Safinamide Mesylate
Generic Name: safinamide mesylate
Brand Names:
Xadago
11 DESCRIPTION XADAGO tablets contain safinamide, which is a MAO-B inhibitor, as the mesylate salt. Safinamide mesylate is (S)-2- [[4-[(3-fluorophenyl) methoxy]phenyl]methyl]aminopropanamide methanesulfonate (1:1) and its structural formula is below. The molecular formula of safinamide mesylate is C 17 H 19 FN 2 O 2 ∙CH 4 O 3 S and its molecular weight is 398.45. Safinamide mesylate is a white to off-white crystalline powder.
Overview
11 DESCRIPTION XADAGO tablets contain safinamide, which is a MAO-B inhibitor, as the mesylate salt. Safinamide mesylate is (S)-2- [[4-[(3-fluorophenyl) methoxy]phenyl]methyl]aminopropanamide methanesulfonate (1:1) and its structural formula is below. The molecular formula of safinamide mesylate is C 17 H 19 FN 2 O 2 ∙CH 4 O 3 S and its molecular weight is 398.45. Safinamide mesylate is a white to off-white crystalline powder.
Uses
1 INDICATIONS AND USAGE XADAGO is indicated as adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease (PD) experiencing "off" episodes. XADAGO is a monoamine oxidase type B (MAO-B) inhibitor indicated as adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease (PD) experiencing "off" episodes ( 1 )
Dosage
2 DOSAGE AND ADMINISTRATION Start with 50 mg administered orally once daily at the same time of day; after two weeks, the dose may be increased to 100 mg once daily, based on individual need and tolerability ( 2.1 ) Hepatic Impairment: Do not exceed 50 mg once daily in patients with moderate hepatic impairment; contraindicated in patients with severe hepatic impairment ( 2.2 , 4 ) 2.1 Dosing Information The recommended starting dosage of XADAGO is 50 mg administered orally once daily (at the same time of day), without regard to meals. After two weeks, the dosage may be increased to 100 mg once daily, based on individual need and tolerability. Daily dosages of XADAGO above 100 mg have not been shown to provide additional benefit, and higher dosages increase the risk for adverse reactions.
Side Effects
6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of labeling: Hypertension [see Warnings and Precautions (5.1) ] Serotonin Syndrome [see Warnings and Precautions (5.2) ] Falling Asleep During Activities of Daily Living [see Warnings and Precautions (5.3) ] Dyskinesia [see Warnings and Precautions (5.4) ] Hallucinations / Psychotic Behavior [see Warnings and Precautions (5.5) ] Impulse Control / Compulsive Behaviors [see Warnings and Precautions (5.6) ] Withdrawal-Emergent Hyperpyrexia and Confusion [see Warnings and Precautions (5.7) ] Retinal Pathology [see Warnings and Precautions (5.8) ] Most common adverse reactions (incidence on XADAGO 100 mg/day at least 2% greater than placebo) were dyskinesia, fall, nausea, and insomnia (...
Interactions
7 DRUG INTERACTIONS Selective Serotonin Reuptake Inhibitors: Monitor patients for serotonin syndrome ( 7.3 ) Sympathomimetic Medications: Monitor patients for hypertension ( 7.5 ) Tyramine: Risk of severe hypertension ( 7.6 ) 7.1 MAO Inhibitors (MAOIs) XADAGO is contraindicated for use with other drugs in the MAOIs class or other drugs that are potent inhibitors of monoamine oxidase (e.g., linezolid, an oxazolidinone antibacterial, which also has reversible nonselective MAO inhibition activity). Co-administration increases the risk of nonselective MAO inhibition, which may lead to hypertensive crisis [see Contraindications (4) and Warnings and Precautions (5.1) ] . At least 14 days should elapse between discontinuation of XADAGO and initiation of treatment with other MAOIs.
