Apomorphine

FDA label

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Titration Continuous dosage: titrate in 0.1 mg/hr to 1 mg/hr increments; adjustments may be made daily or at longer intervals.

Renal Mild or moderate impairment: initial extra dose 0.5–1 mg, not to exceed 1 mg; no adjustment to the continuous dose, maximum daily dose, or subsequent extra doses. Severe impairment: not studied.

Hepatic Mild or moderate impairment: exercise caution and monitor closely (increased Cmax/AUC). Severe impairment: not studied.

At least 3 hours between extra doses; no more than 3 extra doses per day; total daily dose (continuous + extra) ≤98 mg over the waking day (e.g. 16 h).

Instructions

• Subcutaneous infusion ONLY via the ONAPGO pump — never IV (IV crystallization has caused thrombus and pulmonary embolism).
• Express the prescription as mg/hr for the continuous dose and mg for extra doses.
• Initiate and titrate under medical supervision; patient or caregiver must be trained on the delivery system first.
• Premedicate with trimethobenzamide 300 mg TID starting 3 days before the first dose; alternatively start at 1 mg/hr without an antiemetic. Stop trimethobenzamide as soon as nausea is controlled, generally within 2 months (it increases somnolence, dizziness and falls).
• Inspect the solution before use — should be clear and almost colorless; discard if discolored or particulate.
• Infuse into the abdomen (≥2 inches from the navel), top of thigh, lower back, or upper back (upper back only if prepared by a caregiver/HCP); avoid bruised, nodular or irritated sites.
• Change the infusion site every day; use aseptic technique. Use a new single-dose cartridge and cartridge holder each day and discard the unused portion.
• TAPER before stopping — sudden discontinuation or rapid dose reduction can worsen Parkinson's motor symptoms.
• Avoid alcohol. Lie down before and after taking sublingual nitroglycerin.
• If a prolonged interruption occurs (e.g. infusion-site infection), prescribe oral Parkinson's medication in the interim.
• Adjust concomitant anti-Parkinson's medication as needed after starting.

Contraindications

• Concomitant 5-HT3 antagonists — antiemetics (ondansetron, granisetron, dolasetron, palonosetron) and alosetron: profound hypotension and loss of consciousness reported.

Cautions

• Do NOT give IV — thrombus formation and pulmonary embolism from IV crystallization.
• Nausea and vomiting, may be severe; anti-dopaminergic antiemetics (haloperidol, chlorpromazine, promethazine, prochlorperazine, metoclopramide) may worsen Parkinson's.
• Somnolence (22%) and falling asleep during activities of daily living, including driving, sometimes without warning — ordinarily discontinue if it occurs.
• Hypotension/orthostatic hypotension and syncope, especially during dose escalation; additive with alcohol, vasodilators and antihypertensives.
• Increased risk of falls.
• Infusion-site reactions (63%) and infections (4%, most often cellulitis) — monitor and rotate site daily; remove the cannula if infection is suspected.
• Hallucinations and psychotic-like behavior, delusions, confusion, agitation, delirium; weigh risks before use in major psychotic disorder.
• Dyskinesia, new or worsened (~15%).
• Hemolytic anemia, sometimes requiring hospitalization, often Coombs-positive — work up new anemia and consider discontinuation.
• Impulse control/compulsive behaviors (gambling, sexual urges, spending) — ask directly; consider dose reduction or stopping.
• Cardiac events — MI, tachycardia, palpitations, bundle branch block; cardiac arrest and sudden death reported with SC apomorphine.
• QTc prolongation with risk of torsades de pointes or sudden death.
• Hypersensitivity including angioedema and anaphylaxis (contains sodium metabisulfite).
• Fibrotic complications.
• Priapism.
• Elderly: confusion, hallucinations, falls, cardiovascular, respiratory and GI events and discontinuations reported more often in patients ≥65 yr.

Adverse reactions

• Infusion site nodule (44%)
• Nausea (22%)
• Somnolence (22%)
• Infusion site erythema (17%)
• Dyskinesia (15%)
• Headache (13%)
• Insomnia (11%)
• Dizziness (9%)
• Hypotension (7%), asthenia (7%), fatigue (7%), constipation (7%), vomiting (7%)

Pregnancy No adequate human data; animal studies showed increased neonatal death (rats) and cardiac/great-vessel malformations (rabbits) at clinically relevant doses — may cause fetal harm.

Lactation No data on presence in human milk, effects on the breastfed infant, or on milk production; weigh benefits of breastfeeding against maternal need.