Somatropin

By Medically reviewed by hellodoktor

Generic Name: Somatropin Brand Name(s): Somatropin.

Uses

What is Somatropin used for?

Somatropin is used for the treatment of one of the following medical conditions: growth failure, growth hormone deficiency, intestinal disorder (short bowel syndrome) or HIV-related weight loss or wasting.

Somatropin is also used to increase height in children with certain genetic disorders (such as Noonan syndrome, Turner’s syndrome).

How should I take Somatropin?

Your dose and brand of somatropin, and how often you use it will depend on the condition you are treating. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

In some cases, somatropin should not be used in a child. Certain brands of somatropin contain an ingredient that can cause serious side effects or death in very young infants or premature babies. Do not allow an older child to use this medicine without supervision of an adult.

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

Your care provider will show you the best places on your body to inject somatropin. Use a different place each time you give an injection. Do not inject into the same place two times in a row.

Do not shake the medication bottle or you may ruin the medicine. Prepare your dose only when you are ready to give an injection. Do not use if the medicine has changed colors or has particles in it. Call your pharmacist for new medicine.

While using somatropin, you may need frequent blood tests. Your growth progress will need to be tested often. Your eyes and your skin may also need to be checked.

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 have Prader-Willi syndrome, your treatment program may also include weight control. Follow your doctor’s instructions very closely.

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 do I store Somatropin?

How you store this medicine will depend on the somatropin brand and the diluent you are using. After mixing somatropin, you may need to use it right away or you may be able to store it for later use. Throw away any somatropin left over after the expiration date on the label has passed.

There may be different brands of Somatropin that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Somatropin down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Somatropin?

Before using somatropin, tell your doctor or pharmacist if you are allergic to it; 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. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: adrenal gland problems, eye problems (e.g., diabetic retinopathy), recent major surgery/injury, Prader-Willi syndrome, severe breathing problems (acute respiratory failure), diabetes or family history of diabetes, obesity, kidney disease, tumors (cancer, especially of the head/neck), thyroid problems, back problems (scoliosis), a certain genetic condition (Turner syndrome).

If you have diabetes, this drug may increase your blood sugar. Check your blood sugar regularly as directed and share the results with your doctor. Tell your doctor right away if you have symptoms of high blood sugar such as increased thirst/urination. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

When this medication is given to newborns, mix with sterile water for injection that does not contain a preservative. A preservative (benzyl alcohol) which may be found in the liquid used to mix this product can rarely cause serious problems (sometimes death), if given by injection to an infant during the first months of life. The risk is greater with lower birth weight infants and is greater with increased amounts of benzyl alcohol. Symptoms include sudden gasping, low blood pressure, or a very slow heartbeat. Report these symptoms to the doctor right away should they occur.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially effects on blood sugar, or swelling ankles/feet.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known if this drug passes into breast milk. Consult your doctor before breast-feeding.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Somatropin during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Somatropin. Somatropin is pregnancy risk category C according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Somatropin?

Headache, nausea, vomiting, fatigue, muscle pain, or weakness may occur. If these symptoms continue or become bothersome, inform your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she 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.

Tell your doctor right away if you have any serious side effects, including: development of a limp, persistent fatigue, unusual/unexplained weight gain, persistent cold intolerance, persistent slow heartbeat, fast heartbeat, ear pain/itching, hearing problems, joint/hip/knee pain, numbness/tingling, unusual increase in thirst or urination, swelling hands/ankles/feet, change in the appearance or size of any mole, persistent nausea/vomiting, severe stomach/abdominal pain.

Get medical help right away if you have any very serious side effects, including: vision problems/changes, seizure, severe headache.

Rare (possibly fatal) lung/breathing problems may be caused by this medication in children with Prader-Willi syndrome. Those at higher risk include males, severely overweight children, or those with serious lung/breathing problems ( e.g., 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. Tell the doctor right away if these signs occur. Also report any signs of lung infection, such as fever, persistent cough, or trouble breathing.

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.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any of the following symptoms of a serious allergic reaction: rash, itching/severe swelling (especially of the face/tongue/throat), dizziness, trouble breathing.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Somatropin?

Some products that may interact with this drug include: estrogen hormone replacement.

Somatropin may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Somatropin?

Somatropin may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Somatropin?

Somatropin may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Somatropin.

What is the dose of Somatropin for an adult?

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.

Renal Dose Adjustments

The dosage in children with chronic renal disease must be adjusted according to the individual response to therapy.

Dose Adjustments

Adult Growth Hormone Deficiency:

-Decrease the dose as needed for adverse events and/or serum IGF-1 levels above age and gender specific normal range.

-Maintenance doses vary considerably from person to person.

-Consider a lower starting dose and smaller dose increments for older patients, who are more prone to adverse effects than younger individuals.

-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.

-Oral estrogen use may increase the dose requirements in women.

HIV Wasting or Cachexia:

-Treatment with 0.1 mg/kg every other day was associated with fewer side effects and similar improvement in work output as compared to daily dosing.

-Consider a starting dose of 0.1 mg/kg every other day in patients at increased risk for adverse effects.

-Consider a dose reduction (of daily dosing amount, or of dosing frequency) for drug related side effects.

Short Bowel Syndrome:

-Treat moderate fluid retention and arthralgias symptomatically, or reduce dose by 50%.

-Discontinue for up to 5 days for severe toxicities; when symptoms resolve, resume at 50% of original dose.

-Permanently discontinue if severe toxicity recurs or does not disappear within 5 days.

Dialysis

Children with chronic renal disease:

-Hemodialysis: 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.

Other Comments

Administration advice:

-Alternate injection sites.

General:

-Therapy should be supervised by specialists experienced in the diagnosis and management of growth hormone (GH) deficiency.

What is the dose of Somatropin for a child?

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

Dose Adjustments

Pediatric Growth Hormone Deficiency:

Small for Gestational Age (SGA)

-Consider a dose reduction (e.g., gradually towards 0.033 mg/kg once a day) if substantial catch-up growth is observed during the first few years of therapy.

How is Somatropin available?

Somatropin is available in the following dosage forms and strengths:

  • Injectable powder for injection,
  • Injectable kit,
  • Subcutaneous powder for injection,
  • Subcutaneous solution,
  • Subcutaneous kit.

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Somatropin, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

Hello Health Group does not provide medical advice, diagnosis or treatment.

Sources

Review Date: April 26, 2018 | Last Modified: September 12, 2019