Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The most frequently reported adverse reactions (≥ 25%) in clinical trials were dizziness, nausea, confusional state, nystagmus.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact TerSera Therapeutics at 1-844-344-4035 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 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 .
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.
5 WARNINGS AND PRECAUTIONS Cognitive and neuropsychiatric adverse reactions – Cognitive impairment and severe neuropsychiatric symptoms may occur with PRIALT use.
( 5.1 ) Meningitis and other infections – Patients, caregivers, and healthcare providers must be aware of the signs and symptoms of meningitis, including but not limited to fever, headache, stiff neck, altered mental status (e.g., lethargy, confusion, disorientation), nausea or vomiting, and occasionally seizures.
( 5.2 ) Reduced level of consciousness – Patients may become unresponsive or stuporous while receiving PRIALT.
( 5.3 ) Elevation of serum creatine kinase – Patients taking PRIALT may experience elevations in creatine kinase.
Monitor serum CK in patients undergoing treatment with PRIALT periodically.
Like all medications, Prialt can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: