Lunesta Letter - Haymarket Media Group

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Cymbalta provides rapid relief of fibromyalgia pain • Cymbalta provided rapid pain relief in patients with pain from fibromyalgia 1c • A statistically significant reduction in pain over placebo was seen as early as week 1 in fibromyalgia trials 1c Safety and tolerability Nausea Dry mouth Constipation Somnolence * Decreased appetite † Increased sweating Agitation ‡ PRESCRIBING ALERT CYMBALTA 60 MG/DAY IN FIBROMYALGIA CLINICAL TRIALS: EFFECT ON BPI 24-HOUR AVERAGE PAIN SCORE 1c† Improvement % Change in Mean BPI 24-hour Average Pain Score 0 -5 -10 -15 -20 -25 -30 -35 -40 -45 Weeks on Study Drug 0 2 4 6 8 10 12 * * * MOST COMMON ADVERSE EVENTS IN FIBROMYALGIA STUDIES 1d,2 Cymbalta 20-120 mg/day (N=876) (%) 29 18 15 11 11 7 6 * Placebo (N=535) (%) * Somnolence also contains: sedation and hypersomnia † Decreased appetite also contains: anorexia ‡ Agitation also contains: feeling jittery, nervousness, restlessness, tension, and psychomotor agitation Adverse events reported at a rate of ≥5% and at least twice the rate of placebo Data are from two 3-month and two 6-month placebo-controlled studies Overall discontinuation rate due to adverse events: Cymbalta (20-120 mg/day): 20% vs placebo: 12% 2 Please see Important Safety Information, including Boxed Warning, for Cymbalta and enclosed full Prescribing Information. * * 11 5 4 3 2 1 2 * Cymbalta 60 mg/day (N=116) Placebo (N=118) One outpatient study (MMRM) * P≤.05, Cymbalta vs placebo In a separate study, % change in mean BPI 24-hour average pain score improvement was measured at weeks 1, 2, 4, 7, 11, and 151c – Cymbalta 60 mg/day was not significantly different vs placebo at weeks 7, 11, and 15 † As measured by an 11-point Likert Scale Mean baseline score 6.41b BPI= Brief Pain Inventory MMRM=Mixed-effects Models Repeated Measures analysis % of patients on Cymbalta who discontinued due to treatment-emergent adverse events 1d 1.9 0.1 0.3 2.1 0.1 0.5 0.7 (continued on next page)
Important Safety Information PRESCRIBING ALERT Cymbalta is indicated in adults for: • The acute and maintenance treatment of major depressive disorder (MDD) • The acute treatment of generalized anxiety disorder (GAD) • The management of diabetic peripheral neuropathic pain (DPNP) • The management of fibromyalgia (FM) Suicidality and Antidepressant Drugs—Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Cymbalta or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Cymbalta is not approved for use in pediatric patients. Contraindications • Cymbalta should not be used in combination with MAOIs and is contraindicated for at least 14 days after discontinuation of an MAOI. After stopping therapy on Cymbalta, at least 5 days should be allowed before starting an MAOI. • Cymbalta was associated with an increased risk of mydriasis; therefore, it should not be used in patients with uncontrolled narrow-angle glaucoma and used cautiously in patients with controlled narrow-angle glaucoma. • Clinical Worsening and Suicide Risk All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially within the first few months of treatment and when changing the dose. Consider changing the therapeutic regimen, including possibly discontinuing the medication in patients whose depression is persistently worse or includes symptoms of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, or suicidality that are severe, abrupt in onset, or were not part of the patient’s presenting symptoms. If discontinuing treatment, the medication should be tapered. Families and caregivers of patients being treated with antidepressants for any indication should be alerted about the need to monitor patients. • Hepatic failure, sometimes fatal, has been reported in patients treated with Cymbalta. Cymbalta should be discontinued in patients who develop jaundice or other evidence of clinically significant liver dysfunction and should not be resumed unless another cause can be established. • Because it is possible that Cymbalta and alcohol may interact to cause liver injury or that Cymbalta may aggravate pre-existing liver disease, Cymbalta should ordinarily not be prescribed to patients with substantial alcohol use or evidence of chronic liver disease. • Orthostatic hypotension and syncope have been reported with therapeutic doses of Cymbalta. Consideration should be given to discontinuing Cymbalta in patients who experience symptomatic orthostatic hypotension and/or syncope. • Development of a potentially life-threatening serotonin syndrome may occur with SNRIs and SSRIs, including Cymbalta treatment, particularly with concomitant use of serotonergic drugs, including triptans. Concomitant use is not recommended. (continued on back)
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Lunesta Letter - Haymarket Media Group

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