What to Expect

Setting expectations about growing.

While we can’t see into the future or provide answers that are specific to your child, we can give you a general idea of what others have experienced, which can help you set reasonable expectations for therapy with Somatropin 191aa (somatropin [rDNA origin] injection).

When to look for growth.

You should understand that Somatropin 191aa takes time to work—the regimen of daily injections usually lasts several years—so it’s not realistic to expect that your child will begin to grow immediately. It can take as long as six months before you begin to see growth. The greatest results usually do appear within the first year of therapy, though, so don’t get discouraged.

Age plays an important part. In studies, patients who begin therapy at a younger age tend to see more catch-up growth, so early diagnosis is important, and treatment should be started when appropriate and determined by your health care provider.

Talk to Your Child: Make sure your child knows what to expect. This could help avoid disappointment about the time it takes to see the benefits of growth hormone, and might smooth the path for future injections. You may want to set up a special day, perhaps once a quarter, to measure your child. Growth will be easier to identify this way than by measuring more frequently.

How much growth to expect.

The amount your child will grow while taking Somatropin 191aa depends on many factors, including his or her “target height,” which is based on the parents’ height. Your health care practitioner has a formula with which to determine your child’s target height. Some studies have shown that the earlier a patient starts, the better the response to treatment.

Target Height: Talk to your child about the target height. Realistic expectations might increase a child’s confidence in the way the treatment is working. It can also be valuable to discuss the target height and what to expect with other family members, especially relatives who may see the child less frequently and may be likely to comment on growth.

 

How long treatment will last.

As with how much growth can be expected, how long a person should take Somatropin 191aa depends on factors specific to each patient. Not everyone stays on growth hormone therapy for the same length of time. Your doctor can best answer this question for you. It is important that patients don’t stop taking growth hormone until the doctor says it is time to stop.

Good Patient Award: Marking progress is important to many patients, and often especially to children. It’s important not to tie progress to growth, however, as each child grows at an individual pace. Instead, you can focus on your child’s success with injections or simply on the length of the treatment. You might consider giving a “good patient” award after a month of injections, for example. Parents’ attitudes toward the therapy are key to influencing how children view it.

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.