Download PRODUCT MONOGRAPH - Eli Lilly Canada

Based on assessment of clinical trial data, post-marketing data, and spontaneous reports, carpal
tunnel syndrome appears to occur more frequently in patients over 40 years of age than in
younger patients. In almost half of the reported cases, the recommended maximum somatropin
dose had been exceeded. In the majority of cases, the condition resolved spontaneously or with a
decrease in dosage, interruption of treatment, or discontinuation of treatment. The maximum
recommended dosage should not be exceeded.
Pregnant women: There are no adequate and well controlled studies of HUMATROPE
treatment in pregnant women. Therefore, the safety of HUMATROPE has not been established
in this subpopulation. It is not known whether HUMATROPE can cause fetal harm when
administered to a pregnant woman. HUMATROPE should be given to a pregnant woman only if
the benefits clearly outweigh the risks and only under medical supervision.
Female patients should be advised to inform their doctor if they are, or become pregnant, or are
contemplating pregnancy.
Nursing women: There are no studies of HUMATROPE treatment in nursing women. It is not
known whether somatropin is excreted in human milk. Due to its large molecular weight, it is
unlikely that somatropin would be passed intact into human breast milk, and absorption of intact
protein from the gastrointestinal tract of the infant is also unlikely. However, secretion of
breakdown products of somatropin in breast milk has not been studied. Therefore, somatropin
should be used with caution in nursing women.
Geriatrics (≥ 65 years of age): The safety and effectiveness of somatropin have not been
established in patients aged ≥ 65 years.
Older patients may be at greater risk of adverse reactions. A lower starting dose and smaller dose
increments should be considered for older patients.
Obese patients: Obese individuals are more likely to manifest adverse effects when treated with
a weight-based regimen (see DOSAGE AND ADMINISTRATION).
Monitoring and Laboratory Tests
It is recommended that insulin-like growth factor-I (IGF-I) concentrations be monitored
regularly and maintained within the normal range for age and sex (see WARNINGS AND
PRECAUTIONS, General).
Patients with Prader-Willi syndrome should be evaluated for signs of upper airway obstruction
and sleep apnea before initiation of treatment with somatropin. If a somatropin-treated patient
shows signs of upper airway obstruction (including onset of or increased snoring) and/or new
onset of sleep apnea, treatment should be interrupted. All patients with Prader-Willi syndrome
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
(see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS, Congenital Disorders).
HUMATROPE Product Monograph
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