Generic: BUPIVACAINE
Amide Local Anesthetic [EPC]
1. INDICATIONS AND USAGE Bupivacaine liposome injectable suspension is indicated to produce postsurgical: Local analgesia via infiltration in adults Regional analgesia via an interscalene brachial plexus nerve block in adults Limitations of Use The safety and effectiveness of bupivacaine liposome injectable suspension have not been established to produce postsurgical regional analgesia via other nerve blocks besides an interscalene brachial plexus nerve block. Bupivacaine liposome injectable sus...
1. INDICATIONS AND USAGE Bupivacaine liposome injectable suspension is indicated to produce postsurgical: Local analgesia via infiltration in adults Regional analgesia via an interscalene brachial plexus nerve block in adults Limitations of Use The safety and effectiveness of bupivacaine liposome injectable suspension have not been established to produce postsurgical regional analgesia via other nerve blocks besides an interscalene brachial plexus nerve block. Bupivacaine liposome injectable suspension contains bupivacaine, an amide local anesthetic, and is indicated to produce postsurgical: Local analgesia via infiltration in adults ( 1 ). Regional analgesia via an interscalene brachial plexus nerve block in adults ( 1 ). Limitations of Use The safety and effectiveness of bupivacaine liposome injectable suspension have not been established to produce postsurgical regional analgesia via other nerve blocks besides an interscalene brachial plexus nerve block.
5. WARNINGS AND PRECAUTIONS Monitor cardiovascular status, neurological status, and vital signs during and after injection of bupivacaine liposome injectable suspension ( 5.1 ). Because amide-type local anesthetics, such as bupivacaine, are metabolized by the liver, use bupivacaine liposome injectable suspension cautiously in patients with hepatic disease. Patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at a greater risk of developin...
5. WARNINGS AND PRECAUTIONS Monitor cardiovascular status, neurological status, and vital signs during and after injection of bupivacaine liposome injectable suspension ( 5.1 ). Because amide-type local anesthetics, such as bupivacaine, are metabolized by the liver, use bupivacaine liposome injectable suspension cautiously in patients with hepatic disease. Patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at a greater risk of developing toxic plasma concentrations ( 5.1 ). Methemoglobinemia: Cases of methemoglobinemia have been reported in association with local anesthetic use ( 5.1 ). Avoid additional use of local anesthetics within 96 hours following administration of bupivacaine liposome injectable suspension ( 5.2 ). 5.1 Warnings and Precautions for Bupivacaine-Containing Products The safety and effectiveness of bupivacaine liposome injectable suspension, other bupivacaine products, and other amide-containing products depend on proper dosage, correct technique, adequate precautions, and readiness for emergencies. As there is a potential risk of severe life-threatening adverse reactions associated with the administration of bupivacaine, any bupivacaine-containing product should be administered in a setting where trained personnel and equipment are available to promptly treat patients who show evidence of neurological or cardiac toxicity [ see Overdosage ( 10 ) ]. Careful and constant monitoring of cardiovascular and respiratory (adequacy of ventilation) vital signs and the patientโs state of consciousness should be performed after injection of bupivacaine and other amide-containing products. Restlessness, anxiety, incoherent speech, lightheadedness, numbness and tingling of the mouth and lips, metallic taste, tinnitus, dizziness, blurred vision, tremors, twitching, depression, or drowsiness may be early warning signs of central nervous system toxicity. Bupivacaine liposome injectable suspension, other bupivacaine products, and other amide-containing products should also be used with caution in patients with impaired cardiovascular function because they may be less able to compensate for functional changes associated with the prolongation of AV conduction produced by these drugs. Injection of multiple doses of bupivacaine liposome injectable suspension, other bupivacaine products, and other amide-containing products may cause significant increases in plasma concentrations with each repeated dose due to slow accumulation of the drug or its metabolites, or to slow metabolic degradation. Tolerance to elevated blood concentrations varies with the status of the patient. Because amide-type local anesthetics, such as bupivacaine, are metabolized by the liver, these drugs should be used cautiously in patients with hepatic disease. Patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at a greater risk of developing toxic plasma concentrations. Central Nervous System Reactions The incidences of adverse neurologic reactions associated with the use of local anesthetics may be related to the total dose of local anesthetic administered and are also dependent upon the particular drug used, the route of administration, and the physical status of the patient. Many of these effects may be related to local anesthetic techniques, with or without a contribution from the drug. Neurologic effects following infiltration of soft tissue may include persistent anesthesia, paresthesia, weakness, and paralysis, all of which may have slow, incomplete, or no recovery. Central nervous system reactions are characterized by excitation and/or depression. Restlessness, anxiety, dizziness, tinnitus, blurred vision, or tremors may