Dysport

What is Dysport?

• Dysport (botulinum toxin type a) is an acetylcholine release inhibitor and a neuromuscular blocking agent used to treat cervical dystonia, moderate to severe glabellar lines and spasticity.

Botulinum Toxin Mechanism

What are the uses of this medicine?

DYSPORT is a prescription medicine that is injected into muscles and used:

• to treat cervical dystonia (CD) in adults
• to improve the look of moderate to severe frown lines between the eyebrows (glabellar lines) in adults younger than 65 years of age for a short period of time (temporary)
• to treat increased muscle stiffness in people 2 years of age and older with spasticity.

How does this medicine work?

• DYSPORT inhibits release of the neurotransmitter, acetylcholine, from peripheral cholinergic nerve endings.

Toxin activity occurs in the following sequence:

• Toxin heavy chain mediated binding to specific surface receptors on nerve endings
• internalization of the toxin by receptor mediated endocytosis
• pH-induced translocation of the toxin light chain to the cell cytosol and cleavage of SNAP25 leading to intracellular blockage of neurotransmitter exocytosis into the neuromuscular junction.

• This accounts for the therapeutic utility of the toxin in diseases characterized by excessive efferent activity in motor nerves.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• Known hypersensitivity to any botulinum toxin products, cow's milk protein, or to any of the components in the formulation.
• Infection at the proposed injection site(s).

What drug interactions can this medicine cause?

• Concomitant use of DYSPORT and aminoglycosides or other agents interfering with neuromuscular transmission or muscle relaxants, should be observed closely because effect of DYSPORT may be potentiated.
• Use of anticholinergic drugs after administration of DYSPORT may potentiate systemic anticholinergic effects such as blurred vision.
• Excessive weakness may also be exaggerated by administration of a muscle relaxant before or after administration of DYSPORT.
• The effect of administering botulinum neurotoxin products including DYSPORT, at the same time or within several months of each other is unknown.

Is this medicine FDA approved?

• Initial U.S. Approval: 2009

How should this medicine be used?

Recommended dosage: Cervical Dystonia

• Initial dose is 500 Units given intramuscularly as a divided dose among the affected muscles
• Re-treatment every 12 to 16 weeks or longer, as necessary, based on return of clinical symptoms with doses administered between 250 Units and 1000 Units to optimize clinical benefit
• Re-treatment should not occur in intervals of less than 12 weeks
• Titrate in 250 Unit steps according to patient's response

Glabellar Lines

• Administer a total dose of 50 Units, divided in five equal aliquots of 10 Units each, intramuscularly to affected muscles to achieve clinical effect
• Re-treatment should be administered no more frequently than every 3 months

Spasticity in Adults

• Select dose based on muscles affected, severity of spasticity, and treatment and adverse reaction history with botulinum toxins
• Dosing for upper limb spasticity: between 500 Units and 1000 Units
• Dosing for lower limb spasticity: up to 1500 Units
• The maximum recommended total dose per treatment session (upper and lower limb combined) in adults is 1500 Units
• Re-treatment, based on return of clinical symptoms, should not occur in intervals of less than 12 weeks

Spasticity in Pediatric Patients

• Select dose based on the affected muscle, severity of spasticity, and treatment and adverse reaction history with all botulinum toxins.
• Recommended dosing for upper limb spasticity: 8 Units/kg to 16 Units/kg per limb. The maximum recommended total dose administered per treatment session must not exceed 16 Units/kg or 640 Units, whichever is lower.
• Recommended dosing for lower limb spasticity: 10 Units/kg to 15 Units/kg per limb. Total dose per treatment session must not exceed 15 Units/kg for unilateral lower limb injections, 30 Units/kg for bilateral injections, or 1000 Units, whichever is lower.
• The maximum recommended total dose per treatment session is 30 Units/kg or 1000 Units, whichever is lower. Re-treatment, based on return of clinical symptoms, should not occur in intervals of less than 3 months.

Administration:

• DYSPORT is injected into the affected muscles.
• If you are an adult, your doctor may give you another dose of DYSPORT after 12 weeks or longer, if it is needed.
• If you are an adult being treated for CD or spasticity or you are a child (2 to 17 years of age) being treated for spasticity, your doctor may change your dose of DYSPORT until you and your doctor find the best dose for you. Children should not be retreated sooner than every 12-16 weeks
• The dose of DYSPORT is not the same as the dose of any other botulinum toxin product.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 300 Units or 500 Units lyophilized powder in a single-dose vial

This medicine is available in fallowing brand namesː

• DYSPORT

What side effects can this medication cause?

