Nutropin AQ Side Effects

Generic Name: somatropin

Please note - some side effects for Nutropin AQ may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Nutropin AQ - for the Consumer

Nutropin AQ Pen

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Nutropin AQ Pen:

Discomfort at the injection site; mild swelling (eg, of the hands or feet); muscle or joint pain.

Seek medical attention right away if any of these SEVERE side effects occur when using Nutropin AQ Pen:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); body pain or stiffness; burning, tingling, itching, or numbness in the palm of the hand, fingers, or wrist; change in appearance or size of a mole; chest pain; confusion; constant feeling of need to empty the bowel; curvature of the spine; depression; ear pain, discharge, or discomfort; excessive thirst or hunger; fast heartbeat; fever; frequent urination; hearing problems; increased pressure in the head or eye; infection; nausea; one-sided weakness; severe or persistent stomach or back pain; severe or persistent swelling of the ankles, legs, hands, or feet; slurred speech; sudden, severe, or persistent headache or dizziness; visual changes; vomiting.

Children: Ear discomfort or infection; fatigue or weakness; fever, persistent cough, or trouble breathing; hip or knee pain; leukemia; limp; seizures; snoring or irregular breathing during sleep; worsening of psoriasis.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Nutropin AQ

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Nutropin AQ:

Discomfort at the injection site; mild swelling (eg, of the hands or feet); muscle or joint pain.

Seek medical attention right away if any of these SEVERE side effects occur when using Nutropin AQ:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in the urine; breast enlargement in males; burning, tingling, or numbness; change in appearance or size of a mole; chest pain or discomfort; confusion; difficult or painful urination; ear pain, discharge, or discomfort; fever, chills, or persistent cough or sore throat; hearing problems; hip or knee pain; limp; mental or mood changes (eg, aggressiveness, depression); nausea or vomiting; new growth on the skin; one-sided weakness; severe or persistent stomach or back pain; severe or persistent swelling of the ankles, legs, hands, or feet; shortness of breath; slurred speech; snoring or irregular breathing during sleep; sudden, severe, or persistent headache or dizziness; thickened or hardened skin at the injection site; trouble breathing; unusual bruising; visual changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Nutropin AQ NuSpin

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Nutropin AQ NuSpin:

Discomfort at the injection site; mild swelling (eg, of the hands or feet); muscle or joint pain.

Seek medical attention right away if any of these SEVERE side effects occur when using Nutropin AQ NuSpin:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); body pain or stiffness; burning, tingling, itching, or numbness in the palm of the hand, fingers, or wrist; change in appearance or size of a mole; chest pain; confusion; constant feeling of need to empty the bowel; curvature of the spine; depression; ear pain, discharge, or discomfort; excessive thirst or hunger; fast heartbeat; fever; frequent urination; hearing problems; increased pressure in the head or eye; infection; nausea; one-sided weakness; severe or persistent stomach or back pain; severe or persistent swelling of the ankles, legs, hands, or feet; slurred speech; sudden, severe, or persistent headache or dizziness; visual changes; vomiting.

Children: Ear discomfort or infection; fatigue or weakness; fever, persistent cough, or trouble breathing; hip or knee pain; leukemia; limp; seizures; snoring or irregular breathing during sleep; worsening of psoriasis.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Nutropin AQ Vials

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Nutropin AQ Vials:

Discomfort at the injection site; mild swelling (eg, of the hands or feet); muscle or joint pain.

Seek medical attention right away if any of these SEVERE side effects occur when using Nutropin AQ Vials:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); body pain or stiffness; burning, tingling, itching, or numbness in the palm of the hand, fingers, or wrist; change in appearance or size of a mole; chest pain; confusion; constant feeling of need to empty the bowel; curvature of the spine; depression; ear pain, discharge, or discomfort; excessive thirst or hunger; fast heartbeat; fever; frequent urination; hearing problems; increased pressure in the head or eye; infection; nausea; one-sided weakness; severe or persistent stomach or back pain; severe or persistent swelling of the ankles, legs, hands, or feet; slurred speech; sudden, severe, or persistent headache or dizziness; visual changes; vomiting.

