Uzedy

Uzedy injection is an extended-release injectable suspension used in adults to treat schizophrenia (a mental illness that causes disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions).

Uzedy is also approved for the maintenance treatment of bipolar I disorder in adults, as monotherapy or as adjunctive therapy to lithium or valproate.

Uzedy is given by subcutaneous (under the skin) injection, 1 time a month (schizophrenia/bipolar I disorder) or 1 time every 2 months (schizophrenia).

Uzedy belongs to a class of medications called atypical antipsychotics. Risperidone works by changing the activity of certain natural substances in the brain.

A healthcare provider will give you this injection. Follow their instructions concerning other antipsychotic medications that you take. Do not change your dose or dosing schedule without your doctor's advice.

• You may need to take risperidone by mouth (in pill or liquid form) before you start receiving Uzedy injections. Follow your doctor's dosing instructions very carefully.
• Uzedy is injected under the skin (subcutaneously) into the abdomen or upper arm.

Your blood may need to be tested often. Your doctor will need to check your progress regularly, and you may need other medical tests.

The Uzedy product label carries a Boxed Warning for increased risk of death in elderly patients with dementia-related psychosis. It is not approved for use in older adults with dementia-related psychosis.

Warnings and precautions associated with Uzedy include increased incidence of cerebrovascular adverse reactions in elderly patients with dementia-related psychosis; neuroleptic malignant syndrome; tardive dyskinesia; metabolic changes; hyperprolactinemia; orthostatic hypotension and syncope; leukopenia, neutropenia, and agranulocytosis; potential for cognitive and motor impairment; seizures; and priapism.

While you are taking this medicine, 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 this medication.

Uzedy may impair your thinking or reactions and cause drowsiness. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase certain side effects of this medicine.

You should not use Uzedy injection if you are allergic to risperidone or paliperidone.

Risperidone may increase the risk of death in older adults with dementia-related psychosis and is not approved for this use.

To make sure Uzedy is safe for you, tell your doctor if you have ever had:

• heart disease or a heart attack;
• dizziness, rapid heartbeats, fainting;
• a stroke, a TIA or "mini-stroke";
• Parkinson's disease or a type of dementia called Lewy body dementia;
• trouble swallowing;
• low white blood cell (WBC) counts;
• a severe nervous system reaction while using medicine to treat anxiety, mood disorders, or mental illness such as schizophrenia;
• diabetes (in you or a family member);
• high cholesterol or triglycerides;
• uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);
• a seizure;
• low bone mineral density;
• breast cancer;
• dehydration; or
• liver or kidney disease.

Using antipsychotic medicine in the last 3 months of pregnancy may cause serious problems in the newborn. Tell your doctor right away if you get pregnant. Do not stop the medicine without your doctor's advice.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of risperidone on the baby.

It may be harder for you to get pregnant while you are using this medicine.

If you are breastfeeding, tell your doctor if you notice drowsiness, irregular growth, tremors and abnormal muscle movements in the nursing baby.

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

High doses or long-term use of risperidone can cause a serious movement disorder that may not be reversible. The longer you use Uzedy, the more likely you are to develop this disorder, especially if you are a woman or an older adult.

Uzedy injection may cause serious side effects. Call your doctor at once if you have:

• uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking, or eye movement);
• breast swelling and tenderness, nipple discharge, loss of interest in sex, impotence, erectile dysfunction, difficulty having an orgasm, missed menstrual periods;
• feeling unusually hot or cold;
• low blood pressure, fast or pounding heartbeats, fluttering in your chest;
• shortness of breath, sudden dizziness (like you might pass out);
• seizure;
• trouble swallowing;
• signs of infection - fever, chills, sore throat, body aches, unusual tiredness, loss of appetite, bruising or bleeding;
• severe nervous system reaction - very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out;
• high blood sugar - increased thirst, increased urination, dry mouth, fruity breath odor;
• low blood cell counts - fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath; or
• a painful or prolonged erection.

Common Uzedy side effects may include:

• headache;
• blurred vision, rash;
• dizziness, drowsiness, tired feeling;
• tremors, twitching or uncontrollable muscle movements, numbness;
• depressed mood, agitation, anxiety, feeling restless;
• back pain, muscle or joint pain, pain in your arms or legs;
• upset stomach, constipation, dry mouth;
• upper stomach pain, nausea, vomiting, diarrhea;
• increased salivation;
• cold symptoms such as stuffy nose, sneezing, sore throat;
• increased appetite, weight gain; or
• itching, bruising, swelling, irritation, warmth, redness, and a hard lump (induration) where the injection was given.

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 tothe FDA at 1-800-FDA-1088.

Adult Dose of Uzedy for Schizophrenia

Uzedy is administered by subcutaneous (SC) injection once every month or once every 2 months.

• Establish tolerability with oral risperidone before starting Uzedy.
• To start Uzedy, switch from taking oral daily risperidone using the dosing schedule below.
• Start with either a once-monthly injection or a once-every-2-months injection, starting the day after the last dose of oral therapy.

Comparable Daily Oral Risperidone Therapy:

• 2 mg of oral risperidone per day - 50 mg Uzedy SC once monthly or 100 mg once every 2 months,
• 3 mg of oral risperidone per day - 75 mg Uzedy SC once monthly or 150 mg once every 2 months,
• 4 mg of oral risperidone per day - 100 mg Uzedy SC once monthly or 200 mg once every 2 months,
• 5 mg of oral risperidone per day - 125 mg Uzedy SC once monthly or 250 mg once every 2 months.

Adult Dose of Uzedy for Bipolar I Disorder

Uzedy is administered by subcutaneous injection once every month.

• Establish tolerability with oral risperidone before starting Uzedy.
• To start Uzedy, switch from taking oral daily risperidone using the dosing schedule below.
• Administer once a month, starting the day after the last dose of oral therapy.

Comparable Daily Oral Risperidone Therapy:

• 2 mg of oral risperidone per day - 50 mg Uzedy SC once monthly
• 3 mg of oral risperidone per day - 75 mg Uzedy SC once monthly
• 4 mg of oral risperidone per day - 100 mg Uzedy SC once monthly.

Patients Currently Receiving A Risperidone Long-Acting Intramuscular Injection

For patients on a risperidone long-acting injection every 2 weeks: To switch to Uzedy once-monthly injection, begin Uzedy at least 5 weeks after the final risperidone IM injection. Switch at a clinically appropriate dose:

• 25 mg of IM risperidone every 2 weeks - 50 mg Uzedy SC once monthly
• 37.5 mg of IM risperidone every 2 weeks - 75 mg Uzedy SC once monthly
• 50 mg IM risperidone every 2 weeks - 100 mg Uzedy SC once monthly.

Call your doctor for instructions if you miss an appointment for your Uzedy injection.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Do not drink alcohol. Dangerous side effects could occur.

Avoid becoming overheated or dehydrated during exercise, in hot weather, or by not drinking enough fluids. Follow your doctor's instructions about the type and amount of liquids you should drink. In some cases, drinking too much liquid can be as unsafe as not drinking enough.

Avoid driving or hazardous activity until you know how this medicine will affect you. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Using Uzedy injection with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Tell your doctor about all your current medicines. Many drugs can affect Uzedy, especially:

• methylphenidate;
• clozapine; or
• blood pressure medications.

This list is not complete, and many other drugs may interact with risperidone. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Active ingredient: risperidone.Inactive ingredients: dimethyl sulfoxide, methoxy-poly(ethylene glycol)-co-poly(D,L-lactide), and poly(D, L-lactide)-co-poly(ethylene glycol)-co-poly(D, L-lactide).

Teva Neuroscience, Inc., Parsippany, NJ 07054, USA.