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What Nutropin AQ^® (somatropin) Treats

Nutropin treats people who don’t make enough growth hormone on their own.

Growth hormone plays an important role in the development of organs, bones, and tissues for children and teens. In adults it helps your body maintain a healthy balance between lean mass and body fat. Nutropin therapy is approved for the following conditions where growth hormone treatment may be necessary.

How Nutropin Helps GHD in the Following Conditions:

Growth Hormone Deficiency (GHD)

Pediatric Growth Hormone Deficiency (PGHD) may happen when the body is unable to produce enough growth hormone (GH) or use it effectively. GH produced in the body plays a critical role in helping young bodies grow and develop, including improving muscle metabolism, growing bones, and breaking down fats. When levels of GH are too low, there may be an impact on growth and many functions of the body.

PGHD may be present at birth or develop at any time during childhood or adolescence. There are many possible causes of PGHD. Damage to, or an abnormality in, the pituitary gland or the hypothalamus (the part of your brain that controls the pituitary gland) are among them.

If PGHD is diagnosed, the doctor may prescribe GH therapy. The form of GH used as a medication is the same protein that is made naturally in the body.

Nutropin AQ^® (somatropin) therapy

Doctors prescribe Nutropin therapy for children and teenagers who are short or growing slowly because they do not make enough growth hormone on their own.

For appropriate children and teenagers with PGHD, treatment means taking regular GH injections under the ongoing supervision of a healthcare professional (HCP). Treatment continues until the HCP determines that GH therapy should end.

Download PDFs for detailed information

Pediatric Growth Hormone Deficiency Brochure

A Guide for Caregivers of Pediatric Patients with Growth Hormone Deficiency

Get your questions about PGHD and its treatment answered here. Includes information about the benefits and risks of treatment.

Transition from Pediatric to Adult Care Brochure

Transition from Pediatric to Adult Care Brochure

This guide helps pediatric patients design a long-term treatment plan as they move into their adult years. It includes education on treatment expectations, setting adult treatment goals, and a doctor discussion guide.

For pediatric GHD patients who are still GH deficient as adults, a commitment to ongoing therapy is necessary even after finishing puberty and reaching full height because growth hormone helps the body maintain a healthy balance between lean mass and body fat.

When to evolve your treatment goals and treatment team from a pedatric to adult focus:

The American College of Endocrinology recommends when your child is between the ages of 15-18, an adult endocrinologist can work with your child’s pediatrician to determine the level of continued care needed. Tests to determine growth hormone levels and other measurements will be done. If it is determined your child can benefit from ongoing therapy, an adult endocrinologist will help shift treatment goals. Adult treatment goals include improvements in:

Body composition
Cholesterol profile
Bone mineral density

Remember – Treatment goals are not just about height!

Reference: AACE 2019 Guidelines for Management of Growth Hormone Deficiency in Adults and Patients Transitioning from Pediatric to Adult Care.
Available at:
https://www.ncbi.nlm.nih.gov/pubmed/31760824
https://journals.aace.com/doi/pdf/10.4158/GL-2019-0405

Download PDFs for detailed information

Adult Growth Hormone Deficiency Brochure

Transition from Pediatric to Adult Care Brochure

This guide helps pediatric patients design a long-term treatment plan as they move into their adult years. It includes education on treatment expectations, setting adult treatment goals, and a doctor discussion guide.

Adult-onset Adult Growth Hormone Deficiency (AGHD) may occur when an adult’s pituitary gland does not work effectively. Adult-onset AGHD may have been caused by damage to the pituitary gland or hypothalamus, which may impact its ability to make enough GH.

This damage is most commonly caused by a tumor in and around the pituitary. Such a tumor may compress the gland, or the damage may occur when the tumor is removed through neurosurgery. The pituitary gland may also be damaged by infection, blood vessel disease, severe head injury, or radiation treatment. Damage to the pituitary gland may affect the production of one or more pituitary hormones, including GH.

Nutropin AQ^® (somatropin) therapy

Doctors prescribe Nutropin therapy for adults who have growth hormone deficiency that began either in:

Adulthood as a result of pituitary disease, diseases of the hypothalamus, surgery, radiation therapy, or trauma; or
Childhood. Patients treated for growth hormone deficiency in childhood, whose bones have stopped growing, should be reevaluated to see if they need to continue with growth hormone therapy

Download PDF for detailed information

Adult Growth Hormone Deficiency brochure cover

A Guide for Patients with Adult Growth Hormone Deficiency

Learn more about AGHD and treatment options. Includes information about the benefits and risks of treatment.

