Growth Hormone Therapy Norditropin® somatropin 10 mg injection

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Before using, check this product for particles or discoloration. Before injecting each dose, clean the skin you are going to inject into (the injection site) with rubbing alcohol.

Conditions

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine. Read the Patient Information Leaflet and Instructions for Use if available from your pharmacist before you start using this medication and each time you get a refill. Ask your health care professional how to prepare and use this medication. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Norditropin® (somatropin) injection may help people living with certain growth-related disorders

Although not all of these side effects may occur, if they do occur they may need medical attention. Before you have any medical tests, tell healthcare providers that you are using this medicine. Check with your doctor if you or your child notice a change in the results of your blood or urine sugar tests or if you have any questions. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.

Somatropin for Growth Hormone Deficiency

Linear growth is stimulated by affecting cartilaginous growth areas of long bones. Growth is also stimulated by increasing the number and size of skeletal muscle cells, influencing the size somatotropin for sale of organs, and increasing red cell mass through erythropoietin stimulation. The actions of growth hormone on the gut may be direct or mediated via the local or systemic production of IGF.

More common

• In neonates and patients who have benzyl alcohol hypersensitivity, several multi-dose somatropin preparations that contain benzyl alcohol should be used with caution.
• If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.
• Although the guideline was developed with unclear methodology, it appears the evidence supporting its recommendations was up to date.
• Your doctor may want you or your child to have your eyes checked by an ophthalmologist (eye doctor).
• You might not use all of the medicine in each vial (glass container).
• Bone mineral content and BMD should be measured at baseline and at 2-year to 3-year intervals.

Your doctor may adjust your dose to reduce these side effects. The dose of this medicine will be different for different patients. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so. Older adults may be more sensitive to the side effects of this drug, especially effects on blood sugar, or swelling ankles/feet.

Traveling with Norditropin®

There are differences in the etiology of CO-GHD and AO-GHD in adults who have been diagnosed with GHD. GH-stimulation testing should be performed to confirm the diagnosis of adult GHD, except for certain GHD subtypes. Drug interactions may change how your medications work or increase your risk for serious side effects.

The #1 prescribed growth hormone therapy in the U.S.1

You should not use Bacteriostatic Water for Injection if you have had an allergic reaction to benzyl alcohol. If this is a concern, ask your doctor about other ways to mix this medicine. Check with your doctor immediately if headache, nausea, vomiting, blurred vision, or any other change in vision occurs during treatment. Your doctor may want you or your child to have your eyes checked by an ophthalmologist (eye doctor).

• And Norditropin® is approved for more of them than any other treatment.
• The use of this document outside of Canada is done so at the user’s own risk.
• CADTH-developed search filters were applied to limit retrieval to guidelines.
• During somatropin therapy, patients with diabetes or glucose intolerance, as well as those who have risk factors for developing these conditions, should be continuously watched.
• Drug interactions may change how your medications work or increase your risk for serious side effects.

What are a few benefits of the FlexPro® pen?

This website is using a security service to protect itself from online attacks. The action you just performed triggered the security solution. There are several actions that could trigger this block including submitting a certain word or phrase, a SQL command or malformed data. Do not use medications containing lonapegsomatropin while using somatropin. Sign up now to receive news about growth-related disorders and relevant product updates from Novo Nordisk.

Less common

• The risk is greater with lower birth weight infants and is greater with increased amounts of benzyl alcohol.
• Other tips on this page, like following a routine and offering rewards, can also be helpful.
• Your doctor may adjust your dose to reduce these side effects.
• Store this medication in a refrigerator at 36°F to 46°F (2°C to 8°C).
• The guideline presented criteria for the diagnosis of GHD in different populations.
• The guideline begins with a recommendation on the use of GH to treat GHD.
• The safety of Norditropin® has been evaluated in several clinical studies.

Criteria for GH-stimulation testing are presented using different BMI-appropriate cut points depending on the type of test and the specific population. Once a correct diagnosis is established, GH treatment should be initiated at low doses and slowly increased to avoid side effects. Treatment should be periodically monitored for both clinical benefits and side effects.

Which Norditropin® FlexPro® pen may be right for your patients?

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of somatropin injection in children with growth hormone deficiency. Both guidelines12,13 considered the management of GHD, including diagnosis and treatment with GH replacement therapy. Before using somatropin, tell your doctor or pharmacist if you are allergic to it; or to lonapegsomatropin; or if you have any other allergies. This product may contain inactive ingredients (such as benzyl alcohol or metacresol found in some brands), which can cause allergic reactions or other problems.

In-vivo studies have shown that growth hormone enhances transmucosal transport of water, electrolytes, and nutrients. Endogenous growth hormone is responsible for stimulating normal skeletal, connective tissue, muscle, and organ growth in children and adolescents. Somatropin binds to growth hormone (GH) receptors and produces a variety of physiologic effects that can be classified as being direct or indirect. These effects oppose the action of insulin on fat and carbohydrate metabolism and are potentiated by glucocorticoids.

The search strategy comprised both controlled vocabulary, such as the National Library of Medicine’s MeSH (Medical Subject Headings), and keywords. Search concepts were developed based on the elements of the research questions and selection criteria. CADTH-developed search filters were applied to limit retrieval to guidelines. The search was completed on June 2, 2023, and was limited to English-language documents published since January 1, 2013. This medicine may cause fluid retention (extra water in the body). Tell your doctor if you or your child have burning, numbness, pain, or tingling in all fingers except smallest finger, swelling of the hands and feet, or pain, swelling, or stiffness of the muscles.

Products & Services

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. Patients with diabetes should utilize somatropin with caution.

