Gablofen (Page 6 of 6)

14 CLINICAL STUDIES

Spasticity of Spinal Cord Origin

Evidence supporting the efficacy of intrathecal baclofen was obtained in randomized, controlled investigations that compared the effects of either a single intrathecal dose or a three day intrathecal infusion of intrathecal baclofen to placebo in patients with severe spasticity and spasms due to either spinal cord trauma or multiple sclerosis. Intrathecal baclofen was superior to placebo on both principal outcome measures employed: change from baseline in the Ashworth rating of spasticity and the frequency of spasms.

Spasticity of Cerebral Origin

The efficacy of intrathecal baclofen was investigated in three controlled clinical trials; two enrolled patients with cerebral palsy and one enrolled patients with spasticity due to previous brain injury. The first study, a randomized controlled cross-over trial of 51 patients with cerebral palsy, provided strong, statistically significant results; intrathecal baclofen was superior to placebo in reducing spasticity as measured by the Ashworth Scale. A second cross-over study was conducted in 11 patients with spasticity arising from brain injury. Despite the small sample size, the study yielded a nearly significant test statistic (p=0.066) and provided directionally favorable results. The last study, however, did not provide data that could be reliably analyzed.

16 HOW SUPPLIED/STORAGE AND HANDLING

GABLOFEN (baclofen injection) is available in a single use syringe of 1 mL containing 50 mcg (50 mcg/mL) and in single use syringes and vials of 10,000 mcg per 20 mL (500 mcg/mL), 20,000 mcg per 20 mL (1,000 mcg/mL), and 40,000 mcg per 20 mL (2,000 mcg/mL) for intrathecal administration only.

50 mcg per mL

NDC 45945-151-01: 1 mL Syringe – 50 mcg per 1 mL

500 mcg per mL

NDC 45945-155-01: 20 mL Syringe – 10,000 mcg per 20 mL

NDC 45945-155-02: 20 mL Vial – 10,000 mcg per 20 mL

1,000 mcg per mL

NDC 45945-156-01: 20 mL Syringe – 20,000 mcg per 20 mL

NDC 45945-156-02: 20 mL Vial – 20,000 mcg per 20 mL

2,000 mcg per mL

NDC 45945-157-01: 20 mL Syringe – 40,000 mcg per 20 mL

NDC 45945-157-02: 20 mL Vial – 40,000 mcg per 20 mL

Does not require refrigeration.

Do not store above 86°F (30°C).

Do not freeze.

Do not heat sterilize.

17 PATIENT COUNSELING INFORMATION

Risks Related to Sudden Withdrawal of GABLOFEN

Advise patients and caregivers that sudden withdrawal of GABLOFEN, regardless of the cause, can result in serious complications that include high fever, confusion, muscle stiffness, multiple organ-system failure, and death. Inform patients that early symptoms of GABLOFEN withdrawal may include increased spasticity, itching, and tingling of extremities. If GABLOFEN withdrawal or a pump malfunction is suspected, patients should be brought immediately to a hospital for assessment and treatment.

Inform patients and caregivers that sudden withdrawal occurs most frequently due to a delivery problem with the catheter or the pump, or failure to refill the pump on schedule. Advise patients and their caregivers to pay careful attention to infusion system alarms. Instruct patients and caregivers that if they miss their scheduled pump refill, they should immediately contact their physician to reschedule the refill before the pump runs out of drug.

GABLOFEN Overdose

Inform patients and their caregivers that GABLOFEN overdose may occur suddenly or insidiously, and that symptoms may include confusion, drowsiness, lightheadedness, dizziness, slow or shallow breathing, seizures, loss of muscle tone, loss of consciousness, and coma. If an overdose appears likely, patients should be brought immediately to a hospital for assessment and possible emptying of the pump.

Operation of Automobiles and Other Dangerous Machinery

Advise patients that GABLOFEN may cause drowsiness, and that they should exercise caution regarding the operation of automobiles or other dangerous machinery, or activities made hazardous by decreased alertness.

Increased Risk of Drowsiness with Alcohol and Other CNS Depressants

Inform patients and their caregivers that the drowsiness associated with GABLOFEN use can be worsened by alcohol and other CNS depressants. Advise patients to read all medicine labels carefully, and to tell their physician about all prescription and nonprescription drugs they may use.

