Apokyn
- Generic Name: apomorphine
- Brand Name: Apokyn
Apokyn (Apomorphine) side effects drug 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.
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)
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 (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)
© 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.