PRIALT® (ziconotide) intrathecal infusion (25 mcg/mL, 100 mcg/mL) is a prescription medicine used to treat severe chronic pain in adults who cannot take other treatments or when other treatments do not work, stop working, or cause bothersome side effects. PRIALT can only be delivered by or under the direction of a doctor who injects the medicine into your spinal fluid through a special device (a procedure called intrathecal infusion) and should only be used in patients who are appropriate for the procedure.
Important Safety Information
PRIALT may cause serious side effects including psychiatric (mental) symptoms and problems thinking (confusion, memory problems, speech difficulties). The doctor should be called immediately if, while taking PRIALT, you:
- are confused or disoriented
- are less alert
- see or hear things that are not real (hallucinations)
- have changes in mood or consciousness
Your doctor may stop your treatment with PRIALT, give you other medicines, or require you to be hospitalized if you experience any of these symptoms.
You should not be given PRIALT if you:
- are allergic to PRIALT or any of its ingredients
- 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 (a loss of contact with reality, usually including delusions (false beliefs about what is taking place or who one is) or hallucinations (seeing or hearing things that aren't real))
PRIALT may cause or worsen depression, which increases the risk of suicide. People 65 years of age and older have a higher risk for confusion with PRIALT. Taking certain other medicines along with PRIALT may raise the risk of having problems with thinking or alertness. Tell your doctor about all the medicines you are taking.
Meningitis (inflammation of the protective membranes covering the brain and spinal cord) or other infections can happen if the infusion device becomes contaminated. Tell your doctor right away if you have fever, headache, stiff neck, changes in mental status (feeling tired, confused, disoriented), nausea, vomiting, and/or seizures as these may be symptoms of developing meningitis.
PRIALT may cause unconsciousness or reduced mental alertness. Avoid activities where you need to be alert, awake, and have full control of your body (activities like operating machinery or driving a car) during treatment with PRIALT.
Tell the doctor if you experience new or worsening muscle pain, soreness, weakness or if your urine is dark in color as this could be a sign of rare but serious muscle side effects.
You should also tell the doctor if you are pregnant, plan to become pregnant or if you are breastfeeding.
The most common side effects of PRIALT include dizziness, nausea, confusion and uncontrolled eye movements. These are not all the possible side effects of PRIALT. Talk to your doctor about any side effects you may be experiencing.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see accompanying full Prescribing Information, including BOXED Warning, and discuss with your doctor.