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Reimbursement

Amneal Pharmaceutical

Amneal Pharmaceuticals, Inc., including its subsidiaries and affiliated entities (referred to collectively as “Amneal,” “We,” or “Us”) recognizes and respects the privacy rights of individuals with regards to their personal data. This Notice explains what types of personal data Amneal may collect from you and how we use it. It also explains the policies and practices that we have developed to safeguard personal data and to comply with applicable data protection laws. Please read this Notice carefully to understand what personal data we collect, how we collect it, how we use it, who we may disclose it to, and how you can manage your personal data.

If you have any questions concerning Amneal’s privacy practices or are an individual with a disability who would like to access this Notice in a different format, please contact us. Privacy Notice Here.

Medtronic

For information regarding reimbursement of the Medtronic pump, visit Medtronic’s product website here.

 

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.