Warnings
5 WARNINGS AND PRECAUTIONS May cause or exacerbate hypertension ( 5.1 ) May cause serotonin syndrome when used with MAO inhibitors, antidepressants, or opioid drugs ( 5.2 ) May cause falling asleep during activities of daily living ( 5.3 ) May cause or exacerbate dyskinesia; consider levodopa dose reduction ( 5.4 ) May cause hallucinations and psychotic behavior ( 5.5 ) May cause problems with impulse control/compulsive behaviors ( 5.6 ) May cause withdrawal-emergent hyperpyrexia and confusion ( 5.7 ) 5.1 Hypertension XADAGO may cause hypertension or exacerbate existing hypertension. In clinical trials, the incidence of hypertension was 7% for XADAGO 50 mg, 5% for XADAGO 100 mg, and 4% for placebo. 4 CONTRAINDICATIONS XADAGO is contraindicated in patients with: Concomitant use of other drugs in the monoamine oxidase inhibitor (MAOI) class or other drugs that are potent inhibitors of monoamine oxidase, including linezolid. The combination may result in increased blood pressure, including hypertensive crisis [see Warnings and Precautions (5.1) and Drug Interactions (7.1) ] .
Pregnancy
8.1 Pregnancy Risk Summary There are no adequate data on the developmental risk associated with the use of XADAGO in pregnant women. In animals, developmental toxicity, including teratogenic effects, was observed when safinamide was administered during pregnancy at clinically relevant doses. Developmental toxicity was observed at doses lower than those used clinically when safinamide was administered during pregnancy in combination with levodopa/carbidopa. The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S.
Storage
16.2 Storage and Handling Store at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP controlled room temperature].
Frequently Asked Questions
What is Safinamide Mesylate used for?▼
1 INDICATIONS AND USAGE XADAGO is indicated as adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease (PD) experiencing "off" episodes. XADAGO is a monoamine oxidase type B (MAO-B) inhibitor indicated as adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease (PD) experiencing "off" episodes ( 1 )
What are the side effects of Safinamide Mesylate?▼
6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of labeling: Hypertension [see Warnings and Precautions (5.1) ] Serotonin Syndrome [see Warnings and Precautions (5.2) ] Falling Asleep During Activities of Daily Living [see Warnings and Precautions (5.3) ] Dyskinesia [see Warnings and Precautions (5.4) ] Hallucinations / Psychotic Behavior [see Warnings and Precautions (5.5) ] Impulse Control / Compulsive Behaviors [see Warnings and Precautions (5.6) ] Withdrawal-Emergent Hyperpyrexia and Confusion [see Warnings and Precautions (5.7) ] Retinal Pathology [see Warnings and Precautions (5.8) ] Most common adverse reactions (incidence on XADAGO 100 mg/day at least 2% greater than placebo) were dyskinesia, fall, nausea, and insomnia (...
Can I take Safinamide Mesylate during pregnancy?▼
8.1 Pregnancy Risk Summary There are no adequate data on the developmental risk associated with the use of XADAGO in pregnant women. In animals, developmental toxicity, including teratogenic effects, was observed when safinamide was administered during pregnancy at clinically relevant doses. Developmental toxicity was observed at doses lower than those used clinically when safinamide was administered during pregnancy in combination with levodopa/carbidopa. The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S.
What are the important warnings for Safinamide Mesylate?▼
5 WARNINGS AND PRECAUTIONS May cause or exacerbate hypertension ( 5.1 ) May cause serotonin syndrome when used with MAO inhibitors, antidepressants, or opioid drugs ( 5.2 ) May cause falling asleep during activities of daily living ( 5.3 ) May cause or exacerbate dyskinesia; consider levodopa dose reduction ( 5.4 ) May cause hallucinations and psychotic behavior ( 5.5 ) May cause problems with impulse control/compulsive behaviors ( 5.6 ) May cause withdrawal-emergent hyperpyrexia and confusion ( 5.7 ) 5.1 Hypertension XADAGO may cause hypertension or exacerbate existing hypertension. In clinical trials, the incidence of hypertension was 7% for XADAGO 50 mg, 5% for XADAGO 100 mg, and 4% for placebo. 4 CONTRAINDICATIONS XADAGO is contraindicated in patients with: Concomitant use of other drugs in the monoamine oxidase inhibitor (MAOI) class or other drugs that are potent inhibitors of monoamine oxidase, including linezolid. The combination may result in increased blood pressure, including hypertensive crisis [see Warnings and Precautions (5.1) and Drug Interactions (7.1) ] .
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.