Apokyn

What is Apokyn used for?

• Apokyn is used to treat "off" episodes (when a dose wears off) in people with Parkinson's disease.

Before taking Apokyn, tell your doctor:

• If you are allergic to Apokyn; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you are taking any of these drugs: Alosetron, dolasetron, granisetron, ondansetron, or palonosetron.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Apokyn with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Apokyn?

• Tell all of your health care providers that you take Apokyn. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how Apokyn affects you.
• To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
• Do not stop taking Apokyn all of a sudden without calling your doctor. You may have a greater risk of side effects. If you need to stop Apokyn, you will want to slowly stop it as ordered by your doctor.
• Avoid drinking alcohol while taking Apokyn.
• Talk with your doctor before you use other drugs and natural products that slow your actions.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Check blood pressure and heart rate as the doctor has told you.
• If you are allergic to sulfites, talk with your doctor. Some products have sulfites.
• An unsafe heartbeat that is not normal (long QT on ECG) has happened with Apokyn. Chest pain, heart attack, and sudden deaths have also rarely happened in people taking Apokyn. Talk with the doctor.
• Other drugs will be given with Apokyn to help avoid side effects.
• The chance of falling is raised with Apokyn. Falls may lead to very bad problems like head injury and broken bones. The chance of falling is higher in older people. Talk with the doctor.
• Call your doctor right away if you have a painful erection (hard penis) or an erection that lasts for longer than 4 hours. This may happen even when you are not having sex. If this is not treated right away, it may lead to lasting sex problems and you may not be able to have sex.
• Do not share pen or cartridge devices with another person even if the needle has been changed. Sharing these devices may pass infections from one person to another. This includes infections you may not know you have.
• If you are 65 or older, use Apokyn with care. You could have more side effects.
• Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

How is Apokyn best taken?

Use Apokyn as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot into the fatty part of the skin.
• Do not give Apokyn as a shot into a vein. Blood clots (in the lungs) have happened when Apokyn was given as a shot into a vein. Talk with your doctor.
• If you will be giving yourself the shot, your doctor or nurse will teach you how to give the shot.
• Do not use if the solution is cloudy, leaking, or has particles.
• Do not use if solution changes color.
• Wash your hands before and after use.
• Move the site where you give the shot with each shot.
• Do not give into red or irritated skin.
• Throw away needles in a needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow all local rules for getting rid of it. Talk with a doctor or pharmacist if you have any questions.
• If it has been more than 7 days since your last dose, call your doctor to find out how to restart.

What do I do if I miss a dose?

• This medicine is taken on an as needed basis. Do not take more often than told by the doctor.

What are the side effects of Apokyn that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of a urinary tract infection (UTI) like blood in the urine, burning or pain when passing urine, feeling the need to pass urine often or right away, fever, lower stomach pain, or pelvic pain.
• Signs of dehydration like dry skin, mouth, or eyes; thirst; fast heartbeat; dizziness; fast breathing; or confusion.
• Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
• Very bad dizziness or passing out.
• Feeling confused.
• Strong urges that are hard to control (such as eating, gambling, sex, or spending money).
• Trouble controlling body movements that is new or worse.
• Mental, mood, or behavior changes that are new or worse.
• Hallucinations (seeing or hearing things that are not there).
• Sweating a lot.
• Shortness of breath, a big weight gain, or swelling in the arms or legs.
• Chest pain or pressure.
• Fast or abnormal heartbeat.
• Bruising or dark areas of skin.
• Some people have fallen asleep during activities like driving, eating, or talking. Some people did not feel sleepy and felt alert right before falling asleep. This has happened up to 1 year after Apokyn was started. If you fall asleep during activities, do not drive or do other tasks or actions that call for you to be alert while you take Apokyn. Call your doctor right away if this happens or you feel very sleepy.

What are some other side effects of Apokyn?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Upset stomach or throwing up.
• Runny nose.
• Yawning.
• Irritation where the shot is given.
• Feeling dizzy, sleepy, tired, or weak.
• Headache.
• Joint pain.
• Trouble sleeping.
• Back pain.
• Diarrhea or constipation.
• Pain in arms or legs.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Apokyn?

• Store at room temperature.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer information use and disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Apokyn, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Apokyn or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Apokyn. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.