Caplyta dosage, forms, and strengths

Caplyta (lumateperone) is a prescription oral atypical antipsychotic medication. Caplyta is made by Intra-Cellular Therapies, Inc, and it is approved by the Food and Drug Administration (FDA) for the treatment of both schizophrenia and bipolar depression. Caplyta is an oral capsule taken once a day, every day, with or without food.

Caplyta forms and strengths

• Capsule: 10.5 mg, 21 mg, 42 mg

Caplyta dosage for adults

Caplyta is approved for the treatment of schizophrenia and depression associated with bipolar disorder in adults. The recommended dosage of Caplyta and the standard dose of Caplyta are the same. Titration is not needed.

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Caplyta dosage for children

The safety and efficacy of Caplyta has not been established in children. Like other atypical antipsychotics, Caplyta is required to have a boxed warning because it can increase the occurrence of suicidal thoughts or depression, especially in children and even young adults. Anyone taking Caplyta should be monitored for worsening depression and suicidal ideation, as these can lead to an increased risk of death. Seek help immediately for anyone in whom these symptoms seem to arise.

Caplyta dosage restrictions

Caplyta can be used in older adults. However, if a patient has dementia-related psychosis, they should not use Caplyta.

Dosage adjustments are not necessary for renally impaired patients.

If patients are on certain medications that are moderate or strong CYP 3A4 inhibitors, the manufacturer’s dosage recommendations state to take 10.5 mg of Caplyta daily. Caplyta drug interactions with 3A4 inhibitors work to increase available levels of Caplyta, which is why the recommended dose is decreased.

For patients who have moderate to severe hepatic impairment, a dosage adjustment for Caplyta is recommended. Liver impairment is classified based on the Child-Pugh rating, and Child-Pugh class B or C would require a dose adjustment of Caplyta down to 21 mg once daily. If you have a history of liver problems, speak to your healthcare provider about this before starting Caplyta.

How to take Caplyta

It is important to take Caplyta exactly as prescribed by your healthcare provider. Read the medication guide accompanying your prescription and take it as directed on the prescription label.

• Take Caplyta orally once daily at your prescribed dose, with or without food.

• Your healthcare provider may also recommend weight control activities such as diet and exercise and frequent medical tests.

• Caplyta capsules should be stored at room temperature and away from heat and moisture.

• Do not drive or operate machinery until you know how Caplyta will affect you. Caplyta can impair your motor skills.

• Avoid becoming too hot or dehydrated while taking Caplyta

  • Avoid excessive exercise

  • Stay out of the direct sun and avoid extreme heat

  • Avoid wearing too much clothing

  • Drink plenty of water

• The most common adverse reactions include nausea, dizziness, and drowsiness. Tell your prescriber if you experience these effects and they are too bothersome.

Caplyta is associated with some severe adverse events. You may experience metabolic changes, weight gain, increased blood pressure, and an increased risk of diabetes mellitus. There is also an increased risk of stroke. Your healthcare provider may not prescribe Caplyta for you if you have a history of leukopenia, a history of cerebrovascular disease, a history of seizures, or a previous diabetes mellitus diagnosis. These patient populations may require close medical supervision while taking Caplyta.

Caplyta dosage FAQs

How long does it take Caplyta to work?

In studies where symptoms of depression and schizophrenia were measured at baseline and regular intervals after starting Caplyta, improvements were seen as soon as one week. Improvements continued to occur up to the 6-week mark. Caplyta dosing does not have to be titrated as with other antidepressant or antipsychotic medication therapy, but it does take up to 6 weeks to see the full effect. If you have yet to see significant improvement at the six-week mark, do not stop Caplyta; seek medical advice from your provider.

How long does Caplyta stay in your system?

The half-life of Caplyta is 18 hours, and in most patients, it takes the time equivalent to 4 to 5 half-lives to eliminate the majority of a drug from the body. Caplyta will remain present and detectable in the body for 3 or more days after the last dose.

What happens if I miss a dose of Caplyta?

You should take a missed dose as soon as you remember. However, you should skip the missed dose if it is almost time for the next dose. You should not take a double dose.

How long can you take Caplyta?

