Microsoft word - nwh-1002-13 brisdelle hcp isi validated 9-27-13

Brisdelle HCP
INDICATION
BRISDELLE™ (paroxetine) is indicated for the treatment of moderate to severe
vasomotor symptoms (VMS) associated with menopause.
  BRISDELLE is not indicated for the treatment of any psychiatric condition. BRISDELLE contains a lower dose of paroxetine than that used for psychiatric conditions. The safety and efficacy of this lower dose of paroxetine in BRISDELLE have not been established for any psychiatric condition. Patients who require paroxetine for treatment of a psychiatric condition should discontinue BRISDELLE and initiate a paroxetine-containing medication that is indicated for such use. IMPORTANT SAFETY INFORMATION
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
Antidepressants, including selective serotonin reuptake inhibitors (SSRIs), have
been shown to increase the risk of suicidal thoughts and behavior in pediatric and
young adult patients when used to treat major depressive disorder and other
psychiatric disorders. Because BRISDELLE is an SSRI, monitor patients closely
for worsening and for emergence of suicidal thoughts and behaviors. Advise
families and caregivers of the need for close observation and communication with
the prescriber.
CONTRAINDICATIONS:
• Concurrent use with monoamine oxidase inhibitors (MAOIs) o or use within 14 days of MAOI use o or starting BRISDELLE in a patient who is being treated with • Concomitant use with thioridazine or pimozide due to their increased plasma concentrations and because of the potential of QTc prolongation. • Hypersensitivity to any ingredient in BRISDELLE. • Pregnancy because BRISDELLE may cause fetal harm. WARNINGS AND PRECAUTIONS:
 Suicidality: All patients being treated with BRISDELLE should be observed
closely for clinical worsening, suicidality, and unusual changes in behavior,
especially during the initial few months of treatment.
• Serotonin Syndrome: Serotonin syndrome, which is potentially life-threatening, has been reported with concomitant use of serotonergic drugs, and with drugs that impair metabolism of serotonin (in particular, MAOIs). Monitor patients for the emergence of serotonin syndrome. Discontinue BRISDELLE and any concomitant serotonergic agents and initiate supportive treatment. • Tamoxifen: Efficacy of tamoxifen may be reduced when administered concomitantly with BRISDELLE. • Abnormal Bleeding: SSRIs, including BRISDELLE, may increase the risk of bleeding events. Caution patients about the risk of bleeding associated with the concomitant use of BRISDELLE and non-steroidal anti-inflammatory drugs (NSAIDs), aspirin, or other drugs that affect coagulation. • Hyponatremia: may occur as a result of treatment with SSRIs, including BRISDELLE. Elderly patients may be at greater risk and in many cases it can occur in association with syndrome of inappropriate antidiuretic hormone secretion (SIADH). Consider discontinuation of BRISDELLE in patients with symptomatic hyponatremia and institute appropriate medical intervention. • Bone fracture: Epidemiological studies have reported an association between • Activation of Mania/Hypomania: Screen for bipolar disorder and monitor for • Seizures: Use cautiously in patients with a history of seizures or with conditions that potentially lower the seizure threshold. • Akathisia: Can occur, most likely in the first few weeks of treatment. Discontinue treatment with BRISDELLE if akathisia occurs. • Acute Angle Closure Glaucoma: May cause acute angle closure in patients with narrow angle glaucoma; tell patients with narrow angle glaucoma to report visual symptoms. • Cognitive and Motor Impairment: May cause impairment; patients should not operate machinery or motor vehicles until certain that BRISDELLE does not affect them adversely. ADVERSE REACTIONS:
The most common adverse reactions (≥ 2%) reported in clinical trials were: headache,
fatigue, and nausea and vomiting. Of these, nausea occurred primarily within the first 4
weeks of treatment and fatigue occurred primarily within the first week of treatment, and
decreased in frequency with continued therapy.
To report SUSPECTED ADVERSE REACTIONS, contact Noven Therapeutics,
LLC at 1-800-455-8070 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
DRUG INTERACTIONS:
Paroxetine is a strong CYP2D6 inhibitor. Co-administration of BRISDELLE can alter
concentrations of other drugs that are metabolized by CYP2D6. Use caution if co-
administering BRISDELLE with other drugs that are metabolized by CYP2D6.
  These are not all the possible side effects of BRISDELLE. Please read the full
Prescribing Information and Medication Guide.

Source: http://brisdelleprograms.com/images/isi.pdf