Lurasidone: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

LURASIDONE is used to treat the symptoms of schizophrenia in adults and in adolescents (15-17 years of age).

Schizophrenia is characterized by symptoms such as:

• hearing, seeing, or sensing things that are not there
• suspiciousness, mistaken beliefs
• incoherent speech and behavior, and
• emotional flatness.

People with this condition may also feel depressed, guilty, anxious, or tense.

LURASIDONE is also used to treat the symptoms of depression associated with bipolar disorder in adults and adolescents (13-17 years of age) such as:

• sadness
• loss of interest and enjoyment
• lack of energy
• change in appetite
• sleep disturbance, and
• difficulty concentrating.

LURASIDONE is not a cure for your condition, but it can help manage your symptoms.

Your doctor may have prescribed LURASIDONE for another reason.

Ask your doctor if you have any questions about why LURASIDONE has been prescribed for you.

A Reminder: This medicine has been prescribed only for you. Never give it to anyone else.

What it does:

LURASIDONE belongs to a group of medicines called atypical antipsychotics.

Antipsychotic medications affect the chemicals (neurotransmitters) that allow nerve cells to talk to each other. Two of the chemicals in the brain, called dopamine and serotonin, may be out of balance in schizophrenia or bipolar depression. It is not known exactly how LURASIDONE works. However, it seems to help keep the right balance of dopamine and serotonin in your brain.

When it should not be used:

Do not take LURASIDONE if you:

• are allergic to LURASIDONE or any of the ingredients in LURASIDONE

• are taking drugs that affect significantly the way LURASIDONE is broken down in your body:

  • a strong CYP3A4 inhibitor (such as ketoconazole)
  • a strong CYP3A4 inducer (such as rifampin)

What the medicinal ingredient is:

lurasidone hydrochloride

What the nonmedicinal ingredients are:

LURASIDONE contains the following nonmedicinal ingredients: corn starch, croscarmellose sodium, hypromellose, magnesium stearate, mannitol and Opadry® (hypromellose, titanium dioxide, and polyethylene glycol). Additionally, the 80 mg tablet contains iron oxide yellow and FD&C Blue No.2/Indigo Carmine Aluminum Lake

What dosage forms it comes in:

20 mg, 40 mg, 60 mg, 80 mg, and 120 mg tablets

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

Various medicines of the group to which LURASIDONE belongs have been associated with an increased rate of death when used in elderly patients with dementia. LURASIDONE is not approved for use in elderly patients with dementia.

BEFORE you use LURASIDONE, talk to your doctor or pharmacist if you:

• are taking any other medicines (prescriptions or over the counter medicines)

• are pregnant, think you are pregnant, or plan to become pregnant

• are breastfeeding or plan to breastfeed
• are an elderly patient suffering from dementia (loss of memory and other mental abilities)
• exercise vigorously or work in hot or sunny places
• have high blood sugar or a history of diabetes
• have a history of kidney or liver problems
• have involuntary, irregular muscle movements, especially in the face or tongue
• have high blood pressure or rapid heartbeats and a drop in pressure when getting up
• have low blood pressure
• suffer from heart disease or have a family history of heart disease, stroke, or "mini" stroke
• have had problems with the way your heart beats (arrhythmias) or are taking medications that affect how your heart beats
• have heart problems including “QT prolongation”
• are at risk for developing blood clots. Risks include:
• a family history of blood clots
• being over age over 65
• smoking
• being over weight
• a recent major surgery (such as hip or knee replacement)
• not being able to move due to air travel or other reason
• take birth control ("The Pill")
• have or have had breast cancer
• have pituitary tumours
• drink alcohol or use street drugs
• have ever had fainting, blackouts, or seizures
• work with hazardous machinery or drive a motorized vehicle
• have or have had low levels of white blood cells

Other warnings you should know about:

Effects in newborns: In some cases, babies born to a mother taking LURASIDONE while they are pregnant can have serious health problems. Sometimes, the symptoms may get better on their own. Be prepared to get immediate medical help for your newborn if they:

• have trouble breathing
• are overly sleepy
• have muscle stiffness or floppy muscles (like a rag doll)
• have trouble feeding.

Driving and using machines: LURASIDONE may make you feel drowsy. Do not drive a car or operate machinery until you know how LURASIDONE affects you.

Low Blood Pressure: When taking LURASIDONE, some people may faint, feel lightheaded or dizzy, especially when getting up from a lying or sitting position. This is more likely to happen if you are elderly and also at the start of treatment or when the dose is increased. This will usually go away on its own but if it does not, tell your doctor.

Dehydration and overheating: When taking LURASIDONE, it is important not to become too hot or dehydrated. Do not exercise too much and try to avoid extreme heat.

Falls: Feeling sleepy, a fall in blood pressure when you stand up from sitting or lying down, vision or speech problems have been reported with the use of antipsychotic drugs. This can lead to falls that may cause fractures or other fall-related injuries. Certain medications, diseases or conditions can make this worse.

INTERACTIONS WITH THIS MEDICATION

Tell all doctors, dentists, and pharmacists who are treating you that you are taking LURASIDONE.

