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Mirapex ER

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Mirapex ER

SIDE EFFECTS

The following are discussed in greater detail in other sections of the labeling:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse event rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug (or of another development program of a different formulation of the same drug) and may not reflect the rates observed in practice.

During the premarketing development of MIRAPEX ER tablets, patients with early Parkinson's disease were treated with MIRAPEX ER tablets, placebo, or immediate-release pramipexole tablets. In addition, a randomized, double-blind, parallel group trial was conducted in 156 early Parkinson's disease patients (Hoehn & Yahr Stages I-III) to assess overnight switching of immediate-release pramipexole tablets to MIRAPEX ER tablets. In this latter study, concomitant treatment with stable doses of levodopa, monoamine oxidase B inhibitor (MAOB-I) drugs, anticholinergics, or amantadine, individually or in combination, was allowed. In a third trial, advanced Parkinson's disease patients received MIRAPEX ER tablets, placebo, or immediate-release pramipexole tablets as adjunctive therapy to levodopa.

Early Parkinson's Disease

The most commonly observed adverse events ( ≥ 5% and more frequent than placebo) after 33 weeks of treatment with MIRAPEX ER tablets in the trial of early Parkinson's disease patients were somnolence, nausea, constipation, dizziness, fatigue, hallucinations, dry mouth, muscle spasms, and peripheral edema.

Twenty four of 223 (11%) patients treated with MIRAPEX ER tablets for 33 weeks discontinued treatment due to adverse events compared to 4 of 103 (4%) patients who received placebo and approximately 20 of 213 (9%) patients who received immediate-release pramipexole tablets. The adverse event most commonly causing discontinuation of treatment with MIRAPEX ER tablets was nausea (2%).

Table 1 lists adverse events that occurred with a frequency of at least 2% with MIRAPEX ER and were more frequent than with placebo during 33 weeks of treatment in a double-blind, placebo-controlled study in early Parkinson's disease. In this study, patients did not receive concomitant levodopa; however, levodopa was permitted as rescue medication. Adverse events were usually mild (38%) or moderate (41%) in intensity.

Table 1 : Treatment-Emergent Adverse-Event Incidence in a Double-Blind, Placebo-Controlled 33 Week Trial in Early Parkinson's Disease (Events ≥ 2% of Patients Treated with MIRAPEX ER and greater than with Placebo)

Body System/Adverse Event Placebo
(n=103)
%
MIRAPEX ER
(n=223)
%
Immediate-Release Pramipexole
(n=213)
%
Nervous system disorders
  Somnolence 15 36 33
  Dizziness 7 12 12
  Tremor 1 3 3
  Balance disorder 1 2 0
Gastrointestinal disorders
  Nausea 9 22 24
  Constipation 2 14 12
  Dry mouth 1 5 4
  Vomiting 0 4 4
  Upper abdominal pain 1 3 4
  Dyspepsia 2 3 3
  Abdominal discomfort 0 2 1
General disorders and administration site conditions
  Fatigue 4 6 6
  Peripheral edema 4 5 8
  Asthenia 2 3 1
Musculoskeletal and connective tissue disorders
  Muscle spasms 3 5 3
Psychiatric disorders
  Hallucinations, including visual, auditory and mixed 1 5 6
  Insomnia 3 4 4
  Sleep attacks or sudden onset of sleep 1 3 6
  Sleep disorder 1 2 3
  Depression 0 2 0
Injury, poisoning and procedural complications
  Fall 1 4 4
Vascular disorders
  Orthostatic hypotension 1 3 0
Ear and labyrinth disorders
  Vertigo 1 4 2
Metabolism and nutrition disorders
  Increased appetite 1 3 2
Respiratory, thoracic and mediastinal disorders
  Cough 1 3 3

Because this study used a flexible dose titration design, it was not possible to assess the effects of dose on the incidence of adverse events.

Adverse events can initially occur in either the titration or maintenance phase. Some adverse events developed in MIRAPEX ER-treated patients during the titration phase and persisted ( ≥ 7 days) into the maintenance phase (i.e., MIRAPEX ER % -placebo % = treatment difference ≥ 2%); persistent adverse events were somnolence, nausea, constipation, fatigue, and dry mouth.

A double-blind, randomized, parallel group trial evaluated the tolerability of an overnight switch from immediate-release pramipexole tablets to MIRAPEX ER tablets at the same daily dose in 156 early Parkinson's disease patients with or without levodopa. One of 104 patients switched from immediate-release pramipexole tablets to MIRAPEX ER tablets discontinued due to adverse events (vertigo and nausea).

Advanced Parkinson's Disease

The most commonly observed adverse events ( ≥ 5% and greater frequency than in placebo) during 18 weeks of treatment with MIRAPEX ER tablets in the trial of advanced Parkinson's disease patients with concomitant levodopa were dyskinesia, nausea, constipation, hallucinations, headache, and anorexia.

