Generic Name and Formulations:
Safinamide 50mg, 100mg; tabs.
US WorldMeds, LLC
Indications for XADAGO:
As adjunct to levodopa/carbidopa in patients with Parkinson's disease experiencing "off" episodes.
Limitations Of use:
Not effective as monotherapy for treating Parkinson's disease.
Initially 50mg once daily (at same time of day); may increase to 100mg once daily after 2 weeks as tolerated. Moderate hepatic impairment (Child-Pugh B): max 50mg once daily. Taper gradually upon discontinuation.
Severe hepatic impairment (Child-Pugh C). Concomitant other MAOIs including linezolid, opioids (eg, meperidine, methadone, propoxyphene, tramadol), SNRIs, tricyclic, tetracyclic, or triazolopyridine antidepressants, cyclobenzaprine, methylphenidate, amphetamine and their derivatives, St. John's wort, dextromethorphan.
Monitor for new onset or uncontrolled hypertension. Avoid tyramine-rich (>150mg) foods (see full labeling). Dyskinesia: reduce daily dose of levodopa or dopaminergic agent. Consider reducing dose or discontinuing therapy if hallucinations, psychotic disorders, urges/compulsive behaviors develop. Consider discontinuing if excessive daytime sleepiness or if sudden onset of sleep occurs. History of retinal/macular degeneration, uveitis, inherited retinal conditions, family history of hereditary retinal disease, albinism, retinitis pigmentosa, active retinopathy; monitor periodically for visual changes. Discontinue if severe hepatic impairment develops. Pregnancy (Cat.C). Nursing mothers: not recommended.
See Contraindications. Allow at least 14 days after discontinuing safinamide before starting MAOIs, opioids, serotonergics. Possible hypertensive crisis with excess dietary tyramine (see full labeling). Monitor for hypertension and reaction to dietary tyramine if concomitant with isoniazid. Concomitant SSRIs: use lowest effective dose and monitor for serotonin syndrome. Monitor for hypertension if concomitant with sympathomimetics (eg, nasal, oral, ophthalmic, decongestants or cold remedies). Concomitant with BCRP substrates (eg, methotrexate, mitoxantrone, imatinib, irinotecan, lapatinib, rosuvastatin, sulfasalazine, topotecan); monitor. May be antagonized by dopamine antagonists (eg, antipsychotics, metoclopramide).
Dyskinesia, fall, nausea, insomnia; serotonin syndrome, withdrawal-emergent hyperpyrexia and confusion, retinal pathology.
Endocrinology Advisor Articles
- GLP-1 Agonists Superior to DPP-4 Inhibitors for Reducing HbA1c, Weight in T2D
- Effect of HbA1c and Perioperative Glucose on Postoperative Mortality
- Semaglutide May Be Useful for Treating Obesity in People Without Diabetes
- Once-Daily Oral Contraceptive for Men Shows Promise
- Effect of Growth Hormone Treatment on BMD in Adults With Prader-Willi Syndrome
- American College of Physicians Releases 4 Guidelines for HbA1c Targets in T2D
- Dyslipidemia Drug Indications
- No Difference in Weight Loss Outcomes With Low-Fat vs Low-Carbohydrate Diet
- Damaging Effects of Gastric Bypass Surgery on Bone Mass and Microarchitecture
- Gastric Bypass Surgery Linked to Increased Risk for Nonvertebral Fractures
- Updated Clinical Practice Guidelines on Testosterone Therapy in Men With Hypogonadism
- Type 2 Diabetes Associated With Increased Fracture Risk in Postmenopausal Women
- Use of FSH in Early Diagnosis of Turner Syndrome
- Surgical Treatment Better Than Medical Therapy in Severely Obese Adolescents With T2D
- Metformin May Improve Pregnancy Outcomes in Polycystic Ovary Syndrome