Recommended Topic Related To:

Humatrope

"The U.S. Food and Drug Administration today approved Dotarem (gadoterate meglumine) for use in magnetic resonance imaging (MRI) of the brain, spine and associated tissues of patients ages 2 years and older.

Dotarem is a gadolinium-based"...

Humatrope

Humatrope Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Humatrope (somatropin, rDNA origin) for Injection 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, short stature at birth with no catch-up growth, and other causes. It is also used to prevent severe weight loss in people with AIDS, or to treat short bowel syndrome. It is a form of human growth hormone. Common side effects include headache, nausea, vomiting, fatigue, muscle pain, or weakness.

Humatrope dosage and administration schedule is individualized for each patient based on the growth response. Humatrope may interact with insulin or oral diabetes medicines, steroids, cyclosporine, seizure medication, birth control pills, anabolic steroids, or hormone replacement medications for men or women. Tell your doctor all medications you use. Humatrope should be used only when prescribed during pregnancy. It is not known if this drug passes into breast milk. Consult your doctor before breast-feeding.

Our Humatrope (somatropin, rDNA origin) for Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Humatrope in Detail - Patient Information: 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.

Read the entire detailed patient monograph for Humatrope (Somatropin rDNA Origin) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Humatrope Overview - Patient Information: Side Effects

SIDE EFFECTS: 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, severe headache, persistent nausea/vomiting, severe stomach/abdominal pain, vision problems or changes, seizure.

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 immediately if these signs occur. Also report any signs of lung infection, such as fever, persistent cough, or trouble breathing.

A serious allergic reaction to this drug is unlikely, but get medical help right away if it occurs. Symptoms of a serious allergic reaction include: rash, itching/severe swelling (especially of the face/tongue/throat), dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Humatrope (Somatropin rDNA Origin)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Humatrope FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Most Serious And/Or Most Frequently Observed Adverse Reactions

This list presents the most seriousa and/or most frequently observed adverse reactions during treatment with somatropin (including events observed in patients who received brands of somatropin other than Humatrope):

Clinical Trials Experience

Because clinical trials are conducted under varying conditions, adverse reaction rates observed during the clinical trials performed with one somatropin formulation cannot always be directly compared to the rates observed during the clinical trials performed with a second somatropin formulation, and may not reflect the adverse reaction rates observed in practice.

Pediatric Patients

GH Deficiency

As with all protein pharmaceuticals, a small percentage of patients may develop antibodies to the protein. During the first 6 months of Humatrope therapy in 314 naive patients, only 1.6% developed specific antibodies to Humatrope (binding capacity ≥ 0.02 mg/L). None had antibody concentrations which exceeded 2 mg/L. Throughout 8 years of this same study, two patients (0.6%) had binding capacity > 2 mg/L. Neither patient demonstrated a decrease in growth velocity at or near the time of increased antibody production. It has been reported that growth attenuation from pituitary-derived GH may occur when antibody concentrations are > 1.5 mg/L.

In addition to an evaluation of compliance with the treatment program and of thyroid status, testing for antibodies to somatropin should be carried out in any patient who fails to respond to therapy.

In studies with GH deficient pediatric patients, injection site pain was reported infrequently. A mild and transient edema, which appeared in 2.5% of patients, was observed early during the course of treatment.

Turner Syndrome

In a randomized, concurrent-controlled, open-label trial, there was a statistically significant increase in the occurrence of otitis media (43% vs. 26%), ear disorders (18% vs. 5%) and surgical procedures (45% vs. 27%) in patients receiving Humatrope compared with untreated control patients (Table 1). A similar increase in otitis media was observed in an 18-month placebo-controlled trial.

Table 1: Treatment-Emergent Adverse Reactions of Special Interest by Treatment Group in Turner Syndrome

Adverse Reaction Treatment Groupa Significance
Untreated Humatropeb
Total Number of Patients 62 74  
Surgical procedure 17 (27.4%) 33 (44.6%) p ≤ 0.05
Otitis media 16 (25.8%) 32 (43.2%) p ≤ 0.05
Ear disorders 3 (4.8%) 13 (17.6%) p ≤ 0.05
aOpen-label study.
bDose=0.3 mg/kg/wk.

