ziconotide

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

Ziconotide is used to treat severe chronic pain in people who cannot use or do not respond to standard pain-relieving medications.

Ziconotide may also be used for other purposes not listed in this medication guide.

Important information

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

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

Ziconotide must be given only as an intrathecal injection through an infusion pump and should not be injected directly into a vein or other part of the body. Your doctor, nurse, or other healthcare provider will give you this injection.

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

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. Ziconotide 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 using ziconotide

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

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

FDA pregnancy category C. It is not known whether ziconotide is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether ziconotide passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

See also: Pregnancy and breastfeeding warnings (in more detail)

How should I use ziconotide?

Ziconotide is given as an injection into the space around your spinal cord (intrathecal injection) using a computerized, portable infusion pump to control the rate of medication you receive. You may need to use this medication for a period of many years.

Ziconotide must be given only as an intrathecal injection through an infusion pump and should not be injected directly into a vein or other part of the body. Your doctor, nurse, or other healthcare provider will give you this injection.

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

Tell your doctor if the medicine seems to stop working as well in relieving your pain.

To be sure ziconotide is helping your condition and not causing harmful effects, your doctor will need to check your progress on a regular basis. Do not miss any scheduled appointments.

If you also use a narcotic pain medication, do not stop using it suddenly or you may have unpleasant withdrawal symptoms. Talk with your doctor about using less and less of the narcotic medication before stopping completely.

What happens if I miss a dose?

Since ziconotide dosing and infusion pump programming is administered by a healthcare professional, you are not likely to miss a dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine or if your infusion pump is not working properly.

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

What should I avoid?

Avoid drinking alcohol while you are using ziconotide. Ziconotide can cause side effects that may impair your thinking or reactions. Avoid driving or doing anything that requires you to be awake and alert.

Ziconotide side effects

Get emergency medical help if you have any of these signs of an allergic reaction to ziconotide: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

• problems with memory, speech, walking, or thinking;

• feeling like you might pass out;

• double vision or other vision problems;

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

• unusual bleeding or signs of infection around the microinfusion entry or catheter exit sites;

• fever, headache, neck stiffness, chills, increased sensitivity to light, purple spots on the skin, nausea, vomiting, and/or seizure (convulsions);

• extreme drowsiness or tired feeling, depressed mood;

• feeling paranoid, hostile, disoriented, or confused;

• strange sensations in your mouth;

• hallucinations, unusual thoughts or behavior, thoughts of hurting yourself; or

• feeling less alert, decreased consciousness (stupor or lack of response).

Less serious ziconotide side effects may include:

• headache, joint pain;

• mild drowsiness or weakness;

• dizziness, spinning sensation;

• sleep problems, unusual dreams;

• stomach pain, diarrhea, constipation, loss of appetite;

• urinating less than usual; or

• loss of balance or coordination.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

Ziconotide dosing information

Usual Adult Ziconotide Dose for Pain:

Initial ziconotide dose: No more than 2.4 mcg per day (0.1 mcg/hour) by intrathecal (IT) administration

The dosage should be titrated to patient response. Doses may be titrated upward by up to 2.4 mcg/day (0.1 mcg/hour) at intervals of no more than 2 to 3 times per week, up to a recommended maximum of 19.2 mcg/day (0.8 mcg/hour) by day 21. Dose increases in increments of less than 2.4 mcg/day (0.1 mcg/hour) and increases in dose less frequently than 2 to 3 times per week may be used. The average dose level at the end of a 21 day clinical study was 6.9 mcg per day (0.29 mcg/hour).

Usual Geriatric Ziconotide Dose for Pain:

The dose selection for elderly patients should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, and cardiac function, and of concomitant diseases or other drug therapy.

Initial ziconotide dose: No more than 2.4 mcg per day (0.1 mcg/hour) by intrathecal (IT) administration

The dosage should be titrated to patient response. Doses may be titrated upward by up to 2.4 mcg/day (0.1 mcg/hour) at intervals of no more than 2 to 3 times per week, up to a recommended maximum of 19.2 mcg/day (0.8 mcg/hour) by day 21. Dose increases in increments of less than 2.4 mcg/day (0.1 mcg/hour) and increases in dose less frequently than 2 to 3 times per week may be used. The average dose level at the end of a 21 day clinical study was 6.9 mcg per day (0.29 mcg/hour).

What other drugs will affect ziconotide?

Before receiving ziconotide, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). Ziconotide can add to sleepiness caused by these other medications.

Also tell your doctor if you are taking a diuretic (water pill).

This list is not complete and there may be other drugs that can interact with ziconotide. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.