Children: Ear discomfort or infection; fatigue or weakness; fever, persistent cough, or trouble breathing; hip or knee pain; leukemia; limp; seizures; snoring or irregular breathing during sleep; worsening of psoriasis.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Nutropin AQ Side Effects - for the Professional

Nutropin AQ

As with all protein pharmaceuticals, a small percentage of patients may develop antibodies to the protein. GH antibody binding capacities below 2 mg/L have not been associated with growth attenuation. In some cases when binding capacity exceeds 2 mg/L, growth attenuation has been observed. In clinical studies of pediatric patients that were treated with Nutropin® [somatropin (rDNA origin) for injection] for the first time, 0/107 growth hormone–deficient (GHD) patients, 0/125 CRI patients, 0/112 Turner syndrome, 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 Nutropin AQ 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 patients with CRI 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 BUN. No adverse effects of GH antibodies were noted.

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

In a post marketing surveillance study, the National Cooperative Growth Study, the pattern of adverse events in over 8000 patients with idiopathic short stature was consistent with the known safety profile of 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.

Protocol-Defined Targeted Adverse Events in the ISS NCGS Cohort

Reported Events	NCGS (N=8018)
AVN=avascular necrosis;SCFE=slipped capital femoral epiphysis.
Data obtained with several rhGH products (Nutropin, Nutropin AQ, Nutropin Depot and Protropin).
Any Adverse event
Overall	103 (1.3%)
Targeted Adverse event
Overall	103 (1.3%)
Injection-site reaction	28 (0.3%)
New onset or progression of scoliosis	16 (0.2%)
Gynecomastia	12 (0.1%)
Any new onset or recurring tumor (benign)	12 (0.1%)
Arthralgia or arthritis	10 (0.1%)
Diabetes mellitus	5 (0.1%)
Edema	5 (0.1%)
Cancer, neoplasm (new onset or recurrence)	4(0.0%)
Fracture	4(0.0%)
Intracranial hypertension	4(0.0%)
Abnormal bone or other growth	3(0.0%)
Central Nervous system tumor	2(0.0%)
New or recurrent SCFE or AVN	2(0.0%)
Carpal tunnel syndrome	1(0.0%)

Injection site discomfort has been reported. This is more commonly observed in children switched from another GH product to Nutropin AQ. Experience with Nutropin AQ in adults is limited.

Leukemia has been reported in a small number of GHD patients treated with GH. It is uncertain whether this increased risk is related to the pathology of GH deficiency itself, GH therapy, or other associated treatments such as radiation therapy for intracranial tumors. On the basis of current evidence, experts cannot conclude that GH therapy is responsible for these occurrences. The risk to GHD, CRI, or Turner syndrome patients, if any, remains to be established.

Other adverse drug reactions that have been reported in GH-treated patients include the following:

1)

Metabolic: mild, transient peripheral edema. In GHD adults, edema or peripheral edema was reported in 41% of GH‑treated patients and 25% of placebo-treated patients;

2)

Musculoskeletal: arthralgias; carpal tunnel syndrome. In GHD adults, arthralgias and other joint disorders were reported in 27% of GH‑treated patients and 15% of placebo‑treated patients;

3)

Skin: rare increased growth of pre‑existing nevi; patients should be monitored for malignant transformation; and

4)

Endocrine: gynecomastia. Rare pancreatitis.

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Side Effects by Body System - for Healthcare Professionals

General

Somatropin is generally well tolerated with minimal adverse effects.

Oncologic

Oncologic side effects have included rare reports of leukemia, however, the association with human growth hormone is uncertain.