occur, possibly proceeding to convulsions. However, excitement may be transient or absent, with depression being the first manifestation of an adverse reaction. This may quickly be followed by drowsiness merging into unconsciousness and respiratory arrest. Other central nervous system effects may be nausea, vomiting, chills, and constriction of the pupils. The incidence of convulsions associated with the use of local anesthetics varies with the procedure used and the total dose administered. Cardiovascular System Reactions Toxic blood concentrations depress cardiac conductivity and excitability, which may lead to atrioventricular block, ventricular arrhythmias, and cardiac arrest, sometimes resulting in fatalities. In addition, myocardial contractility is depressed and peripheral vasodilation occurs, leading to decreased cardiac output and arterial blood pressure [ See Overdosage ( 10 ) ]. Allergic Reactions Allergic-type reactions are rare and may occur as a result of hypersensitivity to the local anesthetic or to other formulation ingredients. These reactions are characterized by signs such as urticaria, pruritus, erythema, angioneurotic edema (including laryngeal edema), tachycardia, sneezing, nausea, vomiting, dizziness, syncope, excessive sweating, elevated temperature, and possibly anaphylactoid-like symptoms (including severe hypotension). Cross-sensitivity among members of the amide-type local anesthetic group has been reported. The usefulness of screening for sensitivity has not been definitively established. Chondrolysis Intra-articular infusions of local anesthetics following arthroscopic and other surgical procedures is an unapproved use, and there have been postmarketing reports of chondrolysis in patients receiving such infusions. The majority of reported cases of chondrolysis have involved the shoulder joint; cases of gleno-humeral chondrolysis have been described in pediatric patients andadult patients following intra-articular infusions of local anesthetics with and without epinephrine for periods of 48 to 72 hours. There is insufficient information to determine whether shorter infusion periods are not associated with these findings. The time of onset of symptoms, such as joint pain, stiffness, and loss of motion can be variable, but may begin as early as the second month after surgery. Currently, there is no effective treatment for chondrolysis; patients who have experienced chondrolysis have required additional diagnostic and therapeutic procedures and some required arthroplasty or shoulder replacement. Methemoglobinemia Cases of methemoglobinemia have been reported in association with local anesthetic use. Although all patients are at risk for methemoglobinemia, patients with glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, infants under 6 months of age, and concurrent exposure to oxidizing agents or their metabolites are more susceptible to developing clinical manifestations of the condition. If local anesthetics must be used in these patients, close monitoring for symptoms and signs of methemoglobinemia is recommended. Signs of methemoglobinemia may occur immediately or may be delayed some hours after exposure, and are characterized by a cyanotic skin discoloration and/or abnormal coloration of the blood. Methemoglobin levels may continue to rise; therefore, immediate treatment is required to avert more serious central nervous system and cardiovascular adverse effects, including seizures, coma, arrhythmias, and death. Discontinue bupivacaine liposome injectable suspension and any oxidizing agents. Depending on the severity of the signs and symptoms, patients may respond to supportive care, i.e., oxygen therapy, hydration. A more severe clinical presentation may require treatment with methylene blue, exchange transfusion, or hyperbaric oxygen. 5.2 Warnings and Precautions Specific for Bupivacaine Liposome Injectable Suspension As there is a potential risk of severe life-threatening adverse reactions associated with the administration of bupivacaine, bupivacaine liposome injectable suspension should be administered in a setting where trained personnel and equipment are available to promptly treat patients who show evidence of neurological or cardiac toxicity [ See Overdosage ( 10 ) ]. Caution should be taken to avoid accidental intravascular injection of bupivacaine liposome injectable suspension. Convulsions and cardiac arrest have occurred following accidental intravascular injection of bupivacaine and other amide-containing products. Avoid additional use of local anesthetics within 96 hours following administration of bupivacaine liposome injectable suspension [ see Dosage and Administration ( 2.4 ) and Clinical Pharmacology ( 12.3 ) ]. Bupivacaine liposome injectable suspension has not been evaluated for the following uses and, therefore, is not recommended for these routes of administration or types of analgesia: epidural intrathecal intravascular or intra-articular use regional nerve blocks other than interscalene brachial plexus nerve block Bupivacaine liposome injectable suspension has not been evaluated for use in the following patient populations and, therefore, is not recommended for administration to these groups. patients younger than 6 years old for infiltration patients younger than 18 years old for interscalene brachial plexus nerve block pregnant patients The potential sensory and/or motor loss with bupivacaine liposome injectable suspension is temporary and varies in degree and duration depending on the site of injection and dose administered and may last for up to 5 days as seen in clinical trials.
