Somatropin, mammalian derived injection route, subcutaneous route

The 5 mg and 12 mg presentations of GENOTROPIN lyophilized powder contain m-cresol as a preservative. Systemic hypersensitivity reactions have been reported with postmarketing use of somatropins [see Warnings and Precautions (5.6)]. Other common somatropin-related adverse reactions include injection site reactions/rashes and lipoatrophy (6.1) and headaches (6.2). 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.

3 Preparation and Administration

Any pediatric patient with the onset of a limp or complaints of hip or knee pain during somatropin therapy should be carefully evaluated. In general, somatropin is contraindicated in the presence of active malignancy. Any preexisting malignancy should be inactive and its treatment complete prior to instituting therapy with somatropin.

Side Effects

In SGA children/adolescents it is recommended to measure fasting insulin and blood glucose before start of treatment and annually thereafter. In patients with increased risk for diabetes mellitus (e.g. familial history of diabetes, obesity, severe insulin resistance, acanthosis nigricans) oral glucose tolerance testing (OGTT) should be performed. If overt diabetes occurs, growth hormone should not be administered. GENOTROPIN lyophilized powder was compared with placebo in six randomized clinical trials involving a total of 172 adult GHD patients. GENOTROPIN was administered as a daily SC injection at a dose of 0.04 mg/kg/week for the first month of treatment and 0.08 mg/kg/week for subsequent months. Human growth hormone, also known as HGH and somatotropin, is a natural hormone your pituitary gland makes and releases that acts on many parts of the body to promote growth in children.

What is human growth hormone (HGH)?

• Blood sugar levels will need to be checked during treatment, and treatment with insulin may sometimes need to be started or adjusted.
• Nutropin AQ® vial, cartridge, and injection device should be used within 28 days.
• Each cartridge contains 10 mg of the active substance somatropin.
• This is neither a comprehensive description of each product nor a complete list of available therapies.
• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

The doses of antihyperglycemic drugs (i.e., insulin or oral/injectable agents) may require adjustment when somatropin therapy is instituted in these patients. Mortality was higher in patients treated with 5.3 or 8 mg somatropin daily compared to patients receiving placebo, 42% vs. 19%. Based on this information, these types of patients should not be treated with somatropin. Undiagnosed/untreated hypothyroidism may prevent an optimal response to somatropin, in particular, the growth response in children. Patients with Turner syndrome have an inherently increased risk of developing autoimmune thyroid disease and primary hypothyroidism.

When should I see my healthcare provider about my HGH levels?

There are no or limited amount of data from the use of somatropin in pregnant women. Animal studies are insufficient with respect to reproductive toxicity (see section 5.3). Somatropin is not recommended during pregnancy and in women of childbearing potential not using contraception.

More About Drugs and Medications

In neonates and patients who have benzyl alcohol hypersensitivity, several multi-dose somatropin preparations that contain benzyl alcohol should be used with caution. Sterile water for injection, USP should be used for reconstitution and only one dose should be administered per vial if somatropin is to be administered to newborns or patients who have benzoyl alcohol hypersensitivity. Insulin is the main hormone your pancreas makes to lower blood glucose levels when they get too high, and glucagon is the main hormone your pancreas makes to raise glucose levels when they get too low. Other hormones can counteract the effects of insulin, such as epinephrine (adrenaline) and cortisol.

2 Pharmacologic Glucocorticoid Therapy and Supraphysiologic Glucocorticoid Treatment

Blood glucose, or sugar, is the main sugar found in your blood. This sugar is an important source of energy and provides nutrients to your body’s organs, muscles and nervous system. A subcutaneous dose of 5 mg of Omnitrope 5 mg/1.5 ml solution for injection in healthy adults results in plasma Cmax and tmax values of 72 ± 28 µ g/l and 4.0 ± 2.0 hours, respectively. Also see section 4.4 for statements regarding diabetes mellitus and thyroid disorder and section 4.2 for statement on oral oestrogen replacement therapy. Advise patients who have a liver or kidney disease that large amounts of benzyl alcohol can be build up in their body and may cause sides effects (called “ metabolic acidosis” ). Advise pregnant or breast feeding patients that large amounts of benzyl alcohol can be build up in their body and may cause sides effects (called “ metabolic acidosis” ).

