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ONE Treatment for TWO Types of Depression

APLENZIN is a prescription medicine used to treat adults with a certain type of depression called major depressive disorder, and for the prevention of autumn-winter seasonal depression (seasonal affective disorder).1

ONE APLENZIN, Once a Day, Steady 24-Hour Coverage

APLENZIN is a tablet that comes in 3 dosage strengths1

Aplenzin Pill 174 mg.

174 mg

Aplenzin Pill 348 mg.

348 mg

Aplenzin Pill 522 mg.

522 mg

Graphic representation of APLENZIN. Not actual size.

For any dose of APLENZIN your doctor prescribes, you will only have to take 1 tablet, 1 time per day.1

APLENZIN features a patented technology called SmartCoatTM, which allows for a steady release of each APLENZIN tablet in your body over 24 hours.1-3 This means a consistent level of the active ingredient is available in the body and typically will not wear off over the course of each day.

Stay on Track With APLENZIN

Prescription Pad.

It is important to take APLENZIN exactly as prescribed by your doctor.

  • Swallow APLENZIN tablets whole. Do not crush, divide, or chew them1
  • Do not change the dose or stop taking APLENZIN unless advised by
    the prescribing doctor1
  • Do not take an extra tablet to make up for a missed dose. Wait to take the next tablet at the regularly scheduled time (the next day) 1
Sun.

APLENZIN is taken once a day, in the morning, with or without food. It is important to remember to take the prescribed dose of APLENZIN at the same time each day.1

  • Make taking APLENZIN part of your daily morning routine (ie, with breakfast or after brushing your teeth) and try to take it at the same time each morning
  • Set a reminder on your phone or other electronic device
  • Use a weekly pillbox
 

Reasons Why APLENZIN May Be for You

APLENZIN had a well-established safety profile

In clinical trials, APLENZIN was generally well-tolerated. >90% of study participants stayed on treatment.1,4*

*Based on 376 patients taking 300 mg/day of bupropion hydrochloride sustained-release in MDD and 537 patients on bupropion hydrochloride extended-release in SAD; compared with 96% of 385 patients on placebo in MDD trials and 95% of 511 patients on placebo in SAD trials.1,4

Common side effects that may be experienced during treatment with APLENZIN include1:

  • Trouble sleeping
  • Feeling anxious
  • Stuffy nose
  • Nausea
  • Dry mouth
  • Constipation
  • Dizziness
  • Joint aches
  • Trouble sleeping
  • Feeling anxious
  • Stuffy nose
  • Nausea
  • Dry mouth
  • Constipation
  • Dizziness
  • Joint aches
Calendar.

Often some of the common side effects of antidepressants may go away after the first few weeks of treatment.5,6

Two speech bubbles.

Talk to your doctor if you experience any side effects. Your doctor may be able to help manage them.5,6

APLENZIN had a low frequency of causing weight gain*

Weight gain is a common side effect of commonly prescribed antidepressants but was not common in clinical trials with APLENZIN.1,11-15

Clinical trials were done using bupropion hydrochloride (HCl). APLENZIN is bioequivalent to bupropion HCl, which generally means they work the same way.1,8,10

Weight gain and loss during clinical trials in MDD1

  • Patients on 300 mg daily

    (equal to 348 mg/day of APLENZIN)

    Up arrow Down arrow.
  • Patients on 400 mg daily

    (equal to 464 mg/day of APLENZIN)

    Up arrow Down arrow.

*APLENZIN is not indicated for weight loss.

APLENZIN had a low frequency of causing sexual side effects

In clinical trials, orgasm dysfunction was another common side effect of many antidepressants but was not common with APLENZIN.11-16

MDD, major depressive disorder;
SAD, seasonal affective disorder.

There Is Only ONE APLENZIN

APLENZIN is a brand name drug in the bupropion family of antidepressants. Bupropion is the active ingredient in APLENZIN.1

The other commonly prescribed bupropion is bupropion hydrochloride (HCl), which has many different generics available.7 The table takes a closer look at the differences between the 2 drugs.

  APLENZIN1,7 Bupropion HCI7
Active ingredient bupropion bupropion
Salt (inactive ingredient) hydrobromide hydrochloride
Generics available NO YES
Copay Savings Program YES NO
Why stay with APLENZIN?

While APLENZIN does not have a generic equivalent, some pharmacists may consider it to be the same as bupropion HCl. This may result in them substituting an APLENZIN prescription with bupropion HCl.

ONE APLENZIN Many different bupropion HCl generics

Aplenzin pill 522 mg and generic bupropion HCl pills.
Aplenzin pill 522 mg and generic bupropion HCl pills.

