Important Safety Information and Indications
INDICATIONS
Nutropin therapy is indicated for the treatment of
pediatric patients who have short stature or growth failure as a
result of:
- Growth hormone deficiency (GHD)
- Idiopathic short stature (ISS), defined by height standard
deviation score ≤ -2.25, associated with growth rates unlikely to
result in normal adult height, in whom other causes of short stature
have been excluded
- Turner syndrome (TS)
- Chronic kidney disease (CKD) up to the time of renal
transplantation
Nutropin therapy is indicated for the replacement of
endogenous GH in adults with GH deficiency, either:
- Adult-onset, as a result of pituitary disease, hypothalamic
disease, surgery, radiation therapy, or trauma; or
- Childhood-onset. Patients treated for GH deficiency in childhood
who have closed epiphyses should be reevaluated
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
- Acute Critical Illness: Somatropin
should not be used to treat patients with acute critical illness due
to complications following open heart surgery, abdominal surgery or
multiple accidental trauma, or those with acute respiratory failure.
- Prader-Willi Syndrome (PWS) in Children:
Somatropin is contraindicated in patients with PWS who are severely
obese, have a history of upper airway obstruction or sleep apnea, or
have severe respiratory impairment. There have been reports of sudden
death after initiation of somatropin treatment in such patients.
Nutropin AQ is not indicated for the treatment of pediatric patients
who have growth failure due to genetically confirmed PWS.
- Active Malignancy: Somatropin is
contraindicated in patients with any evidence of active malignancy.
Growth hormone deficiency may be an early sign of a pituitary tumor
or other intracranial tumor; the presence of such a tumor should be
excluded before initiation of somatropin treatment. Somatropin should
not be used in patients with any evidence of progression or
recurrence of an underlying intracranial tumor.
- Hypersensitivity: Nutropin AQ is
contraindicated in patients with a known hypersensitivity to
somatropin or any of its excipients. Systemic hypersensitivity
reactions have been reported with postmarketing use of somatropin
products.
- Diabetic Retinopathy: Somatropin is
contraindicated in patients with active proliferative or severe
non-proliferative diabetic retinopathy.
- Closed Epiphysis: Somatropin should
not be used for growth promotion in pediatric patients with closed
epiphysis.
WARNINGS AND PRECAUTIONS
- Acute Critical Illness: Increased
mortality in patients with acute critical illness due to
complications following open heart surgery, abdominal surgery or
multiple accidental trauma, or those with acute respiratory failure
has been reported after treatment with pharmacologic doses of
somatropin. The safety of continuing somatropin treatment in patients
receiving replacement doses for approved indications who concurrently
develop these illnesses has not been established.
- Prader-Willi Syndrome (PWS) in Children:
There have been reports of fatalities after initiating therapy with
somatropin in pediatric patients with PWS who had one or more of the
following risk factors: severe obesity, history of upper airway
obstruction or sleep apnea, or unidentified respiratory infection.
Male patients with one or more of these factors may be at greater
risk than females. Patients with PWS should be evaluated for signs of
upper airway obstruction and sleep apnea before initiation of
treatment with somatropin. If during treatment with somatropin,
patients show signs of upper airway obstruction (including onset of
or increased snoring) and/or new onset sleep apnea, treatment should
be interrupted. All patients with PWS treated with somatropin should
also have effective weight control and be monitored for signs of
respiratory infection, which should be diagnosed as early as possible
and treated aggressively.
- Neoplasms: In childhood cancer
survivors who were treated with radiation to the brain/head for their
first neoplasm and who developed subsequent GHD and were treated with
somatropin, an increased risk of a second neoplasm has been reported.
Monitor all patients with a history of GHD secondary to an
intracranial neoplasm routinely while on somatropin therapy for
progression or recurrence of the tumor. Monitor patients on
somatropin therapy carefully for increased growth, or potential
malignant changes, of preexisting nevi. Because children with certain
rare genetic causes of short stature have an increased risk of
developing malignancies, these patients should be carefully monitored
for development of neoplasms, if treatment with somatropin is
initiated.
- Glucose Intolerance and Diabetes Mellitus:
Previously undiagnosed impaired glucose tolerance and overt diabetes
mellitus may be unmasked during somatropin treatment. New-onset type
2 diabetes mellitus has been reported. As a result, blood glucose
concentrations should be monitored periodically in all patients
taking somatropin, especially in those with risk factors for diabetes
mellitus. Patients with pre-existing type 1 or type 2 diabetes
mellitus or impaired glucose tolerance should be monitored closely
during somatropin treatment. The doses of antihyperglycemic drugs
(i.e. insulin or oral/injectable agents) may require adjustment when
somatropin therapy is instituted in these patients.
- Intracranial Hypertension (IH):
Funduscopic examination is recommended at the initiation of and
periodically during therapy as intracranial hypertension with
papilledema, visual changes, headache, nausea, and/or vomiting have
been reported in a small number of patients treated with somatropin.
If papilledema is observed by funduscopy during treatment with
somatropin, treatment should be stopped. If somatropin-induced IH is
diagnosed, treatment with somatropin can be restarted at a lower dose
after IH-associated signs and symptoms have resolved. Patients with
TS, CKD, and PWS may be at increased risk for the development of IH.
