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Black Box Warning
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See full prescribing information for complete Boxed Warning.
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Content
Overview
Botulinum toxin is a {{{drugClass}}} that is FDA approved for the treatment of cervical dystonia, glabellar lines. There is a Black Box Warning for this drug as shown here. Common adverse reactions include muscular weakness, dysphagia, dry mouth, injection site discomfort, fatigue, headache, neck pain, musculoskeletal pain, dysphonia, injection site pain, and eye disorders, nasopharyngitis, injection site reaction, upper respiratory tract infection, eyelid edema, eyelid ptosis, sinusitis and nausea.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Cervical Dystonia
DYSPORT® (abobotulinumtoxinA) is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for the treatment of adults with cervical dystonia to reduce the severity of abnormal head position and neck pain in both toxin-naïve and previously treated patients.
Dosing Information
The recommended initial dose of DYSPORT® for the treatment of cervical dystonia is 500 Units given intramuscularly as a divided dose among affected muscles in patients with or without a history of prior treatment with botulinum toxin. (A description of the average DYSPORT® dose and percentage of total dose injected into specific muscles in the pivotal clinical trials can be found in TABLE 5 of Section 14.1, Clinical Studies – Cervical Dystonia.) Limiting the dose injected into the sternocleidomastoid muscle may reduce the occurrence of dysphagia. Clinical studies with DYSPORT® in cervical dystonia suggest that the peak effect occurs between two and four weeks after injection. Simultaneous EMG-guided application of DYSPORT® may be helpful in locating active muscles not identified by physical examination alone.
Dose Modification
Where dose modification is necessary for the treatment of cervical dystonia, uncontrolled open-label studies suggest that dose adjustment can be made in 250 Unit steps according to the individual patient's response, with re-treatment every 12 weeks or longer, as necessary, based on return of clinical symptoms. Uncontrolled open-label studies also suggest that the total dose administered in a single treatment should be between 250 Units and 1000 Units. Re-treatment, if needed, should not occur in intervals of less than 12 weeks. Doses above 1000 Units have not been systematically evaluated.
2.1.1 Special Populations
Adults and elderly
The starting dose of 500 Units recommended for cervical dystonia is applicable to adults of all ages [see USE IN SPECIFIC POPULATIONS (8.5)].
Children
The safety and effectiveness of DYSPORT® in the treatment of cervical dystonia in pediatric patients less than 18 years of age has not been assessed [see WARNINGS AND PRECAUTIONS (5.2)].
2.1.2 Instructions for Preparation and Administration
DYSPORT® is supplied as a single-use vial. Each 500 Unit vial of DYSPORT® is to be reconstituted with 1 mL of 0.9% Sodium Chloride Injection USP (without preservative) to yield a solution of 500 Units per mL. Each 300 Unit vial of DYSPORT® is to be reconstituted with 0.6 mL of 0.9% Sodium Chloride Injection USP (without preservative) to yield a solution equivalent to 250 Units per 0.5 mL.
Using an appropriately sized sterile syringe, needle and aseptic technique, draw up 1.0 mL or 0.6 mL of sterile, 0.9% Sodium Chloride Injection USP (without preservative) for 500 and 300 Unit vials, respectively. Insert the needle into the DYSPORT® vial. The partial vacuum will begin to pull the saline into the vial. Any remaining required saline should be expressed into the vial manually. Do not use the vial if no vacuum is observed. Swirl gently to dissolve. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Reconstituted DYSPORT® should be a clear, colorless solution, free of particulate matter, otherwise it should not be injected.
Expel any air bubbles in the syringe barrel. Remove the needle used to reconstitute the product and attach an appropriately sized new sterile needle.
Once reconstituted, DYSPORT® should be stored in a refrigerator at 2–8°C (36–46°F) protected from light and used within 24 hours. Do not freeze reconstituted DYSPORT®. Discard the vial and needle in accordance with local regulations.
Glabellar Lines
DYSPORT® (abobotulinumtoxinA) is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with procerus and corrugator muscle activity in adult patients < 65 years of age.
Dosing Information
The dose of DYSPORT® for the treatment of glabellar lines is a total of 50 Units given intramuscularly in five equal aliquots of 10 Units each to achieve clinical effect (see FIGURE 1).
2.2.1 Special Populations
Adults
A total dose of 50 Units of DYSPORT®, in five equal aliquots, should be administered to achieve clinical effect.
The clinical effect of DYSPORT® may last up to four months. Repeat dose clinical studies demonstrated continued efficacy with up to four repeated administrations. It should be administered no more frequently than every three months. When used for re-treatment, DYSPORT® should be reconstituted and injected using the same techniques as the initial treatment.
Children
DYSPORT® for glabellar lines is not recommended for use in pediatric patients less than 18 years of age [see WARNINGS AND PRECAUTIONS (5.2)].