Eight of 164 (5%) patients treated with MIRAPEX ER tablets for 18 weeks discontinued treatment due to adverse events compared to 7 of 178 (4%) patients who received placebo and 8 of 175 (5%) patients who received immediate-release pramipexole tablets. The most common adverse events leading to discontinuation of treatment with MIRAPEX ER tablets were nausea (1%) and hallucination (1%).

Table 2 lists adverse events that occurred with a frequency of at least 2% with MIRAPEX ER and were more frequent than with placebo during 18 weeks of treatment in patients with advanced Parkinson's disease treated with MIRAPEX ER tablets. In this study, MIRAPEX ER tablets, immediate-release pramipexole tablets, or placebo was administered to patients who were also receiving concomitant levodopa. Adverse events were usually mild (32%) or moderate (17%) in intensity.

Table 2 : Treatment-Emergent Adverse-Event Incidence in a Double-Blind, Placebo-Controlled Trial in Advanced Parkinson's Disease* (Events ≥ 2% of Patients Treated with MIRAPEX ER and greater than with Placebo)

Body System/Adverse Event Placebo
n=178
%
MIRAPEX ER
n=164
%
Immediate-Release Pramipexole
n=175
%
Nervous system disorders
  Dyskinesia 8 17 18
  Headache 3 7 4
  Dizziness (postural) 1 2 3
Gastrointestinal disorders
  Nausea 10 11 11
  Constipation 5 7 6
  Salivary hypersecretion 0 2 0
  Diarrhea 1 2 1
Psychiatric disorders
  Hallucinations, including visual, auditory and mixed  2 9 7
  Insomnia 2 4 4
Metabolism and nutrition disorders
  Anorexia 2 5 1
Musculoskeletal and connective tissue disorders
  Back pain 1 2 3
*18-week final analysis

Because this flexible dose study used a titration design, it was not possible to assess the effects of dose on the incidence of adverse events.

Adverse events can initially occur in either the titration or maintenance phase. Some adverse events developed in MIRAPEX ER-treated patients during the titration phase and persisted ( ≥ 7 days) into the maintenance phase (i.e., MIRAPEX ER % -placebo % = treatment difference ≥ 2%); persistent adverse events were dyskinesia and insomnia.

Laboratory Testing

During the development of MIRAPEX ER tablets, no systematic abnormalities on routine laboratory testing were noted. Therefore, no specific guidance is offered regarding routine monitoring; the practitioner retains responsibility for determining how best to monitor the patient in his or her care.

Other adverse events observed during clinical trials of immediate-release pramipexole tablets

Adverse events not listed above but reported on at least two occasions (one occasion if the event was serious) in clinical studies involving 2509 individuals who received pramipexole immediate-release tablets are listed below. The reported events are included without regard to determination of a causal relationship to pramipexole immediate-release tablets.

Blood and lymphatic system disorders: anemia, iron deficiency anemia, leukocytosis, leukopenia, lymphadenitis, lymphadenopathy, thrombocythaemia, thrombocytopenia

Cardiac disorders: angina pectoris, arrhythmia supraventricular, atrial fibrillation, atrioventricular block first degree, atrioventricular block second degree, bradycardia, bundle branch block, cardiac arrest, cardiac failure, cardiac failure congestive, cardiomegaly, coronary artery occlusion, cyanosis, extrasystoles, left ventricular failure, myocardial infarction, nodal arrhythmia, sinus arrhythmia, sinus bradycardia, sinus tachycardia, supraventricular extrasystoles, supraventricular tachycardia, tachycardia, ventricular fibrillation, ventricular extrasystoles, ventricular hypertrophy

Congenital, familial, and genetic disorders: atrial septal defect, congenital foot malformation, spine malformation

Ear and labyrinth disorders: deafness, ear pain, hearing impaired, hypoacusis, motion sickness, vestibular ataxia

Endocrine disorders: goiter, hyperthyroidism, hypothyroidism

Eye disorders: accommodation abnormalities, amaurosis fugax, blepharitis, blepharospasm, cataract, dacryostenosis acquired, diplopia, dry eye, eye hemorrhage, eye irritation, eye pain, eyelid edema, eyelid ptosis, glaucoma, keratitis, macular degeneration, myopia, photophobia, retinal detachment, retinal vascular disorder, scotoma, vision abnormalities, vision blurred, visual acuity reduced, vitreous floaters

