Prialt Side Effects

Generic Name: ziconotide

Please note - some side effects for Prialt may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Prialt - for the Consumer

Prialt

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Prialt:

Abnormal walking; back pain; bad taste in mouth; burning, aching, tingling sensation on the skin; constipation; diarrhea; dizziness; dry skin; feeling of a whirling motion; incoordination; increased cough; loss of appetite; muscle tension; pain; pain at insertion site; rapid, jerky eye movements; ringing in the ears; runny nose; skin irritation; sleepiness; sore throat; stomach pain; sweating; vision changes.

Seek medical attention right away if any of these SEVERE side effects occur when using Prialt:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal thinking; anxiety; change in mental state (eg, lack of energy, confusion, disorientation); change in mood or perception (eg, hallucinations; unusual sensations in the mouth; paranoia; hostility; delirium; manic reactions; psychosis); chest pain; dark urine; depression; fainting; fever; flu-like symptoms; headache; inability to empty the bladder; memory problems or memory loss; muscle cramps; muscle or joint pain; nausea; nervousness; pounding in the chest; seizures; speech problems; stiff neck; stupor; suicidal thoughts or behaviors; unresponsiveness; urination problems; vomiting; weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Prialt Side Effects - for the Professional

Prialt

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates in clinical practice.

A total of 1254 adult patients received Prialt as a continuous infusion in acute and severe chronic pain trials with an exposure of 662 patient-years. The mean duration of treatment was 193 days with 173 patients (14%) treated for at least 1 year. The average final dose was 17.6 mcg/day (0.73 mcg/hr).

The most frequently reported adverse reactions (≥ 25%) in clinical trials were dizziness, nausea, confusional state and nystagmus. Slower titration of Prialt may result in fewer serious adverse reactions and discontinuation of Prialt for adverse reactions [see Clinical Studies (14) and Dosage and Administration (2)].

Adverse reactions during the slow titration placebo-controlled trial that occurred in 5% or greater of patients and more commonly with Prialt than with placebo are summarized in Table 1.

Table 1. Incidence of Adverse Reactions in Slow Titration Placebo-Controlled Trial by Percent (Events That Occurred in ≥ 5% of Patients and More Commonly with Prialt than with Placebo)

MedDRA System Organ Class MedDRA Preferred term	Prialt      N=112	Placebo      N=108
	Percentage of Patients
Any AE	93	82
Ear and Labyrinth Disorders
Vertigo	7	0
Eye Disorders
Vision Blurred	12	3
Gastrointestinal Disorders
Diarrhea	18	15
Nausea	40	29
Vomiting	16	14
General Disorders and Administration Site Conditions
Asthenia	18	6
Gait Abnormal	14	2
Pyrexia	5	3
Rigors	7	5
Infections and Infestations
Sinusitis	5	2
Metabolism and Nutrition Disorders
Anorexia	6	2
Musculoskeletal and Connective Tissue Disorders
Muscle Spasms	6	4
Pain in Limb	5	2
Nervous System Disorders
Amnesia	8	0
Ataxia	14	1
Dizziness	46	13
Dysarthria	7	0
Dysgeusia	5	5
Headache	13	11
Memory Impairment	7	1
Nystagmus	8	0
Somnolence	17	10
Tremor	7	3
Psychiatric Disorders
Anxiety	8	3
Confusional State	15	5
Insomnia	6	9
Renal and Urinary Disorders
Urinary Retention	9	0
Skin and Subcutaneous Disorders
Pruritis	7	7
Sweating Increased	5	6

Other Adverse Reactions Observed During Clinical Studies of Prialt

The following adverse reactions assessed as related to Prialt have been reported in 2% or greater of patients participating in the clinical studies:

EYE DISORDERS: diplopia, visual disturbance

GASTROINTESTINAL DISORDERS: abdominal pain, constipation, dry mouth, nausea aggravated

GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS: fall, fatigue, lethargy, edema peripheral

INVESTIGATIONS: blood creatine phosphokinase increased

METABOLISM AND NUTRITION DISORDERS: appetite decreased

MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS: muscle cramp, muscle weakness, myalgia, pain in limb

NERVOUS SYSTEM DISORDERS: aphasia, areflexia, balance impaired, burning sensation, coordination abnormal, disturbance in attention, dizziness postural, dysarthria, dysgeusia, hypoaesthesia, mental impairment, paraesthesia, sedation, speech disorder

PSYCHIATRIC DISORDERS: agitation, anxiety, cognitive disorder, confusional state, depression, depression aggravated, disorientation, hallucination, hallucination auditory, hallucination visual, insomnia, irritability, mood disorder, nervousness, paranoia

RENAL AND URINARY DISORDERS: dysuria, urinary hesitation

VASCULAR DISORDERS: hypotension, orthostatic hypotension.

The following medically important adverse reactions occurred in less than 2% of patients were assessed by the clinical investigators as related to Prialt: acute renal failure, atrial fibrillation, cerebrovascular accident, sepsis, meningitis, psychotic disorder, suicidal ideation, respiratory distress, rhabdomyolysis, electrocardiogram abnormal, stupor, loss of consciousness, clonic convulsion and grand mal convulsion. Fatal aspiration pneumonia and suicide attempt were reported in less than 1% of patients.

