Latuda: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

LATUDA 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.

LATUDA 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.

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

Your doctor may have prescribed LATUDA for another reason.

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

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

What it does:

LATUDA 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 LATUDA 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 LATUDA if you:

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

• are taking drugs that affect significantly the way LATUDA 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:

LATUDA contains the following nonmedicinal ingredients: carnauba wax, croscarmellose sodium, hypromellose, magnesium stearate, mannitol, Opadry^® (hypromellose, polyethylene glycol, and titanium dioxide), pregelatinized starch; 80 mg tablet also contains: FD&C Blue No.2 Aluminum Lake and yellow ferric oxide.

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 LATUDA belongs have been associated with an increased rate of death when used in elderly patients with dementia. LATUDA is not approved for use in elderly patients with dementia.

BEFORE you use LATUDA, 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 LATUDA 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: LATUDA may make you feel drowsy. Do not drive a car or operate machinery until you know how LATUDA affects you.

Low Blood Pressure: When taking LATUDA, 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 LATUDA, 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 LATUDA.

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 LATUDA:

• 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 LATUDA. It is recommended that you do not drink alcohol while taking LATUDA.

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

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

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

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

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

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 LATUDA AT THE SAME TIME TO MAKE UP FOR A MISSED DOSE.

Overdose:

If you have taken more LATUDA tablets than your doctor has recommended (or if someone else has taken some of your LATUDA tablets), contact your regional Poison Control Centre and talk to your doctor right away or go to your nearest hospital emergency department. Take the medication package with you.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Like other medicines, LATUDA 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 LATUDA 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 LATUDA 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 LATUDA 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 LATUDA 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 LATUDA 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

  (hyperglycemia). Symptoms of high blood sugar can 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 LATUDA, 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 LATUDA and continue to monitor it for as long as you are being treated.

Your doctor should take blood tests before starting LATUDA. 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 LATUDA, 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 SUSPECTED SIDE EFFECTS

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

--------------------------------------------------------------------------

• Report online at https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html
• Call toll-free at 1-866-234-2345

• Complete a Canada Vigilance Reporting Form and:

  • Fax toll-free to 1-866-678-6789, or

  • Mail to: Canada Vigilance Program Health Canada

    Postal Locator 1908C

    Ottawa, Ontario

    K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect^™ Canada Web site at https://www.canada.ca/en/health-

canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be found at: http://www.ca.sumitomo-pharma.com or by contacting the sponsor, Sumitomo Pharma Canada, Inc. at: 1-866-260-6291.

Last revised: JAN 19, 2024