Idiopathic Short Stature

In a randomized, placebo-controlled study of Humatrope treatment (0.22 mg/kg/week) to adult height in patients with idiopathic short stature, the adverse events reported in Humatrope-treated patients (Table 2) were similar to those observed in other pediatric populations treated with Humatrope. Mean serum glucose concentration did not change during Humatrope treatment. Mean fasting serum insulin concentration increased 10% in the Humatrope treatment group at the end of treatment relative to baseline, but remained within the normal reference range. For the same duration of treatment, the mean fasting serum insulin concentration decreased by 2% in the placebo group. The occurrence rates of above-range values for glucose, insulin, and HbA1c were similar in the Humatrope (somatropin)-and placebo-treated groups. No patient developed diabetes mellitus. Consistent with the known mechanism of growth hormone action, Humatrope-treated patients had greater mean increases, relative to baseline, in serum insulin-like growth factor-I (IGF-I) than placebo-treated patients at each study observation. However, there was no significant difference between the Humatrope and placebo treatment groups in the proportion of patients who had at least one serum IGF-I concentration more than 2.0 SD above the age-and gender-appropriate mean (Humatrope: 9 of 35 patients [26%]; placebo: 7 of 28 patients [25%]).

Table 2: Non-serious Clinically Significant Treatment-Emergent Adverse Reactions by Treatment Group in Idiopathic Short Stature

Adverse Reaction Treatment Group
Placebo Humatrope
Total Number of Patients 31 37
Scoliosis 4 (12.9%) 7 (18.9%)
Otitis media 2 (6.5%) 6 (16.2%)
Hyperlipidemia 1 (3.2%) 3 (8.1%)
Gynecomastia 1 (3.2%) 2 (5.4%)
Hip pain 0 1 (2.7%)
Arthralgia 1 (3.2%) 4 (10.8%)
Arthrosis 2 (6.5%) 4 (10.8%)
Myalgia 4 (12.9%) 9 (24.3%)
Hypertension 0 1 (2.7%)

The adverse events observed in the dose-response study (239 patients treated for 2 years) did not indicate a pattern suggestive of a somatropin dose effect. Among Humatrope dose groups, mean fasting blood glucose, mean glycosylated hemoglobin, and the incidence of elevated fasting blood glucose concentrations were similar. One patient developed abnormalities of carbohydrate metabolism (glucose intolerance and high serum HbA1c) on treatment.

SHOX Deficiency

Clinically significant adverse events (adverse events previously observed in association with growth hormone treatment in general) were assessed prospectively during the 2-year randomized, open-label study; those observed are presented in Table 3. In both treatment groups, the mean fasting plasma glucose concentration at the end of the first year was similar to the baseline value and remained in the normal range. No patient developed diabetes mellitus or had an above normal value for fasting plasma glucose at the end of one-year of treatment. During the 2 year study period, the proportion of patients who had at least one IGF-I concentration greater than 2.0 SD above the age-and gender-appropriate mean was 10 of 27 [37.0%] for the Humatrope-treated group vs. 0 of 24 patients [0.0%] for the untreated group. The proportion of patients who had at least one IGFBP-3 concentration greater than 2.0 SD above the age and gender appropriate mean was 16 of 27 [59.3%] for the Humatrope treated group vs. 7 of 24 [29.2%] for the untreated group.

Table 3: Clinically Significant Treatment-Emergent Adverse Reactionsa,b by Treatment Group in Patients with SHOX Deficiency

Adverse Reaction Treatment Group
Untreated Humatrope
Total Number of Patients 25 27
Patients with at least one event 2 5
Arthralgia 2 (8.0%) 3 (11.1%)
Gynecomastiac 0 (0.0%) 1 (8.3%)
Excessive number of cutaneous nevi 0 (0.0%) 2 (7.4%)
Scoliosis 0 (0.0%) 1 (3.7%)
aAll events were non-serious.
bEvents are included only if reported for a greater number of Humatrope-treated than Untreated patients.
cPercentage calculated for males only (1/12).

