Pronunciation:

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

Brand Names:

• Myobloc

Dosage Forms:

• Solution

Warnings:

Postmarketing reports indicate that 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 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 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 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 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 injection is used to treat the abnormal head position and neck pain that result from cervical dystonia (severe muscle spasms of the neck). This medicine is also used to treat chronic sialorrhea (drooling or excessive salivation) in adults. 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 given only 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 injection 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 injection in the elderly.

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. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• LetibotulinumtoxinA-wlbg

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.

• Bleeding problems or
• Breathing problems (eg, asthma, emphysema) 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.

If you need to receive an injection of any botulinum toxin product within 4 months after receiving this medicine, tell the doctor when you last received a dose of rimabotulinumtoxinB.

This medicine should come with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

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.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are receiving this medicine.

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

Incidence not known

Cough

dizziness

fast heartbeat

hives, itching, or skin rash

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

puffiness or swelling of the eyelids or around the eyes, face, lips or tongue

tightness in the chest

unusual tiredness or 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: