Safety considerations

It is important to know that everyone responds differently to prescription medications, including whether or not they develop side effects. If side effects do occur, PRIALT can be interrupted or stopped suddenly without causing withdrawal effects.¹

A slow dosing approach can help minimize the occurrence of side effects. Talk to your doctor about any concerns you may have about PRIALT safety.

What is the most important safety information I should know about PRIALT?

PRIALT may cause serious mental symptoms and neurological problems.

• You should not receive PRIALT if you have or had a mental condition called psychosis
  
  You or a caregiver should call your doctor right away if you:
• • Are confused
  • Are less alert
  • See or feel things that are not real (hallucinations)
  • Have changes in mood or consciousness
• If you have mental symptoms or neurological problems, PRIALT treatment can be interrupted or stopped suddenly without experiencing withdrawal effects

You should not be given PRIALT if you:

• Are allergic to PRIALT or any ingredient in it
• Have a condition or are receiving a treatment that would cause an injection in your spinal fluid to be unsafe
• Have or had a mental illness called psychosis
• Have an infection at the device injection site, uncontrolled bleeding problems, or a blockage in your spinal cord area

PRIALT can cause serious problems that you should tell your doctor or health care professional about immediately such as:

• Severe Psychiatric Symptoms or Neurological Impairment including changes in mood or perception (hallucinations, including unusual sensations in the mouth and throat), changes and slowing in thinking, depression or suicidal thoughts, confusion, memory impairment, speech disorder, or inability to eat.

• Unconsciousness or Reduced Mental Alertness indicated by changes in mental status (tiredness, confusion, disorientation, or decreased alertness). Some people have lost consciousness while being treated with PRIALT. It may not be safe for you to engage in hazardous activity requiring complete mental alertness or motor coordination such as operating machinery or driving a motor vehicle during treatment

• Meningitis or Other Infections indicated by signs and symptoms that include but are not limited to fever, headache, stiff neck, altered mental status (tiredness, confusion, disorientation or decreased alertness), nausea or vomiting, and sometimes seizures.

• Serious Muscle Damage. Your doctor should regularly monitor you for muscle damage by doing a blood test to check for an increase in serum creatine kinase (CK). Increased CK levels in the blood may mean there is damage to your muscles. High levels of CK in the blood can damage your kidneys. Call your doctor right away if you have new muscle pain, soreness, weakness, or your urine is dark in color.

• The most common side effects with PRIALT are dizziness, nausea, confusion, headache, sleepiness, problems with vision, weakness, and pain.

Note that if any side effects occur with any prescription drug, you are encouraged to report them to the FDA.

Please see accompanying full prescribing information including boxed WARNING and important safety information

Reference: 1. PRIALT^® (ziconotide intrathecal infusion) Prescribing Information.