- Severe Hypersensitivity: Serious
systemic hypersensitivity reactions including anaphylactic reaction
and angioedema have been reported with postmarketing use of
somatropin products. Patients and caregivers should be informed that
such reactions are possible and that prompt medical attention should
be sought if an allergic reaction occurs.
- Fluid Retention: Transient and
dose-dependent fluid retention during somatropin replacement in
adults may occur
- Hypoadrenalism: Patients receiving
somatropin therapy who have or are at risk for pituitary hormone
deficiency(s) may be at risk for reduced serum cortisol levels and/or
unmasking of central (secondary) hypoadrenalism. Patients treated
with glucocorticoid replacement for previously diagnosed
hypoadrenalism may require an increase in their maintenance or stress
doses following initiation of somatropin treatment.
- Hypothyroidism: Patients treated with
somatropin should have periodic thyroid function tests, and thyroid
hormone replacement therapy should be initiated or appropriately
adjusted in cases of unmasked or worsening hypothyroidism.
- Slipped Capital Femoral Epiphysis in
Pediatric Patients (SCFE): SCFE may occur more frequently in
patients with endocrine disorders and in patients undergoing rapid
growth. Any pediatric patient with the onset of a limp or complaints
of hip or knee pain during somatropin therapy should be carefully
evaluated.
- Progression of Preexisting Scoliosis in
Pediatric Patients: Progression of scoliosis can occur in
patients who experience rapid growth. Somatropin has not been shown
to increase the occurrence of scoliosis. Physicians should be alert
to these abnormalities, which may manifest during somatropin therapy.
- Otitis Media and Cardiovascular Disorders in
Patients with Turner Syndrome: Patients with TS should be
evaluated carefully for otitis media and other ear disorders as
somatropin treatment may increase the occurrence of otitis media in
these susceptible patients. In addition, patients with Turner
syndrome should be monitored closely for cardiovascular disorders
(eg, hypertension, aortic aneurysm or dissection, stroke) as they are
at increased risk for these conditions.
- Osteodystrophy in Pediatric Patients with
Chronic Kidney Disease: Children with growth failure
secondary to CKD should be examined periodically for evidence of
progression of renal osteodystrophy. SCFE or avascular necrosis of
the femoral head may be seen in children with advanced renal
osteodystrophy. X-rays of the hip should be obtained prior to
initiating somatropin therapy in CKD patients and physicians and
parents should be alert to the development of a limp or complaints of
hip or knee pain in these patients.
- Lipoatrophy: When somatropin is
administered subcutaneously at the same site over a long period of
time, tissue atrophy may result. This can be avoided by rotating the
injection site.
- Laboratory Tests: Serum levels of
inorganic phosphorus, alkaline phosphatase, parathyroid hormone and
IGF-I may increase during somatropin therapy.
- Pancreatitis: Cases of pancreatitis
have been reported rarely in children and adults receiving
somatropin. Pancreatitis should be considered in any
somatropin-treated patient, especially a child, who develops
persistent, severe abdominal pain. Girls who have TS may be at
greater risk than other somatropin-treated children.
DRUG INTERACTIONS
- Somatropin inhibits 11ß-hydroxysteroid dehydrogenase type 1
(11ßHSD-1) in adipose/hepatic tissue and may significantly impact the
metabolism of cortisol and cortisone. As a consequence, in patients
treated with somatropin, previously undiagnosed central (secondary)
hypoadrenalism may be unmasked, requiring glucocorticoid replacement
therapy. Patients treated with glucocorticoid replacement for
previously diagnosed hypoadrenalism may require an increase in their
maintenance or stress doses following initiation of somatropin
treatment.
- Glucocorticoid replacement therapy should be carefully adjusted in
children with concomitant GH and glucocorticoid deficiency to avoid
both hypoadrenalism and an inhibitory effect on growth. Concomitant
glucocorticoid therapy may inhibit the growth promoting effect of
Nutropin AQ.
- Careful monitoring is advisable when somatropin is administered in
combination with other drugs metabolized by CYP450 liver enzymes
(e.g., corticosteroids, sex steroids, anticonvulsants, cyclosporine),
hormone replacement therapy, insulin and/or other hypoglycemic
agents.
USE IN SPECIFIC POPULATIONS
- Pregnancy/Nursing Mothers: Somatropin
should be used during pregnancy only if clearly needed and with
caution in nursing mothers because it is not known whether somatropin
is excreted in human milk.
- Geriatric Use: Clinical studies of
somatropin did not include sufficient numbers of subjects aged 65
years and over to determine whether they respond differently from
younger patients. Elderly patients may be more sensitive to the
action of somatropin and may be more prone to adverse reactions.
ADVERSE REACTIONS
- Common adverse reactions reported in adult and pediatric patients
taking somatropin include injection site reactions. Additional common
adverse reactions in adults include edema, arthralgia, and carpal
tunnel syndrome
You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side
effects to Genentech at (888) 835-2555.
Please see Nutropin full Prescribing
Information for additional Important Safety Information.
<Back to top