Apokyn Side Effects Center

Last updated on RxList: 5/13/2022
Apokyn Side Effects Center

What Is Apokyn?

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.

What Are Side Effects of Apokyn?

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).

Dosage for Apokyn

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).

What Drugs, Substances, or Supplements Interact with Apokyn?

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.

Apokyn During Pregnancy and Breastfeeding

During pregnancy, Apokyn should be used only when prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

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.

QUESTION

Parkinson's disease is only seen in people of advanced age. See Answer
Apokyn Consumer Information

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

Call your doctor at once if you have:

  • a light-headed feeling, like you might pass out;
  • extreme drowsiness, falling asleep suddenly, even after feeling alert;
  • confusion, hallucinations, unusual thoughts or behavior;
  • twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs;
  • fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out);
  • ongoing nausea or vomiting (even after taking anti-nausea medicine);
  • (with apomorphine sublingual) mouth pain, tingling or ulcers, red or swollen gums, dry lips or mouth, pain when swallowing;
  • new or worsening cough, fever, pain when you breathe, feeling short of breath while lying down;
  • penis erection that is painful or lasts 4 hours or longer;
  • worsening of your Parkinson symptoms; or
  • severe nervous system reaction--very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out.

Serious side effects may be more likely in older adults.

You may have increased sexual urges, unusual urges to gamble, or other intense urges while using this medicine. Talk with your doctor if this occurs.

Common side effects may include:

  • dizziness, drowsiness;
  • nausea, vomiting;
  • pain or swelling in your nose, mouth, or throat;
  • numbness, tingling, burning pain;
  • swelling in your hands or feet;
  • confusion, hallucinations;
  • yawning;
  • runny nose; or
  • uncontrolled muscle movements.

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)

SLIDESHOW

Dementia, Alzheimer's Disease, and Aging Brains See Slideshow
Apokyn Professional Information

SIDE EFFECTS

The following serious adverse reactions are discussed in more detail in the Warnings and Precautions section of labeling:

  • Serious Adverse Reactions After Intravenous Administration [see WARNINGS AND PRECAUTIONS]
  • Nausea and Vomiting [see WARNINGS AND PRECAUTIONS]
  • Falling Asleep During Activities of Daily Living and Somnolence [see WARNINGS AND PRECAUTIONS]
  • Syncope/Hypotension/Orthostatic Hypotension [see WARNINGS AND PRECAUTIONS]
  • Falls [see WARNINGS AND PRECAUTIONS]
  • Hallucinations/Psychotic-Like Behavior [see WARNINGS AND PRECAUTIONS]
  • Dyskinesias [see WARNINGS AND PRECAUTIONS]
  • Impulse Control/Compulsive Behaviors [see WARNINGS AND PRECAUTIONS]
  • Coronary Events [see WARNINGS AND PRECAUTIONS]
  • QTc Prolongation and Potential for Proarrhythymic Effects [see WARNINGS AND PRECAUTIONS]
  • Withdrawal-Emergent Hyperpyrexia and Confusion [see WARNINGS AND PRECAUTIONS]
  • Hypersensitivity [see WARNINGS AND PRECAUTIONS]
  • Fibrotic Complications [see WARNINGS AND PRECAUTIONS]
  • Priapism [see WARNINGS AND PRECAUTIONS]

Clinical Trials 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-naïve 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 PLACEBO
(n = 20) % (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.

DRUG INTERACTIONS

5HT3 Antagonists

Based on reports of profound hypotension and loss of consciousness when APOKYN was administered with ondansetron, the concomitant use of APOKYN with 5HT3 antagonists including antiemetics (for example, ondansetron, granisetron, dolasetron, palonosetron) and alosetron, is contraindicated.

