Treating certain children or adults when the body does not produce enough growth hormone. It is also used to treat children who are not growing normally due to Turner syndrome or certain other conditions (eg, chronic kidney problems, idiopathic short stature). It may also be used to for other conditions as determined by your doctor.
Biotropin is a growth hormone that produces effects that are identical to the body's naturally occurring growth hormone. It affects the growth of bones, muscles, internal organs, and other tissues of the body.
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
Biotropin® [Biotropin (rDNA origin) for injection] is indicated for the long‑term treatment of growth failure due to a lack of adequate endogenous GH secretion.
Biotropin® [Biotropin (rDNA origin) for injection] is also indicated for the treatment of growth failure associated with chronic renal insufficiency up to the time of renal transplantation. Biotropin therapy should be used in conjunction with optimal management of chronic renal insufficiency.
Biotropin® [Biotropin (rDNA origin) for injection] is also indicated for the long‑term treatment of short stature associated with Turner syndrome.
Biotropin® [Biotropin (rDNA origin) for injection] is also indicated for the long‑term treatment of idiopathic short stature, also called non‑growth hormone‑deficient short stature, defined by height SDS ≤–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.
Biotropin® [Biotropin (rDNA origin) for injection] is indicated for the replacement of endogenous growth hormone in adults with growth hormone deficiency who meet either of the following two criteria:
Adult Onset: Patients who have adult growth hormone deficiency 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: Patients who were growth hormone deficient during childhood as a result of congenital, genetic, acquired, or idiopathic causes.
In general, confirmation of the diagnosis of adult growth hormone deficiency in both groups usually requires an appropriate growth hormone stimulation test. However, confirmatory growth hormone stimulation testing may not be required in patients with congenital/genetic growth hormone deficiency or multiple pituitary hormone deficiencies due to organic disease.
How should I use Biotropin?
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
Use Biotropin as directed by your doctor. Check the label on the medicine for exact dosing instructions.
An extra patient leaflet is available with Biotropin. Talk to your pharmacist if you have questions about this information.
Biotropin is given as an injection under the skin. Before you use Biotropin, a health care provider will teach you how to use it. Be sure you understand how to use Biotropin. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
Allow Biotropin to come to room temperature before you use it.
Wash your hands before and immediately after using Biotropin.
Do not use Biotropin if it contains particles, is cloudy or discolored, or if the container is cracked or damaged.
Use the proper technique taught to you by your doctor. Inject deep under the skin, NOT into muscle.
Be sure to rotate your injection site as directed to help avoid thickening or hardening of the skin.
Do NOT shake Biotropin. Swirl gently to mix.
For Biotropin pen: Use Biotropin with the correct pen and cartridge combination. Check with your pharmacist or doctor if you have any questions.
For Biotropin Nuspin: Check the injection device to be sure the correct dose is dialed before you use a dose of Biotropin.
If you need to clean the pen, you may use a damp cloth to wipe it. Do not place it underwater. Do not use alcohol to clean it.
Do not share pen or cartridge devices with another person. Sharing these devices may pass infections from one person to another. This includes infections you may not know you have.
Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
If you miss a dose of Biotropin, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.
Ask your health care provider any questions you may have about how to use Biotropin.
Biotropin is a solution for injection into the skin in a multidose disposable pre-filled pen. It also contains the following inactive ingredients: Mannitol, histidine, poloxamer 188, phenol and water for injections.
For subcutaneous injection.
Therapy with Biotropin should be supervised by a physician who is experienced in the diagnosis and management of pediatric patients with short stature associated with growth hormone deficiency (GHD), chronic kidney disease, Turner syndrome, idiopathic short stature, or adult patients with either childhood-onset or adult-onset GHD.
Dosing For Pediatric Patients
Biotropin dosage and administration schedule should be individualized for each patient. Response to growth hormone (GH) therapy in pediatric patients tends to decrease with time. However, in pediatric patients failure to increase growth rate, particularly during the first year of therapy, suggests the need for close assessment of compliance and evaluation of other causes of growth failure, such as hypothyroidism, under-nutrition, advanced bone age and antibodies to recombinant human GH (rhGH).
Treatment with Biotropin for short stature should be discontinued when the epiphyses are fused.
Pediatric Growth Hormone Deficiency (GHD)
A weekly dosage of up to 0.3 mg/kg of body weight divided into daily subcutaneous injection is recommended. In pubertal patients, a weekly dosage of up to 0.7 mg/kg divided daily may be used.
