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Patient Assistance Programs

Saol Therapeutics is committed to helping patients access Intrathecal Bacolofen (ITB) TherapySM with Lioresal® Intrathecal (baclofen injection). In support of that goal, Saol has partnered with NeedyMeds to facilitate access to Lioresal® Intrathecal at no cost for patients who are uninsured or rendered uninsured.

Qualification criteria include

  • Income limits
  • An approved use of Lioresal® Intrathecal by a qualified healthcare
    provider
  • No insurance or insurance that does not cover Lioresal® Intrathecal

Needy Meds

For more information about this program click the link above or call 877-222-7715

Safety and effectiveness in pediatric patients below the age of 4 have not been established. Lioresal® Intrathecal should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Patients suffering from psychotic disorders, schizophrenia, or confusional states should be treated cautiously with Lioresal® Intrathecal and kept under careful surveillance.

Lioresal® Intrathecal should be given with caution in patients with impaired renal function. Dose reduction may be necessary. Lioresal® Intrathecal should be used with caution in patients with a history of autonomic dysreflexia.

Important Safety Information for Lioresal® Intrathecal (baclofen injection)

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 postimplant clinician and patient information (see WARNINGS).

Indications and Usage

Contraindications

Select Warnings and Precautions

Adverse Reactions

Common Adverse Reactions

Serious Adverse Reactions

Postmarketing Experience

Use in Specific Populations

For more information, including BOX WARNING, refer to Lioresal® Intrathecal (baclofen injection) prescribing information.