lurasidone hydrochloride

Lurasidone (Latuda) belongs to a class of medications known as atypical antipsychotics. Other members of this class include clozapine (Clozaril), risperidone (Risperdal), aripiprazole (Abilify) and ziprasidone (Geodon). Atypical antipsychotics like lurasidone are considered the standard of care for treating schizophrenia. Additionally, in clinical studies lurasidone was shown to be effective in improving mood in many people struggling with bipolar depression. Lurasidone can be taken alone or with either lithium (Lithobid) or valproate (Depakote).

The exact mechanism of action of lurasidone is not known. It may work by blocking receptors for several neurotransmitters (chemicals that nerves use to communicate with each other) in the brain. It binds to dopamine and serotonin type 2 (5-HT2) receptors.

Lurasidone was approved for the treatment of schizophrenia in adults in October, 2010. Almost three years later in July, 2012 the FDA approved lurasidone for the treatment of depressive episodes associated with bipolar I disorder.

Latuda

GENERIC AVAILABLE: No

Yes

The most common side effects of lurasidone include:

• sleepiness or drowsiness,
• akathesia (restlessness or feeling a need to move around),
• difficulty moving,
• slow movements,
• muscle stiffness,
• tremor, and
• nausea.

Lurasidone may increase the risk of stroke that can lead to death in elderly patients with dementia. It is associated with an increased risk of suicidal thoughts or actions especially in children, teenagers, and young adults within the first few months of treatment. Neuroleptic malignant syndrome or NMS, a rare but serious disorder caused by antipsychotic medicines can occur.

Other side effects include:

• Involuntary movements of the face, tongue, or other body parts called tardive dyskinesia;
• high blood sugar (hyperglycemia);
• increased cholesterol and triglycerides;
• weight gain;
• increases in prolactin levels;
• a drop in white blood cell count;
• a decrease in blood pressure especially when rising too quickly from a sitting or lying position;
• seizures; and
• difficulty swallowing.

Lurasidone tablets should be taken with food (at least 350 calories) since administration with food significantly increases its absorption.

Schizophrenia: the recommended starting dose of lurasidone is 40 mg by mouth once a day. The dosage may be increased based on individual patient response or tolerability. For most patients, 40 to160 mg of lurasidone per day has been shown to be effective. The maximum recommended dose is 160 mg per day.

Depressive episodes associated with bipolar I disorder: the recommended starting dose of lurasidone is 20 mg by mouth once daily, alone or with lithium or valproate. The dosage may be increased based on individual patient response or tolerability. For most patients, 20 to 120 mg of lurasidone per day has been shown to be effective. The maximum recommended dose is 120 mg per day.

Kidney disease: dose adjustment is recommended in patients with moderate (creatinine clearance 30 to <50 ml/min) or severe kidney disease (creatinine clearance <30 ml/min). The recommended starting dose in such patients is 20 mg per day and the dose should not exceed 80 mg per day.

Liver disease: dose adjustment is recommended in patients with moderate (Child-Pugh Score= 7 to 9) or severe liver disease (Child-Pugh Score = 10 to15). The recommended starting dose in these patients is 20 mg per day. The dose in patients with moderate liver disease should not exceed 80 mg per day and the dose in patients with severe liver disease should not exceed 40 mg per day.

The safety and effectiveness of lurasidone has not been established in children.

Lurasidone is primarily metabolized or broken down by CYP3A4 liver enzymes. Co-administration with medicines that interfere with the activity of these enzymes can alter the levels of lurasidone in the blood. Lurasidone should not be used concomitantly with strong CYP3A4 inhibitors such as ketoconazole (Extina, Kuric, Nizoral), clarithromycin (Biaxin), ritonavir (Norvir), voriconazole (VFEND), mibefradil (Posicor), and many other drugs due to the risk of increased blood levels of lurasidone. Grapefruit and grapefruit juice may also inhibit CYP3A4 enzymes and should be avoided in patients taking lurasidone.

Lurasidone should not be used concomitantly with strong CYP3A4 inducers such as rifampin (Rimactane), St. John's Wort, phenytoin (Dilantin), and carbamazepine (Tegretol) because blood levels of lurasidone may decrease, resulting in poor treatment outcomes. If used with moderate CYP3A4 inducer for 7 days or more, the dose of lurasidone may need to be increased.

Use of lurasidone in pregnant women has not been adequately evaluated. Due to the lack of conclusive safety data, lurasidone should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus. Lurasidone is classified as FDA pregnancy risk category B (no animal studies demonstrate harm).

Lurasidone was excreted in the milk of rats in animal studies. It is not known if lurasidone is excreted in human breast milk. Since many drugs are excreted in human milk and have the potential of causing harm to the nursing infant, a decision should be made to either discontinue nursing or taking lurasidone.

What preparations of lurasidone hydrochloride Latuda are available?

Oral tablets: 20, 40, 60, 80, and 120 mg.

How should I keep lurasidone hydrochloride Latuda stored?

Tablets should be stored at room temperature, between 15 C to 30 C (59 F to 86 F).