Instructions for Use GENOTROPIN 5

• NutropinAq has also been studied in 171 adults with growth hormone deficiency.
• Young rats at the highest dose showed increased weight gain during suckling but the effect was not apparent by 10 weeks of age.
• Ask your health care professional how to prepare and use this medication.
• The mean terminal half-life of somatropin after intravenous administration in growth hormone deficient adults is about 0.4 hours.
• A lower starting dose and smaller dose increments should be considered for older patients, who are more prone to the adverse effects of somatropin than younger individuals.

Throwing away (disposing of) used needles, cartridges and your GENOTROPIN PEN 12Put the used needles and cartridges in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) the needles and cartridges in the household trash. GENOTROPIN PEN 12 is a reusable multi-dose device holding a 2-chamber cartridge of GENOTROPIN, used to mix and inject GENOTROPIN during a 2 year use period. If you have any questions about your dose or your treatment with GENOTROPIN, call your healthcare provider right away. Battery charge is low and will be empty in 1 month.Afterwards the dose can be set and your pen can be used correctly.

Making growth a habit

• Other adverse drug reactions may be considered somatropin class effects, such as possible hyperglycaemia caused by decreased insulin sensitivity, decreased free thyroxin level and benign intra-cranial hypertension.
• Slipped capital femoral epiphysis and Legg-Calvé -Perthes disease have been reported in children treated with GH.
• Treatment should be discontinued if there is evidence of tumour growth.
• The amount of medicine that you take depends on the strength of the medicine.
• This information is intended to aid in the safe and effective administration of the medication.
• Adults with acromegaly can also have thickened bones and enlarged organs and are more likely to have conditions such as high blood pressure (hypertension), Type 2 diabetes and heart disease.
• If you are using a pen device, do not share your pen device with another person, even if the needle is changed.

The number that aligns with the front edge of the rubber stopper shows you how many milligrams are left in the cartridge. If your cartridge is nearly empty you can also dial the injection button until it cannot go any further, the dose display will then show the maximum dose that can be delivered. When the cartridge is empty, the injection button will not turn any further.

Dosage and Administration

GENOTROPIN 5 mg is a single-patient-use, two-chamber cartridge. GENOTROPIN 5 mg is designed for use with a reusable device (GENOTROPIN PEN 5) for product reconstitution and drug delivery. The reconstituted concentration is 5 mg/mL with a deliverable volume of 1 mL. Patients with Turner syndrome should be evaluated carefully for otitis media and other ear disorders since these patients have an increased risk of ear and hearing disorders. Somatropin treatment may increase the occurrence of otitis media in patients with Turner syndrome. In addition, patients with Turner syndrome should be monitored closely for cardiovascular disorders (e.g., stroke, aortic aneurysm/dissection, hypertension) as these patients are also at risk for these conditions.

Furthermore, overdose with somatropin is likely to cause fluid retention. Serious systemic hypersensitivity reactions including anaphylactic reactions and angioedema have been reported with postmarketing use of somatropins [see Warnings and Precautions (5.6)]. Because these adverse events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Visceral adipose tissue is particularly responsive to somatropin. In addition to enhanced lipolysis, somatropin decreases the uptake of triglycerides into body fat stores. Serum concentrations of IGF-I (Insulin-like Growth Factor-I) and IGFBP3 (Insulin-like Growth Factor Binding Protein 3) are increased by somatropin.

About this medicine

Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval. Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of somatropin injection in the elderly. However, elderly patients are more sensitive to the effects of somatropin, which may require an adjustment of dosage in patients receiving somatropin injection. Freedom from daily injections with once-weekly Sogroya®, the first and only once-weekly growth hormone (GH) treatment for both children and adults with growth hormone deficiency (GHD).