Growth Failure Secondary to Chronic Kidney Disease (CKD)
A weekly dosage of up to 0.35 mg/kg of body weight divided into daily subcutaneous injection is recommended.
Biotropin therapy may be continued up to the time of renal transplantation.
In order to optimize therapy for patients who require dialysis, the following guidelines for injection schedule are recommended:
Hemodialysis patients should receive their injection at night just prior to going to sleep or at least 3 to 4 hours after their hemodialysis to prevent hematoma formation due to the heparin.
Chronic Cycling Peritoneal Dialysis (CCPD) patients should receive their injection in the morning after they have completed dialysis.
Chronic Ambulatory Peritoneal Dialysis (CAPD) patients should receive their injection in the evening at the time of the overnight exchange.
Idiopathic Short Stature (ISS)
A weekly dosage of up to 0.3 mg/kg of body weight divided into daily subcutaneous injections is recommended.
Short Stature Associated with Turner Syndrome (TS)
A weekly dosage of up to 0.375 mg/kg of body weight divided into equal doses 3 to 7 times per week by subcutaneous injection is recommended.
Dosing For Adult Patients
Adult Growth Hormone Deficiency (GHD)
Either of two approaches to Biotropin dosing may be followed: a weight-based regimen or a non-weight-based regimen.
Weight based – Based on the dosing regimen used in the original adult GHD registration trials, the recommended dosage at the start of treatment is not more than 0.006 mg/kg daily. The dose may be increased according to individual patient requirements to a maximum of 0.025 mg/kg daily in patients ≤ 35 years and to a maximum of 0.0125 mg/kg daily in patients over 35 years old. Clinical response, side effects, and determination of age-and gender-adjusted serum insulin-like growth factor (IGF-1) concentrations should be used as guidance in dose titration.
Non-weight based – Alternatively, taking into account the published literature, a starting dose of approximately 0.2 mg/day (range, 0.15 to 0.30 mg/day) may be used without consideration of body weight. This dose can be increased gradually every 1 to 2 months by increments of approximately 0.1 to 0.2 mg/day, according to individual patient requirements based on the clinical response and serum IGF-1 concentrations. The dose should be decreased as necessary on the basis of adverse events and/or serum IGF-1 concentrations above the age-and gender-specific normal range.
Maintenance dosages vary considerably from person to person, and between male and female patients.
A lower starting dose and smaller dose increments should be considered for older patients, who are more prone to the adverse effects of Biotropin than younger individuals. In addition, obese individuals are more likely to manifest adverse effects, when treated with a weight-based regimen. In order to reach the defined treatment goal, estrogen-replete women may need higher doses than men.
Oral estrogen administration may increase the dose requirements in women.
Preparation And Administration
The solution should be clear immediately after removal from the refrigerator. Occasionally, after refrigeration, you may notice that small colorless particles of protein are present in the solution. This is not unusual for solutions containing proteins. Allow the pen cartridge or NuSpin® to come to room temperature and gently swirl. If the solution is cloudy, the contents MUST NOT be injected.
Parenteral drug products should always be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Injection sites, which may be located on the thigh, upper arm, abdomen or buttock, should always be rotated to avoid lipoatrophy.
Biotropin Pen Cartridge
The Biotropin Pen 10 and 20 mg Cartridges are color-banded to help ensure appropriate use with the Biotropin Pen delivery device. Each cartridge must be used with its corresponding color-coded Biotropin Pen.
Wipe the septum of the Biotropin Pen Cartridge with rubbing alcohol or an antiseptic solution to prevent contamination of the contents by microorganisms that may be introduced by repeated needle insertions. It is recommended that Biotropin be administered using sterile, disposable needles. Follow the directions provided in the Biotropin Pen Instructions for Use.
The Biotropin Pen 10 allows for administration of a minimum dose of 0.1 mg to a maximum dose of 4.0 mg, in 0.1 mg increments.
The Biotropin Pen 20 allows for administration of a minimum dose of 0.2 mg to a maximum dose of 8.0 mg, in 0.2 mg increments.
