Vraylar

The active ingredient in Vraylar is Cariprazine Hydrochloride. It modulates serotonin and dopamine levels in the brain by acting as both a partial agonist and antagonist at certain receptors making your moods more stable.

The medication improves depressive symptoms and depressive episodes in MDD, psychiatric signs and symptoms in schizophrenia, and is for short-term acute treatment of manic or mixed episodes that happen with bipolar I disorder.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Vraylar. However, the following is a synopsis of the general guidelines for the use of Vraylar:

• Take Vraylar once a day, with or without food.
• It may be several weeks before your symptoms improve. Continue taking the medication as prescribed, and notify your doctor if your symptoms do not improve.
• High doses or long-term usage of Vraylar can result in a severe mobility problem that may be irreversible. The longer you use this medication, the more likely you are to acquire this disorder, especially if you are an elderly person. This disorder's symptoms include tremors and other involuntary muscle movements.
• Tell your doctor if you notice any weight changes while using this medication.
• Your blood pressure and heart rate will need to be monitored frequently. You may also need regular blood testing.

The most common side effects of Vraylar seen in clinical trials include:

• Sleepiness.
• Nausea or vomiting.
• Indigestion or constipation.
• Feeling tired and having trouble sleeping.
• Increased appetite.
• Dizziness.
• Involuntary muscle movements or restlessness - the need to move around (akathisia).
• Upset stomach.

Some individuals may experience serious side effects while using Vraylar. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Increased risk of death from heart problems, stroke, or infections in older adults with dementia-related psychosis.
• Neuroleptic Malignant Syndrome (NMS): High fever, sweating, disorientation, stiffness, and blood pressure abnormalities.
• Extremely elevated blood sugar levels: feeling excessively hungry or thirsty, urinating more frequently, stomach pain, weakness, and fruity-smelling breath.
• Uncontrolled muscular movements (tardive dyskinesia or extrapyramidal symptoms - EPS): unintentionally thrusting out your tongue, puffing out your cheeks, puckering your mouth, lip smacking, chewing, and tapping.
• Suicidal thoughts or worsening depression behaviors.
• Trouble controlling your body temperature.
• Seizures.
• Dizzy or fainting spells resulting in falls.

-Disclaimer: These are not all of the possible side effects of Vraylar. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Vraylar, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including if you have:

• Vraylar may disrupt the body's ability to regulate core body temperature, increasing risks during strenuous exercise, extreme heat, dehydration, or when using anticholinergic medications.
• Vraylar (cariprazine), like other atypical antipsychotic drugs, can cause metabolic changes that cause weight gain.
• High blood sugar: Increases in blood sugar can happen in some people who take Vraylar.
• Do not use Vraylar if you are allergic to cariprazine.
• Assess fasting plasma glucose before or soon after initiation of antipsychotic medication and monitor periodically during long-term treatment.
• Taking Vraylar during the last three months of pregnancy may cause withdrawal symptoms or health issues in the newborn; consult your healthcare provider if pregnant.

Inform your doctor if you have a history of:

• Heart disease or high blood pressure.
• Stroke or blood clots.
• High cholesterol or triglycerides.
• Liver or kidney disease.
• Diabetes or a family history of diabetes.
• Low white blood cell count.
• Seizures or convulsions.
• Dehydration.
• Do not stop taking Vraylar without consulting your doctor.

Boxed Warning

• Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death and Vraylar is not approved to treat this indication.
• Vraylar and antidepressants may increase suicidal thoughts or actions in children and young adults, especially during initial treatment or dose changes. Closely monitor all people on these medications for worsening symptoms or any suicidal thoughts and behaviors.

You should not take this medication if you are allergic to cariprazine or any inactive ingredients in the formulation. Also, doctors typically won't recommend that people with severe kidney or liver problems take the drug.

It can take at least three weeks to notice a difference in symptoms after taking Vraylar, but it can take eight weeks or more to feel the full effect. Working time is determined by several factors, including:

Symptoms under treatment: The speed with which Vraylar begins to operate is determined by the symptoms for which it is prescribed. For example, patients with schizophrenia may have improvement in 1-2 weeks, whereas those with bipolar I illness may see recovery after 3 weeks.

The longer you follow your treatment plan, the more beneficial the drug will be.

When Vraylar is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Antibiotics such as erythromycin (Eryc, EryPed, others).
• Anti-fungal drugs such as itraconazole (Sporanox, Tolsura), ketoconazole (Nizoral), posaconazole (Noxafil), voriconazole (Vfend).
• HIV medications.
• Seizure medications such as carbamazepine (Carbatrol, Tegretol, others), phenytoin (Dilantin, Phenytek), oxcarbazepine (Oxtellar XR, Trileptal).
• Antidepressants such as bupropion (Wellbutrin SR, Wellbutrin XL, others), venlafaxine (Effexor XR), citalopram (Celexa), and nefazodone.
• Rifabutin.
• Certain cancer medications.

For schizophrenia and bipolar mania, the typical starting dose for Vraylar (cariprazine) is 1.5 mg taken orally once daily. Your psychiatrist may increase your dose after a few days. The normal dose range is 1.5 mg to 6 mg once daily.

Bipolar depression and MDD: The typical starting dose is 1.5 mg taken orally once a day. Your psychiatrist may increase your dose after two weeks. The normal dose range is 1.5 mg to 3 mg once daily.

Store in a cool dry place, at room temperature as well as out of the reach of children.

AbbVie and Gedeon Richter Plc jointly developed Vraylar (cariprazine).

No, currently there is no generic version of Vraylar available in the U.S.

Stopping Vraylar medication may cause your symptoms to return or worsen. If a person's symptoms worsen, they may require hospitalization. Always consult with your healthcare provider for additional information before changing or discontinuing any treatment.

Vraylar (cariprazine) should not be used during pregnancy due to potential risks to the unborn baby. Animal studies indicate that Vraylar may cause fetal harm. Additionally, babies born to mothers who used Vraylar in the last three months of pregnancy may experience symptoms such as muscle stiffness or shakiness, drowsiness, feeding or breathing difficulties, and constant crying. Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you.

There is no data on whether Vraylar passes into breast milk or its effects on milk production. The InfantRisk Center advises against its use during breastfeeding due to potential adverse effects in infants, including extrapyramidal and withdrawal symptoms, agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorders. If you are breastfeeding or planning to breastfeed, consult your doctor to discuss whether Vraylar is suitable for you and to develop an appropriate treatment or feeding plan.