Indication: FORFIVO XL® is indicated for the treatment of Major Depressive Disorder (MDD) in adults.
IMPORTANT SAFETY INFORMATION FOR FORFIVO XL®
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS;
AND NEUROPSYCHIATRIC REACTIONS
SUICIDALITY and ANTIDEPRESSANT DRUGS: Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term trials. These trials did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in subjects aged 65 and older. In patients of all ages who are started on antidepressant therapy, monitor 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. FORFIVO XL is not approved for use in pediatric patients. NEUROPSYCHIATRIC REACTIONS IN PATIENTS TAKING BUPROPION FOR SMOKING CESSATION: Serious neuropsychiatric reactions have occurred in patients taking bupropion for smoking cessation. The majority of these reactions occurred during bupropion treatment, but some occurred in the context of discontinuing treatment. In many cases, a causal relationship to bupropion treatment is not certain, because depressed mood may be a symptom of nicotine withdrawal. However, some of the cases occurred in patients taking bupropion who continued to smoke. Although FORFIVO XL is not approved for smoking cessation, observe all patients for neuropsychiatric reactions. Instruct the patient to contact a healthcare provider if such reactions occur.
FORFIVO XL is contraindicated in patients
- with a seizure disorder.
- treated currently with other bupropion products because seizure incidence is dose dependent.
- with a current or prior diagnosis of bulimia or anorexia nervosa because a higher incidence of seizure was observed in such patients treated with bupropion.
- undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs.
- administered monoamine oxidase inhibitors (MAOIs) (intended to treat psychiatric disorders) concomitantly with FORFIVO XL or within 14 days of discontinuing FORFIVO XL. The use of FORFIVO XL within 14 days of discontinuing treatment with an MAOI is also contraindicated. Starting FORFIVO XL in a patient treated with reversible MAOIs such as linezolid or intravenous methylene blue is contraindicated.
- with known hypersensitivity to bupropion or the other ingredients of FORFIVO XL tablets.
WARNINGS AND PRECAUTIONS
Suicidal Thoughts and Behaviors 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 during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases. Families and caregivers of patients being treated with antidepressants for major depressive disorder (MDD) or other indications, both psychiatric and nonpsychiatric, should be alerted about the need to monitor patients on a daily basis for the emergence of agitation, irritability, or unusual changes in behavior, as well as the emergence of suicidality, and to report such symptoms immediately to healthcare providers.
Neuropsychiatric Symptoms and Suicide Risk in Smoking Cessation Treatment FORFIVO XL is not approved for smoking cessation treatment, but bupropion hydrochloride (HCl) sustained-release is approved for this use. Serious neuropsychiatric symptoms have been reported in patients taking bupropion for smoking cessation. These have included changes in mood (including depression and mania), psychosis, hallucinations, paranoia, delusions, homicidal ideation, hostility, agitation, aggression, anxiety, and panic, as well as suicidal ideation, suicide attempt, and completed suicide. Observe patients for the occurrence of neuropsychiatric reactions. Instruct patients to contact a healthcare professional if such reactions occur. A causal relationship to bupropion treatment is not certain in many cases because depressed mood can be a symptom of nicotine withdrawal. However, some of the cases occurred in patients taking bupropion who continued to smoke.
Seizures Bupropion is associated with a dose-related risk of seizures. FORFIVO XL should be discontinued and not restarted in patients who experience a seizure while on treatment. The risk of seizures is also related to patient factors, clinical situations, and concomitant medications that lower the seizure threshold [see Warnings and Precautions in full prescribing information]. Consider these risks before initiating treatment with FORFIVO XL. FORFIVO XL is contraindicated in patients with a seizure disorder or conditions that increase the risk of seizure.
Hypertension Treatment with FORFIVO XL can result in elevated blood pressure and hypertension. Assess blood pressure before initiating treatment with FORFIVO XL, and monitor periodically during treatment. The risk of hypertension is increased if FORFIVO XL is used concomitantly with MAOIs or other drugs that increase dopaminergic or noradrenergic activity. Data from a comparative trial of bupropion HCl, nicotine transdermal system (NTS), and placebo as an aid to smoking cessation suggest a higher incidence of treatment emergent hypertension in patients treated with the combination of sustained-release bupropion HCl and NTS.
Activation of Mania/Hypomania Antidepressant treatment can precipitate a manic, mixed, or hypomanic manic episode. Prior to initiating FORFIVO XL, screen patients for a history of bipolar disorder and the presence of risk factors for bipolar disorder (eg, family history of bipolar disorder, suicide, or depression). FORFIVO XL is not approved for the treatment of bipolar depression.
Psychosis and Other Neuropsychiatric Reactions Depressed patients treated with bupropion have had a variety of neuropsychiatric signs and symptoms, including delusions, hallucinations, psychosis, concentration disturbance, paranoia, and confusion. Some of these patients had a diagnosis of bipolar disorder. In some cases, these symptoms abated upon dose reduction and/or withdrawal of treatment. Discontinue FORFIVO XL if these reactions occur.
Angle-closure Glaucoma The pupillary dilation that occurs following use of many antidepressant drugs including FORFIVO XL may trigger an angle closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy.
Hypersensitivity Reactions Anaphylactoid/anaphylactic reactions characterized by symptoms such as pruritus, urticaria, angioedema, and dyspnea requiring medical treatment have been reported in clinical trials with bupropion. In addition, there have been rare, spontaneous postmarketing reports of erythema multiforme, StevensJohnson syndrome, and anaphylactic shock associated with bupropion. Instruct patients to discontinue FORFIVO XL and consult a healthcare provider if they develop an allergic or anaphylactoid/anaphylactic reaction during treatment. There are reports of arthralgia, myalgia, fever with rash, and other symptoms of serum sickness suggestive of delayed hypersensitivity.
Clinical Trials Experience: Commonly Observed Adverse Reactions in Controlled Clinical Trials of Sustained-release Bupropion HCl The most common adverse reactions were (incidence ≥ 5%; ≥ 2 times placebo rate): dry mouth, nausea, insomnia, dizziness, pharyngitis, abdominal pain, agitation, anxiety, tremor, palpitation, sweating, tinnitus, myalgia, anorexia, urinary frequency, and rash.
You are encouraged to report negative side effects of prescription drugs to Alvogen at 1-866-770-3024 or the FDA at www.fda.gov/medwatch or call 1-800-FDA-1088.>
FORFIVO XL is a registered trademark of IntelGenx Corporation.