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|Somatropin, Recombinant

GROWTH HORMONE (Systemic)

Some commonly used brand names are:

In the U.S.—

• Genotropin ²
• Genotropin Miniquick ²
• Humatrope ²
• Norditropin cartridges ²
• Norditropin NordiFlex ²
• Nutropin ²
• Nutropin AQ ²
• Protropin ¹
• Saizen ²
• Serostim ²

In Canada—

• Humatrope ²
• Nutropin ²
• Nutropin AQ ²
• Protropin ¹
• Saizen ²
• Serostim ²

Category

• Growth hormone—Somatrem; Somatropin

Description

Somatrem and somatropin are man-made versions of human growth hormone. Growth hormone is naturally produced by the pituitary gland and is necessary to stimulate growth in children. Man-made growth hormone may be used in children who have certain conditions that cause failure to grow normally. These conditions include growth hormone deficiency (inability to produce enough growth hormone), kidney disease, Prader-Willi Syndrome (PWS), and Turner"s syndrome. Growth hormone is also used in adults to treat growth failure and to treat weight loss caused by acquired immunodeficiency syndrome (AIDS).

This medicine is available only with your doctor"s prescription, in the following dosage forms:

• Parenteral
• Somatrem
  • Injection (U.S. and Canada)
• Somatropin, Recombinant
  • Injection (U.S. and Canada)

Before Using This Medicine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For growth hormone, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to growth hormone. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives (especially benzyl alcohol), or dyes.

Pregnancy—Growth hormone has not been studied in pregnant women. However, in animal studies, growth hormone has not been shown to cause birth defects or other problems. This drug should be used during pregnancy only if clearly needed. Tell your doctor if you are pregnant or plan on becoming pregnant.

Breast-feeding—It is not known whether growth hormone passes into breast milk. However, you should tell your doctor if you are nursing.

Children—There is no specific information comparing use of growth hormone in children with acquired immunodeficiency syndrome (AIDS) with use in other age groups.

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of growth hormone in the elderly with use in other age groups, it is not expected to cause different side effects or problems in older people than it does in younger adults. However, elderly patients may be more sensitive to the action of growth hormone drugs and may be more at risk to develop adverse reactions.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking growth hormone, it is especially important that your health care professional know if you are taking any of the following:

• Corticosteroids (cortisone-like medicines)—These medicines can interfere with the effects of growth hormone

Other medical problems—The presence of other medical problems may affect the use of growth hormone. Make sure you tell your doctor if you have any other medical problems, especially:

• Acute critical illnesses (e.g., complications following open heart or abdominal surgery, accidental trauma, or respiratory failure)—Growth hormone use has not been studied in patients with these serious illnesses. Your doctor will weigh the benefits and risks before starting you on this medicine.
• Brain tumor—Growth hormone should not be used in patients who have a brain tumor that is still growing
• Diabetes mellitus (sugar diabetes) or a family history of diabetes mellitus—Growth hormone may prevent insulin from working as well as it should; your doctor may have to change your dose of insulin
• Diabetic retinopathy (inflammation of the retina in diabetic patients)—Growth hormone should not be used in these patients.
• Prader-Willi syndrome [a rare genetic disorder]—Certain patients with this rare genetic disorder may be at increased risk for side effects from growth hormone therapy. You and your doctor will decide if growth hormone is right for you.
• Tumors—If you already have a tumor, your doctor should treat you for it before beginning this medicine. If the tumor comes back, growth hormone medicine should be stopped.
• Underactive thyroid—This condition can interfere with the effects of growth hormone

Proper Use of This Medicine

Some medicines given by injection may sometimes be given at home to patients who do not need to be in the hospital. If you are using this medicine at home, your health care professional will teach you how to prepare and inject the medicine. You will have a chance to practice preparing and injecting it. Be certain that you understand exactly how the medicine is to be prepared and injected .

It is important to read the patient information and instructions for use, if provided with your medicine, each time your prescription is filled.

It is important to follow any instructions from your doctor about the careful selection and rotation of injection sites on your body . This will help to prevent skin problems.

Put used needles and syringes in a puncture-resistant disposable container or dispose of them as directed by your health care professional. Do not reuse needles and syringes .

Dosing—The dose of these medicines will be different for different patients. Follow your doctor"s orders or the directions on the label . The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.

