Download MYOBLOC and Cervical Dystonia: A Patient’s Guide for more information.
Download the MYOBLOC Copay Program Brochure for more information.
Your healthcare provider can enroll you OR you can call 1.877.268.7697 to enroll.
Terms and Conditions for Patients
1. This offer is valid for commercially-insured patients only and is good for use only with a MYOBLOC prescription at the time the prescription is filled or after the product is administered to the patient. 2. Depending on insurance coverage, eligible insured patients may pay no more than zero dollars ($0) for MYOBLOC and the administrative services associated with MYOBLOC, up to a maximum savings limit of four thousand dollars ($4,000) per year. Patient out-of-pocket expense may vary. 3. This offer is not valid for patients enrolled in Medicare, Medicaid, or other federal or state healthcare programs, or private indemnity or HMO insurance plans that reimburse you for the entire cost of your prescription drugs. Patients may not use this Program if they are Medicare-eligible and enrolled in an employer-sponsored health plan or medical or prescription drug benefit program for retirees. 4. The offer is valid for one (1) year. 5. US WorldMeds reserves the right to rescind, revoke, or amend this offer without notice. 6. Offer good only in the USA, including Puerto Rico, at participating pharmacies or healthcare providers. 7. Void if prohibited by law, taxed, or restricted. 8. Residents of Michigan, Rhode Island, and Minnesota are not eligible for assistance with payment for injection or injection guidance-related costs, but may receive assistance with MYOBLOC. 9. This Program is not transferable. The selling, purchasing, trading, or counterfeiting of this Program is prohibited by law. 10. This Program is not insurance. 11. By redeeming this assistance, you represent that you are an eligible patient and that you understand and agree to comply with the terms and conditions of this offer.
MYOBLOC is a prescription medicine that is injected into neck muscles and used to treat the abnormal head position and neck pain that happens with cervical dystonia (CD) in adults.
It is not known whether MYOBLOC is safe or effective in children. It is not known whether MYOBLOC is safe or effective for other types of muscle spasms.
Side effects with MYOBLOC are generally mild to moderate and temporary, and are more common with higher doses. The most frequently reported side effects with MYOBLOC were dry mouth, swallowing difficulties, indigestion and injection site pain. Dry mouth and swallowing difficulties were the side effects that most often resulted in discontinuation of treatment. These are not all the possible side effects of MYOBLOC, please see the full Important Safety Information.
Do not take MYOBLOC if you:
Cervical dystonia (CD) is a neurological movement disorder that causes the muscles in your neck to contract (tighten) involuntarily. This muscle tightening can cause you to hold your head and neck in painful, abnormal positions. These positions can cause you to face challenges and discomfort in your day-to-day life.1
Normally, your brain sends chemical signals to your head and neck muscles to keep their movements smooth and controlled. In patients with CD, these signals work improperly. When acetylcholine, one of the chemical signals, is released at above-normal amounts, it causes muscles to be tense and overactive.
In some cases of CD, causes can be linked to neck, head and shoulder injuries, and certain drugs.2 While the exact cause is not clear, research is still being conducted to explore the factors that can contribute to CD.
Typically, CD symptoms are gradual and include:
Pain is a common complaint of most patients with CD:
The MYOBLOC Copay Program may be able to help. The Copay Program helps eligible CD patients with out of pocket expenses for MYOBLOC. Learn more about the MYOBLOC Copay Program here.
MYOBLOC is available at no charge to patients approved for the Patient Assistance Program.
To learn more call 1-888-461-2255, Option 3.
MYOBLOC® (rimabotulinumtoxinB) Injection is indicated for the treatment of adults with cervical dystonia to reduce the severity of abnormal head position and neck pain associated with cervical dystonia.
WARNING: DISTANT SPREAD OF TOXIN EFFECT
Postmarketing reports indicate that 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 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 occurred at doses comparable to those used to treat cervical dystonia and at lower doses [see Warnings and Precautions].
MYOBLOC is contraindicated in patients with a known hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation.
MYOBLOC is contraindicated for use in patients with infection at the proposed injection site(s).
The potency Units of MYOBLOC are specific to the preparation and assay method utilized. They 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.
Treatment with MYOBLOC and other botulinum toxin products can result in swallowing or breathing difficulties. Patients with preexisting 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.
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.
Treatment of cervical dystonia with botulinum toxins may weaken neck muscles that serve as accessory muscles of ventilation. This may result in a critical loss of breathing capacity in patients with respiratory disorders who may have become dependent upon these accessory muscles. There have been postmarketing reports of serious breathing difficulties, including respiratory failure, in cervical dystonia patients. Patients treated with botulinum toxin may require immediate medical attention should they develop problems with swallowing, speech or respiratory disorders. These reactions can occur within hours to weeks after injection with botulinum toxin.
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 MYOBLOC.
This product contains albumin, a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases. A theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD) also is considered extremely remote. No cases of transmission of viral diseases or CJD have ever been identified for albumin.
Only 9 subjects without a prior history of tolerating injections of type A botulinum toxin have been studied. Treatment of botulinum toxin naïve patients should be initiated at lower doses of MYOBLOC.
Co-administration of MYOBLOC and aminoglycosides or other agents interfering with neuromuscular transmission (e.g., curare-like compounds) should only be performed with caution as the effect of the toxin may be potentiated.
The effect of administering different botulinum neurotoxin serotypes at the same time or within less than 4 months of each other is unknown. However, neuromuscular paralysis may be potentiated by co-administration or overlapping administration of different botulinum toxin serotypes.
It is not known whether MYOBLOC can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. MYOBLOC should be given to a pregnant woman only if clearly needed.
The most commonly reported adverse events associated with MYOBLOC treatment in all studies were dry mouth, dysphagia, dyspepsia, and injection site pain. Dry mouth and dysphagia were the adverse reactions most frequently resulting in discontinuation of treatment. There was an increased incidence of dysphagia with increased dose in the sternocleidomastoid muscle. The incidence of dry mouth showed some dose-related increase with doses injected into the splenius capitis, trapezius and sternocleidomastoid muscles.
To report SUSPECTED ADVERSE REACTIONS or product complaints, contact US WorldMeds at 1-888-461-2255, Option 2. You may also report SUSPECTED ADVERSE REACTIONS to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.