What Is Humatrope?

Humatrope is a man-made form of human growth hormone. It was first approved in 1987 to treat children who are growing slowly because they do not make enough growth hormone on their own.

Humatrope is available in 6 mg, 12 mg, and 24 mg cartridges for use in a HumatroPen® injection device. Humatrope is also available in vials for use with a syringe and needle.

HumatroPen ImagesHumatroPen Images

Who Is Humatrope For?

Humatrope is used to treat children who are short or growing slowly because they:

  • Do not make enough growth hormone on their own
  • Have Turner Syndrome
  • 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 for whom no other cause of short stature can be found
  • Have SHOX deficiency
  • Were born smaller than normal for the number of weeks of pregnancy and do not catch up in height by 2 to 4 years of age

Humatrope is used to treat adults who have growth hormone deficiency that began either in:

  • Adulthood (as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma); or
  • Childhood. Patients treated for growth hormone deficiency in childhood whose bones have stopped growing should be reevaluated to determine if they should continue growth hormone

How Does Humatrope Work?

Humatrope is a man-made form of growth hormone. Growth hormone is essential for growth—made by the pituitary gland (located at the base of the brain), then released into the bloodstream, where it travels to the body's tissues. Here it stimulates production of another hormone important for growth, called insulin-like growth factor 1, or IGF-1. Growth hormone works to stimulate growth, in large part due to its effect in producing IGF-1.

Pituitary gland: a pea-sized gland located at the base of the brain that produces a number of very important hormones. The pituitary gland is sometimes called the body’s "master gland" because it controls the production of hormones by many of the glands in the body, including the adrenal glands, thyroid gland, ovaries, and testes.

What Can I Expect?

Although results may be different for everyone, Humatrope has data from clinical studies to help support treatment decisions. Throughout treatment, help your child remember that growth is a gradual process that takes time, even with treatment. Talk with your doctor about setting realistic expectations for your child's treatment, and include your child in the conversation. Helping a child understand what to expect may help them stay motivated to continue therapy.

Where Can I Learn About Safety?

Humatrope underwent studies that assessed safety and tolerability. When prescribing treatment for your child, your doctor is able to carefully consider the results of those studies by reviewing the Prescribing Information for Humatrope. You can also read through the Full Prescribing Information, as well as the Important Safety Information for Humatrope on this site. If you want help in understanding that information, or if you have specific questions about Humatrope safety and tolerability with your child in mind, please discuss them with your doctor.

About Growth

There is a wide range of normal heights during childhood. Click silhouette to see examples* of normal height ranges at different ages.

*Examples use the 3rd and 97th percentiles for US children as the upper and lower limits of the normal range.

2 Years of Age
Boys: About 32.0 to 37.0 inches
Girls: About 31.0 to 36.5 inches
5 Years of Age
For both boys and girls:
About 39.0 to 46.0 inches
10 Years of Age
Boys: About 49.5 to 60.0 inches
Girls: About 49.5 to 59.5 inches
15 Years of Age
Boys: About 61.0 to 72.5 inches
Girls: About 59.0 to 68.5 inches
There is a wide range of normal heights during childhood.

SELECT SAFETY INFORMATION

  • Do not take Humatrope if you are having serious complications after having open heart surgery, abdominal surgery, or serious injuries involving many body systems, or are having life-threatening breathing problems. Deaths have been reported in such cases.

How Is Growth Measured?

Regular, accurate measurements of weight and height are an important part of a child's health care. In infancy, length and weight should be regularly checked at doctor visits. During early childhood, measurements are usually taken about twice each year, and more often if there is anything unusual about a child's growth.

About Growth Charts

Growth Charts

To see if your child is growing normally, your doctor will compare your child's growth to other children of the same age and sex. Growth charts showing the averages and normal ranges for height, weight, weight-to-height ratio, and head size of children at different ages are used to check your child's growth over time.

About Stadiometer

Stadiometer

Throughout a child's school years, it is helpful to collect accurate measurements at least once a year. Among the many ways to measure height and weight, doctors and nurses generally use an instrument called a stadiometer for accurate height measurements.

What Are Growth Disorders?

A growth disorder or condition is a diagnosis your doctor may make to understand or explain why your child isn't growing as normally expected.

Many factors may affect how much and how rapidly a child grows, and how tall he or she will be as an adult. Before diagnosing a child with a growth disorder, a doctor has to rule out other common causes of growth problems, such as poor nutrition, deficiencies of hormones other than growth hormone, and other illnesses.

What Conditions Does Humatrope Treat?

View options

Growth Failure in Children Born Small for Gestational Age (SGA)

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Between 3 & 10 in 100 babies are born smaller than normal for gestational age.
Though most of these children reach normal height, about 1 in 10 remains small.

Humatrope is used to treat children who are short or growing slowly because they were born smaller than normal for the number of weeks of pregnancy and do not catch up in height by 2 to 4 years of age.

For more information, please speak to your healthcare professional.

SELECT SAFETY INFORMATION

  • Do not use Humatrope in children with Prader-Willi syndrome who are severely obese or have a history of blocked upper airways or other severe breathing problems, or sleep apnea. Deaths have been reported in such cases. Humatrope is not approved for the treatment of patients with Prader-Willi syndrome.

Growth Failure in Children With Growth Hormone Deficiency

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Humatrope is used to treat children who are short or growing slowly because they do not make enough growth hormone on their own. Growth hormone deficiency happens when the pituitary gland — a pea-sized gland located at the base of the brain — doesn’t make enough growth hormone.

For more information, please speak to your healthcare professional.

SELECT SAFETY INFORMATION

  • Do not use Humatrope if you have active cancer. 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 Humatrope.

Idiopathic Short Stature (ISS) in Children

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Humatrope is used to treat children with 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 for whom no other cause of short stature can be found.

Children whose growth problem cannot currently be diagnosed may be considered to have ISS, which means short stature with no known cause. Despite the great amount of understanding that pediatric endocrinologists have gained about causes of slow growth and short stature, there are still many factors that affect growth that are not yet fully understood.

For more information, please speak to your healthcare professional.

SELECT SAFETY INFORMATION

  • Serious allergic reactions have been reported with Humatrope. Humatrope is contraindicated if you know you have allergies to growth hormone or any of its ingredients. Tell your doctor if you have an allergic reaction. Do not mix Humatrope with the supplied diluent if you are allergic to metacresol or glycerin.

Short Stature in Girls With Turner Syndrome

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Turner syndrome affects 1 in every 2,000 females and does not affect males.

Humatrope is used to treat girls who are short or growing slowly because they have Turner syndrome.

Turner Syndrome is a genetic condition due to partial or complete absence of one of the sex chromosomes. Short stature is one of the most common features of Turner Syndrome, affecting about 95% of individuals who are diagnosed clinically with the condition. The average height of affected adult women without treatment is about 4 feet, 8 inches.

For more information, please speak to your healthcare professional.

SELECT SAFETY INFORMATION

  • Your doctor should check your blood sugar regularly while you are taking Humatrope, especially if you have diabetes, pre-diabetes, or risk factors for diabetes. New cases of type 2 diabetes have been reported in patients taking Humatrope.

Growth Failure in Children With SHOX Deficiency

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Humatrope is used to treat children who are short or growing slowly because they have SHOX deficiency.

SHOX deficiency occurs as a result of the deletion (removal), mutation (change), or reduced expression of the SHOX gene. SHOX deficiency may be inherited from an affected parent and passed on to children, or may occur unexpectedly in a family with no other affected members.

For more information, please speak to your healthcare professional.

SELECT SAFETY INFORMATION

  • Tell your doctor if you have any visual changes accompanied by headache, nausea, and/or vomiting while taking Humatrope. This may be a sign of increased pressure in the brain.

Growth Hormone Deficiency in Adults

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Humatrope is used to treat adults who have growth hormone deficiency that began either in:

  • Adulthood (as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma); or
  • Childhood. Patients treated for growth hormone deficiency in childhood whose bones have stopped growing should be reevaluated to determine if they should continue growth hormone.

For additional information, please speak to your healthcare professional.

SELECT SAFETY INFORMATION

  • Adults may retain water during Humatrope treatment. This may be brief and may increase with higher doses of Humatrope.

How to Help Your Child With a Growth Issue

Your child can’t wait to grow up, especially when a growth disorder is holding them back. That’s why children with short stature may need extra support and encouragement to help them deal with the challenges of being smaller. Professional counseling may be helpful if children are worried about their height or are being teased by other children. Doctors, other healthcare providers, or patient support groups may be able to provide useful tips.

Ideas to think about:

  • Treat children according to age, not size, and encourage others to do the same
  • Talk with your child about how to handle teasing issues that might occur at school or outside the home
  • Encourage children to participate in sports and other activities they enjoy. Help your child see that small size is not a disadvantage in some activities and may be an advantage in others
  • Provide children with helpful tools to ensure they can reach important things at home, such as bathroom items, clothes, food, dishes, toys, and books
  • Encourage children to talk about their feelings
  • Answer questions as best you can and encourage your child to write down questions you can't answer. Let your child ask the questions at the next doctor's visit — children may feel more in control if they understand what's going on

Disclaimer: The suggestions included are not intended to be medical advice. Families should check with healthcare professionals regarding the emotional health of their children.

