What is botulinum toxin type A?
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.
Botulinum toxin type A is used to treat cervical dystonia (severe spasms in the neck muscles),
or severe underarm sweating (hyperhidrosis).
Botulinum toxin type A is also used to treat certain eye muscle conditions caused by nerve
disorders. This includes uncontrolled blinking or spasm of the eyelids, and a condition in which the eyes
do not point in the same direction.
Botulinum toxin type A is also used to temporarily lessen the appearance of facial wrinkles.
Botulinum toxin type A may also be used for other purposes not listed in this medication guide.
What should I discuss with my healthcare provider before taking botulinum toxin type A?
You should not receive this medication if you are allergic to botulinum toxin, or if you have
an infection, swelling, or muscle weakness in the area where the medicine will be injected.
If you have any of these other conditions, you may need a dose adjustment or special tests to
safely receive this medication.
Botulinum toxin type A is made using human plasma (part of the blood) and
may contain viruses and other infectious agents that can cause disease. Although donated human plasma
is screened, tested, and treated to reduce the risk of it containing anything that could cause disease,
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 is harmful to an
unborn baby. Before you receive this medication, tell your doctor if you are pregnant or plan to become
pregnant during treatment.
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.
How should I take botulinum toxin type A?
Botulinum toxin type A is given as an injection into a muscle. A doctor, nurse, or other
healthcare provider will give you this injection.
Botulinum toxin injections should be given only by a trained medical professional, even
when used for cosmetic purposes.
Your botulinum toxin injection may be given into more than one area at a time, depending on the
condition being treated.
While receiving botulinum toxin injections for an eye muscle conditions, you may need to use
eye drops, ointment, a special contact lens or other device to protect the surface of your eye. Follow
your doctor's instructions.
If you are being treated for excessive sweating, shave your underarms about 24 hours before
you will receive your injection. Do not apply underarm antiperspirants or deodorants for 24 hours
before you receive the injection. Avoid exercise and hot foods or beverages within 30 minutes before
the injection.
It may take up to 2 weeks after injection before neck muscle spasm symptoms begin to
improve. You may notice the greatest improvement at 6 weeks after injection.
It may take only 1 to 3 days after injection before eye muscle spasm symptoms begin to
improve. You may notice the greatest improvement at 2 to 6 weeks after injection.
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.
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.
What happens if I miss a dose of botulinum toxin type A?
Since botulinum toxin has a temporary effect and is given at widely spaced intervals, missing a
dose is not likely to be harmful.
Where can I get more information about botulinum toxin type A?
Your pharmacist has information about botulinum toxin type A written for health professionals that you may read.
What are the possible side effects of botulinum toxin type A?
Get emergency medical help if you have any of these
signs of an allergic
reaction:
hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
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 any of these serious side effects, some of which can
occur up to several weeks after an injection:
-
trouble breathing, talking, or swallowing;
-
drooping eyelids;
-
unusual or severe muscle weakness (especially in a body
area that was not injected with the medication);
-
loss of bladder control;
-
problems with vision or depth perception;
-
crusting or drainage from your eyes;
-
severe skin rash or itching; or
-
chest pain or heavy feeling, pain spreading to the arm or
shoulder, general ill feeling.
Less serious side effects may include:
-
muscle weakness near where the medicine was injected;
-
bruising, bleeding, pain, or tenderness where the injection
was given;
-
headache, muscle stiffness, neck or back pain;
-
fever, cough, sore throat, runny nose, nausea, flu
symptoms,
-
dizziness, drowsiness, anxiety;
-
dry mouth, dry eyes;
-
increased sweating in areas other than the underarms;
-
itchy or watery eyes, increased sensitivity to light; or
-
eyelid swelling or bruising.
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.
What is the most important information I should know about botulinum toxin type A?
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 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 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, or heart disease.
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 avoid while taking botulinum toxin type A?
Avoid using underarm antiperspirants or deodorants for 24 hours after a botulinum toxin
injection if you are being treated for excessive underarm sweating.
Avoid going back to your normal physical activities too quickly after receiving a botulinum toxin
injection.
What other drugs will affect botulinum toxin type A?
Before you receive this medication, tell your doctor if you are also taking:
-
an antibiotic such as amikacin (Amikin), gentamicin (Garamycin),
kanamycin (Kantrex), neomycin (Mycifradin, Neo-Fradin, Neo-Tab), paromomycin (Humatin,
Paromycin), streptomycin, tobramycin (Nebcin, Tobi).
This list is not complete and there may be other drugs that can interact with
botulinum toxin type A. Tell your doctor about all your prescription and over-the-counter medications,
vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new
medication without telling your doctor.
What happens if I have an overdose of botulinum toxin type A?