Baclofen Intrathecal and Migalastat Hydrochloride

• Generic Name: baclofen
• Dosage Forms: n.a.
• Other Brand Names: Lioresal Intrathecal, Gablofen, FIRST Baclofen, Lioresal, Ozobax

Intrathecal baclofen is used to help relax certain muscles in your body. It relieves the spasms, cramping, and tightness of muscles caused by medical problems such as multiple sclerosis, cerebral palsy, or certain injuries to the spine. Intrathecal baclofen does not cure these problems, but it may allow other treatment, such as physical therapy, to be more helpful in improving your condition.

Intrathecal baclofen acts on the central nervous system (CNS) to produce its muscle relaxant effects. Its actions on the CNS may also cause some of the medicine's side effects.

Baclofen is delivered by a drug pump directly into the spinal fluid of your back. A doctor will surgically place the pump and monitor the dose of the medication that is delivered by the pump. The dose of intrathecal baclofen will be different for different patients and will depend on the type of muscle tightness that you have.

Intrathecal baclofen is given only by or under the direct supervision of a doctor.

• Generic Name: migalastat
• Dosage Forms: n.a.
• Other Brand Names: Galafold

Migalastat hydrochloride is an alpha-galactosidase A (alpha-Gal A) pharmacological chaperone indicated for the treatment of adults with a confirmed diagnosis of Fabry disease and an amenable galactosidase alpha gene (GLA) variant based on in vitro assay data.

This indication is approved under accelerated approval based on reduction in kidney interstitial capillary cell globotriaosylceramide (KIC GL-3) substrate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.