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Description:Version-1.0.11.0_20210115 For healthcare professional use only. -- For healthcare professional use only. Feb 26, 2021 Welcome to the Circle of Care TM . A secure portal brought to you by US WorldMeds.
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Version-1.0.11.0_20210115 For healthcare professional use only. -- For healthcare professional use only. Feb 26, 2021 Welcome to the Circle of Care TM . A secure portal brought to you by US WorldMeds. 24/7 Online Support View your service requests anytime Real time patient status updates Accessible via any Internet-connected device: PC, tablet, smart phone Secure Login Login User Name Password Forgot your password? Login Not Registered? Register Practice © 2021. US WorldMeds, LLC is the exclusive licensee and distributor of APOKYN in the United States and Its territories. APOKYN is a registered trademark of BRITUSWIP. MYOBLOC is a registered trademark of Solstice Neurosciences, LLC, a wholly-owned subsidiary of US WorldMeds, LLC Portal powered by CareMetx, LLC. © 2014 CareMetx, LLC. All rights reserved. Important Safety Information Show More APOKYN ® (apomorphine hydrochloride injection) Indication APOKYN (apomorphine hydrochloride injection) is indicated for the acute, intermittent treatment of hypomobility, "off" episodes ("end-of-dose wearing-off" and unpredictable "on-off" episodes) in patients with advanced Parkinson’s disease (PD). APOKYN has been studied as an adjunct to other medications. Important Safety Information for Healthcare Providers Contraindication: Concomitant use of APOKYN with 5HT 3 antagonists is contraindicated based on reports of profound hypotension and loss of consciousness when APOKYN was administered with ondansetron. Contraindication: APOKYN is contraindicated in patients who have demonstrated hypersensitivity/allergic reaction to the drug or any of its excipients (notably sodium metabisulfite). Angioedema or anaphylaxis may occur. Subcutaneous injection: APOKYN should be administered by subcutaneous injection, NOT intravenously, because serious adverse events like thrombus formation and pulmonary embolism may occur. Patients and care partners must receive detailed instructions about preparing and injecting doses, with particular attention paid to the correct use of the dosing pen. Nausea and vomiting: At recommended doses of APOKYN, severe nausea and vomiting can be expected. Therefore, trimethobenzamide hydrochloride should be started 3 days prior to the initial dose of APOKYN and continued as long as necessary to control nausea and vomiting, and generally no longer than two months. In clinical trials, 50% of patients (262/522) discontinued trimethobenzamide hydrochloride after about 2 months of APOKYN. Falling asleep during activities of daily living (ADL): There have been reports of patients treated with APOKYN 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. Symptomatic hypotension: Dopamine agonists, including APOKYN, can cause hypotension, orthostatic hypotension, and syncope. Alcohol, antihypertensive medications, and vasodilating medications may potentiate the hypotensive effect of apomorphine. Patients should avoid alcohol when using APOKYN. Patients taking APOKYN should lie down before and after taking sublingual nitroglycerin. Falls: Patients with PD are at risk of falling due to underlying postural instability, possible concomitant autonomic instability, and from syncope caused by the blood pressure lowering effects of the drugs used to treat PD. Hallucinations/psychotic-like behavior: APOKYN has been associated with new or worsening mental status and behavioral changes, which may be severe, including psychotic-like behavior. This abnormal thinking and behavior can consist of paranoid ideation, delusions, hallucinations, confusion, disorientation, aggressive behavior, agitation and delirium. Dyskinesias: APOKYN may cause dyskinesia or exacerbate pre-existing dyskinesia. Intense urges: Some people with PD have reported new or increased gambling urges, increased sexual urges, and other intense urges, while taking PD medicines, including APOKYN. Because patients may not recognize these behaviors as abnormal, it is important for prescribers to specifically ask patients or their care partners about the development of new or increased gambling urges, sexual urges, uncontrolled spending, or other urges while being treated with APOKYN. Physicians should consider dose reduction or stopping the medication if a patient develops such urges while taking APOKYN. Cardiac events: 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. QT Prolongation —Caution is recommended when administering APOKYN to patients with an increased risk of QT prolongation, such as those with hypokalemia, hypomagnesemia, bradycardia, a genetic predisposition, or who use other drugs that prolong the QT/QTc interval. Adverse events: The most common adverse events seen in controlled trials were yawning, drowsiness/somnolence, dyskinesias, dizziness/postural hypotension, rhinorrhea, nausea and/or vomiting, hallucinations/confusion, and edema/swelling of extremities. Injection site reactions, including bruising, granuloma, and pruritus, have been reported. To report SUSPECTED ADVERSE REACTIONS or product complaints, contact US WorldMeds at 1-877-727-6596 (1-877-7APOKYN). You may also report SUSPECTED ADVERSE REACTIONS to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Please see full Prescribing Information and Pen Instructions for Use / Patient Information . All trademarks are property of their respective owners. MYOBLOC ® (rimabotulinumtoxinB) Injection INDICATIONS MYOBLOC ® (rimabotulinumtoxinB) injection is indicated for: the treatment of cervical dystonia (CD) to reduce the severity of abnormal head position and neck pain associated with CD in adults the treatment of chronic sialorrhea in adults WARNING: DISTANT SPREAD OF TOXIN EFFECT See full prescribing information for complete boxed WARNING. The effects of MYOBLOC® and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity but symptoms can also occur in adults, particularly in those patients who have an underlying condition that would predispose them to these symptoms. Contraindications MYOBLOC is contraindicated in patients with: A known hypersensitivity to any botulinum toxin product or to any of the components in the formulation Infection at the proposed injection site(s) Warnings and Precautions Lack of Interchangeability Between Botulinum Toxin Products The potency units of MYOBLOC are specific to the preparation and biological activity assay method utilized. Due to differences in the aspects of this assay such as the vehicle, dilution scheme, and laboratory protocols for various potency assays, potency units are not interchangeable with other preparations of botulinum toxin products and, therefore, units of biological activity of MYOBLOC cannot be compared to or converted into units of any other botulinum toxin products assessed with any other specific assay method. Hypersensitivity Reactions Serious hypersensitivity reactions have been reported with botulinum toxin products. Angioedema, urticaria, and rash have occurred with MYOBLOC treatment. Hypersensitivity reactions can also include anaphylaxis, serum sickness, soft tissue edema, and dyspnea. If serious and/or immediate hypersensitivity reactions occur, discontinue further injection of MYOBLOC and institute appropriate medical therapy immediately. The use of MYOBLOC in patients with a known hypersensi...
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