Gastrointestinal disorders: abdominal distension, aphthous stomatitis, ascites, cheilitis, colitis, colitis ulcerative, dyspepsia, dysphagia, duodenal ulcer, duodenal ulcer hemorrhage, enteritis, eructation, fecal incontinence, gastric ulcer, gastric ulcer hemorrhage, gastritis, gastrointestinal hemorrhage, gastroesophageal reflux disease, gingivitis, haematemesis, haematochezia, hemorrhoids, hiatus hernia, hyperchlorhydria, ileus, inguinal hernia, intestinal obstruction, irritable bowel syndrome, esophageal spasm, esophageal stenosis, esophagitis, pancreatitis, periodontitis, rectal hemorrhage, reflux esophagitis, tongue edema, tongue ulceration, toothache, umbilical hernia

General disorders: chest discomfort, chills, death, drug withdrawal syndrome, face edema, feeling cold, feeling hot, feeling jittery, fever, gait disturbance, impaired healing, influenza-like illness, irritability, localized edema, edema, malaise, pitting edema, thirst

Hepatobiliary disorders: biliary colic, cholecystitis, cholecystitis chronic, cholelithiasis

Immune system disorders: drug hypersensitivity

Infections and infestations: abscess, acute tonsillitis, appendicitis, bronchiolitis, bronchitis, bronchopneumonia, cellulitis, cystitis, dental caries, diverticulitis, ear infection, eye infection, folliculitis, fungal infection, furuncle, gangrene, gastroenteritis, gingival infection, herpes simplex, herpes zoster, hordeolum, influenza, intervertebral discitis, laryngitis, lobar pneumonia, nail infection, onychomycosis, oral candidiasis, orchitis, osteomyelitis, otitis externa, otitis media, paronychia, pyelonephritis, pyoderma, sepsis, skin infection, tonsillitis, tooth abscess, tooth infection, upper respiratory tract infection, urethritis, vaginal candidiasis, vaginal infection, viral infection, wound infection

Injury, poisoning, and procedural complications: accidental falls, drug toxicity epicondylitis, road traffic accident, sunburn, tendon rupture

Metabolism and nutrition disorders: cachexia, decreased appetite, decreased weight, dehydration, diabetes mellitus, fluid retention, gout, hypercholesterolemia, hyperglycemia, hyperlipidemia, hyperuricemia, hypocalcemia, hypoglycemia, hypokalemia, hyponatremia, hypovitaminosis, increased creatine PK, metabolic alkalosis

Musculoskeletal and connective tissue disorders: bone pain, bursitis, fasciitis, flank pain, intervertebral disc disorder, intervertebral disc protrusion, joint effusion, joint stiffness, joint swelling, monarthritis, muscle rigidity, musculoskeletal stiffness, myasthenia, myopathy, myositis, nuchal rigidity, osteoarthritis, osteonecrosis, osteoporosis, pain in extremity, polymyalgia, rheumatoid arthritis, shoulder pain, spinal osteoarthritis, tendonitis, tenosynovitis, twitching

Neoplasms benign, malignant, and unspecified: abdominal neoplasm, adenocarcinoma, adenoma benign, basal cell carcinoma, bladder cancer, breast cancer, breast neoplasm, chronic lymphocytic leukemia, colon cancer, colorectal cancer, endometrial cancer, gallbladder cancer, gastric cancer, gastrointestinal neoplasm, hemangioma, hepatic neoplasm, hepatic neoplasm malignant, lip and/or oral cavity cancer, lung neoplasm malignant, lung cancer metastatic, lymphoma, malignant melanoma, melanocytic naevus, metastases to lung, multiple myeloma, oral neoplasm benign, neoplasm, neoplasm malignant, neoplasm prostate, neoplasm skin, neuroma, ovarian cancer, prostate cancer, prostatic adenoma, pseudo lymphoma, renal neoplasm, skin cancer, skin papilloma, squamous cell carcinoma, thyroid neoplasm, uterine leiomyoma

Nervous system disorders: ageusia, akinesia, amnesia, akathisia, anticholinergic syndrome, aphasia, brain edema, carotid artery occlusion, carpal tunnel syndrome, cerebral artery embolism, cerebral hemorrhage, cerebral infarction, cerebral ischemia, chorea, cognitive disorder, coma, convulsion, coordination abnormal, dementia, depressed level of consciousness, disturbance in attention, dizziness postural, dysarthria, dysgraphia, dystonia, extrapyramidal syndrome, facial palsy, grand mal convulsion, hemiplegia, hyperaesthesia, hyperkinesia, hyperreflexia, hyporeflexia, hypertonia, hypesthesia, hypotonia, lethargy, loss of consciousness, memory impairment, migraine, muscle contractions involuntary, myoclonus, narcolepsy, neuralgia, neuropathy, nystagmus, parosmia, psychomotor hyperactivity, sciatica, sedation, sensory disturbance, sleep phase rhythm disturbance, sleep talking, stupor, syncope vasovagal, tension headache, thinking abnormalities

