Dysport

DYSPORT — botulinum toxin type a injection, powder, lyophilized, for solution
Galderma Laboratories, L.P.

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WARNING: DISTANT SPREAD OF TOXIN EFFECT

Postmarketing reports indicate that the effects of DYSPORT 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 and in approved indications, cases of spread of effect have been reported at doses comparable to or lower than the maximum recommended total dose [see Warnings and Precautions (5.1) ].

1 INDICATIONS AND USAGE

1.1 Cervical Dystonia

DYSPORT is indicated for the treatment of cervical dystonia in adults.

1.2 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 adults less than 65 years of age.

1.3 Spasticity

DYSPORT is indicated for the treatment of spasticity in patients 2 years of age and older.

2 DOSAGE AND ADMINISTRATION

2.1 Instructions for Safe Use

The potency Units of DYSPORT 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 Warnings and Precautions (5.2) and Description (11) ].

Reconstituted DYSPORT is intended for intramuscular injection only.

2.2 Preparation of Dysport Solution for Administration

DYSPORT is supplied as a dry powder, in single-dose 300 Unit and 500 Unit vials, which must be reconstituted with preservative-free 0.9% Sodium Chloride Injection, USP using aseptic technique prior to intramuscular injection. Table 1 provides dilution instructions for the 300 Unit and 500 Unit vials, depending on the desired final concentration. The desired final concentration after dilution varies depending on the indication (see Table 2 for the recommended solution concentration after dilution).

Table 1: Dilution Instructions for DYSPORT Vials (500 Units and 300 Units)
*
Preservative-free 0.9% Sodium Chloride Injection, USP Only
Diluent * per 500 Unit Vial Resulting Dose Unites 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 mL 25 Units
2.5 mL 20 Units 1.5 mL 20 Units
2.5 mL 12 Units
5 mL 10 Units 3 mL 10 Units

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% (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, no more than 2.5 mL of 0.9% Sodium Chloride Injection, USP should be introduced into the vial. Complete the following steps:

  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 vital aside.
  2. Withdraw 2.5 mL of Preservative-free 0.9 Sodium Chloride Infection, USP into a 5 mL syringe
  3. Take the 5 mL syringe with 2.5 ml Preservative-free 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 0.9% Sodium Chloride Injection, USP.

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

After reconstitution, DYSPORT should be used for only one injection session and for only one patient. Discard any unused portion. Once reconstituted, unused DYSPORT may be stored in the original container, in a refrigerator at 2°C to 8°C (36°F to 46°F), protected from light for up to 24 hours until time of use. 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.

Table 2: Recommended Solution Concentration and Dosing Range of DYSPORT by Indication
Indication Recommended Concentration Recommended DYSPORT Dose
Cervical Dystonia, Adults 50 Units/0.1 mL or25 Units/0.1 mL 500 Units to 1000 Units
Glabellar Lines, Adults 12 Units/0.1 mLor 20 Units/0.1 mL 50 Units, divided in five equal aliquots of 10 Units (0.08 mL) each or 50 Units, divided in five equal aliquots of 10 Units (0.05 mL) each
Spasticity, Adults* 10 Units/0.1 mLor20 Units/0.1 mL Upper Limb: 500 Units to 1000 Units Lower Limb: 1000 Units to 1500 Units Maximum total dose per treatment session = 1500 Units
Spasticity, Pediatric Patients 20 Units/0.1 mL or50 Units/0.1 mL** Upper Limb: 8 Units/kg to 16 Units/kg per limb
  • Maximum total dose per treatment session = 16 Units/kg or 640 Units, whichever is lower
Lower Limb: 10 Units/kg to 15 Units/kg per limb
  • Maximum total dose per treatment session for unilateral limb injections = 15 Units/kg or 1000 Units, whichever is lower
  • Maximum total dose per treatment session for bilateral limb injections = 30 Units/kg or 1000 Units, whichever is lower
Maximum total dose per treatment session = 30 Units/kg or 1000 Units, whichever is lower

* No more than 1 mL should generally be administered at any single injections site
No more than 0.5 mL of DYSPORT should be administered in any single injection site
** Further dilution with preservative-free 0.9% Sodium Chloride Injection, USP, may be required to achieve the final volume for injection.

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