Prialt 25mcg/ml Inj, 20ml
WARNING: Severe mental or mood problems may happen with this drug. If you have ever had mental or mood problems, talk with your doctor. This drug may not be right for you. Call your doctor right away if you have confusion, hallucinations (seeing or hearing things that are not there), memory problems or loss, or thoughts of suicide. Call your doctor right away if you have any changes in speech, mood or actions, or alertness. @ COMMON USES: It is used to manage pain.
Drug Class
Analgesic
Pharmacologic Class
N-type calcium channel blocker
Pregnancy Category
Category C
FDA Approved
Dec 2004
DEA Schedule
Not Controlled
Overview
What is this medicine?
Prialt is a strong pain medicine given directly into the fluid around your spinal cord. It works differently from opioids by blocking specific pain signals in your spinal cord, helping to relieve severe chronic pain when other treatments haven't worked or aren't tolerated.
How to Use This Medicine
To use this medication correctly, follow your doctor's instructions and carefully read all accompanying information. Adhere to the dosage and administration guidelines provided. This medication is administered via injection into the spine.
For storage and disposal, consult with your doctor, nurse, or pharmacist to determine the best approach if you need to keep this medication at home.
If you miss a dose, contact your doctor promptly to receive guidance on the next steps to take.
For storage and disposal, consult with your doctor, nurse, or pharmacist to determine the best approach if you need to keep this medication at home.
If you miss a dose, contact your doctor promptly to receive guidance on the next steps to take.
Lifestyle & Tips
- Avoid driving or operating heavy machinery, especially during dose titration, until you know how Prialt affects you, as it can cause dizziness, confusion, and impaired coordination.
- Report any new or worsening mental health symptoms (e.g., sadness, anxiety, hallucinations, unusual thoughts) to your doctor immediately.
- Report any new or worsening muscle weakness, difficulty walking, or changes in sensation.
- Do not stop Prialt suddenly without consulting your doctor, as this can lead to withdrawal symptoms or worsening pain.
- Carry an identification card stating you are receiving intrathecal Prialt.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Initial dose: 2.4 mcg/day (0.1 mcg/hr) by continuous intrathecal infusion. Titrate by increments of no more than 2.4 mcg/day (0.1 mcg/hr) at intervals of no more than 2-3 times per week. Maximum recommended dose: 19.2 mcg/day (0.8 mcg/hr).
Dose Range:
2.4 - 19.2 mg
Condition-Specific Dosing:
intrathecal_infusion:
Administer via an intrathecal catheter connected to an external or implanted programmable pump. Must be diluted prior to use for continuous infusion.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended.
Severe:
No specific dose adjustment recommended.
Dialysis:
Not applicable, as systemic exposure is minimal with intrathecal administration.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended.
Severe:
No specific dose adjustment recommended.
Pharmacology
Mechanism of Action
Ziconotide is a synthetic, non-opioid, N-type calcium channel blocker. It selectively blocks N-type voltage-sensitive calcium channels (VSCCs) located on the primary afferent nociceptors in the superficial laminae of the spinal cord. This blockade inhibits the release of pronociceptive neurotransmitters (e.g., substance P, calcitonin gene-related peptide, glutamate) from the presynaptic terminals, thereby interrupting pain signal transmission.
Pharmacokinetics
Absorption:
Bioavailability:
Not applicable (intrathecal administration, minimal systemic absorption)
Tmax:
Not applicable (continuous infusion)
FoodEffect:
Not applicable
Distribution:
Vd:
Not available (minimal systemic distribution)
ProteinBinding:
Not available
CnssPenetration:
Yes (direct spinal cord delivery)
Elimination:
HalfLife:
Approximately 4.6 hours (in CSF)
Clearance:
Not available (minimal systemic clearance)
ExcretionRoute:
Not available (metabolized by peptidases)
Unchanged:
Not available
Pharmacodynamics
OnsetOfAction:
Days to weeks (due to slow titration)
PeakEffect:
Variable, depends on titration to optimal dose
DurationOfAction:
Continuous with ongoing infusion
Safety & Warnings
BLACK BOX WARNING
Severe psychiatric symptoms and neurological impairment have occurred during intrathecal ziconotide administration. Patients with a pre-existing history of psychosis should not be treated with Prialt. All patients should be monitored for evidence of cognitive impairment, hallucinations, or changes in mood or consciousness. Patients with a history of depression or suicidal ideation should be monitored closely. In clinical trials, cases of suicidal ideation and suicide attempts were reported. Discontinuation of Prialt may be necessary if these symptoms occur.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of meningitis, including:
+ Headache with fever
+ Stiff neck
+ Upset stomach
+ Confusion
+ Sensitivity to light
Seizures
Changes in balance
Feeling sluggish
Anxiety
Muscle pain or weakness
Dark urine
