Fleqsuvy Drug Information

Important Information

FLEQSUVY is a concentrated formulation. Verify the strength and the dose of the product prior to prescribing, dispensing, and administering.

Recommended Dosage Initiate

FLEQSUVY with a low dosage, preferably in divided doses, administered orally. The following gradually increasing dosage regimen is suggested, but should be adjusted based on clinical response and tolerability: 1 mL (5 mg) 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 Additional increases may be necessary up to the maximum recommended dosage of 80 mg daily.

Administration Instructions Shake well

FLEQSUVY oral suspension before administration. Discard unused portion 2 months after first opening. A calibrated measuring device is recommended to measure and deliver the prescribed dose accurately.

A household teaspoon or tablespoon is not an adequate measuring device. Nasogastric Tube Administration FLEQSUVY can be administered via a nasogastric (NG) tube at sizes 8 French or larger using the following steps: Ensure the NG feeding tube is flushed with appropriate amount of purified water (15 to 30 mL) prior to administration of FLEQSUVY. Draw the required dose of FLEQSUVY in the appropriate oral or enteral syringe and administer the dose via the feeding tube. The medication may remain in the dosing syringe for up to 4 hours prior to administration.

If residual drug remains in the dosing syringe, draw up purified water into the syringe, shake gently, and administer through the feeding tube. Flush the feeding tube with at least 25 mL of purified water.

Discontinuation of

FLEQSUVY When discontinuing FLEQSUVY, reduce the dosage slowly and avoid abrupt withdrawn from the drug to help minimize the risk of adverse reactions .

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The most common adverse reaction is transient drowsiness. In one controlled study of 175 patients, transient drowsiness was observed in 63% of those receiving baclofen compared to 36% of those in the placebo group.

Other common adverse reactions (up to 15%) are dizziness and weakness. Adverse reactions with a frequency of ≥1% are listed in Table 1. Table 1. Common (≥1%) Adverse Reactions in Patients Treated with Baclofen for Spasticity ADVERSE REACTION PERCENT Drowsiness 10-63% Dizziness 5-15% Weakness 5-15% Nausea 4-12% Confusion 1-11% Hypotension 0-9% Headache 4-8% Insomnia 2-7% Constipation 2-6% Urinary Frequency 2-6% Fatigue 2-4% The following adverse reactions not included in Table 1, classified by body system, were also reported: Neuropsychiatric: euphoria, excitement, depression, hallucinations, paresthesia, muscle pain, tinnitus, slurred speech, coordination disorder, tremor, rigidity, dystonia, ataxia, blurred vision, nystagmus, strabismus, miosis, mydriasis, diplopia, dysarthria, epileptic seizure Cardiovascular: dyspnea, palpitation, chest pain, syncope Gastrointestinal: dry mouth, anorexia, taste disorder, abdominal pain, vomiting, diarrhea, and positive test for occult blood in stool Genitourinary: enuresis, urinary retention, dysuria, impotence, inability to ejaculate, nocturia, hematuria Other: rash, pruritus, ankle edema, excessive perspiration, weight gain, nasal congestion The following laboratory tests have been found to be abnormal in patients receiving baclofen: increased SGOT, elevated alkaline phosphatase, and elevation of blood sugar.

CNS Depressants and Alcohol

FLEQSUVY can cause CNS depression, including drowsiness and sedation, which may be additive when used concomitantly with other CNS depressants or alcohol .

Pregnancy Risk Summary There are no adequate data on the risk of major birth defects, miscarriages, or other maternal adverse outcomes associated with the use of FLEQSUVY in pregnant women. There are adverse effects on fetal outcomes associated with withdrawal from baclofen after delivery (see Clinical Considerations ). Oral administration of baclofen to pregnant rats resulted in an increased incidence of fetal structural abnormalities at a dose that was also associated with maternal toxicity. The background risk of major birth defects and miscarriage for the indicated population is unknown.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions FLEQSUVY may increase the risk of late-onset neonatal withdrawal symptoms . Data Animal Data Baclofen given orally has been shown to increase the incidence of omphaloceles (ventral hernias) in fetuses of rats given approximately 13 times on a mg/kg basis, or 3 times on a mg/m 2 basis, the maximum oral dose recommended for human use; this dose also caused reductions in food intake and weight gain in the dams. This abnormality was not seen in mice or rabbits.

Pediatric Use Safety and effectiveness in pediatric patients below the age of 12 have not been established.

is contraindicated in patients with hypersensitivity to baclofen. Hypersensitivity to baclofen

Symptoms of Baclofen Overdose With overdose of baclofen, patients may present in

coma or with progressive drowsiness, lightheadedness, dizziness, somnolence, accommodation disorders, respiratory depression, seizures, or hypotonia progressing to loss of consciousness.

Treatment for Overdose

The treatment of baclofen overdose includes gastric decontamination, maintaining an adequate airway and respirations.