6. ADVERSE REACTIONS The following serious adverse reactions have been associated with bupivacaine hydrochloride in clinical trials and are described in greater detail in other sections of the labeling: Central Nervous System Reactions [ see Warnings and Precautions ( 5.1 ) ] Cardiovascular System Reactions [ see Warnings and Precautions ( 5.1 ) ] Allergic Reactions [ see Warnings and Precautions ( 5.1 ) ] Chondrolysis [ see Warnings and Precautions ( 5.1 ) ] Methemoglobinemia [ see Warnings and...
6. ADVERSE REACTIONS The following serious adverse reactions have been associated with bupivacaine hydrochloride in clinical trials and are described in greater detail in other sections of the labeling: Central Nervous System Reactions [ see Warnings and Precautions ( 5.1 ) ] Cardiovascular System Reactions [ see Warnings and Precautions ( 5.1 ) ] Allergic Reactions [ see Warnings and Precautions ( 5.1 ) ] Chondrolysis [ see Warnings and Precautions ( 5.1 ) ] Methemoglobinemia [ see Warnings and Precautions ( 5.1 ) ] Accidental intravascular injection [ see Warnings and Precautions ( 5.2 ) ] Adverse reactions reported with an incidence greater than or equal to 10% following bupivacaine liposome injectable suspension administration via: Infiltration in adults were nausea, constipation, and vomiting ( 6.1 ). Nerve block in adults were nausea, pyrexia, headache, and constipation ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact eVenus Pharmaceutical Laboratories, Inc. at 1-609-395-8625 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical studies 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 studies of another drug and may not reflect the rates observed in practice. Adverse Reactions Reported in All Local Infiltration Clinical Studies in Adults The safety of bupivacaine liposome injectable suspension (local administration into the surgical site) was evaluated in 10 randomized, double-blind, clinical studies (including Studies 1 and 2 [ see Clinical Studies ( 14.2 ) ]) that included 823 adult patients who had various surgical procedures. Patients were administered a bupivacaine liposome injectable suspension dose ranging from 66 to 532 mg (two times the maximum recommended dose of 266 mg). In these studies, following bupivacaine liposome injectable suspension administration, the: Most common adverse reactions (incidence greater than or equal to 10%) were nausea, constipation, and vomiting. Common adverse reactions (incidence greater than or equal to 2% to less than 10%) were pyrexia, dizziness, peripheral edema, anemia, hypotension, pruritus, tachycardia, headache, insomnia, postoperative anemia, muscle spasms, hemorrhagic anemia, back pain, somnolence, and procedural pain. Less common adverse reactions (incidence less than 2%) were chills, erythema, bradycardia, anxiety, urinary retention, pain, edema, tremor, postural dizziness, paresthesia, syncope, incision site edema, procedural hypertension, procedural hypotension, procedural nausea, muscular weakness, neck pain, generalized pruritus, pruritic rash, hyperhidrosis, cold sweat, urticaria, palpitations, sinus bradycardia, supraventricular extrasystoles, ventricular extrasystoles, ventricular tachycardia, hypertension, pallor, anxiety, confusional state, depression, agitation, restlessness, hypoxia, laryngospasm, apnea, respiratory depression, respiratory failure, increased body temperature, increased blood