Drug reference
(soe-ma-troe′pin) Genotropin, Genotropin MiniQuick, Humatrope, Norditropin FlexPro, Nutropin AQ NuSpin 10, Nutropin AQ, NuSpin 20, Nutropin AQ NuSpin 5, Omnitrope, Saizen, Saizenprep, Serostim, Zomacton, Zomacton
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Func. class.: Pituitary hormone
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Chem. class.: Growth hormone
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Do not confuse: somatropin/SUMAtriptan/somatrem
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ACTION: Stimulates growth; somatro- pin is similar to natural growth hormone; both preparations were developed with the use of recombinant DNA
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USES: Pituitary growth hormone defi- ciency (hypopituitary dwarfism), chil- dren with human growth hormone defi- ciency/growth failure, AIDS wasting syndrome, cachexia, adults with soma- tropin deficiency syndrome (SDS), short stature in Noonan syndrome, SHOX defi- ciency, Turner’s syndrome, Prader-Willi syndrome
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CONTRAINDICATIONS: Hyper- sensitivity to benzyl alcohol, creosol; closed epiphyses, intracranial lesions, acute respiratory failure, Prader-Willi syndrome with obesity, trauma Precautions: Pregnancy, breastfeed- ing, newborn, geriatric patients, diabe- tes mellitus, hypothyroidism, prolonged treatment in adults, scoliosis, sleep apnea, chemotherapy, respiratory dis- ease, glycerin hypersensitivity (with for- mulations that contain these products)
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SIDE EFFECTS CNS: Headache, growth of intracranial tumor, fever, aggressive behavior ENDO: Hyperglycemia, ketosis, hypothy- roidism, thyroid hormone replacement may be needed GI: Nausea, vomiting, pancreatitis GU: Hypercalciuria INTEG: Rash, urticaria, pain; inflamma- tion at inj site, hematoma MS: Tissue swelling, joint and muscle pain SYST: Antibodies to growth hormone
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INTERACTIONS Increase: epiphyseal closure—andro- gens, thyroid hormones Decrease: growth—glucocorticosteroids Decrease: insulin, antidiabetic effect— dosage adjustment may be needed Drug/Lab Test Increase: glucose, urine glucose Decrease: glucose, thyroid hormones
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DOSAGE AND ROUTES Genotropin • Child: SUBCUT 0.16-0.24 mg/kg/wk divided into 6 or 7 daily inj; give in abdo- men, thigh, buttocks • Adult: SUBCUT 0.04-0.08 mg/kg/wk divided into 6-7 daily doses Humatrope • Adult: IM 0.006 international units/ kg/day, max 0.0125 units/kg/day • Child: SUBCUT/IM 0.18 mg/kg divided into equal doses either on 3 alternate days or 6×/wk, max weekly dose 0.3 mg/kg Nutropin/Nutropin AQ (growth hormone deficiency) • Child: SUBCUT 0.3 mg/kg/wk Serostim • Adult: SUBCUT at bedtime >55 kg, 6 mg; >45-55 kg, 5 mg; 35-45 kg, 4 mg Norditropin • Child: SUBCUT 0.024-0.034 mg/kg 6-7×/wk GH deficiency • Adult: SUBCUT (Saizen) 0.005 mg/ kg/day; may increase after 4 wk to max 0.01 mg/kg/day
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Available forms: Powder for inj (lyophilized) 1.5 mg (4 units/mL), 4 mg (12 units/vial), 5 mg (13 units/vial), 5 mg (15 units/vial) rDNA origin, 5.8 mg (15 units/mL), 6 mg (18 units/mL), 8 mg (24 units/vial), 10 mg (26 units/vial); inj 10 mg (30 units/vial), 5 mg/1.5 mL, 10 mg/1.5 mL, 15 mg/1.5 mL
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Administer: • Give IM or subcut; do not use IV • Discontinue therapy if final height is achieved or epiphyseal fusion occurs • Visually inspect parenteral products S for particulate matter and discolor- ation Reconstitution and storage Genotropin • Powder, available in a 5-mg cartridge (green tip) and a 12-mg cartridge (purple tip); the 5- and 12-mg cartridges may be used with the Genotropin Pen or the Ge- notropin Mixer; also in various doses rang- ing from 0.2 mg to 2 mg, in single use, auto-mix devices called Genotropin Miniquicks • Cartridges: store cartridges refriger- ated before reconstitution, do not freeze; protect from light; after the pow- der and diluent are mixed, gently tip the cartridge upside down a few times until powder is dissolved; if solution is cloudy, do not use; following reconstitu- tion, the 5-mg cartridge contains 5 mg/ mL; the 12-mg cartridge contains 12 mg/mL; 5-mg and 12-mg cartridges contain overfill; the cartridges contain diluent with preservative (m-cresol) and may be stored refrigerated ≤28 days after reconstitution; do not use the 5-mg and 12-mg cartridges in patients with m-cresol hypersensitivity • Genotropin Miniquicks: after dis- pensing but before reconstitution, store at ≤77° ≤3 mo; a reconstitution device is supplied; this product contains a diluent with no preservative, refrigerate after reconstitution and use within 24 hr; use reconstituted solution only once and dis- card remaining Humatrope • Before reconstitution, store refriger- ated • Vials: reconstitute each 5-mg vial with 1.5-5 mL of the diluent (contains m- cresol as a preservative) or bacteriostatic water for injection (contains benzyl alcohol as a preservative); swirl until contents are dissolved; do not shake; if the solution is cloudy, do not use; small, colorless parti- cles may be present after refrigeration; vials reconstituted