Lurasidone Side effects

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• Side effects of Lurasidone in details
• Lurasidone contraindications
• Lurasidone reviews

What are the possible side effects of Lurasidone?

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

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

High doses or long-term use of Lurasidone can cause a serious movement disorder that may not be reversible. Symptoms of this disorder include uncontrollable muscle movements of your lips, tongue, eyes, face, arms, or legs. The longer you take Lurasidone, the more likely you are to develop a serious movement disorder. The risk of this side effect is higher in women and older adults.

Call your doctor at once if you have:

• breast swelling or tenderness, nipple discharge, changes in menstrual periods, vaginal dryness;

• dizziness, fainting, fast or slow heartbeats;

• trouble swallowing;

• seizure (convulsions), uncontrolled muscle movements;

• blood cell disorders - sudden weakness or ill feeling, fever, chills, sore throat, mouth sores, swollen gums, pain when swallowing, skin sores, cold or flu symptoms, cough, trouble breathing;

• high blood sugar - increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss; or

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

Common Lurasidone side effects may include:

• drowsiness;

• nausea;

• feeling restless or being unable to sit still; or

• tremors, muscle stiffness, problems with muscle movement.

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.

Side effects of Lurasidone in details

The following adverse reactions are discussed in more detail in other sections of the labeling:

• Increased Mortality in Elderly Patients with Dementia-Related Psychosis
• Suicidal Thoughts and Behaviors
• Cerebrovascular Adverse Reactions, Including Stroke, in Elderly Patients with Dementia-related Psychosis
• Neuroleptic Malignant Syndrome
• Tardive Dyskinesia
• Metabolic Changes (Hyperglycemia and Diabetes Mellitus, Dyslipidemia, and Weight Gain)
• Hyperprolactinemia
• Leukopenia, Neutropenia, and Agranulocytosis
• Orthostatic Hypotension and Syncope
• Seizures
• Potential for Cognitive and Motor Impairment
• Body Temperature Dysregulation
• Suicide
• Activation of Mania/Hypomania
• Dysphagia
• Neurological Adverse Reactions in Patients with Parkinson's Disease or Dementia with Lewy Bodies

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The information below is derived from an integrated clinical study database for Lurasidone consisting of 3799 patients exposed to one or more doses of Lurasidone for the treatment of schizophrenia and bipolar depression in placebo-controlled studies. This experience corresponds with a total experience of 1250.9 patient-years. A total of 1106 Lurasidone-treated patients had at least 24 weeks and 371 Lurasidone-treated patients had at least 52 weeks of exposure.

Adverse events during exposure to study treatment were obtained by general inquiry and voluntarily reported adverse experiences, as well as results from physical examinations, vital signs, ECGs, weights and laboratory investigations. Adverse experiences were recorded by clinical investigators using their own terminology. In order to provide a meaningful estimate of the proportion of individuals experiencing adverse events, events were grouped in standardized categories using MedDRA terminology.

Schizophrenia

The following findings are based on the short-term, placebo-controlled premarketing studies for schizophrenia in which Lurasidone was administered at daily doses ranging from 20 to 160 mg (n=1508).

Commonly Observed Adverse Reactions

The most common adverse reactions (incidence ≥ 5% and at least twice the rate of placebo) in patients treated with Lurasidone were somnolence, akathisia, extrapyramidal symptoms, and nausea.

Adverse Reactions Associated with Discontinuation of Treatment

A total of 9.5% (143/1508) Lurasidone-treated patients and 9.3% (66/708) of placebo-treated patients discontinued due to adverse reactions. There were no adverse reactions associated with discontinuation in subjects treated with Lurasidone that were at least 2% and at least twice the placebo rate.

Adverse Reactions Occurring at an Incidence of 2% or More in Lurasidone-Treated Patients

Adverse reactions associated with the use of Lurasidone (incidence of 2% or greater, rounded to the nearest percent and Lurasidone incidence greater than placebo) that occurred during acute therapy (up to 6 weeks in patients with schizophrenia) are shown in Table 15.

