Apokyn

Apokyn is a prescription medication used in the treatment of acute episodes of reduced mobility, also known as 'off periods', that can occur in advanced Parkinson's disease. Apokyn belongs to a group of drugs called non-ergoline dopamine agonists. These work to treat episodes of reduced mobility through a mechanism which is not yet fully understood, but involves improving motor function through the effects of dopamine.

This medication is available in an injectable form to be given directly under the skin at the onset of an 'off period'. 

Common side effects of Apokyn include yawning, nausea, and runny nose.

Apokyn can also cause dizziness and/or drowsiness. Do not drive or operate heavy machinery until you know how Apokyn affects you.

Apokyn is a prescription medication used in the treatment of acute episodes of reduced mobility, also known as 'off periods', that can occur in advanced Parkinson's disease. These episodes are frequently associated with the timing of other Parkinson's disease medications 'wearing off'.

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

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Serious side effects have been reported with Apokyn. See the “Apokyn Precautions” section.

Common side effects of Apokyn include the following:

• yawning
• drowsiness
• nausea
• runny nose
• chest pain
• hallucinations
• swelling of hands, arms, legs, and feet
• confusion
• insomnia
• headache
• anxiety
• diarrhea

This is not a complete list of Apokyn side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• 5HT3 antagonists including antiemetics such as dolasetron, granisetron, palonosetron, and ondansetron
• dopamine antagonists including neuroleptics such as ziprasidone
• dopamine antagonists such as metoclopramide
• any medications that are predominantly eliminated from your body by your liver. Consult with your pharmacist to help identify any of these medications that you might be taking.
• any medications used in the treatment of high blood pressure
• medications that prolong the QT/QTc Interval

 This is not a complete list of Apokyn drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Apokyn including the following:

• Severe allergic reactions. Severe and potentially life-threatening allergic reactions are possible with Apokyn. Discontinue use and get emergency medical attention immediately if you develop any of the following symptoms of a severe allergic reaction:
  • sudden difficulty breathing
  • sudden and abnormal swelling of the lips, tongue, and/or throat
  • sudden development of a red blister-like skin rash
  • sudden drop in blood pressure
• Blood Clots. Injecting Apokyn into a vein (intravenous) can cause blood clots. Do not inject Apokyn in your vein.
• Nausea and vomiting. Severe nausea and vomiting can happen with Apokyn. Your healthcare provider may prescribe a medicine called trimethobenzamide (Tigan) to help prevent nausea and vomiting. Some patients can stop taking Tigan after using Apokyn for several months. Some patients may need to keep taking Tigan to help prevent nausea and vomiting. Talk to your healthcare provider before you stop taking Tigan.
• Excessive drowsiness during the day. There have been reports of severe episodes of sudden drowsiness in a small number of patients using Apokyn. Your physician will assess your risk for this rare side effect, but it is very important that you notify your physician of any sleeping disorders you have.
• Dizziness. Apokyn can lower your blood pressure and cause dizziness. Dizziness can happen when Apokyn treatment is started or when the Apokyn dose is increased. Do not get up too fast from sitting or after lying down, especially if you have been sitting or lying down for a long period of time.
• Falls. Patients with Parkinson's disease are already at risk of falling due to the nature of the disease. Clinical researchers were unable to determine whether falls that occurred in clinical trials of Apokyn were related to use of Apokyn or only due to underlying Parkinson's disease. Consult with your physician about your risk for falls during treatment with Apokyn.
• Hallucinations and psychotic behavior. Hallucinations and psychotic behavior were reported in a small number of patients during clinical trials with Apokyn. Risk may increase with underlying mental illness. Consult with your physician about your level of risk for developing hallucinations or psychotic behavior during your treatment with Apokyn.
• sudden uncontrolled movements (dyskinesias). Some people with PD may get sudden, uncontrolled movements after treatment with some PD medicines. Apokyn can cause or make dyskinesias worse.
• intense urges. Some people with PD have reported new or increased gambling urges, increased sexual urges, and other intense urges, while taking PD medicines, including Apokyn
• Fainting. In clinical trials, about 2% of patients receiving Apokyn experienced fainting. Consult with your physician about your risk for developing fainting episodes while taking Apokyn.
• Abnormal heart rhythms. Abnormal heart rhythms have been reported in patients receiving Apokyn, especially those already at high risk for developing abnormal heart rhythms. Consult with your physician about your level of risk for developing abnormal heart rhythms during treatment with Apokyn.
• Low blood pressure. Low blood pressure has been known to occur in patients taking medications similar to Apokyn in combination with medications used to treat high blood pressure. Be sure to report all of your medications to your physician prior to beginning treatment with Apokyn.
• Heart problems. Tell your doctor immediately or seek medical attention If you have shortness of breath, fast heartbeat, or chest pain while taking this medication. 
• Injection site reactions. During clinical trials, 26% of patients using Apokyn experienced injection site reactions that included bruising, itching, and other complications. Inform your physician if you have experienced injection site reactions with other medications in the past.
• Fever and confusion. This can happen in some people when their PD medicine is stopped or there is a fast decrease in the dose of their PD medicine.
• Skin cancer (melanoma). Some people with PD may have an increased chance of getting a skin cancer called melanoma. People with PD should have a healthcare provider check their skin for skin cancer regularly.
• Tissue changes. Some people have had changes in the tissues of their pelvis, lungs, and heart valves when taking medicines called nonergot derived dopamine agonists like Apokyn. 
• Drug abuse. Although rare, Apokyn is occasionally abused leading to hallucinations, reduced mobility, and occasional psychotic behavior. Consult with your physician if you have a history of drug abuse prior to beginning treatment with Apokyn.
• Reduced mobility. Although rare, reduced mobility was reported in a small number of patients using Apokyn during clinical trials shortly after receiving Apokyn. Consult with your physician if you believe you are experiencing reduced mobility after administration of Apokyn.
• Priapism. Although rare, painful erections lasting longer than four hours were reported in a small number of male patients during clinical trials of Apokyn. Get medical attention immediately if you experience an erection lasting longer than four hours.

Do not take Apokyn if you

• are allergic to Apokyn, sulfites, or to any of its ingredients
• take 5HT3 antagonists, including antiemetics (e.g., ondansetron, granisetron, dolasetron, palonosetron) and alosetron

Apokyn can also cause dizziness and/or drowsiness. Do not drive or operate heavy machinery until you know how Apokyn affects you.

Do not drink alcohol while you are using Apokyn. It can increase your chance of developing serious side effects.

Do not take medicines that make you sleepy while you are using Apokyn.

Do not change your body position too fast. Get up slowly from sitting or lying. Apokyn can lower your blood pressure and cause dizziness or fainting.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Apokyn, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Apokyn, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Apokyn or to any of its ingredients
• are allergic to any medicines containing sulfites
• have heart disease
• have high blood pressure or take blood-pressure lowering medications
• have any mental illnesses
• have a history of drug abuse
• drink alcohol
• have kidney or liver disease
• have difficulty staying awake during the daytime
• have dizziness
• have fainting spells
• have low blood pressure
• have asthma
• have had a stroke or other brain problems
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Apokyn falls into category C. Based on animal data, may cause fetal harm. There are no well-controlled studies that have been done in pregnant women. Apokyn should be used during pregnancy only if the possible benefit outweighs the possible risk to the unborn baby.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Apokyn crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Apokyn.

Recieve Apokyn exactly as prescribed.

• Apokyn comes in an injectable form to be given directly under the skin, typically at the onset of an 'off period'. 
• Do not inject Apokyn unless you and your caregiver have been taught the correct way and both of you understand all of the directions. Ask your healthcare provider if you do not understand something.
• Your healthcare provider will tell you what dose of Apokyn to use and how often you should take it. Your healthcare provider will also tell you how to change your dose of Apokyn, if needed. Do not change your dose of Apokyn or use it more often unless your healthcare provider has told you to.

Injecting Apokyn:

• Apokyn is a clear and colorless liquid. Do not use Apokyn if it appears cloudy, colored, or to contain particles, and call your pharmacist.
• Choose an injection site on your stomach area, upper arm, or upper leg. Change your injection site each time Apokyn is used, this will lower your chances of having a skin reaction at the site where you inject Apokyn. Do not inject Apokyn into an area of skin that is sore, red, infected or damaged.
• Inject Apokyn under your skin (subcutaneously). Do not inject Apokyn into a vein.
• Keep a record of how much Apokyn you have used each time you inject or your care partner gives you an injection.
• Use a new needle with each injection. Never reuse a needle.
• Do not give another dose of Apokyn sooner than 2 hours after the last dose.
• The maximum dosing is 5 times per day and with total daily doses greater than 2 mL (20 mg).
• Your healthcare provider will prescribe Apokyn that comes in prefilled glass cartridges that are used with a special multiple-dose injector pen.
• Your Apokyn pen is dosed in milliliters (mL), not milligrams (mg). Make sure your prescription tells you how many milliliters (mL) to use.
• Your healthcare provider may prescribe another medicine called an antiemetic to take while you are using Apokyn. Antiemetic medicines help to decrease the symptoms of nausea and vomiting that can happen with Apokyn.
• If you take too much Apokyn, you may experience more side effects than usual and they may be stronger than usual. If you are experiencing severe or serious side effects, such as such as chest pain or prolonged erection lasting more than 4 hours,contact your healthcare provider immediately. If you are unable to contact your healthcare provider, you should have someone take you to the Emergency Room.

Receive this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your age

The recommended dose range of Apokyn for the treatment of acute episodes of reduced mobility associated with advanced Parkinson's disease is 2 mg to 6 mg injected subcutaneously at the onset of an 'off period'.

If you take too much Apokyn, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If Apokyn is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store at room temperature, 68°F to 77°F (20°C to 25°C)
• Keep this and all medicines out of the reach of children