AbobotulinumtoxinA

AbobotulinumtoxinA is a prescription medication used to treat the symptoms of Cervical Dystonia, Glabellar Lines, and Spasticity. 

• AbobotulinumtoxinA is available under various brand names: Dysport 

Common side effects of AbobotulinumtoxinA include:

• muscle weakness near where the medicine was injected,
• dizziness,
• depressed mood,
• bruising, bleeding, pain, redness, or swelling at the injection site,
• headache,
• muscle pain,
• pain in your arms or legs,
• fever,
• cough,
• sore throat,
• runny or stuffy nose,
• drooping eyelids,
• dry or puffy eyes,
• nausea,
• dry mouth,
• trouble swallowing, and
• feeling tired

Serious side effects of AbobotulinumtoxinA include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• trouble breathing, talking, or swallowing,
• hoarse voice,
• drooping eyelids,
• problems with vision,
• unusual or severe muscle weakness,
• loss of bladder control,
• pain or burning while urinating,
• red or pink urine,
• crusting or drainage from the eyes,
• severe skin rash,
• itching,
• fast, slow, or uneven heartbeats,
• chest pain or heavy feeling,
• pain spreading to the arm or shoulder, and
• general ill feeling

Rare side effects of abobotulinumtoxinA include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheartedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Injection, powder for reconstitution

• 300 units/vial
• 500 units/vial

Cervical Dystonia

Adult dosage

• Initial: 500-unit IM divided among affected muscles
• Retreat every 12-16 weeks or longer: 250–1000-unit Intramuscular
• Titrate in 250-unit steps

Spasticity

Adult dosage

Upper limb spasticity

• Dose per muscle
  • In the clinical trial, doses of 500-1000 units were divided among selected upper limb muscles at a given treatment session
  • Flexor carpi radialis: 100-200 units in 1-2 sites
  • Flexor carpi ulnaris: 100-200 units in 1-2 sites
  • Flexor digitorum profundus: 100-200 units in 1-2 sites
  • Flexor digitorum sublimis: 100-200 units in 1-2 sites
  • Brachialis: 200-400 units in 1-2 sites
  • Brachioradialis: 100-200 units in 1-2 sites
  • Biceps brachii: 200-400 units divided into 1-2 sites
  • Pronator Teres: 100-200 units in 1 site

Lower limb spasticity

• Dose per muscle
  • In the clinical trial, doses of 1000-1500 units were divided among selected lower limb muscles at a given treatment session
  • Gastrocnemius medial head: 100-150 units in 1 site
  • Gastrocnemius lateral head: 100-150 units in 1 site
  • Soleus: 330-500 units in 3 sites
  • Tibialis posterior: 200-300 units in 2 sites
  • Flexor digitorum longus: 130-200 units in 1-2 sites
  • Flexor hallucis longus: 70-200 units in 1 site

Pediatric dosage

Upper limb

• 8-16 units/kg per limb
• Maximum total dose per treatment session: 16 units/kg or 650 units, whichever is lower

Dosage range per muscle

• Brachialis: 3-6 units/kg divided in 1-2 injection sites
• Brachioradialis: 1.5-3 units/kg in 1 injection site
• Biceps brachii: 3-6 units/kg divided in 1-2 injection sites
• Pronator teres: 1-2 units/kg in 1 injection site
• Pronator quadratus: 0.5-1 unit/kg in 1 injection site
• Flexor carpi radialis (FCR): 2-4 units/kg divided in 1-2 injection sites
• Flexor carpi ulnaris (FCU): 1.5-3 units/kg in 1 injection site
• Flexor digitorum profundus (FDP): 1-2 units/kg in 1 injection site
• Flexor digitorum superficialis (FDS): 1.5-3 units/kg divided into up to 4 injection sites

Lower limb

• 10-15 units/kg per limb

Maximum doses

• Unilateral limb injection: 15 units/kg or 1000 units, whichever is lower
• Bilateral limb injections: 30 units/kg or 1000 units, whichever is lower
• The maximum total dose per treatment session: 30 units/kg or 1000 units, whichever is lower

Dosage range per muscle per leg

• Gastrocnemius (unilateral injection): 6-9 units/kg divided into up to 4 injection sites
• Soleus (unilateral injection): 4-6 units/kg divided into 1-2 injection sites

Glabellar Lines

Adult dosage

• 50 units total divided into 5 equal doses of IM to affected muscles
• Retreat no sooner than 3 months

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• AbobotulinumtoxinA has severe interactions with no other drugs.
• AbobotulinumtoxinA has serious interactions with the following drugs:
  • incobotulinumtoxinA
  • onabotulinumtoxinA
  • prabotulinumtoxinA
  • rimabotulinumtoxinB
• AbobotulinumtoxinA has moderate interactions with at least 82 other drugs.
• AbobotulinumtoxinA has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Hypersensitivity
• Allergy to cow milk protein
• Injection site infection 

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using abobotulinumtoxinA?”

Long-Term Effects

• See “What Are Side Effects Associated with Using abobotulinumtoxinA?”

Cautions

• The botulinum toxin contained in Dysport can spread to other body areas beyond where it was injected. This can cause serious life-threatening side effects.
• 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.
• Dysport is made from donated human plasma and may contain viruses or other infectious agents. Donated plasma is tested and treated to reduce the risk of contamination, but there is still a small possibility it could transmit disease. Ask your doctor about any possible risks.
• Using this medicine more often than prescribed will not make it more effective and may result in serious side effects.
• Dysport may impair your vision or depth perception. Avoid driving or hazardous activity until you know how this medicine will affect you.
• Avoid going back to your normal physical activities too quickly after receiving an injection.

Pregnancy and Lactation

• There are no adequate and well-controlled clinical studies on pregnant women
• Use only during pregnancy if the potential benefit justifies the potential risk to the fetus
• In rats, abobotulinumtoxinA produced adverse effects on mating behavior and fertility
• Lactation
  • There are no data on the presence of human or animal milk, the effects on the breastfed infant, or the effects on milk production
  • Consider developmental and health benefits of breastfeeding along with the mother’s clinical need and any potential adverse effects on the breastfed infant or from the underlying maternal condition