Olanzapine and Samidorphan

IMPORTANT WARNING:

Studies have shown that older adults with dementia (a brain disorder that affects the ability to remember, think clearly, communicate, and perform daily activities and that may cause changes in mood and personality) who take antipsychotics (medications for mental illness) such as olanzapine have an increased chance of death during treatment. Older adults with dementia may also have a greater chance of having a stroke or mini-stroke during treatment.

The combination of olanzapine and samidorphan is not approved by the Food and Drug Administration (FDA) for the treatment of behavior disorders in older adults with dementia. Talk to the doctor who prescribed this medication if you, a family member, or someone you care for has dementia and is taking olanzapine and samidorphan. For more information visit the FDA website: http://www.fda.gov/Drugs.

WHY is this medicine prescribed?

The combination of olanzapine and samidorphan is used to treat the symptoms of schizophrenia (a mental illness that causes disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions) in adults. It is also used alone or with other medications to treat episodes of mania (frenzied, abnormally excited or irritated mood) in adults with bipolar disorder (manic depressive disorder; a disease that causes episodes of depression, episodes of mania, and other abnormal moods). The combination of olanzapine and samidorphan is also used to prevent episodes of mania in adults with bipolar disorder. Olanzapine is in a class of medications called atypical antipsychotics. It works by changing the activity of certain natural substances in the brain. Samidorphan is an opioid antagonist. It works to reduce possible side effects from olanzapine, including weight gain.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

The combination of olanzapine and samidorphan comes as a tablet to take by mouth. It is usually taken once a day with or without food. Take olanzapine and samidorphan at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take olanzapine and samidorphan exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the tablets whole; do not split them.

Your doctor will may start you on a low dose of olanzapine and samidorphan and gradually increase your dose.

The combination of olanzapine and samidorphan may help control your symptoms, but it will not cure your condition. Continue to take olanzapine and samidorphan even if you feel well. Do not stop taking olanzapine and samidorphan without talking to your doctor. Your doctor will probably want to decrease your dose gradually.

What SPECIAL PRECAUTIONS should I follow?

Before taking olanzapine and samidorphan,

• tell your doctor and pharmacist if you are allergic to olanzapine, samidorphan, any other medications, or any of the ingredients in tablets. Ask your pharmacist or check the Medication Guide for a list of the ingredients.

• tell your doctor if you are taking any opioid (narcotic) medications or street drugs. Also tell your doctor if you have taken any of these medications in the past 14 days or if you have recently stopped using opioid medications or opioid street drugs and are now experiencing withdrawal symptoms. Ask your doctor if you are not sure if a medication you have taken is an opioid. Your doctor will tell you not to take olanzapine and samidorphan if you have taken or used opioids in the past 14 days.

• some medications should not be taken with olanzapine and samidorphan. Other medications may cause dosing changes or extra monitoring when taken with olazapine and samidorphan. Make sure you have discussed any medications you are currently taking or plan to take before starting olanzapine and samidorphanwith your doctor and pharmacist. Before starting, stopping, or changing any medications while taking olanzapine and samidorphan, please get the advice of your doctor or pharmacist.

• the following herbal product may interact with olanzapine and samidorphan: St. John's wort. Be sure to let your doctor and pharmacist know that you are taking this medication before you start taking olanzapine and samidorphan. Do not start this medication while taking olanzapine and samidorphan without discussing with your healthcare provider.

• tell your doctor if you use or have ever used street drugs or have overused prescription medications and if you have or have ever had a stroke, a mini-stroke, heart disease or a heart attack, an irregular heartbeat, heart failure, urinary problems, seizures, breast cancer, any condition that makes it difficult for you to swallow, high or low blood pressure, a high level of fats (cholesterol and triglycerides) in your blood, a low number of white blood cells, prostate disease, have or had high prolactin levels, paralytic ileus (condition in which food cannot move through the intestine); or high blood sugar, or if you or anyone in your family has or has ever had diabetes, or liver or kidney disease. Tell your doctor if you have constipation, severe vomiting or diarrhea or signs of dehydration now, or if you develop these symptoms at any time during your treatment.

• tell your doctor if you are pregnant, especially if you are in the last few months of your pregnancy, or if you plan to become pregnant or are breastfeeding. If you become pregnant while taking olanzapine and samidorphan, call your doctor. Olanzapine may cause problems in newborns following delivery if it is taken during the last months of pregnancy.

• you should know that this medication may decrease fertility in women. Talk to your doctor about the risks of taking olanzapine and samidorphan.

• you should know that olanzapine and samidorphan may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.

• ask your doctor about the safe use of alcoholic beverages while you are taking olanzapine and samidorphan. Alcohol can make the side effects from olanzapine and samidorphan worse.

• tell your doctor if you use tobacco products. Cigarette smoking may decrease the effectiveness of this medication.

• you should know that you may experience hyperglycemia (increases in your blood sugar) while you are taking this medication, even if you do not already have diabetes. If you have schizophrenia, you are more likely to develop diabetes than people who do not have schizophrenia, and taking olanzapine and samidorphan or similar medications may increase this risk. Tell your doctor immediately if you have any of the following symptoms while you are taking olanzapine and samidorphan: extreme thirst, frequent urination, extreme hunger, blurred vision, or weakness. It is very important to call your doctor as soon as you have any of these symptoms, because high blood sugar can cause a serious condition called ketoacidosis. Ketoacidosis may become life-threatening if it is not treated at an early stage. Symptoms of ketoacidosis include: dry mouth, nausea and vomiting, shortness of breath, breath that smells fruity, and decreased consciousness.

• you should know that olanzapine and samidorphan may cause fast or slow heartbeat, dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. This is more common when you first start taking olanzapine. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.

• you should know that olanzapine and samidorphan may make it harder for your body to cool down when it gets very hot. Tell your doctor if you plan to do vigorous exercise or be exposed to extreme heat.

What SPECIAL DIETARY instructions should I follow?

Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medicine.

Be sure to drink plenty of water every day while you are taking this medication.

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Olanzapine and samidorphan may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• weight gain
• increased appetite
• dry mouth
• constipation
• tiredness
• dizziness, feeling unsteady, or having trouble keeping your balance
• headache

Some side effects can be serious. If you experience any of these symptoms or those in the SPECIAL PRECAUTIONS section, call your doctor immediately:

• sore throat, fever, chills, and other signs of infection
• very stiff muscles
• excess sweating
• confusion
• fast or irregular heartbeat
• rash that may occur with fever, swollen glands, or swelling of the face
• unusual movements of your face or body that you cannot control
• neck muscle spasms, throat tightness, or difficulty swallowing or breathing
• seizures
• falling
• difficulty breathing or swallowing

Taking olanzapine and samidorphan may cause the level of fats in your blood to increase. Talk to your doctor about the risks of taking olanzapine.

Olanzapine and samidorphan may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Your medication comes with a desiccant packet (small packet that contains a substance that absorbs moisture to keep the medication dry) in the container. Do not eat or inhale it. Throw it away in the household trash out of reach of children and pets.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include:

• drowsiness
• seizures
• decreased breathing
• agitation
• fast or rapid heartbeat
• sudden movements that you cannot control
• coma (loss of consciousness for a period of time)

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to olanzapine and samidorphan.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.