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Dysport

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Dysport




Indications
Dosage
How Supplied

INDICATIONS

Cervical Dystonia

DYSPORT® is indicated for the treatment of adults with cervical dystonia.

Glabellar Lines

DYSPORT® is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with procerus and corrugator muscle activity in adult patients less than 65 years of age.

Upper Limb Spasticity

DYSPORT® is indicated for the treatment of upper limb spasticity in adult patients, to decrease the severity of increased muscle tone in elbow flexors, wrist flexors and finger flexors.

DOSAGE AND ADMINISTRATION

Instructions For Safe Use

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]. Reconstituted DYSPORT® is intended for intramuscular injection only.

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 (Table 1).

Table 1: Dilution Instructions for DYSPORT® Vials (500 Units and 300 Units)

Diluent* per 500 Unit Vial Resulting Dose Units per 0.1 mL Diluent* per 300 Unit Vial Resulting Dose Units per 0.1 mL
1 mL 50 Units 0.6 mL 50 Units
2.5 mL 20 Units 1.5 mL 20 Units
-- -- 2.5 mL 12 Units
5 mL** 10 Units 3 mL 10 Units
*Preservative-free 0.9% Sodium Chloride Injection, USP Only
Note: These dilutions are calculated for an injection volume of 0.1 mL. A decrease or increase in the DYSPORT® dose is also possible by administering a smaller or larger injection volume (i.e. 0.05 mL (50% decrease in dose), 0.08 mL (20% decrease in dose) or 0.15 mL (50% increase in dose)).
** When using 5 mL of diluent for a 500 Unit vial of DYSPORT®, complete the following steps (see also 2.4 Dosing in Upper Limb Spasticity).
1. Reconstitute a 500 Unit vial of DYSPORT® with 2.5 mL of Preservative-free 0.9% Sodium Chloride Injection, USP, gently mix, and set the vial aside.
2. Withdraw 2.5 mL of Preservative-free 0.9% Sodium Chloride Injection, USP, into a 5 mL syringe.
3. Take the 5 mL syringe with 2.5 mL Preservative-free 0.9% Sodium Chloride Injection, USP, and draw up the DYSPORT® solution from the reconstituted vial without inverting and mix gently. The resulting concentration will be 10 units/0.1 mL.
4. Use immediately after reconstitution in the syringe. Dispose of any unused saline.

After reconstitution, DYSPORT® should be used for only one injection session and for only one patient. Once reconstituted, DYSPORT® should be stored in the original container, in a refrigerator at 2 °C to8°C (36 °F to 46°F), protected from light for up to 24 hours. It must be discarded if not used within 24 hours. Do not freeze reconstituted DYSPORT®. Discard the vial and needle in accordance with local regulations.

Dosing In 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 8 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.

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.

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].

Pediatric Patients

The safety and effectiveness of DYSPORT® in the treatment in pediatric patients less than 18 years of age has not been assessed [see WARNINGS AND PRECAUTIONS].

Instructions for Preparation and Administration for the Treatment of Cervical Dystonia

DYSPORT® is supplied as a single-use vial. Only use sterile preservative-free 0.9% Sodium Chloride Injection, USP for reconstitution of DYSPORT®. Each 500 Unit vial of DYSPORT® is to be reconstituted with 1 mL of preservative- free 0.9% Sodium Chloride Injection USP to yield a solution of 50 Units per 0.1 mL. Each 300 Unit vial of DYSPORT® is to be reconstituted with 0.6 mL of preservative-free 0.9% Sodium Chloride Injection USP to yield a solution equivalent to 50 Units per 0.1 mL.

Using an appropriately sized sterile syringe, needle and aseptic technique, draw up 1 mL or 0.6 mL of sterile, preservative- free 0.9% Sodium Chloride Injection USP for 500 Unit 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.

Discard the vial and needle in accordance with local regulations.

Dosing In 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).

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.

Pediatric Patients

DYSPORT® for glabellar lines is not recommended for use in pediatric patients less than 18 years of age [see WARNINGS AND PRECAUTIONS].

Instructions for Preparation and Administration for the Treatment of Glabellar Lines

DYSPORT® is supplied as a single-use vial. Only use sterile preservative-free 0.9% Sodium Chloride Injection, USP for reconstitution of DYSPORT®. Each 300 Unit vial of DYSPORT® is to be reconstituted with 2.5 mL of preservative-free 0.9% Sodium Chloride Injection USP prior to injection. The concentration of the resulting solution will be 10 Units per 0.08 mL (12 Units per 0.1 mL) to be delivered in five equally divided aliquots of 0.08 mL each. DYSPORT® may also be reconstituted with 1.5 mL of preservative-free 0.9% Sodium Chloride Injection USP for a solution of 10 Units per 0.05 mL (20 Units per 0.1 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 preservative- free 0.9% Sodium Chloride Injection USP 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.