Indications and Important Safety Information for Humatrope

Humatrope® (somatropin for injection) is used to treat:

  • Children who do not make enough growth hormone on their own, have short stature associated with Turner syndrome, or have SHOX deficiency; 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 for whom no other cause of short stature can be found; were born smaller than normal for the number of weeks of pregnancy and who do not catch up in height by 2 to 4 years of age.
  • Adults who have growth hormone deficiency that began either in adulthood (as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma) or in childhood. Patients treated for growth hormone deficiency in childhood whose bones have stopped growing should be reevaluated to determine if they should continue growth hormone.

Important Safety Information for Humatrope

What is the most important information I should know about Humatrope?

  • Do not take Humatrope if you are having serious complications after having open heart surgery, abdominal surgery, or serious injuries involving many body systems, or are having life-threatening breathing problems. Deaths have been reported in such cases.
  • Do not use Humatrope in children with Prader-Willi syndrome who are severely obese or have a history of blocked upper airways or other severe breathing problems, or sleep apnea. Deaths have been reported in such cases. Humatrope is not approved for the treatment of patients with Prader-Willi syndrome.
  • Do not use Humatrope if you have active cancer. 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 Humatrope.
  • Serious allergic reactions have been reported with Humatrope. Humatrope is contraindicated if you know you have allergies to growth hormone or any of its ingredients. Tell your doctor if you have an allergic reaction. Do not mix Humatrope with the supplied diluent if you are allergic to metacresol or glycerin.
  • Your doctor should check your blood sugar regularly while you are taking Humatrope, especially if you have diabetes, pre-diabetes, or risk factors for diabetes. New cases of type 2 diabetes have been reported in patients taking Humatrope.
  • Tell your doctor if you have any visual changes accompanied by headache, nausea, and/or vomiting while taking Humatrope. This may be a sign of increased pressure in the brain.
  • Adults may retain water during Humatrope treatment. This may be brief and may increase with higher doses of Humatrope.
  • If you have hypoadrenalism and are on glucocorticoid replacement therapy, your doctor may increase your dosage when you initiate growth hormone treatment.
  • Your doctor should test your thyroid function periodically during Humatrope therapy. Thyroid hormone treatment may need to be started or adjusted.
  • Fracture in the ball of the hip joint can occur in children who have endocrine problems and in children who have rapid growth. Any child taking Humatrope who develops a limp or complains of hip or knee pain should be seen by a doctor to check for this.
  • Progression of curvature of the spine (scoliosis) can occur in children who have rapid growth. Humatrope has not been shown to increase the occurrence of this condition. If the child has scoliosis, the doctor should carefully monitor the progression of the scoliosis during Humatrope treatment.
  • Cases of pancreatitis (inflammation of the pancreas) have been reported rarely in children and adults receiving growth hormone. Consult a doctor if you develop abdominal pain while taking Humatrope.
  • You should rotate your injection sites to avoid breakdown of skin and fat. Seek prompt medical attention for any allergic reaction you experience to the injection of Humatrope.

Who should not take Humatrope?

Humatrope should not be used by:

  • People with serious complications after having open heart surgery, abdominal surgery, serious injuries involving many body systems, or with life-threatening breathing problems
  • Children with Prader-Willi syndrome who are severely obese or have a history of severe breathing problems
  • People with active cancer
  • People who have had an allergic reaction to growth hormone
  • People with diabetic disease of the retina (the lining in the back of the eyeball)
  • Children who have closed growth plates in their bones

What should I tell my doctor before taking Humatrope?

Tell your doctor about all of your prescription and over the counter drugs, including cyclosporine, hormone replacement therapy, insulin or other diabetes medications, drugs containing steroids, or drugs for seizures. These medications may need to be adjusted while taking Humatrope.

What are the possible side effects of Humatrope?

Common side effects reported in adults and children taking Humatrope include injection site reactions, allergic reactions to the diluent, and hypothyroidism. Additional common side effects in adults include swelling, joint pain, muscle pain, carpal tunnel syndrome, unusual skin sensations, and high blood sugar. You are encouraged to report negative side effects of prescription drugs to the Food and Drug Administration (FDA). Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

How should I store Humatrope?

Humatrope must be kept refrigerated (36° to 46°F [2° to 8°C]) before and after it is mixed. Do not freeze. Once Humatrope has been mixed and is in liquid form, cartridges must be used within 28 days and vials must be used within 14 days. Throw away any unused Humatrope in a cartridge after 28 days and in a vial after 14 days. Before giving an injection, check the manufacturer’s expiration date on the cartridge or vial. Do not use the cartridge or vial if it has expired.

Humatrope is available by prescription only.

Click to access Patient Information-Cartridge, Patient Information-Vial, and Full Prescribing Information.

See Full Pen User Manual that accompanies the HumatroPen® 6 mg, 12 mg, and 24 mg.

HG CON ISI 14OCT2016