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Apokyn

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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

The following adverse reactions are discussed in more detail in the WARNINGS AND PRECAUTIONS section of labeling:

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, the incidence of adverse reactions (number of unique patients experiencing an adverse reaction associated with treatment per total number of patients treated) observed in the clinical trials of a drug cannot be directly compared to the incidence of adverse reactions in the clinical trials of another drug and may not reflect the incidence of adverse reactions observed in practice.

In placebo-controlled trials, most patients received only one subcutaneous dose of APOKYN. All patients received concomitant levodopa and 86% received a concomitant dopamine agonist. All patients had some degree of spontaneously occurring periods of hypomobility (“off episodes”) at baseline.

The most common adverse reactions (APOKYN incidence at least 10% greater than placebo incidence) observed in a placebo-controlled trial were yawning, drowsiness/somnolence, dyskinesias, dizziness/postural hypotension, rhinorrhea, nausea and/or vomiting, hallucination/confusion, and edema/swelling of extremities.

Table 1 presents the most common adverse reactions reported by APOKYN-na´ve Parkinson's disease patients who were enrolled in a randomized placebo-controlled, parallel group trial and who were treated for up to 4 weeks (Study 1) [see Clinical Studies Individual APOKYN doses in this trial ranged from 2 mg to 10 mg, and were titrated to achieve tolerability and control of symptoms.

Table 1: Adverse Reactions Occurring in Two or More APOKYN-Treated Patients in Study 1

  APOKYN
(n = 20) %
PLACEBO
(n = 9) %
Yawning 40 0
Dyskinesias 35 11
Drowsiness or Somnolence 35 0
Nausea and/or Vomiting 30 11
Dizziness or Postural Hypotension 20 0
Rhinorrhea 20 0
Chest Pain/Pressure/Angina 15 11
Hallucination or Confusion 10 0
Edema/Swelling of Extremities 10 0

Other Adverse Reactions

Injection Site Reactions

Patients treated with APOKYN subcutaneous injections during clinical studies, 26% of patients had injection site reactions, including bruising (16%), granuloma (4%), and pruritus (2%).

In addition to those in Table 1, the most common adverse reactions in pooled APOKYN trials (occurring in at least 5% of the patients) in descending order were injection site reaction, 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.

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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