The only FDA-approved, non-narcotic, non-opioid, intrathecal option for pain

• Difficulty speaking
• Changes in mood, new or worsening depression or suicidal thoughts
• New muscle pain or muscle cramps

Who should NOT take PRIALT?

You should not take PRIALT if:

• You have a mental health condition called psychosis, described as a loss of contact with reality, which may include delusions (believing things that are not actually true), or hallucinations (seeing or hearing things that are not real)
• You are allergic to PRIALT or to any of its ingredients

What are the other possible serious side effects of PRIALT?

Mental (psychiatric) problems, difficulty thinking. PRIALT may cause psychiatric problems or make it difficult to think properly. People who are 65 years of age and older have a higher risk for confusion. PRIALT may cause or worsen depression, which increases the risk of suicide.

Reduced mental alertness. PRIALT can reduce your mental alertness or cause you to become unconscious. While taking PRIALT, avoid activities that require you to be alert and awake, and have full control of your body – examples of activities to avoid include operating machinery or driving a car.

Muscle problems. PRIALT can cause rare but serious muscle problems. Tell your doctor if you have any of the following:

• New or worsening muscle pain, soreness, or weakness
• Dark-colored urine

What should I tell my doctor before receiving treatment with PRIALT?

• Before receiving PRIALT, tell your doctor about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Certain medicines can increase the risk of experiencing confusion and reduced mental alertness with PRIALT.
• Tell your doctor about all of your medical conditions, including if you are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed.

What are the most common side effects of PRIALT?

• Dizziness
• Nausea
• Confusion
• Uncontrolled eye movements

These are not all the possible side effects of PRIALT. Your doctor may stop treatment if serious side effects happen. Be sure to contact your healthcare team right away if you have questions or are worried about any side effects.

What does PRIALT treat?

PRIALT 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).

You are encouraged to report negative side effects of prescription drugs to the FDA at 1‑800‑FDA‑1088 or www.FDA.gov/medwatch. You may also contact ESTEVE Pharmaceuticals, S.A. at 1‑888‑306‑6259 or drugsafety.us@esteve.com.

Please see accompanying Full Prescribing Information, including BOXED WARNING.