pressure (BP),decreased BP, decreased oxygen saturation, urinary incontinence, blurred vision, tinnitus, drug hypersensitivity, and hypersensitivity. Neurological and Cardiac Adverse Reactions In the bupivacaine liposome injectable suspension surgical site infiltration studies, following bupivacaine liposome injectable suspension administration adverse reactions with an incidence greater than or equal to 1% in the: Nervous System Disorders system organ class were dizziness (6.2%), headache (3.8%), somnolence (2.1%), hypoesthesia (1.5%), and lethargy (1.3%). Cardiac Disorders system organ class were tachycardia (3.9%) and bradycardia (1.6%). Adverse Reactions Reported in All Local Infiltration Placebo-Controlled Trials in Adults Adverse reactions with an incidence greater than or equal to 2% reported by adult patients in clinical studies who underwent a bunionectomy (Study 1) or hemorrhoidectomy (Study 2) [ see Clinical Studies ( 14.2 ) ] that compared 106 mg of bupivacaine liposome injectable suspension (8 mL) to placebo and 266 mg of bupivacaine liposome injectable suspension (20 mL) to placebo are shown in Table 1. Table 1: Treatment-Emergent Adverse Reactions with an Incidence Greater than or Equal to 2%: Local Infiltration Placebo-Controlled Studies in Adults (Studies 1 and 2) a Study 1: Bunionectomy b Study 2: Hemorrhoidectomy; TEAE = treatment-emergent adverse event. At each level of summation (overall, system organ class, preferred term), patients are only counted once. Preferred terms are included where at least 2% of patients reported the event in any treatment group. STUDY 1 a STUDY 2 b Bupivacaine Liposome Injectable Suspension Placebo Bupivacaine Liposome Injectable Suspension Placebo System Organ Class Preferred Term (106 mg) (N=97) n (%) (N=96) n (%) (266 mg) (N=95) n (%) (N=94) n (%) Any TEAE 53 (54.6) 59 (61.5) 10 (10.5) 17 (18.1) Gastrointestinal Disorders 41 (42.3) 38 (39.6) 7 (7.4) 13 (13.8) Nausea 39 (40.2) 36 (37.5) 2 (2.1) 1 (1.1) Vomiting 27 (27.8) 17 (17.7) 2 (2.1) 4 (4.3) Constipation 2 (2.1) 1 (1.0) 2 (2.1) 2 (2.1) Anal Hemorrhage 0 (0.0) 0 (0.0) 3 (3.2) 4 (4.3) Painful Defecation 0 (0.0) 0 (0.0) 2 (2.1) 5 (5.3) Rectal Discharge 0 (0.0) 0 (0.0) 1 (1.1) 3 (3.2) Nervous System Disorders 20 (20.6) 30 (31.3) 0 (0.0) 0 (0.0) Dizziness 11 (11.3) 25 (26.0) 0 (0.0) 0 (0.0) Headache 5 (5.2) 8 (8.3) 0 (0.0) 0 (0.0) Somnolence 5 (5.2) 1 (1.0) 0 (0.0) 0 (0.0) Syncope 2 (2.1) 0 (0.0) 0 (0.0) 0 (0.0) Skin And Subcutaneous Tissue Disorders 8 (8.2) 7 (7.3) 0 (0.0) 0 (0.0) Generalized Pruritus 5 (5.2) 6 (6.3) 0 (0.0) 0 (0.0) Pruritus 3 (3.1) 1 (1.0) 0 (0.0) 0 (0.0) Investigations 5 (5.2) 3 (3.1) 4 (4.2) 3 (3.2) Increased Alanine Aminotransferase 3 (3.1) 3 (3.1) 1 (1.1) 0 (0.0) Increased Aspartate Aminotransferase 3 (3.1) 2 (2.1) 0 (0.0) 0 (0.0) Increased Blood Creatinine 2 (2.1) 0 (0.0) 0 (0.0) 0 (0.0) Increased Body Temperature 0 (0.0) 0 (0.0) 3 (3.2) 3 (3.2) General Disorders and Administration Site Conditions 4 (4.1) 0 (0.0) 1 (1.1) 1 (1.1) Feeling Hot 2 (2.1) 0 (0.0) 0 (0.0) 0 (0.0) Pyrexia 2 (2.1) 0 (0.0) 1 (1.1) 1 (1.1) Infections And Infestations 2 (2.1) 1 (1.0) 0 (0.0) 0 (0.0) Fungal Infection 2 (2.1) 1 (1.0) 0 (0.0) 0 (0.0) Injury, Poisoning and Procedural Complications 2 (2.1) 0 (0.0) 0 (0.0) 0 (0.0) Post Procedural Swelling 2 (2.1) 0 (0.0) 0 (0.0) 0 (0.0) Metabolism And Nutrition Disorders 2 (2.1) 2 (2.1) 0 (0.0) 0 (0.0) Decreased Appetite 2 (2.1) 