Small for Gestational Age

Study 1 - In a 2-year, multicenter, randomized study, 193 non-GH deficient children with short stature born SGA who failed to demonstrate catch-up growth were treated with 2 different Humatrope treatment regimens: a fixed dose of 0.067 mg/kg/day (FHD group) or an individually adjusted dose regimen (IAD group; starting dose 0.035 mg/kg/day which could be increased as early as Month 3 to 0.067 mg/kg/day based on a validated growth prediction model). The most frequently reported adverse events were common childhood infectious diseases. Adverse events possibly/probably related to Humatrope were otitis media and headaches (where there was a suggestion of a modest dose response), and slipped capital femoral epiphysis (1 child) [see WARNINGS AND PRECAUTIONS and section on Most Serious and/or Most Frequently Observed Adverse Reactions]. There were no clear cut cases of new-onset diabetes mellitus, no children treated for hyperglycemia, and no children whose fasting blood glucose exceeded 126 mg/dL at any time during the study. However, 6 children (4 in the FHD group and 2 in the IAD group whose dose was increased from 0.035 mg/kg/day to 0.067 mg/kg/day [one at Month 3 and one at Year 1]) manifested impaired fasting glucose at Year 2. Two of these six children displayed impaired fasting glucose during the study as well, and one of them was required to discontinue Humatrope at Month 15 as a consequence [see WARNINGS AND PRECAUTIONS and section on Most Serious and/or Most Frequently Observed Adverse Reactions]. A modestly dose-dependent increase in mean serum IGF-I SDS concentrations within the reference range was observed; of note, at study completion, 20-25% of these children had serum IGF-I SDS values > +2.

Study 2 - A 2-year, open-label, single-arm study of Humatrope at a dosage of 0.067 mg/kg/day in 35 non-GH deficient children with short stature born SGA who failed to demonstrate catch-up growth did not reveal further safety data of note.

Study 3 - Additional safety information was obtained from 340 short children born SGA followed in an observational study who received an average Humatrope dosage of 0.041 mg/kg/day (maximum dose: 0.084 mg/kg/day) for an average of 3.0 years. Type 2 diabetes mellitus apparently precipitated by Humatrope therapy was reported in a single patient, but appeared to resolve after discontinuation of Humatrope treatment, as the child had a normal oral glucose tolerance test and was receiving no antihyperglycemic medications 9 months after the drug was discontinued. One patient manifested carpal tunnel syndrome [see section on Most Serious and/or Most Frequently Observed Adverse Reactions] and another developed an exacerbation of preexisting scoliosis [see WARNINGS AND PRECAUTIONS and section on Most Serious and/or Most Frequently Observed Adverse Reactions] which may have been related to Humatrope treatment.

In both Study 1 and Study 2, after treatment with Humatrope, bone maturation did not accelerate excessively, and the timing of puberty was age-appropriate in boys and girls.

Therefore, it can be concluded that no novel adverse events potentially related to treatment with Humatrope were reported in either short-term study or were apparent after a review of the post-marketing, observational, safety database.

Adult Patients

In clinical studies in which high doses of Humatrope were administered to healthy adult volunteers, the following events occurred infrequently: headache, localized muscle pain, weakness, mild hyperglycemia, and glucosuria.

Adult-Onset GH Deficiency

In the first 6 months of controlled blinded trials during which patients received either Humatrope or placebo, adult-onset GH deficient adults who received Humatrope experienced a statistically significant increase in edema (Humatrope 17.3% vs. placebo 4.4%, p=0.043) and peripheral edema (11.5% vs. 0%, respectively, p=0.017). In patients with adult-onset GH deficiency, edema, muscle pain, joint pain, and joint disorder were reported early in therapy and tended to be transient or responsive to dosage titration.

Two of 113 adult-onset patients developed carpal tunnel syndrome after beginning maintenance therapy without a low dose (0.00625 mg/kg/day) lead-in phase. Symptoms abated in these patients after dosage reduction.

All treatment-emergent adverse events with ≥ 5% overall occurrence rate during 12 or 18 months of replacement therapy with Humatrope are shown in Table 4 (adult-onset patients) and in Table 5 (childhood-onset patients).

Adult patients treated with Humatrope who had been diagnosed with GH deficiency in childhood reported side effects less frequently than those with adult-onset GH deficiency.

Table 4: Treatment-Emergent Adverse Reactions with ≥ 5% Overall Occurrence in Adult-Onset Growth Hormone-Deficient Patients Treated with Humatrope for 18 Months as Compared with 6-Month Placebo and 12-Month Humatrope Exposurea

Adverse Reaction 18 Months Exposure [Placebo (6 Months)/GH (12 Months)]
(N=46)
18 Months GH Exposure
(N=52)
n % n %
Edemab 7 15.2 11 21.2
Arthralgia 7 15.2 9 17.3
Paresthesia 6 13.0 9 17.3
Myalgia 6 13.0 7 13.5
Pain 6 13.0 7 13.5
Rhinitis 5 10.9 7 13.5
Peripheral edemac 8 17.4 6 11.5
Back pain 5 10.9 5 9.6
Headache 5 10.9 4 7.7
Hypertension 2 4.3 4 7.7
Acne 0 0 3 5.8
Joint disorder 1 2.2 3 5.8
Surgical procedure 1 2.2 3 5.8
Flu syndrome 3 6.5 2 3.9
aAbbreviations: GH=Humatrope; N=number of patients receiving treatment in the period stated; n=number of patients reporting each treatment-emergent adverse event.
bp=0.04 as compared to placebo (6 months).
cp=0.02 as compared to placebo (6 months).

