Abobotulinumtoxin A Injection

Name: Abobotulinumtoxin A Injection

Description

Botulinum toxin type A, the active ingredient in DYSPORT® (abobotulinumtoxinA), is a purified neurotoxin type A complex produced by fermentation of the bacterium Clostridium botulinum type A, Hall Strain. It is purified from the culture supernatant by a series of precipitation, dialysis, and chromatography steps. The neurotoxin complex is composed of the neurotoxin, hemagglutinin proteins and non-toxin non-hemagglutinin protein.

DYSPORT® is supplied in a single-use, sterile vial for reconstitution intended for intramuscular injection. Each vial contains 300 Units or 500 Units of lyophilized abobotulinumtoxinA, human serum albumin (125 mcg) and lactose (2.5 mg). DYSPORT® may contain trace amounts of cow's milk proteins [see CONTRAINDICATIONS].

One unit of DYSPORT® corresponds to the calculated median lethal intraperitoneal dose (LD50) in mice. The method for performing the assay is specific to Ipsen's product DYSPORT® . Due to differences in specific details such as vehicle, dilution scheme and laboratory protocols for various mouse LD50 assays, Units of biological activity of DYSPORT® are not interchangeable with Units of any other botulinum toxin or any toxin assessed with any other specific assay method [see Dosage Forms and Strengths].

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

Overdose

Excessive doses of DYSPORT® may be expected to produce neuromuscular weakness with a variety of symptoms. Respiratory support may be required where excessive doses cause paralysis of respiratory muscles. In the event of overdose, the patient should be medically monitored for symptoms of excessive muscle weakness or muscle paralysis [see WARNINGS AND PRECAUTIONS]. Symptomatic treatment may be necessary.

Symptoms of overdose are likely not to be present immediately following injection. Should accidental injection or oral ingestion occur, the person should be medically supervised for several weeks for signs and symptoms of excessive muscle weakness or paralysis.

There is no significant information regarding overdose from clinical studies.

In the event of overdose, antitoxin raised against botulinum toxin is available from the Centers for Disease Control and Prevention (CDC) in Atlanta, GA. However, the antitoxin will not reverse any botulinum toxin-induced effects already apparent by the time of antitoxin administration. 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. More information can be obtained at http://www.cdc.gov/ncidod/srp/drugs/drug- service.html.

What is the most important information i should know about dysport (dysport)?

The botulinum toxin contained in this medication can spread to other body areas beyond where it was injected. This has caused serious life-threatening side effects in some people receiving botulism toxin injections, even for cosmetic purposes.

Call your doctor at once if you have a hoarse voice, drooping eyelids, vision problems, severe muscle weakness, loss of bladder control, or trouble breathing, talking, or swallowing. Some of these effects can occur up to several weeks after a botulinum toxin injection.

Botulinum toxin injections should be given only by a trained medical professional, even when used for cosmetic purposes.

Do not seek botulinum toxin injections from more than one medical professional at a time. If you switch healthcare providers, be sure to tell your new provider how long it has been since your last botulinum toxin injection.

Using this medication more often than prescribed will not make it more effective and may result in serious side effects.

You should not receive this medication if you are allergic to botulinum toxin or cow's milk, or if you have an infection, swelling, or muscle weakness in the area where the medicine will be injected.

Before receiving a botulinum toxin injection, tell your doctor if you have ALS ( Lou Gehrig's disease), myasthenia gravis, Lambert-Eaton syndrome, a breathing disorder, trouble swallowing, facial muscle weakness, a change in the appearance of your face, seizures, bleeding problems, heart disease, diabetes, if you have had or will have surgery, or if you have ever received other botulinum toxin injections such as Botox or Myobloc.

The effects of a botulinum toxin injection are temporary. Your symptoms may return completely within 3 months after an injection. After repeat injections, it may take less and less time before your symptoms return, especially if your body develops antibodies to the botulinum toxin.

What should i discuss with my healthcare provider before i receive dysport (dysport)?

You should not receive this medication if you are allergic to botulinum toxin or cow's milk, or if you have an infection, swelling, or muscle weakness in the area where the medicine will be injected. Tell your doctor if you have ever had a side effect after receiving a botulinum toxin in the past

If you have any of these other conditions, you may need a dose adjustment or special tests:

  • amyotrophic lateral sclerosis (ALS, or "Lou Gehrig's disease");
  • myasthenia gravis;
  • Lambert-Eaton syndrome;
  • a breathing disorder such as asthma or emphysema;
  • problems with swallowing;
  • facial muscle weakness (droopy eyelids, weak forehead, trouble raising your eyebrows);
  • a change in the normal appearance of your face;
  • a seizure disorder;
  • bleeding problems;
  • heart disease;
  • diabetes;
  • if you have had or plan to have surgery (especially on your face); or
  • if you have ever received other botulinum toxin injections such as Botox or Myobloc (especially in the last 4 months).

Dysport is made from human plasma (part of the blood) which may contain viruses and other infectious agents. Donated plasma is tested and treated to reduce the risk of it containing infectious agents, but there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

FDA pregnancy category C. It is not known whether botulinum toxin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication..

It is not known whether botulinum toxin passes into breast milk or if it could harm a nursing baby. Do not receive this medication without telling your doctor if you are breast-feeding a baby.

What should i avoid after receiving dysport (dysport)?

Dysport may impair your vision or depth perception. Be careful if you drive or do anything that requires you to be able to see clearly.

Avoid going back to your normal physical activities too quickly after receiving an injection.

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