Idiopathic Short Stature (ISS)

When a child or a teenager is growing poorly, but his or her body appears to be making normal amounts of growth hormone (GH), he or she is said to have Idiopathic Short Stature (ISS). “Idiopathic” means the cause is unknown; “short stature” means the child or teenager is markedly shorter than others of his or her age and gender.

Nutropin AQ^® (somatropin) therapy

Doctors prescribe Nutropin therapy for children and teenagers who are short or growing slowly because they:

Have idiopathic short stature, which means they are shorter than 98.8% of other children of the same age and sex; are growing at a rate not likely to allow them to reach normal adult height; and no other cause of short stature can be found

Taking GH therapy means taking regular injections of growth hormone (such as Nutropin) until the growing ends of your bones fuse, or as your doctor recommends.

Turner Syndrome-Associated Short Stature

Turner syndrome (TS) is a genetic condition that affects about 1 in every 2,500 female live births. TS occurs when one of a girl’s two X chromosomes is absent or incomplete. The most common feature of TS is short stature, which affects nearly 100% of girls with TS. That’s because the missing or incomplete X chromosome contains a gene that helps girls grow to a normal height.

From birth through their teen years, girls with TS grow more slowly than unaffected children. In fact, the average adult height of women with TS is about 4’8”, while unaffected women average about 5’4”.

Nutropin AQ^® (somatropin) therapy

Doctors prescribe Nutropin therapy for children and teenagers who are short or growing slowly because they have Turner syndrome.

For most girls with TS, one part of treatment means taking regular GH injections under the ongoing supervision of a healthcare professional (HCP). Treatment continues until growth stops or the HCP determines that GH therapy should end.

Download PDF for detailed information

Turner Syndrome Brochure

A Guide for Caregivers of Patients with Turner Syndrome

Find out more about how TS impacts growth in girls, and get answers on how growth hormone therapy can help. Includes information about the benefits and risks of treatment.Find out more about how TS impacts growth in girls, and get answers on how growth hormone therapy can help. Includes information about the benefits and risks of treatment.

Chronic Kidney Disease-Associated Growth Disease

Chronic Kidney Disease (CKD) is a loss of kidney function over a period of months or years. Most young people with CKD produce as much growth hormone (GH)
as anyone their age. The problem is that their kidneys aren’t filtering waste from their blood as well as they should. Because so much waste is trapped in their blood, their bodies aren’t able to use GH effectively. Because of CKD, GH and insulin-like growth factor (IGF) can’t connect properly. GH signals IGF to travel to muscles, organs, and bones and tells the bones to grow. It also helps improve muscle metabolism. When GH and IGF aren’t working together, it means:

Growth may be slowed or stopped
Muscles, organs, and bones may not get the GH they need to develop properly

Nutropin AQ^® (somatropin) therapy

Doctors prescribe Nutropin therapy for children and teenagers with growth failure associated with CKD up to the time of kidney transplant. Nutropin is the only growth hormone with the FDA approved indication of treatment of children with growth failure who have CKD up to the time of renal transplantation.

Download PDF for detailed information

Chronic Kidney Disease Brochure

A Guide for Caregivers of Patients who have Chronic Kidney Disease

Maintaining growth can be a problem for children with CKD. Find out more about how CKD impacts growth in this helpful brochure. Includes information about the benefits and risks of treatment.

Select Important Safety Information

What should you tell your doctor before starting Nutropin therapy?

If you have pituitary hormone deficiency(s) (an inability of the pituitary gland to produce sufficient hormones) or adrenal hormone deficiency (an inability of the adrenal glands to produce sufficient hormones, primarily cortisol), your doctor may further monitor your hormone levels or your hormone replacement therapy closely while you are taking Nutropin therapy.

INDICATIONS:

WHO IS NUTROPIN THERAPY FOR?

Nutropin AQ^® (somatropin) injection for subcutaneous use is a human growth hormone that is available by prescription only.
Doctors prescribe Nutropin therapy for children and teenagers who are short or growing slowly because they:

Do not make enough growth hormone on their own
Have idiopathic short stature, which means they are shorter than 98.8% of other children of the same age and sex; are growing at a rate not likely to allow them to reach normal adult height; and no other cause of short stature can be found
Have Turner syndrome
Have chronic kidney disease (CKD) up to the time of kidney transplant

Doctors prescribe Nutropin therapy for adults who have growth hormone deficiency that began either in:

Adulthood as a result of pituitary disease, diseases of the hypothalamus, surgery, radiation therapy, or trauma; or
Childhood. Patients treated for growth hormone deficiency in childhood, whose bones have stopped growing, should be reevaluated to see if they need to continue with growth hormone therapy

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

IMPORTANT SAFETY INFORMATION

Nutropin therapy and your safety:

Please read this Important Safety Information carefully. Then, if you have any questions, talk with your doctor.