Table 15: Adverse Reactions in 2% or More of Lurasidone-Treated Patients and That Occurred at Greater Incidence than in the Placebo-Treated Patients in Short-term Schizophrenia Studies

Dose-Related Adverse Reactions in the Schizophrenia Studies

Akathisia and extrapyramidal symptoms were dose-related. The frequency of akathisia increased with dose up to 120 mg/day (5.6% for Lurasidone 20 mg, 10.7% for Lurasidone 40 mg, 12.3% for Lurasidone 80 mg, and 22.0% for Lurasidone 120 mg). Akathisia was reported by 7.4% (9/121) of patients receiving 160 mg/day. Akathisia occurred in 3.0% of subjects receiving placebo. The frequency of extrapyramidal symptoms increased with dose up to 120 mg/day (5.6% for Lurasidone 20 mg, 11.5% for Lurasidone 40 mg, 11.9% for Lurasidone 80 mg, and 22.0% for Lurasidone 120 mg).

Bipolar Depression (Monotherapy)

The following findings are based on the short-term, placebo-controlled premarketing study for bipolar depression in which Lurasidone was administered at daily doses ranging from 20 to 120 mg (n=331).

Commonly Observed Adverse Reactions

The most common adverse reactions (incidence ≥ 5%, in either dose group, and at least twice the rate of placebo) in patients treated with Lurasidone were akathisia, extrapyramidal symptoms, somnolence, nausea, vomiting, diarrhea, and anxiety.

Adverse Reactions Associated with Discontinuation of Treatment

A total of 6.0% (20/331) Lurasidone-treated patients and 5.4% (9/168) of placebo-treated patients discontinued due to adverse reactions. There were no adverse reactions associated with discontinuation in subjects treated with Lurasidone that were at least 2% and at least twice the placebo rate.

Adverse Reactions Occurring at an Incidence of 2% or More in Lurasidone-Treated Patients

Adverse reactions associated with the use of Lurasidone (incidence of 2% or greater, rounded to the nearest percent and Lurasidone incidence greater than placebo) that occurred during acute therapy (up to 6 weeks in patients with bipolar depression) are shown in Table 16.

Table 16: Adverse Reactions in 2% or More of Lurasidone-Treated Patients and That Occurred at Greater Incidence than in the Placebo-Treated Patients in a Short-term Monotherapy Bipolar Depression Study

Dose-Related Adverse Reactions in the Monotherapy Study

In the short-term, placebo-controlled study (involving lower and higher Lurasidone dose ranges) the adverse reactions that occurred with a greater than 5% incidence in the patients treated with Lurasidone in any dose group and greater than placebo in both groups were nausea (10.4%, 17.4%), somnolence (7.3%, 13.8%), akathisia (7.9%, 10.8%), and extrapyramidal symptoms (4.9%, 9.0%) for Lurasidone 20 to 60 mg/day and Lurasidone 80 to 120 mg/day, respectively.

Bipolar Depression

Adjunctive Therapy with Lithium or Valproate

The following findings are based on two short-term, placebo-controlled premarketing studies for bipolar depression in which Lurasidone was administered at daily doses ranging from 20 to 120 mg as adjunctive therapy with lithium or valproate (n=360).

Commonly Observed Adverse Reactions

The most common adverse reactions (incidence ≥ 5% and at least twice the rate of placebo) in subjects treated with Lurasidone were akathisia and somnolence.

Adverse Reactions Associated with Discontinuation of Treatment

A total of 5.8% (21/360) Lurasidone-treated patients and 4.8% (16/334) of placebo-treated patients discontinued due to adverse reactions. There were no adverse reactions associated with discontinuation in subjects treated with Lurasidone that were at least 2% and at least twice the placebo rate.

Adverse Reactions Occurring at an Incidence of 2% or More in Lurasidone-Treated Patients

Adverse reactions associated with the use of Lurasidone (incidence of 2% or greater, rounded to the nearest percent and Lurasidone incidence greater than placebo) that occurred during acute therapy (up to 6 weeks in patients with bipolar depression) are shown in Table 17.

Table 17: Adverse Reactions in 2% or More of Lurasidone-Treated Patients and That Occurred at Greater Incidence than in the Placebo-Treated Patients in the Short-term Adjunctive Therapy Bipolar Depression Studies

Extrapyramidal Symptoms

Schizophrenia

In the short-term, placebo-controlled schizophrenia studies, for Lurasidone-treated patients, the incidence of reported events related to extrapyramidal symptoms (EPS), excluding akathisia and restlessness, was 13.5% versus 5.8% for placebo-treated patients. The incidence of akathisia for Lurasidone-treated patients was 12.9% versus 3.0% for placebo-treated patients. Incidence of EPS by dose is provided in Table 18.

