Gablofen is a muscle relaxer and an antispastic agent.

Gablofen is used to treat severe spasticity, a movement disorder often brought on by multiple sclerosis, cerebral palsy, spinal cord injury, brain trauma and stroke.

Gablofen may also be used for other purposes not listed in this medication guide.

Sudden withdrawal of Gablofen may result in serious complications that include high fever, confusion, muscle stiffness, organ failure and death. Early symptoms of Gablofen withdrawal may include increased spasticity, itching, and tingling of extremities.

If Gablofen withdrawal or a pump malfunction is suspected, you should be taken immediately to a hospital for assessment and treatment.

Sudden withdrawal occurs most frequently due to a delivery problem with the catheter or the pump, or failure to refill the pump on schedule. Pay careful attention to infusion system alarms. If you miss your scheduled pump refill, you should immediately contact your doctor or healthcare provider to reschedule the refill before the pump runs out of drug.

Gablofen can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol. It can increase some of the side effects of Gablofen. Do not use Gablofen at a time when muscle tone is needed to assure safe balance and movement for certain activities. In some situations, it may endanger your physical safety to be in a state of reduced muscle tone.

Gablofen is given as an injection into the space around your spinal cord (intrathecal injection) using a computerized, portable infusion pump to control the rate of medication you receive. You may need to use this medication for a long period of time.

Gablofen must be given only as an intrathecal injection through an infusion pump and should not be injected directly into a vein or other part of the body. Your doctor, nurse, or other healthcare provider will give you this injection.

Your doctor may occasionally change your dose or infusion pump flow rate to make sure you get the best results from this medication.

You may have withdrawal symptoms such as seizures or hallucinations, when you stop using Gablofen after using it over a long period of time. Do not stop using this medication suddenly. Always talk to your doctor. You may need to use less and less before you stop the medication completely.

Store Gablofen at room temperature away from moisture and heat.

Do not use this medication if you are allergic to Gablofen.

Before taking Gablofen, tell your doctor if you are allergic to any drugs, or if you have:

• kidney disease;
• epilepsy or other seizure disorder; or
• a history of stroke or blood clots.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take this medication.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether Gablofen passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Older adults may be more sensitive to the effects of this medicine.

Do not give this medication to a child younger than 4 years old.

Since Gablofen dosing and infusion pump programming is administered by a healthcare professional, you are not likely to miss a dose.

Seek emergency medical attention if you think you have used too much of this medicine or if your infusion pump is not working properly.

Signs of overdose include drowsiness, lightheadedness, dizziness, somnolence, respiratory depression, seizures, hypotonia and loss of consciousness progressing to coma.

Gablofen can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol. It can increase some of the side effects of Gablofen.

Avoid using other medicines that make you sleepy (such as cold medicine, pain medication, muscle relaxers, and medicine for seizures, depression or anxiety). They can add to sleepiness caused by Gablofen.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

• seizure (convulsions);
• confusion, hallucinations; or
• an uneven heartbeat.

Less serious side effects may include:

• drowsiness, dizziness, weakness, tired feeling;
• agitation;
• low blood pressure;
• headache;
• confusion;
• sleep problems (insomnia);
• nausea, constipation; or
• increased urinary frequency or urinary retention.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

There may be other drugs that can affect Gablofen. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.