Dysport 500 U/1
Botulinum Toxin Type A · INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION · Ipsen Biopharmaceuticals, Inc.
Dysport is a injection, powder, lyophilized, for solution containing botulinum toxin type a at 500 U/1, taken intramuscular. Manufactured by Ipsen Biopharmaceuticals, Inc..
Key Facts
- Brand Name
- Dysport
- Generic Name
- Botulinum Toxin Type A
- NDC Code (Product)
15054-0500- Manufacturer
- Ipsen Biopharmaceuticals, Inc.
- Strength
- 500 U/1
- Dosage Form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAMUSCULAR
- Marketing Status
- Application #
- BLA125274
- Drug Class
- Acetylcholine Release Inhibitor [EPC]; Neuromuscular Blocker [EPC]
- Marketing Start
- 11/02/2009
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE DYSPORT is an acetylcholine release inhibitor and neuromuscular blocking agent indicated for: the treatment of cervical dystonia in adults ( 1.1 ) the temporary improvement in the appearance of moderate to severe glabellar lines associated with procerus and corrugator muscle activity in adults < 65 years of age ( 1.2 ) The treatment of spasticity in patients 2 years of age and older ( 1.3 ) 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.
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Preparation of DYSPORT Solution for Administration ( 2.2 ) Once reconstituted, store in original container in a refrigerator 2°C to 8°C (36°F to 46°F) and use within 24 hours Do not freeze after reconstitution Reconstitution instructions are specific for the 300 Unit and 500 Unit vials Reconstituted DYSPORT is intended for intramuscular injection only. After reconstitution, DYSPORT should be used for only one injection session and for only one patient. Cervical Dystonia ( 2.3 ) • 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 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 ( 2.4 ) 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 ( 2.5 ) Select dose …
Contraindications
4 CONTRAINDICATIONS DYSPORT is contraindicated in patients with: Known hypersensitivity to any botulinum toxin products, cow's milk protein, or to any of the components in the formulation [ see Warnings and Precautions (5.3) ] . This product may contain trace amounts of cow's milk protein [ see Description (11) ] . Infection at the proposed injection site(s). • Hypersensitivity to: • any botulinum toxin product or excipients ( 4 , 5.3 ) • cow's milk protein ( 4 , 5.3 ) • Infection at the proposed injection site(s) ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Concomitant use of DYSPORT and aminoglycosides or other agents interfering with neuromuscular transmission or muscle relaxants, should be observed closely because the effect of DYSPORT may be potentiated (7.1, 7.4) Anticholinergic drugs may potentiate systemic anticholinergic effects (7.2) The effect of administering different botulinum neurotoxins during the course of treatment with DYSPORT is unknown (7.3) 7.1 Aminoglycosides and Other Agents Interfering with Neuromuscular Transmission Co-administration of DYSPORT and aminoglycosides or other agents interfering with neuromuscular transmission (e.g., curare-like agents) should only be performed with caution because the effect of the botulinum toxin may be potentiated. If co-administered, observe the patient closely. 7.2 Anticholinergic Drugs Use of anticholinergic drugs after administration of DYSPORT may potentiate systemic anticholinergic effects such as blurred vision. 7.3 Other Botulinum Neurotoxin Products The effect of administering botulinum neurotoxin products including DYSPORT, at the same time or within several months of each other is unknown. Excessive weakness may be exacerbated by another administr…
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are discussed below and elsewhere in labeling: Spread of Toxin Effect [ see Warning s and Precautions (5.1)] Lack of Interchangeability between Botulinum Toxin Products [ see Warnings and Precautions (5.2) ] Hypersensitivity Reactions [ see Warnings and Precautions (5.3) ] Dysphagia and Breathing Difficulties [ see Warnings and Precautions (5.4) ] Facial Anatomy in the Treatment of Glabellar Lines [ see Warnings and Precautions (5.5) ] Dry Eye with the Treatment of Glabellar Lines [see Warnings and Precautions (5.6) ] Pre-existing Neuromuscular Disorders [ see Warnings and Precautions (5.7) ] Human Albumin and Transmission of Viral Diseases [ see Warnings and Precautions (5.8) ] Intradermal Immune Reaction [ see Warnings and Precautions (5.9) ] Pre-existing Conditions at the Injection Site [ See Warnings and Precautions (5.10) ] Most commonly observed adverse reactions are ( 6.1 ): Cervical Dystonia (≥ 5%): muscular weakness, dysphagia, dry mouth, injection site discomfort, fatigue, headache, musculoskeletal pain, dysphonia, injection site pain and eye disorders Glabellar Lines (≥2%): nasopharyngitis, headache, injection s…
Frequently Asked Questions
What is Dysport used for?
Dysport contains Botulinum Toxin Type A. It is a injection, powder, lyophilized, for solution taken intramuscular. Consult your doctor for specific uses.
Is Dysport a controlled substance?
Dysport is not classified as a controlled substance by the DEA.
What is the generic name for Dysport?
The generic name for Dysport is Botulinum Toxin Type A. There are 1 other brand versions of Botulinum Toxin Type A.
What is the NDC code for Dysport 500 U/1?
The NDC (National Drug Code) for Dysport 500 U/1 is 15054-0500, listed by Ipsen Biopharmaceuticals, Inc..