GROWTHHORMONE (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
Note: | For quick reference, the following growth hormones are numbered tomatch the corresponding brand names. |
| This information applies to the following medicines: |
| 1. | Somatrem (SOE-ma-trem) |
| 2. | Somatropin, Recombinant (soe-ma-TROE-pin, re-KOM-bi-nant) |
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 necessaryto stimulate growth in children. Man-made growth hormone may be used in childrenwho have certain conditions that cause failure to grow normally. These conditionsinclude growth hormone deficiency (inability to produce enough growth hormone),kidney disease, Prader-Willi Syndrome (PWS), and Turner's syndrome. Growthhormone is also used in adults to treat growth failure and to treat weightloss caused by acquired immunodeficiency syndrome (AIDS).
This medicine is available only with your doctor's prescription, in thefollowing 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 willdo. 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 orallergic reaction to growth hormone. Also tell your health care professionalif 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 birthdefects or other problems. This drug should be used during pregnancy onlyif clearly needed. Tell your doctor if you are pregnant or plan on becomingpregnant.
Breast-feeding?It is not known whether growth hormone passes intobreast milk. However, you should tell your doctor if you are nursing.
Children?There is no specific information comparing use ofgrowth hormone in children with acquired immunodeficiency syndrome (AIDS)with use in other age groups.
Older adults?Many medicines have not been studied specificallyin older people. Therefore, it may not be known whether they work exactlythe same way they do in younger adults. Although there is no specific informationcomparing 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 peoplethan it does in younger adults. However, elderly patients may be more sensitiveto the action of growth hormone drugs and may be more at risk to develop adversereactions.
Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. When you are takinggrowth hormone, it is especially important that your health care professionalknow if you are taking any of the following:
- Corticosteroids (cortisone-like medicines)?These medicinescan interfere with the effects of growth hormone
Other medical problems?The presence of other medicalproblems may affect the use of growth hormone. Make sure you tell your doctorif you have any other medical problems, especially:
- Acute critical illnesses (e.g., complications following open heartor abdominal surgery, accidental trauma, or respiratory failure)?Growthhormone use has not been studied in patients with these serious illnesses.Your doctor will weigh the benefits and risks before starting you on thismedicine.
- Brain tumor?Growth hormone should not be used in patients whohave a brain tumor that is still growing
- Diabetes mellitus (sugar diabetes) or a family history of diabetesmellitus?Growth hormone may prevent insulin from working as well asit should; your doctor may have to change your dose of insulin
- Diabetic retinopathy (inflammation of the retina in diabetic patients)?Growthhormone should not be used in these patients.
- Prader-Willi syndrome [a rare genetic disorder]?Certain patientswith this rare genetic disorder may be at increased risk for side effectsfrom growth hormone therapy. You and your doctor will decide if growth hormoneis right for you.
- Tumors?If you already have a tumor, your doctor should treatyou for it before beginning this medicine. If the tumor comes back, growthhormone medicine should be stopped.
- Underactive thyroid?This condition can interfere with the effectsof growth hormone
Proper Use of This Medicine
Some medicinesgiven by injection may sometimes be given at home to patients who do not needto be in the hospital. If you are using this medicine at home, your healthcare professional will teach you how to prepare and inject the medicine. Youwill have a chance to practice preparing and injecting it. Be certain that you understand exactly how the medicine is to be preparedand 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 yourdoctor about the careful selection and rotation of injection sites on yourbody. This will help to prevent skin problems.
Put used needles and syringes in a puncture-resistantdisposable container or dispose of them as directed by your healthcare professional. Do not reuse needles and syringes.
Dosing?The dose of these medicines will be differentfor different patients. Follow your doctor's orders orthe directions on the label. The following information includes onlythe average doses of these medicines. If your dose isdifferent, 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 determinedby 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 dosesand usually is injected under the skin, but may be injected into a muscleas 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 determinedby 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?Doseis based on body weight and must be determined by your doctor. At first, itis usually 0.004 milligram (mg) per kilogram (kg) (0.0002 mg per pound) ofbody weight injected under the skin once a day. Your doctor may then increasethe dose if needed. The dose is given using a NordiPen injection device forNorditropin cartridges and a prefilled pen for Norditropin NordiFlex.
