Prialt (ziconotide acetate)
Analgesic, Neuronal-type Calcium Channel Blocker Intrathecal Vial (Ml)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Ziconotide, a synthetic form of a conopeptide isolated from the venom of the marine snail Conus magus, is a potent nonopiate analgesic.
Ziconotide, a synthetic form of a naturally occurring conopeptide found in the venom of the marine snail Conus magus, is a 25-amino acid polybasic peptide containing 3 disulfide bridges. Ziconotide produces potent antinociceptive effects by selectively binding to N-type voltage-sensitive calcium channels on the primary nociceptive afferent nerves in the superficial layers of the spinal cord, thus blocking neurotransmission from primary nociceptive afferents.
Ziconotide does not bind to opiate receptors, and the pharmacologic effects of the drug are not blocked by opiate antagonists. Ziconotide does not potentiate opiate-induced respiratory depression.
Intrathecal administration of ziconotide results in little systemic exposure. Following passage from the CSF into the systemic circulation, ziconotide is expected to be degraded to peptide fragments and their constituent amino acids by endopeptidases and exopeptidases present in most organs.
USES: This medication is a non-opioid pain reliever that is used to treat ongoing pain when other treatments or medications cannot control your pain. Ziconotide works by blocking the nerves in the spinal cord that send pain signals. It decreases ongoing pain caused by cancer, AIDS, failed back surgery, multiple sclerosis, neuropathy, and other causes.
Generic name: ziconotide acetate
Pronunciation: (zye-KON-oh-tide)
Drug class: Analgesic, Neuronal-type Calcium Channel Blocker
Therapeutic class: Analgesic, Anti-inflammatory or Antipyretic
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Prialt
Indications
The following indications are listed for Prialt:
- Severe Chronic Pain
Dosing
Ziconotide therapy should be initiated using a slow dosage titration schedule in order to minimize the risk of adverse effects that are serious or require drug discontinuance. A faster titration schedule should be used only if an urgent need for analgesia outweighs the risk to patient safety.
The recommended initial dosage of ziconotide for management of severe chronic pain in adults is 2.4 mcg per 24 hours (0.1 mcg/hour) or less. Dosage is then titrated based on patient response. Dosage can be increased 2 or 3 times per week in increments of up to 2.4 mcg per 24 hours (0.1 mcg/hour), up to a maximum recommended dosage of 19.2 mcg per 24 hours (0.8 mcg/hour) by day 21. In a study that evaluated efficacy of ziconotide using the slow dosage titration schedule, the average dosage at day 21 was 6.9 mcg per 24 hours (0.29 mcg/hour); the maximum dosage was 19.2 mcg per 24 hours.
Ziconotide therapy can be interrupted or discontinued abruptly without withdrawal effects.
Ziconotide is administered intrathecally using a programmable implanted variable-rate microinfusion device (i.e., Medtronic SynchroMed(R) EL or SynchroMed(R) II) or an external microinfusion device and catheter (i.e., CADD-Micro(R) ambulatory infusion pump) by or under the supervision of a qualified clinician familiar with the drug, the techniques of intrathecal administration, and the device being used. The device manufacturer's manual should be consulted for specific instructions and precautions for performing a reservoir rinse, initial filling, refilling the reservoir or replacing the drug cartridge, and programming.
An appropriate vial strength and final concentration of the drug should be selected in accordance with the manufacturer's instructions. The commercially available preparation containing ziconotide 25 mcg/mL may be used undiluted; the preparation containing ziconotide 100 mcg/mL may be used undiluted or may be diluted with 0.9% sodium chloride injection prior to placement in the pump. Sodium chloride solutions containing preservatives are not appropriate for intrathecal administration and should not be used to dilute ziconotide. Diluted ziconotide solutions should be refrigerated; freezing should be avoided. Infusion of diluted ziconotide solutions should be initiated within 24 hours of preparation.
Ziconotide is not for IV administration.
| Drug label | Dosing type | Instructions |
|---|---|---|
| Prialt 100 Mcg/Ml Vial | Maintenance | Infuse 0.1 mcg/hour by cont intrathecal inf route. |
| Prialt 500 Mcg/5 Ml Vial | Maintenance | Infuse 0.1 mcg/hour by cont intrathecal inf route. |
| Prialt 500 Mcg/20 Ml Vial | Maintenance | Infuse 0.1 mcg/hour by cont intrathecal inf route. |
No dosing information is available for this tab.
Drug interactions
There is no enhanced messaging for this drug.
