d possible dose adjustment of oral medications that require titration or have a narrow therapeutic index is recommended. (5.5) (7.1)
USE IN SPECIFIC POPULATIONS
The safety and efficacy of GATTEX in pediatric patients have not been established. (8.4)
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 6/2014
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Dosing Information 2.2 Monitoring to Assess Safety 2.3 Dosage Modifications in Renal Impairment 2.4 Discontinuation of Treatment 2.5 Preparation for Administration 3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Acceleration of Neoplastic Growth 5.2 Intestinal Obstruction 5.3 Biliary and Pancreatic Disease 5.4 Fluid Overload 5.5 Increased Absorption of Concomitant Oral Medication 6 ADVERSE REACTIONS
6.1 Clinical Trials Experience 6.2 Immunogenicity 6.3 Postmarketing Experience 7 DRUG INTERACTIONS
7.1 Potential for Increased Absorption of Oral Medications 7.2 Concomitant Drug Therapy 8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 8.6 Renal Impairment 8.7 Hepatic Impairment 10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action 12.2 Pharmacodynamics 12.3 Pharmacokinetics 13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 14 CLINICAL STUDIES
14.1 Study 1 (Placebo-controlled) and Study 2 (Open-label extension of Study 1) 14.2 Study 3 (Placebo-controlled) and Study 4 (Blinded uncontrolled extension of Study 3) 16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied 16.2 Storage and Handling 17 PATIENT COUNSELING INFORMATION
17.1 Acceleration of Neoplastic Growth 17.2 Intestinal Obstruction 17.3 Gallbladder and Bile Duct Disease 17.4 Pancreatic Disease 17.5 Cardiovascular Disease 17.6 Risks Resulting from Increased Absorption of Concomitant Oral Medication 17.7 Instructions * Sections or subsections omitted from the full prescribing information are not listed. Close
1 INDICATIONS AND USAGE
GATTEX® (teduglutide [rDNA origin]) for injection is indicated for the treatment of adult patients with Short Bowel Syndrome (SBS) who are dependent on parenteral support. [see Clinical Pharmacology (12.2)]
2 DOSAGE AND ADMINISTRATION
2.1 Dosing InformationThe 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 SafetyA 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 r |