2.2.2 Instructions for Preparation and Administration
DYSPORT® is supplied as a single-use vial. Each 300 Unit vial of DYSPORT® is to be reconstituted with 2.5 mL of 0.9% Sodium Chloride Injection USP (without preservative) prior to injection. The concentration of the resulting solution will be 10 Units per 0.08 mL to be delivered in five equally divided aliquots of 0.08 mL each. DYSPORT® may also be reconstituted with 1.5 mL of 0.9% Sodium Chloride Injection USP (without preservative) for a solution of 10 Units per 0.05 mL to be delivered in five equally divided aliquots of 0.05 mL each.
Using an appropriately sized sterile syringe, needle and aseptic technique, draw up 2.5 mL or 1.5 mL of 0.9% Sodium Chloride Injection USP (without preservative). Insert the needle into the DYSPORT® vial. The partial vacuum will begin to pull the saline into the vial. Any remaining required saline should be expressed into the vial manually. Do not use the vial if no vacuum is observed. Swirl gently to dissolve. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Reconstituted DYSPORT® should be a clear, colorless solution, free of particulate matter otherwise it should not be injected.
Draw a single patient dose of DYSPORT® into a sterile syringe. Expel any air bubbles in the syringe barrel. Remove the needle used to reconstitute the product and attach a 30 gauge needle.
Once reconstituted, DYSPORT® should be stored in a refrigerator at 2–8°C (36–46°F) protected from light and used within 24 hours. Do not freeze reconstituted DYSPORT®. Discard the vial and needle in accordance with local regulations.
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Dosing Information
Dosage
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Dosing Information
Dosage
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
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Developed by:
Class of Recommendation:
Strength of Evidence:
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Guideline-Supported Use of Botulinum toxin in adult patients.
Non–Guideline-Supported Use
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Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Botulinum toxin in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Condition1
Dosing Information
Dosage
Condition2
There is limited information regarding FDA-Labeled Use of Botulinum toxin in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
Condition1
Developed by:
Class of Recommendation:
Strength of Evidence:
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Guideline-Supported Use of Botulinum toxin in pediatric patients.
Non–Guideline-Supported Use
Condition1
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Botulinum toxin in pediatric patients.
Contraindications
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Warnings
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See full prescribing information for complete Boxed Warning.
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Content
Description
Precautions
Description
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Botulinum toxin in the drug label.
Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Botulinum toxin in the drug label.
Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Botulinum toxin in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Botulinum toxin during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Botulinum toxin with respect to nursing mothers.
Pediatric Use
There is no FDA guidance on the use of Botulinum toxin with respect to pediatric patients.
Geriatic Use
There is no FDA guidance on the use of Botulinum toxin with respect to geriatric patients.
Gender
There is no FDA guidance on the use of Botulinum toxin with respect to specific gender populations.
Race
There is no FDA guidance on the use of Botulinum toxin with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Botulinum toxin in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Botulinum toxin in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Botulinum toxin in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Botulinum toxin in patients who are immunocompromised.
Administration and Monitoring
Administration
The potency Units of DYSPORT® 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 DYSPORT® cannot be compared to or converted into units of any other botulinum toxin products assessed with any other specific assay method [see DESCRIPTION (11)].
Reconstitution instructions are specific for each of the 300 Unit vial and the 500 Unit vial. These volumes yield concentrations specific for the use for each indication.
2.1 Cervical Dystonia
The recommended initial dose of DYSPORT® for the treatment of cervical dystonia is 500 Units given intramuscularly as a divided dose among affected muscles in patients with or without a history of prior treatment with botulinum toxin. (A description of the average DYSPORT® dose and percentage of total dose injected into specific muscles in the pivotal clinical trials can be found in TABLE 5 of Section 14.1, Clinical Studies – Cervical Dystonia.) Limiting the dose injected into the sternocleidomastoid muscle may reduce the occurrence of dysphagia. Clinical studies with DYSPORT® in cervical dystonia suggest that the peak effect occurs between two and four weeks after injection. Simultaneous EMG-guided application of DYSPORT® may be helpful in locating active muscles not identified by physical examination alone.
Dose Modification
Where dose modification is necessary for the treatment of cervical dystonia, uncontrolled open-label studies suggest that dose adjustment can be made in 250 Unit steps according to the individual patient's response, with re-treatment every 12 weeks or longer, as necessary, based on return of clinical symptoms. Uncontrolled open-label studies also suggest that the total dose administered in a single treatment should be between 250 Units and 1000 Units. Re-treatment, if needed, should not occur in intervals of less than 12 weeks. Doses above 1000 Units have not been systematically evaluated.
2.1.1 Special Populations
Adults and elderly
The starting dose of 500 Units recommended for cervical dystonia is applicable to adults of all ages [see USE IN SPECIFIC POPULATIONS (8.5)].
Children
The safety and effectiveness of DYSPORT® in the treatment of cervical dystonia in pediatric patients less than 18 years of age has not been assessed [see WARNINGS AND PRECAUTIONS (5.2)].
