somatropin

Pronunciation

Generic Name: somatropin (soe ma TROE pin)
Brand Name: Genotropin, Genotropin Miniquick, Humatrope, Norditropin, Norditropin Cartridge, Norditropin FlexPro Pen, Norditropin Nordiflex Pen, Nutropin, Nutropin AQ, Omnitrope, Saizen, Serostim, Tev-tropin, Zorbtive, ...show all 23 brand names

What is somatropin?

Somatropin is a form of human growth hormone. Human growth hormone is important in the body for the growth of bones and muscles.

Somatropin is used to treat growth failure in children and adults who lack natural growth hormone, and in those with chronic kidney failure, Noonan syndrome, Turner syndrome, Prader-Willi syndrome, short stature at birth with no catch-up growth, and other causes. Somatropin is also used to prevent severe weight loss in people with AIDS, or to treat short bowel syndrome.

Somatropin may also be used for purposes not listed in this medication guide.

What is the most important information I should know about somatropin?

Before you receive somatropin, tell your doctor about all your past and present medical conditions, especially allergies, trauma, surgery, diabetes, cancer, breathing problems, liver or kidney disease, scoliosis, high blood pressure, pancreas disorder, underactive thyroid, or a brain tumor.

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Also tell your doctor about all other medications you use, especially steroids or diabetes medications. Your dosages of these medicines may need to be changed when you start using somatropin. Do not stop using a steroid suddenly or change any of your medication doses without your doctor's advice.

If you have Prader-Willi syndrome and are using somatropin, call your doctor promptly if you develop signs of lung or breathing problems such as shortness of breath, coughing, or new or increased snoring.

Call your doctor at once if you have sudden and severe pain in your upper stomach with nausea and vomiting, fast heartbeat, increased thirst or urination, weight loss, or vision changes and sudden, severe pain behind your eyes.

What should I discuss with my healthcare provider before using somatropin?

Before you receive somatropin, tell your doctor if you have ever had an allergic reaction to a growth hormone medicine, or to drug preservatives such as benzyl alcohol, metacresol or glycerin.

You should not use this medication if you are allergic to somatropin, or if you have:

  • diabetic retinopathy (a serious eye condition caused by diabetes);

  • cancer; or

  • Prader-Willi syndrome and are also overweight or have sleep apnea or severe respiratory (lung) problems.

You should also not use somatropin if you have a serious medical condition after having:

  • open heart surgery or stomach surgery;

  • trauma or other medical emergency; or

  • breathing problems (such as lung failure).

To make sure you can safely take somatropin, tell your doctor if you have any of these other conditions:

  • liver disease;

  • kidney disease (or if you are on dialysis);

  • diabetes;

  • a pituitary gland disorder;

  • scoliosis;

  • high blood pressure (hypertension);

  • a pancreas disorder (especially in children);

  • a history of cancer;

  • carpal tunnel syndrome;

  • underactive thyroid; or

  • a brain tumor or lesion.

FDA pregnancy category B. Some brands of somatropin are not expected to harm an unborn baby, including Genotropin, Omnitrope, Saizen, Serostim, and Zorbtive.

FDA pregnancy category C. It is not known whether certain other brands of somatropin will harm an unborn baby, including Humatrope, Norditropin, Nutropin, and Tev-tropin.

Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether somatropin passes into breast milk or if it could harm a nursing baby. Do not use somatropin without telling your doctor if you are breast-feeding a baby.

How should I use somatropin?

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Your dose and brand of somatropin, and how often you give it will depend on what you are being treated for. Follow the directions on your prescription label.

Somatropin is injected into a muscle or under the skin. You may be shown how to use injections at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

Use a different place on your body each time you give the injection. Your care provider will show you the best places on your body to inject the medication. Do not inject into the same place two times in a row. Do not inject this medicine into skin or muscle that is red, sore, infected, or injured.

Do not shake the medication bottle or you may ruin the medicine. When mixing somatropin with a diluent (liquid), use a gentle swirling motion. Do not use the medication if it has changed colors or has particles in it. Call your doctor for a new prescription.

Use a disposable needle only once. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

To be sure this medication is helping your condition and not causing harm, your blood and growth progress will need to be tested often. Your eyes may also need to be checked. Visit your doctor regularly.

If you are being treated for short bowel syndrome, follow the diet plan created for you by your doctor or nutrition counselor to help control your condition. Somatropin is not a cure for short bowel syndrome.

If you use a form of somatropin that comes in a cartridge for use with an injection pen, use only the pen injection system provided with the somatropin brand you use.

How you store this medicine will depend on what brand you are using and what diluent you are mixing somatropin with. After mixing somatropin, you may need to use it right away or you may be able to store it for later use. Read and carefully follow the instructions provided with your medicine about proper storage of somatropin before and after it has been mixed. Ask your pharmacist if you have any questions about proper storage of your medication.

Throw away any somatropin left over after the expiration date on the label has passed.

What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Call your doctor if you miss more than 3 doses in a row.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose can cause tremors or shaking, cold sweats, increased hunger, headache, drowsiness, weakness, dizziness, fast heartbeat, and nausea. Long-term overdose may cause excessive growth.

What should I avoid while using somatropin?

If you use Zorbtive to treat short bowel syndrome, avoid drinking fruit juices or soda beverages. Follow the instructions of your doctor or nutrition counselor about what types of liquids you should drink while using Zorbtive.

Avoid drinking alcohol if you have short bowel syndrome. Alcohol can irritate your stomach and could make your condition worse.

Somatropin side effects

If you have Prader-Willi syndrome, call your doctor promptly if you develop signs of lung or breathing problems such as shortness of breath, coughing, or new or increased snoring. Rare cases of serious breathing problems have occurred in patients with Prader-Willi syndrome who use somatropin.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;

  • increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, and weight loss;

  • sudden and severe pain behind your eyes, vision changes;

  • swelling in your head, face, hands, or feet; or

  • numbness or tingling in your wrist, hand, or fingers.

Less serious side effects may include:

  • headache, feeling tired;

  • redness, soreness, swelling, rash, itching, pain, or bruising where the medicine was injected;

  • pain in your arms or legs, joint stiffness or pain;

  • muscle pain; or

  • cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

Somatropin dosing information

Usual Adult Dose for Adult Human Growth Hormone Deficiency:

Weight Based Regimen:
Initial dose: Not more than 0.004 mg/kg subcutaneously once a day (or a total of 0.04 mg/kg per week in divided doses).
Maximum dose: 0.016 mg/kg once a day (0.08 mg/kg per week in divided doses)

Non-Weight Based Regimen:
Approximately 0.2 mg subcutaneously once a day (range: 0.15 to 0.3 mg once a day)

Comments:
-The weekly dose should be divided over 6 or 7 days of subcutaneous injections.
-May increase dose (weight or non-weight based) at 4 to 8 week intervals, by increments of approximately 0.1 to 0.2 mg per day (not more than 0.004 mg/kg per day), based on clinical response and serum IGF-I concentrations.
-The dose should be decreased as necessary on the basis of adverse events and/or serum IGF-I concentrations above the age- and gender-specific normal range.
-Maintenance dosages vary considerably from person to person, and between male and female patients.
-Obese individuals are more likely to manifest adverse effects when treated with a weight-based regimen. -To reach the defined treatment goal, estrogen-replete women may need higher doses than men.

Uses: Replacement of endogenous growth hormone (GH) in adults with growth hormone deficiency (GHD) who meet either of the following two criteria:
-Adult Onset (AO): Patients who have GHD, either alone or associated with multiple hormone deficiencies (hypopituitarism), as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma; or
-Childhood Onset (CO): Patients who were GH deficient during childhood as a result of congenital, genetic, acquired, or idiopathic causes. Reevaluate patients treated for childhood GHD whose epiphyses are closed before continuing therapy at the reduced dose level recommended for adults.
-Confirmation of the diagnosis of adult GHD in both groups involves an appropriate growth hormone provocative test with two exceptions: (1) patients with multiple other pituitary hormone deficiencies due to organic disease; and (2) patients with congenital/genetic growth hormone deficiency.

Usual Adult Dose for Cachexia:

0.1 mg/kg subcutaneously once a day at bedtime

Under 35 kg/ 75 lbs: 0.1 mg/kg subcutaneously once a day at bedtime
35 to 45 kg/ 75 to 99 lbs: 4 mg subcutaneously once a day at bedtime
45 to 55 kg/ 99 to 121 lbs: 5 mg subcutaneously once a day at bedtime
Over 55 kg/ 121 lbs: 6 mg subcutaneously once a day at bedtime

Maximum dose: 6 mg once a day

Comments:
-Most of the effect on work output and lean body mass were seen after 12 weeks of treatment.
-There are no data on safety or efficacy with use beyond 48 weeks.
-There are no data on safety or efficacy of intermittent treatment.

Use: Treatment of HIV patients with wasting or cachexia to increase lean body mass and body weight, and improve physical endurance.

