tonmya

Important safety information

Embryofetal Toxicity : Based on animal data, TONMYA may cause neural tube defects when used two weeks prior to conception and through the first trimester of pregnancy. Advise females of reproductive potential of the potential risk and to use effective contraception during treatment and for two weeks after the final dose. ( 5.1 , 8.1 , 8.3 ) Serotonin Syndrome: Potentially life-threatening serotonin syndrome has been reported with cyclobenzaprine when used in combination with other drugs. Immediately discontinue concomitant treatment with TONMYA and a serotonergic agent if serotonin syndrome symptoms occur and initiate supportive symptomatic treatment. If concomitant treatment with TONMYA and other serotonergic drugs is clinically warranted, careful observation is advised, particularly during treatment initiation or dosage increases. ( 5.2 ) Tricyclic Antidepressant-like Adverse Reactions: TCAs have been reported to produce arrhythmias, sinus tachycardia, prolongation of the conduction time leading to myocardial infarction and stroke. TCAs lower the seizure threshold, and are associated with serious CNS reactions. If clinically significant CNS symptoms develop, consider discontinuation of TONMYA. ( 5.3 ) Atropine-like Adverse Reactions: Use with caution in patients with a history of urinary retention, angle-closure glaucoma, increased intraocular pressure and in patients taking anticholinergic medications. ( 5.4 ) CNS Depression and Risk of Operating a Motor Vehicle or Hazardous Machinery: TONMYA monotherapy may cause CNS depression. Advise patients not to operate a motor vehicle or other dangerous machinery until they are reasonably certain that TONMYA therapy will not adversely affect their ability to engage in such activities. (5.5) Oral Mucosal Adverse Reactions : In clinical studies, oral mucosal adverse reactions occurred more frequently in TONMYA-treated patients compared to placebo-treated patients. Advise patients to moisten the mouth with sips of water before administration of TONMYA to reduce the risk of oral sensory changes (hypoesthesia). Consider discontinuation of TONMYA if severe reactions occur. ( 5.6 ) 5.1 Embryofetal Toxicity Based on data from animal reproduction studies, TONMYA may cause an increased risk of neural tube defects when administered to a pregnant female two weeks prior to conception and during the first trimester of pregnancy. Neural tube defects (splayed vertebral arches and spina bifida occulta) were observed in a rabbit embryofetal development study at the highest maternal dose tested, in the absence of maternal toxicity. Because neural tube development occurs early in pregnancy, often before pregnancy is recognized, advise females of reproductive potential of the potential risk to the fetus and avoid use of TONMYA two weeks prior to conception and through the first trimester of pregnancy. Perform a pregnancy test prior to initiation of treatment with TONMYA to exclude use of TONMYA during the first trimester of pregnancy. Advise females of reproductive potential to use effective contraception during TONMYA treatment and for two weeks after the final dose [see Use in Specific Populations (8.1 , 8.3) ]. 5.2 Serotonin Syndrome The development of a potentially life-threatening serotonin syndrome has been reported with cyclobenzaprine when used in combination with other drugs, such as selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), tramadol, bupropion, meperidine, verapamil, or MAO inhibitors. The concomitant use of TONMYA with MAO inhibitors is contraindicated [see Contraindications (4) ] . Serotonin syndrome symptoms may include mental status changes (e.g., confusion, agitation, hallucinations), autonomic instability (e.g., diaphoresis, tachycardia, labile blood pressure, hyperthermia), neuromuscular abnormalities (e.g., tremor, ataxia, hyperreflexia, clonus, muscle rigidity), and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Treatment with TONMYA and any concomitant serotonergic agents should be discontinued immediately if serotonin syndrome symptoms occur and supportive symptomatic treatment should be initiated. If concomitant treatment with TONMYA and other serotonergic drugs is clinically warranted, careful observation is advised, particularly during treatment initiation or dosage increases. 5.3 Tricyclic Antidepressant-like Adverse Reactions Cyclobenzaprine is structurally related to tricyclic antidepressants (TCAs). TCAs have been reported to produce arrhythmias, sinus tachycardia, prolongation of the conduction time leading to myocardial infarction and stroke [see Contraindications (4) ] . Some of the more TCA-associated serious central nervous system (CNS) reactions have occurred in short-term studies of oral cyclobenzaprine. If clinically significant CNS symptoms develop, consider discontinuation of TONMYA. Caution should be used when TCAs are given to patients with a history of seizure disorder, because TCAs may lower the seizure threshold. Patients with a history of seizures should be monitored during TCA use to identify recurrence of seizures or increase in frequency of seizures. 5.4 Atropine-like Adverse Reactions Because of its atropine-like action, TONMYA should be used with caution in patients with a history of urinary retention, angle-closure glaucoma, increased intraocular pressure, and in patients taking anticholinergic drugs. 5.5 CNS Depression and Risk of Operating a Motor Vehicle or Hazardous Machinery TONMYA monotherapy may cause CNS depression and concomitant use of TONMYA with alcohol, barbiturates, or other CNS depressants may increase the risk of CNS depression [see Drug Interactions (7) ]. Symptoms of CNS depression include somnolence. Advise patients not to operate a motor vehicle or dangerous machinery until they are reasonably certain that TONMYA therapy will not adversely affect their ability to engage in such activities. 5.6 Oral Mucosal Adverse Reactions Oral mucosal adverse reactions, including sensory changes (e.g., numbness, tingling), discomfort, pain, irritation, inflammation, and lesions, occurred more frequently in patients treated with TONMYA compared to placebo (43% vs. 8%) [see Adverse Reactions (6.1) ]. Reactions typically occurred within minutes of administration and most resolved within 60 minutes. Five patients experienced severe oral mucosal adverse reactions, including sensory changes (paresthesia, hypoesthesia), inflammation (glossitis), oral pain, and dry mouth . Most severe oral mucosal adverse reactions resolved within days after TONMYA was discontinued and no treatment was required. Advise patients to moisten the mouth with sips of water before administration of TONMYA to reduce the risk of oral sensory changes (hypoesthesia). Advise patients to report severe oral mucosal adverse reactions to their healthcare provider. Consider discontinuation of TONMYA if severe reactions occur.