APOKYN

This medication is used to treat the symptoms of Parkinson's disease. It can improve your ability to move during frequent "off" periods. It can decrease shakiness (tremor), stiffness, slowed movement, and unsteadiness. This medication is thought to work by helping to restore the balance of a certain natural substance (dopamine) in the brain.

Apomorphine is used to treat "off" episodes when they occur. It is not used to prevent "off" episodes. This drug should not be used instead of your usual medications for Parkinson's disease. Continue taking all your medications as directed by your doctor.

Read the Patient Information Leaflet and Instructions for Use if available from your pharmacist before you start using apomorphine and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

Learn all preparation and usage instructions in the product package. If any of the information is unclear, consult your doctor or pharmacist.

Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Check the dose carefully before injecting. Apomorphine is given by the milliliter, not by the milligram. There are 10 milligrams of drug in each milliliter of this liquid, so if the wrong measuring unit is used, you may accidentally inject 10 times the amount of drug you need. Be sure you have the correct dose to prevent accidental overdose. If you are not sure how to measure your dose correctly, consult your pharmacist before injecting.

If you are using the prefilled cartridge/pen, keep track of the doses used to make sure there is enough medication left in the device to give you a full dose.

Clean the injection site before injecting. Inject this medication under the skin as needed to treat decreased/frozen muscle movement ("off" episode) as directed by your doctor. You may need to use this medication several times a day. Do not use a second injection for the same "off" episode. Wait at least 2 hours between injections.

Do not inject this medication into a vein. It is important to change the location of the injection site with each dose to avoid problem areas under the skin. Therefore, choose a different injection site with each dose. The abdomen, thighs, and upper arms are recommended sites for the injection. Do not inject into skin that is irritated, sore, or infected. Learn how to store and discard needles and medical supplies safely. Never reuse syringes or needles. Consult your pharmacist for details.

Dosage is based on your medical condition and response to treatment. To decrease the risk of side effects (e.g., nausea, drowsiness, low blood pressure) when you first start using apomorphine, your doctor will slowly increase your dosage until the best dose for you is reached. Your doctor will usually have you use the first dose in the office where your blood pressure can be checked and you can be watched for side effects. A health care professional will also teach you to inject this medication correctly. Nausea is very common with this medication. To decrease the risk of nausea, your doctor may direct you to start taking another medication (e.g., trimethobenzamide) 3 days before your first dose of apomorphine and to continue taking as directed for up to 2 months.

Use this medication as prescribed. If you stop using this medication for longer than 1 week, you may need to increase your dose slowly back to your previous dosage. Talk with your doctor about how to restart the medication. Do not stop using this medication without your doctor's approval.

If you are using this medication frequently and suddenly stop using it, you may have withdrawal symptoms (such as fever, muscle stiffness, confusion). To help prevent withdrawal, your doctor may lower your dose slowly. Withdrawal is more likely if you have used apomorphine for a long time or in high doses. Tell your doctor or pharmacist right away if you have withdrawal.

Rarely, abnormal drug-seeking behavior (drug abuse) is possible with this medication. Do not increase your dose or use it more frequently than prescribed. Properly stop the medication when so directed.

Tell your doctor if your condition persists or worsens.

Redness/swelling/pain/itching at the injection site, nausea, vomiting, headache, sweating, dizziness, drowsiness, yawning, or runny nose may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: uncontrolled movements, mental/mood changes (e.g., depression, hallucinations, trouble sleeping), muscle cramps/spasm, swelling of the hands/legs/ankles/feet, unusual strong urges (such as increased gambling, increased sexual urges).

Get medical help right away if you have any very serious side effects, including: chest pain, shortness of breath, unusually fast/pounding/irregular heartbeat, severe dizziness, fainting, slurred speech, vision changes, weakness on one side of the body.

Some people using apomorphine have fallen asleep suddenly during their usual daily activities (such as talking on the phone, driving). In some cases, sleep occurred without any feelings of drowsiness beforehand. This sleep effect may occur anytime during treatment with apomorphine even if you have used this medication for a long time. If you experience increased sleepiness or fall asleep during the day, do not drive or take part in other possibly dangerous activities until you have discussed this effect with your doctor. Your risk of this sleep effect is increased by using alcohol or other medications that can make you drowsy. See also Precautions section.

You may also develop a sudden drop in blood pressure that can cause dizziness, nausea, and fainting. This effect may also increase your risk of a fall. This drop in blood pressure is more likely when you are first starting the medication, when your dose is increased, or when you get up suddenly. To lower your risk, get up slowly from a sitting or lying position. Avoid alcohol.

For males, in the very unlikely event you have a painful, prolonged erection (lasting more than 4 hours), stop using this drug and seek immediate medical attention, or permanent problems could occur.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using apomorphine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as sulfites), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: asthma, heart problems (e.g., chest pain, heart attack), slow/fast/irregular heartbeat (e.g., arrhythmia), mental/mood disorders (e.g., confusion, hallucinations, psychosis, schizophrenia), kidney problems, liver problems, symptoms of low blood pressure (e.g., dizziness, fainting), sleep disorder (e.g., sleep apnea, narcolepsy), stroke or other brain problem.

Apomorphine may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.

The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using apomorphine, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using apomorphine safely.

This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis). See also Side Effects section.

Older adults may be at greater risk for the side effects of this drug, especially falls, hallucinations, and QT prolongation (see above).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Syringes can be filled the night before use and stored in the refrigerator until the next day. Discard this type of pre-filled syringe if not used in 24 hours.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: alosetron, antipsychotics (e.g., chlorpromazine, haloperidol, thiothixene), certain drugs for nausea (including metoclopramide, phenothiazines such as prochlorperazine, serotonin blockers such as ondansetron, granisetron), drugs for high blood pressure (including beta blockers such as atenolol), vasodilators (e.g., nitrates), "water pills" (diuretics such as furosemide, thiazides).

Many drugs besides apomorphine may affect the heart rhythm (QT prolongation), including amiodarone, dofetilide, pimozide, procainamide, quinidine, sotalol, macrolide antibiotics (such as erythromycin), among others.

Tell your doctor or pharmacist if you are taking other products that cause drowsiness including alcohol, marijuana (cannabis), antihistamines (such as cetirizine, diphenhydramine), drugs for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), and opioid pain relievers (such as codeine, hydrocodone).

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: very severe nausea/vomiting, loss of consciousness.

Not applicable.

Do not share this medication with others.

People with Parkinson's disease may have an increased risk for developing skin cancer (melanoma). Tell your doctor promptly if you notice a change in the appearance or size of moles or other unusual skin changes. Ask your doctor if you should have regular skin exams.