Merz Pharmaceuticals, LLC takes another step in delivering value to the movement disorder community by reducing the price of XEOMIN®(incobotulinumtoxinA) by nearly 20 percent
Merz Pharmaceuticals, LLC, makers of XEOMIN (incobotulinumtoxinA), has announced that in addition to its industry leading Co-Pay Program, XEOMIN is now priced to deliver more value to patients, providers and the healthcare system.
To ensure access to Xeomin therapy for the greatest number of patients effective October 6, 2011, XEOMIN’s price has been reduced by nearly 20 percent. This change was initiated by Merz as part of its ongoing efforts to ensure broad access to XEOMIN for patients who have come to rely on this highly refined molecule, which is free from accessory proteins.
The industry-leading Xeomin Co-pay Program effectively eliminates out-of-pocket expenses as a barrier to treatment with XEOMIN by reimbursing eligible patients, who are appropriate for treatment with XEOMIN as determined by their physician, up to $500 per treatment and $2,000 per year.
Merz also offers a dedicated XEOMIN support team for patients and physicians at 1-888-4-XEOMIN (1-888-493-6646), to help with the Co-Pay Program, Patient Assistance Program, and obtaining medical information.
XEOMIN has been available in the U.S. for one year and, along with Merz, has established a very positive presence in the movement disorder community. Merz is committed to supporting patients and physicians in the cervical dystonia (CD) and blepharospasm community and will maintain this price advantage for XEOMIN while continuing to provide best-in-class patient and physician support and services.
INDICATIONS AND USAGE
The U.S. Food and Drug Administration (FDA) approved XEOMIN in July 2010 for cervical dystonia in adults, to decrease the severity of abnormal head position and neck pain in both botulinum toxin-naive and previously treated patients, and blepharospasm in adults who have been previously treated with onabotulinumtoxinA (Botox®).
IMPORTANT SAFETY INFORMATION
WARNING: Distant Spread of Toxin Effect
Postmarketing reports indicate that the effects of XEOMIN and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence and breathing difficulties. 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 treated for spasticity and other conditions, particularly in those patients who have underlying conditions that would predispose them to these symptoms. In unapproved uses, including spasticity in children and adults, and in approved indications, cases of spread of effect have been reported at doses comparable to those used to treat cervical dystonia and at lower doses [see Warnings and Precautions (5.1)].
XEOMIN is contraindicated in patients with a known hypersensitivity to the active substance botulinum toxin type A or to any of the components in the formulation and in the presence of infection at the proposed injection site(s).
WARNINGS AND PRECAUTIONS
· The potency units of XEOMIN are not interchangeable with other preparations of botulinum toxin products. Therefore, units of biological activity of XEOMIN cannot be compared to or converted into units of any other botulinum toxin products.
· Hypersensitivity reactions have been reported with botulinum toxin products (anaphylaxis, serum sickness, urticaria, soft tissue edema, and dyspnea). If serious and/or immediate hypersensitivity reactions occur further injection of XEOMIN should be discontinued and appropriate medical therapy immediately instituted.
· Treatment with XEOMIN and other botulinum toxin products can result in swallowing or breathing difficulties. Patients with pre-existing swallowing or breathing difficulties may be more susceptible to these complications. In most cases, this is a consequence of weakening of muscles in the area of injection that are involved in breathing or swallowing. When distant effects occur, additional respiratory muscles may be involved [See Boxed Warning]. Deaths as a complication of severe dysphagia have been reported after treatment with botulinum toxin. Dysphagia may persist for several months, and require use of a feeding tube to maintain adequate nutrition and hydration. Aspiration may result from severe dysphagia and is a particular risk when treating patients in whom swallowing or respiratory function is already compromised. These reactions can occur within hours to weeks after injection with botulinum toxin.
· Cervical Dystonia: Patients with smaller neck muscle mass and patients who require bilateral injections into the sternocleidomastoid muscles are at greater risk of dysphagia. Limiting the dose injected into the sternocleidomastoid muscle may decrease the occurrence of dysphagia.
· Blepharospasm: Injection of XEOMIN into the orbicularis oculi muscle may lead to reduced blinking and corneal exposure with possible ulceration or perforation. Lower lid injections should not be repeated if diplopia occurred with previous botulinum toxin injections.
· Individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or neuromuscular junctional disorders (e.g., myasthenia gravis or Lambert-Eaton syndrome) should be monitored particularly closely when given botulinum toxin. Patients with neuromuscular disorders may be at increased risk of clinically significant effects including severe dysphagia and respiratory compromise from typical doses of XEOMIN.
Cervical Dystonia: The most commonly observed adverse reactions (incidence ≥10% of patients and twice the rate of placebo) for XEOMIN 120 Units and XEOMIN 240 Units, respectively, were: dysphagia (13%, 18%), neck pain (7%, 15%), muscle weakness (7%, 11%), and musculoskeletal pain (7%, 4%).
Blepharospasm: The most common adverse reactions (incidence ≥10% of patients and twice the rate of placebo) for XEOMIN were eyelid ptosis (19%), dry mouth (16%), visual impairment (12%), diarrhea (8%), and headache (7%).
Concomitant treatment of XEOMIN and aminoglycoside antibiotics, spectinomycin, or other agents that interfere with neuromuscular transmission (e.g., tubocurarine-like agents), or muscle relaxants, should be observed closely because the effect of XEOMIN may be potentiated.
USE IN PREGNANCY
Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. XEOMIN should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Please see full Prescribing Information for XEOMIN, including Boxed WARNING, available at www.XEOMIN.com.
XEOMIN is a registered trademark of MerzPharma GmbH & Co KGaA.
Botox® is a registered trademark of Allergan, Inc.