Myobloc

DRUG DESCRIPTION

MYOBLOC (rimabotulinumtoxinB) injection is a sterile liquid formulation of a purified neurotoxin that acts at the neuromuscular junction to produce flaccid paralysis. The neurotoxin is produced by fermentation of the bacterium Clostridium botulinum type B (Bean strain) and exists in noncovalent association with hemagglutinin and nonhemagglutinin proteins as a neurotoxin complex. The neurotoxin complex is recovered from the fermentation process and purified through a series of precipitation and chromatography steps.

MYOBLOC (botulinum toxin type b) is provided as a clear and colorless to light-yellow sterile injectable solution in 3.5-mL glass vials. Each single-use vial of formulated MYOBLOC contains 5,000 Units of botulinum toxin type B per milliliter in 0.05% human serum albumin, 0.01 M sodium succinate, and 0.1 M sodium chloride at approximately pH 5.6.

One unit of MYOBLOC (botulinum toxin type b) corresponds to the calculated median lethal intraperitoneal dose (LD50) in mice. The method for performing the assay is specific to Solstice Neurosciences' manufacture of MYOBLOC (botulinum toxin type b) . Due to differences in specific details such as the vehicle, dilution scheme and laboratory protocols for various mouse LD50 assays, units of biological activity of MYOBLOC (botulinum toxin type b) cannot be compared to or converted into units of any other botulinum toxin or any toxin assessed with any other specific assay method. Therefore, differences in species sensitivities to different botulinum neurotoxin serotypes preclude extrapolation of animal dose-activity relationships to human dose estimates. The specific activity of MYOBLOC (botulinum toxin type b) ranges between 70 to 130 Units/ng.

What are the possible side effects of botulinum toxin type B (Myobloc)?

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...

Read All Potential Side Effects and See Pictures of Myobloc

What are the precautions when taking botulinum toxin type b (Myobloc)?

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, 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, signs of infection near the injection site, muscle/nerve disorders such as Lou Gehrig's disease (ALS) or myasthenia gravis, seizures, trouble swallowing (dysphagia), breathing problems (such as asthma, emphysema, aspiration-type pneumonia).

This drug may make cause muscle weakness, droopy eyelids, or blurred vision. Do not drive, use machinery, or do...

Read All Potential Precautions of Myobloc


Myobloc Consumer (continued)

SIDE EFFECTS: 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.

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

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is unlikely, but get medical help right away if it occurs. Symptoms of a serious allergic reaction may include: itching/swelling (especially of the face/tongue/throat), rash, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: 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, 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, signs of infection near the injection site, muscle/nerve disorders such as Lou Gehrig's disease (ALS) or myasthenia gravis, seizures, trouble swallowing (dysphagia), breathing problems (such as asthma, emphysema, aspiration-type pneumonia).

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.

Caution is advised if using this drug in children for muscle spasms, because they may be more sensitive to its possible side effects (such as 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. Consult your doctor before breast-feeding


Myobloc Patient Information Including Side Effects

Brand Names: Myobloc

Generic Name: botulinum toxin type B (Pronunciation: BOT ue LYE num TOX in type B)

  • What is this drug (Myobloc)?
  • What are the possible side effects of botulinum toxin type B (Myobloc)?
  • What is the most important information I should know about botulinum toxin type B (Myobloc)?
  • What should I discuss with my healthcare provider before I receive botulinum toxin type B (Myobloc)?
  • How is botulinum toxin type B given (Myobloc)?
  • What happens if I miss a dose (Myobloc)?
  • What happens if I overdose (Myobloc)?
  • What should I avoid after receiving botulinum toxin type B (Myobloc)?
  • What other drugs will affect botulinum toxin type B (Myobloc)?
  • Where can I get more information?

What is this drug (Myobloc)?

Botulinum toxin type B 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 B is used to treat cervical dystonia (severe spasms in the neck muscles).

Botulinum toxin type B may also be used for other purposes not listed in this medication guide.

What are the possible side effects of botulinum toxin type B (Myobloc)?

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;
  • unusual or severe muscle weakness (especially in a body area that was not injected with the medication);
  • loss of bladder control; or
  • chest pain.

Less serious side effects may include:

  • dry mouth, nausea, upset stomach;
  • pain where the injection was given;
  • headache, back or joint pain;
  • cough, runny nose, throat, flu symptoms;
  • pain or stiffness in your neck;
  • dizziness, drowsiness, anxiety; or
  • muscle weakness near where the medicine was injected.

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 B (Myobloc)?

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.

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, or Lambert-Eaton syndrome.

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.

Related Drug Centers
  • Myobloc


Related Drugs Index: