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Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication. Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health.

These factors may affect how you should use this medication. Cancer: There is an increased risk of tumour growth, both cancerous and non-cancerous, when growth hormone is used by survivors of childhood cancer.

Discuss any concerns you may have with your doctor. Diabetes: Somatropin may cause an increase in blood sugar levels and glucose tolerance may change. If you have diabetes, you may find it necessary to monitor your blood sugar more frequently while using this medication.

If you have diabetes or are at risk for developing diabetes, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Hypothyroidism low level of thyroid hormone : If you have uncontrolled hypothyroidism, treatment with somatropin may not work as well as it could. Discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Treatment with somatropin may trigger hypothyroidism. If you experience unexplained weight gain, muscle aches or stiffness, constipation, dry skin or fatigue, this may be a result of too little thyroid hormone and you should contact your doctor as soon as possible.

Pancreatitis: Somatotropin can cause the pancreas to become inflamed. If you have a history of pancreatitis, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Report signs of pancreatitis such as abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, or swollen abdomen to your doctor immediately. Scoliosis: People with scoliosis are at risk of their condition worsening while taking somatropin. If you have scoliosis, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Turner Syndrome: When somatropin is used to encourage growth in children with Turner Syndrome, there may be an increased risk of certain side effects. These children may be at increased risk of developing increased blood pressure in the brain.

Because they are at an increased risk of ear and hearing disorders, the doctor should thoroughly review the child's medical history.

If you or your child has ear or hearing problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if somatropin passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: Some formulations of this medication contain the preservative benzyl alcohol. Be careful about giving these formulations to children under the age of 3 years.

Seniors: The safety and effectiveness of using this medication have not been established for adults over 65 years of age. If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:. An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed. Medications other than those listed above may interact with this medication.

Tell your doctor or prescriber about all prescription, over-the-counter non-prescription , and herbal medications you are taking. Also tell them about any supplements you take.

Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them. All material copyright MediResource Inc. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition.

Source: www. Search Search. How does this medication work? What will it do for me? How should I use this medication? Your doctor will determine the appropriate dose of somatropin to be injected. Keep this medication out of the reach of children. What form s does this medication come in?

Vial Each vial of sterile lyophilized powder for reconstitution contains 5. Who should NOT take this medication? Do not use somatropin if you: are allergic to somatropin or any ingredients of this medication have active cancer have an active brain tumour have an acute illness due to complications of surgery, have respiratory breathing failure, or have just had a serious accident have Prader-Willi syndrome and are severely obese or have severe breathing problems have had a kidney transplant have vision problems due to long-term effects of diabetes are a child with closed epiphyses growth plates Do not give this medication to children with closed epiphyses bone growth plates.

What side effects are possible with this medication? Check with your doctor as soon as possible if any of the following side effects occur: a limp numbness, tingling or pain in the arms, legs or face pain in hip or knee signs of anemia low red blood cells; e.

Using the Noonan reference, height gain from baseline increased 1. During the first 2 years of treatment, height velocity was greater in the group receiving 0. Maximum Dosage Limits: Somatropin, rh-GH doses must be individualized and are highly variable depending on the nature and severity of the disease, the formulation being used, and on patient response.

Route-Specific Administration: Injectable Administration : Administer somatropin by intramuscular or subcutaneous injection. Do NOT administer intravenously. Discontinue therapy if final height is achieved or epiphyseal fusion occurs. Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit.

Subcutaneous Administration : Subcutaneous injection of somatropin volumes greater than 1 ml of reconstituted solution is not recommended. Inject SC taking care not to inject intradermally. Allow refrigerated solutions to come to room temperature prior to injection.

Subcutaneous injections may be given in the thigh, buttocks, or abdomen. Rotate injection sites daily. Intramuscular Administration : Inject somatropin deeply into a large muscle. Aspirate prior to injection to avoid injection into a blood vessel. The FDA determined this evidence regarding recombinant human growth hormone and increased risk of death to be inconclusive. The authors concluded that the increase in mortality found in the SAGhE study was most likely related to basic characteristics of the growth hormone deficiency population i.

Serum levels of inorganic phosphorus, alkaline phosphatase, and parathyroid hormone may increase with somatropin therapy. Somatropin products are contraindicated in patients with a known hypersensitivity to somatropin or any of the product excipients. Serious systemic hypersensitivity reactions including anaphylactic reactions and angioedema have been reported with post-marketing use of somatropin products.

Patients and caregivers should be informed that there is a risk of serious hypersensitivity reactions or anaphylaxis and that prompt medical attention should be sought if an allergic reaction occurs. Several of the products contain m-cresol as a preservative. Some of the formulations recommend using sterile water for injection as a diluent in patients with m-cresol hypersensitivity; other products recommend using other formulations.

The package insert of the specific product should be consulted for further information when using somatropin in patients with m-cresol hypersensitivity. Similarly, some of the formulations also contain glycerin. Do not use formulations of somatropin that contain glycerin in patients with glycerin hypersensitivity. Somatropin is contraindicated for growth promotion in pediatric patients with epiphyseal closure. Linear growth can no longer occur in these patients.

