GABLOFEN- baclofen injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BACLOFEN (UNII: H789N3FKE8) (BACLOFEN - UNII:H789N3FKE8)

Available from:

Mallinckrodt Inc (Brand Pharmaceuticals)

INN (International Name):

BACLOFEN

Composition:

BACLOFEN 50 ug in 1 mL

Administration route:

INTRATHECAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

GABLOFEN is indicated for use in the management of severe spasticity in adult and pediatric patients age 4 years and above. Patients should first respond to a screening dose of intrathecal baclofen prior to consideration for long term infusion via an implantable pump. For spasticity of spinal cord origin, chronic infusion of GABLOFEN via an implantable pump should be reserved for patients unresponsive to oral baclofen therapy, or those who experience intolerable CNS side effects at effective doses. Patients with spasticity due to traumatic brain injury should wait at least one year after the injury before consideration of long term intrathecal baclofen therapy. GABLOFEN is intended for use by the intrathecal route in single bolus test doses (via spinal catheter or lumbar puncture) and, for chronic use, only with the Medtronic SynchroMed® II Programmable Pump or other pumps labeled for intrathecal administration of GABLOFEN  [see Clinical Studies (14)] . Prior to implantation of a device for chronic intrathec

Product summary:

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.

Authorization status:

New Drug Application

Summary of Product characteristics

GABLOFEN- BACLOFEN INJECTION
MALLINCKRODT INC (BRAND PHARMACEUTICALS)
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
GABLOFEN SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR GABLOFEN.
GABLOFEN (BACLOFEN INJECTION), FOR INTRATHECAL USE
INITIAL U.S. APPROVAL: 1992
WARNING: DO NOT DISCONTINUE ABRUPTLY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
ABRUPT DISCONTINUATION OF INTRATHECAL BACLOFEN, REGARDLESS OF THE
CAUSE, HAS RESULTED IN SEQUELAE THAT
INCLUDE HIGH FEVER, ALTERED MENTAL STATUS, EXAGGERATED REBOUND
SPASTICITY, AND MUSCLE RIGIDITY, THAT IN RARE
CASES HAS ADVANCED TO RHABDOMYOLYSIS, MULTIPLE ORGAN-SYSTEM FAILURE
AND DEATH.
PREVENTION OF ABRUPT DISCONTINUATION OF INTRATHECAL BACLOFEN REQUIRES
CAREFUL ATTENTION TO PROGRAMMING
AND MONITORING OF THE INFUSION SYSTEM, REFILL SCHEDULING AND
PROCEDURES, AND PUMP ALARMS. PATIENTS AND
CAREGIVERS SHOULD BE ADVISED OF THE IMPORTANCE OF KEEPING SCHEDULED
REFILL VISITS AND SHOULD BE EDUCATED
ON THE EARLY SYMPTOMS OF BACLOFEN WITHDRAWAL. SPECIAL ATTENTION SHOULD
BE GIVEN TO PATIENTS AT APPARENT
RISK (E.G., SPINAL CORD INJURIES AT T-6 OR ABOVE, COMMUNICATION
DIFFICULTIES, HISTORY OF WITHDRAWAL
SYMPTOMS FROM ORAL OR INTRATHECAL BACLOFEN). CONSULT THE TECHNICAL
MANUAL OF THE IMPLANTABLE INFUSION
SYSTEM FOR ADDITIONAL POST-IMPLANT CLINICIAN AND PATIENT INFORMATION.
(5.4)
RECENT MAJOR CHANGES
Warnings and Precautions, Potential for Contamination due to Non-
sterile External Surface of Prefilled Syringe (5.2) 02/2015
INDICATIONS AND USAGE
GABLOFEN is a gamma-aminobutyric acid (GABA) ergic agonist indicated
for use in the management of severe
spasticity of cerebral or spinal origin in adult and pediatric
patients age 4 years and above. (1)
GABLOFEN should be reserved for patients unresponsive to oral baclofen
therapy, or those who experience
intolerable central nervous system side effects at effective doses.
(1)
Patients should first respond to a screening dose of intrathecal
baclofe