 Important Safety Information for patients and care partners Important Safety Information for healthcare professionals Important Safety Information for You should not take APOKYN® if you are allergic to APOKYN or its ingredients, notably the sulfite called metabisulfite. Do not take APOKYN if you are being treated with certain drugs called 5HT3 antagonists (such as Anzemet®*, Kytril®†, and Zofran®‡) that are used for nausea and vomiting or irritable bowel syndrome. People taking this type of drug with apomorphine had severely low blood pressure and "blacked out." APOKYN must be injected just under the skin and not into a vein. Your doctor may prescribe a medicine called Tigan®§ to help prevent nausea and vomiting. Some patients can stop taking Tigan after using APOKYN for some time. Some patients may need to continue taking Tigan to help prevent nausea and vomiting. Talk to your doctor before you stop taking Tigan. If you experience shortness of breath, fast heartbeat, or chest pain while taking APOKYN, you should call a doctor right away. APOKYN may lower blood pressure and cause dizziness and fainting, especially when starting treatment or if the dose is increased. Patients should not get up too fast from sitting or after lying down to minimize these problems. Some patients taking APOKYN may get sleepy during the day or fall asleep without warning doing everyday activities. Until it is known how APOKYN affects your ability to stay alert, you should not drive a car or operate machinery. Some patients may notice soreness, redness, bruising, or itching at the injection site. Changing the injection site with each injection and putting ice on the site before and after the injection may lessen these effects. The most common side effects seen in clinical studies with APOKYN were: yawning; sudden uncontrolled movements; nausea and/or vomiting; sleepiness; dizziness; runny nose; seeing and hearing things that are not real; swelling of hands, arms, legs, and feet; chest pain; increased sweating; flushing; and unusually pale complexion. Please see full Prescribing Information. top of page Important Safety Information for Contraindications: APOKYN® is contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients (notably metabisulfite). Concomitant use of APOKYN with 5HT3 antagonists is contraindicated based on reports of profound hypotension and loss of consciousness when apomorphine was administered with ondansetron. Nausea and Vomiting: At recommended doses of apomorphine, severe nausea and vomiting can be expected. Therefore, trimethobenzamide hydrochloride should be started 3 days prior to the initial dose of APOKYN and continued for at least 2 months. In clinical trials, 50% of patients (262/522) discontinued trimethobenzamide hydrochloride after 2 months of APOKYN. Symptomatic Hypotension: Dopamine agonists, including APOKYN, can cause hypotension, orthostatic hypotension, and syncope. These adverse events occurred with initial dosing and long-term treatment. Whether hypotension contributes to other significant events seen (eg, falls) is unknown. SC Injection: APOKYN should be administered by subcutaneous injection, NOT intravenously, because serious adverse events may occur. Cardiac Effects: QT Prolongation—Caution is recommended when administering APOKYN to patients with increased risk of QT prolongation, such as those with hypokalemia, hypomagnesemia, bradycardia, or a genetic predisposition, or who use other drugs that prolong the QT/QTc interval. Coronary Events—APOKYN reduces resting systolic and diastolic blood pressure and has the potential to exacerbate coronary (and cerebral) ischemia. Therefore, exercise caution when prescribing APOKYN for patients with known cardiovascular and cerebrovascular disease. Falling Asleep During Activities of Daily Living (ADL): There have been literature reports of patients treated with apomorphine subcutaneous injections who suddenly fell asleep while engaged in ADL. Patients should be advised not to drive or participate in potentially dangerous activities until it is known how APOKYN affects them. Patients should be continually reassessed for daytime drowsiness or sleepiness. Adverse Events: Injection site reactions, including bruising, granuloma, and pruritus, have been reported. The most common adverse events seen in controlled trials were yawning, dyskinesias, nausea and/or vomiting, somnolence, dizziness, rhinorrhea, hallucinations, edema, chest pain, increased sweating, flushing, and pallor. Treatment-emergent adverse events (incidence greater than or equal to 10%) and associated rate of treatment discontinuation during open-label, long-term use (N=550)
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