Psychiatric disorders: affect lability, aggression, agitation, bradyphrenia, bruxism, suicide, delirium, delusions, delusional disorder persecutory type, disorientation, dissociation, emotional distress, euphoric mood, initial insomnia, libido increased, mania, middle insomnia, mood altered, nightmare, obsessive thoughts, obsessive-compulsive disorder, panic reaction, paranoid reaction, parasomnia, personality disorder, psychotic disorder, restlessness, sleep walking, suicidal ideation

Renal and urinary disorders: chromaturia, dysuria, glycosuria, hematuria, urgency, nephrolithiasis, neurogenic bladder, nocturia, oliguria, pollakiuria, proteinuria, renal artery stenosis, renal colic, renal cyst, renal failure, renal impairment, urinary frequency, urinary incontinence, urinary retention, urinary tract infection

Reproductive system and breast disorders: amenorrhea, breast pain, dysmenorrhea, epididymitis, gynaecomastia, impotence, menopausal symptoms, menorrhagia, metrorrhagia, ovarian cyst, priapism, prostatitis, sexual dysfunction, uterine hemorrhage, vaginal discharge, vaginal hemorrhage

Respiratory, thoracic, and mediastinal disorders: apnea, aspiration, asthma, choking, chronic obstructive pulmonary disease, dry throat, dysphonia, dyspnea exertional, epistaxis, haemoptysis, hiccups, hyperventilation, increased bronchial secretion, laryngospasm, nasal congestion, nasal dryness, nasal polyps, obstructive airways disorder, pharyngolaryngeal pain, pleurisy, pneumonia, pneumonia aspiration, pneumothorax, postnasal drip, productive cough, pulmonary embolism, pulmonary edema, respiratory alkalosis, respiratory distress, respiratory failure, respiratory tract congestion, rhinitis allergic, rhinorrhea, sinus congestion, sleep apnoea syndrome, sneezing, snoring, tachypnea, wheezing

Skin and subcutaneous tissue disorders: acne, alopecia, cold sweat, dermal cyst, dermatitis, dermatitis bullous, dermatitis contact, dry skin, ecchymosis, eczema, erythema, hyperkeratosis, livedo reticularis, night sweats, periorbital edema, petechiae, photosensitivity allergic reaction, psoriasis, purpura, rash erythematous, rash maculo-papular, rash papular, rosacea, seborrhea, seborrheic dermatitis, skin burning sensation, skin discoloration, skin disorders, skin exfoliation, skin hyperpigmentation, skin hypertrophy, skin irritation, skin nodule, skin odor abnormal, skin ulcer, urticaria

Vascular disorders: aneurysm, angiopathy, arteriosclerosis, circulatory collapse, deep vein thrombosis, embolism, hematoma, hot flush, hypertensive crisis, lymphoedema, pallor, phlebitis, Raynaud's phenomenon, shock, thrombophlebitis, thrombosis, varicose vein

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of immediate-release pramipexole tablets, primarily in Parkinson's disease patients. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Decisions to include these reactions in labeling are typically based on one or more of the following factors: (1) seriousness of the reaction, (2) frequency of reporting, or (3) strength of causal connection to pramipexole tablets. Similar types of events were grouped into a smaller number of standardized categories using the MedDRA terminology: abnormal behavior, abnormal dreams, accidents (including fall), blackouts, compulsive shopping, fatigue, hallucinations (all kinds), headache, hypotension (including postural hypotension), inappropriate antidiuretic hormone secretion (SIADH), increased eating (including binge eating, compulsive eating, and hyperphagia), libido disorders (including increased and decreased libido, and hypersexuality), pathological gambling, pruritus, syncope, vomiting, and weight increase.

Read the Mirapex ER (pramipexole dihydrochloride extended-release tablets) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

No drug interaction studies were conducted with MIRAPEX ER tablets since the potential for drug interactions mainly depends on the active drug substance pramipexole and not the formulation. Data are available for the immediate-release pramipexole tablet formulation [see CLINICAL PHARMACOLOGY].

Dopamine Antagonists

Since pramipexole is a dopamine agonist, it is possible that dopamine antagonists, such as the neuroleptics (phenothiazines, butyrophenones, thioxanthenes) or metoclopramide, may diminish the effectiveness of MIRAPEX ER tablets.

Drug/Laboratory Test Interactions

There are no known interactions between pramipexole and laboratory tests.

Drug Abuse And Dependence

Controlled Substance

Pramipexole is not a controlled substance.

Abuse and Dependence

Pramipexole has not been systematically studied in animals or humans for its potential for abuse, tolerance, or physical dependence. However, in a rat model of cocaine self-administration, pramipexole had little or no effect.

Read the Mirapex ER Drug Interactions Center for a complete guide to possible interactions

Last reviewed on RxList: 5/27/2014
This monograph has been modified to include the generic and brand name in many instances.

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