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Indication

INDICATION

WELLBUTRIN XL® (bupropion hydrochloride extended-release tablets) is indicated for the treatment of major depressive disorder (MDD), and for the prevention of seasonal major depressive episodes in patients with a diagnosis of seasonal affective disorder (SAD). Periodically reevaluate long-term usefulness for the individual patient.

IMPORTANT SAFETY INFORMATION

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS

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.

Contraindications

WELLBUTRIN XL is contraindicated in:

  • patients with a seizure disorder
  • patients with a current or prior diagnosis of bulimia or anorexia nervosa, due to a higher incidence of seizures
  • patients undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, or antiepileptic drugs
  • patients taking other bupropion products, including Zyban
  • patients taking a monoamine oxidase inhibitor (MAOI) or within 14 days of discontinuing MAOI treatment due to an increased risk of hypertensive reactions. Starting WELLBUTRIN XL in a patient treated with reversible MAOIs such as linezolid or intravenous methylene blue is contraindicated.
  • patients with hypersensitivity to bupropion or other ingredients of WELLBUTRIN XL

Warnings and Precautions

  • WELLBUTRIN XL is not approved for smoking cessation treatment; however, bupropion HCl sustained-release is approved for this use. Postmarketing reports of serious or clinically significant neuropsychiatric adverse events with smoking cessation treatment have included changes in mood (including depression and mania), psychosis, hallucinations, paranoia, delusions, homicidal ideation, aggression, hostility, agitation, anxiety, and panic, as well as suicidal ideation, suicide attempt, and completed suicide. Observe patients attempting to quit smoking with WELLBUTRIN XL for the occurrence of such symptoms and instruct them to discontinue WELLBUTRIN XL and contact a healthcare provider if they experience such adverse events.
  • Bupropion is associated with a dose-related risk of seizures. The dose should not exceed 300 mg once daily. Increase the dose gradually. Discontinue WELLBUTRIN XL and do not restart treatment if the patient experiences a seizure. Use with extreme caution in patients with a history of seizure or cranial trauma, or in patients treated with other medications that lower the seizure threshold.
  • Treatment with WELLBUTRIN XL can result in elevated blood pressure and hypertension. Assess blood pressure before initiating treatment with WELLBUTRIN XL and monitor periodically during treatment.
  • Antidepressant treatment can precipitate a manic, mixed, or hypomanic manic episode. Prior to initiating WELLBUTRIN XL, screen patients for a history of bipolar disorder and the presence of risk factors for bipolar disorder (e.g., family history of bipolar disorder, suicide, or depression). WELLBUTRIN XL is not approved for the treatment of bipolar depression.
  • 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 WELLBUTRIN XL if these reactions occur.
  • The pupillary dilation that occurs following use of many antidepressant drugs including WELLBUTRIN XL may trigger an angle closure attack (Angle-Closure Glaucoma) in a patient with anatomically narrow angles who does not have a patent iridectomy.
  • Anaphylactoid/anaphylactic reactions have occurred during clinical trials with bupropion, as well as rare, postmarketing reports of erythema multiforme, Stevens-Johnson syndrome, and anaphylactic shock associated with bupropion.  

Adverse Reactions

  • The most common adverse reactions that occurred in at least 5% of patients treated with bupropion HCl sustained-release (300 mg and 400 mg per day) and at a rate at least twice the placebo rate were: anorexia, dry mouth, nausea, insomnia, dizziness, pharyngitis, abdominal pain, agitation, anxiety, tremor, palpitation, sweating, tinnitus, myalgia, urinary frequency, and rash.

Drug Interactions

  • An increased dose of bupropion may be necessary if co-administered with CYP2B6 inducers based on clinical exposure but should not exceed the maximum recommended dose. Bupropion inhibits CYP2D6 and can increase concentrations of: antidepressants, antipsychotics, beta-blockers, and Type 1C antiarrhythmics. Consider dose reduction when using with bupropion. Dose bupropion with caution when used with drugs that lower seizure threshold. CNS toxicity can occur when bupropion is used concomitantly with dopaminergic drugs.
  • WELLBUTRIN XL can cause false-positive urine test results for amphetamines.

Use in Specific Populations

  • In patients with moderate to severe hepatic impairment (Child-Pugh score: 7 to 15), the maximum dose is 150 mg every other day. In patients with mild hepatic impairment (Child-Pugh score: 5 to 6) or renal impairment (glomerular filtration rate <90 mL/min), consider reducing the dose and/or frequency of dosing.
  • Advise patients to read the FDA-approved patient labeling (Medication Guide). 

To report SUSPECTED ADVERSE REACTIONS, contact Bausch Health at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Click here for full Prescribing Information including Boxed Warning regarding suicidal thoughts and behaviors.

Read More
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INDICATION

WELLBUTRIN XL® (bupropion hydrochloride extended-release tablets) is indicated for the treatment of major depressive disorder (MDD), and for the prevention of seasonal major depressive episodes in patients with a diagnosis of seasonal affective disorder (SAD). Periodically reevaluate long-term usefulness for the individual patient.

IMPORTANT SAFETY INFORMATION

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS

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.

Contraindications

WELLBUTRIN XL is contraindicated in:

  • patients with a seizure disorder
  • patients with a current or prior diagnosis of bulimia or anorexia nervosa, due to a higher incidence of seizures
  • patients undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, or antiepileptic drugs
  • patients taking other bupropion products, including Zyban
  • patients taking a monoamine oxidase inhibitor (MAOI) or within 14 days of discontinuing MAOI treatment due to an increased risk of hypertensive reactions. Starting WELLBUTRIN XL in a patient treated with reversible MAOIs such as linezolid or intravenous methylene blue is contraindicated.
  • patients with hypersensitivity to bupropion or other ingredients of WELLBUTRIN XL

Warnings and Precautions

  • WELLBUTRIN XL is not approved for smoking cessation treatment; however, bupropion HCl sustained-release is approved for this use. Postmarketing reports of serious or clinically significant neuropsychiatric adverse events with smoking cessation treatment have included changes in mood (including depression and mania), psychosis, hallucinations, paranoia, delusions, homicidal ideation, aggression, hostility, agitation, anxiety, and panic, as well as suicidal ideation, suicide attempt, and completed suicide. Observe patients attempting to quit smoking with WELLBUTRIN XL for the occurrence of such symptoms and instruct them to discontinue WELLBUTRIN XL and contact a healthcare provider if they experience such adverse events.
  • Bupropion is associated with a dose-related risk of seizures. The dose should not exceed 300 mg once daily. Increase the dose gradually. Discontinue WELLBUTRIN XL and do not restart treatment if the patient experiences a seizure. Use with extreme caution in patients with a history of seizure or cranial trauma, or in patients treated with other medications that lower the seizure threshold.
  • Treatment with WELLBUTRIN XL can result in elevated blood pressure and hypertension. Assess blood pressure before initiating treatment with WELLBUTRIN XL and monitor periodically during treatment.
  • Antidepressant treatment can precipitate a manic, mixed, or hypomanic manic episode. Prior to initiating WELLBUTRIN XL, screen patients for a history of bipolar disorder and the presence of risk factors for bipolar disorder (e.g., family history of bipolar disorder, suicide, or depression). WELLBUTRIN XL is not approved for the treatment of bipolar depression.
  • 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 WELLBUTRIN XL if these reactions occur.
  • The pupillary dilation that occurs following use of many antidepressant drugs including WELLBUTRIN XL may trigger an angle closure attack (Angle-Closure Glaucoma) in a patient with anatomically narrow angles who does not have a patent iridectomy.
  • Anaphylactoid/anaphylactic reactions have occurred during clinical trials with bupropion, as well as rare, postmarketing reports of erythema multiforme, Stevens-Johnson syndrome, and anaphylactic shock associated with bupropion.  

