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Note: This document contains side effect information about apomorphine. Some of the dosage forms listed on this page may not apply to the brand name Apokyn.
Applies to apomorphine: subcutaneous solution
Along with its needed effects, apomorphine (the active ingredient contained in Apokyn) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking apomorphine:
Some side effects of apomorphine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Applies to apomorphine: compounding powder, subcutaneous solution
The most commonly reported adverse reactions have included yawning, drowsiness/somnolence, dyskinesias, dizziness/postural hypotension, rhinorrhea, nausea, vomiting, hallucination/confusion, and edema/swelling of extremities.
This drug is known to cause severe nausea and vomiting when administered at recommended doses; because of this, premedication with antiemetics is recommended. In a clinical trial in which patients received premedication with trimethobenzamide, 31% and 11% of patients had nausea and vomiting, respectively.
Very common (10% or more): Nausea and/or vomiting (30%)
Common (1% to 10%): Constipation, diarrhea
Uncommon (0.1% to 1%): Stomatitis, transient metallic taste
Very common (10% or more): Orthostatic hypotension (up to 20%), chest pain/pressure/angina (15%)
Common (1% to 10%): Syncope, hypotension, edema/swelling of extremities, congestive heart failure
Rare (0.01% to 0.1%): QTc interval prolongation
Frequency not reported: Profound hypotension and loss of consciousness, thrombus formation, angina, myocardial infarction, cardiac arrest and/or sudden death, QTC prolongation
Concomitant use of ondansetron with apomorphine has resulted in profound hypotension and loss of consciousness. Because of this, US labeling has concomitant use of 5HT3 antagonists and apomorphine as contraindicated.
Thrombus formation due to intravenous crystallization of apomorphine has occurred with IV administration; this drug should not be administered IV.
In clinical studies, 4% of patients receiving this drug experienced angina, myocardial infarction, cardiac arrest and/or sudden death. The specific incidence of each event is unknown; some cases of angina and myocardial infarction occurred in close proximity to apomorphine administration, while other cases of cardiac arrest and sudden death occurred at time not related to dosing.
In a placebo-controlled study, single apomorphine doses from 2 mg to 8 mg resulted in mean differences from placebo in QTc (as measured by Holter monitor) of 0, 1, and 7 milliseconds with 4, 6, and 8 mg does, respectively. In another study, single-doses of apomorphine 2 to 10 mg (mean 5.2 mg) resulted in a mean difference in QTc interval of about 3 milliseconds at 20- and 90-minutes post-dose. For the entire study, 2 patients exhibited larger QTc increases (greater than 60 milliseconds from pre-dose; 1 patient at 2 and 6 mg; 1 patient at 6 mg).
Very common (10% or more): Hallucinations (up to 14%)
Common (1% to 10%): Confusion, insomnia, depression
Frequency not reported: Impulse control/compulsive behaviors
Postmarketing reports: New or worsening mental status and behavioral changes including psychotic-like behavior, paranoid ideation, delusions, disorientation, aggressive behavior, agitation, and delirium
For patients taking medications that increase central dopaminergic tone including this drug, there have been case reports of intense urges to gamble, increased sexual urges, intense urges to spend money uncontrollably, and the inability to control these urges.
Very common (10% or more): Falls (up to 30%)
Common (1% to 10%): Fatigue
Very common (10% or more): Injection site reactions (26%)
Frequency not reported: Panniculitis
Very common (10% or more): Drowsiness or somnolence (up to 35%), dyskinesia (up to 35%)
Common (1% to 10%): Headache, aggravated Parkinson's disease, weakness
Frequency not reported: Falling asleep during activities of daily living
Injection site reactions including bruising, granuloma, and pruritus have occurred with subcutaneous injections. Local induration and nodules (usually asymptomatic) often develop with continuous use. At higher doses, erythema, tenderness and induration at site of subcutaneous injection may occur. Panniculitis has been reported when a skin biopsy has been performed.
Common (1% to 10%): Urinary tract infection
Uncommon (0.1% to 1%): Spontaneous penile erection
Rare (0.01% to 0.1%): Painful erection
Very rare (less than 0.01%): Priapism
Common (1% to 10%): Ecchymosis
Uncommon (0.1% to 1%): Thrombocytopenia
Rare (0.01% to 0.1%): Coombs' positive hemolytic anemia, eosinophilia
Sodium metabisulfite is an excipient in many apomorphine (the active ingredient contained in Apokyn) solutions. Angioedema and anaphylaxis and bronchospasm have been reported with this excipient in sulfite sensitive individuals.
Frequency not reported: Angioedema, anaphylaxis, bronchospasm
Common (1% to 10%): Limb pain, arthralgia, back pain
Uncommon (0.1% to 1%): Increased lacrimation
Common (1% to 10%): Dehydration
Very common (10% or more): Yawning (40%), rhinorrhea (20%)
Common (1% to 10%): Pneumonia, dyspnea
Uncommon (0.1% to 1%): Breathing difficulties
Frequency not reported: Pulmonary embolism
Pulmonary embolism due to intravenous crystallization of apomorphine has occurred with IV administration; this drug should not be administered IV.
Uncommon (0.1% to 1%): Reduced facial hair growth, local and generalized rashes
Uncommon (0.1% to 1%): Transient rise in serum prolactin, loss of libido