In addition, slipped capital femoral epiphysis may occur more frequently in patients with endocrine disorders or in patients undergoing rapid growth. Response to somatropin therapy in children tends to decrease over time. However, in children in whom growth rate is not increased, especially during the first year of treatment, compliance as well as other causes of growth failure including thyroid abnormalities, malnutrition, advanced bone age, and antibodies to somatropin should be assessed.

Any child taking somatropin that complains of hip or knee pain or the development of a limp should be evaluated by a clinician. Slipped capital femoral epiphysis may occur more frequently in patients with endocrine disorders or in children undergoing rapid growth. In addition, children with growth failure secondary to renal impairment should be evaluated for progression of renal osteodystrophy. Slipped capital femoral epiphysis or avascular necrosis of the femoral head may occur in children with advanced renal osteodystrophy; x-rays of the hip should occur prior to initiating therapy with somatropin.

The FDA has determined the evidence regarding recombinant human growth hormone and increased risk of death to be inconclusive; a number of study design weaknesses were found which limit the interpretability of the study results. The FDA will update the public when new information is available. Healthcare professionals and patients should continue to prescribe and use recombinant human growth hormone according to the labeled recommendations.

Benzyl alcohol has been associated with toxicity in newborns. If somatropin is to be used in neonates or in patients with benzoyl alcohol hypersensitivity, sterile water for injection, USP should be used for reconstitution and only one dose should be used per vial. Somatropin is contraindicated in patients with active neoplastic disease. Any pre-existing neoplastic disease, specifically intracranial lesions including pituitary tumors must be inactive, and chemotherapy and radiation therapy complete, prior to beginning somatropin therapy.

Intracranial tumors, in particular meningiomas, were the most common of these second neoplasms. It is unknown whether there is any relationship between somatropin replacement therapy and CNS tumor recurrence in adults. Monitor all patients with a history of growth hormone deficiency secondary to an intracranial neoplasm routinely while on somatropin therapy for progression or recurrence of the tumor.

Because children with certain rare genetic causes of short stature have an increased risk of developing malignancies, consider the risks and benefits of starting somatropin in these patients. If treatment with somatropin is initiated, these patients should be carefully monitored for development of neoplasms.

Monitor patients on somatropin therapy carefully for increased growth, or potential malignant changes, of preexisting nevi. Somatropin therapy should be discontinued if evidence of neoplasia develops. The safety of continuing somatropin treatment in patients receiving replacement doses for approved indications who currently develop these illnesses has not been established.

Therefore, the potential benefit of treatment continuation with somatropin in patients having acute critical illnesses should be weighed against the potential risk. Additionally, somatropin is contraindicated for use in pediatric patients with Prader-Willi syndrome and respiratory insufficiency as there have been reports of fatalities see Prader-Willi discussion. The manufacturers of Genotropin and Norditropin indicate that adult patients with obesity receiving somatropin for growth hormone deficiency may be more likely to experience adverse events when dosed by weight see Dosage.

Using a daily dose that is not weight-based may be preferable. Additionally, somatropin is contraindicated for use in pediatric patients with Prader-Willi syndrome and obesity as there have been reports of fatalities see Prader-Willi discussion. Somatropin is contraindicated in patients with Prader-Willi syndrome who are severely obese or have severe respiratory impairment.

Unless patients with Prader-Willi syndrome also have a diagnosis of growth hormone deficiency, somatotropin is not indicated for long-term treatment of pediatric patients who have growth failure due to genetically confirmed Prader-Willi syndrome. There have been reports of fatalities with the use of growth hormone in pediatric patients with Prader-Willi syndrome who had one or more of the following risk factors: severe obesity, history of respiratory insufficiency or sleep apnea, or unidentified respiratory infection.

Male patients with one or more of these factors may be at increased risk. Patients with Prader-Willi syndrome should be evaluated for upper airway obstruction before initiation of treatment with growth hormone.

If during treatment with growth hormone patients show signs of upper airway obstruction including onset of or increased snoring , treatment should be interrupted.

All patients with Prader-Willi syndrome should be evaluated for sleep apnea and monitored if sleep apnea is suspected. All patients with Prader-Willi syndrome should also have effective weight control and be monitored for signs of respiratory infections, which should be diagnosed as early as possible and treated aggressively.

Patients with Prader-Willi syndrome may also be at increased risk of intracranial hypertension. Somatropin should be used cautiously in patients with diabetes mellitus.

Patients with diabetes or glucose intolerance and those patients with risk factors for diabetes or glucose intolerance should be monitored closely during treatment with somatropin. Risk factors for glucose intolerance include obesity including obese patients with Prader-Willi Syndrome , Turner syndrome, or a family history of type II diabetes. Because somatropin may reduce insulin sensitivity, especially at higher doses, patients should be monitored for evidence of glucose intolerance.

