Buy Fleqsuvy (baclofen)

What is Fleqsuvy (baclofen) for?

Fleqsuvy (baclofen) is a gamma-aminobutyric acid (GABA-ergic) agonist indicated for the treatment of spasticity resulting from multiple sclerosis (MS) or patients with other spinal cord diseases or injuries.^[1]

It is a grape-flavored oral suspension formulation supplied in bottles of either 120mL or 300mL, each containing 25 mg per 5 mL (5 mg/mL) baclofen.^[1]

How does Fleqsuvy (baclofen) work?

How baclofen, the active ingredient in Fleqsuvy, works is not fully understood. It is a muscle relaxant that can relieve the spasms, cramping, and tightness of muscles caused by medical problems, including MS or other spinal cord diseases or injuries.^[2]

Baclofen is a derivative of the neurotransmitter gamma- aminobutyric acid (GABA). GABA is a naturally occurring chemical that blocks certain brain signals and decreases activity in your nervous system. GABA can bind to a protein in your brain known as a GABA receptor, producing a calming effect on muscles.^[3]

Where has Fleqsuvy (baclofen) been approved?

Fleqsuvy (baclofen) was approved for the treatment of people with spasticity from MS or with other spinal cord diseases or injuries by:

• The Food and Drug Administration (FDA), USA on February 7, 2022.^[4]

Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team.

How is Fleqsuvy (baclofen) taken?

Treatment with Fleqsuvy is initiated with a low dosage, followed by gradually increasing dosages. The standard dosage regimen is:^[1]

• 1 mL (5 mg) taken orally three times a day for three days
• 2 mL (10 mg) three times a day for three days
• 3 mL (15 mg) three times a day for three days
• 4 mL (20 mg) three times a day for three days

The dosage can be adjusted based on how well you respond to treatment and if you tolerate the drug well. Additional increases may be necessary up to the maximum recommended dosage of 4 mL (20 mg) four times a day (80 mg daily).^[1]

It is recommended to measure the dosage with a calibrated measuring device, as a household teaspoon or tablespoon is not accurate enough.^[1]

When discontinuing Fleqsuvy (baclofen) treatment, reduce the dosage slowly because abrupt discontinuation of baclofen has resulted in serious adverse reactions including death.^[1]

Complete information about Fleqsuvy (baclofen) dosage (modifications) and administration can be found in the official prescribing information listed in our references section.^[1]

Note: Please consult with your treating doctor for personalised dosing.

Are there any known adverse reactions or side effects of Fleqsuvy (baclofen)?

Common adverse reactions

The most common side effects (≥15% of patients) listed in the prescribing information include:^[1]

• Drowsiness
• Dizziness
• Weakness

Serious adverse reactions

The serious adverse reactions listed in the prescribing information include:^[1]

• Exacerbation of the following: psychotic disorders, schizophrenia, or confusional states; autonomic dysreflexia; epilepsy. Use with caution if you have one of these conditions.
• With overdose of Fleqsuvy: coma or with progressive drowsiness, lightheadedness, dizziness, somnolence, accommodation disorders, respiratory depression, seizures, or hypotonia progressing to loss of consciousness.

Use in a specific population

Data suggests that Fleqsuvy (baclofen) may be fatal for a fetus; it is therefore advised to avoid pregnancies and breastfeeding.^[1]

Your newborn baby may have withdrawal symptoms; it is therefore advised to gradually reduce the dosage and stop taking Fleqsuvy before giving birth.^[1]

Fleqsuvy should be given with caution to patients with kidney disease, and it may be necessary to reduce the dosage.^[1]

For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information.^[1]

References

1. Full prescribing information [FDA]: Fleqsuvy (baclofen) [PDF] Azurity Pharmaceuticals, Feb 2022

2. Baclofen
Mayoclinic.org, cited Mar 2022

3. What Does Gamma Aminobutyric Acid (GABA) Do?
Healthline.com, cited Mar 2022

4. Azurity Pharmaceuticals, Inc. Announces FDA Approval Of Fleqsuvy™ (baclofen oral suspension)
Press release, Feb 2022