As well, be sure to tell them about any other medications you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

Inform your doctor if you start or stop taking any of the following medications as they may interact with LURASIDONE:

• Drugs used to treat fungal infections such as ketoconazole, itraconazole, fluconazole
• Drugs used to treat HIV infection and AIDS such as ritonavir
• Anti-seizure drugs such as phenobarbital or phenytoin
• Drugs used to lower blood pressure such as diltiazem or verapamil
• Certain antibiotics used to treat infections such as rifampin or erythromycin
• Drugs used to treat problems with your heart beat (antiarrhythmics)
• Diuretics (water pills)

The effects of alcohol could be made worse while taking LURASIDONE. It is recommended that you do not drink alcohol while taking LURASIDONE.

You should avoid consuming grapefruit, grapefruit juice, or products containing grapefruit extract while receiving LURASIDONE.

PROPER USE OF THIS MEDICATION

Usual Adult and Adolescent (15-17 years old) Dose:

Schizophrenia:

Usual starting dose: 40 mg once a day. The highest recommended dose for adolescents is 80 mg.

Usual Adult and Adolescent (13-17 years old) Dose:

Depression Associated with Bipolar Disorder:

Usual starting dose: 20 mg once a day alone or in combination with lithium or valproate.

Take LURASIDONE exactly the way your doctor has prescribed it, every day and at the same time. You should check with your doctor or pharmacist if you are not sure. Your doctor has decided on the best dose for you based on your individual situation. Your doctor may increase or decrease your dose depending on your response.

Take LURASIDONE with food (at least 350 calories) and swallow whole with water.

If you have moderate liver problems, your daily dose of LURASIDONE should not be more than 80 mg. If you have severe liver problems, your daily dose of LURASIDONE should not be more than 40 mg.

If you have moderate or severe kidney problems, your daily dose of LURASIDONE should not be more than 80 mg.

LURASIDONE is not for use in children under 15 years of age with symptoms of schizophrenia. LURASIDONE is not for use in children under 13 years of age being treated for the symptoms of depression associated with bipolar disorder.

Overdose:

Missed Dose:

If you miss a dose by a few hours, take it as soon as possible. If you are close to your next dose, just skip the missed dose and take your next dose at your regular time. DO NOT TAKE 2 DOSES OF LURASIDONE AT THE SAME TIME TO MAKE UP FOR A MISSED DOSE.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Like other medicines, LURASIDONE can cause some side effects. These side effects are likely to be minor and temporary. However, some may be serious and need medical attention.

The most common side effects of LURASIDONE in adult patients with schizophrenia are:

• drowsiness/sleepiness
• feeling of restlessness (akathisia)
• abnormal movements, tremor, muscle stiffness, slowing of movement
• nausea

The most common side effects of LURASIDONE in adolescent patients (15-17 years) with schizophrenia are:

• drowsiness/sleepiness
• nausea
• feeling of restlessness (akathisia)
• abnormal movements, tremor, muscle stiffness, slowing of movement
• vomiting

The most common side effects of LURASIDONE in adult patients with depression associated with bipolar disorder are:

• feeling of restlessness (akathisia)
• abnormal movements, tremor, muscle stiffness, slowing of movement.

The most common side effects of LURASIDONE in adolescent patients (13-17 years) with depression associated with bipolar disorder are:

• nausea
• weight gain
• inability to sleep (insomnia)
• drowsiness/sleepiness

Other side effects of LURASIDONE include:

• Symptoms of an allergic reaction including rash, itching, flushing, and/or inflammation of the mouth and/or skin (see also SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM).

• Increase in the amount of sugar (glucose) in the blood

  • include feeling very thirsty and/or hungry, needing to urinate more than usual, feeling weak or tired, feeling sick to your stomach, feeling confused, fruity smelling breath.
  • Decreased blood pressure. Symptoms of decreased blood pressure can include lightheadedness or fainting when rising too quickly from a sitting or lying position.

The following may also occur with LURASIDONE, and may be seen in routine blood testing:

• decrease in the amount of white blood cells

• increase in the amount of hormone prolactin in the blood which:

  • in women, may lead to swelling of breasts and unexpected production of breast milk and changes in the regularity of monthly periods; and
  • in men, may lead to diminished sexual function and breast enlargement

If you have high levels of prolactin (measured with a blood test) and a condition called hypogonadism you may be at an increased risk of breaking a bone due to osteoporosis. This occurs in both men and women.

Your doctor should check your body weight before starting LURASIDONE and continue to monitor it for as long as you are being treated.

Your doctor should take blood tests before starting LURASIDONE. They will monitor blood sugar and the number of infection fighting white blood cells. Your doctor should continue to monitor your blood for as long as you are being treated.

You should tell your doctor if you notice any symptoms that worry you, even if you think the problems are not connected with the medicine or are not listed here.

This is not a complete list of side effects. For any unexpected effects while taking LURASIDONE, contact your doctor or pharmacist.

HOW TO STORE IT

Store at room temperature (15 – 30^oC).

The expiry date of this medicine is printed on the package label. Do not use the medicine after this date. Keep out of the reach and sight of children.

Reporting Side Effects

MORE INFORMATION

If you want more information about LURASIDONE:

•

• Talk to your healthcare professional

•

• Find the full product monograph that is prepared for

  healthcare professionals and includes this Consumer

  Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website

  https://www.sanis.com/products/,

  o

  • or by calling 1-866-236-4076,

o

• or by e-mail at: quality@sanis.com

Last revised: JUN 13, 2024