NUTROPIN THERAPY IS NOT FOR:

Patients having serious complications after undergoing open heart surgery, abdominal surgery, serious injuries involving many body systems, or life-threatening breathing problems. Deaths have been reported in such cases
Children who have Prader-Willi syndrome (PWS) and are very overweight or have a history of severe breathing problems. Deaths have been reported in children with PWS who are very overweight, have a history of blocked upper airways, sleep apnea (pauses in breathing during sleeping), or other severe breathing problems
Patients who have active cancer. Because growth hormone deficiency can be an early sign of some tumors in the brain or pituitary gland, the presence of these types of tumors should be ruled out by your doctor before you start Nutropin therapy
Patients who are allergic to somatropin, the active ingredient in Nutropin therapy, or the inactive ingredients in Nutropin therapy
Adults or children with certain types of eye disease caused by diabetes
Children and teenagers whose bones have finished growing

What should you tell your doctor before starting Nutropin therapy?

If you take cyclosporine, hormone replacement therapy, insulin or other diabetes medications, drugs containing steroids, or drugs for seizures. These medications may need to be adjusted during Nutropin therapy
If you had cancer as a child. An increased risk of a new tumor, particularly certain brain tumors, has been reported in patients taking Nutropin therapy. If you have pre-existing tumors or growth hormone deficiency caused by abnormal tissue in the brain, you should be watched closely for the worsening or return of this condition
If you have diabetes, risk factors for diabetes, or impaired glucose tolerance. If so, your doctor should monitor your blood sugar closely during Nutropin therapy. New cases of type 2 diabetes have been reported in patients taking Nutropin therapy
If you have pituitary hormone deficiency(s) (an inability of the pituitary gland to produce sufficient hormones) or adrenal hormone deficiency (an inability of the adrenal glands to produce sufficient hormones, primarily cortisol). Your doctor may further monitor your hormone levels or your hormone replacement therapy closely while you are taking Nutropin therapy
If you are pregnant, nursing, or plan to become pregnant. It is not known whether Nutropin is excreted in human milk. Nutropin therapy should be used during pregnancy only when clearly needed

While taking Nutropin, contact your doctor immediately if you experience:

Changes in upper airway obstruction (including onset of or increased snoring) and/or new onset sleep apnea, in patients with PWS. These patients should also have effective weight control and be monitored by a doctor for signs of respiratory infection
Changes in vision, a bad headache, or nausea with or without vomiting. This may be a sign of increased pressure in the brain
Any allergic reaction you experience to the injection of Nutropin therapy
A limp or have hip or knee pain
- A fracture in the ball of the hip joint can occur in children who have endocrine problems and in children who have rapid growth
- Children with growth failure due to CKD should be examined periodically for evidence of loss of bone minerals. Hip x-rays should be taken before starting Nutropin therapy in these children
Progression of scoliosis (curvature of the spine) that can occur in children who have rapid growth. Nutropin therapy has not been shown to increase the occurrence of this condition
Increases in laboratory test serum levels of inorganic phosphorus, alkaline phosphatase, parathyroid hormone (PTH), or IGF-1
Abdominal pain. Cases of pancreatitis (inflammation of the pancreas) have been reported rarely in children and adults receiving Nutropin therapy

Other important information about Nutropin

Adults may retain water during Nutropin therapy. This may be brief but may increase with higher doses of Nutropin therapy
Patients should have their thyroid function tested periodically during Nutropin therapy. Thyroid hormone treatment may need to be started or adjusted
Patients should be sure to inject Nutropin at a different recommended place on their body each time to avoid tissue breakdown. A doctor or nurse should provide injection training and supervise the first injection
The use of Nutropin therapy has not been studied in patients over 65 years of age. Elderly patients may be more sensitive to Nutropin therapy and may experience more side effects
Patients with Turner syndrome should be monitored closely by a doctor for ear infections and cardiovascular problems during Nutropin therapy

What are common possible side effects of Nutropin therapy?

Common side effects reported in adults and children taking Nutropin therapy include injection site reactions. Additional common side effects in adults include swelling, joint pain, and carpal tunnel syndrome.

You may report side effects to FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.

How should you store Nutropin?

Nutropin must be kept refrigerated (36° to 46°F [2° to 8°C]). Do not freeze. Cartridges and NuSpin pens must be used within 28 days of initial use. Throw away any unused Nutropin after 28 days of initial use. Before giving an injection, check the manufacturer’s expiration date on the cartridge or pen. Do not use if it has expired. Do not inject medication if the solution is cloudy.

Please see accompanying Nutropin full Prescribing Information for additional Important Safety Information.