AbobotulinumtoxinA

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Generic Name: AbobotulinumtoxinA Brand Name(s): Generics only. No brands available. Avability: Rx Pregnancy Category: N

Uses

What is AbobotulinumtoxinA used for?

AbobotulinumtoxinA, also called botulinum toxin type A, is made from the bacteria that causes botulism. Botulinum toxin blocks nerve activity in the muscles, causing a temporary reduction in muscle activity.

There are different types of botulinum toxin products (toxin A and B) with different uses (eye problems, muscle stiffness/spasms, migraines, cosmetic, overactive bladder). Different brands of this medication deliver different amounts of medication. Your doctor will choose the correct product for you.

Botulinum toxin is used to treat certain eye disorders such as crossed eyes (strabismus) and uncontrolled blinking (blepharospasm), to treat muscle stiffness/spasms or movement disorders (such as cervical dystonia, torticollis), and to reduce the cosmetic appearance of wrinkles. It is also used to prevent headaches in people with very frequent migraines. Botulinum toxin relaxes muscle by blocking the release of a chemical called acetylcholine.

Botulinum toxin is also used to treat overactive bladder by patients who do not respond to or who cannot tolerate the side effects of other medications. It helps to reduce leaking of urine, feeling of needing to urinate right away, and frequent trips to the bathroom.

It is also used to treat severe underarm sweating and drooling/excess saliva. Botulinum toxin works by blocking the chemicals that turn on the sweat and salivary glands.

Botulinum toxin is not a cure, and your symptoms will gradually return as the medication wears off.

How should I take AbobotulinumtoxinA?

This medication is given by injection by an experienced health care professional. It is injected into the affected muscles (intramuscularly) when treating eye disorders, muscle stiffness/spasms, and wrinkles. When used to prevent migraines, it is injected into the muscles of the head and neck. It is injected into the skin (intradermally) for the treatment of excessive sweating. For the treatment of drooling/excess saliva, this medication is injected into the salivary glands. When treating overactive bladder, it is injected into the bladder.

Your dose, the number of injections, the site of injections, and how often you receive the medication will be determined by your condition and your response to therapy. Most people start to see an effect within a few days to 2 weeks, and the effect usually lasts 3 to 6 months.

How do I store AbobotulinumtoxinA?

Store undiluted vials under refrigeration at 2°C to 8°C. Protect from light. After reconstitution, store vials in original container under refrigeration, protect from light, and use within 24 hours (does not contain preservative); single-use vials. Do not freeze after reconstitution.

There may be different brands of AbobotulinumtoxinA that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush AbobotulinumtoxinA down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using AbobotulinumtoxinA?

Before using this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as cow’s milk protein found in some products), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor your medical history, especially of: bleeding problems, eye surgery, certain eye problem (glaucoma), heart disease, diabetes, signs of infection near the injection site, urinary tract infection, inability to urinate, muscle/nerve disorders (such as Lou Gehrig’s disease-ALS, myasthenia gravis), seizures, trouble swallowing (dysphagia), breathing problems (such as asthma, emphysema, aspiration-type pneumonia), treatment with any botulinum toxin product (especially in the last 4 months).

This drug may make cause muscle weakness, droopy eyelids, or blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before having surgery, tell your doctor or dentist that you are using this medication.

Some brands of this medication contain albumin made from human blood. Even though the blood is carefully tested, and this medication goes through a special manufacturing process, there is an extremely small chance that you may get serious infections from the medication. Consult your doctor or pharmacist for more information.

Older adults using this drug for overactive bladder may be more sensitive to the side effects of this drug, especially urinary effects.

Children using this drug for muscle spasms may be more sensitive to the side effects of this drug, including difficulty breathing or swallowing. See Warning section. Discuss the risks and benefits with the doctor.

This medication should be used only if clearly needed during pregnancy. Discuss the risks and benefits with your doctor. Use for the cosmetic treatment of wrinkles is not recommended during pregnancy.

It is not known whether this medication passes into breast milk.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this AbobotulinumtoxinA during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking AbobotulinumtoxinA. AbobotulinumtoxinA is pregnancy risk category N according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from AbobotulinumtoxinA?

Because this medication is given at the site of your condition, most of the side effects occur close to where the medication is injected. Redness, bruising, infection, and pain at the injection site may occur.

Dizziness, mild difficulty swallowing, respiratory infections such as cold or flu, pain, nausea, headache, and muscle weakness may occur when this medication is used to relax muscles. Double vision, drooping or swollen eyelid, eye irritation, dry eyes, tearing, reduced blinking, and increased sensitivity to light may also occur.

If any of these effects persist or worsen, notify your doctor or pharmacist promptly. You may require protective eye drops/ointments, an eye patch, or other treatment.

When this medication is used to prevent migraines, side effects such as headache, neck pain, and drooping eyelid may occur.

