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NUTROPIN AQ® Nuspin® PRODUCT MONOGRAPH PrNUTROPIN AQ® NuSpin® somatropin injection solution; NuSpin® injection device prefilled with cartridge: NUTROPIN AQ® NuSpin® 5 (5 mg/2 mL) NUTROPIN AQ® NuSpin® 10 (10 mg/2 mL) NUTROPIN AQ® NuSpin® 20 (20 mg/2 mL) Growth Hormone Distributed by: Date of Revision: Hoffmann-La Roche Limited June 5, 2018 7070 Mississauga Road Mississauga, Ontario L5N 5M8 www.rochecanada.com Manufactured by: Genentech, Inc., USA Submission Control No: 216635 ® Registered trade-marks of Genentech, Inc, used under license. © Copyright 1996-2018 of Hoffmann-La Roche Limited Table of Contents PART I: HEALTH PROFESSIONAL INFORMATION ........................................................ 3 SUMMARY PRODUCT INFORMATION ....................................................................... 3 DESCRIPTION................................................................................................................... 3 INDICATIONS AND CLINICAL USE ............................................................................. 3 CONTRAINDICATIONS .................................................................................................. 4 WARNINGS AND PRECAUTIONS ................................................................................. 5 ADVERSE REACTIONS ................................................................................................. 15 DRUG INTERACTIONS ................................................................................................. 17 DOSAGE AND ADMINISTRATION ............................................................................. 18 OVERDOSAGE ............................................................................................................... 21 ACTION AND CLINICAL PHARMACOLOGY ........................................................... 22 STORAGE AND STABILITY ......................................................................................... 26 DOSAGE FORMS, COMPOSITION AND PACKAGING ............................................ 26 PART II: SCIENTIFIC INFORMATION .............................................................................. 27 PHARMACEUTICAL INFORMATION ......................................................................... 27 CLINICAL TRIALS ......................................................................................................... 28 DETAILED PHARMACOLOGY .................................................................................... 36 TOXICOLOGY ................................................................................................................ 38 REFERENCES ................................................................................................................. 40 PART III: CONSUMER INFORMATION............................................................................. 44 Page 2 of 55 PrNUTROPIN AQ® NuSpin® somatropin injection Growth Hormone PART I: HEALTH PROFESSIONAL INFORMATION SUMMARY PRODUCT INFORMATION Route of Dosage Form / Strength Clinically Relevant Non-medicinal Administration Ingredients subcutaneous solution; NuSpin® injection device None. prefilled with 5 mg/2 mL, 10 mg/2 For a complete listing of non- mL, or 20 mg/2 mL cartridge medicinal ingredients see Dosage Forms, Composition and Packaging section. DESCRIPTION Somatropin is a single-chain protein of 191 amino acids, including four cysteine residues present as two intrachain disulfides. Somatropin is synthesized in a specific laboratory strain of E. coli bacteria (which has been modified by the addition of a plasmid coding for hGH) as a precursor consisting of the rhGH molecule preceded by the secretion signal from an E. coli protein. This precursor is then cleaved in the plasma membrane of the cell. The native protein is secreted into the periplasm where it is folded appropriately. The primary and secondary structures of somatropin are identical with pituitary-derived human growth hormone. INDICATIONS AND CLINICAL USE Pediatric Patients NUTROPIN AQ (somatropin injection) is indicated for: the long-term treatment of children who have growth failure due to growth hormone inadequacy. Page 3 of 55 the treatment of children who have growth failure associated with chronic renal insufficiency up to the time of renal transplantation. Therapy with NUTROPIN AQ should be used in conjunction with optimal management of chronic renal insufficiency. the long-term treatment of short stature associated with Turner syndrome. Adult Patients NUTROPIN AQ is indicated for: the replacement of endogenous growth hormone (GH) in patients with adult GH deficiency (GHD) who meet both of the following criteria: 1. Biochemical diagnosis of adult GH deficiency by means of a subnormal response to a standard growth hormone stimulation test (peak GH ≤5µg/L), and 2. Adult-onset: Patients who have adult GH deficiency either alone or with multiple hormone deficiencies (hypopituitarism) as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma; or 3. Childhood-onset: Patients who were GH deficient during childhood, confirmed as an adult before replacement therapy with NUTROPIN AQ is started. CONTRAINDICATIONS NUTROPIN AQ (somatropin injection) is contraindicated in patients who are hypersensitive to somatropin or to any ingredient in the formulation. For a complete listing, see the DOSAGE FORMS, COMPOSITION AND PACKAGING section of the product monograph. Somatropin should not be initiated to treat patients with acute critical illness due to the complications following open heart or abdominal surgery, multiple accidental trauma or to patients having acute respiratory failure. Clinical studies demonstrated that high doses of somatropin were associated with a significantly increased morbidity and mortality in those patients (see WARNINGS AND PRECAUTIONS: General). Somatropin should not be used for growth promotion in pediatric patients with closed epiphyses. Growth hormones have no effect on cartilaginous growth areas of the long bone. Treatment of pediatric growth disorders with somatropin should be discontinued when the patient has reached satisfactory adult height, or the epiphyses are closed (see WARNINGS AND PRECAUTIONS: Musculoskeletal). Somatropin should not be used or should be discontinued when there is any evidence of neoplastic activity. Antitumor therapy should be completed before somatropin is Page 4 of 55 initiated. Somatropin should be discontinued if there is evidence of recurrent tumor growth (see WARNINGS AND PRECAUTIONS: Carcinogenesis and Mutagenesis). Intracranial tumor shall be inactive and anti-malignancy treatment must be completed with evidence of remission prior to instituting therapy with somatropin. Patients should be examined frequently for progression or recurrence of the underlying process (see WARNINGS AND PRECAUTIONS: Carcinogenesis and Mutagenesis). Somatropin should not be administered in patients with active proliferative or severe non- proliferative diabetic retinopathy. Somatropin is contraindicated in patients with Prader-Willi syndrome 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 when somatropin was used in such patients. NUTROPIN AQ is not indicated for the treatment of pediatric patients who have growth failure due to genetically confirmed Prader-Willi syndrome (see WARNINGS AND PRECAUTIONS). WARNINGS AND PRECAUTIONS • Somatropin therapy should be directed by physicians experienced in the diagnosis and management of pediatric patients with growth hormone deficiency, Turner syndrome, chronic renal insufficiency (CRI) or adult patients with either childhood-onset or adult-onset growth hormone deficiency (see INDICATIONS AND CLINICAL USE). • Any switch from one brand of growth hormone to another should be made cautiously and only under medical supervision. • There have been reports of fatalities after initiating therapy with somatropin in pediatric patients with Prader-Willi syndrome who had one or more of the following risk factors: severe obesity, history of upper airway obstruction or sleep apnea, or unidentified respiratory infection (see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS: Congenital Disorders). General • A significant increase in mortality was reported among somatropin treated patients with acute critical illnesses in intensive care units due to complications following open heart surgery or abdominal surgery, multiple accidental trauma or acute respiratory failure compared with those receiving placebo (see CONTRAINDICATIONS and ADVERSE REACTIONS). • It is recommended that Insulin-like Growth Factor-I (IGF-I) concentrations be monitored regularly (see DOSAGE AND ADMINISTRATION). Page 5 of 55 • Concomitant glucocorticoid therapy may inhibit the response to somatropin (see WARNINGS AND PRECAUTIONS: Drug Interactions and DRUG INTERACTIONS). • Instructions on appropriate use should be given (see PART III: CONSUMER INFORMATION, PROPER USE OF THIS MEDICATION, INFORMATION FOR THE PARENT/PATIENT). • The injection site should be rotated to minimize the risk of lipoatrophy occurring (see DOSAGE AND ADMINISTRATION). • To avoid transmission of disease, cartridge shall not be used by more than one person. • Patients being treated with somatropin should be informed of the potential benefits and risks associated with treatment. Patients should be instructed to contact their physician should they experience any side effects or discomfort during treatment with somatropin
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