Mallinckrodt, the “M” brand mark, the Mallinckrodt Pharmaceuticals logo and, except as otherwise stated, other brands are trademarks of a Mallinckrodt company. SynchroMed is a trademark of Medtronic, Inc. © 2015 Mallinckrodt.

Distributed by:
Mallinckrodt Brand Pharmaceuticals, Inc.
Hazelwood, MO 63042 USA

Issued 02/2015

P/N: 750-0543-1

Mallinckrodt™
Pharmaceuticals

Principal Display Panel

NDC 45945-151-01
Contains one x 1 mL

Gablofen ®
(baclofen injection)
50 mcg/mL
For intrathecal use only
Single Use Syringe-Discard Unused Portion
Rx only
Distributed by:
Mallinckrodt Brand Pharmaceuticals, Inc.
Hazelwood, MO 63042 USA

Mallinckrodt™
Pharmaceuticals

780-05440Rev 05/2015

Principal Display Panel
(click image for full-size original)

Principal Display Panel

NDC 45945-155-01
Contains one x 20 mL syringe

Gablofen ®
(baclofen injection)
10,000 mcg/20 mL
(500 mcg/mL)
Sterile solution for intrathecal use only
Rx only
For Maintenance Dosing with Intrathecal Pump.
Single Use Syringe-Discard Unused Portion

Mallinckrodt™
Pharmaceuticals

Distributed by:
Mallinckrodt Brand Pharmaceuticals, Inc.
Hazelwood, MO 63042 USA

780-05407Rev 10/2015

Principal Display Panel
(click image for full-size original)

Principal Display Panel

NDC 45945-156-01
Contains one x 20 mL syringe

Gablofen ®
(baclofen injection)
20,000 mcg/20 mL
(1,000 mcg/mL)
Sterile solution for intrathecal use only
Rx only
For Maintenance Dosing with Intrathecal Pump.
Single Use Syringe-Discard Unused Portion

Mallinckrodt™
Pharmaceuticals

Distributed by:
Mallinckrodt Brand Pharmaceuticals, Inc.
Hazelwood, MO 63042 USA

780-05412Rev 10/2015

Principal Display Panel
(click image for full-size original)

Principal Display Panel

NDC 45945-157-01
Contains one x 20 mL syringe

Gablofen ®
(baclofen injection)
40,000 mcg/20 mL
(2,000 mcg/mL)
Sterile solution for intrathecal use only
Rx only
For Maintenance Dosing with Intrathecal Pump.
Single Use Syringe-Discard Unused Portion

Mallinckrodt™
Pharmaceuticals

Distributed by:
Mallinckrodt Brand Pharmaceuticals, Inc.
Hazelwood, MO 63042 USA

780-05423Rev 10/2015

Principal Display Panel
(click image for full-size original)
GABLOFEN baclofen injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:45945-151
Route of Administration INTRATHECAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BACLOFEN (BACLOFEN) BACLOFEN 50 ug in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:45945-151-01 1 mL in 1 SYRINGE, GLASS None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022462 11/19/2010 01/31/2018
GABLOFEN baclofen injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:45945-155
Route of Administration INTRATHECAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BACLOFEN (BACLOFEN) BACLOFEN 500 ug in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:45945-155-01 20 mL in 1 SYRINGE, GLASS None
2 NDC:45945-155-02 20 mL in 1 VIAL, GLASS None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022462 11/19/2010 09/30/2018
GABLOFEN baclofen injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:45945-156
Route of Administration INTRATHECAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BACLOFEN (BACLOFEN) BACLOFEN 1000 ug in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:45945-156-01 20 mL in 1 SYRINGE, GLASS None
2 NDC:45945-156-02 20 mL in 1 VIAL, GLASS None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022462 07/10/2012 07/31/2019
GABLOFEN baclofen injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:45945-157
Route of Administration INTRATHECAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BACLOFEN (BACLOFEN) BACLOFEN 2000 ug in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:45945-157-01 20 mL in 1 SYRINGE, GLASS None
2 NDC:45945-157-02 20 mL in 1 VIAL, GLASS None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022462 11/19/2010 01/31/2020
Labeler — Mallinckrodt Inc (Brand Pharmaceuticals) (047021092)

Revised: 03/2017 Mallinckrodt Inc (Brand Pharmaceuticals)

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