Myobloc

MYOBLOC- rimabotulinumtoxinb injection, solution
Solstice Neurosciences, LLC

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 (5.1)].

1 INDICATIONS AND USAGE

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.

2 DOSAGE AND ADMINISTRATION

2.1 Instructions for Safe Use

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 cannot be compared to or converted into units of any other botulinum toxin products [see Warnings and Precautions (5.2), Description (11)] .

Each single-dose vial should only be used during one session and only for one patient. Discard any remaining solution in the vial.

MYOBLOC is ready to use; no reconstitution required.

MYOBLOC may be diluted with 0.9% Sodium Chloride Injection. Once diluted, the product must be used within 4 hours as the formulation does not contain a preservative.

2.2 Dosing for Cervical Dystonia

The recommended initial dosage of MYOBLOC for cervical dystonia patients with a prior history of tolerating botulinum toxin injections is 2,500 Units to 5,000 Units divided among affected muscles [see Clinical Studies (14.1)] . Patients without a prior history of tolerating botulinum toxin injections should receive a lower initial dosage [see Adverse Reactions (6.1)] . Subsequent dosing should be determined by the patient’s individual response. MYOBLOC should be administered by physicians familiar with and experienced in the assessment and management of patients with cervical dystonia.

The duration of effect in patients responding to MYOBLOC treatment for cervical dystonia has been observed in studies to be between 12 and 16 weeks at doses of 5,000 Units or 10,000 Units [see Clinical Studies (14.1)] .

2.3 Dosing for Chronic Sialorrhea

Dosing Information

The recommended dosage of MYOBLOC for chronic sialorrhea is 1,500 Units to 3,500 Units, divided among the parotid and submandibular glands (Table 1). Patient response to treatment should be considered when determining subsequent MYOBLOC dosage [see Clinical Studies (14.2)] . The typical duration of effect of each treatment is up to 3 months; however, the effect may vary in individual patients. The frequency of MYOBLOC repeat treatments should be determined by clinical response but should generally be no more frequent than every 12 weeks.

Table 1: Dosing by Gland for Chronic Sialorrhea in Adults
Gland Recommended Dosage
Parotid 500 Units to 1,500 Units per gland
Submandibular 250 Units per gland

Administration Information

A suitable sterile needle (e.g., 30-gauge, 0.5 inch) should be used for intra-salivary gland administration.

Figure 1: Glands for Injection in Chronic Sialorrhea

Figure 1
(click image for full-size original)

Guidelines for locating salivary glands using anatomical landmarks (Figure 1):

  • 1. To inject the parotid gland, bisect the distance between the tip of the tragus (Site A) and the angle of the mandible (Site B). Inject one finger breadth anterior to this site (Injection Site 1).
  • 2. To inject the submandibular gland, bisect the distance between the angle of the mandible (Site B) and the tip of the chin (Site C). Inject one finger breadth medial to the inferior surface of the point of bisection (Injection Site 2).

In clinical studies, MYOBLOC was injected using anatomical landmarks to localize the salivary glands, or using ultrasound guidance for gland location. Both methods produced similar reduction in the unstimulated salivary flow rate.

3 DOSAGE FORMS AND STRENGTHS

MYOBLOC is a clear and colorless to light-yellow solution available as:

  • Injection: 2,500 Units/0.5 mL in a single-dose vial
  • Injection: 5,000 Units/mL in a single-dose vial
  • Injection: 10,000 Units/2 mL (5,000 Units/mL) in a single-dose vial

4 CONTRAINDICATIONS

MYOBLOC is contraindicated in patients with:

5 WARNINGS AND PRECAUTIONS

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. The symptoms are consistent with the mechanism of action of botulinum toxin and 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 related to spread of toxin effects. 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, and 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, symptoms consistent with spread of toxin effect have been reported at doses comparable to or lower than doses used to treat cervical dystonia.

5.2 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 [see Description (11)] .

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2022. All Rights Reserved.