What Is Humatrope?

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

Since that time, Humatrope has also been approved for the treatment of several additional growth disorders (idiopathic short stature, Turner syndrome, small for gestational age, SHOX deficiency) and for growth hormone deficiency in adults.

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.

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

Humatrope is available in 6 mg, 12 mg, and 24 mg cartridges.

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.
  • 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.

What Conditions Does Humatrope Treat?

Growth Failure in Children Born Small for Gestational Age (SGA)
Between 3 and 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. Between 3 and 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. Between 3 and 10 in every 100 babies are born smaller than normal. This is called being born "small for gestational age." Most of these children catch up to the normal height range in the first few years of life. However, about 1 in 10 who are born small for gestational age remain small.

Children born SGA who don't catch up in height by about the age of 4 are typically shorter than other kids their age, and may be fairly thin. Humatrope is indicated to treat only the short stature associated with this condition.

For additional information, please speak to your healthcare professional.

SELECT SAFETY INFORMATION

  • If you have hypoadrenalism and are on glucocorticoid replacement therapy, your doctor may increase your dosage when you initiate growth hormone treatment.
Growth Failure in Children With Growth Hormone Deficiency

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 occurs when the pituitary gland — a small pea-sized gland located at the base of the brain — produces an inadequate amount of growth hormone.

This deficiency in growth hormone typically results in a slower rate of growth (growth failure) and may cause other symptoms as well. Humatrope is indicated to treat only the growth failure associated with growth hormone deficiency.

What causes growth hormone deficiency?

There are a number of possible reasons for reduced growth hormone production in childhood. There may have been altered formation of the hypothalamus (the region of the brain that controls the pituitary gland) or the pituitary gland itself before birth. In most cases, the cause of growth hormone deficiency in children is not known.

Head injuries, brain tumors, and brain damage due to disease, trauma, or radiation therapy can also cause reduced functioning of the pituitary gland. Various tests may help to identify the cause of deficiencies in pituitary function.

For additional information, please speak to your healthcare professional.

SELECT SAFETY INFORMATION

  • Your doctor should test your thyroid function periodically during Humatrope therapy. Thyroid hormone treatment may need to be started or adjusted.
Idiopathic Short Stature (ISS) in Children

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.

While tests can determine the cause of the growth problem in some children, for other children, no clear cause for the growth problem can be found using the techniques available today. Scientists are working to better understand the growth process and the problems that can occur, and in time, they may learn the cause of the reduced growth in many more children with ISS.

How is ISS diagnosed?

If you or your child's pediatrician has a concern about your child's growth, your child likely will be referred to a pediatric endocrinologist, a doctor who is trained to evaluate hormone problems in childhood. Some of the most common problems that these specialists see in their offices and clinics are related to growth and physical development — too slow, too fast, too little, too much — and these doctors are experts in evaluating such problems. The following diagram demonstrates an approach that a doctor may use to diagnose ISS.

AN APPROACH TO EVALUATION OF SHORT STATURE
Ask your doctor about the steps taken to evaluate short stature Ask your doctor about the steps taken to evaluate short stature

For additional information, please speak to your healthcare professional.

SELECT SAFETY INFORMATION

  • 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.
Short Stature in Children With Turner Syndrome
Turner Syndrome affects 1 in every 2,000 females and does not affect males.

Humatrope is used to treat children 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. It affects about 1 in every 2,000 females and does not affect males.

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.

Some girls with Turner syndrome do not have any obvious signs of the condition, other than short stature. Although there are several characteristics that may be present in patients who have Turner syndrome, Humatrope is indicated to treat only the short stature associated with this condition.

For additional information, please speak to your healthcare professional.

SELECT SAFETY INFORMATION

  • 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.
Growth Failure in Children With SHOX Deficiency

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

SHOX deficiency occurs as a result of deletion, mutation, 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.

What is the SHOX gene?

SHOX is an abbreviation for the short stature homeobox-containing gene. Two functional copies of the SHOX gene are required for normal growth.

What is SHOX deficiency?

  • SHOX deficiency occurs as a result of deletion, mutation, or reduced expression of the SHOX gene.
  • SHOX deficiency may be inherited from an affected parent or may occur in a child who has no other affected family members.

Although there are several characteristics that may be present in children who have SHOX deficiency, many of these children do not have any obvious signs of the condition, other than short stature. Humatrope is indicated to treat only the short stature associated with this condition.

For additional information, please speak to your healthcare professional.

SELECT SAFETY INFORMATION

  • 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.
Growth Hormone Deficiency in Adults

Adults who do not produce enough growth hormone from their pituitary gland have growth hormone deficiency. This deficiency may have been present since childhood (childhood-onset growth hormone deficiency) or may have started during adulthood (adult-onset growth hormone deficiency). 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.

What is growth hormone deficiency in adults?

Adults who do not produce enough growth hormone from their pituitary gland — the pea-sized gland at the base of the brain that produces a number of important hormones — have a condition called adult growth hormone deficiency. There are 2 main types of growth hormone deficiency in adults: growth hormone deficiency that begins in childhood and continues into adulthood after growth in height has finished (known as childhood-onset deficiency) and growth hormone deficiency that begins in adulthood in a person who was healthy during childhood (known as adult-onset deficiency).

What are some of the causes of growth hormone deficiency in adults?

Some causes of childhood-onset growth hormone deficiency that continues into adulthood include genetic conditions, incomplete development of the pituitary gland, tumors around the pituitary gland or elsewhere in the brain, and surgery or radiation treatment of the brain. In addition, some cases of growth hormone deficiency that last from childhood into adulthood have no clear cause.

The most common cause of growth hormone deficiency that starts in adulthood in an individual who was healthy as a child is a non-cancerous tumor of the pituitary gland called an adenoma. Either the tumor itself, or treatment for the tumor, may result in deficiencies of growth hormone and other hormones normally made by the pituitary gland. Other causes of adult-onset growth hormone deficiency include tumors elsewhere in the brain, head injury, brain hemorrhage, inflammation, and a number of less common conditions.

When more than one pituitary hormone is deficient (in patients whose condition began either in childhood or adulthood), the condition is called hypopituitarism. Deficiencies of other pituitary hormones may affect the function of other glands in the body, including the thyroid gland, adrenal glands, and testes or ovaries. Humatrope is approved to treat only growth hormone deficiency in adults; other hormone deficiencies that may be present in patients with hypopituitarism require specific therapies as determined by the treating physician.

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.
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.
See Full Pen User Manual that accompanies the HumatroPen® 6 mg, 12 mg, and 24 mg.
HG CON ISI 14OCT2016