Usual Adult Dose for Short Bowel Syndrome:

Approximately 0.1 mg/kg subcutaneously once a day

Maximum dose: 8 mg once a day

Duration of therapy: 4 weeks

Comments:
-Administration for more than 4 weeks has not been adequately studied.
-Use in conjunction with optimal management of Short Bowel Syndrome (SBS).
-Optimal management of SBS may include dietary adjustments, enteral feedings, parenteral nutrition, fluid, and micronutrient supplements, as needed.
-Specialized nutritional support may consist of a high carbohydrate, low-fat diet, adjusted for patient requirements and preferences.
-Nutritional supplements may be added at the discretion of the treating physician.
-Changes to concomitant medications should be avoided.
-Patients and physicians should monitor for adverse events.

Use: Treatment of Short Bowel Syndrome in patients receiving specialized nutritional support.

Usual Pediatric Dose for Pediatric Growth Hormone Deficiency:

Pediatric Growth Hormone Deficiency (GHD):
0.024 to 0.034 mg/kg subcutaneously once a day, 6 to 7 times a week

Prader-Willi syndrome (PWS):
Up to 0.24 mg/kg per week; divided over 6 or 7 days of subcutaneous injections

Comments:
-The weekly dose should be divided over 6 or 7 days of subcutaneous injections.
-GHD: Generally, a dose of 0.16 to 0.3 mg/kg body weight per week is recommended.
-GHD: In pubertal patients, a weekly dosage of up to 0.7 mg/kg divided into daily doses may be used.
-PWS: Generally, a dose of 0.16 to 0.24 mg/kg body weight per week is recommended.
-Individualize dosage and administration schedule based on the growth response.
-Serum insulin-like growth factor I (IGF-I) levels may be useful during dose titration.
-Response to therapy in pediatric patients tends to decrease with time, however, failure to increase height velocity, particularly during the first year of treatment, should prompt close assessment of compliance and evaluation of other causes of poor growth, such as hypothyroidism, under-nutrition, advanced bone age, and antibodies to recombinant human growth hormone.
-Treatment for short stature should be discontinued when the epiphyses are fused.

Uses:
-Treatment of pediatric patients who have growth failure due to inadequate secretion of endogenous growth hormone (GH).
-Treatment of pediatric patients who have growth failure due to Prader-Willi syndrome (PWS). The diagnosis of PWS should be confirmed by appropriate genetic testing

Usual Pediatric Dose for Turner's Syndrome:

Up to 0.067 mg/kg subcutaneously once a day

Comments:
-Generally, a dose of 0.375 mg/kg body weight per week is recommended.
-The weekly dose should be divided over 6 or 7 days of subcutaneous injections.
-Individualize dosage and administration schedule based on the growth response.
-Serum insulin-like growth factor I (IGF-I) levels may be useful during dose titration.
-Response to therapy in pediatric patients tends to decrease with time, however, failure to increase height velocity, particularly during the first year of treatment, should prompt close assessment of compliance and evaluation of other causes of poor growth, such as hypothyroidism, under-nutrition, advanced bone age, and antibodies to recombinant human growth hormone.
-Treatment for short stature should be discontinued when the epiphyses are fused.

Use: Treatment of short stature associated with Turner Syndrome (TS).

Usual Pediatric Dose for Idiopathic Short Stature:

Up to 0.053 mg/kg subcutaneously once a day

Comments:
-Generally, a dose of up to 0.47 mg/kg body weight per week is recommended.
-The weekly dose should be divided over 6 or 7 days of subcutaneous injections.
-Individualize dosage and administration schedule based on the growth response.
-Serum insulin-like growth factor I (IGF-I) levels may be useful during dose titration.
-Response to therapy in pediatric patients tends to decrease with time, however, failure to increase height velocity, particularly during the first year of treatment, should prompt close assessment of compliance and evaluation of other causes of poor growth, such as hypothyroidism, under-nutrition, advanced bone age, and antibodies to recombinant human growth hormone.
-Treatment for short stature should be discontinued when the epiphyses are fused.

Use: Treatment of idiopathic short stature (ISS), also called non-GHD short stature, defined by height SDS lower than -2.25, and associated with growth rates unlikely to permit attainment of adult height in the normal range, in pediatric patients whose epiphyses are not closed and for whom diagnostic evaluation excludes other causes associated with short stature that should be observed or treated by other means.

Usual Pediatric Dose for Growth Retardation -- Chronic Renal Failure:

Up to 0.35 mg/kg of body weight per week, divided into daily subcutaneous injections

Duration of therapy: Therapy may be continued up to the time of renal transplantation.