Adverse Reactions

  • The most common adverse reactions that occurred in at least 5% of patients treated with bupropion HCl sustained-release (300 mg and 400 mg per day) and at a rate at least twice the placebo rate were: anorexia, dry mouth, nausea, insomnia, dizziness, pharyngitis, abdominal pain, agitation, anxiety, tremor, palpitation, sweating, tinnitus, myalgia, urinary frequency, and rash.

Drug Interactions

  • An increased dose of bupropion may be necessary if co-administered with CYP2B6 inducers based on clinical exposure but should not exceed the maximum recommended dose. Bupropion inhibits CYP2D6 and can increase concentrations of: antidepressants, antipsychotics, beta-blockers, and Type 1C antiarrhythmics. Consider dose reduction when using with bupropion. Dose bupropion with caution when used with drugs that lower seizure threshold. CNS toxicity can occur when bupropion is used concomitantly with dopaminergic drugs.
  • WELLBUTRIN XL can cause false-positive urine test results for amphetamines.

Use in Specific Populations

  • In patients with moderate to severe hepatic impairment (Child-Pugh score: 7 to 15), the maximum dose is 150 mg every other day. In patients with mild hepatic impairment (Child-Pugh score: 5 to 6) or renal impairment (glomerular filtration rate <90 mL/min), consider reducing the dose and/or frequency of dosing.
  • Advise patients to read the FDA-approved patient labeling (Medication Guide). 

To report SUSPECTED ADVERSE REACTIONS, contact Bausch Health at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Click here for full Prescribing Information including Boxed Warning regarding suicidal thoughts and behaviors.

Read More

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Prescribe brand-name WELLBUTRIN XL for your patients

The generic versions of WELLBUTRIN XL may look considerably different from the original branded product

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WELLBUTRIN XL

Illustration of various generic versions of pills in different shapes and colors.

GENERIC VERSIONS OF WELLBUTRIN XL

Graphic representation of WELLBUTRIN XL and generic versions of WELLBUTRIN XL. Not actual size.

  • Some pharmacists may substitute a WELLBUTRIN XL prescription with a generic formulation of bupropion HCl. Patients can only take advantage of brand benefits, like SmartCoat™ technology and dedicated access and patient support, when they receive brand name WELLBUTRIN XL3,4
  • Patients on generic bupropion HCl may receive a different generic formulation each month, which means they can receive a product that may change in size, shape, color, taste, smell, and packaging5

Write/Select DAW1, Brand Medically Necessary on your WELLBUTRIN XL scripts

Help ensure patients get the brand-name product and potentially avoid adherence issues.5,7

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Prior authorization (PA) support

Resources to help healthcare providers manage the PA process.

PA CONSIDERATIONS FOR WELLBUTRIN XL
SAMPLE LETTER OF MEDICAL NECESSITY 
MEDICARE PART D COVERAGE DETERMINATION FORM

Copay savings 

Most eligible* commercially insured patients may pay as little as $0.

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*This offer is not valid for patients covered by Medicare, Medicaid or any other federal or state funded healthcare program or where prohibited by law. Please see full eligibility criteria above.

 
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Insurance
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WELLBUTRIN XL support from CoverMyMeds® allows healthcare providers to: 

  • Manage quick and efficient prior authorizations 
  • Receive fast approvals 
  • Automatically renew previous prior authorizations
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REFERENCES:

  1. WELLBUTRIN XL (bupropion hydrochloride extended-release) Prescribing Information. Bausch Health Companies Inc.
  2. U.S. Food and Drug Administration. Approval letter, NDA 21-515. Published August 28, 2003. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21515ltr.pdf. Accessed September 25, 2024.
  3. US Patent 6096341.
  4. US Patent 6143327.
  5. Straka RJ, Keohane DJ, Liu LZ. Potential clinical and economic impact of switching branded medications to generics. Am J Ther. 2017;24(3):e278-e289.
  6. Brown T. Inactive ingredients in medications cause trouble for some. https://www.medscape.com/viewarticle/910411. Accessed October 14, 2024.
  7. U.S. Food and Drug Administration. Size, shape, and other physical attributes of generic tablets and capsules. Published October 2022. https://www.fda.gov/media/161902/download. Accessed September 30, 2024.