2 (2.1) 0 (0.0) 0 (0.0) Adverse Reactions Reported in Placebo-Controlled Nerve Block Clinical Studies in Adults The safety of bupivacaine liposome injectable suspension was evaluated in four randomized, double-blind, placebo-controlled nerve block clinical studies (Studies 3, 6, 7, 8) [ see Clinical Studies ( 14.3 , 14.4 )] involving 469 bupivacaine liposome injectable suspension-treated adult patients and 357 placebo-treated patients who had various surgical procedures. Patients were administered placebo or a bupivacaine liposome injectable suspension dose of either 133 or 266 mg (two times the maximum recommended dose for these nerve blocks). In these studies, following bupivacaine liposome injectable suspension administration via nerve block (perineural use) the: Most Common adverse reactions (incidence greater than or equal to 10%) were nausea, pyrexia, and constipation. Common adverse reactions (incidence greater than or equal to 2% to less than 10%) were muscle twitching, dysgeusia, urinary retention, fatigue, headache, confusional state, hypotension, hypertension, oral hypoesthesia, generalized pruritus, hyperhidrosis, tachycardia, sinus tachycardia, anxiety, fall, increased body temperature, peripheral edema, sensory loss, increased hepatic enzyme, hiccups, hypoxia, and post-procedural hematoma. Less common adverse reactions (incidence less than 2%) were arrhythmia, atrial fibrillation, first degree atrioventricular block, bradycardia, left bundle branch block, right bundle branch block, cardiac arrest, impaired hearing, blurred vision, visual impairment, asthenia, chills, hyperthermia, cellulitis, lung infection, pneumonia, procedural nausea, wound dehiscence, wound secretion, electrocardiogram QT prolonged, white blood cell count increased, arthralgia, back pain, joint swelling, decreased mobility, muscle spasms, muscular weakness, musculoskeletal pain, paraesthesia, presyncope, sedation, somnolence, syncope, delirium, dysuria, urinary incontinence, atelectasis, cough, dyspnea, lung infiltration, blister, drug eruption, erythema, rash, urticaria, deep vein thrombosis, hematoma, and orthostatic hypotension. The most common and common adverse reactions for the four randomized, double-blind, placebo-controlled nerve block clinical studies (Studies 3, 6, 7, 8) are shown in Table 3. Neurological and Cardiac Adverse Reactions In the bupivacaine liposome injectable suspension nerve block placebo-controlled studies, following bupivacaine liposome injectable suspension administration adverse reactions with an incidence greater than or equal to 1% in the: Nervous System Disorders system organ class were motor dysfunction (14.9%), dysgeusia (7.2%), headache (5.1%), hypoesthesia (2.3%), and sensory loss (2.3%). Cardiac Disorders system organ class were tachycardia (3%), sinus tachycardia (2.3%), and bradycardia (1.3%). Table 3: Treatment-Emergent Adverse Reactions with an Incidence Greater than or Equal to 2%: Nerve Block Placebo-Controlled Studies (Studies 3, 6, 7, and 8) At each level of summation (overall, system organ class, preferred term), patients are only counted once. Preferred terms are included where at least 2% of patients reported the event in any treatment group. TEAE = treatment-emergent adverse event. SYSTEM ORGAN CLASS Preferred Term Bupivacaine Liposome Injectable Suspension 133 mg (N=168) n (%) Bupivacaine Liposome Injectable Suspension 266 mg (N=301) n (%) Placebo (N=357) n (%) Number of Patients with at Least One TEAE 152 (90.5) 260 (86.4) 299 (83.8) Blood and Lymphatic System Disorders 2 (1.2) 22 (7.3) 15 (4.2) Anemia 2 (1.2) 18 (6.0) 13 (3.6) Cardiac Disorders 13 (7.7) 34 (11.3) 38 (10.6) Atrial Fibrillation 1 (0.6) 4 (1.3) 8 (2.2) Sinus Tachycardia 3 (1.8) 8 (2.7) 4 (1.1) Tachycardia 3 (1.8) 11 (3.7) 10 (2.8) Gastrointestinal Disorders 84 (50.0) 154 (51.2) 184 (51.5) Constipation 29 (17.3) 66 (21.9) 68 (19.0) Dyspepsia 3 (1.8) 7 (2.3) 7 (2.0) Oral Hypoesthesia 6 (3.6) 8 (2.7) 7 (2.0) Nausea 62 (36.9) 111 (36.9) 133 (37.3) Vomiting 17 (10.1) 55 (18.3) 73 (20.4) General Disorders and Administration Site Conditions 52 (31.0) 102 (33.9) 91 (25.5) Fatigue 7 (4.2) 15 (5.0) 15 (4.2) Feeling Cold 0 10 (3.3) 8 (2.2) Peripheral Edema 4 (2.4) 6 (2.0) 8 (2.2) Peripheral Swelling 3 (1.8) 8 (2.7) 4 (1.1) Pyrexia 36 (21.4) 70 (23.3) 64 (17.9) Injury, Poisoning and Procedural Complications 18 (10.7) 44 (14.6) 32 (9.0) Postoperative Anemia 0 8 (2.7) 10 (2.8) Contusion 4 (2.4) 1 (0.3) 0 Fall 4 (2.4) 8 (2.7) 1 (0.3) Post Procedural Hematoma 4 (2.4) 1 (0.3) 0 Procedural Hypotension 2 (1.2) 13 (4.3) 7 (2.0) Investigations 18 (10.7) 31 (10.3) 31 (8.7) Increased Body Temperature 1 (0.6) 10 (3.3) 4 (1.1) Increased Hepatic Enzyme 7 (4.2) 1 (0.3) 3 (0.8) Metabolism and Nutrition Disorders 13 (7.7) 18 (6.0) 25 (7.0) Hypokalemia 7 (4.2) 9 (3.0) 14 (3.9) Musculoskeletal and Connective Tissue Disorders 22 (13.1) 47 (15.6) 41 (11.5) Decreased Mobility 0 6 (2.0) 5 (1.4) Muscle Twitching 14 (8.3) 21 (7.0) 25 (7.0) Nervous System Disorders 72 (42.9) 101 (33.6) 112 (31.4) Dizziness 8 (4.8) 28 (9.3) 40 (11.2) Dysgeusia 12 (7.1) 22 (7.3) 21 (5.9) Headache 14 (8.3) 10 (3.3) 10 (2.8) Hypoesthesia 6 (3.6) 5 (1.7) 2 (0.6) Motor Dysfunction 35 (20.8) 35 (11.6) 37 (10.4) Sensory Loss 4 (2.4) 7 (2.3) 1 (0.3) Psychiatric Disorders 10 (6.0) 33 (11.0) 44 (12.3) Anxiety 3 (1.8) 9 (3.0) 6 (1.7) Confusional State 3 (1.8) 15 (5.0) 14 (3.9) Insomnia 5 (3.0) 10 (3.3) 19 (5.3) Renal and Urinary Disorders 9 (5.4) 31 (10.3) 31 (8.7) Urinary Retention 5 (3.0) 23 (7.6) 22 (6.2) Respiratory, Thoracic and Mediastinal Disorders 18 (10.7) 30 (10.0) 31 (8.7) Dyspnea 2 (1.2) 4 (1.3) 8 (2.2) Hiccups 4 (2.4) 4 (1.3) 1 (0.3) Hypoxia 4 (2.4) 3 (1.0) 3 (0.8) Skin and Subcutaneous Tissue Disorders 24 (14.3) 63 (20.9) 84 (23.5) Hyperhidrosis 1 (0.6) 14 (4.7) 15 (4.2) Pruritus 10 (6.0) 45 (15.0) 55 (15.4) Generalized Pruritus 6 (3.6) 7 (2.3) 14 (3.9) Vascular Disorders 16 (9.5) 30 (10.0) 44 (12.3) Hypertension 3 (1.8) 15 (5.0) 21 (5.9) Hypotension 11 (6.5) 8 (2.7) 19 (5.3) 6.2 Postmarketing Experience Because adverse reactions reported during postmarketing 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. These adverse reactions are consistent with those observed in clinical studies and most commonly involve the following system organ classes: Injury, Poisoning, and Procedural Complications (e.g., drug-drug interaction, procedural pain), Nervous System Disorders (e.g., palsy, seizure), General Disorders And Administration Site Conditions (e.g., lack of efficacy, pain), Skin And Subcutaneous Tissue Disorders (e.g., erythema, rash), and Cardiac Disorders (e.g., bradycardia, cardiac arrest).
Medical Disclaimer: This information is for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare provider before making any decisions about your medications. Data sourced from openFDA.