intrathecal baclofen
Intrathecal baclofen (Lioresal) is a muscle relaxant. It's given to adults and children ages 4 years and older to treat severe spasticity caused by certain conditions, like spinal cord injuries, that can't be treated with oral baclofen. Intrathecal baclofen (Lioresal) is typically given as a continuous infusion through an implantable pump. But before you can undergo the procedure to receive the pump, your healthcare team will inject test doses of intrathecal baclofen (Lioresal) to see if it works for you. Some side effects of this medication include nausea, sleepiness, and dizziness.
What is Intrathecal baclofen (Lioresal)?
What is Intrathecal baclofen (Lioresal) used for?
- Severe spasticity in people who are either having too many side effects from oral baclofen or who aren't getting enough symptom relief from it
How Intrathecal baclofen (Lioresal) works
Baclofen is a muscle relaxant. The way it works isn't well-understood. It's thought to ease spasticity by relaxing the nerves that make your muscles tighten or cramp up.
Intrathecal baclofen (Lioresal) is given directly into the intrathecal space (space around the spinal cord), typically via a pump.
Drug facts
Side effects of Intrathecal baclofen (Lioresal)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Muscle weakness (up to 35%)
- Sleepiness (up to 21%)
- Headache (up to 11%)
- Nausea and vomiting (up to 11%)
- Convulsions (up to 10%)
- Dizziness (8%)
- "Pins and needles" feeling in arms and legs (up to 7%)
- Stiff muscles (up to 6%)
- Constipation (up to 5%)
Less Common Side Effects
- Dry mouth
- Confusion
- Trouble urinating
- Pain
- Diarrhea
- Slow breathing
- Swelling in the arms and legs
- Depression
- More saliva than usual
- Itching
Intrathecal baclofen (Lioresal) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Overdose: sleepiness, dizziness, slowed breathing, seizures
- Withdrawal: muscle spasms, itching, low blood pressure, "pins and needles" sensation, hallucinations, seizures
- Extreme sleepiness
More on Intrathecal baclofen (Lioresal) side effects
The following Intrathecal baclofen (Lioresal) side effects have also been reported
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 immediately if any of the following side effects occur:
Less common or rare
Bloody or dark urine
fainting
mental depression or other mood changes
ringing or buzzing in the ears
seeing or hearing things that are not there
skin rash or itching
Get emergency help immediately if any of the following symptoms of overdose occur:
Symptoms of overdose
Blurred vision
convulsions
difficult or troubled breathing
dizziness
drowsiness
irregular, fast or slow, or shallow breathing
lightheadedness
loss of strength or energy
muscle pain or weakness
pale or blue lips, fingernails, or skin
sleepiness or unusual drowsiness
unusual weak feeling
unusually slow or troubled breathing
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
Confusion
dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
headache
increased need to urinate
passing urine more often
sweating
trouble sleeping
unusual tiredness or weakness
Less common or rare
Abdominal or stomach pain or discomfort
clumsiness, unsteadiness, trembling, or other problems with muscle control
false sense of well-being
loss of appetite
muscle or joint pain
numbness or tingling in the hands or feet
pounding heartbeat
slurred speech or other speech problems
swelling of the ankles
unexplained muscle stiffness
unusual excitement
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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Pros and cons of Intrathecal baclofen (Lioresal)
Pros
- A possible option for those who can't take oral baclofen
- Less side effects compared to oral baclofen
- Infused through a pump, so don't need to remember to take medication by mouth daily
- Might be an option for children as young as 4 years old
Pharmacist tips for Intrathecal baclofen (Lioresal)
- Mark your appointments on your calendar to see your prescriber, including appointments to get any refills for the medication. This will make sure you're being properly monitored and you're not at risk for running out of intrathecal baclofen (Lioresal), which can cause withdrawal (e.g., sudden muscle spasms, itching, seizures).
- Seek medical help right away if you notice signs of an overdose, such as changes in heart rate, sleepiness, delirium, and poor strength due to poor muscle tone.
- Intrathecal baclofen (Lioresal) can make you feel very tired or dizzy. Let your care team know if you're taking other medications that make you tired. Avoid driving or performing any activity that requires a lot of attention until you know how this medication affects you.
