Apomorphine Sublingual

Apomorphine sublingual is used to treat ''off'' episodes (times of difficulty moving, walking, and speaking that may happen as medication wears off or at random) in people with advanced Parkinson's disease (PD; a disorder of the nervous system that causes difficulties with movement, muscle control, and balance). Apomorphine is in a class of medications called dopamine agonists. It works by acting in place of dopamine, a natural substance produced in the brain that is needed to control movement.

Apomorphine comes as a sublingual film to take under the tongue. Apomorphine sublingual is usually used when needed, according to your doctor's directions. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use apomorphine sublingual exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

Do not use a second dose of apomorphine sublingual for treatment of the same "off" episode. Wait at least 2 hours between doses and do not use more than 5 doses a day.

Your doctor will give you another medication called trimethobenzamide to take when you begin to use apomorphine sublingual. This medication will help decrease your chance of developing nausea and vomiting while you are using apomorphine, especially during the beginning of treatment. Your doctor will probably tell you to begin taking trimethobenzamide 3 days before you begin to use apomorphine, and to continue taking it for up to 2 months. You should know that taking trimethobenzamide along with apomorphine may increase your risk of drowsiness, dizziness, and falls. However, do not stop taking trimethobenzamide without first talking to your doctor.

You will receive your first dose of apomorphine in a medical office where your doctor can closely monitor your condition to determine your dose. After that, your doctor will tell you to use apomorphine sublingual at home and to monitor for adverse effects.

To use apomorphine sublingual film, follow these steps:

1. Drink water to moisten your mouth.
2. Open the pouch using the wing tabs. Make sure to place your fingers directly on the raised dots on each wing tab. Gently pull the wing tabs apart to open the pouch. Do not open the foil package until you are ready to use the medication. Do not cut or tear the film.
3. Hold apomorphine sublingual film between your fingers by the outside edges and remove the entire film from the pouch. Use apomorphine sublingual film whole. If it is broken, discard it and use a new dose.
4. Place entire sublingual film under your tongue as far back under your tongue as you can. Close your mouth.
5. Leave the film in place until it dissolves completely. It may take 3 minutes for the film to dissolve. Do not chew or swallow the film. Do not swallow your saliva or talk as the film dissolves.
6. Open your mouth to see if the film has completely dissolved.
7. After the sublingual film has completely dissolved, you may swallow again.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

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

Before using apomorphine,

• tell your doctor and pharmacist if you are allergic to apomorphine, any other medications, sulfites, or any other ingredients in apomorphine sublingual. Ask your pharmacist for a list of the ingredients.
• Some medications should not be taken with apomorphine. Make sure you have discussed any medications you are currently taking or plan to take before starting apomorphine with your doctor and pharmacist. Before starting, stopping or changing any medications while taking apomorphine, please get the advice of your doctor or pharmacist.
• tell your doctor if you drink alcohol or if you have or have ever had a prolonged QT interval (a rare heart problem that may cause irregular heartbeat, fainting, or sudden death), fainting spells, low levels of potassium or magnesium in the blood, a slow or irregular heartbeat, low blood pressure, a sleep disorder, a stroke, mini-stroke, or other brain problems, asthma, sudden uncontrolled movements and falls, mental illness, or heart, kidney, or liver disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while using apomorphine sublingual, call your doctor.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are using apomorphine sublingual.
• you should know that apomorphine may make you drowsy. Do not drive a car, operate machinery, or do anything that might put you at risk of getting hurt until you know how this medication affects you.
• you should not drink alcohol while you are using apomorphine. Alcohol can make the side effects from apomorphine worse.
• you should know that apomorphine may cause dizziness, lightheadedness, nausea, sweating, and fainting when you get up too quickly from a lying or sitting position. This is more common when you first start using apomorphine or increase your dose. To avoid this problem, get out of bed or get up from a seated position slowly, resting your feet on the floor for a few minutes before standing up.
• you should know that some people who have taken medications such as apomorphine have developed gambling problems or other intense urges or behaviors that were compulsive or unusual for them, such as increased sexual urges or behaviors. There is not enough information to tell whether the people developed these problems because they took the medication or for other reasons. Call your doctor if you have an urge to gamble that is difficult to control, you have intense urges, or you are unable to control your behavior. Tell your family members about this risk so that they can call the doctor even if you do not realize that your gambling or any other intense urges or unusual behaviors have become a problem.
• you should know that you may suddenly fall asleep during your regular daily activities while you are using apomorphine sublingual. You may not feel drowsy before you fall asleep. If you suddenly fall asleep while you are doing an everyday activity such as eating, talking, or watching television, call your doctor. Do not drive a car or operate machinery until you talk to your doctor.

Unless your doctor tells you otherwise, continue your normal diet.

This medication is usually used as needed.

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

• nausea
• vomiting
• dry mouth
• headache
• runny nose
• tiredness
• excessive sweating

Some side effects can be serious. If you experience any of these symptoms or those listed in SPECIAL PRECAUTIONS, call your doctor immediately or get emergency medical treatment:

• rash; hives; itching; swelling of the face, throat, tongue, or lips; flushing; throat tightness; or difficulty breathing or swallowing
• falling down
• hallucinations (seeing things or hearing voices that do not exist), aggressive behavior, agitation, feeling like people are against you, or disorganized thoughts
• high fever, stiff muscles, changes in breathing or heartbeat, or confusion
• shortness of breath, fast heartbeat, chest pain, or fainting
• painful erection that does not go away
• pale skin, dizziness, fast heartbeat, confusion, yellow skin or eyes, fever, unusual tiredness or weakness, chest pain, dark colored urine, shortness of breath, or trouble breathing
• mouth redness, sores, dryness, swelling, or pain
• pain with swallowing

Some laboratory animals that were given apomorphine as an injection developed eye disease. It is not known if apomorphine sublingual increases the risk of eye disease in humans. Talk to your doctor about the risks of using this medication.

Apomorphine sublingual may cause other side effects. Call your doctor if you have any unusual problems while using 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).

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).

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.

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.

Keep all appointments with your doctor.

Do not let anyone else use 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.

• Kynmobi^®