Comments:
-Therapy should be used in conjunction with optimal management of chronic kidney disease.
-Individualize dosage and administration schedule based on the growth response.
-Response to therapy in pediatric patients tends to decrease with time, however, failure to increase height velocity, particularly during the first year of treatment, should prompt close assessment of compliance and evaluation of other causes of poor growth, such as hypothyroidism, under-nutrition, advanced bone age, and antibodies to recombinant human growth hormone.
-Treatment for short stature should be discontinued when the epiphyses are fused.
-To optimize therapy for dialysis patients, the following injection schedules are recommended:
-Hemodialysis patients: administer at night just prior to going to sleep, or at least 3 to 4 hours after hemodialysis to prevent hematoma formation due to heparin.
-Chronic Cycling Peritoneal Dialysis (CCPD): administer in the morning after dialysis is completed.
-Chronic Ambulatory Peritoneal Dialysis (CAPD): administer in the evening at the time of the overnight exchange.

Use: Treatment of growth failure secondary to chronic kidney disease (CKD) up to the time of renal transplantation.

Usual Pediatric Dose for Noonan's Syndrome:

Up to 0.066 mg/kg subcutaneously once a day

Comments:
-Not all Noonan syndrome patients have short stature; some will achieve a normal adult height without treatment.
-Establish that the patient does have short stature before starting treatment.
-Individualize dosage and administration schedule based on the growth response.
-Serum insulin-like growth factor I (IGF-I) levels may be useful during dose titration.
-Response to therapy in pediatric patients tends to decrease with time, however, failure to increase height velocity, particularly during the first year of treatment, should prompt close assessment of compliance and evaluation of other causes of poor growth, such as hypothyroidism, under-nutrition, advanced bone age, and antibodies to recombinant human growth hormone.
-Treatment for short stature should be discontinued when the epiphyses are fused.

Use: Treatment of pediatric patients with short stature associated with Noonan Syndrome

Usual Pediatric Dose for Short Stature for Age:

Small for Gestational Age (SGA):
Up to 0.067 mg/kg subcutaneously daily

Short stature homeobox-containing gene (SHOX) deficiency:
0.05 mg/kg subcutaneously once a day (0.35 mg/kg per week in divided doses)

Comments:
-The weekly dose should be divided over 6 or 7 days of subcutaneous injections.
-SGA: Generally, a dose of up to 0.48 mg/kg body weight per week is recommended.
-SGA: Recent literature recommends initial treatment with larger doses (e.g., 0.067 mg/kg once a day), especially in very short children (HSDS of lower than -3), and/or older/pubertal children.
-SGA: In younger children (approximately less than 4 years, who respond the best in general) with less severe short stature (baseline HSDS values between -2 and -3), consider initiating treatment at a lower dose (0.033 mg/kg/day), and titrating the dose as needed over time.
-Individualize dosage and administration schedule based on the growth response.
-Serum insulin-like growth factor I (IGF-I) levels may be useful during dose titration.
-Response to therapy in pediatric patients tends to decrease with time, however, failure to increase height velocity, particularly during the first year of treatment, should prompt close assessment of compliance and evaluation of other causes of poor growth, such as hypothyroidism, under-nutrition, advanced bone age, and antibodies to recombinant human growth hormone.
-Treatment for short stature should be discontinued when the epiphyses are fused.

Uses:
-Treatment of pediatric patients with short stature born small for gestational age (SGA) with no catch-up growth by age 2 to 4 years.
-Treatment of short stature or growth failure in children with short stature homeobox-containing gene (SHOX) deficiency.

Usual Pediatric Dose for Cachexia:

0.04-0.07 mg/kg subcutaneously once a day

Comments:
-Safety and effectiveness in pediatric patients with HIV have not been established.
-Somatropin clearance appears similar in adults and children, but no pharmacokinetic studies have been conducted in children with HIV.
-Two small studies (total of 16 patients) of up to 26 weeks duration showed therapy was well tolerated with safety observations consistent with the adult studies.

Use: Treatment of HIV patients with wasting or cachexia to increase lean body mass and body weight, and improve physical endurance

What other drugs will affect somatropin?

Before using somatropin, tell your doctor if you use insulin or take oral (by mouth) medicine to treat diabetes. Somatropin may affect blood sugar levels and you may need to adjust your dose of the diabetes medication. Do not change the dose of your diabetes medication without your doctor's advice.

Tell your doctor if you use any type of steroid medicine such as cortisone, dexamethasone, methylprednisolone, prednisone, and others. Steroids can make somatropin less effective and your doses may need to be adjusted. Do not stop using a steroid suddenly. Follow your doctor's instructions.

Tell your doctor about all other medications you use, especially cyclosporine (Gengraf, Neoral, Sandimmune), seizure medication, birth control pills, anabolic steroids, or hormone replacement medications for men or women.

This list is not complete and other drugs may interact with somatropin. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

  • Your pharmacist can provide more information about somatropin.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 12.01. Revision Date: 2011-08-10, 3:24:13 PM.

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