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Genotropin

Last reviewed on RxList: 11/11/2019
Genotropin Side Effects Center

Last reviewed on RxList 11/11/2019

What Is Genotropin?

Genotropin (somatropin [rDNA origin]) for Injection is a form of human growth hormone used to treat:

Genotropin is also used to:

What Are Side Effects for Genotropin?

Common side effects of Genotropin include:

Tell your doctor if you have serious side effects of Genotropin including:

  • development of a limp,
  • persistent fatigue,
  • unusual or unexplained weight gain,
  • persistent cold intolerance,
  • persistent slow heartbeat,
  • fast heartbeat,
  • ear pain or itching,
  • hearing problems,
  • joint/hip/knee pain,
  • numbness or tingling,
  • unusual increase in thirst or urination,
  • swelling hands/ankles/feet,
  • change in the appearance or size of any mole,
  • persistent nausea or vomiting, or
  • severe stomach or abdominal pain.

Dosage for Genotropin

Dosage and administration schedule for Genotropin is individualized based on the growth response of each patient. Dose is determined by the patient's weight and is given as an intravenous injection

What Drugs, Substances, or Supplements Interact with Genotropin?

Genotropin may interact with:

  • insulin or take oral diabetes medicine,
  • steroids,
  • seizure medication,
  • birth control pills,
  • anabolic steroids, or
  • hormone replacement medications for men or women

Other drugs may interact with Genotropin. Tell your doctor all prescription and over-the-counter medications and supplements you use.

Genotropin During Pregnancy and Breastfeeding

Genotropin should be used only when prescribed during pregnancy. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Genotropin (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.

QUESTION

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Genotropin Consumer Information

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

Serious breathing problems may occur in patients with Prader-Willi syndrome who use somatropin. 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.

Also call your doctor at once if you have:

  • pain in your knees or hips, walking with a limp;
  • ear pain, swelling, warmth, or drainage;
  • numbness or tingling in your wrist, hand, or fingers;
  • severe swelling or puffiness in your hands and feet;
  • changes in behavior;
  • vision problems, unusual headaches;
  • changes in the shape or size of a mole;
  • pain or swelling in your joints;
  • pancreatitis--severe pain in your upper stomach spreading to your back, nausea and vomiting;
  • high blood sugar--increased thirst, increased urination, dry mouth, fruity breath odor;
  • increased pressure inside the skull--severe headaches, ringing in your ears, dizziness, nausea, vision problems, pain behind your eyes; or
  • signs of an adrenal gland problem--extreme weakness, severe dizziness, weight loss, changes in skin color, feeling very weak or tired.

Common side effects may include:

  • pain, itching, or skin changes where the medicine was injected;
  • swelling, rapid weight gain;
  • muscle or joint pain;
  • numbness or tingling;
  • stomach pain, gas;
  • headache, back pain; or
  • cold or flu symptoms, stuffy nose, sneezing, sore throat, ear pain.

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 Genotropin (Somatropin [rDNA origin])

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Digestive Disorders: Common Misconceptions See Slideshow
Genotropin Professional Information

SIDE EFFECTS

The following important adverse reactions are also described elsewhere in the labeling:

  • Increased mortality in patients with acute critical illness [see WARNINGS AND PRECAUTIONS]
  • Fatalities in children with Prader-Willi syndrome [see WARNINGS AND PRECAUTIONS]
  • Neoplasms [see WARNINGS AND PRECAUTIONS]
  • Glucose intolerance and diabetes mellitus [see WARNINGS AND PRECAUTIONS]
  • Intracranial hypertension [see WARNINGS AND PRECAUTIONS]
  • Severe hypersensitivity [see WARNINGS AND PRECAUTIONS]
  • Fluid retention [see WARNINGS AND PRECAUTIONS]
  • Hypoadrenalism [see WARNINGS AND PRECAUTIONS]
  • Hypothyroidism [see WARNINGS AND PRECAUTIONS]
  • Slipped capital femoral epiphysis in pediatric patients [see WARNINGS AND PRECAUTIONS]
  • Progression of preexisting scoliosis in pediatric patients [see WARNINGS AND PRECAUTIONS]
  • Otitis media and cardiovascular disorders in patients with Turner syndrome [see WARNINGS AND PRECAUTIONS]
  • Lipoatrophy [see WARNINGS AND PRECAUTIONS]
  • Pancreatitis [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 Children With GHD

In clinical studies with GENOTROPIN in pediatric GHD patients, the following events were reported infrequently: injection site reactions, including pain or burning associated with the injection, fibrosis, nodules, rash, inflammation, pigmentation, or bleeding; lipoatrophy; headache; hematuria; hypothyroidism; and mild hyperglycemia.

Clinical Trials In PWS

In two clinical studies with GENOTROPIN in pediatric patients with Prader-Willi syndrome, 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 GENOTROPIN, 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. Anti-hGH antibodies were not detected in any of the patients treated with GENOTROPIN.

Clinical Trials In Children With Turner Syndrome

In two clinical studies with GENOTROPIN in pediatric patients with Turner syndrome, the most frequently reported adverse events were respiratory illnesses (influenza, tonsillitis, otitis, sinusitis), joint pain, and urinary tract infection. The only treatment-related adverse event that occurred in more than 1 patient was joint pain.

Clinical Trials In Children With Idiopathic Short Stature

In two open-label clinical studies with GENOTROPIN in pediatric patients with ISS, the most commonly encountered adverse events include upper respiratory tract infections, influenza, tonsillitis, nasopharyngitis, gastroenteritis, headaches, increased appetite, pyrexia, fracture, altered mood, and arthralgia. In one of the two studies, during GENOTROPIN treatment, 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 GENOTROPIN 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 1 displays the adverse events reported by 5% or more of adult GHD patients in clinical trials after various durations of treatment with GENOTROPIN. 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 1 : Adverse Events Reported by ≥ 5% of 1,145 Adult GHD Patients During Clinical Trials of GENOTROPIN and Placebo, Grouped by Duration of Treatment

Adverse Event Double Rlind Phase Open Label Phase GENOTROPIN
Placebo 0-6 mo.
n = 572 % Patients
GENOTROPIN 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 17.5 * 5.6 0 1.7
Arthralgia 4.2 17.3 * 6.9 6.3 3.3
Upper respiratory infection 14.5 15.5 13.1 15.9 13.3
Pain, extremities 5.9 14.7 * 6.7 1.6 3.3
Edema, peripheral 2.6 10.8 * 3.0 0 0
Paresthesia 1.9 9.6 * 2.2 3.2 0
Headache 7.7 9.9 6.2 0 0
Stiffness of extremities 1.6 7.9 * 2.4 1.6 0
Fatigue 3.8 5.8 4.6 6.3 1.7
Myalgia 1.6 4.9 * 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.
* Increased significantly when compared to placebo, P ≤.025: Fishers 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 GENOTROPIN. All 12 patients had predisposing factors, e.g., elevated glycated hemoglobin levels and/or marked obesity, prior to receiving GENOTROPIN. Of the 3,031 patients receiving GENOTROPIN, 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.

Anti-hGH Antibodies

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 GENOTROPIN 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.

In 419 pediatric patients evaluated in clinical studies with GENOTROPIN lyophilized powder, 244 had been treated previously with GENOTROPIN or other growth hormone preparations and 175 had received no previous growth hormone therapy. Antibodies to growth hormone (anti-hGH antibodies) were present in six previously treated patients at baseline. Three of the six became negative for anti-hGH antibodies during 6 to 12 months of treatment with GENOTROPIN. Of the remaining 413 patients, eight (1.9%) developed detectable anti-hGH antibodies during treatment with GENOTROPIN; none had an antibody binding capacity > 2 mg/L. There was no evidence that the growth response to GENOTROPIN was affected in these antibody-positive patients.

Periplasmic Escherichia coli Peptides

Preparations of GENOTROPIN contain a small amount of periplasmic Escherichia coli peptides (PECP). Anti-PECP antibodies are found in a small number of patients treated with GENOTROPIN, but these appear to be of no clinical significance.

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.

Serious systemic hypersensitivity reactions including anaphylactic reactions and angioedema have been reported with post-marketing use of somatropin products [see WARNINGS AND PRECAUTIONS].

Leukemia has been reported in a small number of GHD 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 serious adverse reactions have been observed with use of somatropin (including events observed in patients who received brands of somatropin other than GENOTROPIN): acute critical illness [see WARNINGS AND PRECAUTIONS] , sudden death [see WARNINGS AND PRECAUTIONS] , intracranial tumors [see WARNINGS AND PRECAUTIONS] , central hypothyroidism [see WARNINGS AND PRECAUTIONS] , cardiovascular disorders, and pancreatitis [see WARNINGS AND PRECAUTIONS] .

Slipped capital femoral epiphysis and Legg-Calve-Perthes disease (osteonecrosis/avascular necrosis; occasionally associated with slipped capital femoral epiphysis) have been reported in children treated with growth hormone [see WARNINGS AND PRECAUTIONS]. Cases have been reported with GENOTROPIN.

The following additional adverse reactions have been observed during the appropriate use of somatropin: headaches (children and adults), gynecomastia (children), and significant diabetic retinopathy.

New-onset type 2 diabetes mellitus has been reported.

Read the entire FDA prescribing information for Genotropin (Somatropin [rDNA origin])

Related Resources for Genotropin

Read the Genotropin User Reviews »

© Genotropin Patient Information is supplied by Cerner Multum, Inc. and Genotropin Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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