Glucose intolerance or acromegaly may occur with chronic overdosage of somatropin. Dose adjustments of antidiabetic medications may be necessary when somatropin is initiated. Due to the effects of somatropin on insulin sensitivity and blood glucose concentrations, somatropin is contraindicated in patients with diabetic retinopathy.

Because growth hormone increases growth rate, patients with scoliosis can experience progression of scoliosis. Patients should be monitored for progression of scoliosis. In addition, skeletal abnormalities including scoliosis are commonly seen in untreated Turner's syndrome, Noonan's syndrome, and Prader-Willi syndrome patients. Clinicians should be aware of these abnormalities, which may manifest during growth hormone therapy.

Patients treated with glucocorticoid replacement for previously diagnosed adrenal insufficiency may require an increase in their maintenance or stress doses following initiation of somatropin treatment. In addition, patients with untreated hypothyroidism will have an inadequate response to somatropin therapy.

Changes in thyroid hormone plasma levels may develop during somatropin therapy because patients with Turner's syndrome have an inherent risk of developing autoimmune thyroid disease. Periodic thyroid function tests should be performed and treatment with thyroid hormone initiated when indicated. Symptoms usually occurred within the first eight weeks of somatropin therapy. Resolution of intracranial hypertension-associated symptoms occurred after discontinuation of somatropin therapy or after a reduction in the hormone dose.

Funduscopic examination is recommended at the initiation and periodically during the course of somatropin therapy.

Patients with chronic renal insufficiency, Prader-Willi syndrome, and Turner's syndrome may be at increased risk for developing intracranial hypertension. No adequate and well controlled studies have been conducted in pregnant humans, and the potential for somatropin to cause adverse effects on the fetus or reproductive system is unknown. In animal studies that have been performed, differing doses exceeding the regular human dose revealed no evidence of impaired fertility or harm to the fetus.

Inform females of childbearing age that use of somatropin during pregnancy has not been studied in humans, therefore, the effects of the drug on the fetus are unknown. Limited published literature reports no adverse effects on breast-feeding infants with maternal administration of somatropin and no decrease in milk production or change in milk content during treatment with somatropin.

Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, healthcare providers are encouraged to report the adverse effect to the FDA.

In addition, patients with Turner's syndrome should be monitored closely for cardiovascular disorders such as stroke, aortic aneurysm, and hypertension because these patients are also at risk for these conditions.

Clinical studies of somatropin did not include sufficient numbers of geriatric subjects; however, reported clinical experience has not identified differences in responses between geriatric and younger adult patients. In general, dose selection for an older adult should be cautious, usually starting at the low end of the dosing range. Geriatric patients are more at risk for the adverse effects of therapy compared to pediatric and younger adult patients.

There are no data are available to suggest that somatropin has beneficial effects in treating aging and age-related conditions and the enhancement of sporting performance; therefore, the prescription of the drug to adult patients for any reason other than the well-defined approved uses of the drug is not recommended.

However, the Beers expert panel considers hormone replacement after pituitary gland removal to be an acceptable use in the elderly. During clinical trials, 47 women receiving somatropin showed no difference from placebo with respect to reduction in visceral adipose tissue VAT. Reasons for the lack of effectiveness may be the concomitant use of estrogen 6 patients or a lower baseline VAT level as compared to men. Lower VAT levels have been demonstrated in several clinical trials to be associated with a reduced response to somatropin.

Patients who develop persistent, severe abdominal pain during somatropin treatment should be evaluated for pancreatitis, especially pediatric patients. Use with caution in patients with a past history of pancreatitis or with risk factors for pancreatitis. Pancreatitis has been rarely reported in adults and children receiving somatropin, with pediatric patients appearing to be at greater risk compared to adults.

Girls with Turner syndrome may have an even greater risk of developing pancreatitis compared to others undergoing somatropin treatment. No data are available regarding the presence of somatropin in human milk, the effects of somatropin on the breast-fed infant, or the effects of somatropin on milk production.

The effects of somatropin Humatrope on bone mineral density BMD and bone mineral content BMC have been evaluated in patients with adult-onset growth hormone deficiency and adults with childhood-onset GH deficiency still requiring somatropin therapy as adults transition patients.

No significant change in hip BMD was seen in women or men. In transition patients, patients randomized to The occurrence of osteoporotic fracture was not studied. Doses of somatropin of up to 0. Compared with untreated patients, after 32 weeks visceral adipose tissue VAT in patients treated with somatropin decreased by The effect of reducing VAT in adult GHD patients with somatropin on long-term cardiovascular morbidity and mortality has not been determined.

Leukemia has been reported in a small number of growth hormone deficient patients treated with somatropin. It is uncertain if this increased risk is related to the pathology of growth hormone deficiency itself, growth hormone therapy, or other associated treatments such as radiation therapy for intracranial tumors. Both fluid retention and peripheral edema have been commonly reported in patients receiving somatropin.

Peripheral edema is more common in adults than children. Symptoms usually occur within the first 8 weeks of treatment initiation.



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