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Gablofen (baclofen injection) is used to treat severe spasms caused by problems in the brain or spine in adults and children 4 years and older. Gablofen is for patients who do not have relief, or have side effects they cannot tolerate from taking baclofen by mouth.
IMPORTANT RISK INFORMATION
WARNING: DO NOT STOP GABLOFEN SUDDENLY
Suddenly stopping baclofen given into your spine can cause fever, changes in alertness, thoughts, or mood, an increase in spasms, and stiff muscles, that in rare events can lead to muscle breakdown, failure of organs in the body, and death.
It is very important that you keep scheduled refill visits and be able to recognize the early symptoms of baclofen withdrawal. Some people have a higher chance of having withdrawal, such as patients with certain spinal injuries, difficulty communicating, or a history of withdrawal symptoms from baclofen taken by mouth or given into the spine. Read the technical manual of the pump for additional patient information.
DO NOT USE GABLOFEN IF:
- You are allergic to baclofen.
- Gablofen should not be injected into a vein, muscle, under the skin, or as an epidural.
- An overdose that can kill you can occur if Gablofen is injected into the wrong place in your pump.
- Gablofen can cause decreased activity in your brain, your heart not being able to pump enough blood, and severe breathing problems which can kill you. Trained medical professionals must be present during screening, dose changes, and pump refills.
- Taking too much Gablofen can cause tiredness, light-headedness, dizziness, breathing problems, seizures, decreased muscle strength, and loss of consciousness that could lead to coma.
- If you have psychotic problems, schizophrenia, or other mental problems, Gablofen could make these problems worse.
- People have died while receiving Gablofen into their spine.
- Suddenly stopping Gablofen can cause a condition that can lead to uncontrolled high blood pressure.
- Gablofen dosing may be more difficult if you are sick. Having an infection when your pump is placed increases the risk of complications from the surgery.
- May cause tiredness. Be careful when driving and performing other tasks in which you should be fully alert. Tiredness may become more severe when Gablofen is used with alcohol or other medications that make you less alert.
- May cause a mass to form in your spine.
- May cause cysts to form on the ovaries in women.
- Serious Side Effects
- Suddenly stopping Gablofen can lead to serious side effects such as high fever, confusion, stiffness in muscles, failure of organs in the body, and death. Early signs of Gablofen withdrawal include an increase in muscle spasms, itching, and tingling feelings in the arms and legs. If you think you are experiencing Gablofen withdrawal or your pump is not working correctly, you should go to a hospital immediately.
- The side effects of receiving too much Gablofen can happen very quickly or can happen gradually and be difficult to notice. The side effects of receiving too much Gablofen include confusion, tiredness, light-headedness, dizziness, slow or short breathing, seizures, less strength in the muscles, loss of consciousness, and coma.
- Other serious side effects: may cause a mass to form in your spine, drainage, infection, infection in your spine (meningitis), difficulty in controlling the middle part of your body, leakage of fluid from the spine, coma, and death.
- Common Side Effects
- The most common side effects in patients with muscle spasms that come from the spine were less strength in the muscles (25.3%), tiredness (20.9%), dizziness, nausea/vomiting, low blood pressure, headache, and convulsions.
- The most common side effects in patients with muscle spasms that come from the brain were less strength in the muscles (34.7%), tiredness (18.7%), headache (10.7%), feeling agitated, constipation, low number of white blood cells, feeling cold, and difficulty urinating.
- Other common side effects are breathing that is too shallow or too slow, stiffness in the muscles, feelings of tingling, pricking, or burning, mouthwatering, back pain, itching, diarrhea, swelling in the arms or legs, less strength, pain, confusion, difficulty talking, lazy eye, accidental injury, and dry mouth.
USE IN SPECIFIC POPULATIONS
- Pregnancy: The effect of baclofen in labor and delivery is unknown.
- Baclofen passes into the breast milk and may cause serious side effects in your baby.
- Gablofen is not approved for children below the age of 4 years old.