Genotropin
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Genotropin
Genotropin Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Genotropin (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.
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. 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 should be used only when prescribed during pregnancy. It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.
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.
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.
Genotropin 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 Genotropin (Somatropin [rDNA origin]) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Genotropin Overview - Patient Information: Side Effects
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 Genotropin (Somatropin [rDNA origin])»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Genotropin 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:
- b Sudden 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]
- b Intracranial 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, b Glucose intolerance including impaired glucose tolerance/impaired fasting glucose as well as overt diabetes mellitus [see WARNINGS AND PRECAUTIONS]
- b Intracranial hypertension [see WARNINGS AND PRECAUTIONS]
- b Significant diabetic retinopathy [see CONTRAINDICATIONS]
- b Slipped capital femoral epiphysis in pediatric patients [see WARNINGS AND PRECAUTIONS]
- b Progression of preexisting scoliosis in pediatric patients [see WARNINGS AND PRECAUTIONS]
- a Fluid retention manifested by edema, arthralgia, myalgia, nerve compression syndromes including carpal tunnel syndrome/paraesthesias [see WARNINGS AND PRECAUTIONS]
- a Unmasking of latent central hypothyroidism [see WARNINGS AND PRECAUTIONS]
- a Injection 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 children with GHD
In clinical studies with GENOTROPIN (somatropin [rdna origin]) 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 (somatropin [rdna origin]) 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 (somatropin [rdna origin]) , 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 (somatropin [rdna origin]) .
Clinical Trials in children with Turner Syndrome
In two clinical studies with GENOTROPIN (somatropin [rdna origin]) 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 (somatropin [rdna origin]) 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 (somatropin [rdna origin]) 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 (somatropin [rdna origin]) 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 (somatropin [rdna origin]) . 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 (somatropin [rdna origin]) and Placebo, Grouped by Duration
of Treatment
| Adverse Event | Double Blind Phase | Open Label Phase GENOTROPIN |
|||
| Placebo 0-6 mo. n = 572 % Patients |
GENOTROPIN (somatropin [rdna origin]) 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 |
| * Increased significantly when compared to
placebo, P ≤ .025: Fisher´s Exact Test (one-sided) n = number of patients receiving treatment during the indicated period. % = percentage of patients who reported the event during the indicated period. |
|||||
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 (somatropin [rdna origin]) . All 12 patients had predisposing factors, e.g., elevated glycated hemoglobin levels and/or marked obesity, prior to receiving GENOTROPIN (somatropin [rdna origin]) . Of the 3,031 patients receiving GENOTROPIN (somatropin [rdna origin]) , 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 protein drugs, a small percentage of patients may develop antibodies to the protein. GH antibodies with binding capacities lower than 2 mg/L have not been associated with growth attenuation. In a very small number of patients, when binding capacity was greater than 2 mg/L, interference with the growth response was observed.
In 419 pediatric patients evaluated in clinical studies with GENOTROPIN (somatropin [rdna origin]) lyophilized powder, 244 had been treated previously with GENOTROPIN (somatropin [rdna origin]) 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 (somatropin [rdna origin]) . Of the remaining 413 patients, eight (1.9%) developed detectable anti-hGH antibodies during treatment with GENOTROPIN (somatropin [rdna origin]) ; none had an antibody binding capacity > 2 mg/L. There was no evidence that the growth response to GENOTROPIN (somatropin [rdna origin]) was affected in these antibody-positive patients.
Periplasmic Escherichia coli Peptides
Preparations of GENOTROPIN (somatropin [rdna origin]) contain a small amount of periplasmic Escherichia coli peptides (PECP). Anti-PECP antibodies are found in a small number of patients treated with GENOTROPIN (somatropin [rdna origin]) , but these appear to be of no clinical significance.
Post-Marketing Surveillance
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 appropriate use of somatropin: headaches (children and adults),rare gynecomastia (children), and rare pancreatitis (children).
Read the entire FDA prescribing information for Genotropin (Somatropin [rDNA origin]) »
Additional Genotropin Information
Genotropin - User Reviews
Genotropin User Reviews
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Report Problems to the Food and Drug Administration
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