The Biotropin NuSpin 5, 10 and 20 are multi-dose, dial-a-dose injection devices prefilled with Biotropin in a 5 mg/2 mL, 10 mg/2 mL or 20 mg/ 2 mL cartridge, respectively, for subcutaneous use. It is recommended that Biotropin be administered using sterile, disposable needles. Follow the directions provided in the Biotropin NuSpin 5, 10 or 20 Instructions for Use.
The Biotropin NuSpin 5 allows for administration of a minimum dose of 0.05 mg to a maximum dose of 1.75 mg, in increments of 0.05 mg.
The Biotropin NuSpin 10 allows for administration of a minimum dose of 0.1 mg to a maximum dose of 3.5 mg, in increments of 0.1 mg.
The Biotropin NuSpin 20 allows for administration of a minimum dose of 0.2 mg to a maximum dose of 7.0 mg, in increments of 0.2 mg.
Dosage Forms And Strengths
Biotropin is available in the following pen cartridge and NuSpin forms:
Pen Cartridge: 10 mg/2 mL (yellow color band), and 20 mg/2 mL (purple color band)
NuSpin: 5 mg/2 mL (clear device), 10 mg/2 mL (green device), and 20 mg/2 mL (blue device)
Pen Cartridge (2 mL):
Biotropin NuSpin (2 mL):
Storage And Handling
Biotropin cartridge and NuSpin injection device contents are stable for 28 days after initial use when stored at 2-8°C/36-46°F (under refrigeration). Avoid freezing Biotropin in the cartridge or NuSpin injection device. Biotropin is light sensitive and the cartridges and Biotropin NuSpin should be protected from light. Store the cartridge and Biotropin NuSpin injection device refrigerated in a dark place when they are not in use.
Manufactured by: Genentech, Inc., A Member of the Roche Group, 1 DNA Way, South San Francisco, CA 94080–4990. Revised: March 2014
11β-Hydroxysteroid Dehydrogenase Type 1 (11βHSD-1)
The microsomal enzyme 11βHSD-1 is required for conversion of cortisone to its active metabolite, cortisol, in hepatic and adipose tissue. Growth hormone (GH) and Biotropin inhibit 11βHSD-1. Consequently, individuals with untreated GH deficiency have relative increases in 11βHSD-1 and serum cortisol. Introduction of Biotropin treatment may result in inhibition of 11βHSD-1 and reduced serum cortisol concentrations. As a consequence, previously undiagnosed central (secondary) hypoadrenalism may be unmasked and glucocorticoid replacement may be required in patients treated with Biotropin. In addition, patients treated with glucocorticoid replacement for previously diagnosed hypoadrenalism may require an increase in their maintenance or stress doses following initiation of Biotropin treatment; this may be especially true for patients treated with cortisone acetate and prednisone since conversion of these drugs to their biologically active metabolites is dependent on the activity of 11βHSD-1.
Pharmacologic Glucocorticoid Therapy and Supraphysiologic Glucocorticoid Treatment
Pharmacologic glucocorticoid therapy and supraphysiologic glucocorticoid treatment may attenuate the growth-promoting effects of Biotropin in children. Therefore, glucocorticoid replacement therapy should be carefully adjusted in children with concomitant GH and glucocorticoid deficiency to avoid both hypoadrenalism and an inhibitory effect on growth.
The use of Biotropin in patients with Chronic Kidney Disease (CKD) requiring glucocorticoid therapy has not been evaluated. Concomitant glucocorticoid therapy may inhibit the growth promoting effect of Biotropin. Therefore, if glucocorticoid replacement is required for CKD, the glucocorticoid dose should be carefully adjusted to avoid an inhibitory effect on growth. In the clinical trials there was no evidence of drug interactions with Biotropin and commonly used drugs used in the management of CKD.
Cytochrome P450 (CYP450)-Metabolized Drugs
Limited published data indicate that Biotropin treatment increases CYP450-mediated antipyrine clearance in man. These data suggest that Biotropin administration may alter the clearance of compounds known to be metabolized by CYP450 liver enzymes (e.g., corticosteroids, sex steroids, anticonvulsants, cyclosporine). Careful monitoring is advisable when Biotropin is administered in combination with other drugs known to be metabolized by CYP450 liver enzymes. However, formal drug interaction studies have not been conducted.
Because oral estrogens may reduce insulin-like growth factor (IGF-1) response to Biotropin treatment, girls and women receiving oral estrogen replacement may require greater Biotropin dosages.