Childhood-Onset GH Deficiency

Two double-blind, placebo-controlled trials were conducted in 67 adult patients with childhood-onset GH deficiency who had received previous somatropin treatment during childhood. Patients were randomized to receive either placebo injections or Humatrope (0.00625 mg/kg/day [6.25 μg/kg/day] for the first 4 weeks, then 0.0125 mg/kg/day [12.5 μg/kg/day] thereafter) for the first 6 months, followed by open-label Humatrope for the next 12 months for all patients. The patients in these studies reported side effects less frequently than those with adult-onset GH deficiency. During the placebo-controlled phase (first 6 months) of the study, elevations of serum glutamic oxaloacetic transferase were reported significantly more often for Humatrope-treated (12.5%) than placebo-treated patients (0.0%, p=0.031). No other events were reported significantly more often for Humatrope-treated patients during the placebo-controlled phase. The following events were reported for at least 5% of patients in either of the 2 treatment groups over the 18-month duration of the study, listed in descending order of maximum frequency for either group: aspartate aminotransferase increased 13%, headache 11%, edema 9%, pain 9%, alanine aminotransferase increased 6%, asthenia 6%, myalgia 6%, respiratory disorder 6%.

Table 5: Treatment-Emergent Adverse Reactions with ≥ 5% Overall Occurrence in Childhood-Onset Growth Hormone-Deficient Patients Treated with Humatrope for 18 Months as Compared with 6-Month Placebo and 12-Month Humatrope Exposurea

Adverse Reaction 18 Months Exposure [Placebo (6 Months)/GH (12 Months)] (N=35) 18 Months GH Exposure (N=32)
n % n %
Flu syndrome 8 22.9 5 15.6
AST increasedb 2 5.7 4 12.5
Headache 4 11.4 3 9.4
Asthenia 1 2.9 2 6.3
Cough increased 0 0 2 6.3
Edema 3 8.6 2 6.3
Hypesthesia 0 0 2 6.3
Myalgia 2 5.7 2 6.3
Pain 3 8.6 2 6.3
Rhinitis 2 5.7 2 6.3
ALT increased 2 5.7 2 6.3
Respiratory disorder 2 5.7 1 3.1
Gastritis 2 5.7 0 0
Pharyngitis 5 14.3 1 3.1
aAbbreviations: GH=Humatrope; N=number of patients receiving treatment in the period stated; n=number of patients reporting each treatment-emergent adverse event; ALT=alanine aminotransferase, formerly SGPT; AST=aspartate aminotransferase, formerly SGOT.
bp=0.03 as compared to placebo (6 months).

Post-Marketing Experience

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.

Other adverse events that have been reported in somatropin-treated patients include the following:

Neurologic - Headaches (common in children and occasional in adults).

Skin - Increase in size or number of cutaneous nevi, especially in patients with Turner syndrome and those with SHOX deficiency [see WARNINGS AND PRECAUTIONS].

Endocrine - Gynecomastia.

Gastrointestinal - Pancreatitis. Cases of pancreatitis have been reported rarely in children and adults receiving somatropin treatment, with some evidence supporting a greater risk in children compared with adults. Published literature indicates that girls who have Turner syndrome may be at greater risk than other somatropin-treated children. Pancreatitis should be considered in any somatropin-treated patient, especially a child, who develops abdominal pain [see WARNINGS AND PRECAUTIONS].

Metabolic - New-onset type 2 diabetes mellitus in patients.

Neoplasia - Leukemia has been reported in a small number of GH deficient children treated with somatropin, somatrem (methionylated rhGH), and GH of pituitary origin. It is uncertain whether these cases of leukemia are related to GH therapy, the pathology of GH deficiency 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 GH deficiency, if any, remains to be established [see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS].

In an ongoing post-marketing observational study of somatropin treatment in 3,102 GH-deficient adults, hypertension, dyspnea, and sleep apnea were reported by 1% to less than 10% of patients after various durations of treatment.

Read the entire FDA prescribing information for Humatrope (Somatropin rDNA Origin) »

A A A

Humatrope - User Reviews

Humatrope User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Humatrope sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Women's Health

Find out what women really need.