Country: United States
Language: English
Source: NLM (National Library of Medicine)
Botulinum Toxin Type A (UNII: E211KPY694) (Botulinum Toxin Type A - UNII:E211KPY694)
Ipsen Biopharmaceuticals, Inc.
Botulinum Toxin Type A
Botulinum Toxin Type A 500 U
INTRAMUSCULAR
PRESCRIPTION DRUG
DYSPORT is indicated for the treatment of cervical dystonia in adults. 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. DYSPORT is indicated for the treatment of spasticity in patients 2 years of age and older. 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). Risk Summary 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. DYSPORT produced embryo-fetal toxicity in relation to maternal toxicity when given to pregnant rats and
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. Instead contact 855-463-5127. Cervical Dystonia, Spasticity in Adults and Pediatric Patients 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
Biologic Licensing Application
Ipsen Biopharmaceuticals, Inc. ---------- This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised 9/2023 MEDICATION GUIDE DYSPORT® (DIS-port) (abobotulinumtoxinA) for Injection What is the most important information I should know about DYSPORT? DYSPORT may cause serious side effects that can be life threatening including: • Problems breathing or swallowing • Spread of toxin effects These problems can happen within hours, or days to weeks after an injection of DYSPORT. Call your doctor or get medical help right away if you have any of these problems after treatment with DYSPORT: 1. Problems swallowing, speaking, or breathing. These problems can happen within hours, or days to weeks after an injection of DYSPORT usually because the muscles that you use to breathe and swallow can become weak after the injection. Death can happen as a complication if you have severe problems with swallowing or breathing after treatment with DYSPORT. • People with certain breathing problems may need to use muscles in their neck to help them breathe. These patients may be at greater risk for serious breathing problems with DYSPORT. • Swallowing problems may last for several weeks. People who cannot swallow well may need a feeding tube to receive food and water. If swallowing problems are severe, food or liquids may go into your lungs. People who already have swallowing or breathing problems before receiving DYSPORT have the highest risk of getting these problems. 2. Spread of toxin effects. In some cases, the effect of botulinum toxin may affect areas of the body away from the injection site and cause symptoms of a serious condition called botulism. The symptoms of botulism include: • loss of strength and muscle weakness all over the body • blurred vision and drooping eyelids • trouble saying words clearly (dysarthria) • trouble breathing • double vision • hoarseness or change or loss of voice (dysphonia) • loss of bladder control • trouble swallowing These symptoms can happen Read the complete document
DYSPORT- BOTULINUM TOXIN TYPE A INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION IPSEN BIOPHARMACEUTICALS, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE DYSPORT SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DYSPORT. DYSPORT (ABOBOTULINUMTOXINA) FOR INJECTION, FOR INTRAMUSCULAR USE INITIAL U.S. APPROVAL: 2009 WARNING: DISTANT SPREAD OF TOXIN EFFECT _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_ 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 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 OCCUR IN ADULTS, PARTICULARLY IN THOSE PATIENTS WHO HAVE UNDERLYING CONDITIONS THAT WOULD PREDISPOSE THEM TO THESE SYMPTOMS (5.1). RECENT MAJOR CHANGES Dosage and Administration (2.2, 2.3, 2.5, 2.6) 1/2023 Warning and Precautions (5.5, 5.10) 9/2023 INDICATIONS AND USAGE DYSPORT is an acetylcholine release inhibitor and a 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) DOSAGE AND ADMINISTRATION Preparation of DYSPORT Solution for Administration (2.2) Once reconstituted, store in original container in a refrigerator at 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 Read the complete document