Download somatropin (recombinant) (soe-ma-troe-pin)

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02/17/2014 10:22AM
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somatropin (recombinant) (soe-ma-troe-pin)
Genotropin
Classification
Therapeutic: hormones
Pharmacologic: growth hormones
Pregnancy Category C
Indications
Growth failure in children due to Prader-Willi syndrome. Growth failure in children
due to deficiency of growth hormone. Growth failure in children born small for gestational age (SGA) who fail to manifest catch-up growth by age 2. Short stature associated with Turner syndrome. Idiopathic short stature in children. Growth hormone
deficiency in adults as a result of pituitary disease, hypothalamic disease, surgery, radiation or trauma.
Action
Plate # 0-Composite
pg 1 # 1
Contraindications/Precautions
Contraindicated in: Closure of epiphyses; Active neoplasia; Hypersensitivity to
growth hormone or m-cresol preservative; Acute critical illness (therapy should not
be initiated) or respiratory failure; Diabetic retinopathy; Prader-Willi syndrome with
obesity and respiratory impairment (risk of fatal complications; can be used only if
growth hormone deficiency is documented).
Use Cautiously in: Growth hormone deficiency due to intracranial lesion; Coexisting adrenocorticotropic hormone (ACTH) deficiency; Diabetes (may cause insulin
resistance); Thyroid dysfunction; Pedi: Girls with Turner syndrome may be atqrisk
for pancreatitis; Geri:qsensitivity,qrisk of adverse reactions; OB, Lactation:
Safety not established.
Adverse Reactions/Side Effects
CV: edema of the hands and feet. Endo: hyperglycemia, hypothyroidism, insulin resistance. GI: PANCREATITIS. Local: pain at injection site, local lipoatrophy or lipodystrophy with subcutaneous use. MS: arthralgia.
Interactions
Drug-Drug: Excessive corticosteroid use (equivalent to 10– 15 mg/m2/day) may
Produce growth (skeletal and cellular). Metabolic actions include: Increased protein presponse to growth hormone.
synthesis, Increased carbohydrate metabolism, Lipid mobilization, Retention of sodium, phosphorus, and potassium. Somatropin has the same amino acid sequence as Route/Dosage
naturally occurring growth hormone and is produced by recombinant DNA tech- Subcut (Children): Growth hormone inadequacy– 0.16– 0.24 mg/kg/wk divided
niques. Growth hormone enhances GI tract mucosal transport of water, electrolytes in 6– 7 daily doses. Prader-Willi syndrome— 0.24 mg/kg/wk divided into 6– 7
and nutrients. Therapeutic Effects: Increased skeletal growth in children with daily doses. Children SGA at birth— 0.48 mg/kg/wk divided into 6– 7 daily doses.
growth hormone deficiency. Replacement of somatropin in deficient adults. In- Turner syndrome— 0.33 mg/kg/wk divided into 6– 7 daily doses. Idiopathic short
creased bone density in adult growth hormone– deficient patients.
stature— 0.47 mg/kg/wk divided into 6– 7 daily doses.
Subcut (Adults): 0.04mg/kg/wk initially divided in 6– 7 daily doses or 0.2 mg/day
Pharmacokinetics
starting dose (without consideration of body weight) then graduallyqby 0.1– 0.2
Absorption: Well absorbed (80%).
mg/day q 1– 2 months until clinical response achieved (max dose 0.08 mg/kg/wk).
Distribution: Localize to highly perfused organs (liver, kidneys).
Metabolism and Excretion: Broken down in renal cells to amino acids that are
NURSING IMPLICATIONS
recirculated; some liver metabolism.
Assessment
Half-life: Subcut— 3.8 hr.
● Growth Failure: Monitor bone age annually and growth rate determinations,
TIME/ACTION PROFILE (growth)
height, and weight every 3– 6 mo during therapy.
ROUTE
ONSET
PEAK
DURATION
● Lab Test Considerations: Monitor thyroid function prior to and during therIM, subcut
within 3 mo
unknown
12–48 hr
apy. May decrease T4, radioactive iodine uptake, and thyroxine-binding capacity.
⫽ Canadian drug name.
⫽ Genetic Implication.
CAPITALS indicate life-threatening, underlines indicate most frequent.
Strikethrough ⫽ Discontinued.
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02/17/2014 10:22AM
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Hypothyroidism necessitates concurrent thyroid replacement for growth hormone to be effective. Serum inorganic phosphorus, alkaline phosphatase, and
parathyroid hormone mayqwith somatropin therapy.
● Monitor blood glucose periodically during therapy. Diabetic patients may require
qinsulin dose.
● Monitor for development of neutralizing antibodies if growth rate does not exceed
2.5 cm/6 mo.
● Monitor alkaline phosphatase closely in patients with adult growth hormone deficiency.
Potential Nursing Diagnoses
Disturbed body image (Indications)
Implementation
● Rotate injection sites with each injection.
● Genotropin intra-mix: Dissolve powder with solution provided with 2-chamber
Plate # 0-Composite
pg 2 # 2
● Assure parents and child that these dose forms are synthetic and therefore not ca-
pable of transmitting Creutzfeldt-Jakob disease, as was the original somatropin,
which was extracted from human cadavers.
● Advise parents to monitor blood glucose closely in children with diabetes mellitus.
Parents should also be advised to report persistent severe abdominal
pain; may be a symptom of pancreatitis.
● Emphasize need for regular follow-up with endocrinologist to ensure appropriate
growth rate, to evaluate lab work, and to determine bone age by x-ray exam.
Evaluation/Desired Outcomes
● Child’s attainment of adult height in growth failure secondary to pituitary growth
hormone deficiency or idiopathic causes. Therapy is limited to period before closure of epiphyseal plates (approximately up to 14– 15 yr in girls, 15– 16 yr in
boys).
● Replacement of growth hormone in deficient adults.
Why was this drug prescribed for your patient?
cartridge as directed. Gently tip cartridge upside down a few times until contents
are completely dissolved. Do not shake; shaking can denature the active ingredient. The 1.5-mg cartridge is stable following dilution for 24 hr if refrigerated. The
5.8-mg and 13.8-mg cartridges contain preservatives and are stable for 14 days if
refrigerated.
● Genotropin Pen: Prepare and administer as directed in patient instruction insert.
Store in the refrigerator.
● Genotropin MiniQuick: For single use only. Inject immediately after reconstitution; may be refrigerated for 24 hr after reconstitution. Follow directions on patient package insert for reconstitution and administration.
● Subcut: Injection volume should not exceed 1 mL.
Patient/Family Teaching
● Instruct patient and parents on correct procedure for reconstituting medication,
site selection, technique for subcut injection, and disposal of needles and syringes. Review dose schedule. Parents should report persistent pain or edema at injection site.
● Explain rationale for prohibition of use for increasing athletic performance. Administration to persons without growth hormone deficiency or after epiphyseal
closure may result in acromegaly (coarsening of facial features; enlarged hands,
feet, and internal organs; increased blood glucose; hypertension).
䉷 2015 F.A. Davis Company
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