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Rimabotulinumtoxinb (Intramuscular route)

Pronunciation:

rim-a-bot-ue-LYE-num-tox-in-bee

Brand Names:

  • Myobloc

Dosage Forms:

  • Solution

Warnings:

Intramuscular route(Injectable)

The effects of rimabotulinumtoxinB and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity but symptoms can also occur in adults, particularly in those patients who have underlying conditions that would predispose them to these symptoms. Cases of spread of effect have occurred at doses comparable to those used to treat cervical dystonia and at lower doses .

Classifications:

Therapeutic—

Cervical Agent

Pharmacologic—

Neuromuscular Blocker, Non-Depolarizing

Uses of This Medicine:

RimabotulinumtoxinB is used to treat the abnormal head position and neck pain that result from cervical dystonia (severe muscle spasms of the neck). RimabotulinumtoxinB is a botulinum toxin B product. It works on the nervous system to relax the muscles.

RimabotulinumtoxinB is injected into the muscles that are affected. Depending on your condition, more than one treatment may be required.

This medicine is available only with your doctor's prescription and will be administered by your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of rimabotulinumtoxinB in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of rimabotulinumtoxinB in the elderly.

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Amyotrophic lateral sclerosis (Lou Gehrig's disease) or
  • Lambert-Eaton syndrome (nerve-muscle disorder) or
  • Motor neuropathy (muscle or nerve problem) or
  • Myasthenia gravis (severe muscle weakness)—May cause side effects to become worse.
  • Breathing problems or
  • Dysarthria (trouble with speaking) or
  • Dysphagia (trouble with swallowing) or
  • Dysphonia (voice problem) or
  • Ptosis (droopy eyelid) or
  • Urinary incontinence (problems passing urine)—Use with caution. May make these conditions worse.
  • Infection at the injection site—Should not be used in patients with this condition.

Proper Use of This Medicine:

Your doctor will give you this medicine in a hospital or clinic. This medicine is given as a shot into one of your muscles.

Your doctor will only use rimabotulinumtoxinB (Myobloc®) to treat your condition. Other botulinum toxin products may not work the same way and require a different dose.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it.

Serious muscle reactions have occurred within hours to weeks after receiving this medicine. If you start to have muscle weakness or trouble with swallowing, talking, or breathing, call your doctor right away. In some situations, these problems could be life-threatening and may require treatment in a hospital or clinic.

This medicine may make your muscles weak and cause vision problems. Avoid driving, using machines, or doing anything else that could be dangerous if you feel weak or are not able to see well.

One part of this medicine is made from donated human blood. Some human blood products have transmitted certain viruses to people who have received them. The risk of getting a virus from medicines made of human blood has been greatly reduced in recent years. This is the result of required testing of human donors for certain viruses, and testing during the manufacture of these medicines. Although the risk is low, talk with your doctor if you have concerns.

Side Effects of This Medicine:

Along with its needed effects, a medicine 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:

More common
Difficulty with swallowing
infection
neck pain
uncontrolled twisting movements of the neck
Rare
Difficulty with breathing or speaking
muscle weakness

Some side effects 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
Acid or sour stomach
back pain
belching
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
cough
difficulty with moving
dizziness
dry mouth
flu-like syndrome
headache
heartburn or indigestion
lack or loss of strength or energy
muscle pain, stiffness, or weakness
nausea
pain, swelling, or redness in the joints
stomach discomfort, upset, or pain

Some side effects 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:


Last Updated: 11/4/2014

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