Postmarketing Experience

The following adverse events have been reported during post-approval use of Prialt. Because these events are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure: Hypersensitivity reactions including angioedema, serious skin reactions including bullous dermatitis, skin ulcers, skin exfoliation, and burning skin sensation.

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Side Effects by Body System - for Healthcare Professionals

Nervous system

Nervous system side effects including dizziness (up to 47%), confusion (18% to 33%), somnolence (up to 22%), memory impairment (7% to 22%), ataxia (up to 16%), abnormal gait (15%), speech disorder (9% to 14%), headache (13%), aphasia (8% to 12%), hypertonia (11%), nystagmus (8%), abnormal thinking (8%), amnesia (up to 8%), dysesthesia (7%), hallucinations (7%), nervousness (7%), paresthesia (7%), tremor (7%), dysarthria (7%), vertigo (up to 7%), and dysgeusia (5%) have been reported. Abnormal dreams, agitation, abnormal cerebrospinal fluid, depression, difficulty concentrating, dry mouth, emotional lability, hostility, hyperesthesia, incoordination, mental slowing, meningitis, neuralgia, paranoid reaction, decreased reflexes, stupor, and twitching have been reported in at least 2% of patients participating in the clinical trials. Cerebrovascular accident, grand mal convulsion, meningitis, myoclonus, and rhabdomyolysis have been reported in less than 2% of patients participating in the clinical trials.

A 42% incidence of confusion has been reported in patients 65 years of age and older. A 29% incidence of confusion has been reported in patients under 65 year of age.

Cognitive impairment may appear gradually after several weeks of treatment. The various cognitive effects of ziconotide are generally reversible within 2 weeks after drug discontinuation.

Gastrointestinal

Gastrointestinal side effects including nausea (up to 41%), diarrhea (up to 19%), vomiting (up to 16%), and anorexia (up to 10%) have been reported. Constipation, gastrointestinal disorder, nausea, nausea with vomiting, and dyspepsia have been reported in at least 2% of patients participating in the clinical trials.

Hepatic

Hepatic side effects have included serum creatine kinase (CK) levels above the upper limit of normal (40%). Eleven percent of patients had serum CK that were 3 or more times the upper limit of normal.

In cases where CK was fractionated, only the muscle isoenzyme (MM) was elevated.

General

General side effects including asthenia (up to 22%), headache (15%), abnormal gait (14%), pain (11%), rigors (7%), and fever (up to 7%) have been reported. Abdominal pain, accidental injury, back pain, catheter complication, cellulitis, chest pain, infection, malaise, neck pain, neck rigidity, and flu syndrome have been reported in at least 2% of patients participating in the clinical trials.

Psychiatric

Psychiatric side effects including confusional state (15%), hallucinations (12%), anxiety (8%), insomnia (6%), paranoid reactions (3%), hostility (2%), delirium (2%), psychosis (1%), and manic reactions (0.4%) have been reported.

Ocular

Ocular side effects including blurred vision (12%) and abnormal vision (10%) have been reported. Diplopia and photophobia have been reported in at least 2% of patients participating in the clinical trials.

Local

Local side effects have included catheter site pain, pump site pain, pump site complication, and pump site mass which have been reported in at least 2% of patients participating in the clinical trials.

Cardiovascular

Cardiovascular side effects including hypertension, hypotension, postural hypotension, syncope, tachycardia, and vasodilation have been reported in at least 2% of patients participating in the clinical trials. Atrial fibrillation and abnormal cardiograms have been reported in less than 2% of patients participating in the clinical trials.

Hematologic

Hematologic side effects including anemia and ecchymosis have been reported in at least 2% of patients participating in the clinical trials.

Metabolic

Metabolic side effects including increased creatinine phosphokinase, dehydration, edema, hypokalemia, peripheral edema, and weight loss have been reported in at least 2% of patients participating in the clinical trials.

Musculoskeletal

Musculoskeletal side effects including arthralgia, arthritis, leg cramps, myalgia, muscle spasm, limb pain, and myasthenia have been reported in at least 2% of patients participating in the clinical trials.

Respiratory

Respiratory side effects including bronchitis, increased cough, dyspnea, lung disorder, pharyngitis, pneumonia, rhinitis, and sinusitis have been reported in at least 2% of patients participating in the clinical trials. Respiratory distress has been reported in less than 2% of patients participating in the clinical trials. Fatal aspiration pneumonia has been reported in less than 1% of patients participating in clinical trials.

Dermatologic

Dermatologic side effects including cutaneous surgical complication, dry skin, pruritus, rash, skin disorder, and sweating have been reported in at least 2% of patients participating in the clinical trials.

Other

Other side effects including vertigo have been reported in 7% of patients. Taste perversion and tinnitus have been reported in at least 2% of patients participating in the clinical trials. Sepsis and suicidal ideations have been reported in less than 2% of patients participating in the clinical trials.

Renal

Renal side effects including urinary retention (9%) have been reported. Urinary incontinence, urinary tract infection, and impaired urination have been reported in at least 2% of patients participating in the clinical trials. Acute kidney failure has been reported in less than 2% of patients participating in the clinical trials.

Genitourinary

Genitourinary side effects including urinary retention (9%) have been reported.

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