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WHY MYOBLOC?

MYOBLOC is a unique botulinum toxin therapy, approved by the FDA as an effective treatment for CD in adults.

MYOBLOC is the only botulinum toxin type B available.

In multiple clinical studies, MYOBLOC injections have demonstrated an improvement in abnormal head positioning and neck pain associated with CD.1-3

How does MYOBLOC work?

MYOBLOC disables a protein that would typically trigger the release of excessive acetylcholine, which causes muscles to become tense and spasm.

When your healthcare provider injects MYOBLOC into affected muscles, it blocks the release of acetylcholine, allowing them to relax.4

Over time, your healthcare provider will adjust the dose of MYOBLOC to achieve maximum pain relief and muscle spasm control.

WHAT TO EXPECT FROM YOUR MYOBLOC TREATMENT

PAIN RELIEF AS EARLY AS 2 WEEKS6,7

Patients who respond to MYOBLOC may:

  • Notice improvements to their head and neck position5
  • Feel relief for 12-16 weeks1,2
  • Experience pain relief as early as two weeks after injection6,7
  • Maintain their daily activities between doses

MYOBLOC treatment is administered in your healthcare provider’s office

  • Small amounts of MYOBLOC will be injected into your affected muscles

  • You may need adjustments to your dosing to receive maximum benefit

Possible side effects with MYOBLOC

Side effects 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.5

Please refer to the full Prescribing Information, including Boxed Warning and Medication Guide for all the possible side effects, and talk with your doctor.

References:

  1. 1. Brashear A, Lew MF, Dykstra DD, et al. Safety and efficacy of NeuroBloc (botulinum toxin type B) in type A-responsive cervical dystonia. Neurology 1999;53:1439–1446.
  2. 2. Brin MF, Lew MF, Adler CH, et al. Safety and efficacy of NeuroBloc (botulinum toxin type B) in type A-resistant cervical dystonia. Neurology. 1999;53:1431–1438.
  3. 3. Lew MF, Adornato BT, Duane DD, et al. Botulinum toxin type B: a double-blind, placebo-controlled, safety and efficacy study in cervical dystonia. Neurology. 1997;49:701–707.
  4. 4. Montecucco C, Papini E et al. FEBS Letters 346(1994) 92–981.
  5. 5. MYOBLOC® Us Prescribing Information. Solstice Neurosciences, LLC, Louisville, KY:2010.
  6. 6. Data on file; MYO-021-0907. Solstice Neurosciences, LLC; Louisville, KY: 2007.
  7. 7. Data on file; MYO-022-0907. Solstice Neurosciences, LLC; Louisville, KY: 2007.

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

IMPORTANT SAFETY INFORMATION

MYOBLOC® may cause serious side effects that can be life threatening. Call your doctor or get medical help right away if you have any of these problems anytime (hours to weeks) after treatment with MYOBLOC:

  • Problems swallowing, speaking, or breathing if the muscles that you use to breathe and swallow become weak after the injection. Death can happen as a complication if you have severe problems with swallowing or breathing after treatment with MYOBLOC.
  • People with certain breathing problems may need to use muscles in their neck to help them breathe and may be at greater risk for serious breathing problems with MYOBLOC.
  • Swallowing problems may last for several months. People who cannot swallow well may need a feeding tube to receive food and water. If swallowing problems are severe, food or liquids may go into your lungs. People who already have swallowing or breathing problems before receiving MYOBLOC have the highest risk of getting these problems.
  • Spread of toxin effects. In some cases, the effect of botulinum toxin may affect areas of the body away from the injection site and cause symptoms of a serious condition called botulism. The symptoms of botulism include loss of strength and muscle weakness all over the body, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice (dysphonia), trouble saying words clearly (dysarthria), loss of bladder control, trouble breathing, trouble swallowing (dysphagia).

MYOBLOC is a prescription medicine used in adults that is injected into:

  • Muscles and used to treat the abnormal head position and neck pain that happens with cervical dystonia (CD)
  • Glands that make saliva and is used to treat long-lasting (chronic) drooling (sialorrhea)

Do not receive MYOBLOC if you: are allergic to MYOBLOC or any of its ingredients (see Medication Guide for ingredients); had an allergic reaction to any other botulinum toxin product such as BOTOX® or BOTOX® Cosmetic, DYSPORT®, or XEOMIN®; have a skin infection at the planned injection site.

Tell your doctor about all your medical conditions, including if you have: a disease that affects your muscles or nerves (such as ALS or Lou Gehrig’s disease, myasthenia gravis, or Lambert-Eaton syndrome); had any side effect from any botulinum toxin product in the past; a breathing problem, such as asthma or emphysema; a history of swallowing problems or aspiration; bleeding problems; drooping eyelids; plans to have surgery; had surgery on your face.

Tell your doctor if you: are pregnant or plan to become pregnant (it is not known if MYOBLOC can harm your unborn baby); are breastfeeding or plan to breastfeed (it is not known if MYOBLOC passes into breast milk).

Tell your doctor about all medicines you take, including: prescription and over-the-counter medicines, vitamins, and herbal supplements. Using MYOBLOC with certain other medicines may cause serious side effects. Do not start any new medicines until you have told your doctor that you have received MYOBLOC in the past.

Especially tell your doctor if you: received any other botulinum toxin product in the last 4 months; received injections of botulinum toxin such as BOTOX® or BOTOX® Cosmetic, DYSPORT®, or XEOMIN® in the past (tell your doctor exactly which product you received); recently received an antibiotic injection; take muscle relaxants; take allergy or cold medicines; take sleep medicine.

MYOBLOC can cause serious side effects, including allergic reactions. Symptoms of allergic reaction may include: itching, rash, redness, swelling, wheezing, trouble breathing, or dizziness or feeling faint. Tell your doctor or get medical help right away if you get wheezing, or trouble breathing, or if you get dizzy or faint.

Other side effects of MYOBLOC include:

  • Cervical Dystonia: dry mouth, trouble swallowing, injection site discomfort or pain, headache
  • Sialorrhea: dry mouth, trouble swallowing

For more information, refer to the Medication Guide or talk with your doctor.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.