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Zorbtive Generic Name & Formulations
Legal Class
Rx
General Description
Somatropin (rDNA origin) 8.8mg; per vial; lyophilized pwd for SC inj after reconstitution; diluent contains benzyl alcohol.
Pharmacological Class
Growth hormone (GH).
How Supplied
Vials—1 (w. diluent)
Manufacturer
Zorbtive Indications
Indications
Short bowel syndrome in conjunction with nutritional support (see full labeling).
Zorbtive Dosage and Administration
Adult
Rotate inj site. Initially 0.1mg/kg SC inj once daily; max 8mg/day. Treat for 4 weeks. If fluid retention or arthralgia occurs; reduce dose by 50%. Discontinue therapy for up to 5 days if severe toxicities occur; if resolved, resume at 50% of original dose; if unresolved within 5 days or recurs, discontinue permanently.
Children
Not established.
Zorbtive Contraindications
Contraindications
Active malignancy. Acute critical illness due to complications following open heart or abdominal surgery, multiple accidental trauma, or acute respiratory failure. Active proliferative or severe non-proliferative diabetic retinopathy.
Zorbtive Boxed Warnings
Not Applicable
Zorbtive Warnings/Precautions
Warnings/Precautions
Monitor for potential malignant changes of preexisting nevi. Increased mortality in those with acute critical illness (see Contraindications). Impaired glucose tolerance/diabetes mellitus: monitor blood glucose. Hypoadrenalism: monitor serum cortisol levels. Evaluate thyroid function in those with hypopituitarism before starting and after 4 weeks treatment; correct thyroid function, if needed. Perform funduscopic evaluation for intracranial hypertension at initiation; discontinue if papilledema occurs. Elderly. Pregnancy. Nursing mothers.
Zorbtive Pharmacokinetics
See Literature
Zorbtive Interactions
Interactions
May antagonize glucocorticoids. Concomitant antidiabetic treatment may need to be adjusted.
Zorbtive Adverse Reactions
Adverse Reactions
Edema (eg, facial, peripheral), arthralgia, inj site pain, flatulence, abdominal pain, vomiting, pain, nausea; hypersensitivity reactions, tissue turgor (swelling in hands/feet), musculoskeletal discomfort, carpal tunnel syndrome (reduce dose or discontinue if unresolved), acute pancreatitis.
Zorbtive Clinical Trials
See Literature
Zorbtive Note
Not Applicable
Zorbtive Patient Counseling
See Literature