The most common side effects of DYSPORT in people with cervical dystonia include:

• muscle weakness
• dry mouth
• feeling of tiredness
• muscle pain
• problems speaking
• eye problems
• difficulty swallowing
• injection site pain or discomfort
• headache

The most common side effects of DYSPORT in people with glabellar lines include:

• stuffy or runny nose and sore throat
• injection site pain
• upper respiratory infection
• blood in urine
• headache
• injection site reaction
• swelling of eyelids
• drooping eyelids
• sinus infection
• nausea

The most common side effect of DYSPORT in adults with upper limb spasticity include:

• muscle weakness

The most common side effects of DYSPORT in adults with lower limb spasticity include:

• muscle weakness
• pain in your arms or legs
• fall

The most common side effects of DYSPORT in children (2 to 17 years of age) with upper limb spasticity include:

• upper respiratory tract infection
• sore throat

The most common side effects of DYSPORT in children (2 to 17 years of age) with lower limb spasticity include:

• stuffy or runny nose and sore throat
• cough
• fever

This medicine may cause serious side effects, including:

• Problems breathing or swallowing
• Spread of toxin effects

What special precautions should I follow?

• The potency units of DYSPORT are not interchangeable with other preparations of botulinum toxin products.
• Treatment with DYSPORT and other botulinum toxin products can result in swallowing or breathing difficulties. Immediate medical attention may be required in cases of respiratory, speech or swallowing difficulties.
• Recommended dose and frequency of administration should not be exceeded.
• Dry eye has been reported with the use of DYSPORT in the treatment of glabellar line; if symptoms persist, consider referring patient to an ophthalmologist.
• Patients with neuromuscular disorders may be at increased risk of clinically significant effects including severe dysphagia and respiratory compromise from typical doses of DYSPORT.
• Postmarketing safety data from DYSPORT and other approved botulinum toxins suggest that botulinum toxin effects may, in some cases, be observed beyond the site of local injection.
• Serious hypersensitivity reactions have been reported with DYSPORT. Hypersensitivity reactions include anaphylaxis, serum sickness, urticaria, soft tissue edema, and dyspnea. If such a serious hypersensitivity reaction occurs, discontinue further injection of DYSPORT and institute appropriate medical therapy immediately.
• This product contains albumin, a derivative of human blood. There is a theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD), but if that risk actually exists, the risk of transmission would also be considered extremely remote.
• The safety of DYSPORT for the treatment of hyperhidrosis has not been established. DYSPORT is approved only for intramuscular injection.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• neuromuscular weakness
• paralysis of respiratory muscles

Treatment of overdosage:

• In the event of overdose, the patient should be medically monitored for symptoms of excessive muscle weakness or muscle paralysis.
• Symptomatic treatment may be necessary.
• Respiratory support may be required where excessive doses cause paralysis of respiratory muscles.
• In the event of overdose, antitoxin raised against botulinum toxin is available from the Centers for Disease Control and Prevention (CDC) in Atlanta, GA.
• In the event of suspected or actual cases of botulinum toxin poisoning, please contact your local or state Health Department to process a request for antitoxin through the CDC.
• If you do not receive a response within 30 minutes, please contact the CDC directly at 770-488-7100.

Can this medicine be used in pregnancy?

• There are no adequate and well-controlled clinical studies with DYSPORT in pregnant women.
• DYSPORT should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus.

Can this medicine be used in children?

Cervical Dystonia

• Safety and effectiveness in pediatric patients have not been established.

Glabellar Lines

• DYSPORT is not recommended for use in pediatric patients less than 18 years of age.

Spasticity

• Safety and effectiveness have been established in pediatric patients 2 years of age and older.
• Safety and effectiveness in pediatric patients below the age of 2 years have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: (botulinum toxin Type A)
• Inactive ingredients: human albumin and lactose. DYSPORT may contain cow's milk protein.

Who manufactures and distributes this medicine?

• Distributed by: Ipsen Biopharmaceuticals, Inc. Cambridge, MA 02142 and Galderma Laboratories, L.P. Fort Worth, TX 76177; Manufactured by: Ipsen Biopharm Ltd., Wrexham, LL13 9UF, UK U.S.

What should I know about storage and disposal of this medication?

• DYSPORT® (abobotulinumtoxinA) for injection is a sterile, lyophilized powder supplied in a single-dose, glass vial.
• Unopened vials of DYSPORT must be stored refrigerated between 2°C to 8°C (36°F 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.

• Dailymed label info on Dysport
• FDA Dysport

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