Omnitrope

Omnitrope

Omnitrope Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Omnitrope (somatropin [rDNA origin] 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.

The Omnitrope dosage and administration schedule should be individualized based on the growth response of each patient, or the condition being treated. Omnitrope may interact with insulin or oral diabetes medicines, steroids, cyclosporine, seizure medication, birth control pills, or hormone replacement medications for men or women. Tell your doctor all medications and supplements you use. Omnitrope should be used only when prescribed during pregnancy. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Omnitrope (somatropin [rDNA origin] 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.

Omnitrope 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 Omnitrope (Somatropin [ rDNA origin] Injection) »

What is Prescribing information?

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

Omnitrope FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Most Serious and/or Most Frequently Observed Adverse Reactions

This list presents the most seriousb and/or most frequently observeda adverse reactions during treatment with somatropin:

  • bSudden death in pediatric patients with Prader-Willi Syndrome with risk factors including severe obesity, history of upper airway obstruction or sleep apnea and unidentified respiratory infection [see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS].
  • bIntracranial tumors, in particular meningiomas, in teenagers/young adults treated with radiation to the head as children for a first neoplasm and somatropin [see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS]
  • a,bGlucose intolerance including impaired glucose tolerance/impaired fasting glucose as well as overt diabetes mellitus [WARNINGS AND PRECAUTIONS]
  • bIntracranial hypertension [see WARNINGS AND PRECAUTIONS]
  • bSignificant diabetic-retinopathy [see CONTRAINDICATIONS]
  • bSlipped capital femoral epiphysis in pediatric patients [see WARNINGS AND PRECAUTIONS]
  • bProgression of preexisting scoliosis in pediatric patients [see WARNINGS AND PRECAUTIONS]
  • bPancreatitis [see WARNINGS AND PRECAUTIONS]
  • aFluid retention manifested by edema, arthralgia, myalgia, nerve compression syndromes including carpal tunnel syndrome/paraesthesias [see WARNINGS AND PRECAUTIONS]
  • aUnmasking of latent central hypothyroidism [see WARNINGS AND PRECAUTIONS]
  • aInjection site reactions/rashes and lipoatrophy (as well as rare generalized hypersensitivity reactions) [see WARNINGS AND PRECAUTIONS]

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.

Clinical Trials in Pediatric GHD Patients

The following events were observed during clinical studies with Omnitrope® Cartridge conducted in children with GHD:

Table 1: Incidence of Adverse Reactions Reported in ≥ 5% Pediatric Patients with GHD During Treatment with Omnitrope® Cartridge (N=86)

Adverse Event n (%)
Elevated HbA1c 12 (14%)
Eosinophilia 10 (12%)
Hematoma 8 (9%)
n=number of patients receiving treatment
n=number of patients who reported the event during study period
%=percentage of patients who reported the event during study period

The following events were observed during clinical studies with Omnitrope® for injection conducted in children with GHD:

Table 2: Incidence of Adverse Reactions Reported in ≥ 5% Pediatric Patients with GHD During Treatment with Omnitrope® for Injection (N=44)

Adverse Event n (%)
Hypothyroidism 7 (16%)
Eosinophilia 5 (11%)
Elevated HbA1c 4 (9%)
Hematoma 4 (9%)
Headache 3 (7%)
Hypertriglyceridemia 2 (5%)
Leg Pain 2 (5%)
n=number of patients receiving treatment
n=number of patients who reported the event during study
period %= percentage of patients who reported the event during study period

Clinical Trials in PWS

In two clinical studies in pediatric patients with Prader-Willi Syndrome carried out with another somatropin product, the following drug-related events were reported: edema, aggressiveness, arthralgia, benign intracranial hypertension, hair loss, headache, and myalgia.

Clinical Trials in Children with SGA

In clinical studies of 273 pediatric patients born small for gestational age treated with another somatropin product, the following clinically significant events were reported: mild transient hyperglycemia, one patient with benign intracranial hypertension, two patients with central precocious puberty, two patients with jaw prominence, and several patients with aggravation of preexisting scoliosis, injection site reactions, and self-limited progression of pigmented nevi.

