Rimabotulinumtoxinb

1 INDICATIONS AND USAGE MYOBLOC is an acetylcholine release inhibitor indicated for: Treatment of cervical dystonia to reduce the severity of abnormal head position and neck pain associated with cervical dystonia in adults ( 1.1 ) Treatment of chronic sialorrhea in adults ( 1.2 ) 1.1 Cervical Dystonia MYOBLOC is indicated for the treatment of cervical dystonia to reduce the severity of abnormal head position and neck pain associated with cervical dystonia in adults. 1.2 Chronic Sialorrhea MYOBLOC is indicated for the treatment of chronic sialorrhea in adults.

6 ADVERSE REACTIONS The following clinically significant adverse reactions to MYOBLOC are discussed in greater detail in other sections of the labeling: Spread of Toxin Effect [see Warnings and Precautions (5.1) ] Lack of Interchangeability Between Botulinum Toxin Products [see Warnings and Precautions (5.2) ] Hypersensitivity Reactions [see Warnings and Precautions (5.3) ] Dysphagia and Breathing Difficulties [see Warnings and Precautions (5.4) ] Human Albumin and Transmission of Viral Diseases [see Warnings and Precautions (5.5) ] The most common adverse reactions (>5% of MYOBLOC-treated patients at any dose and >5% more common than placebo) include: Cervical Dystonia: dry mouth, dysphagia, injection site pain, and headache ( 6.1 ) Chronic Sialorrhea: dry mouth and dysphagia ( 6.1 ) To r...

8.1 Pregnancy Risk Summary There are no adequate data on the developmental risks associated with the use of MYOBLOC in pregnant women. No developmental toxicity was observed in pregnant rats administered MYOBLOC by intramuscular injection during gestation and lactation, at doses producing maternal toxicity. In the U.S. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown.

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. 5 WARNINGS AND PRECAUTIONS Spread of toxin effects; swallowing and breathing difficulties can lead to death. Seek immediate medical attention if respiratory, speech or swallowing difficulties occur ( 5.1 , 5.4 ) MYOBLOC potency units cannot be compared to or converted into units of other botulinum toxins ( 5.2 ) Patients with neuromuscular disorders should be monitored closely for swallowing/breathing difficulty ( 5.4 ) 5.1 Spread of Toxin Effect Postmarketing safety data from MYOBLOC and other approved botulinum toxins suggest that botulinum toxin effects may, in some cases, be observed beyond the site of local injection. 4 CONTRAINDICATIONS MYOBLOC is contraindicated in patients with: A known hypersensitivity to any botulinum toxin product or to any of the components in the formulation [see Warnings and Precautions (5.3) , Description (11) ] Infection at the proposed injection site(s) MYOBLOC is contraindicated in patients with: Known hypersensitivity to any botulinum toxin preparation or to any of the components...