Usual Adult Dose for Cervical Dystonia

For patients who have demonstrated tolerability to botulinum toxin:
Initial dose: 2500 to 5000 Units IM divided among affected muscles

For patients who have not demonstrated tolerability to botulinum toxin:

• Lower initial doses are recommended

Subsequent dosing should be optimized according to patient's response

• Duration of effect: 12 to 16 weeks (at doses of 5000 to 10,000 Units)

Comments:

• This drug should be administered by physicians familiar and experienced in the assessment and management of patients with cervical dystonia.

Use: To reduce the severity of abnormal head position and neck pain associated with cervical dystonia.

Usual Adult Dose for Sialorrhea

Initial dose: 1500 to 3500 Units divided among the parotid and submandibular glands:

• Parotid: 500 to 1500 Units per gland
• Submandibular: 250 Units per gland

Subsequent dosing should be based on patient's response; typical duration of effect for each treatment is up to 3 months, but may vary in individual patients
Frequency of treatment: Generally, no more frequent than every 12 weeks

Comments:

• Consult package labeling for additional administration guidance including illustration of gland placement.
• In clinical trials, both anatomical landmarks and ultrasound guidance were used for gland location; both methods produced similar reduction in the unstimulated salivary flow rate.

Use: For the treatment of chronic sialorrhea.

Renal Dose Adjustments

No adjustment recommended

Liver Dose Adjustments

No adjustment recommended

Dose Adjustments

Cervical dystonia: Elderly: Limited data, therefore no conclusions regarding the safety and efficacy in this age group have been determined.
Chronic sialorrhea: No overall differences in safety or effectiveness were observed, but greater sensitivity of some older patients cannot be ruled out.

Precautions

US BOXED WARNING: DISTANT SPREAD OF TOXIN EFFECT

• Postmarketing reports indicate that the effects of this drug 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 in approved indications, cases of spread of effect have occurred at doses comparable to those used to treat cervical dystonia and at lower doses.

CONTRAINDICATIONS:

• Known hypersensitivity to any botulinum toxin product or any component in the formulation
• Infection at the proposed injection site(s)

Safety and effectiveness have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

No data available

Other Comments

Administration advice:
Cervical Dystonia:

• For IM administration only

Chronic Sialorrhea:

• For intra-salivary gland administration (parotid and submandibular) only
• See product information for guidance locating salivary glands

Preparation techniques:

• Single-dose vials, for use during 1 session in 1 patient only; discard remaining solution
• Reconstitution is not required; however, may be diluted with normal saline
• Once diluted, product must be used within 4 hours
• Do not shake vial

Storage requirements:

• Protect from light
• Store refrigerated (36F to 46F [2C to 8C]); do not freeze

General:

• Potency units are not interchangeable with other preparations of botulinum toxin products and can therefore not be compared to, or converted into units of any other botulinum toxin product.
• This drug should be administered by physicians familiar and experienced in the assessment and management of patients with cervical dystonia.

Monitoring:

• Monitor for distant spread of toxin effect

Patient advice:

• Patients should be instructed to read the US FDA-approved patient labeling (Medication Guide).
• Patients should be instructed to seek immediate medical attention if swallowing, speech or respiratory difficulties occur.
• Patients should understand that toxin effects may spread within hours, days, or weeks after an injection; patients should contact their healthcare professional with new or worsening symptoms.
• Patients should understand that loss of muscle strength, muscle weakness, or blurred vision may occur; patients should avoid driving a car or engaging in other potentially hazardous activities if these events develop.

Frequently asked questions

• What is botulinum toxin used to treat?