- Avoid drinking alcohol while receiving intrathecal baclofen (Lioresal). Alcohol can worsen certain side effects, such as sleepiness and dizziness. If avoiding alcohol is difficult for you, talk to your prescriber about safer medication options, or resources to help you quit drinking.
- If you're pregnant or thinking of becoming pregnant, let your healthcare team know. intrathecal baclofen (Lioresal) hasn't been well-studied during human pregnancy, but animal studies suggest that it can cause birth defects in unborn babies. In addition, babies born to mothers who took intrathecal baclofen (Lioresal) throughout pregnancy also experienced withdrawal symptoms at birth.
Common questions about Gablofen
Gablofen is used to treat severe spasticity caused by certain brain and spinal cord conditions, including spinal cord injuries. It's not a first-choice option for these conditions. But your healthcare team might recommend Gablofen for you if you're not able to tolerate the side effects from oral baclofen or if oral baclofen no longer works well for you. Because Gablofen is delivered directly to the area around the spinal cord, your dose of Gablofen is much lower compared to the dose of oral baclofen. This means that you're less likely to experience side effects, such as sleepiness and confusion.
Gablofen is given as an intrathecal (IT) infusion. Your healthcare team will place an implantable pump under the skin in the belly area. This pump can continuously release baclofen into the IT space, which is the area around spine that contains spinal cord fluid. Please note that before you can receive the pump, your healthcare team will inject test doses of Gablofen through a lumbar puncture to see if this medication works well for you.
A healthcare professional will place the Gablofen pump under the skin of your stomach while you're under anesthesia (sleep medicine). In order to do so, you'll need to undergo a minor surgery. Once the pump is in place, a small tube (also called a catheter) then deliver Gablofen from the pump to your spine.
A qualified healthcare professional can refill your pump. Your prescriber will typically set up refill appointments with you to refill your Gablofen pump before it runs out. Make sure to mark these appointments in your calendar to avoid the risk of running out of medication. Suddenly stopping Gablofen can lead to withdrawal, which can be life-threatening.
If you missed your appointment to refill your Gablofen pump, contact your prescriber immediately. They can help set you up with a new refill appointment. Or, they might recommend going to the emergency room for further treatment if you're at risk for completely running out of medication. This is because suddenly stopping Gablofen can cause serious and life-threatening withdrawal symptoms, including high fever, confusion, and seizures.
Muscle weakness is the most common side effect of Gablofen. This is because it treats muscle spasms by relaxing the nerves of your muscles. Let your healthcare team know if your muscles are too weak to the point where it's affecting your ability to go about your day. They'll consider lowering your dose. Sleepiness and dizziness are also common side effects of Gablofen. Being too sleepy or dizzy can affect your ability to think, react, and focus. So don't drive or do anything requiring your full attention, especially during the first few days following treatment or a change in your dose, until you know how this medication affects you. If you have any questions about a particular baclofen side effect, talk with your care team.
No, Gablofen isn't a controlled substance because it's unlikely to lead to dependence or abuse.
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Risks and warnings for Intrathecal baclofen (Lioresal)
Intrathecal baclofen (Lioresal) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Withdrawal when stopping intrathecal baclofen (Lioresal) suddenly
- Risk factors: Disconnection of the catheter that delivers the medication | Low volume of medication | Dead battery of the pump | Catheter blockage
Everyone receiving intrathecal baclofen (Lioresal) is potentially at risk for severe and life-threatening withdrawal. Symptoms of early withdrawal include muscle spasms, fever, and itching. If not treated in time, symptoms can worsen to hallucinations (seeing or hearing things that aren't real), delirium, seizures, and rigid muscles. Seek medical help right away if you start to show any symptoms of withdrawal.
Withdrawal can happen because of problems with the actual pump and catheter, such as a dead pump battery, catheter blockage, or disconnection of the catheter that delivers the medication from the pump and into your spine. Withdrawal can also happen if your pump runs out of medication. Your care team will schedule refill appointments with you. Make sure to mark these appointments on your calendar so your pump can be refilled.
