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Medically reviewed by, Russell Braun RPH
Vraylar (Cariprazine) is in a class of drugs called atypical antipsychotics. These drugs help to balance out certain neurotransmitters in the brain, specifically dopamine and acetylcholine.
The drugs are called atypical because they do not produce side effects as frequently as the older “typical” antipsychotic drugs. Atypicals have fewer extrapyramidal side effects, the most common called tardive dyskinesia (TD). Extrapyramidal side effects appear similar to a person with Parkinson’s disease.
What is Vraylar used for?
Vraylar has been approved by the Food and Drug Administration (FDA) to treat schizophrenia and short term manic or mixed mood disorders (depression) associated with bipolar.
Schizophrenia is a mental disorder where people will have hallucinations and seem to lose touch with reality. It is an ongoing disorder that can have symptoms that are disabling in many cases if left untreated.
Vraylar has been shown to decrease hallucinations and help people feel less agitated.
Bipolar is a mental disorder where people swing from highs often called mania to lows that come with severe depression. In the manic phase people feel euphoric and become agitated easily. Often they can be so energized they may not sleep. During the low, people may remove themselves from normal social activities due to being depressed.
These swings can greatly affect peoples lives making it hard for them to keep a job or stay connected with friends and family. Most people with bipolar will not think they need any treatment during the manic phase. However, poor decision making typically tips others off to the disorder.
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Bipolar is a challenge for the patient, family and friends. This workbook is a wonderful guide for all three parties to help manage the disorder and cope with various issues that arise. Many people are amazed at how lifestyle changes that are backed by science can make a significant improvement. The Bipolar Survival Guide is a great resource for anyone dealing with Bipolar.
What you need to know about Vraylar
Vraylar has also been shown to be effective in treating the manic or mixed episodes of bipolar in addition to depression due to bipolar.
Black box warning
Please be aware that Vraylar has a black box warning from the Food and Drug Administration (FDA).
A black box warning is one the FDA makes a manufacturer put on the label of the medication to warn consumers and medical professionals about serious adverse effects a medication can have.
For Vraylar after is was approved for use in the United States the FDA received reports of an increased risk of death when the drug was used for psychosis related to dementia.
Vraylar should not be used in elderly people who have mental changes due to dementia or Alzheimers disease.
#1 How long does it take for Vraylar to kick in?
Both schizophrenia and bipolar disorder can be lifelong mental disorders. In most cases treatment is required. It can take several weeks to determine if Vraylar is completely controlling your symptoms.
Vraylar is a capsule that can be taken once a day with or without food. The normal starting dose can range between 1.5mg to 6mg. Dose adjustments may be required by your doctor to reach the optimal range for you. Because the symptoms are subjective, meaning they can’t be read by a lab or other test, documenting how you feel is very important.
In 5 Reasons to Bullet Journal Medications, I explain how to capture your feelings and side effects both before and during a trial of medication. This can be a very cost effective exercise as nobody wants to pay for an expensive medication that is really not helping them.
Improvements to watch for
During clinical trials, hallucinations and delusional thinking typically improved in one to two weeks after starting Vraylar. Feeling of normalcy where you want to return to social interactions again may also take a few weeks.
You should talk to your doctor about how you are progressing and have your bullet journal notes in hand to help make the best decisions possible. Being patient and waiting on a lower dose to have the full effects can decrease the chance of side effects seen with higher doses.
While symptoms may never completely go away, a typical trial period of 2 to 3 months is when most patients will see benefits from Vralyar.
#2 Does Vraylar make you gain weight?
A small amount of weight gain has been seen in clinical trials with Vraylar. This is consistent with other atypical antipsychotics side effect profile. The studies were over 6 weeks and found patients on placebo (a sugar pill) gained 0.7 pounds and those taking Vraylar gained 2.2 pounds.
The weight gain likely has to do with increases in blood sugar that have been reported with Vraylar. The body takes excess sugar and turns it into fat storage. If you have diabetes or a family history of diabetes, you should talk with your doctor about this prior to starting Vraylar.
When starting Vraylar it is a good idea to monitor your weight before, during and after use of the drug.
#3 Which antipsychotics cause the least weight gain?
Unfortunately, manufacturers of brand name drugs rarely want to study there drugs head to head with other drugs. The fear of their drug being shown to be less effective or cause more side effects could hurt their sales.
Due to this fact, there is no good studies looking at what antipsychotic drug causes the least weight gain. However, one study compared the amount of weight gain with Vralyar vs. placebo compared to other atypical antipsychotics vs. placebo.
The small amount of weight gained with Vraylar vs. placebo compared to other drugs means it should be one of the least likely to cause significant weight gain.
Vraylar is a brand only drug at this time and therefore is very expensive. The cash pay cost for a 30 day supply of Vraylar is $1197 according to GoodRx.
That coms out to $14,364 per year!
Obviously, that is more than most people can afford. Therefore, if your doctor wants you to be on Vraylar, you need to explore all your money saving options.
#5 Is there a generic for Vraylar?
Vraylar is manufactured by Allergan and they brought the drug to the United States market in 2015. Unfortunately, there is no generic available yet.
The expected patent expiration date is March of 2027. Through in typical lawsuits that often surround pharmaceutical patent expiration and it could easily be 2028 before the first generic manufacturer comes out with a less costly version.
You need to confirm with your insurer if Vraylar is on formulary. If it is on formulary is it a preferred medication? The more preferred the lower your copay will be.
While most insurers do cover Vraylar, some may want you to have tried another atypical antipsychotic first, that is lower cost.
Regardless of the formulary status your doctor may still have to complete a prior authorization (PA). A PA is a requirement for approval to pay for a medication by many health insurers. They will require your doctor to complete paperwork to ensure medication is being used properly. Without the PA your insurance will not pay for the medication.
A part of some PA’s is step therapy. Since older atypical antipsychotics are effective and are much lower cost than Vraylar, you insurer may have a step therapy policy in place. They would want to know per your doctor if you had tried and failed some older less expensive medications. Your doctor will need to document this as part of the prior authorization process.
Is Vraylar covered by Medicare?
Most Medicare plans do provide some form of coverage for Vraylar. Medicare Advantage plan almost all cover Vraylar as well. While some will have it as a preferred drug, others might require some form of prior authorization or step therapy.
#7 Therapeutic alternatives
Regardless of your formulary or PA requirements you should ask your doctor about therapeutic alternatives. Much like the insurer may put a step therapy in place, this is you looking out for your wallet.
The table below is a list of atypical antipsychotics. Some are available generically and thus have a must lower cost overall.
|Brand name||Generic name|
Older typical antipsychotic drugs that have generic options available have been shown to have similar effect to the atypicals. They do have risk of extrapyramidal side effects. However, they can be used safely, don’t believe what the manufacturers seem to push, that the side effects of the older medications make them extremely dangerous.
The table below lists some older typical antipsychotics.
Side effects exist for any drug brand or generic. As long as you are documenting your experience with your medication and keeping your doctor informed the side effects can be managed.
What do you do if you discuss therapeutic alternatives to Vraylar, but your doctor still wants you to try it? The next step should be to ask for samples. As with any brand name drug you are prescribed you should always ask for samples. The reason is that the sample will give you a chance to determine if you can tolerate this drug before you actually have to pay for it.
Most doctors who would be treating you for schizophrenia or bipolar disorder should have samples available as the manufacturer is more than willing to provide them.
As discussed previously, bullet journaling medication effects is vital while you have samples available. This will help you determine if you should continue taking Vraylar or ask your doctor for another treatment.
#9 Patient Assistance Programs (PAP’s)
Patient assistance programs are your next step if you are prescribed Vraylar. The PAP program is put on by the Allergan the manufacturer of Vraylar and provides medication at low or no cost.
To qualify for this program you must meet the following criteria:
- A U.S. citizen or legal entrant
- Under insured, meaning your insurance does not cover this drug
- Medicare Part D eligible if you have been denied extra help program
- Able to provide proof of income
You can print the form off of the NeedyMeds.org website. Search under patient savings, and then Vraylar and look for PAP programs. Once you complete the application and income verification you will take the form to your doctor for a signature. A decision may take up to 4 weeks to be processed.
Allergan doesn’t give income limits so it never hurts to apply!
If you do qualify you will be enrolled for a year. After the year is up you have to reapply and provide updated income information.
#10 Copay coupon card
Copay coupon cards are provided by pharmaceutical manufacturers to assist patients with insurance to be able to afford their out of pocket expenses.
That could be a copay, coinsurance or deductible. The Vraylar savings program coupon allows you to pay no more than $15 on each 30 day supply with up to 12 refills.
Important things to remember
- Can’t be used with any form of government insurance such as Medicare or Medicaid.
- You must have commercial insurance to use the program, if you are uninsured this can’t be used.
If you have a high deductible health plan (HDHP) you may have a copay accumulator. What is that you ask?
Copay accumulators are when your insurance tracks how much money you receive from drug manufacturers in the form of copay coupon cards. That amount is NOT applied to your deductible. Meaning you would still have to pay the amount the Vraylar card pays in order to meet your deductible.
This can be a rude awakening if you fill Vraylar several times with a copay coupon card paying the full $1197 price each time. Many people have a very hard time at the pharmacy as they think they have reached their deductible. Only to find out that none of the money spent on Vraylar using this card applies toward the deductible amount!
#11 Medicare Extra Help
For patients who are low income and have tried other ideas provided here, there is another option. Extra help is a federal program that helps patients with Medicare through a low income subsidy.
Extra help is like it’s name implies in addition to your Medicare plan. Therefore, your plans formulary requirements will need to be followed. Click here for more information on the Medicare Extra Help program.
Vraylar is an effective, yet very costly medication to treat schizophrenia and bipolar. Weighing it’s cost and potential for weight gain versus other treatment options will provide the best outcome for you.
Click here to get Dr. Jason Reed’s exclusive list of medication questions you MUST ask your doctor, for FREE!
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Have you tried Vraylar? Also, please share if it helped you? Please chime in below with your comments and thoughts.