The beneficial effects of somatropin (growth hormone [GH] replacement therapy) in adults are now established. Long-term somatropin administration in GH-deficient adults improves body composition, muscle strength, quality of life, bone mass and density, and lipoprotein pattern. The extent to which somatropin therapy can also reduce cardiovascular morbidity and mortality in GH-deficient adults remains to be determined. Thorough long-term monitoring of glucose metabolism, cardiovascular measurements, and underlying pituitary disease, is, however, mandatory. The PES guideline provides recommendations for the clinical management of children and adolescents with GHD. The guideline begins with a recommendation on the use of GH to treat GHD.

Short-bowel Syndrome

• 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.
• Also report any signs of lung infection, such as fever, cough, or trouble breathing.
• Selected from data included with permission and copyrighted by First Databank, Inc.
• Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
• In addition, people with endocrine abnormalities or those going through rapid growth may experience slipping capital femoral epiphysis more frequently.
• Some laboratory results may vary as a result of somatropin medication.
• Growth is also stimulated by increasing the number and size of skeletal muscle cells, influencing the size of organs, and increasing red cell mass through erythropoietin stimulation.
• Ask your healthcare professional how you should dispose of any medicine you do not use.
• This medicine is usually mixed with Bacteriostatic Water for Injection.

Perform the injection when your child is relaxed and mentally prepared. Other tips on this page, like following a routine and offering rewards, can also be helpful. Using this medicine may increase your or your child’s risk of getting cancer. If you will be taking this medicine for a long time, it is very important that your doctor check your or your child’s progress at regular visits. Blood and urine tests may be needed to check for any problems or unwanted effects that may be caused by this medicine.

• Please refer to each product’s full Prescribing Information including instructions for use.
• We identified 2 evidence-based guidelines that provided detailed recommendations regarding the identification, diagnosis, and treatment of GHD in adults and children.
• Patients should be aware of the potential short-term and long-term adverse effects of GH treatment.
• All Prader-Willi syndrome patients should also maintain healthy weights and be closely watched for any indications of respiratory infections, which should be identified as soon as possible and quickly treated.
• You may report side effects to FDA at FDA-1088 or at /medwatch.
• In the first level of screening, titles and abstracts were reviewed and potentially relevant articles were retrieved and assessed for inclusion.
• Overall, both guidelines12,13 were robust in terms of scope and development, rigour of development, and clarity of presentation.

During treatment with somatropin, Turner’s syndrome patients should be evaluated carefully for otitis media and other ear disorders since these patients have an increased risk of ear or hearing disorders. 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. It has been shown that somatropin medication can result in elevated intracranial pressure, papilledema, visual abnormalities, headaches, nausea, and/or vomiting. Within the first eight weeks of somatropin medication, symptoms often started to appear. The symptoms of intracranial hypertension went away either when somatropin medication was stopped or after the hormone’s dosage was decreased. When starting somatropin therapy and at intervals thereafter, funduscopic examination is advised.

Routine cardiac testing, DXA scanning, and measurement of lipid profiles of patients receiving GH treatment are not recommended. GH-stimulation testing should not be the sole diagnostic criterion for GHD, and the test is not needed in certain populations with specific conditions. Laboratories should provide standardized GH assays using standard somatropin. Sex steroid priming before GH-stimulation testing may be considered in prepubertal children. GH treatment should be started with a low dose, although some patients may need higher doses.

We identified 2 evidence-based guidelines that provided detailed recommendations regarding the identification, diagnosis, and treatment of GHD in adults and children. Both guidelines were developed in the US, therefore their recommendations are applicable to the Canadian clinical context. Its recommendations and the rationales for the development of those recommendations are presented in Table 6 in Appendix 5. Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines.

Evidence supporting the recommendations was mostly derived from short-term outcomes because prospective studies for long-term outcomes have more logistical and cost challenges. The lack of correlation between short-term and long-term outcomes creates some uncertainties about certain evidence-based recommendations. Due to variability among patients, recommendations made at the population level may not be optimal for a particular individual. We did not identify any Canadian guidelines for diagnosis and treatment of GHD in children and adults.

Serum IGF-1 levels should be used to monitor response to changes in GH dose. GH treatment is continued until the growth rate falls below 2.5 cm/year. Patients should be aware of the potential short-term and long-term adverse effects of GH treatment. Re-evaluate the somatotropic axis in children diagnosed with GHD during the transition period (i.e., from pediatric to adult care).

Both guidelines12,13 clearly described how the recommendations were developed and evaluated. Additional details regarding the characteristics of the included guidelines are provided in Appendix 2. Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional. This medicine is usually mixed with Bacteriostatic Water for Injection.

Growth hormone is made by the pituitary gland, which is a pea-sized gland at the base of the brain. Recommendations pertaining to the definition of adult GHD are presented in Appendix 4. In brief, adult GHD can be categorized into CO-GHD and AO-GHD. AO-GHD can be caused by tumours in the hypothalamic-pituitary area or brain injury. Articles were excluded if they did not meet the selection criteria outlined in Table 1. Guidelines with unclear methodology were not included in the text, but their characteristics and findings are presented in Appendix 5.

After first injection, Norditropin® pens can either be stored outside of the refrigerator (up to 77 °F) for use within 3 weeks, or in the refrigerator (between 36 °F and 46 °F) for use within 4 weeks. Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements. The Nutropin® or Saizen® vials and Zorbtive® that has been mixed should be used within 14 days. The Saizen® click.easy® cartridge that has been mixed should be used within 21 days. Nutropin AQ® vial, cartridge, and injection device should be used within 28 days.