Immunologic

Immunologic adverse reactions have included the rare development of persistent antibodies in patients treated with recombinant human growth hormone. The development of antibodies may be greater with the use of somatrem than with somatropin, although the overall incidence is very low.

An IgG antibody has been identified. No antibodies to the IgE class have been detected. Growth hormone antibody binding capacities less than 2 mg/L have not led to growth attenuation. Testing for antibodies should be carried out in any patient failing to respond to treatment.

Primate studies have failed to reveal evidence of histopathological changes due to immune complex formation.

Nervous system

Nervous system effects have included headaches, weakness, paresthesia and hypethesia.

Musculoskeletal

Musculoskeletal side effects have included localized muscle pain, carpal tunnel syndrome, aggravation of preexisting scoliosis, jaw prominence and slipped capital femoral epiphysis. Patients with Short Stature Homeobox Containing Gene (SHOX) Deficiency have reported scoliosis and arthralgia.

Endocrine

Endocrine side effects have included mild hyperglycemia, gynecomastia, and, rarely pancreatitis. New-onset type 2 diabetes mellitus in children and adults has been reported in postmarketing experience. Elevations in IGF-1 (insulin like growth factor 1) and insulin levels have occurred consistently in adults. Alterations in thyroid hormone metabolism may occur.

Serum levels of inorganic phosphorus, alkaline phosphatase and parathyroid hormone (PTH) may increase during treatment with somatropin. The mechanism is unknown. These potential changes should be considered when evaluating patient laboratory measurements.

During postmarketing surveillance, cases of new onset glucose intolerance, diabetes mellitus and exacerbations of preexisting diabetes mellitus have been reported in patients receiving the Serostim brand of somatropin. Some patients developed ketoacidosis and diabetic coma. In some patients, these conditions improved when Serostim was discontinued but not in all patients.

Cardiovascular

Edema occurs more often in adults, appears to be dose-related, and is due to the antinatriuretic effect of growth hormone.

Cardiovascular side effects have included mild, transient, peripheral edema in up to 2.5% of patients during early treatment with somatropin. Intracranial hypertension is a rare effect that may present with papilledema, visual changes, headache, nausea and vomiting. Postmarketing reports have included hypertension.

Other

Athletes using human growth hormone for doping purposes may experience cardiac, renal, and splenic hypertrophy, cardiac myopathy, fluid retention, glucose intolerance, abnormal bone growth, and an increased risk of cancers.

Chronic use of human growth hormone by athletes can lead to toxicity seen in acromegaly.

There is no risk of acquiring Creutzfeldt-Jakob disease from recombinant human growth hormone, as with the previously marketed pituitary derived human growth hormone.

Dermatologic

Dermatologic side effects have included rash, pruritus, increased sweating and increased growth of preexisting nevi (hereditary malformation of the skin). Patients with Short Stature Homeobox Containing Gene (SHOX) Deficiency have reported excessive number of cutaneous nevi.

Metabolic

Metabolic side effects have included mild transient hyperglycemia and lipolysis in adults which resulted in a statistically significant decrease in total body fat (14% to 20%) and a significant reductions in total cholesterol and/or LDL levels. No changes in HDL have been observed. Elderly patients have exhibited triglyceride elevations. The long-term effect of recombinant human growth hormone on lipid metabolism is unknown.

Local

Local side effects have included localized injection site reactions and pain.

Other

Other side effects have included an increased incidence of otitis media and other ear disorders in Turner syndrome patients. Other side effects reported in Turner syndrome patients have included influenza-like illness, upper respiratory tract infection, eczema, excessive growth of hands and feet, and exacerbation of preexisting scoliosis.

Gastrointestinal

Gastrointestinal side effects have included diarrhea, nausea and vomiting.

Hypersensitivity

Hypersensitivity side effects have included allergic reactions.

Respiratory

Respiratory side effects have included rhinitis, bronchitis and upper respiratory tract infections. Postmarketing reports have included dyspnea and sleep apnea.

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