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APOKYN- apomorphine hydrochloride injection


  1. What Is Apokyn?
  2. Do Not Take Apokyn If You Are:
  3. Before You Start Using Apokyn, Tell Your Healthcare Provider If You:
  4. How Should I Use Apokyn?
  5. What Should I Avoid While Using Apokyn?
  6. Apokyn May Cause Serious Side Effects. Call Your Healthcare Provider Right Away If You Have Any Of The Serious Side Effects, Including:
  7. Active Ingredient:
  8. Inactive Ingredients:
  9. Patient Information
  10. Distributed By:

What Is Apokyn? 

APOKYN is a prescription medicine used to treat acute, intermittent episodes of poor mobility called "off" episodes (end-of-dose wearing "off" or unpredictable "on-off" episodes) in people with advanced Parkinson's disease (PD).

It is not known if APOKYN is safe and effective in children.

Do Not Take Apokyn If You Are: 

  • taking certain medicines to treat nausea called 5HT3antagonists including, ondansetron, granisetron, dolasetron, palonosetron, and alosetron. People taking ondansetron together with apomorphine, the active ingredient in APOKYN, have had very low blood pressure and lost consciousness or "blacked out."
  • allergic to apomorphine hydrochloride or to any of the ingredients in APOKYN and experience hives, itching, rash, or swelling (e.g., eyes, tongue, etc.). APOKYN also contains a sulfite called sodium metabisulfite. Sulfites can cause severe, life-threatening allergic reactions in some people. An allergy to sulfites is not the same as an allergy to sulfa. People with asthma are more likely to be allergic to sulfites. Call your healthcare provider if you have hives, itching, rash, swelling of the eyes, tongue, lips, chest pain, trouble breathing or swallowing.

Before You Start Using Apokyn, Tell Your Healthcare Provider If You: 

  • have difficulty staying awake during the daytime
  • have dizziness
  • have fainting spells
  • have low blood pressure
  • have asthma
  • are allergic to any medicines containing sulfites
  • have liver problems
  • have kidney problems
  • have heart problems
  • have had a stroke or other brain problems
  • have a mental problem called a major psychotic disorder
  • drink alcohol
  • are pregnant or plan to become pregnant. It is not known if APOKYN will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if APOKYN passes into your breast milk. You and your healthcare provider should decide if you will take APOKYN or breastfeed. You should not do both.

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

Using APOKYN with certain other medicines may affect each other. Using APOKYN with other medicines can cause serious side effects.

  • If you take nitroglycerin under your tongue while using APOKYN, your blood pressure may decrease and cause dizziness. After taking nitroglycerin, you should lie down and try to continue lying down for at least 45 minutes. You should avoid standing for 45 minutes after taking nitroglycerin.

Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine.

How Should I Use Apokyn? 

  • Read the Instructions for Use starting on page 6 of this leaflet for specific information about the right way to use APOKYN.
  • Use APOKYN exactly as your healthcare provider tells you to use it.
  • Your healthcare provider will tell you how much APOKYN to use and teach you the right way to use it.
  • Your healthcare provider may change your dose if needed.
  • Do notchange your dose of APOKYN or use it more often than prescribed unless your healthcare provider has told you to.
  • Do notgive another dose of APOKYN sooner than 2 hours after the last dose.
  • Your healthcare provider will prescribe APOKYN that comes in prefilled glass cartridges that are used with a special multiple-dose pen injector.
  • Your APOKYN pen is dosed in milliliters (mL),notmilligrams (mg). Make sure your prescription tells you how many milliliters (mL) to use.
  • Inject APOKYN under your skin (subcutaneously).Do notinject 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.
  • APOKYN is a clear and colorless liquid. Do not use APOKYN if it appears cloudy, colored, or to contain particles, and call your pharmacist.
  • 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, call your healthcare provider. If you experience severe or serious side effects such as chest pain or prolonged erection lasting more than 4 hours, go to the nearest hospital emergency room.

What Should I Avoid While Using Apokyn? 

  • Do notdrink alcohol while you are using APOKYN. It can increase your chance of developing serious side effects.
  • Do nottake medicines that make you sleepy while you are using APOKYN.
  • Do notdrive, operate machinery, or do other dangerous activities until you know how APOKYN affects you.
  • Do notchange your body position too fast. Get up slowly from sitting or lying. APOKYN can lower your blood pressure and cause dizziness or fainting.

Apokyn May Cause Serious Side Effects. Call Your Healthcare Provider Right Away If You Have Any Of The Serious Side Effects, Including: 

  • allergic reaction. An allergic reaction with side effects of hives, itching, rash, swelling (e.g., eyes, tongue, etc.); trouble breathing and/or swallowing may occur after injecting APOKYN.
  • blood clots.Injecting APOKYN into a vein (intravenous) can cause blood clots.Do notinject 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.
  • sleepiness or falling asleep during the day.Some people treated with APOKYN may get sleepy during the day or fall asleep without warning while doing everyday activities such as talking, eating, or driving a car.
  • 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 notget 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.The changes that can happen with Parkinson's disease (PD), and the effects of some PD medicines, can increase the risk of falling. APOKYN may also increase your risk of falling.
  • hallucinations or psychotic-like behavior.APOKYN can cause or worsen psychotic-like behavior including hallucinations (

    • Store APOKYN at room temperature, 68 F to 77 F (20 C to 25 C).
    • Safely throw away medicine that is out of date or no longer needed.

    Keep APOKYN and all medicines out of the reach of children.

    General information about the safe and effective use of APOKYN.

    Medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. Do not use APOKYN for a condition for which it was not prescribed. Do not give APOKYN to other people, even if they have the same symptoms that you have. It may harm them.

    This Patient Information leaflet summarizes the most important information about APOKYN. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about APOKYN that is written for health professionals.

    For more information, go towww.apokyn.comor call 1-877-727-6596.

Active Ingredient: 

apomorphine hydrochloride, USP

Inactive Ingredients: 

sodium metabisulfite, NF, benzyl alcohol, NF, water for injection, USP. It may also contain sodium hydroxide, NF and/or hydrochloric acid, NF.

This Patient Information and Instructions for Use has been approved by the U.S. Food and Drug Administration.

Distributed by: US WorldMeds, LLC
Louisville, KY 40241
Revised: 05 2019

US WorldMeds, LLC is the exclusive licensee and distributor of APOKYN in the United States and Its territories.
2019. APOKYN is a registered trademark of BRITUSWIP.

INS10001.02

BD MedicalPharmaceutical Systems
1 Becton Drive
Franklin Lakes, NJ 07417, USA

BD and BD Logo are trademarks of Becton, Dickinson and Company.
2019. BD

Patient Information 

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use)

Administration with the APOKYN Pen

Instruct patients and caregivers that the APOKYN Pen is dosed in milliliters, not milligrams.

Inform patients and caregivers that it is possible to dial in their usual dose of APOKYN even though the cartridge may contain less than that amount of drug. In this case, they will receive only a partial dose with the injection, and the amount left to inject will appear in the dosing window. To complete the correct dose, patients/caregivers will need to "re-arm" the device and dial in the correct amount of the remaining dose. Patients and caregivers should be alerted to the fact that there may be insufficient drug left in the cartridge to deliver a complete dose (for example, patients and caregivers should be urged to keep records of how many doses they have delivered for each cartridge, so that they can replace any cartridge that has an inadequate amount of drug remaining).

Instruct patients to rotate the injection site and to observe proper aseptic technique.

Advise patients that APOKYN is intended only for subcutaneous injection and must not be given intravenously because of the risk of serious complications such as thrombus formation and pulmonary embolism due to crystallization[seeWarnings and Precautions (5.1)].

Hypersensitivity / Allergic Reactions

Advise patients that hypersensitivity/allergic reaction characterized by urticaria, rash, pruritus, and/or various manifestations of angioedema may occur because of APOKYN or any of its excipients including a sulfite (i.e., sodium metabisulfite). Inform patients with a sulfite sensitivity that they may experience various allergic-type reactions, including anaphylactic symptoms and life-threatening asthmatic attacks[seeWarnings and Precautions (5.12)].Advise patients who experience any hypersensitivity/allergic reaction to APOKYN that they should not take APOKYN again[seeContraindications (4)].

Nausea and Vomiting

Advise patients that they may experience severe nausea and/or vomiting and that they should begin taking trimethobenzamide 300 mg orally 3 times per day for 3 days prior to starting APOKYN injections. Advise patients that APOKYN taken with trimethobenzamide may increase the risks for somnolence, dizziness, and falls. Inform patients that their healthcare provider will tell them when trimethobenzamide can be discontinued[seeWarnings and Precautions (5.2)].

Falling Asleep Suddenly and Sedation / Sleepiness

Alert patients to the potential sedating effects of APOKYN, including somnolence and falling asleep while engaged in activities of daily living. Instruct patients not to drive a car or engage in other potentially dangerous activities until they have gained sufficient experience with APOKYN to gauge whether or not it affects their mental and/or motor performance adversely. Advise patients that if increased somnolence or episodes of falling asleep during activities of daily living (e.g., watching television, passenger in a car, etc.) occur, they should not drive or participate in potentially dangerous activities until they have contacted their physician. Because of possible additive effects of alcohol use, advise patients to limit their alcohol intake[seeWarnings and Precautions (5.3)].

Hypotension / Orthostatic Hypotension

Advise patients that they may develop postural (orthostatic) hypotension with or without symptoms such as dizziness, nausea, syncope, and sometimes sweating. Hypotension and/or orthostatic symptoms may occur more frequently during initial therapy or with an increase in dose at any time (cases have been seen after months of treatment). Instruct patients to rise slowly after sitting or lying down after taking APOKYN. Inform patients that alcohol and nitroglycerin (and possibly other vasodilators and antihypertensive medications) may potentiate the hypotensive effect of APOKYN[seeWarnings and Precautions (5.4)].Instruct patients ideally to lie down before taking sublingual nitroglycerin and to remain supine and avoid standing for at least 45 minutes after nitroglycerin. Instruct patients taking APOKYN to avoid alcohol while using APOKYN and of the increased hypotensive effects of APOKYN taken with nitroglycerin or by taking APOKYN after alcohol ingestion.

Falls

Alert patients that they may have increased risk for falling when using APOKYN[seeWarnings and Precautions (5.5)].

Hallucinations and/or Psychotic-Like Behavior

Inform patients that hallucinations or other manifestations of psychotic-like behavior can occur. Tell patients if they have a major psychotic disorder, ordinarily they should not use APOKYN because of the risk of exacerbating the psychosis. Patients with a major psychotic disorder should also be aware that many treatments for psychosis may decrease the effectiveness of APOKYN[seeWarnings and Precautions (5.6)].

Dyskinesia

Inform patients that APOKYN may cause and/or exacerbate pre-existing dyskinesias[seeWarnings and Precautions (5.7)].

Impulse Control / Compulsive Behaviors

Patients and their caregivers should be alerted to the possibility that they may experience intense urges to spend money uncontrollably, intense urges to gamble, increased sexual urges, binge eating and/or other intense urges and the inability to control these urges while taking APOKYN[seeWarnings and Precautions (5.8)].

Coronary Events

Inform patients that APOKYN may cause coronary events including angina and myocardial infarction and these outcomes could possibly be related to significant hypotension/orthostatic hypotension[seeWarnings and Precautions (5.9)].

QTc Prolongation and Potential for Proarrhythymic Effects

Alert patients that APOKYN may cause QTc prolongation and might produce proarrhythmic effects that could cause torsades de pointes and sudden death. Palpitations and syncope may signal the occurrence of an episode of torsades de pointes[seeWarnings and Precautions (5.10)].

Withdrawal-Emergent Hyperpyrexia and Confusion

Advise patients to contact their healthcare provider if they wish to discontinue APOKYN or decrease the dose of APOKYN[seeWarnings and Precautions (5.11)].

Priapism

Advise patients that APOKYN may cause prolonged painful erections and that if this occurs that they should seek medical attention immediately[seeWarnings and Precautions (5.14)].

Injection Site Reactions

Inform patients that injections of APOKYN may result in injection site reactions including bruising, granuloma, and pruritus[seeAdverse Reactions (6.1)].

Distributed By: 

US WorldMeds, LLC
4441 Springdale Rd
Louisville, KY 40241

US WorldMeds, LLC is the exclusive licensee and distributor of APOKYN in the United States and Its territories.

2019. APOKYN is a registered trademark of BRITUSWIP.



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