• Maintenance dosages vary considerably from person to person, and between male and female patients.
• Store this medication in a refrigerator at 36°F to 46°F (2°C to 8°C).
• GENOTROPIN is indicated for the treatment of pediatric patients who have growth failure due to an inadequate secretion of endogenous growth hormone.
• NutropinAq is also used to treat adults with a deficiency (low levels) of growth hormone.
• Your body makes over 50 hormones, and many of them interact with each other, creating a complex web of processes.
• In addition, rapid growth in any child can cause progression of scoliosis.

Do not use Sogroya® if:

Try storing supplies together in a dedicated bag or caddy—one that your child can decorate! 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. You can email the site owner to let them know you were blocked. Please include what you were doing when this page came up and the Cloudflare Ray ID found at the bottom of this page.

What are a few benefits of the FlexPro® pen?

Physicians should be alert to these abnormalities, which may manifest during somatropin therapy. Response to somatropin therapy in pediatric patients tends to decrease with time. Leukaemia has been reported in a small number of growth hormone deficiency patients, some of whom have been treated with somatropin.

Omnitrope 5 mg/1.5 ml solution for injection in cartridge

These anomalies, which could appear with growth hormone therapy, should be known to clinicians. If sleep apnea is suspected in any Prader-Willi syndrome patient, that patient should also be watched. 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. Additionally, cerebral hypertension may be more common in Prader-Willi syndrome patients. When used to promote growth in pediatric patients with epiphyseal closure, somatropin is not recommended.

Clinical Studies

Patients with growth hormone deficiency are characterised by extracellular volume deficit. When treatment with somatropin is started this deficit is rapidly corrected. Adverse reactions related to fluid retention, such as peripheral oedema and arthralgia are very common; musculoskeletal stiffness, myalgia and paraesthesia are common.

These effects on body composition were maintained when treatment was continued beyond 6 months. Bone mineral density declined after 6 months of treatment but returned to baseline values after 12 somatropin buy months of treatment. Slipped capital femoral epiphyses may occur more frequently in patients with endocrine disorders (including GHD and Turner syndrome) or in patients undergoing rapid growth.

• The dose of this medicine will be different for different patients.
• Throw away any mixed medicine that has not been used within this time.
• Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist.
• Heavy snoring or irregular breathing during sleep (sleep apnea) are signs of airway obstruction.
• The GENOTROPIN 5 mg and 12 mg cartridges are color-coded to help ensure proper use with the GENOTROPIN PEN delivery device.
• Somatropin may increase your risk of getting a tumor or cancer.
• Somatropin treatment may increase the occurrence of otitis media in patients with Turner syndrome.
• An increased chromosome fragility has been observed in one in vitro study on lymphocytes taken from patients after long term treatment with somatropin and following the addition of the radiomimetic drug bleomycin.

If your pen has been damaged, it should not be used and should be disposed of as instructed by your healthcare provider. Somatropin induces retention of sodium, potassium, and phosphorus. Serum concentrations of inorganic phosphate are increased in patients with GHD after therapy with GENOTROPIN. Generally, a dose of up to 0.48 mg/kg body weight/week is recommended. Generally, a dose of 0.33 mg/kg body weight/week is recommended. Generally, a dose of 0.24 mg/kg body weight/week is recommended.

Before starting growth hormone therapy, patients with Prader-Willi syndrome should have their upper airways inspected for obstruction. Treatment with growth hormone should be stopped if patients exhibit symptoms of upper airway blockage (including the beginning or worsening of snoring). Somatropin is a potent metabolic hormone of importance for the metabolism of lipids, carbohydrates and proteins. In children with inadequate endogenous growth hormone, somatropin stimulates linear growth and increases growth rate. In adults as well as in children, somatropin maintains a normal body composition by increasing nitrogen retention and stimulation of skeletal muscle growth, and by mobilisation of body fat.