Oral/Injectable Hypoglycemic Agents
In patients with diabetes mellitus requiring drug therapy, the dose of insulin and/or oral/injectable hypoglycemic agents may require adjustment when Biotropin therapy is initiated.
Most Serious and/or Most Frequently Observed Adverse Reactions
This list presents the most seriousInjection site reactions/rashes and lipoatrophy (as well as rare generalized hypersensitivity reactions).
Clinical Trials Experience
Because clinical trials are conducted under varying conditions, adverse reaction rates observed during the clinical trials performed with one Biotropin formulation cannot always be directly compared to the rates observed during the clinical trials performed with a second Biotropin formulation, and may not reflect the adverse reaction rates observed in practice.
Growth Hormone Deficiency (GHD)
Injection site discomfort has been reported. This is more commonly observed in childrens witched from another Biotropin product to Biotropin.
In a randomized, controlled trial, there was a statistically significant increase, as compared to untreated controls, in otitis media (43% vs. 26%) and ear disorders (18% vs. 5%) in patients receiving Biotropin.
Idiopathic Short Stature (ISS)
In a post-marketing surveillance study, the National Cooperative Growth Study (NCGS), the pattern of adverse events in over 8,000 patients with ISS was consistent with the known safety profile of growth hormone (GH), and no new safety signals attributable to GH were identified. The frequency of protocol-defined targeted adverse events is described in the table, below.
Table 1: Protocol-Defined Targeted Adverse Events in the ISS NCGS Cohort
(N = 8018)
Any Adverse Event
Targeted Adverse Event
New onset or progression of scoliosis
Any new onset or recurring tumor (benign)
Arthralgia or arthritis
Cancer, neoplasm (new onset or recurrence)
Abnormal bone or other growth
Central nervous system tumor
New or recurrent SCFE or AVN
Carpal tunnel syndrome
AVN=avascular necrosis; SCFE = slipped capital femoral epiphysis. Data obtained with several rhGH products (Biotropin, Biotropin, Biotropin Depot and Protropin).
In subjects treated in a long-term study of Biotropin for ISS, mean fasting and postprandial insulin levels increased, while mean fasting and postprandial glucose levels remained unchanged. Mean hemoglobin A1c (A1C) levels rose slightly from baseline as expected during adolescence; sporadic values outside normal limits occurred transiently.
Growth Hormone Deficiency
In clinical studies with Biotropin in GHD adults, edema or peripheral edema was reported in 41% of GH-treated patients and 25% of placebo-treated patients. In GHD adults, arthralgias and other joint disorders were reported in 27% of GH-treated patients and 15% of placebo-treated patients.
Biotropin therapy in adults with GHD of adult-onset was associated with an increase of median fasting insulin level in the Biotropin 0.0125 mg/kg/day group from 9.0 μU/mL at baseline to 13.0 μU/mL at Month 12 with a return to the baseline median level after a 3-week post-washout period of GH therapy. In the placebo group there was no change from 8.0 μU/mL at baseline to Month 12, and after the post-washout period, the median level was 9.0 μU/mL. The between-treatment group difference on the change from baseline to Month 12 in median fasting insulin level was significant, p < 0.0001. In childhood-onset subjects, there was an increase of median fasting insulin level in the Biotropin 0.025 mg/kg/day group from 11.0 μU/mL at baseline to 20.0 μU/mL at Month 12, in the Biotropin 0.0125 mg/kg/day group from 8.5 μU/mL to 11.0 μU/mL, and in the placebo group from 7.0 μU/mL to 8.0 μU/mL. The between-treatment group differences for these changes were significant, p = 0.0007.
In subjects with adult-onset GHD, there were no between-treatment group differences on change from baseline to Month 12 in mean A1C level, p = 0.08. In childhood-onset GHD, the mean A1C level increased in the Biotropin 0.025 mg/kg/day group from 5.2% at baseline to 5.5% at Month 12, and did not change in the Biotropin 0.0125 mg/kg/day group from 5.1% at baseline or in the placebo group from 5.3% at baseline. The between-treatment group differences were significant, p = 0.009.
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. The adverse events reported during post-marketing surveillance do not differ from those listed/discussed above in Sections 6.1 and 6.2 in children and adults.