When this medication is used for excessive sweating, side effects such as non-underarm sweating, respiratory infections such as cold or flu, headache, fever, neck or back pain, and anxiety may occur.

When this medication is used for overactive bladder, side effects such as urinary tract infections, burning/painful urination, fever, or difficulty urinating may occur.

If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with AbobotulinumtoxinA?

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: itching/swelling (especially of the face/tongue/throat), rash, severe dizziness, trouble breathing.

AbobotulinumtoxinA may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with AbobotulinumtoxinA?

AbobotulinumtoxinA may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with AbobotulinumtoxinA?

AbobotulinumtoxinA may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this AbobotulinumtoxinA.

What is the dose of AbobotulinumtoxinA for an adult?

Usual Adult Dose for Cervical Dystonia

Initial dose: 500 Units IM divided among affected muscles

-Adjustments may be made in accordance with response; adjustments are generally made in steps of 250 Units

Re-treatment: No sooner than 12 weeks, based on return of clinical symptoms

Maximum Dose: 1000 Units per treatment

Usual Adult Dose for Glabellar Lines

Initial dose: 50 Units IM divided into 5 equal aliquots (10 Units each)

Re-treatment: No sooner than 3 months

Usual Adult Dose for Upper Limb Spasticity

Individualize dose based on the size, number and location of muscles involved; severity of spasticity; presence of local muscle weakness; and previous response to treatment and/or adverse event history with botulinum toxins

Clinical Trial Doses:

-Upper Limb Spasticity: 500 and 1000 Units IM in divided doses at a given treatment session

-Lower Limb Spasticity: 1000 and 1500 Units IM in divided doses at a given treatment session

Re-treatment: No sooner than 12 weeks

Maximum total dose (upper and lower limbs combined): 1500 Units per treatment

Usual Adult Dose for Spasticity

Individualize dose based on the size, number and location of muscles involved; severity of spasticity; presence of local muscle weakness; and previous response to treatment and/or adverse event history with botulinum toxins

Clinical Trial Doses:

-Upper Limb Spasticity: 500 and 1000 Units IM in divided doses at a given treatment session

-Lower Limb Spasticity: 1000 and 1500 Units IM in divided doses at a given treatment session

Re-treatment: No sooner than 12 weeks

Maximum total dose (upper and lower limbs combined): 1500 Units per treatment

Usual Adult Dose for Lower Limb Spasticity

Individualize dose based on the size, number and location of muscles involved; severity of spasticity; presence of local muscle weakness; and previous response to treatment and/or adverse event history with botulinum toxins

Clinical Trial Doses:

-Upper Limb Spasticity: 500 and 1000 Units IM in divided doses at a given treatment session

-Lower Limb Spasticity: 1000 and 1500 Units IM in divided doses at a given treatment session

Re-treatment: No sooner than 12 weeks

Maximum total dose (upper and lower limbs combined): 1500 Units per treatment

Renal Dose Adjustments

No adjustment recommended

Liver Dose Adjustments

No adjustment recommended

Dose Adjustments

Elderly: Use with caution due to the greater frequency of concomitant disease and other drug therapies

Precautions

The safety and effectiveness of use in patients 65 years or older for the temporary improvement of glabellar lines has not been established

What is the dose of AbobotulinumtoxinA for a child?

Usual Pediatric Dose for Lower Limb Spasticity

Age: 2 years or older:

Individualize dose based on the size, number and location of muscles involved; severity of spasticity; presence of local muscle weakness; and previous response to treatment and/or adverse event history with botulinum toxins

Gastrocnemius-Soleus Complex:

-Gastrocnemius Muscle: 6 to 9 Units/kg IM divided in up to 4 injections

-Soleus: 4 to 6 Units/kg IM divided in up to 2 injections

Total: 10 to 15 Units/kg IM divided across both muscles in up to 6 injections

Unilateral Lower Limb injections: 10 to 15 Units/kg IM in divided doses into affected spastic muscles

Bilateral Lower Limb injections: 20 to 30 Units/kg IM in divided doses into affected spastic muscles

Maximum Dose: 1000 Units OR 15 Units/kg (unilateral) or 30 Units/kg (bilateral) whichever is less, per treatment session

Precautions

Safety and effectiveness have not been established for the treatment of cervical dystonia, glabellar lines, proximal muscles of the lower limbs, or upper limb spasticity in patients less than 18 years of age.

Safety and effectiveness have not been established for the treatment of lower limb spasticity in patients less than 2 years of age.

How is AbobotulinumtoxinA available?

AbobotulinumtoxinA is available in the following dosage forms and strengths:

  • Injectable powder for injection,
  • Intramuscular powder for injection.

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of AbobotulinumtoxinA, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

Hello Health Group does not provide medical advice, diagnosis or treatment.

Sources

Review Date: November 5, 2018 | Last Modified: November 5, 2018

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