Graphic representation of APLENZIN and generic versions of bupropion HCl. Not actual size.

  • Generic versions of bupropion HCl may have different inactive ingredients.8 Inactive ingredients do not affect how well the medicine works, but they may cause different side effects8,9
  • With each monthly refill of a generic bupropion HCl, you could receive a generic from a different drug manufacturer. This means getting a pill each month that could look, smell, and taste different from the pill you had the month before8,10
  • If your pharmacist substitutes APLENZIN with a generic bupropion HCl, you may end up having to take more than 1 pill per day, depending on the dosage strengths available at the pharmacy. This could result in having to pay more than 1 copay
When your doctor writes DAW1 (dispense as written) on your APLENZIN prescription, ensure that the pharmacist fills it for APLENZIN. This way you will get the same brand name medicine each month and, if you are an eligible* commercially insured patient, you may be able to save with the APLENZIN Copay Savings Program.
*Maximum benefits apply. Additional terms and conditions apply. For full eligibility requirements, please see Savings tab above.

Ask for APLENZIN

There are steps you can take to help ensure your pharmacist fills your prescription for APLENZIN and doesn’t substitute the prescription for a generic bupropion HCl.

Step 1.

Ask your doctor to write DAW1 or “brand medically necessary” on the prescription. DAW1 means “dispense as written.”

Step 2.

Let your pharmacy know that you and your doctor want the prescription to be filled with APLENZIN and not substituted with a generic bupropion HCl.

Step 3.

Click here to find out if you are eligible* to enroll in the Copay Savings Program. If eligible, enroll in the Copay Savings Program prior to picking up your prescription. Bring your Copay Savings Card with you to the pharmacy when you pick up your prescription so that you can get your savings.

Step 4.

Check your prescription before leaving the pharmacy. APLENZIN is a white to off-white round tablet with “BR” and the dose strength shown on the tablet.1

*Maximum benefits apply. Additional terms and conditions apply. For full eligibility requirements, please see Savings tab above.

*Maximum benefits apply. Additional terms and conditions apply. For full eligibility requirements, please see Savings tab above.

Questions to Ask Your Doctor or Pharmacist

For your doctor

Doctor.
  • Who from your office can help me find out if my insurance company will cover brand name APLENZIN?
  • Will you write my prescription for APLENZIN so that the pharmacist knows not to substitute with a generic bupropion HCl?

For your pharmacist

Pharmacist.
  • Am I set up in your system to automatically receive APLENZIN? If not, can I please have that updated?
  • Will you ask me before substituting the brand name with a generic?
If you find your APLENZIN has been substituted with a generic bupropion HCl, ask to talk to your doctor to confirm he or she authorized this substitution.

REFERENCES:

  1. APLENZIN (bupropion hydrobromide extended-release) Prescribing Information. Bausch Health Companies Inc.
  2. U.S. Securities and Exchange Commission (SEC). Biovail 2006 Annual Report. https://www.sec.gov/Archives/edgar/data/885590/000104746907002355/a2176855zex-99_1.htm. Accessed June 15, 2020.
  3. US Patent 7671094 B2.
  4. Modell JG, Rosenthal NE, Harriett AE, et al. Seasonal affective disorder and its prevention by anticipatory treatment with bupropion XL. Biol Psychiatry. 2005;58(8):658-667.
  5. Mayo Clinic. Bupropion (oral route). https://www.mayoclinic.org/drugs-supplements/bupropion-oral-route/description/drg-20062478. Accessed June 15, 2020.
  6. InformedHealth.org. Depression: how effective are antidepressants? https://www.ncbi.nlm.nih.gov/books/NBK361016/?report=printable. Accessed June 15, 2020.
  7. U.S. Food & Drug Administration. Drugs@FDA: FDA-Approved Drugs. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm. Accessed June 15, 2020.
  8. 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.
  9. Brown T. Inactive ingredients in medications cause trouble for some. Medscape. https://www.medscape.com/viewarticle/910411. Accessed June 15, 2020.
  10. Peters JR. From our perspective: the importance of the physical characteristics of generic drug. U.S. Food & Drug Administration. https://www.fda.gov/drugs/newsevents/ucm471446.htm. Accessed June 15, 2020.
  11. Ashton AK, Jamerson BD, Weinstein WL, Wagoner C. Antidepressant-related adverse effects impacting treatment compliance: results of a patient survey. Curr Ther Res Clin Exp. 2005;66(2):96-106.
  12. Kelly K, Posternak M, Alpert JE. Toward achieving optimal response: understanding and managing antidepressant side effects. Dialogues Clin Neurosci. 2008;10(4):409-418.
  13. Fortney JC, Pyne JM, Edlund MJ, et al. Reasons for antidepressant nonadherence among veterans treated in primary care clinics. J Clin Psychiatry. 2011;72(6):827-834.
  14. Hu XH, Bull SA, Hunkeler EM, et al. Incidence and duration of side effects and those rated as bothersome with selective serotonin reuptake inhibitor treatment for depression: patient report versus physician estimate. J Clin Psychiatry. 2004;65(7):959-965.
  15. Gelenberg AJ, Freeman MP, Markowitz JC, et al. Practice guideline for the treatment of patients with major depressive disorder (revision). American Psychiatric Association. Am J Psychiatry. 2000;157(4 suppl):1-45.
  16. Clayton AH, Croft HA, Horrigan JP, et al. Bupropion extended release compared with escitalopram: effects on sexual functioning and antidepressant efficacy in 2 randomized, double-blind, placebo-controlled studies. J Clin Psychiatry. 2006;67(5):736-746.

INDICATION

APLENZIN® (bupropion hydrobromide extended-release tablets) is a prescription medicine used to treat adults with a certain type of depression called major depressive disorder, and for the prevention of autumn-winter seasonal depression (seasonal affective disorder).

IMPORTANT SAFETY INFORMATION

WARNING: CHANGES IN THINKING AND BEHAVIOR, DEPRESSION, AND SUICIDAL THOUGHTS OR ACTIONS

Suicidal Thoughts or Actions and Antidepressant Drugs

Antidepressants may increase the risk of suicidal thoughts or actions in some children, teenagers, or young adults within the first few months of treatment. Depression or other serious mental illnesses are the most important causes of suicidal thoughts and actions. People who have (or have a family history of) bipolar illness or suicidal thoughts or actions may have a particularly high risk. Pay close attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings. Call your healthcare provider right away if symptoms such as anxiety, irritability, impulsivity, trouble sleeping, aggressive behavior or suicidal thoughts are new, worse or worry you. APLENZIN has not been evaluated for use in patients under the age of 18.

Call your healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you:

  • thoughts about suicide or dying
  • attempts to commit suicide
  • new or worse depression
  • new or worse anxiety
  • feeling very agitated or restless
  • panic attacks
  • trouble sleeping (insomnia)
  • new or worse irritability
  • acting aggressive, being angry, or violent
  • acting on dangerous impulses
  • an extreme increase in activity and talking (mania)
  • other unusual changes in behavior or mood

Although APLENZIN is not a treatment for quitting smoking, it contains the same active ingredient (bupropion) as ZYBAN which is used to help patients quit smoking.

Some people have had serious side effects while taking bupropion to help them quit smoking, including:

New or worse mental health problems, such as changes in behavior or thinking, aggression, hostility, agitation, depression, or suicidal thoughts or actions. Some people had these symptoms when they began taking bupropion, and others developed them after several weeks of treatment, or after stopping bupropion. These symptoms happened more often in people who had a history of mental health problems before taking bupropion than in people without a history of mental health problems.

Stop taking APLENZIN and call your healthcare provider right away if you, your family, or caregiver notice any of these symptoms. Work with your healthcare provider to decide whether you should continue to take APLENZIN. In many people, these symptoms went away after stopping APLENZIN, but in some people symptoms continued after stopping APLENZIN. It is important for you to follow-up with your healthcare provider until your symptoms go away.

Before taking APLENZIN, tell your healthcare provider if you have ever had depression or other mental health problems. You should also tell your healthcare provider about any symptoms you had during other times you tried to quit smoking, with or without bupropion.

What Other Important Information Should I Know About APLENZIN?

  • Seizures: There is a chance of having a seizure (convulsion, fit) with APLENZIN, especially in people with certain medical problems or who take certain medicines. Do not take any other medicines while you are taking APLENZIN unless your healthcare provider has said it is okay to take them. If you have a seizure while taking APLENZIN, stop taking the tablets and call your healthcare provider right away.
  • High blood pressure (hypertension): Some people get high blood pressure, which can be severe, while taking APLENZIN.
  • Manic episodes: Some people may have periods of mania while taking APLENZIN. If you have any of the following symptoms of mania, call your healthcare provider:
    • greatly increased energy
    • severe trouble sleeping
    • racing thoughts
    • reckless behavior
    • unusually grand ideas
    • excessive happiness or irritability
    • talking more or faster than usual
  • Unusual thoughts or behaviors: Some patients may have unusual thoughts or behaviors while taking APLENZIN, including delusions (e.g. believe you are someone else), hallucinations (seeing or hearing things that are not there), paranoia (feeling that people are against you), or feeling confused. If this happens to you, call your healthcare provider.
  • Visual problems: Some people are at risk of glaucoma if they take APLENZIN. You should see an eye doctor to determine whether you are at risk prior to starting therapy. If you experience any of the following symptoms you should see an eye doctor:
    • eye pain
    • changes in vision
    • swelling or redness in or around the eye
  • Severe allergic reactions: Some patients have severe allergic reactions to APLENZIN. Stop taking APLENZIN and call your healthcare provider right away if you get a rash, itching, hives, fever, swollen lymph glands, painful sores in the mouth or around the eyes, swelling of the lips or tongue, chest pain, or have trouble breathing. These could be signs of a serious allergic reaction.

Do not take APLENZIN if you:

  • have or had a seizure disorder or epilepsy.
  • have or had an eating disorder such as anorexia nervosa or bulimia.
  • are taking any other medicines that contain bupropion, including WELLBUTRIN, WELLBUTRIN SR, WELLBUTRIN XL, ZYBAN, or FORFIVO XL. Bupropion is the same active ingredient that is in APLENZIN.
  • drink a lot of alcohol and abruptly stop drinking, or use medicines called sedatives (these make you sleepy), benzodiazepines, or anti-seizure medicines, and you stop using them all of a sudden.
  • take a monoamine oxidase inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid.
    • do not take an MAOI within 2 weeks of stopping APLENZIN unless directed to do so by your healthcare provider.
    • do not start APLENZIN if you stopped taking an MAOI in the last 2 weeks unless directed to do so by your healthcare provider.
  • are allergic to the active ingredient in APLENZIN, bupropion, or to any of the inactive ingredients.

Although APLENZIN is not a treatment for quitting smoking, it contains the same active ingredient (bupropion) as ZYBAN, which is used to help patients quit smoking. Before taking APLENZIN, tell your healthcare provider if you have ever had depression, suicidal thoughts or actions, or other mental health problems or any symptoms you had during other times you tried to quit smoking with or without bupropion. Also, tell your healthcare provider about your other medical conditions, including if you:

  • have liver problems, especially cirrhosis of the liver.
  • have kidney problems.
  • have, or have had, an eating disorder such as anorexia nervosa or bulimia.
  • have had a head injury.
  • have had a seizure (convulsion, fit).
  • have a tumor in your nervous system (brain or spine).
  • have had a heart attack, heart problems, or high blood pressure.
  • are a diabetic taking insulin or other medicines to control your blood sugar.
  • drink alcohol.
  • abuse prescription medicines or street drugs.
  • are pregnant or plan to become pregnant.
  • are breastfeeding. APLENZIN passes into your milk in small amounts.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Many medicines increase your chances of having seizures or cause other serious side effects if you take them while you are using APLENZIN.

APLENZIN may cause serious side effects. The most common side effects of APLENZIN include: trouble sleeping, stuffy nose, dry mouth, dizziness, feeling anxious, nausea, constipation, and joint aches.

Read the Medication Guide carefully before you start using APLENZIN. If you have any questions about APLENZIN, ask your healthcare provider or pharmacist.

Click here for full Prescribing Information including Medication Guide and Boxed Warning regarding suicidal thoughts and actions.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. You may also contact Bausch Health Customer Service at 1-800-556-1937.

INDICATION

APLENZIN® (bupropion hydrobromide extended-release tablets) is a prescription medicine used to treat adults with a certain type of depression called major depressive disorder, and for the prevention of autumn-winter seasonal depression (seasonal affective disorder).

IMPORTANT SAFETY INFORMATION

WARNING: CHANGES IN THINKING AND BEHAVIOR, DEPRESSION, AND SUICIDAL THOUGHTS OR ACTIONS

Suicidal Thoughts or Actions and Antidepressant Drugs

Antidepressants may increase the risk of suicidal thoughts or actions in some children, teenagers, or young adults within the first few months of treatment. Depression or other serious mental illnesses are the most important causes of suicidal thoughts and actions. People who have (or have a family history of) bipolar illness or suicidal thoughts or actions may have a particularly high risk. Pay close attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings. Call your healthcare provider right away if symptoms such as anxiety, irritability, impulsivity, trouble sleeping, aggressive behavior or suicidal thoughts are new, worse or worry you. APLENZIN has not been evaluated for use in patients under the age of 18.