Leukemia has been reported in a small number of GHD children treated with Biotropin, somatrem (methionylated rhGH) and GH of pituitary origin. It is uncertain whether these cases of leukemia are related to GH therapy, the pathology of GHD itself, or other associated treatments such as radiation therapy. On the basis of current evidence, experts have not been able to conclude that GH therapy per se was responsible for these cases of leukemia. The risk for children with GHD, CKD, or TS, if any, remains to be established.
The following additional adverse reactions have been reported in GH-treated patients: gynecomastia (children), and pancreatitis [(Children and adults, see WARNINGS AND PRECAUTIONS].
As with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to Biotropin with the incidence of antibodies to other products may be misleading. In the case of GH, antibodies with binding capacities lower than 2 mg/L have not been associated with growth attenuation. In a very small number of patients treated with Biotropin, when binding capacity was greater than 2 mg/L, interference with the growth response was observed.
In clinical studies of pediatric patients that were treated with Biotropin for the first time, 0/107 GHD patients, 0/125 CKD patients, 0/112 TS, and 0/117 ISS patients screened for antibody production developed antibodies with binding capacities ≥ 2 mg/L at six months. In a clinical study of patients that were treated with Biotropin for the first time, 0/38 GHD patients screened for antibody production for up to 15 months developed antibodies with binding capacities ≥2 mg/L.
Additional short-term immunologic and renal function studies were carried out in a group of pediatric patients with CKD after approximately one year of treatment to detect other potential adverse effects of antibodies to GH. Testing included measurements of C1q, C3, C4, rheumatoid factor, creatinine, creatinine clearance, and blood urea nitrogen (BUN). No adverse effects of GH antibodies were noted.
Treatment with pharmacologic amounts of Biotropin is contraindicated in patients with acute critical illness due to complications following open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure. Two placebo-controlled clinical trials in non-GHD adult patients (n = 522) with these conditions in intensive care units revealed a significant increase in mortality (41.9% vs. 19.3%) among Biotropin-treated patients (doses 5.3–8 mg/day) compared to those receiving placebo.
Prader-Willi Syndrome (PWS) in Children
Biotropin is contraindicated in patients with PWS who are severely obese, have a history of upper airway obstruction or sleep apnea, or have severe respiratory impairment. There have been reports of sudden death when Biotropin was used in such patients. Biotropin is not indicated for the treatment of pediatric patients who have growth failure due to genetically confirmed PWS..
In general, Biotropin is contraindicated in the presence of active malignancy. Any pre-existing malignancy should be inactive and its treatment complete prior to instituting therapy with Biotropin. Biotropin should be discontinued if there is evidence of recurrent activity. Since growth hormone deficiency (GHD) may be an early sign of the presence of a pituitary tumor (or, rarely, other brain tumors), the presence of such tumors should be ruled out prior to initiation of treatment. Biotropin should not be used in patients with any evidence of progression or recurrence of an underlying intracranial tumor.
Biotropin is contraindicated in patients with active proliferative or severe non-proliferative diabetic retinopathy.
Biotropin should not be used for growth promotion in pediatric patients with closed epiphysis.
Biotropin is contraindicated in patients with a known hypersensitivity to Biotropin, excipients, or diluent. Localized reactions are the most common hypersensitivity reaction.
The results of a survey conducted on ndrugs.com for Biotropin are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Biotropin. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.
1 consumer reported useful
Was the Biotropin drug useful in terms of decreasing the symptom or the disease? According to the reports released by ndrugs.com website users, the below mentioned percentages of users say the drug is useful / not useful to them in decreasing their symptoms/disease. The usefulness of the drug depends on many factors, like severity of the disease, perception of symptom, or disease by the patient, brand name used [matters only to a certain extent], other associated conditions of the patient. If the drug is not effective or useful in your case, you need to meet the doctor to get re-evaluated about your symptoms/disease, and he will prescribe an alternative drug.
Consumer reported price estimates
No survey data has been collected yet
2 consumers reported time for results
To what extent do I have to use Biotropin before I begin to see changes in my health conditions? As part of the reports released by ndrugs.com website users, it takes 1 week and a few days before you notice an improvement in your health conditions. Please note, it doesn't mean you will start to notice such health improvement in the same time frame as other users. There are many factors to consider, and we implore you to visit your doctor to know how long before you can see improvements in your health while taking Biotropin. To get the time effectiveness of using Biotropin drug by other patients, please click here.
2 consumers reported age
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Information checked by Dr. Sachin Kumar, MD Pharmacology