About LATUDA

Why LATUDA?

Latuda® (lurasidone HCl) is a once-a-day prescription medicine FDA-approved to treat bipolar depression in adults and children (10 to 17 years). And, in clinical studies, LATUDA was effective for people struggling with bipolar depression.

“Can LATUDA help reduce my symptoms of bipolar depression?”

LATUDA is the first FDA-approved medication for bipolar depression that can either be taken on its own by children (10 to 17 years) and adults or as part of a treatment plan along with a mood-stabilizer, either lithium or valproate, by adults. In clinical studies of adults and children (10 to 17 years) LATUDA was effective in reducing symptoms of bipolar depression.

Adults taking LATUDA alone

44% reduction in depressive symptoms 44 percent

reduction
in depressive symptoms
vs. placebo

Adults taking LATUDA alone reported a 44% reduction in their depressive symptoms versus placebo

Children taking LATUDA alone

37% reduction in depressive symptoms 37 percent

reduction
in depressive symptoms
vs. placebo

Children (10 to 17 years) reported a 37% reduction in their symptoms versus placebo

Adults taking LATUDA with a mood stabilizer* reported a 27% reduction in their depressive symptoms versus placebo
*Mood stabilizer: lithium or valproate

In studies, adults who took LATUDA alone demonstrated improved scores in...

“What are the most common side effects?”

When you are starting any medication, it's very important for you to understand the side effects and benefits of that medicine. Talk to your doctor and ask any questions you need answered.

In clinical studies, the most common side effects with LATUDA included:

Adult icon

Adults treated
with LATUDA:

  • restlessness

  • difficult or slow movement

  • sleepiness or drowsiness

Children and teens
(10 to 17 years) taking LATUDA:

  • nausea

  • weight gain

  • problems sleeping

children and teens icon

It's important for you to talk to your doctor and to keep talking to your doctor. From explaining the benefits of your medicine to understanding possible side effects, your doctor is your best resource. Should you experience anything out of the ordinary, talk to your doctor. 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.

Weight change reported in clinical trials

No substantial impact on weight

95% of adults taking LATUDA saw no clinically meaningful impact on weight (defined as a ≥7% change at 6 weeks). Weight gain may occur. You and your doctor should monitor your weight regularly.

Average weight change at week 6

No substantial impact on weight for monotherapy No substantial impact on weight LATUDA 20 60 mg No substantial impact on weight LATUDA 80 120 mg

Week 24

No substantial impact on weight LATUDA 20 120 mg week 24

No substantial impact on weight

95% of adults taking LATUDA saw no clinically meaningful impact on weight (defined as a ≥7% change at 6 weeks). Weight gain may occur. You and your doctor should monitor your weight regularly.

Average weight change at week 6

No substantial impact on weight for adjunctive therapy No substantial impact on weight LI VPA week 6

Week 24

No substantial impact on weight LI VPA week 24

Average weight change at week 6

weight change for peds_PLACEBO weight change for peds_LAT
  • Data are from adult patients who received LATUDA in the short-term study and continued in the 24-week, uncontrolled, open-label extension study. Patients were flexibly dosed based on response to treatment after completing the initial 6-week, double-blind studies

What to remember when taking LATUDA

The first thing you need to do is talk to your doctor who has worked with you to determine the right strength to help you. And it's important that you continue to stay in contact throughout the journey.

Medication icon

Stick with it.

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Stick with it.

Be patient. For some people, LATUDA may work gradually.

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hydration icon

Keep cool and
stay
hydrated.

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Keep cool and
stay
hydrated.

Your temperature may fluctuate when taking LATUDA.

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no alcohol icon

Stay away from alcohol.

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Stay away from alcohol.

Alcohol may worsen any side effects.

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no grapefruit icon

Say “NO” to grapefruit.

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Say “NO” to grapefruit.

Grapefruit can affect the amount of LATUDA in your blood.

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food icon

Eat at least 350 calories
before taking LATUDA.

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Eat at least 350 calories
before taking LATUDA.

Food will help your body absorb LATUDA more efficiently.

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drowsiness icon

Watch out for
drowsiness.

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Watch out for
drowsiness.

It may take time to get used to LATUDA. Be careful when operating machinery.

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Ask for help icon

Ask for help.

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Ask for help.

Talk to your doctor if symptoms worsen.

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Take LATUDA once a day icon

Take LATUDA
once a day.

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Take LATUDA
once a day.

Take LATUDA as your doctor prescribes.

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