There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
Concomitant treatments or medical conditions (e.g., presence of infection at the microinfusion injection site, uncontrolled bleeding diathesis, spinal canal obstruction that impairs CSF circulation) that make intrathecal therapy hazardous.
History of psychosis.
Known hypersensitivity to ziconotide or any ingredient in the formulation.
- Psychotic disorder
- Increased risk of bleeding due to coagulation disorder
- Increased creatine kinase level
Adverse reactions
Adverse effects reported in 25% or more of patients receiving ziconotide include dizziness, nausea, confusion, headache, somnolence, nystagmus, asthenia, and pain.
More Frequent
- Acute cognitive impairment
- Hallucinations
Less Frequent
- Atrial fibrillation
- Bacterial sepsis
- Drug-induced psychosis
- Meningitis
- Pneumonia
- Renal failure
- Rhabdomyolysis
- Severe dyspnea
- Suicidal ideation
- Tonic clonic seizure
Rare or Very Rare
- Angioedema
- Aspiration pneumonia
- Bullous dermatitis
- Exfoliative dermatitis
- Seizure disorder
- Suicidal
More Frequent
- Altered mental status
- Anorexia
- Aphasia
- Ataxia
- Diarrhea
- Dizziness
- Drowsy
- Dysarthria
- Dysesthesia
- Fever
- Gait abnormality
- General weakness
- Headache disorder
- Hypertonia
- Memory impairment
- Nausea
- Nervousness
- Nystagmus
- Pain
- Paresthesia
- Symptoms of anxiety
- Urinary retention
- Vertigo
- Visual changes
- Vomiting
Less Frequent
- Abdominal pain with cramps
- Abnormal desquamation
- Accidental injury
- Agitation
- Anemia
- Arthralgia
- Arthritis
- Back pain
- Bronchitis
- Cardiac arrhythmia
- Chest pain
- Chills
- Concentration difficulty
- Constipation
- Cough
- Cramps in legs
- Dehydration
- Depression
- Diplopia
- Disorder of the digestive system
- Dry skin
- Dysgeusia
- Dyspepsia
- Dyspnea
- Dysuria
- Ecchymosis
- Edema
- Erythema
- Flu-like symptoms
- Hostility
- Hyperhidrosis
- Hypertension
- Hypokalemia
- Hyporeflexia
- Hypotension
- Increased creatine kinase level
- Infection
- Injection site sequelae
- Insomnia
- Malaise
- Mood changes
- Muscle fasciculation
- Muscle weakness
- Myalgia
- Myoclonus
- Neck pain
- Neck stiffness
- Neuralgia
- Nightmares
- Orthostatic hypotension
- Paranoid disorder
- Pharyngitis
- Photophobia
- Pruritus of skin
- Psychiatric disorder
- Respiration changes
- Rhinitis
- Sinusitis
- Skin rash
- Skin scaling
- Stupor
- Syncope
- Tachycardia
- Tinnitus
- Urinary incontinence
- Urinary tract infection
- Vasodilation of blood vessels
- Viral infection
- Weight loss
- Xerostomia
Rare or Very Rare
- Skin ulcer
- Stinging of skin
- Tremor
Precautions
No enhanced messaging available.
Safety and efficacy not established in patients younger than 18 years of age.
Category C. (See Users Guide.)
Not known whether ziconotide is distributed into milk. Discontinue nursing or the drug, taking into account the importance of the drug to the mother.
In clinical studies, 22% of patients were 65 years of age or older and 7% were 75 years of age or older. In all studies, the incidence of confusion was higher in individuals 65 years of age or older than in younger adults. No substantial difference in efficacy in geriatric patients relative to younger adults.
Select dosage with caution, starting at the low end of the dosage range, because of age-related decreases in hepatic, renal, and/or cardiac function and potential for concomitant disease and drug therapy.
ICD codes
| Code | Type | Description |
|---|---|---|
| Severe chronic pain | ||
| G89.2 | ICD10CM | Chronic pain, not elsewhere classified |
| G89.21 | ICD10CM | Chronic pain due to trauma |
| G89.22 | ICD10CM | Chronic post-thoracotomy pain |
| G89.28 | ICD10CM | Other chronic postprocedural pain |
| G89.29 | ICD10CM | Other chronic pain |
| G89.4 | ICD10CM | Chronic pain syndrome |
| G90.513 | ICD10CM | Complex regional pain syndrome I of upper limb, bilateral |
ICD code information from First Databank (FDB).
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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