- Children?Dose is based on body weight and must be determinedby your doctor. The usual total weekly dose is 0.16 to 0.3 mg per kg (0.073to 0.136 mg per pound) of body weight. This is divided into smaller dosesand usually is injected under the skin, but may be injected into a muscleas determined by your doctor.
- Children using Norditropin Cartridges or Norditropin NordiFlex?Doseis based on body weight and must be determined by your doctor. The usual doseis 0.024 to 0.034 mg per kg (0.011 to 0.015 mg per pound of body weight) injectedunder the skin, on 6 to 7 days a week. The dose is given using a NordiPeninjection device for Norditropin cartridges and a prefilled pen for NorditropinNordiFlex.
- For treatment of growth failure caused by kidney disease:
- Children?Dose is based on body weight and must be determinedby your doctor. The usual total weekly dose is 0.35 mg per kg (0.16 mg perpound) of body weight. This is divided into smaller daily doses and is injectedunder 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 determinedby your doctor. The usual total weekly dose is 0.375 mg per kg (0.17 mg perpound) of body weight. This is divided into smaller doses and is injectedunder the skin.
- For treatment of growth failure caused by Prader-Willi syndrome:
- Children?Dose is based on body weight and must be determinedby your doctor. The usual total weekly dose is 0.24 mg per kg (0.11 mg perpound) of body weight. This is divided into 6 or 7 smaller doses over thecourse of the week and is injected under the skin.
- For treatment of weight loss caused by acquired immunodeficiencydisease (AIDS):
- Adults weighing more than 121 pounds (55 kg)?6 mg injectedunder the skin once a day at bedtime.
- Adults weighing 99 to 121 pounds (45 to 55 kg)?5 mg injectedunder the skin once a day at bedtime.
- Adults weighing 77 to 98 pounds (35 to 44 kg)?4 mg injectedunder the skin once a day at bedtime.
- Adults weighing less than 77 pounds (35 kg)?Dose is based onbody weight and must be determined by your doctor. It is usually 0.1 mg perkg (0.045 mg per pound) of body weight injected under the skin once a dayat 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 orthe manufacturer.
- Do not keep outdated medicine or medicine no longer needed. Be surethat 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 regularvisits.
Side Effects of This Medicine
Leukemia has been reportedin a few patients after treatment with growth hormone. However, it is notdefinitely known whether the leukemia was caused by the growth hormone. Leukemiahas also been reported in patients whose bodies do not make enough growthhormone 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, whodo not need growth hormone, serious unwanted effects may occur because levelsin the body become too high. These effects include the development of diabetes;abnormal growth of bones and internal organs such as the heart, kidneys, andliver; atherosclerosis (hardening of the arteries); and hypertension (highblood 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 mayneed medical attention. Check with your doctor as soon as possible if anyof the following side effects occur:
More common
Abnormal or decreased touch sensation; blurred vision; burning, crawling, itching, numbness,prickling, "pins and needles", or tingling feelings; dizziness; ear infection or other ear problems (inpatients with Turner's syndrome); nervousness; pounding in the ears; severe headache; slow or fast heartbeat
Other side effects may occur that usually do not need medicalattention. These side effects may go away during treatment as your body adjuststo the medicine. However, check with your doctor if any of the following sideeffects continue or are bothersome:
Less common or rare
Carpal tunnel syndrome; discouragement; enlargement of breasts; feeling sad or empty; increased growth of birthmarks; irritability; joint pain; loss of interest or pleasure; muscle pain, cramps, or stiffness; skeletal pain; sleepiness; swelling ofhands, feet, or lower legs; trouble concentrating; unable to sleep; unusualtiredness or weakness
Other side effects not listed above may also occur in some patients. Ifyou notice any other effects, check with your doctor.
Revised: 01/24/2005