with the diluent or bacterio- static water are stable for 14 days when refrigerated; for vials reconstituted with sterile water, use the vial only once and discard if not used immediately, refrigerate and use within 24 hr; avoid freezing • Cartridges: reconstitute cartridges using only the supplied diluent syringe; once reconstituted, the cartridges are stable for up to 28 days when stored refrigerated; store the injection device without the needle attached; avoid freez- ing reconstituted solutions Norditropin • Do not use reconstituted solution if cloudy or contains particulate matter • Before use, store refrigerated • Reconstitution of the cartridges is not required; each cartridge size (5 mg, 10 mg, or 15 mg per 1.5-mL cartridge) • After a cartridge has been inserted into the NordiPen injector or once a Nordi- Flex pen is in use, the pen should be stored refrigerated and used within 4 wk; alternatively, the 5-mg and 10-mg car- tridges may be stored in the pen at room temperature, for ≤3 wk Nutropin • Before reconstitution, store refriger- ated • Reconstitute each 5-mg vial with 1-5 mL bacteriostatic water for injection (benzyl alcohol preserved) and each 10- mg vial with 1-10 mL of bacteriostatic water for injection (benzyl alcohol pre- served); if using for newborns, reconsti- tute with sterile water for injection; swirl vial; do not shake; if the solution is cloudy after reconstitution or refrigera- tion, do not use; small, colorless parti- cles may be present after refrigeration • Solutions reconstituted with bacterio- static water for injection are stable for 14 days refrigerated • Solutions reconstituted with sterile wa- ter for injection should be used immedi- ately and only once; discard any unused portions; avoid freezing reconstituted solutions Nutropin AQ • Does not require reconstitution; solu- tion should be clear; small, colorless par- ticles may be present after refrigeration; allow vial or pen cartridge to come to room temperature, and gently swirl; if solution is cloudy, do not use • Pen cartridge: use only with Nutropin AQ Pen; the Nutropin AQ 10 pen allows use of a minimum 0.1-mg dose to a maxi- mum 4-mg dose, in 0.1-mg increments; the Nutropin AQ 20 pen allows use of a minimum 0.2-mg dose to a maximum 8-mg dose, in 0.2-mg increments • Prefilled device: a prefilled multi- dose, dial-a-dose device is available in 3 strengths; administer using disposable needles • After initial use, products are stable for 28 days refrigerated; avoid freezing; pro- tect from light Omnitrope • Before reconstitution, store vials refrig- erated; store in the carton; Omnitrope is sensitive to light • Vials: reconstitute with diluent pro- vided; swirl do not shake; if the solution is cloudy after reconstitution, the con- tents must not be used; after reconstitu- tion, the 1.5-mg vial may be refrigerated ≤24 hr; the 1.5-mg vial does not contain a preservative and should only be used once; discard remaining; the 5.8-mg vial diluent contains benzyl alcohol as a pre- servative; after reconstitution, the con- tents must be used within 3 wk; after the first injection, store the 5.8-mg vial in the carton, to protect from light, in the refrigerator; avoid freezing • Omnitrope Pen 5 cartridge: each 5-mg cartridge must be inserted into the Omnitrope Pen 5 delivery system; the car- tridge contains benzyl alcohol as a preserva- tive; after the first use, store refrigerated ≤28 days; protect from light, avoid freezing • Omnitrope Pen 10 cartridge: each 10-mg cartridge must be inserted into the Omnitrope Pen 10 delivery system; after the first use, store refrigerated ≤28 days; protect from light, avoid freezing Saizen • Before reconstitution, store at room temperature • Vials: reconstitute each 5-mg vial/1-3 mL bacteriostatic water for injection; reconstitute each 8.8-mg vial/ 2-3 mL bacteriostatic water for injection (ben- zyl alcohol preserved); swirl until con- tents are dissolved completely; do not shake; the solution should be clear; if it is cloudy immediately after reconstitu- tion or refrigeration, do not use; small colorless particles may be present after refrigeration; after reconstitution, store vials mixed with bacteriostatic water for injection refrigerated use within 14 days; for vials mixed with sterile water for injection, use immediately, and any unused portion should be discarded; avoid freezing • Cartridges: available in 4-mg and 8.8- mg Click.easy cartridges Serostim • Before reconstitution, store vials and diluent at room temperature (15°-30°C; 59°-86°F) • Vials: reconstitute 5-mg or 6-mg vials/ 0.5-1 mL of supplied diluent (sterile water for injection); reconstitute the 4-mg vial with 0.5-1 mL of bacteriostatic water for injection (benzyl alcohol pre- served), 8.8-mg vial with 1-2 mL of bac- teriostatic water for injection (benzyl alcohol preserved); swirl; do not shake; the solution should be clear; if it is cloudy, do not use; small colorless parti- cles may be present after refrigeration; if reconstituted with sterile water for injec- tion, use within 24 hr; if reconstituted with bacteriostatic water for injection (benzyl alcohol preserved), the solution is stable for up to 14 days under refrig- eration (2°-8°C or 36°-46°F); avoid freezing • Cartridges: available in 8.8-mg Click. easy® cartridges after reconstitution, car- tridges