Prialt is a non-narcotic pain reliever that works by blocking pain signals from the nerves to the brain.

Prialt injection is given by intrathecal administration for around-the-clock treatment of severe chronic pain that cannot be treated with other pain medications.

Prialt is not intended for IV (intravenous) use.

Severe psychiatric symptoms and neurological impairment may occur during treatment with Prialt. You should not receive this medicine if you have a history of psychiatric illness or psychotic event.

You should not use Prialt if you are allergic to ziconotide, or if you have an uncontrolled bleeding or blood clotting disorder.

Your doctor may occasionally change your dose or infusion pump flow rate to make sure you get the best results from this medicine.

Tell your doctor if the medicine seems to stop working as well in relieving your pain. Tell your doctor if you regularly use other medicines that make you sleepy. Prialt can add to sleepiness caused by these other medications.

Call your doctor at once if you have a serious side effect, especially fever, neck stiffness, seizure (convulsions), extreme drowsiness or tired feeling, confusion, disorientation, hallucinations, thoughts of hurting yourself, or decreased consciousness.

Before taking this medicine

You should not be treated with Prialt if you are allergic to ziconotide, or if you have:

• an uncontrolled or untreated bleeding disorder; or

• a problem affecting your spine (such as arthritis, bone disorder, or narrowing of the spinal canal).

Some people using ziconotide have had new or worsening mental problems. You should not be treated with Prialt if you have a history of psychosis (delusions or loss of contact with reality).

Tell your doctor if you have recently used opioid medicine.

Tell your doctor if you are pregnant or plan to become pregnant.

You should not breastfeed while using Prialt.

Prialt is given around the clock using an infusion pump attached to a catheter placed into the space around your spinal cord (intrathecal injection). The infusion pump may be surgically implanted into your body or worn on the outside of your body. The pump controls how quickly the medicine is injected into your body.

Ziconotide may affect your thoughts, memory, speech, or daily activities. This effect may come on gradually after you've used this medicine for several weeks. Your doctor may occasionally change your dose or infusion pump flow rate.

Ziconotide doses are based on weight. Your dose needs may change if you gain or lose weight.

Tell your doctor if the medicine seems to stop relieving your pain, or if your infusion pump is not working properly.

If your catheter becomes contaminated, you may develop an infection. Call your doctor right away if you have symptoms such as fever, headache, confusion, neck stiffness, nausea, or vomiting.

If you also use opioid pain medicine, do not stop using it suddenly or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using opioid medicine.

You may need to use Prialt for a period of many years.

Your doctor will need to check your progress on a regular basis.

Usual Adult Dose for Chronic Pain:

Initial dose: 0.1 mcg/hr (2.4 mcg/day) via intrathecal device
-Titrate dose in increments of up to 2.4 mcg/day at intervals of no more than 2 to 3 times per week based on analgesic response and adverse events; adjust pump infusion flow rate as required to achieve new dosing
Maximum dose: 19.2 mcg/day (0.8 mcg/hr)

Comments:
-Administration should be under the direction of a physician experienced in the technique of intrathecal administration and who is familiar with the drug and device labeling.
-This drug is intended for intrathecal delivery using the Medtronic SynchroMed(R) II Infusion System and CADD-Micro Ambulatory Infusion Pump; refer to manufacturer's manual for specific instructions and precautions for programming the microinfusion device and/or refilling the reservoir.

Use: For the management of severe chronic pain in adult patients for whom intrathecal therapy is warranted, and who are intolerant of, or refractory to other treatment, such as systemic analgesics, adjunctive therapies, or intrathecal morphine.

You should not be treated with Prialt if you are allergic to ziconotide, or if you have:

• an uncontrolled or untreated bleeding disorder; or

• a problem affecting your spine (such as arthritis, bone disorder, or narrowing of the spinal canal).

Some people using ziconotide have had new or worsening mental problems. You should not be treated with Prialt if you have a history of psychosis (delusions or loss of contact with reality).

Tell your doctor if you have recently used opioid medicine.

Tell your doctor if you are pregnant or plan to become pregnant.

You should not breastfeed while using Prialt.

Since your infusion pump programming control your dosing, you are not likely to miss a dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include severe dizziness or drowsiness, vision problems, speech problems, stiffness in your neck or back, nausea and vomiting, or loss of consciousness.

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.

Avoid drinking alcohol.

Get emergency medical help if you have signs of an allergic reaction to Prialt: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Ziconotide can affect your central nervous system and you may feel less alert. A person caring for you should seek emergency medical attention if you are hard to wake up.

Call your doctor at once if you have:

• new or worsening muscle pain, soreness, or weakness, and/or dark urine;

• a light-headed feeling (like you might pass out);

• strange sensations in your mouth;

• skin sores, itching, blisters, breakdown of the outer layer of skin;

• confusion (especially in older adults);

• problems with memory or thought;

• unusual changes in mood or behavior - anger, aggression, paranoia, hallucinations, racing thoughts, risk-taking behavior;

• symptoms of depression - feelings of low self-worth, loss of interest in things you once enjoyed, new sleep problems, thoughts about hurting yourself; or

• symptoms of meningitis - fever, headache, neck stiffness, increased sensitivity to light, nausea, vomiting, confusion, or drowsiness.

Common Prialt side effects may include:

• dizziness;

• confusion;

• nausea; or

• unusual or involuntary eye movements.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Using Prialt with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Tell your doctor about all your other medicines, especially:

• a diuretic or "water pill";

• seizure medicine; or

• medicine to treat anxiety, mood disorders, or mental illness such as schizophrenia.

This list is not complete. Other drugs may interact with ziconotide, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.