Intrathecal baclofen overdose
- Risk factors: Pump malfunction | Errors with refilling the pump
Seek medical help right away if you notice signs of an overdose, such as changes in heart rate, sleepiness, delirium, trouble breathing, and poor strength due to poor muscle tone. You'll need to receive treatment, which includes emptying your pump. A healthcare professional will need to investigate the cause of the overdose, which can be due to too high of a dose or something wrong with the pump.
Worsening of other health conditions
Make sure to tell your care team about all of your medical conditions before starting intrathecal baclofen (Lioresal) because it can worsen the symptoms of certain conditions. Examples include mental health problems (e.g., schizophrenia), high blood pressure due to spinal cord injury (autonomic dysreflexia), seizures, and people who need muscle tone for posture or balance.
Extreme sleepiness or dizziness
- Risk factors: Taking with alcohol or illicit drugs | Taking other medications that cause drowsiness | People over 65
Receiving intrathecal baclofen (Lioresal) can make you feel sleepy and dizzy. These side effects can affect your ability to think, concentrate, and focus. Don't drink alcohol or take other medications that cause sleepiness or dizziness while receiving intrathecal baclofen (Lioresal) because it can make these side effects worse. Avoid activities that require you to be alert, like driving or operating machinery, until you know how the medication affects you.
Ovarian cysts
Though rare, some females who have multiple sclerosis developed ovarian cysts within a year after starting oral baclofen. It's unclear whether the cysts were caused by baclofen or other factors, but they typically went away on their own. If you notice any pelvic pain or changes to your menstrual cycles while using intrathecal baclofen (Lioresal), talk to your prescriber.
Intrathecal baclofen (Lioresal) dosage
Tablet| Dosage | Quantity | Price as low as | Price per unit |
|---|---|---|---|
| 10mg | 60 tablets | $10.61 | $0.18 |
| 20mg | 90 tablets | $14.42 | $0.16 |
| 5mg | 90 tablets | $18.00 | $0.20 |
Typical dosage for Intrathecal baclofen (Lioresal)
Intrathecal baclofen (Lioresal) is typically given as a continuous infusion via an implantable pump into the space around the spinal cord.
Before your healthcare team can implant the pump to deliver intrathecal baclofen (Lioresal), they'll inject test doses of baclofen through a lumbar puncture to make sure this medication is working well for you. If this medication helps with your spasticity, you'll undergo a minor surgery to have the intrathecal baclofen (Lioresal) pump implanted under the skin of the belly area.
Once you've received the intrathecal baclofen (Lioresal) pump, your healthcare team will determine and adjust your maintenance dose of intrathecal baclofen (Lioresal) based on different factors, such as your age and how well intrathecal baclofen (Lioresal) is working to treat your symptoms. The maintence dose can range from 22 mcg/day to 1400 mcg/day, but most of the time people rarely need doses higher than 1000 mcg/day.
Interactions between Intrathecal baclofen (Lioresal) and other drugs
More on Intrathecal baclofen (Lioresal) interactions
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 taking 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.
- Alfentanil
- Alprazolam
- Amifampridine
- Benzhydrocodone
- Bromazepam
- Buprenorphine
- Butorphanol
- Calcium Oxybate
- Cannabidiol
- Cetirizine
- Clobazam
- Codeine
- Dihydrocodeine
- Donepezil
- Doxylamine
- Esketamine
- Fentanyl
- Flibanserin
- Gabapentin
- Gabapentin Enacarbil
- Hydrocodone
- Hydromorphone
- Ketamine
- Lemborexant
- Levocetirizine
- Levorphanol
- Lofexidine
- Loxapine
- Magnesium Oxybate
- Meperidine
- Methadone
- Metoclopramide
- Midazolam
- Morphine
- Morphine Sulfate Liposome
- Nalbuphine
- Oxycodone
- Oxymorphone
- Pentazocine
- Periciazine
- Potassium Oxybate
- Pregabalin
- Remifentanil
- Remimazolam
- Scopolamine
- Sodium Oxybate
- Sufentanil
- Tapentadol
- Tramadol
- Trazodone
- Zolpidem
How much does Intrathecal baclofen (Lioresal) cost?
$10.61
What are alternatives to Intrathecal baclofen (Lioresal)?
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