Cariprazine

Generic name: Cariprazine
Brand names: Vraylar
Dosage form: capsule (1.5mg, 3mg, 4.5mg)
Drug class: Atypical antipsychotics

Usage of Cariprazine

Cariprazine (Vraylar) is an antipsychotic used to treat schizophrenia, specific types of bipolar I disorder, and as an add-on treatment for major depressive disorder (MDD). Cariprazine is from the drug class atypical antipsychotics.

Cariprazine is thought to work by managing chemicals in the brain (neurotransmitters), including serotonin and dopamine. Although the mechanism of action of cariprazine is unknown, its effect may be from a combination of partial agonist activity at central dopamine D₂ and serotonin 5-HT1A receptors and antagonist activity at serotonin 5-HT2A receptors.

Cariprazine is specifically indicated to treat adults with:

Schizophrenia

Acute manic or mixed episodes associated with bipolar I

Depressive episodes associated with bipolar I disorder (bipolar depression)

Adjunctive treatment with an antidepressant therapy (ADT) for major depressive disorder (MDD).

Cariprazine, under the brand name Vraylar, became an FDA-approved medicine on September 17, 2015.

Cariprazine side effects

Common cariprazine side effects may include:

involuntary muscle movements;

upset stomach, vomiting;

drowsiness; or

feeling restless.

Serious cariprazine side effects

Get emergency medical help if you have signs of an allergic reaction to cariprazine: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

sudden numbness or weakness (especially on one side of the body);

problems with vision or speech,

a light-headed feeling, like you might pass out;

severe distress or agitation;

a seizure;

uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);

trouble swallowing, or accidentally inhaling food or drink;

low white blood cell counts - fever, chills, sore throat, mouth sores, skin sores, sore throat, cough, trouble breathing, feeling light-headed;

high blood sugar - increased thirst, increased urination, dry mouth, fruity breath odor; or

severe nervous system reaction - very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out.

Cariprazine can have long-lasting effects on your body. Some side effects could occur for several weeks after you stop using this medicine. You may also have new side effects whenever your dose is changed.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before taking Cariprazine

You should not use cariprazine if you are allergic to it or any ingredients contained in this medicine. Click here for a full list of Vraylar ingredients

Cariprazine is not approved for use by anyone younger than 18 years old.

To make sure cariprazine is safe for you, tell your doctor if you have:

high cholesterol or triglycerides (a type of fat in the blood);

a stroke or blood clot;

heart disease;

have or had a low white blood cell count;

high blood pressure;

liver or kidney disease;

diabetes;

have or had seizures (convulsions) or

if you are dehydrated.

Pregnancy

Tell your healthcare provider if you plan to become pregnant, are pregnant or become pregnant. Taking cariprazine while pregnant may cause harm to your unborn baby. Taking antipsychotic medicine in the last 3 months of pregnancy may cause withdrawal symptoms, breathing problems, feeding problems, fussiness, tremors, and limp or stiff muscles in the newborn. If you get pregnant, tell your doctor right away. Do not stop taking this medicine without your doctor's advice.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of cariprazine on the baby.

Breastfeeding

It may not be safe to breastfeed while using this medicine. Talk to your healthcare provider about the best way to feed your baby while being treated with cariprazine.

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How to use Cariprazine

Usual Adult Dose for Schizophrenia:

Initial dose: 1.5 mg orally once a day Titration regimen: The dose may be increased to 3 mg once a day on Day 2; further dose adjustments should be made in 1.5 to 3 mg increments based on efficacy and tolerability. Maintenance dose: 1.5 to 6 mg orally once a day Maximum dose: 6 mg/day.