Difficulty passing urine
Muscle cramps
Muscle spasms
Inability to control eye movements
Changes in eyesight
Trouble walking
Shakiness
Skin ulcers
Severe skin irritation
Pain in arms or legs
Pneumonia symptoms, such as:
+ Fever
+ Chest pain
+ Cough
+ Shortness of breath
+ Wheezing (note: pneumonia has been reported in some cases, and in rare instances, it has been fatal)
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help if they bother you or do not go away:
Feeling dizzy, sleepy, tired, or weak
Diarrhea
Upset stomach
Vomiting
Sinus pain
Decreased appetite
Headache
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of meningitis, including:
+ Headache with fever
+ Stiff neck
+ Upset stomach
+ Confusion
+ Sensitivity to light
Seizures
Changes in balance
Feeling sluggish
Anxiety
Muscle pain or weakness
Dark urine
Difficulty passing urine
Muscle cramps
Muscle spasms
Inability to control eye movements
Changes in eyesight
Trouble walking
Shakiness
Skin ulcers
Severe skin irritation
Pain in arms or legs
Pneumonia symptoms, such as:
+ Fever
+ Chest pain
+ Cough
+ Shortness of breath
+ Wheezing (note: pneumonia has been reported in some cases, and in rare instances, it has been fatal)
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help if they bother you or do not go away:
Feeling dizzy, sleepy, tired, or weak
Diarrhea
Upset stomach
Vomiting
Sinus pain
Decreased appetite
Headache
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe dizziness or lightheadedness
- Confusion or memory problems
- Hallucinations (seeing or hearing things that aren't there)
- Unusual thoughts or behaviors
- Severe depression or thoughts of harming yourself
- Difficulty walking or loss of balance (ataxia)
- Muscle weakness or severe muscle pain
- Slurred speech
- Numbness or tingling in your hands or feet
- Severe nausea or vomiting
- Difficulty urinating
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
Certain health conditions, including:
+ Bleeding problems
+ Infections at the injection site
+ Spinal problems
This list is not exhaustive, and it is crucial to discuss all your health problems and medications with your doctor.
To ensure your safety, please disclose all of the following to your doctor and pharmacist:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* All your health problems
Before starting, stopping, or changing the dose of any medication, including this one, you must consult with your doctor to confirm that it is safe to do so.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
Certain health conditions, including:
+ Bleeding problems
+ Infections at the injection site
+ Spinal problems
This list is not exhaustive, and it is crucial to discuss all your health problems and medications with your doctor.
To ensure your safety, please disclose all of the following to your doctor and pharmacist:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* All your health problems
Before starting, stopping, or changing the dose of any medication, including this one, you must consult with your doctor to confirm that it is safe to do so.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. While using this drug, avoid operating a vehicle or engaging in any activities that require alertness, as it may impair your ability to do so. Regular blood tests will be necessary, as directed by your doctor, to monitor your condition; be sure to discuss any concerns or questions with your doctor. Before consuming alcohol, using marijuana or other cannabis products, or taking any prescription or over-the-counter medications that may cause drowsiness, consult with your doctor to ensure safe use. If you are 65 years or older, exercise caution when taking this medication, as you may be more susceptible to side effects. If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor to discuss the potential benefits and risks to both you and your baby.
Overdose Information
Overdose Symptoms:
- Exaggerated pharmacological effects: severe dizziness, confusion, somnolence, stupor, coma, severe nausea, vomiting, ataxia, nystagmus, speech difficulties, muscle weakness, seizures, respiratory depression.
What to Do:
Seek immediate medical attention. Management is supportive, including discontinuation of the infusion, monitoring vital signs, and providing respiratory support if needed. There is no specific antidote. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Major Interactions
Moderate Interactions
- Anticholinergic drugs: May exacerbate urinary retention or constipation.
Monitoring
Baseline Monitoring
Pain assessment (e.g., VAS, NRS)
Rationale: To establish baseline pain severity and monitor treatment efficacy.
Timing: Prior to initiation
Neurological examination
Rationale: To assess baseline cognitive function, motor function, and sensory status, and to monitor for neurological adverse events.
Timing: Prior to initiation
Psychiatric evaluation (including suicidal ideation)
Rationale: To assess baseline mental status and monitor for psychiatric adverse events, especially given the Black Box Warning.
Timing: Prior to initiation
Creatinine kinase (CK)
Rationale: To establish baseline and monitor for myopathy/rhabdomyolysis, though rare.