• For somatrem
• For injection dosage form:
  • For treatment of growth failure caused by growth hormone deficiency:
    • Children—Dose is based on body weight and must be determined by your doctor. The usual total weekly dose is 0.3 milligram (mg) per kilogram (kg) (0.136 mg per pound) of body weight. This is divided into smaller doses and usually is injected under the skin, but may be injected into a muscle as determined by your doctor.

• For somatropin
• For injection dosage form:
  • For treatment of growth failure caused by growth hormone deficiency:
    • Adults—Dose is based on body weight and must be determined by your doctor. At first, it is usually 0.005 milligram (mg) per kilogram (kg) (0.0023 mg per pound) of body weight injected under the skin once a day. Your doctor may then increase the dose if needed.
    • Adults using Norditropin Cartridges or Norditropin NordiFlex—Dose is based on body weight and must be determined by your doctor. At first, it is usually 0.004 milligram (mg) per kilogram (kg) (0.0002 mg per pound) of body weight injected under the skin once a day. Your doctor may then increase the dose if needed. The dose is given using a NordiPen injection device for Norditropin cartridges and a prefilled pen for Norditropin NordiFlex.
    • Children—Dose is based on body weight and must be determined by your doctor. The usual total weekly dose is 0.16 to 0.3 mg per kg (0.073 to 0.136 mg per pound) of body weight. This is divided into smaller doses and usually is injected under the skin, but may be injected into a muscle as determined by your doctor.
    • Children using Norditropin Cartridges or Norditropin NordiFlex—Dose is based on body weight and must be determined by your doctor. The usual dose is 0.024 to 0.034 mg per kg (0.011 to 0.015 mg per pound of body weight) injected under the skin, on 6 to 7 days a week. The dose is given using a NordiPen injection device for Norditropin cartridges and a prefilled pen for Norditropin NordiFlex.
  • For treatment of growth failure caused by kidney disease:
    • Children—Dose is based on body weight and must be determined by your doctor. The usual total weekly dose is 0.35 mg per kg (0.16 mg per pound) of body weight. This is divided into smaller daily doses and is injected under the skin or into a muscle.
  • For treatment of growth failure caused by Turner"s syndrome:
    • Children—Dose is based on body weight and must be determined by your doctor. The usual total weekly dose is 0.375 mg per kg (0.17 mg per pound) of body weight. This is divided into smaller doses and is injected under the skin.
  • For treatment of growth failure caused by Prader-Willi syndrome:
    • Children—Dose is based on body weight and must be determined by your doctor. The usual total weekly dose is 0.24 mg per kg (0.11 mg per pound) of body weight. This is divided into 6 or 7 smaller doses over the course of the week and is injected under the skin.
  • For treatment of weight loss caused by acquired immunodeficiency disease (AIDS):
    • Adults weighing more than 121 pounds (55 kg)—6 mg injected under the skin once a day at bedtime.
    • Adults weighing 99 to 121 pounds (45 to 55 kg)—5 mg injected under the skin once a day at bedtime.
    • Adults weighing 77 to 98 pounds (35 to 44 kg)—4 mg injected under the skin once a day at bedtime.
    • Adults weighing less than 77 pounds (35 kg)—Dose is based on body weight and must be determined by your doctor. It is usually 0.1 mg per kg (0.045 mg per pound) of body weight injected under the skin once a day at bedtime.
    • Children—Use and dose must be determined by your doctor.

Storage—To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Store at temperature directed by your health care professional or the manufacturer.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

It is important that your doctor check your progress at regular visits .

Side Effects of This Medicine

Leukemia has been reported in a few patients after treatment with growth hormone. However, it is not definitely known whether the leukemia was caused by the growth hormone. Leukemia has also been reported in patients whose bodies do not make enough growth hormone and who have not yet been treated with man-made growth hormone. However, discuss this possible effect with your doctor.

If growth hormone is given to children or adults with normal growth, who do not need growth hormone, serious unwanted effects may occur because levels in the body become too high. These effects include the development of diabetes; abnormal growth of bones and internal organs such as the heart, kidneys, and liver; atherosclerosis (hardening of the arteries); and hypertension (high blood pressure).

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention. Check with your doctor as soon as possible if any of the following side effects occur:

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Revised: 01/24/2005

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