Gablofen

Gablofen is a prescription medication used to relieve spasms and increased muscle tone caused by multiple sclerosis or spinal injury. This medication belongs to a group of drugs called muscle relaxants. Although the way it works is not fully understood, Gablofen may decrease the number and severity of muscle spasms by inhibiting nerve signals.

This medication comes as an injectable liquid to be given directly into the spinal fluid by a healthcare professional.

Common side effects include weakness, drowsiness, and dizziness. Do not drive or operate machinery until you know how this medication affects you.

Gablofen is a prescription medication used to alleviate signs and symptoms of muscle spasms caused by multiple sclerosis or spinal cord injuries and other spinal cord diseases.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Mallinckrodt Inc (Brand Pharmaceuticals)

​Serious side effects have been reported. See "Gablofen Precautions" section.

Common side effects include:

• drowsiness
• dizziness
• weakness
• fatigue
• headache
• insomnia
• nausea

Less common side effects include:

• confusion
• low blood pressure (hypotension)
• constipation
• frequent urination

This is not a complete list of Gablofen side effects. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• alcohol
• benzodiazepines (drugs used to treat anxiety, panic attacks and other conditions) such as alprazolam (Xanax), chlordiazepoxide (Librium), clobazam (Onfi), clonazepam (Klonopin), diazepam (Valium), lorazepam (Ativan), temazepam (Restoril) and others
• opioids (narcotic pain medicines) such as hydrocodone (in Lortab, in Vicodin), morphine (Avinza, Kadian, MS Contin, others), oxycodone (Oxycontin)
• tricyclic antidepressants such as amitriptyline, amoxapine, desipramine (Norpramin), doxepin, imipramine (Tofranil), nortriptyline (Pamelor), protriptyline (Vivactil), and trimipramine (Surmontil)
• sleep medicines such as eszopiclone (Lunesta), ramelteon (Rozerem), zaleplon (Sonata), zolpidem (Ambien)
• muscle relaxants such as carisoprodol (Soma), cyclobenzaprine (Amrix, Flexeril), dantrolene (Dantrium) or metaxalone (Skelaxin)
• other medicines that cause sedation

This is not a complete list of Gablofen drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported including:

• hallucinations and seizures after stopping medication too quickly. Withdrawal symptoms can occur if Gablofen is stopped too quickly. Talk to your doctor before stopping this medication, especially if you have been taking it for a long time. For intrathecal Gablofen, see "Gablofen FDA Warning" section.
• increased risk of seizures. Gablofen can increase risk of seizures, especially in those with seizure disorders (epilepsy).
• worsening mental illness. Talk to your doctor about mental illness.

Dose reduction may be necessary in patients with kidney disease. This medication is excreted by the kidneys. If you have kidney disease, your doctor may recommend a lower dose.

People who have suffered a stroke may be less able to tolerate Gablofen and may not benefit from taking it.

Do not take Gablofen if you are allergic to any of its ingredients.

Gablofen can cause drowsiness. Do not drive or operate machinery until you know how it affects you.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Gablofen, there are no specific foods that you must exclude from your diet when receiving this medication.

Before receiving Gablofen, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to any ingredient in Gablofen
• have kidney disease
• have epilepsy or seizures
• have cerebral palsy
• have Parkinson's disease
• have a psychiatric condition
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Gablofen falls into category C. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Gablofen, when taken orally, has been detected in human breast milk. It is not known whether detectable levels of drug are present in milk of nursing mothers receiving Gablofen. Because of the potential for serious adverse reactions in nursing infants from Gablofen, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. 

Gablofen is also available in an injectable form to be used in more severe cases. It is given through a pump into the spinal fluid.

Gablofen for injection

A doctor will surgically place the pump that will deliver the dose of the medication. The dose of intrathecal Gablofen will be different for different patients and will depend on the type of muscle tightness that you have.

Since this medication is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

Injectable:

Abrupt discontinuation of intrathecal (into the spine) Gablofen, regardless of the cause, has resulted in sequelae that include high fever, altered mental status, exaggerated rebound spasticity, and muscle rigidity, that in rare cases has advanced to rhabdomyolysis, multiple organ-system failure and death.  

Prevention of abrupt discontinuation of intrathecal Gablofen requires careful attention to programming and monitoring of the infusion system, refill scheduling and procedures, and pump alarms. Patients and caregivers should be advised of the importance of keeping scheduled refill visits and should be educated on the early symptoms of Gablofen withdrawal.  Special attention should be given to patients at apparent risk (e.g. spinal cord injuries at T-6 or above, communication difficulties, history of withdrawal symptoms from oral or intrathecal Gablofen). Consult the technical manual of the implantable infusion system for additional postimplant clinician and patient information.