are stable refrigerated for ≤21 days; avoid freezing Serostim LQ • Before use, store refrigerated • Available in 6-mg single-use cartridges that do not require reconstitution; administer using sterile disposable sy- ringes and needles • Bring to room temperature before use; discard single-use cartridge after use, dis- S card cartridges after the expiration date; do not freeze; protect from light Zomacton (formerly Tev-Tropin) • Before reconstitution, store refrigerated • Reconstitute each 5-mg vial with 1-5 mL bacteriostatic 0.9% sodium chloride (benzyl alcohol preserved) for injection; swirl; do not shake; the solution should be clear; if it is cloudy immediately after reconstitution, do not inject; small, col- orless particles may be present after refrigeration; when administering to newborns, reconstitute with sterile nor- mal saline for injection that is unpre- served • Solution reconstituted with bacterio- static 0.9% sodium chloride is stable for 14 days when stored refrigerated; solution reconstituted with sterile nor- mal saline should be used only once; discard remaining solution; avoid freezing Valtropin • Before dispensing, store vials and diluent refrigerated; after dispensing, may be stored at or below 77°F for up to 3 mo • Reconstitute each 5-mg vial with the entire contents of the accompanying dilu- ent, which contains metacresol as a pre- servative; swirl vial; do not shake; the solution should be clear, if it is cloudy or contains particulate matter, do not use; final concentration 3.33 mg/mL • After reconstitution with the provided diluent, solutions may be stored refriger- ated for up to 14 days; after reconstitu- tion with sterile water for injection, use only one dose of Valtropin per vial and discard the unused portion Zorbtive • Unreconstituted vials of drug and dilu- ent may be stored at room temperature until expiration date • Reconstitute each vial of 4 mg, 5 mg, or 6 mg with 0.5-1 mL sterile water for injection, reconstitute each 8.8 mg with 1-2 mL bacteriostatic water for injection (0.9% benzyl alcohol pre- served); in newborns or those with a benzyl alcohol hypersensitivity, sterile water for injection may be used; swirl; do not shake; the solution should be clear; if it is cloudy after reconstitution or refrigeration, do not use; small col- orless particles may be present after refrigeration • After reconstitution with sterile water for injection, use the solution immedi- ately and discard any unused portion; when using bacteriostatic water for injec- tion, reconstituted solutions are stable for up to 14 days refrigerated; avoid freezing IM route • Inject deeply into a large muscle; aspi- rate; rotate injection sites daily SUBCUT route • Volumes >1 mL of reconstituted solu- tion are not recommended; do not inject intradermally • Allow refrigerated solutions to come to room temperature before injection • Subcutaneous injections may be given in the thigh, buttocks, or abdomen; ro- tate injection sites daily
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Assess: • Signs/symptoms of diabetes • Growth hormone antibodies if patient fails to respond to therapy • Thyroid function tests: T3, T4, TSH to identify hypothyroidism • Allergic reaction: rash, itching, fever, nausea, wheezing • Hypercalciuria: urinary stones; groin, flank pain; nausea, vomiting, urinary fre- quency, hematuria, chills • Growth rate, bone age of child at inter- vals during treatment • Respiratory infection: in those with Prader-Willi syndrome, may have sleep apnea, upper airway obstruction; discon- tinue if obstruction occurs • Rapid growth: assess for slipped capi- tal femoral epiphysis; may also occur in endocrine disorders • Monitor ophthalmologic status base- line and periodically; intracranial hyper- tension may occur • Beers: avoid in older adults except as hormone replacement following pituitary gland removal • Pregnancy/breastfeeding: effects un- known; cautious use in breastfeeding
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Evaluate: • Therapeutic response: growth in children
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CLINICAL CONSIDERATIONS
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Patient and caregiver information: • That treatment may continue for years; that regular assessments are required • To maintain a growth record; to report knee/hip pain or limping • That treatment is very expensive • About subcut injection; to rotate injec- tion site to avoid tissue atrophy; not to shake medication; to report peripheral edema, swelling to the provider HIGH ALERT
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PHARMACOKINETICS Half-life 15-60 min, duration 7 days, metabolized in liver
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• Child: SUBCUT 0.16-0.24 mg/kg/wk divided into 6 or 7 daily inj; give in abdo- men, thigh, buttocks
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• Child: SUBCUT/IM 0.18 mg/kg divided into equal doses either on 3 alternate days or 6×/wk, max weekly dose 0.3 mg/kg Nutropin/Nutropin AQ (growth hormone deficiency)
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• Child: SUBCUT 0.3 mg/kg/wk Serostim
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• Child: SUBCUT 0.024-0.034 mg/kg 6-7×/wk GH deficiency
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