Generic Name: rimabotulinumtoxinb (RYE-ma-BOT-ue-li-num-TOX-in-B)
Brand Name: Myobloc
The effects of Myobloc may spread from the injection site to other areas of the body, causing symptoms of a serious condition called botulism. These symptoms have been reported hours to weeks after patients have received Myobloc. Symptoms may include loss of strength; muscle weakness; double or blurred vision; drooping eyelids; hoarseness; loss of voice; loss of bladder control; or trouble speaking, breathing, or swallowing. The risk may be greater in children being treated for spasticity (muscle spasms), but these symptoms may also occur in adults. Contact your doctor right away if these symptoms occur.
Severe and sometimes fatal breathing or swallowing problems have been reported. The risk may be greater in patients who already have breathing or swallowing problems. Tell your doctor if you have or are at risk of developing breathing or swallowing problems.
Myobloc is used for:
Reducing the severity of abnormal head position and neck pain associated with a certain neck problem (cervical dystonia). It may also be used for other conditions as determined by your doctor.
Myobloc is a neurotoxin. It works by blocking nerve impulses to the muscles, temporarily paralyzing the muscle.
Do NOT use Myobloc if:
- you are allergic to any ingredient in Myobloc or another botulinum toxin product
- you have an infection at the injection site
Contact your doctor or health care provider right away if any of these apply to you.
Before using Myobloc:
Some medical conditions may interact with Myobloc. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have nerve problems or diseases (eg, amyotrophic lateral sclerosis, motor neuropathy), muscle problems or diseases (eg, myasthenia gravis, Lambert-Eaton syndrome), bleeding disorders, seizures, or severe weakness or wasting of the muscles at the injection site
- if you have a history of heart problems (eg, irregular heartbeat, a recent heart attack); swallowing problems; breathing problems (eg, asthma); eye problems (eg, glaucoma); or an overactive thyroid
- if you have a skin infection, or inflammation, scarring, or other skin disorders at the injection site
- if you plan to have surgery
- if you have received Myobloc or any other botulinum toxin product in the past, especially within the past 4 months
- if you have never received Myobloc or any other botulinum toxin product
- if you have recently received an antibiotic by injection, or you also take muscle relaxants, allergy or cold medicine, or sleep medicine
Some MEDICINES MAY INTERACT with Myobloc. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Aminoglycosides (eg, gentamicin), anticholinesterase medicines (eg, neostigmine), lincosamides (eg, clindamycin), magnesium, neuromuscular blockers (eg, atracurium), polymyxin, or quinidine because the risk of toxic effects may be increased
- Anticoagulants (eg, warfarin) because the risk of bleeding at the injection site may be increased
This may not be a complete list of all interactions that may occur. Ask your health care provider if Myobloc may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Myobloc:
Use Myobloc as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Myobloc comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Myobloc refilled.
- Myobloc is usually given as an injection at your doctor's office, hospital, or clinic.
- If you miss a dose of Myobloc, contact your doctor right away.
Ask your health care provider any questions you may have about how to use Myobloc.
Important safety information:
- Myobloc may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Myobloc with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. If loss of strength, muscle weakness, or vision problems occur, avoid driving or performing other possibly unsafe tasks.
- Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
- Do not switch brands of Myobloc. Contact your doctor if you have any questions.
- Myobloc contains albumin, which comes from human blood. There is a very rare risk of getting a viral disease or a central nervous system disease called Creutzfeldt-Jakob disease from products with albumin. No cases of these problems have been found in patients who have used Myobloc.
- To prevent injury, resume normal activities gradually after using Myobloc.
- Myobloc should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: It is not known if Myobloc can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Myobloc while you are pregnant. It is not known if Myobloc is found in breast milk. If you are or will be breast-feeding while you use Myobloc, check with your doctor. Discuss any possible risks to your baby.
Possible side effects of Myobloc:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Anxiety; back pain; dizziness; drowsiness; dry eyes; dry mouth; flu-like symptoms; headache; increased cough; indigestion; nausea; neck pain; pain, redness, swelling, or tenderness at the injection site; runny nose; sensitivity to light; sweating; upset stomach; weakness of the muscles at or near the injection site.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bleeding at the injection site; chest pain; difficulty swallowing or breathing; double or blurred vision, or other vision changes; drooping eyelid; fever, chills, or persistent sore throat; irregular heartbeat; loss of bladder control; loss of strength; paralysis; pneumonia; seizures; severe or persistent muscle weakness or dizziness; shortness or breath; speech changes or problems; swelling of the hands or feet; vaginal irritation, odor, or discharge; wheezing.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include body weakness; difficulty breathing; paralysis.Proper storage of Myobloc:
Myobloc is usually handled and stored by a health care provider. If you are using Myobloc at home, store Myobloc as directed by your pharmacist or health care provider. Keep Myobloc out of the reach of children and away from pets.
- If you have any questions about Myobloc, please talk with your doctor, pharmacist, or other health care provider.
- Myobloc is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take Myobloc or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Myobloc. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Myobloc. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Myobloc.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.