Table 18: Incidence of EPS Compared to Placebo in Schizophrenia Studies

Bipolar Depression

Monotherapy

In the short-term, placebo-controlled monotherapy bipolar depression study, for Lurasidone-treated patients, the incidence of reported events related to EPS, excluding akathisia and restlessness was 6.9% versus 2.4% for placebo-treated patients. The incidence of akathisia for Lurasidone-treated patients was 9.4% versus 2.4% for placebo-treated patients. Incidence of EPS by dose groups is provided in Table 19.

Table 19: Incidence of EPS Compared to Placebo in the Monotherapy Bipolar Depression Study

Adjunctive Therapy with Lithium or Valproate

In the short-term, placebo-controlled adjunctive therapy bipolar depression studies, for Lurasidone-treated patients, the incidence of EPS, excluding akathisia and restlessness, was 13.9% versus 8.7% for placebo. The incidence of akathisia for Lurasidone-treated patients was 10.8% versus 4.8% for placebo-treated patients. Incidence of EPS is provided in Table 20.

Table 20: Incidence of EPS Compared to Placebo in the Adjunctive Therapy Bipolar Depression Studies

In the short-term, placebo-controlled schizophrenia and bipolar depression studies, data was objectively collected on the Simpson Angus Rating Scale (SAS) for extrapyramidal symptoms (EPS), the Barnes Akathisia Scale (BAS) for akathisia and the Abnormal Involuntary Movement Scale (AIMS) for dyskinesias.

Schizophrenia

The mean change from baseline for Lurasidone-treated patients for the SAS, BAS and AIMS was comparable to placebo-treated patients, with the exception of the Barnes Akathisia Scale global score (Lurasidone, 0.1; placebo, 0.0). The percentage of patients who shifted from normal to abnormal was greater in Lurasidone-treated patients versus placebo for the BAS (Lurasidone, 14.4%; placebo, 7.1%), the SAS (Lurasidone, 5.0%; placebo, 2.3%) and the AIMS (Lurasidone, 7.4%; placebo, 5.8%).

Bipolar Depression

Monotherapy

The mean change from baseline for Lurasidone-treated patients for the SAS, BAS and AIMS was comparable to placebo-treated patients. The percentage of patients who shifted from normal to abnormal was greater in Lurasidone-treated patients versus placebo for the BAS (Lurasidone, 8.4%; placebo, 5.6%), the SAS (Lurasidone, 3.7%; placebo, 1.9%) and the AIMS (Lurasidone, 3.4%; placebo, 1.2%).

Adjunctive Therapy with Lithium or Valproate

The mean change from baseline for Lurasidone-treated patients for the SAS, BAS and AIMS was comparable to placebo-treated patients. The percentage of patients who shifted from normal to abnormal was greater in Lurasidone-treated patients versus placebo for the BAS (Lurasidone, 8.7%; placebo, 2.1%), the SAS (Lurasidone, 2.8%; placebo, 2.1%) and the AIMS (Lurasidone, 2.8%; placebo, 0.6%).

Dystonia

Class Effect: Symptoms of dystonia, prolonged abnormal contractions of muscle groups, may occur in susceptible individuals during the first few days of treatment. Dystonic symptoms include: spasm of the neck muscles, sometimes progressing to tightness of the throat, swallowing difficulty, difficulty breathing, and/or protrusion of the tongue. While these symptoms can occur at low doses, they occur more frequently and with greater severity with high potency and at higher doses of first-generation antipsychotic drugs. An elevated risk of acute dystonia is observed in males and younger age groups.

Schizophrenia

In the short-term, placebo-controlled schizophrenia clinical studies, dystonia occurred in 4.2% of Lurasidone-treated subjects (0.0% Lurasidone 20 mg, 3.5% Lurasidone 40 mg, 4.5% Lurasidone 80 mg, 6.5% Lurasidone 120 mg and 2.5% Lurasidone 160 mg) compared to 0.8% of subjects receiving placebo. Seven subjects (0.5%, 7/1508) discontinued clinical trials due to dystonic events – four were receiving Lurasidone 80 mg/day and three were receiving Lurasidone 120 mg/day.

Bipolar Depression

Monotherapy

In the short-term, flexible-dose, placebo-controlled monotherapy bipolar depression study, dystonia occurred in 0.9% of Lurasidone-treated subjects (0.0% and 1.8% for Lurasidone 20 to 60 mg/day and Lurasidone 80 to 120 mg/day, respectively) compared to 0.0% of subjects receiving placebo. No subject discontinued the clinical study due to dystonic events.

Adjunctive Therapy with Lithium or Valproate

In the short-term, flexible-dose, placebo-controlled adjunctive therapy bipolar depression studies, dystonia occurred in 1.1% of Lurasidone-treated subjects (20 to 120 mg) compared to 0.6% of subjects receiving placebo. No subject discontinued the clinical study due to dystonic events.

Other Adverse Reactions Observed During the Premarketing Evaluation of Lurasidone

Following is a list of adverse reactions reported by patients treated with Lurasidone at multiple doses of ≥ 20 mg once daily within the premarketing database of 2905 patients with schizophrenia. The reactions listed are those that could be of clinical importance, as well as reactions that are plausibly drug-related on pharmacologic or other grounds. Reactions listed in Table 15 or those that appear elsewhere in the Lurasidone label are not included. Although the reactions reported occurred during treatment with Lurasidone, they were not necessarily caused by it.

Reactions are further categorized by organ class and listed in order of decreasing frequency according to the following definitions: those occurring in at least 1/100 patients (frequent) (only those not already listed in the tabulated results from placebo-controlled studies appear in this listing); those occurring in 1/100 to 1/1000 patients (infrequent); and those occurring in fewer than 1/1000 patients (rare).

Blood and Lymphatic System Disorders: Infrequent: anemia

Cardiac Disorders: Frequent: tachycardia; Infrequent: AV block 1st degree, angina pectoris, bradycardia

Ear and Labyrinth Disorders: Infrequent: vertigo

Eye Disorders: Frequent: blurred vision

Gastrointestinal Disorders: Frequent: abdominal pain, diarrhea; Infrequent: gastritis

General Disorders and Administrative Site Conditions: Rare: sudden death

Investigations: Frequent: CPK increased

Metabolism and Nutritional System Disorders: Frequent: decreased appetite

Musculoskeletal and Connective Tissue Disorders: Rare: rhabdomyolysis

Nervous System Disorders: Infrequent: cerebrovascular accident, dysarthria

Psychiatric Disorders: Infrequent: abnormal dreams, panic attack, sleep disorder

Renal and Urinary Disorders: Infrequent: dysuria; Rare: renal failure

Reproductive System and Breast Disorders: Infrequent: amenorrhea, dysmenorrhea; Rare: breast enlargement, breast pain, galactorrhea, erectile dysfunction

Skin and Subcutaneous Tissue Disorders: Frequent: rash, pruritus; Rare: angioedema

Vascular Disorders: Frequent: hypertension

Clinical Laboratory Changes

Schizophrenia

Serum Creatinine: In short-term, placebo-controlled trials, the mean change from Baseline in serum creatinine was +0.05 mg/dL for Lurasidone-treated patients compared to +0.02 mg/dL for placebo-treated patients. A creatinine shift from normal to high occurred in 3.0% (43/1453) of Lurasidone-treated patients and 1.6% (11/681) on placebo. The threshold for high creatinine value varied from > 0.79 to > 1.3 mg/dL based on the centralized laboratory definition for each study (Table 21).

Table 21: Serum Creatinine Shifts from Normal at Baseline to High at Study End-Point in Schizophrenia Studies

Bipolar Depression

Monotherapy

Serum Creatinine: In the short-term, flexible-dose, placebo-controlled monotherapy bipolar depression study, the mean change from Baseline in serum creatinine was +0.01 mg/dL for Lurasidone-treated patients compared to -0.02 mg/dL for placebo-treated patients. A creatinine shift from normal to high occurred in 2.8% (9/322) of Lurasidone-treated patients and 0.6% (1/162) on placebo (Table 22).

Table 22: Serum Creatinine Shifts from Normal at Baseline to High at Study End-Point in a Monotherapy Bipolar Depression Study

Adjunctive Therapy with Lithium or Valproate

Serum Creatinine: In short-term, placebo-controlled premarketing adjunctive studies for bipolar depression, the mean change from Baseline in serum creatinine was +0.04 mg/dL for Lurasidone-treated patients compared to -0.01 mg/dL for placebo-treated patients. A creatinine shift from normal to high occurred in 4.3% (15/360) of Lurasidone-treated patients and 1.6% (5/334) on placebo (Table 23).

