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Apokyn

Last reviewed on RxList: 3/31/2017
Apokyn Side Effects Center

Last reviewed on RxList 3/31/2017

Apokyn (apomorphine hydrochloride injection) is a dopamine agonist, which works by helping restore the balance of dopamine in the brain, used to treat "wearing-off" episodes (muscle stiffness, loss of muscle control) in people with advanced Parkinson's disease. Common side effects of Apokyn include:

  • injection site reactions (redness, swelling, pain, itching, bruising, or hardening of the skin),
  • nausea,
  • vomiting,
  • headache,
  • increased sweating,
  • dizziness,
  • drowsiness,
  • yawning,
  • runny nose,
  • swelling in your hands or feet,
  • pale skin,
  • flushing (warmth, redness, or tingly feeling),
  • sudden uncontrolled movements, or
  • hallucinations (seeing and hearing things that are not real).

Tell your doctor if you have unlikely but serious side effects of Apokyn including:

  • uncontrolled movements,
  • mental/mood changes (e.g., depression, hallucinations, trouble sleeping),
  • muscle cramps or spasm,
  • swelling of the hands/legs/ankles/feet, or
  • unusual strong urges (such as increased gambling, increased sexual urges).

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.

Apokyn Consumer Information

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)

Apokyn Professional Information

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)

Related Resources for Apokyn

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Read the Apokyn User Reviews »

© Apokyn Patient Information is supplied by Cerner Multum, Inc. and Apokyn Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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