Antihypertensive Medications And Vasodilators

In clinical studies, the following adverse events were experienced more commonly in patients receiving concomitant antihypertensive medications or vasodilators (n=94) than in patients not receiving these medications (n=456): hypotension (10% vs 4%)[see WARNINGS AND PRECAUTIONS], myocardial infarction (3% vs 1%), serious pneumonia (5% vs 3%), serious falls (9% vs 3%), and bone and joint injuries (6% vs 2%). Some of the events may be related to the increased incidence of hypotension in patients receiving concomitant antihypertensive medications or vasodilators [see WARNINGS AND PRECAUTIONS].

Concomitant administration of 0.4 mg sublingual nitroglycerin with APOKYN in healthy subjects causes greater decreases in blood pressure compared to APOKYN alone. When nitroglycerin and APOKYN were concomitantly administered to healthy subjects, the mean largest decrease (the mean of each subject’s largest drop in blood pressure measured within the 6-hour period following administration of APOKYN) in supine systolic and diastolic blood pressure (measured over 6 hours) was 9.7 mm Hg and 9.3 mm Hg, respectively [see CLINICAL PHARMACOLOGY]. The mean largest decrease in standing systolic and diastolic blood pressure was 14.3 mm Hg and 13.5 mm Hg, respectively. Some individuals experienced very large decreases in standing systolic and diastolic blood pressure, up to a maximum decrease of 65 mm Hg and 43 mm Hg, respectively.

In comparison, the mean largest decrease in supine systolic and diastolic blood pressure when APOKYN was administered alone was 6.1 mm Hg and 7.3 mm Hg, respectively, and in standing systolic and diastolic blood pressure was 6.7 mm Hg and 8.4 mm Hg, respectively.

Patients taking APOKYN should lie down before and after taking sublingual nitroglycerin [see WARNINGS AND PRECAUTIONS].

Alcohol

Concomitant administration of high dose (0.6 g/kg) or low dose (0.3 g/kg) ethanol with APOKYN in healthy subjects causes greater decreases in blood pressure compared to APOKYN alone.

When high dose ethanol and APOKYN were concomitantly administered to healthy subjects, the mean largest decrease (the mean of each subject’s largest drop in blood pressure measured within the 6-hour period following administration of APOKYN) for supine systolic and diastolic blood pressure was 9.1 mm Hg and 10.5 mm Hg, respectively [see CLINICAL PHARMACOLOGY]. The mean largest standing systolic and diastolic blood pressure decrease was 11.3 mm Hg and 12.6 mm Hg, respectively. In some individuals, the decrease was as high as 61 mm Hg and 51 mm Hg, respectively, for standing systolic and diastolic blood pressure.

When low dose ethanol and APOKYN were concomitantly administered, the mean largest decrease in supine systolic and diastolic blood pressure was 10.2 mm Hg and 9.9 mm Hg, respectively. The mean largest decrease in standing systolic and diastolic blood pressure was 8.4 mm Hg and 7.1 mm Hg, respectively.

In comparison, the mean largest decrease in supine systolic and diastolic blood pressure when APOKYN was administered alone was 6.1 mm Hg and 7.3 mm Hg, respectively, and in standing systolic and diastolic blood pressure was 6.7 mm Hg 8.4 mm Hg, respectively.

Patients should avoid drinking alcohol after using APOKYN [see WARNINGS AND PRECAUTIONS].

Dopamine Antagonists

Since APOKYN is a dopamine agonist, it is possible that concomitant use of dopamine antagonists, such as the neuroleptics (phenothiazines, butyrophenones, thioxanthenes) or metoclopramide, may diminish the effectiveness of APOKYN. Patients with major psychotic disorders, treated with neuroleptics, should be treated with dopamine agonists only if the potential benefits outweigh the risks.

Drugs Prolonging The QT/QTc Interval

Caution should be exercised when prescribing APOKYN concomitantly with drugs that prolong the QT/QTc interval [see WARNINGS AND PRECAUTIONS].

Read the entire FDA prescribing information for Apokyn (Apomorphine)

© 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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