Table 23: Serum Creatinine Shifts from Normal at Baseline to High at Study End-Point in the Adjunctive Therapy Bipolar Depression Studies

What is the most important information I should know about Lurasidone?

• Lurasidone may cause drowsiness, dizziness, lightheadedness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Lurasidone with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Do not drink alcohol while you are taking Lurasidone.
• Check with your doctor before using medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are taking Lurasidone; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
• Lurasidone may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
• Do not become overheated in hot weather or while you are being active; heatstroke may occur.
• Watch patients who take Lurasidone closely. Contact the doctor at once if new, worsened, or sudden symptoms, such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or any unusual change in mood or behavior, occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.
• Lurasidone may raise your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.
• Diabetes patients - Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
• Lurasidone may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
• NMS is a possibly fatal syndrome that can be caused by Lurasidone. Symptoms may include fever; stiff muscles; confusion; abnormal thinking; fast or irregular heartbeat; and sweating. Contact your doctor at once if you have any of these symptoms.
• Some patients who take Lurasidone may develop muscle movements that they cannot control. This is more likely to happen in elderly patients, especially women. The chance that this will happen or that it will become permanent is greater in those who take Lurasidone in higher doses or for a long time. Muscle problems may also occur after short-term treatment with low doses. Tell your doctor at once if you have muscle problems with your arms; legs; or your tongue, face, mouth, or jaw (eg, tongue sticking out, puffing of cheeks, mouth puckering, chewing movements) while taking Lurasidone.
• Lurasidone may increase the amount of a certain hormone (prolactin) in your blood. Symptoms may include enlarged breasts, missed menstrual period, decreased sexual ability, or nipple discharge. Contact your doctor right away if you experience any of these symptoms.
• Lab tests, including fasting blood glucose, cholesterol, and complete blood cell counts, may be performed while you use Lurasidone. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use Lurasidone with caution in the ELDERLY; they may be more sensitive to its effects, especially dizziness when standing or uncontrolled muscles movements.
• Lurasidone should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Lurasidone while you are pregnant. Using Lurasidone during the third trimester may result in uncontrolled muscle movements or withdrawal symptoms in the newborn. Discuss any questions or concerns with your doctor. It is not known if Lurasidone is found in breast milk. If you are or will be breast-feeding while you use Lurasidone, check with your doctor. Discuss any possible risks to your baby.

Lurasidone contraindications

Lurasidone is not for use in psychotic conditions related to dementia. Lurasidone may cause heart failure, sudden death, or pneumonia in older adults with dementia-related conditions.

You should not use this medication if you are allergic to Lurasidone, or if you are also using ketoconazole (Extina, Ketozole, Nizoral, Xolegal) or rifampin (Rifater, Rifadin, Rifamate).

Before you take Lurasidone, tell your doctor if you have liver disease, kidney disease, heart disease, high blood pressure, heart rhythm problems, a history of heart attack or stroke, high cholesterol or triglycerides, low white blood cell (WBC) counts, seizures, diabetes, Parkinson's disease, trouble swallowing, or a history of breast cancer or suicidal thoughts.

While you are taking Lurasidone, you may be more sensitive to temperature extremes such as very hot or cold conditions. Avoid getting too cold, or becoming overheated or dehydrated. Drink plenty of fluids, especially in hot weather and during exercise. It is easier to become dangerously overheated and dehydrated while you are taking Lurasidone.

Lurasidone may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Drinking alcohol can increase certain side effects of Lurasidone.

Stop using Lurasidone and call your doctor at once if you have very stiff (rigid) muscles, high fever, sweating, confusion, fast or pounding heartbeats, feeling like you might pass out, tremors, or twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs.

There are many other drugs that can interact with Lurasidone. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

References

1. DailyMed. "LURASIDONE HYDROCHLORIDE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
2. European Chemicals Agency - ECHA. "(1R,2S,6R,7S)-4-{[(1R,2R)-2-{[4-(1,2-benzothiazol-3- yl)piperazin-1-yl]methyl}-cyclohexyl]methyl}-4- azatricyclo[5.2.1.0^{2,6}]decane-3,5-dione: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).
3. HSDB. "Lurasidone". https://toxnet.nlm.nih.gov/cgi-bin/s... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology