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Apokyn

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Apokyn

Apokyn

Apokyn Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Apokyn (apomorphine hydrochloride injection) is used to treat "wearing-off" episodes (muscle stiffness, loss of muscle control) in people with advanced Parkinson's disease. It is a dopamine agonist, which works by helping restore the balance of dopamine in the brain. Common side effects include redness/swelling/pain/itching at the injection site, nausea, vomiting, headache, sweating, dizziness, drowsiness, yawning, or runny nose.

Apokyn is administered by subcutaneous (under the skin) injection. The dose is adjusted based on effectiveness and tolerance, starting at 0.2 mL (2 mg) and up to a maximum recommended dose of 0.6 mL (6 mg). Apokyn may interact with arsenic trioxide, bepridil, blood pressure medications, cisapride, chloroquine, halofantrine, metoclopramide, niacin, erectile dysfunction medications, narcotics, antibiotics, medicines to treat psychiatric disorders, or heart rhythm medicines. Tell your doctor all medications and supplements you use. During pregnancy, Apokyn should be used only when prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Apokyn (apomorphine hydrochloride) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Apokyn in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • nausea or vomiting that continues after taking an anti-nausea medication;
  • feeling like you might pass out;
  • dizziness, fainting, fast or pounding heartbeat, feeling short of breath;
  • depression, confusion, hallucinations, unusual or inappropriate behavior;
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • slow heart rate, weak pulse, fainting, slow breathing (breathing may stop);
  • severe headache;
  • worsening of your Parkinson symptoms;
  • twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs; or
  • penis erection that is painful or lasts 4 hours or longer.

Less serious side effects may include:

  • drowsiness, yawning;
  • runny nose;
  • swelling in your hands or feet;
  • pale skin, increased sweating;
  • flushing, (warmth, redness, or tingly feeling); or
  • bruising, redness, pain, itching, or hardening of your skin where the injection was given.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Apokyn (Apomorphine) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Apokyn Overview - Patient Information: Side Effects

SIDE EFFECTS: 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 immediately if any of these unlikely but serious side effects occur: uncontrolled movements, mental/mood changes (e.g., depression, hallucinations, trouble sleeping), muscle cramps/spasm, swelling of the hands/legs/ankles/feet, compulsive behaviors (such as gambling).

Seek immediate medical attention if any of these rare but very serious side effects occur: 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 reported falling asleep suddenly during their usual daily activities (e.g., talking on the phone, driving). In some cases, sleep occurred without any feelings of drowsiness beforehand. This sleep effect may occur any time during treatment. Therefore, you should not drive or take part in other possibly dangerous activities until you are certain that this medication will not cause drowsiness or sudden sleep. 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 is increased with use of alcohol or other medications that can make you drowsy.

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, seek immediate medical attention 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.

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

Read the entire patient information overview for Apokyn (Apomorphine)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Apokyn FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Clinical Trial Experience

Adverse Events Incidence in Controlled Clinical Studies

APOKYN® (apomorphine) has been administered to 550 Parkinson's disease patients who were taking some form of L-Dopa along with other Parkinson's disease medications. Eighty-six percent of patients were taking a concomitant dopamine agonist. All patients had some degree of spontaneously occurring hypomobility (“off episodes”) at baseline. Adverse events were recorded by the clinical investigators using terminology of their own choosing. To provide a meaningful estimate of the proportion of individuals having adverse events, similar types of events were grouped into a smaller number of standardized categories using MEDDRA dictionary terminology.

The most common adverse events seen in controlled trials were yawning, dyskinesias, nausea and/or vomiting, somnolence, dizziness, rhinorrhea, hallucinations, edema, chest pain, increased sweating, flushing, and pallor.

The most extensive experience with apomorphine in randomized, controlled trials comes from a multicenter randomized placebo-controlled parallel group trial conducted in apomorphine-na´ve PD patients treated for up to 4 weeks (Table 1). Individual apomorphine doses in this trial ranged from 2-10 mg, optimized to achieve control of symptoms comparable to each patient's response to his or her usual dose of L-dopa. The prescriber should be aware that these figures cannot be used to predict the incidence of adverse events in the course of usual medical practice where patient characteristics and other factors differ from those that prevailed in the clinical studies. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators. However, the cited figures do provide the prescribing physician with some basis for estimating the relative contribution of drug and nondrug factors to the adverse-event incidence rate in the population studied.

Table 1 : Summary of Adverse Events Occurring in Two or More Patients

Adverse Event APOMORPHINE
n = 20
PLACEBO
n = 9
N % N %
Any Adverse Reaction 17 85 8 89
Yawning 8 40 0 0
Dyskinesias 7 35 1 11
Drowsiness or Somnolence 7 35 0 0
Nausea and/or Vomiting 6 30 1 11
Dizziness or Postural Hypotension 4 20 0 0
Rhinorrhea 4 20 0 0
Chest Pain/Pressure/Angina 3 15 1 11
Hallucination or Confusion 2 10 0 0
Edema/Swelling of Extremities 2 10 0 0

Other Adverse Events Observed During All Phase 2/3 Clinical Trials

APOKYN (apomorphine) has been administered to 550 patients; 89% had at least one adverse event (AE). The most common AEs in addition to those in Table 1 (occurring in at least 5% of the patients and at least plausibly related to treatment) in descending order were injection site complaint, fall, arthralgia, insomnia, headache, depression, urinary tract infection, anxiety, congestive heart failure, limb pain, back pain, Parkinson's disease aggravated, pneumonia, confusion, sweating increased, dyspnea, fatigue, ecchymosis, constipation, diarrhea, weakness, and dehydration.

Post Marketing Experience

In addition to the adverse events reported during clinical trials, the following adverse reactions have been identified during post-approval use of APOKYN® (apomorphine) in Parkinson's disease patients. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following psychiatric disorders were reported: impulse control symptoms, pathological gambling, and increased libido (including hypersexuality).

Drug Abuse And Dependence

Potential for Abuse

A rarely reported motivation for apomorphine abuse (escalation of dose beyond prescribed frequency) is the use of apomorphine to attempt to avoid all symptoms of all “off” events when “off” events occur frequently. A second, rarely reported, motivation for apomorphine abuse is a psychosexual reaction related to the stimulation of penile erection and increase in libido. Adverse events that have been reported in males with overuse include frequent penile erections, atypical sexual behavior, heightened libido, dyskinesias, agitation, confusion, and depression. No studies have been conducted to evaluate the potential for dependence when apomorphine is used as acute (rescue) treatment of “off” episodes in the patients with “on/off” or “wearing-off” effects associated with late stage Parkinson's disease.

Read the entire FDA prescribing information for Apokyn (Apomorphine) »

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Apokyn - User Reviews

Apokyn User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Apokyn sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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