Timing: Prior to initiation
Routine Monitoring
Pain assessment
Frequency: Daily during titration, then regularly (e.g., weekly to monthly) during maintenance
Target: Individualized, aiming for acceptable pain relief
Action Threshold: Lack of efficacy or worsening pain may require dose adjustment or re-evaluation.
Neurological status (cognitive function, motor, sensory)
Frequency: Daily during titration, then regularly (e.g., weekly to monthly) during maintenance
Target: Stable or improved
Action Threshold: New or worsening cognitive impairment, motor weakness, or sensory changes require immediate evaluation and potential dose reduction/discontinuation.
Psychiatric symptoms (mood, behavior, suicidal ideation)
Frequency: Daily during titration, then regularly (e.g., weekly to monthly) during maintenance
Target: Stable or improved
Action Threshold: New or worsening depression, anxiety, hallucinations, psychosis, or suicidal ideation require immediate evaluation and potential dose reduction/discontinuation.
Creatinine kinase (CK)
Frequency: Periodically, or if muscle pain/weakness occurs
Target: Within normal limits
Action Threshold: Significant elevation may indicate myopathy and require investigation.
Pump function and catheter integrity
Frequency: Regularly per pump manufacturer guidelines and clinical need
Target: Normal operation
Action Threshold: Malfunction requires immediate attention.
Symptom Monitoring
- Severe nausea
- Dizziness
- Confusion
- Memory impairment
- Gait disturbance
- Ataxia
- Muscle weakness
- Speech difficulties
- Hallucinations
- Psychosis
- Depression
- Anxiety
- Suicidal ideation
- Urinary retention
- Peripheral edema
Special Patient Groups
Pregnancy
Use only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown adverse effects on development at doses higher than clinical exposure.
Trimester-Specific Risks:
First Trimester:
Potential for developmental toxicity based on animal data.
Second Trimester:
Potential for developmental toxicity based on animal data.
Third Trimester:
Potential for developmental toxicity based on animal data.
Lactation
It is unknown whether ziconotide is excreted in human milk. Due to the potential for serious adverse reactions in breastfed infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Infant Risk:
Risk unknown, but potential for serious adverse effects. L3 (Moderately Safe - no human data, animal data suggest risk or no data available; weigh risk vs. benefit).
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Not recommended for use in this population.
Geriatric Use
Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Elderly patients may be more susceptible to adverse effects, particularly cognitive impairment and gait disturbance. Start with lower doses and titrate slowly, monitoring closely for adverse events.
Clinical Information
Clinical Pearls
- Prialt is a highly specialized medication for severe chronic pain, typically used after other therapies have failed or are not tolerated.
- It is administered exclusively via intrathecal infusion, requiring specialized training for prescribers and careful patient selection.
- Slow and careful titration is crucial to minimize adverse effects and optimize efficacy. Rapid titration increases the risk of severe neurological and psychiatric adverse events.
- Patients and caregivers must be educated on the signs and symptoms of severe psychiatric and neurological adverse events, including suicidal ideation, and instructed to report them immediately.
- Regular monitoring of cognitive function, mood, and neurological status is essential throughout therapy.
- Prialt is not an opioid and does not carry the same risks of respiratory depression or opioid-related addiction, but it has its own unique and serious side effect profile.
- Consider a trial of intrathecal morphine before ziconotide if appropriate, as morphine has a more established safety profile and is often effective.
Alternative Therapies
- Intrathecal morphine
- Intrathecal hydromorphone
- Intrathecal bupivacaine
- Intrathecal clonidine
- Spinal cord stimulation (SCS)
- Dorsal root ganglion (DRG) stimulation
- Peripheral nerve stimulation
- Radiofrequency ablation
- Neuroablative procedures
- Systemic opioids (if tolerated and not refractory)
- Systemic non-opioid analgesics (e.g., NSAIDs, gabapentinoids, antidepressants)
- Cognitive behavioral therapy (CBT)
- Physical therapy
Cost & Coverage
Average Cost:
Highly variable, typically several thousand USD per vial per 20ml vial (25mcg/ml)
Insurance Coverage:
Specialty Tier (requires prior authorization, often limited to specific indications and failure of other therapies)
General Drug Facts
If your symptoms or health problems persist or worsen, it is essential to contact your doctor for further guidance. To ensure safe use, never share your medication with others, and do not take medication prescribed for someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly. Unless instructed otherwise, do not flush medications down the toilet or drain them. If you are unsure about the proper disposal method, consult your pharmacist for guidance. Many communities offer drug take-back programs, which your pharmacist can help you locate. Some medications may come with an additional patient information leaflet; check with your pharmacist to see if this applies to your prescription. If you have any questions or concerns about your medication, discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time it was taken to ensure prompt and effective treatment.