Usual Adult Dose for Bipolar I with Manic or Mixed Episodes:

Initial dose: 1.5 mg orally once a day Titration regimen: The dose should be increased to 3 mg once a day on Day 2; further dose adjustments should be made in 1.5 to 3 mg increments based on efficacy and tolerability. Maintenance dose: 3 to 6 mg orally once a day Maximum dose: 6 mg/day

Usual Adult Dose for Bipolar Depression:

Initial dose: 1.5 mg orally once a day Titration regimen: The dose can be increased to 3 mg once a day on Day 15 based on efficacy and tolerability. Maintenance dose: 1.5 mg to 3 mg orally once a day Maximum dose: 3 mg/day

Usual Adult Dose for Adjunctive Therapy to Antidepressants for MDD:

Initial dose: 1.5 mg orally once a day Titration regimen: The dose can be increased to 3 mg once a day on Day 15 based on efficacy and tolerability. In clinical trials, dosage titration at intervals of less than 14 days resulted in a higher incidence of adverse reactions. Maintenance dose: 1.5 mg to 3 mg orally once a day Maximum dose: 3 mg/day.

General Comments on dosing

Comments:

Due to the long half-life, changes in dose will not be fully reflected in plasma for several weeks; monitor for adverse reactions and treatment response several weeks after beginning therapy and after each dose adjustment.

Doses above 6mg once a day have not shown increased effectiveness sufficient to outweigh dose-related adverse reactions.

Dosage Adjustments will be needed for CYP3A4 Inhibitors and Inducers.

Click the link below for more detailed information on cariprazine dosing.

Warnings

Cariprazine is not approved for use in older adults with dementia-related psychosis. It may increase the risk of death in older adults with dementia-related psychosis and is not approved for this use.

Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients. All antidepressant-treated patients should be closely monitored for clinical worsening and emerging of suicidal thoughts and behaviors. The safety and effectiveness of this medicine have not been established in pediatric patients.

Cariprazine may disrupt the body’s ability to reduce core body temperature. Exposure to extreme heat, strenuous exercise, dehydration, and anticholinergic medications may cause an increase in body temperature. Use this medicine with caution in these circumstances.

What other drugs will affect Cariprazine

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Taking cariprazine with other drugs that make you sleepy or slow your breathing can cause dangerous side effects or death. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Medicines that are strong CYP3A4 Inhibitors or are CYP3A4 Inducers interact with cariprazine, tell your healthcare provider if your are on these medications. Click on the link below to check for interactions with this medicine.

Many drugs can interact with cariprazine. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.

Popular FAQ

Abilify (aripiprazole) and Vraylar (cariprazine) are both classified as atypical antipsychotic medications. They help treat mental health conditions such as schizophrenia, bipolar disorder (also known as manic-depression) and as additive treatment for major depressive disorder. These medicines work by changing the actions of chemicals in the brain to help stabilize your thoughts, actions and moods. Continue reading

Vraylar (cariprazine) takes time to work and patients often see a gradual reduction in symptoms over several weeks. Symptoms tend to continue to improve the longer the medication is taken. Patients with schizophrenia may start to notice an improvement in their symptoms within 1-2 weeks of starting treatment with Vraylar, while those with bipolar I disorder are likely to notice some improvement in symptoms after 3 weeks. Patients who are taking Vraylar as an add on therapy for major depressive disorder should see an improvement in their overall depression symptoms in 6-8 weeks. Continue reading

Most side effects with Vraylar will subside with time after your body has become used to the medicine. However, some side effects can be serious, have long-lasting effects or be irreversible. Speak to your doctor for medical advice if you have side effects that concern you with Vraylar or any other medication. Continue reading

Caffeine is not listed as having a drug interaction with the atypical antipsychotic medicine Vraylar (generic name: cariprazine). However, Vraylar may lead to restlessness, the feeling of the need to move around (akathisia), or trouble with sleeping (insomnia) in some patients. Call a health care provider right away if you or your family member has any of these symptoms while receiving Vraylar. Continue reading

Vraylar (cariprazine), like other atypical antipsychotic drugs, can cause metabolic changes that cause weight gain. However, weight gain is less of a troublesome side effect of Vraylar than it is of some other antipsychotics. Continue reading

Vraylar (cariprazine) is not a controlled drug or substance. It is an atypical antipsychotic. It is used to treat people with schizophrenia, bipolar I disorder, and as an add-on treatment for people with major depressive disorder. Continue reading

Yes, sleepiness or drowsiness can be a common side effect with Vraylar in about 6% to 7% of patients compared to 4% receiving a placebo (inactive) medicine. Continue reading

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