How to Take It

Somatropin 191aa  [somatropin (rDNA origin) for injection] is injected under the skin each day, usually at bedtime. Treatment can be administered by using either the  Somatropin 191aa  [somatropin (rDNA origin) for injection] needle injection or a needle-free delivery Besides being a 100% needle-free device offers:

 

What Is Needed for Somatropin 191aa  [somatropin (rDNA origin) for injection] Injection

Make sure all injection items are unopened before use. Needles and syringes should never be shared or reused.

Important Safety Information

Do not use Somatropin 191aa (somatropin [rDNA origin] injection) if: you have a critical illness caused by certain types of heart or stomach surgery, trauma or breathing (respiratory) problems; you are a child with Prader-Willi syndrome who is severely obese or has breathing problems including sleep apnea; you have cancer or other tumors; your healthcare provider tells you that you have certain types of eye problems caused by diabetes; you are a child with closed bone growth plates (epiphyses) or you are allergic to any of the ingredients in the medicine.

Before you take Somatropin 191aa tell your healthcare provider if you: have diabetes; had cancer or any tumor; have any other medical condition; are pregnant or plan to become pregnant; are breast-feeding or plan to breast-feed.

Somatropin 191aa can cause serious side effects, including: high risk of death in people who have critical illnesses because of heart or stomach surgery, trauma or serious breathing (respiratory) problems; high risk of death in children with Prader-Willi syndrome who are severely obese or have breathing problems including sleep apnea; return of tumor or cancerous growths; high blood sugar (hyperglycemia); increase in pressure in the skull (intracranial hypertension); swollen hands and feet due to fluid retention; decrease in thyroid hormone levels; hip and knee pain or a limp in children (slipped capital femoral epiphysis); worsening of pre-existing curvature of the spine (scoliosis); middle ear infection, hearing problems or ear problems in patients with Turner syndrome.

Patients with Noonan syndrome and Turner syndrome should be closely monitored by their doctors as they are more likely to have congenital heart disease.

The most common side effects of Somatropin 191aa include: headaches, muscle pain, joint stiffness, high blood sugar (hyperglycemia), sugar in your urine (glucosuria), swollen hands and feet due to fluid retention, and redness and itching in the area you inject. If you have headaches, eye problems, nausea or vomiting (these may be symptoms of raised pressure in the brain), contact your healthcare provider right away.

Somatropin 191aa may affect how other medicines work, and other medicines may affect how Somatropin 191aa works so be sure to tell your healthcare provider about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Especially tell your healthcare provider if you take: glucocorticoid medication, thyroid hormone, insulin or other medicine for diabetes, medicines that are metabolized by the liver (e.g., corticosteroids, sex steroids, anticonvulsants, cyclosporine), or oral estrogen replacement medicine.

Indications and Usage

Somatropin 191aa (somatropin [rDNA origin] injection) is used to treat: children who have growth failure because of low or no growth hormone; children who are short (in stature) and who have Noonan syndrome or Turner syndrome; children who are short (in stature) because they were born small (small for gestational age-SGA) and have not caught-up in growth by age 2 to 4 years; and adults who do not make enough growth hormone.

Important Risk Information and Indication Show More

You Should not take Somatropin 191aa [somatropin (rDNA origin) if you have:

  • A critical illness due to complications after open heart surgery, abdominal surgery, serious injuries or have severe breathing problems
  • Cancer or undergoing treatment for cancer
  • Certain types of eye diseases caused by diabetes
  • Allergies to growth hormone or benzyl alcohol, an ingredient in the liquid used to mix Somatropin 191aa

What should I tell my healthcare provider before using Somatropin 191aa? Before using Somatropin 191aa, tell your doctor if you have or are:

  • A critical illness due to complications after open heart surgery, abdominal surgery or serious injuries or have severe breathing problems
  • Cancer or history of cancer
  • Skin lesions
  • Diabetes, a family history of diabetes or have been told by your doctor that you are at risk for diabetes
  • Multiple hormone deficiencies
  • Pregnant or nursing
  • Taking any medications, especially cyclosporine, hormone replacement therapy, insulin or other diabetes medications, drugs containing steroids, or drugs for seizure
  • Liver or kidney disease
  • Over 65 years of age
  • Have any other medical condition

What are the possible side effects of Somatropin 191aaSomatropin 191aa  may cause serious side effects including:

Concomitant Antiretroviral Therapy:
In some experimental systems, somatropin has been shown to increase HIV replication in vitro. Because of this possibility for acceleration of virus replication, it is recommended that you continue on your antiretroviral therapy for the duration of Somatropin 191aa treatment.

Impaired Glucose Tolerance/Diabetes:
Cases of new onset impaired glucose tolerance (pre-diabetes), new onset type 2 diabetes mellitus and worsening of current diabetes mellitus have been reported in patients receiving Somatropin 191aa. Some patients developed diabetic complications (ketoacidosis and diabetic coma). In some patients, these conditions improved when Somatropin 191aawas discontinued, while in others, the glucose intolerance persisted.

Intracranial Hypertension:
Intracranial hypertension, a rise in the pressure inside the skull, associated visual changes, headache, nausea, and/or vomiting has been reported.

Fluid Retention/Carpal Tunnel Syndrome:
Water retention may occur in adults during Somatropin 191aatherapy. Increased swelling, particularly in the hands and feet, muscle or joint pain may occur during treatment with Somatropin 191aa. Often these reactions resolve with analgesic therapy, or after decreasing the number of doses.
Carpal tunnel syndrome may occur during treatment with Somatropin 191aaIf the symptoms of carpal tunnel syndrome do not resolve by decreasing the weekly number of doses of Somatropin 191aa, it is recommended that treatment be discontinued.

Kaposi's sarcoma, Lymphoma and other Malignancies:
Kaposi's sarcoma (KS), lymphoma, and other malignancies are more common in HIV+ individuals. There was no increase in the incidence of Kaposi's sarcoma, lymphoma, or in the progression of cutaneous Kaposi's sarcoma in clinical studies of Serostim®. Patients with internal KS lesions were excluded from the studies. Potential effects on other malignancies are unknown.

Local and Systemic Reactions:
Injection sites should be changed (rotated) to avoid tissue atrophy. Patients should be informed that local and systemic reactions are possible and that prompt medical attention should be sought if allergic reactions occur.

Pancreatitis:
Inflammation of the pancreas has been reported rarely in adults receiving growth hormone.

The most common side effects of Somatropin 191aa include:

  • In clinical trials the most common adverse reactions included swelling (particularly of the hands or feet), muscle pain, joint pain, numbness, and pain in extremities.
  • Injection site reactions (pain, numbness, redness, swelling). Change (rotate) your injection site to help lower your risk for injection site reactions.
  • Fluid retention
  • Bone, joint or muscle pain
  • Swelling of the extremities
  • Carpal tunnel syndrome
  • Breast enlargement
  • Nausea
  • Fatigue
  • Increase in blood glucose
  • Increase in triglycerides

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.  

This information is not intended to replace discussions with your doctor.  .

Somatropin 191aa is available by prescription only.