AbobotulinumtoxinA

Name: AbobotulinumtoxinA

Dysport side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; feeling like you might pass out; swelling of your face, lips, tongue, or throat.

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

Call your doctor at once if you have any of these side effects, some of which can occur up to several weeks after an injection:

  • trouble breathing, talking, or swallowing;

  • hoarse voice, drooping eyelids;

  • problems with vision;

  • unusual or severe muscle weakness (especially in a body area that was not injected with the medication);

  • loss of bladder control;

  • pain or burning when you urinate, red or pink urine;

  • crusting or drainage from your eyes;

  • severe skin rash or itching;

  • fast, slow, or uneven heartbeats; or

  • chest pain or heavy feeling, pain spreading to the arm or shoulder, general ill feeling.

Common side effects may include:

  • muscle weakness near where the medicine was injected;

  • dizziness, depressed mood;

  • bruising, bleeding, pain, redness, or swelling where the injection was given;

  • 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; or

  • feeling tired.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Uses for AbobotulinumtoxinA

Currently, 3 botulinum toxin type A preparations (abobotulinumtoxinA [Dysport], incobotulinumtoxinA [Xeomin], and onabotulinumtoxinA [Botox, Botox Cosmetic]) and one botulinum toxin type B preparation (rimabotulinumtoxinB [Myobloc]) are commercially available in the US.1 2 5 384 403 These preparations are not interchangeable; assay methods used to determine potency of botulinum toxins are specific to each individual manufacturer and/or formulation.1 2 5 381 384 385 391 396 399 403 410

Cervical Dystonia

Management of cervical dystonia (spasmodic torticollis) in adults to decrease severity of abnormal head position and neck pain;384 385 387 designated an orphan drug by FDA for this use.389

Botulinum toxins considered first-line therapy for cervical dystonia.387 391 AbobotulinumtoxinA shown to produce objective and subjective improvements in functional impairment and/or disability.384 385 387 Evidence supporting use largely based on clinical trials of short duration using single injection cycles; additional studies needed to establish long-term efficacy and safety, optimum treatment intervals, and administration techniques (e.g., use of electromyogram [EMG] guidance versus palpation).387

Glabellar Facial Lines

Temporary improvement in appearance of moderate to severe glabellar facial (“frown”) lines associated with corrugator and/or procerus muscle activity in adults <65 years of age.384 393 394

Temporarily weakens corrugator and procerus muscle complex, reducing generation of expression-related glabellar facial lines.393 396 397

Stability

Storage

Parenteral

Powder for Injection

2–8°C; protect from light.384

Following reconstitution, store at 2–8°C and use within 4 hours; do not freeze.384

What are some other side effects of AbobotulinumtoxinA?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

For all uses of abobotulinumtoxinA:

  • Irritation where the shot is given.

For spasms of the neck:

  • Headache.
  • Feeling tired or weak.
  • Muscle pain or weakness.
  • Less blinking.
  • Dry eyes.
  • Dry mouth.

For lines and wrinkles of the face:

  • Headache.
  • Upset stomach.
  • Stuffy nose.
  • Runny nose.
  • Nose or throat irritation.
  • Signs of a common cold.

For muscle stiffness in the elbow, wrist, or finger muscles:

  • Muscle pain or weakness.
  • Dizziness.
  • Stuffy nose.
  • Runny nose.
  • Nose or throat irritation.

For muscle stiffness in the calf muscles:

  • Muscle weakness.
  • Pain in arms or legs.
  • Stuffy nose.
  • Runny nose.
  • Nose or throat irritation.
  • Flu-like signs.
  • Signs of a common cold.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Dosing Geriatric

Cervical dystonia: Refer to adult dosing. No specific adjustment recommended.

Glabellar lines: Not recommended in patients ≥65 years of age.

Spasticity: Refer to adult dosing.

Administration

Cervical dystonia: Use an appropriately sized gauge needle to administer intramuscularly. Limiting the dose injected into the sternocleidomastoid muscle may reduce the occurrence of dysphagia. Simultaneous EMG-guided application may be helpful in locating active muscle not identified by physical examination alone.

Glabellar lines: Use a 30-gauge needle to administer intramuscularly. Apply pressure on the superior medial orbital rim, and inject into each of 5 sites (2 injections in each corrugator muscle and 1 in the procerus muscle). Ensure injected volume/dose is accurate and where feasible keep to a minimum. Avoid injection near the levator palpebrae superioris, particularly in patients with larger brow depressor complexes. Medial corrugator injections should be at least 1 cm above the bony supraorbital ridge. Do not inject toxin closer than 1 cm above the central eyebrow.

Spasticity (upper or lower limb): Use an appropriately sized sterile syringe and needle to administer intramuscularly. Although actual location of the injection sites can be determined by palpation, the use of an injection guiding technique (eg, electromyography or electrical stimulation) is recommended to target the injection sites. Do not administer >0.5 mL for pediatric patients (lower limb spasticity) or >1 mL for adult patients (upper or lower limb spasticity) in any single injection site.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience injection site irritation, headache, nausea, signs of common cold, dizziness, flu-like signs, reduced blinking, rhinitis, rhinorrhea, pharyngitis, dry eyes, or dry mouth. Have patient report immediately to prescriber signs of infection, seizures, hematuria, change in voice, difficulty swallowing, difficulty breathing, difficulty speaking, severe muscle pain, muscle weakness, loss of strength and energy, vision changes, eye pain, depression, severe eye irritation, blurred vision, urinary incontinence, diplopia, or drooping eyelids (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating, and advising patients.

