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.
Before Using
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
There is no specific information comparing use of growth hormone in children with acquired immunodeficiency syndrome (AIDS) with use in other age groups.
Geriatric
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.
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.
Breastfeeding
It is not known whether growth hormone passes into breast milk. However, you should tell your doctor if you are nursing.
Drug Interactions
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 any of these medicines, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using medicines in this class with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Acarbose
- Albiglutide
- Alclometasone
- Alogliptin
- Amcinonide
- Balofloxacin
- Beclomethasone
- Besifloxacin
- Betamethasone
- Budesonide
- Bupropion
- Canagliflozin
- Chlorotrianisene
- Chlorpropamide
- Ciclesonide
- Ciprofloxacin
- Clobetasol
- Clobetasone
- Clocortolone
- Conjugated Estrogens
- Conjugated Estrogens Synthetic A
- Conjugated Estrogens Synthetic B
- Cortisone
- Dapagliflozin
- Deflazacort
- Desonide
- Desoximetasone
- Dexamethasone
- Dienestrol
- Diethylstilbestrol
- Diflorasone
- Diflucortolone
- Difluprednate
- Dulaglutide
- Empagliflozin
- Enoxacin
- Ertugliflozin
- Esterified Estrogens
- Estradiol
- Estramustine
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of medicines in this class. 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
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 medicines in this class 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.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
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 treatment of growth failure caused by growth hormone deficiency:
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.
- For treatment of growth failure caused by growth hormone deficiency:
Storage
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Store at temperature directed by your health care professional or the manufacturer.
Side Effects
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).
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:
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 (in patients with Turner's syndrome)
- nervousness
- pounding in the ears
- severe headache
- slow or fast heartbeat
Less common
- Chest pain
Rare
- Abdominal pain or bloating
- changes in vision
- depression of skin at place of injection
- headache
- limp
- nausea and vomiting
- pain and swelling at place of injection
- pain in hip or knee
- skin rash or itching
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Back pain
- chills
- cough or cough producing mucus
- constipation
- depressed mood
- diarrhea
- difficulty in breathing
- difficulty in moving
- dizziness
- dry skin and hair
- ear congestion
- feeling cold
- fever
- general feeling of discomfort or illness
- hair loss
- hoarseness or husky voice
- loss of appetite
- loss of voice
- runny nose
- shivering
- shortness of breath
- sore throat
- slowed heartbeat
- sneezing
- stuffy nose
- sweating
- swollen joints
- tightness in chest
- trouble sleeping
- weight gain
- wheezing
Less common or rare
- Carpal tunnel syndrome
- 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 of hands, feet, or lower legs
- trouble concentrating
- unable to sleep
- unusual tiredness or weakness
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
CON-XXXXXXXX
