Somatropin referral European Medicines Agency EMA

Somatropin increases insulin but fasting blood glucose is commonly unchanged. Children with hypopituitarism may experience fasting hypoglycaemia. 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. There have been no clinical studies conducted with somatropin containing products in breast-feeding women. It is not known if somatropin is excreted into breast milk, but absorption of intact protein from the gastrointestinal tract of the infant is extremely unlikely. Therefore caution should be exercised when Omnitrope is administered to breast-feeding women.

Which data has the CHMP reviewed?

In patients on oral estrogen replacement, a larger dose of somatropin may be required to achieve the defined treatment goal [see Dosage and Administration (2.2)]. Monitor all patients with a history of GHD secondary to an intracranial neoplasm routinely while on somatropin therapy for progression or recurrence of the tumor. GENOTROPIN is contraindicated in patients with a known hypersensitivity to somatropin or any of its excipients.

5 Idiopathic Short Stature

Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco. DAll unused Norditropin® products must be refrigerated (36 °F to 46 °F) prior to first use. Get free medicine home delivery in over 1800 cities across India.

More questions about treatment and growth?

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.

Important Safety Information

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• Sogroya® may affect the way some medicines work, and some medicines may affect how Sogroya® works.
• IGF-1 plays a critical role in preventing (inhibiting) the release of the HGH through a negative feedback loop by stimulating somatostatin and inhibiting GHRH release.
• Maintenance dosages vary considerably from person to person, and between male and female patients.
• Battery charge is low and will be empty in 1 month.Afterwards the dose can be set and your pen can be used correctly.

In patients with growth hormone deficiency, central (secondary) hypothyroidism may first become evident or worsen during somatropin treatment. Therefore, patients treated with somatropin should have periodic thyroid function tests and thyroid hormone replacement therapy should be initiated or appropriately adjusted when indicated. NutropinAq has been studied in children with growth failure caused by a lack of growth hormone (230 patients), Turner syndrome (117 patients) or kidney disease (195 patients). NutropinAq has also been studied in 171 adults with growth hormone deficiency. NutropinAq was compared with a placebo (a dummy treatment) or with a group of untreated patients, except in the studies of children with a lack of growth hormone where there was no comparison with any other group. The main measures in the studies in children were the speed of growth during the study and the height at the end of the study.

• Visceral adipose tissue is particularly responsive to somatropin.
• Children should be checked for certain breathing problems (upper airway obstruction) before and during treatment.
• Somatropin is not recommended during pregnancy and in women of childbearing potential not using contraception.
• Choose a location that is quiet and comfortable and has enough space for the supplies you’ll be using, like alcohol wipes and a sharps container.
• After first use the cartridge should remain in the pen and has to be kept in a refrigerator (2° C – 8° C) for a maximum of 28 days.
• 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.
• Before injecting each dose, clean the skin you are going to inject into (the injection site) with rubbing alcohol.
• In order to reach the defined treatment goal, estrogen-replete women may need higher doses than men.

Do not use Sogroya® if:

Put the used GENOTROPIN MINIQUICK and needles in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) the needles and syringes in the household trash. Check your GENOTROPIN MINIQUICK to be sure you have the dose your healthcare provider prescribed. The injection button is rotated too fast or too slow.Point the pen away from your face, press the injection button, press the red release button and continue preparing your dose. The indicative scale along the side of the cartridge window is a guide.

Side Effects

Find affordable medicine substitutes, save up to 50% on health products, up to 80% off on lab tests and free doctor consultations. Store this medication in a refrigerator at 36°F to 46°F (2°C to 8°C). Some laboratory results may vary as a result of somatropin medication.

3 Preparation and Administration

IGF-1 appears to be the principal mediator of the action of growth hormone, whereas IGF-2 has more insulin-like activity. The principal anabolic actions of IGFs include stimulation of amino acid transport, stimulation of DNA, RNA, and protein synthesis, and induction of cell proliferation and growth. IGF-1 is directly responsible for chondrogenesis, skeletal growth, and the growth of soft tissue. Linear growth is stimulated by affecting cartilaginous growth areas of long bones.

• Take all other medicines or supplements your doctor has prescribed as part of your combination treatment.
• It has to be administered using sterile, disposable pen needles.
• Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals.
• The observed difference is due to slow absorption from the subcutaneous injection site.
• GENOTROPIN is indicated for the treatment of growth failure in pediatric patients born small for gestational age (SGA) who fail to manifest catch-up growth by age 2 years.
• Norditropin® is the only growth hormone approved for children who are short in stature and who have Noonan syndrome.

Medical Professionals

Keep track of where you give each shot to make sure you rotate body areas. This medicine is available only with your doctor’s prescription. Sign up now to receive news about growth-related disorders and relevant product updates from Novo Nordisk.

What benefit has NutropinAq shown during the studies?

You may report side effects to FDA at FDA-1088 or at /medwatch. Somatropin may increase your risk of getting a tumor or cancer. Discuss the details and the risks and benefits of this medication with your doctor. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. If this medicine is used for short bowel syndrome, consult your doctor if a special diet (high carbohydrate/low-fat) or the use of nutritional supplements may be helpful.

INDIA’S LARGEST HEALTHCARE PLATFORM

There is no information regarding the presence of somatropin in human milk. Limited published data indicate that exogenous somatropin does not increase normal breastmilk concentrations of growth hormone. No adverse effects related to somatropin in the breastfeed infant have been reported.

The injection button is rotated too fast or too slow.Point your pen away from your face, press the injection button, press the red release button and continue preparing your dose. The selected dose size.The number indicates the dose size (in mg) that your pen will deliver if the injection button is fully pressed in. Some liquid may appear from the needle tip, and the numbers may disappear from the dose display. To correct this, turn the injection button in the opposite direction of the arrow until numbers reappear on the dose display.

Somatropin 5 Mg (15 Unit) Solution For Injection – Uses, Side Effects, and More

Researchers don’t have enough information about the long-term effects of HGH treatment. Be sure to reference your lab’s normal range on your lab report when analyzing your results. If you have any questions about your results, talk to your healthcare provider. Metabolism consists of the chemical reactions in your body that change the food you eat into energy.

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.

How is NutropinAq used?

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.

Preparing for injection

• Patients who received GENOTROPIN showed significant increases in linear growth during the first year of study, compared with patients who received no treatment (see Table 3).
• A total of 38 patients were treated with GENOTROPIN alone in the two studies.
• 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).
• Intracranial tumours, in particular meningiomas, in patients treated with radiation to the head for their first neoplasm, were the most common of these second neoplasms.
• Other adverse events that have been reported include generalized edema and hypoesthesia.
• Diagnosis and therapy with somatropin should be initiated and monitored by physicians who are appropriately qualified and experienced in the diagnosis and management of patients with growth disorders.
• Patients and caregivers who will administer GENOTROPIN should receive appropriate training and instruction on the proper use of GENOTROPIN from the physician or other suitably qualified health care professional.

Those at higher risk include males, severely overweight children, or those with serious lung/breathing problems ( such as sleep apnea, lung infections, lung disease). Children should be checked for certain breathing problems (upper airway obstruction) before and during treatment. Heavy snoring or irregular breathing during sleep (sleep apnea) are signs of airway obstruction. Also report any signs of lung infection, such as fever, cough, or trouble breathing.

Patient Counseling Information

• Leukaemia has been reported in a small number of growth hormone deficiency patients, some of whom have been treated with somatropin.
• The dose may be increased according to individual patient requirements to not more than 0.08 mg/kg/week at 4–8 week intervals.
• With somatropin medication, serum levels of inorganic phosphorus, alkaline phosphatase, and parathyroid hormone may rise.
• GENOTROPIN was administered as a daily SC injection, and the dose was calculated for each patient every 3 months.
• Rare (possibly fatal) lung/breathing problems may be caused by this medication in children with Prader-Willi syndrome.

Patients received GENOTROPIN at a dose between 0.13 to 0.33 mg/kg/week. The safety and efficacy of GENOTROPIN in the treatment of pediatric patients with Prader-Willi syndrome (PWS) were evaluated in two randomized, open-label, controlled clinical trials. Patients received either GENOTROPIN or no treatment for the first year of the studies, while all patients received GENOTROPIN during the second year. GENOTROPIN was administered as a daily SC injection, and the dose was calculated for each patient every 3 months. In Study 1, the treatment group received GENOTROPIN at a dose of 0.24 mg/kg/week during the entire study. During the second year, the control group received GENOTROPIN at a dose of 0.48 mg/kg/week.

Children with acromegaly may also have general weakness, delayed puberty and headaches. However, once your growth plates have fused, HGH cannot make you taller. Instead, after you’ve reached your final height, HGH helps maintain your body’s structure and has other important effects on your metabolism. In another study with somatropin, no increase in chromosomal abnormalities was found in the lymphocytes of patients who had received long-term somatropin therapy. Somatropin induces hepatic LDL cholesterol receptors, and affects the profile of serum lipids and lipoproteins. In general, administration of somatropin to growth hormone deficient patients results in reduction in serum LDL and apolipoprotein B.

Because of this, a single blood test to measure HGH measurement is difficult to interpret and is not usually medically useful. In adults, hypopituitarism that results in HGH deficiency may develop due to a benign pituitary adenoma (a noncancerous tumor) or damage to your pituitary gland or hypothalamus. The size and duration of the pulses vary with the time of day and your age and sex. Because of this, random HGH measurements are rarely useful to healthcare providers in confirming or ruling out a diagnosis. Instead, HGH measurement tests are most useful when measured as part of a stimulation or suppression test.

However, HGH and IGF-1 secretion are regulated by each other, where HGH triggers IGF-1 release and the IGF-1 inhibits HGH release in a feedback loop. In healthy people, HGH release is inhibited by hyperglycemia (high blood sugar) and stimulated by sleep, stress, exercise, hypoglycemia (low blood sugar) and amino acids. Several other endocrine hormones also regulate HGH, including insulin-like growth factor 1 (IGF-1). IGF-1 is a major suppressor of GH production, whereas thyroxine, glucocorticoids and ghrelin stimulate HGH release. Administer the appropriate dose by subcutaneous injection using a sterile pen needle. Remove the pen needle and dispose of it in accordance with local requirements.

The medicine is given once a day by injection under the skin, using the injection pen specially designed for the NutropinAq cartridge. The patient or their carer can inject NutropinAq after training by a doctor or a nurse. The doctor calculates the dose for each patient individually depending on the patient’s condition. The dose may need to be adjusted over time, depending on the patient’s response, age and body weight. Appropriate studies have not been performed on the relationship of age to the effects of somatropin injection in children with short bowel syndrome.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Do not use medications containing lonapegsomatropin while using somatropin. During pregnancy, this medication should be used only when clearly needed. If you notice other effects not listed above, contact your doctor or pharmacist.

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. 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. Store unopened vials, cartridges, and injection devices of Nutropin® and Nutropin AQ® in the refrigerator, away from heat and direct light. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.

Patients limping during treatment with somatropin should be examined clinically. In December 2010, the French medicines regulatory agency was made aware of preliminary results of a long-term population-based study in France of patients treated during childhood with somatropin-containing medicines. The study, called ‘Santé Adulte GH Enfant’ (SAGhE) study, was initiated in October 2007 and aimed at somatropin buy improving knowledge on the safety and appropriateness of somatropin treatment. It looked at data on 10,000 adults who started treatment between 1985 and 1996, using a mandatory national registry. Changes in body composition were also observed in the patients receiving GENOTROPIN (see Table 4). Treatment with GENOTROPIN did not accelerate bone age, compared with patients who received no treatment.

This chart is not intended to be a comparison of efficacy or safety of any of these products. PenMate® is a reusable cover for the FlexPro® 5 mg, 10 mg, and 15 mg pens.c Once you attach it to the end of your pen, it completely covers the needle so you don’t see it go into your skin during injection. PenMate® also has a large gripping surface so you can hold it firmly in your hands. When GH reaches the liver, it tells the liver to release a second hormone that helps with growth.

AAll unused Norditropin® products must be refrigerated (36 °F to 46 °F) prior to first use. 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. Your pen should not be used near electrical or electronic equipment, including mobile phones.