are girls with Turner Syndrome short?

A: The most common feature of TS, short stature, affects nearly 100% of girls with TS. The missing or incomplete X chromosome contains a gene that helps children grow to a normal height. From birth through their teen years, girls with TS grow more slowly than unaffected children. The average adult height of unaffected women is 5’4” while women with TS average about 4’8” unless they receive growth hormone treatment.

How might Nutropin therapy help?

A: When tested, growth hormone levels may appear normal in girls with TS, yet studies have shown that growth hormone therapy improves growth despite this fact. For this reason, your healthcare professional may not feel the need to test your daughter’s growth hormone level. Nutropin treatment may help many girls with TS get closer to their full growth potential, increasing their average adult height

When should my daughter begin Nutropin therapy?

A: Nutropin and Nutropin AQ are indicated for the treatment of short stature associated with TS. Treatment often begins when a child’s height falls below the 5th percentile on the normal growth curve for females (in other words, 95% of children her age are taller than she). For girls with TS, this often happens between the ages of 2 and 5.

Will my child need other medications?

A: Be sure to ask your doctor about your daughter's treatment. Your child may need other medications and, unless your healthcare professional tells you otherwise, they should not be stopped while your daughter is on Nutropin therapy. There are many other medications that girls with TS may have to take. Remember to list all of the medications your daughter takes when talking with her healthcare professional.

How long will my child have to take Nutropin therapy?

A: Talk with your doctor about the expected scope of your daughter's treatment. Healthcare professionals recommend continuing growth hormone therapy until the doctor determines that GH therapy should end. When a girl enters puberty, her body starts to produce more estrogen, which promotes bone fusion and stops bone growth. Therefore, it is important for you to discuss puberty and estrogen replacement with your healthcare professional. Estrogen replacement therapy should be timed to limit this potential negative effect on growth, yet still allow for puberty to occur at a normal age.

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

A: Your healthcare professional will review your child’s treatment plan—taking into account the other medications she’s taking—and determine the best time of day to give your child her injection.

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.

Do TS patients who receive GH therapy need to have their thyroid function monitored?

A: Patients with TS have an increased risk for developing autoimmune thyroid disease and primary hypothyroidism. Therefore, patients should have periodic thyroid function tests and thyroid replacement therapy should be initiated or appropriately adjusted when indicated.

Is there any special safety information for patients with Turner Syndrome?

A: Patients with TS should be evaluated carefully for middle-ear infection and other ear disorders, since these patients have an increased risk of having both problems. Patients with TS should be monitored closely for cardiovascular disorders such as aortic dissection, stroke, aneurysm, or high blood pressure.

What are the side effects of Nutropin and Nutropin AQ?

A: 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.

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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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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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