Gablofen (intrathecal baclofen) is a U.S. Food and Drug Administration (FDA) approved therapy for treatment of severe spasms caused by problems in the brain or spine in adults and children over age 4. It is designed for people with diseases such as multiple sclerosis (MS) who can not tolerate baclofen by mouth or do not experience relief from tablets.
Intrathecal baclofen therapy (ITB) is an established and widely accepted treatment option. Because it is administered directly into the intrathecal space (injected), the results are better at lower doses than oral medications, and with fewer adverse effects.
ITB therapy consists of a pump with a chamber that is placed by a surgeon under the skin of the stomach. It is connected to the intrathecal space by a small tube. The chamber is filled with liquid baclofen. The pump is programmed to distribute the medicine around the clock for controlling spasticity as needed.
This medicine has a black box warning that appears on the prescription drug’s label to call attention to serious or life-threatening risks. Abrupt discontinuation of injected Gablofen may cause high fever, altered mental status, an increase in spasms, and muscle rigidity. In rare cases, abruptly stopping the medication has led to organ failure and death. Careful attention to programming, monitoring the pump, refill scheduling, and pump alarm care is needed in order to avoid abrupt discontinuation of the drug.
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