2.1.2 Instructions for Preparation and Administration
DYSPORT® is supplied as a single-use vial. Each 500 Unit vial of DYSPORT® is to be reconstituted with 1 mL of 0.9% Sodium Chloride Injection USP (without preservative) to yield a solution of 500 Units per mL. Each 300 Unit vial of DYSPORT® is to be reconstituted with 0.6 mL of 0.9% Sodium Chloride Injection USP (without preservative) to yield a solution equivalent to 250 Units per 0.5 mL.
Using an appropriately sized sterile syringe, needle and aseptic technique, draw up 1.0 mL or 0.6 mL of sterile, 0.9% Sodium Chloride Injection USP (without preservative) for 500 and 300 Unit vials, respectively. Insert the needle into the DYSPORT® vial. The partial vacuum will begin to pull the saline into the vial. Any remaining required saline should be expressed into the vial manually. Do not use the vial if no vacuum is observed. Swirl gently to dissolve. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Reconstituted DYSPORT® should be a clear, colorless solution, free of particulate matter, otherwise it should not be injected.
Expel any air bubbles in the syringe barrel. Remove the needle used to reconstitute the product and attach an appropriately sized new sterile needle.
Once reconstituted, DYSPORT® should be stored in a refrigerator at 2–8°C (36–46°F) protected from light and used within 24 hours. Do not freeze reconstituted DYSPORT®. Discard the vial and needle in accordance with local regulations.
2.2 Glabellar Lines
The dose of DYSPORT® for the treatment of glabellar lines is a total of 50 Units given intramuscularly in five equal aliquots of 10 Units each to achieve clinical effect (see FIGURE 1).
2.2.1 Special Populations
Adults
A total dose of 50 Units of DYSPORT®, in five equal aliquots, should be administered to achieve clinical effect.
The clinical effect of DYSPORT® may last up to four months. Repeat dose clinical studies demonstrated continued efficacy with up to four repeated administrations. It should be administered no more frequently than every three months. When used for re-treatment, DYSPORT® should be reconstituted and injected using the same techniques as the initial treatment.
Children
DYSPORT® for glabellar lines is not recommended for use in pediatric patients less than 18 years of age [see WARNINGS AND PRECAUTIONS (5.2)].
2.2.2 Instructions for Preparation and Administration
DYSPORT® is supplied as a single-use vial. Each 300 Unit vial of DYSPORT® is to be reconstituted with 2.5 mL of 0.9% Sodium Chloride Injection USP (without preservative) prior to injection. The concentration of the resulting solution will be 10 Units per 0.08 mL to be delivered in five equally divided aliquots of 0.08 mL each. DYSPORT® may also be reconstituted with 1.5 mL of 0.9% Sodium Chloride Injection USP (without preservative) for a solution of 10 Units per 0.05 mL to be delivered in five equally divided aliquots of 0.05 mL each.
Using an appropriately sized sterile syringe, needle and aseptic technique, draw up 2.5 mL or 1.5 mL of 0.9% Sodium Chloride Injection USP (without preservative). Insert the needle into the DYSPORT® vial. The partial vacuum will begin to pull the saline into the vial. Any remaining required saline should be expressed into the vial manually. Do not use the vial if no vacuum is observed. Swirl gently to dissolve. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Reconstituted DYSPORT® should be a clear, colorless solution, free of particulate matter otherwise it should not be injected.
Draw a single patient dose of DYSPORT® into a sterile syringe. Expel any air bubbles in the syringe barrel. Remove the needle used to reconstitute the product and attach a 30 gauge needle.
Once reconstituted, DYSPORT® should be stored in a refrigerator at 2–8°C (36–46°F) protected from light and used within 24 hours. Do not freeze reconstituted DYSPORT®. Discard the vial and needle in accordance with local regulations.
2.2.3 Injection Technique
Glabellar facial lines arise from the activity of the lateral corrugator and vertical procerus muscles. These can be readily identified by palpating the tensed muscle mass while having the patient frown. The corrugator depresses the skin creating a "furrowed" vertical line surrounded by tensed muscle (i.e., frown lines). The location, size, and use of the muscles vary markedly among individuals. Physicians administering DYSPORT® must understand the relevant neuromuscular and/or orbital anatomy of the area involved and any alterations to the anatomy due to prior surgical procedures.
Risk of ptosis can be mitigated by careful examination of the upper lid for separation or weakness of the levator palpebrae muscle (true ptosis), identification of lash ptosis, and evaluation of the range of lid excursion while manually depressing the frontalis to assess compensation.
In order to reduce the complication of ptosis, the following steps should be taken:
Avoid injection near the levator palpebrae superioris, particularly in patients with larger brow depressor complexes.
Medial corrugator injections should be placed at least 1 centimeter above the bony supraorbital ridge.
Ensure the injected volume/dose is accurate and where feasible kept to a minimum.
Do not inject toxin closer than 1 centimeter above the central eyebrow.
To inject DYSPORT®, advance the needle through the skin into the underlying muscle while applying finger pressure on the superior medial orbital rim. Inject patients with a total of 50 Units in five equally divided aliquots. Using a 30 gauge needle, inject 10 Units of DYSPORT® into each of five sites, two in each corrugator muscle, and one in the procerus muscle (see FIGURE 1).
