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Nps Pharmaceuticals Drugs
2.1 Dosing Information
The recommended daily dose of GATTEX is 0.05 mg/kg body weight administered by subcutaneous injection once daily. Alternation of sites for subcutaneous injection is recommended, and can include the thighs, arms, and the quadrants of the abdomen. GATTEX should not be administered intravenously or intramuscularly. If a dose is missed, that dose should be taken as soon as possible on that day. Do not take 2 doses on the same day.
2.2 Monitoring to Assess Safety
A colonoscopy (or alternate imaging) of the entire colon with removal of polyps should be done within 6 months prior to starting treatment with GATTEX. A follow-up colonoscopy (or alternate imaging) is recommended at the end of 1 year of GATTEX. If no polyp is found, subsequent colonoscopies should be done no less frequently than every 5 years. If a polyp is found, adherence to current polyp follow-up guidelines is recommended.
Patients should undergo initial laboratory assessments (bilirubin, alkaline phosphatase, lipase and amylase) within 6 months prior to starting treatment with GATTEX. Subsequent laboratory assessments are recommended every 6 months. If clinically meaningful elevation is seen, further diagnostic workup is recommended as clinically indicated (ie, imaging of the biliary tract, liver, or pancreas). [see Warnings and Precautions (5.1) (5.5)]
2.3 Dosage Modifications in Renal Impairment
Reduce the dose by 50% in patients with moderate and severe renal impairment (creatinine clearance less than 50 mL/min), and end-stage renal disease [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)]
2.4 Discontinuation of Treatment
Discontinuation of treatment with GATTEX may result in fluid and electrolyte imbalance. Therefore, patients' fluid and electrolyte status should be carefully monitored.
2.5 Preparation for Administration
Reconstitute each vial of GATTEX by slowly injecting the 0.5 mL of preservative-free Sterile Water for Injection provided in the prefilled syringe. Allow the vial containing GATTEX and water to stand for approximately 30 seconds and then gently roll the vial between your palms for about 15 seconds. Do not shake the vial. Allow the mixed contents to stand for about 2 minutes. Inspect the vial for any undissolved powder. If undissolved powder is observed, gently roll the vial again until all material is dissolved. Do not shake the vial. If the product remains undissolved after the second attempt, do not use. GATTEX does not contain any preservatives and is for single-use only. Discard any unused portion. The product should be used within 3 hours after reconstitution. [see How Supplied/Storage and Handling (16.2)]
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