Discard the vial and needle in accordance with local regulations.

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).

Figure 1

Injection site - Illustration

Dosing In Upper Limb Spasticity

Special Populations

Adults

Dosing in initial and subsequent treatment sessions should be tailored to the individual based on the siz muscles involved, severity of spasticity, the presence of local muscle weakness, the patient's response to adverse event history with DYSPORT®. In the pivotal clinical trial, doses of 500 Units and 1000 Units muscles, Table 2 and Figure 2, at a given treatment session.

No more than 1 mL should generally be administered at any single injection site.

Table 2: DYSPORT® Dosing by Muscle for Upper Limb Spasticity

Muscles Injected Recommended Dose DYSPORT® Recommended Number of Injection(s) per Muscle
Flexor carpi radialis (FCR) 100 Units to 200 Units 1 to 2
Flexor carpi ulnaris (FCU) 100 Units to 200 Units 1 to 2
Flexor digitorum profundus (FDP) 100 Units to 200 Units 1 to 2
Flexor digitorum superficialis (FDS) 100 Units to 200 Units 1 to 2
Brachialis 200 Units to 400 Units 1 to 2
Brachioradialis 100 Units to 200 Units 1 to 2
Biceps Brachii (BB) 200 Units to 400 Units 1 to 2
Pronator Teres 100 Units to 200 Units 1

Figure 2: Muscles for Injection for Upper Limb Spasticity

Muscles for Injection for Upper Limb Spasticity - Illustration

Although actual location of the injection sites can be determined by palpation, the use of injection guiding technique e.g. electromyography, electrical stimulation is recommended to target the injection sites.

Repeat DYSPORT® treatment should be administered when the effect of a previous injection has diminished, but no sooner than 12 weeks after the previous injection. A majority of patients in clinical studies were retreated between 12-16 weeks; however some patients had a longer duration of response, i.e. 20 weeks. The degree and pattern of muscle spasticity at the time of re-injection may necessitate alterations in the dose of DYSPORT® and muscles to be injected. Clinical improvement may be expected one week after administration of DYSPORT®.

Pediatric Patients

The safety and effectiveness of DYSPORT® in the treatment of upper limb spasticity in pediatric patients less than 18 years of age has not been demonstrated. [see WARNINGS AND PRECAUTIONS]

Instructions for Preparation and Administration for the Treatment of Upper Limb Spasticity in Adults

DYSPORT® is supplied as a single-use vial. Only use sterile preservative-free 0.9% Sodium Chloride Injection, USP for reconstitution of DYSPORT®. The recommended concentration is 100 Units/mL or 200 Units/mL with preservative-free 0.9% Sodium Chloride Injection USP) (see Table 1).

Using an appropriately sized sterile syringe, needle and aseptic technique, draw up the required volume (Table 1) of preservative-free 0.9% Sodium Chloride Injection USP.

Insert the needle into the DYSPORT® vial. The partial vacuum will begin to pull the saline into the vial. No more than 2.5 mL of saline should be introduced into the vial (see footnote in Table 1). Do not use the vial if a vacuum is absent. Gently swirl 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.

Discard the vial and needle in accordance with local regulations.

HOW SUPPLIED

Dosage Forms And Strengths

For injection: 300 Units or 500 Units of lyophilized powder in a single-use vial for reconstitution with preservative-free 0.9% Sodium Chloride Injection, USP.

Storage And Handling

DYSPORT® for Injection is supplied in a sterile, single-use, glass vial. DYSPORT® must be stored under refrigeration at 2°to 8°C (36°to 46°F). Protect from light.

Do not use after the expiration date on the vial. All vials, including expired vials, or equipment used with DYSPORT® should be disposed of carefully as is done with all medical waste.

DYSPORT® contains a unique hologram on the carton. If you do not see the hologram, do not use the product. Instead contact 877- 397-7671.

Cervical Dystonia and Adult Upper Limb Spasticity

500 Unit Vial

Each vial contains 500 Units of freeze-dried abobotulinumtoxinA.

Box containing 1 vial—NDC 15054-0500-1
Box containing 2 vials—NDC 15054-0500-2

300 Unit Vial

Each vial contains 300 Units of freeze-dried abobotulinumtoxinA.

Box containing 1 vial—NDC 15054-0530-6

Glabellar Lines

Each vial contains 300 Units of freeze-dried abobotulinumtoxinA.

Box containing 1 vial— NDC 0299-5962-30

Distributed by: Ipsen Biopharmaceuticals, Inc. Basking Ridge, NJ 07920 and Galderma Laboratories, L.P. Fort Worth, TX76177; Manufactured by: Ipsen Biopharmaceuticals, Inc. Wrexham, LL13 9UF, UK. Revised Jul 2015

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 3/17/2016

Indications
Dosage
How Supplied

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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