Caplyta is a long-term treatment for bipolar depression or schizophrenia. You may experience some common side effects with Caplyta, such as dry mouth, nausea, dizziness, and drowsiness. These should improve or become more tolerable with time. If they continue to be bothersome, or if you have a more serious side effect, you should speak to your healthcare provider about your options. Do not stop taking Caplyta without first talking to your healthcare provider. More serious side effects may include feeling unsteady, uncontrolled muscle movements, tightness in your neck or throat, weight gain, or high blood sugar. Caplyta may also cause seizures, high blood pressure, or low white blood cells. Speak to your prescriber or pharmacist immediately if you experience any of these. 

How do I stop taking Caplyta?

You should not stop taking Caplyta suddenly without speaking with your healthcare provider. If you are experiencing a life-threatening allergic reaction, seek medical help immediately. This medical emergency includes hives with your lips, tongue, or airway swelling. If stopping Caplyta treatment or transitioning to another medication, your healthcare professional will taper the dose down to minimize side effects and withdrawal symptoms. They will guide you in a dose reduction in the smallest possible increments over a period of time. At the same time, they may be tapering your dose of another medication upwards. You can help your prescriber during this time by keeping a log or diary of effects. Withdrawal effects can range from mild nausea and increased sweating to confusion and hallucinations. The risk of withdrawal symptoms increases with the amount of time you have been taking the drug.

What is the maximum dosage for Caplyta?

The maximum dosage of Caplyta is 42 mg once daily. This is also the starting dose. Caplyta does not require titrating up.

Can you overdose on Caplyta?

Your Caplyta daily dose should not exceed 42 mg. A toxic dose has not been established. Taking too much Caplyta would be expected to cause an increase in sedation and somnolence. It could lead to a higher likelihood of serious adverse events such as high blood sugar (diabetes), uncontrolled muscle movements (tardive dyskinesia), or neuroleptic malignant syndrome (NMS). 

What interacts with Caplyta?

Metoclopramide is contraindicated with Caplyta, and the two medications should not be prescribed or taken together. Concomitant use should be avoided as the combined effect can lead to tardive dyskinesia or other extrapyramidal symptoms (EPS). Inducers of the hepatic enzyme CYP3A4 could decrease lumateperone levels. Examples of strong CYP3A4 inducers are phenytoin and phenobarbital. Strong CYP3A4 inhibitors can increase lumateperone levels. Examples of 3A4 inhibitors are antifungal medications such as ketoconazole or potent antibiotics like clarithromycin and erythromycin. 

What happens when you mix Caplyta and alcohol?

Alcohol can cause liver impairment, especially if consumed at high levels or consistently. This would necessitate a dose adjustment in Caplyta if there is evidence of liver disease. Alcohol, in general, should be avoided in patients who are experiencing symptoms of bipolar depression or schizophrenia, as alcohol consumption can make the symptoms and disorder worse. This can include a worsening of depression and mood or suicidal thoughts and behavior.

Is it safe to take Caplyta during pregnancy?

The use of Caplyta may interfere with fertility and reproductive health in both men and women. It may be more difficult to become pregnant when taking Caplyta. There is no available data on the risk to an unborn fetus when the mother is consuming Caplyta. As with other antipsychotic and antidepressant medications, the risk of the untreated disease must be weighed against the largely unknown risks to the baby. It is known that Caplyta crosses into the breastmilk, but the effects on a newborn child are unknown. There are other antipsychotic drugs, such as olanzapine and quetiapine, which have more data for safety available in regards to taking while breastfeeding. Your prescriber may consider a different treatment option if you choose to breastfeed.

Sources

• Indications in Bipolar Depression - CAPLYTA® (lumateperone), www.caplytahcp.com (2024)

• Caplyta: Uses, Dosage, Side Effects & Warnings, www.drugs.com (2023)

• DailyMed - CAPLYTA- lumateperone capsule, www.dailymed.nlm.nih.gov (2023)

• Primary Efficacy - CAPLYTA® (lumateperone), www.caplytahcp.com (2024)

• A Method for Tapering Antipsychotic Treatment That May Minimize the Risk of Relapse, Schizophr Bull (2021)

• Lumateperone tosylate, A Selective and Concurrent Modulator of Serotonin, Dopamine, and Glutamate, in the Treatment of Schizophrenia, Health Psychol Res (2021)