Clinical trials in children with Idiopathic Short Stature

In two open-label clinical studies conducted with another somatropin product in pediatric patients with ISS, the most commonly encountered adverse events were upper respiratory tract infections, influenza, tonsillitis, nasopharyngitis, gastroenteritis, headaches, increased appetite, pyrexia, fracture, altered mood, and arthralgia. In one of the two studies during treatment with this other somatropin product, the mean IGF-1 standard deviation (SD) scores were maintained in the normal range. IGF-1 SD scores above +2 SD were observed as follows: 1 subject (3%), 10 subjects (30%) and 16 subjects (38%) in the untreated control, 0.23 and the 0.47 mg/kg/week groups respectively, had at least one measurement; while 0 subjects (0%), 2 subjects (7%) and 6 subjects (14%) had two or more consecutive IGF-1 measurements above +2 SD.

Clinical Trials in Adults with GHD

In clinical trials with another somatropin product in 1,145 GHD adults, the majority of the adverse events consisted of mild to moderate symptoms of fluid retention, including peripheral swelling, arthralgia, pain and stiffness of the extremities, peripheral edema, myalgia, paresthesia, and hypoesthesia. These events were reported early during therapy, and tended to be transient and/or responsive to dosage reduction.

Table 3 displays the adverse events reported by 5% or more of adult GHD patients in clinical trials after various durations of treatment with another somatropin product. Also presented are the corresponding incidence rates of these adverse events in placebo patients during the 6-month double-blind portion of the clinical trials.

Table 3: Adverse Events Reported by ≥ 5% of 1,145 Adult GHD Patients During Clinical Trials of Another Somatropin Product and Placebo, Grouped by Duration of Treatment

Adverse Event Double Blind Phase Open Label Phase Another Somatropin Product
Placebo 0-6 mo.
(n = 572)
% Patients
Another Somatropin Product 0-6 mo.
(n = 573)
% Patients
6-12 mo
.(n = 504)
% Patients
12-18 mo.
(n = 63)
% Patients
18-24 mo.
(n = 60)
% Patients
Swelling, peripheral 5.1 17.5a 5.6 0 1.7
Arthralgia 4.2 17.3a 6.9 6.3 3.3
Upper respiratory infection 14.5 15.5 13.1 15.9 13.3
Pain, extremities 5.9 14.7a 6.7 1.6 3.3
Edema, peripheral 2.6 10.8a 3.0 0 0
Paresthesia 1.9 9.6a 2.2 3.2 0
Headache 7.7 9.9 6.2 0 0
Stiffness of extremities 1.6 7.9a 2.4 1.6 0
Fatigue 3.8 5.8 4.6 6.3 1.7
Myalgia 1.6 4.9a 2.0 4.8 6.7
Back pain 4.4 2.8 3.4 4.8 5.0
n=number of patients receiving treatment during the indicated period %=percentage of patients who reported the event during the indicated period
a Increased significantly when compared to placebo, P ≤ .025: Fisher's Exact Test (one-sided)

Post-Trial Extension Studies in Adults

In expanded post-trial extension studies, diabetes mellitus developed in 12 of 3,031 patients (0.4%) during treatment with another somatropin product. All 12 patients had predisposing factors, e.g., elevated glycated hemoglobin levels and/or marked obesity, prior to receiving this other somatropin product. Of the 3,031 patients receiving this other somatropin product, 61 (2%) developed symptoms of carpal tunnel syndrome, which lessened after dosage reduction or treatment interruption (52) or surgery (9). Other adverse events that have been reported include generalized edema and hypoesthesia.

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 influences by several factors including assay methodology, sample handling, timing of sample col,ection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to OMNITROPE with the incidence of antibodies to other products may be misleading. In the case of growth hormone, antibodies with binding capacities lower than 2 mg/mL have not been associated with growth attenuation. In a very small number of patients treated with somatropin, when binding capacity was greater than 2 mg/mL, interference with the growth response was observed.

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.

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 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, if any, remains to be established [see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS].

The following additional adverse reactions have been observed during the use of somatropin: headaches (children and adults), gynecomastia (children), and pancreatitis (children and adults [see WARNINGS AND PRECAUTIONS]).

Metabolic

New-onset type 2 diabetes mellitus in patients.

Read the entire FDA prescribing information for Omnitrope (Somatropin [ rDNA origin] Injection) »

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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.


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