AbobotulinumtoxinA Interactions

This is not a complete list of AbobotulinumtoxinAdrug interactions. Ask your doctor or pharmacist for more information.

Warnings

Black Box Warnings

Effects of all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects

These symptoms may include asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, and breathing difficulties

These symptoms have been reported hours to weeks after injection

Swallowing and breathing difficulties can be life threatening, and death have been reported

The risk of symptoms is probably greatest in children treated for spasticity, but symptoms can also occur in adults treated for spasticity and other conditions, particularly in those patients who have underlying conditions that would predispose them to these symptoms

In unapproved uses, including spasticity in children and adults, and in approved indications, cases of spread of effect have been reported at doses comparable to those used to treat cervical dystonia and at lower doses

Contraindications

Hypersensitivity

Allergy to cow milk protein

Injection site infection

Cautions

Asthma, neuromuscular disorder, facial abnormalities, ptosis

Concomitant anticholinergic drugs, neuromuscular blockers or muscle relaxants

Toxin may spread - watch for dyspnea, dysphagia or speech impairment

Product contains albumin, a derivative of human blood; based on effective donor screening and product manufacturing processes; carries an extremely remote risk for transmission of viral diseases and variant Creutzfeldt-Jakob disease (vCJD); 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; no cases of transmission of viral diseases, CJD, or vCJD have ever been identified for licensed albumin or albumin contained in other licensed products

Neutralizing antibody formation and loss of efficacy associated with higher doses or more frequent administration of the drug

Arrhythmia and myocardial infarction reported with use

Dysphagia reported with use for cervical dystonia; may persist for several weeks following administration and could cause the patient to require alternative feeding methods, including a feeding tube; smaller neck muscle mass, injections into the elevator scapulae or injections into the sternocleidomastoid muscle may increase risk of dysphagia; risk of aspiration may result from severe dysphagia when swallowing is already compromised; occurrence may be reduced by limiting the dose injected into sternocleidomastoid muscle

Use caution in patients with neuromuscular disease, including myasthenia gravis and Eaton-Lambert syndrome, and neuropathic disorders, such as, amyotrophic lateral sclerosis

Injection of the orbicularis muscle may reduce blinking and lead to corneal exposure and ulceration, when treating blepharospasm

Use caution when treating patients with preexisting respiratory disease; treatment of cervical dystonia, may weaken accessory muscles necessary to patients to maintain adequate ventilation; serious breathing difficulties, including respiratory failure reported

Pregnancy & Lactation

Pregnancy: There are no adequate and well-controlled clinical studies in pregnant women; only use during pregnancy if potential benefit justifies potential risk to fetus

Lactation: There are no data on the presence of drug in human or animal milk, the effects on the breastfed child, or effects on milk production; the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on breastfed infant from the drug or from the underlying maternal condition

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

In Summary

Commonly reported side effects of abobotulinumtoxinA include: dysphagia, headache, myasthenia, nasopharyngitis, voice disorder, and xerostomia. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to abobotulinumtoxinA: intramuscular powder for solution

Along with its needed effects, abobotulinumtoxinA may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking abobotulinumtoxinA:

More common
  • Difficulty with swallowing or speaking
  • hoarseness
  • muscle or bone pain
  • muscle weakness
  • seizures
  • sore throat
  • voice changes
Less common
  • Blistering, burning, crusting, dryness, or flaking of the skin
  • body aches or pain
  • chills
  • cough
  • cough producing mucus
  • diarrhea
  • difficult or labored breathing
  • ear congestion
  • fever
  • general feeling of discomfort or illness
  • headache
  • itching, scaling, severe redness, soreness, or swelling of the skin
  • joint pain
  • loss of appetite
  • loss of voice
  • muscle aches and pains
  • nausea
  • shivering
  • sneezing
  • stiff muscles
  • stuffy or runny nose
  • sweating
  • tightness in the chest
  • trouble sleeping
  • unusual tiredness or weakness
  • vomiting
Incidence not known
  • Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • dizziness
  • fast heartbeat
  • flushing or redness of the skin
  • hives, itching, rash
  • partial or slight paralysis of the face
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • unusually warm skin

Some side effects of abobotulinumtoxinA may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
  • blurred vision
  • decreased vision
  • double vision
  • dry eyes
  • dry mouth
  • eye pain
  • itching of the eyes
  • problems with focusing of the eyes
  • seeing double
Less common
  • Drooping upper eyelids
  • pain or tenderness around the eyes and cheekbones
Incidence not known
  • Change in color vision
  • difficulty seeing at night
  • dizziness or lightheadedness
  • feeling of constant movement of self or surroundings
  • increased sensitivity of the eyes to sunlight
  • sensation of spinning

Usual Adult Dose for Glabellar Lines

50 units divided into 5 equal aliquots of 10 units each, should be administered to affected muscles to achieve clinical effect

Comments:
-The clinical effect of this drug may last up to 4 months.
-Repeat dose studies demonstrated continued efficacy with up to 4 repeated administrations.
-This drug should be administered no more frequently than every 3 months. -When used for re-treatment, this drug should be reconstituted and injected using the same techniques as the initial treatment.

Use: For the temporary improvement in the appearance of moderate to severe glabellar lines associated with procerus and corrugator muscle activity in adult patients less than 65 years of age

Renal Dose Adjustments

No adjustment recommended

(web3)