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Gattex

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Gattex

INDICATIONS

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].

DOSAGE AND ADMINISTRATION

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.

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]

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 and CLINICAL PHARMACOLOGY]

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.

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]

HOW SUPPLIED

Dosage Forms And Strengths

For Injection: Each single-use glass vial contains a dose of 5 mg teduglutide as a lyophilized powder that upon reconstitution with the 0.5 mL Sterile Water for Injection provided in the prefilled syringe delivers a maximum of 0.38 mL of the reconstituted sterile solution which contains 3.8 mg of teduglutide.

GATTEX® (teduglutide [rDNA origin]) for injection is supplied in a sterile, single-use glass vial containing 5 mg of teduglutide as a white, lyophilized powder to be reconstituted with 0.5 mL Sterile Water for Injection. The product to be dispensed is either a one-vial kit or a 30-vial kit. The one-vial kit is pre-assembled and ready to be used. The 30-vial kit is to be assembled by a pharmacist with the following two cartons:

Carton of Drug Vials (NDC 68875-0101-2)
  • Thirty single-use vials of drug (NDC 68875-0101-1)
Carton of Ancillary Supplies (NDC 68875-0101-3)
  • Thirty disposable prefilled syringes containing diluent (0.5 mL Sterile Water for Injection USP) for reconstitution
  • Thirty separate needles (22G x 1½ in) to attach to the syringes for reconstitution
  • Thirty sterile disposable 1-mL syringes with needle (26G x 5/8 in)
  • Sixty alcohol swabs

The pharmacist in a dispensing pharmacy will assemble a 30-vial kit by transferring the trays containing 30 vials from a Carton of Drug Vials into a Carton of Ancillary Supplies. The final patient kits should contain the items listed as follows:

30-vial kit (NDC 68875-0101-3)
  • Thirty single-use vials of drug (NDC 68875-0101-1)
  • Thirty disposable prefilled syringes containing 0.5 mL Sterile Water for Injection USP for reconstitution, with 30 separate needles (22G x 1½ in) to attach to the syringes
  • Thirty sterile disposable 1-mL syringes with needle (26G x 5/8 in) for dosing
  • Sixty alcohol swabs
One-vial kit (NDC 68875-0101-4)

One single-use vial of drug (NDC 68875-0101-1)

  • One disposable prefilled syringe containing 0.5 mL Sterile Water for Injection USP for reconstitution, with a separate needle (22G x 1½ in) to attach to the syringe
  • One sterile disposable 1-mL syringe with needle (26G x 5/8 in) for dosing
  • Four alcohol swabs

Reconstitution with 0.5 mL of preservative-free Sterile Water for Injection, provided in a prefilled syringe, is required prior to subcutaneous administration of the drug. Reconstituted GATTEX is a sterile, clear, colorless to light straw-colored 10 mg/mL solution, which should be free from particulates. Upon reconstitution with the 0.5 mL Sterile Water for Injection provided in the prefilled syringe, a maximum of 0.38 mL of the reconstituted solution which contains 3.8 mg of teduglutide can be withdrawn from the vial for dosing.

Storage and Handling

Prior to Dispensing: Store refrigerated at 2°C to 8°C (36°F and 46°F) for Cartons of Drug Vials and the One-vial kits. Do not freeze. Do not use beyond the expiration date on the label. Store at room temperature up to 25°C (77°F) for the Cartons of Ancillary Supplies.

Instruction for the Pharmacist

Prior to Dispensing: Store at 2°C to 8°C (36°F to 46°F) for Cartons of Drug Vials and the One-vial kits. Do not freeze.

Dispensing Instructions: Dispense with a 90-day “use by” dating and specify “Store at room temperature up to 25°C (77°F). Do not freeze.” Dispense Medication Guide to each patient.

Reconstituted GATTEX is a sterile, clear, colorless to light straw-colored solution, which should be free from particulates. The drug should be completely dissolved before the solution is withdrawn from the vial. Do not shake or freeze the reconstituted solution. If the product remains undissolved after the second attempt, do not use. GATTEX does not contain any preservatives and is for single-use only. Any unused portion should be discarded. The product should be used within 3 hrs after reconstitution.

Manufactured by: Hospira, Inc., 1776 N. Centennial Drive, McPherson, KS 67460. U.S.A. Distributed by: NPS Pharmaceuticals, 550 Hills Drive, 3rd Floor, Bedminster, NJ 07921. U.S.A. Issued: December 2012

Last reviewed on RxList: 1/7/2013
This monograph has been modified to include the generic and brand name in many instances.

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