Safinamide

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Safinamide must be given in combination with levodopa and carbidopa and it should not be used alone.

Safinamide is usually taken once per day at the same time each day.

You may take safinamide with or without food.

Your blood pressure will need to be checked often.

Store at room temperature away from moisture and heat.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Safinamide must be given in combination with levodopa and carbidopa and it should not be used alone.

Safinamide is usually taken once per day at the same time each day.

You may take safinamide with or without food.

Your blood pressure will need to be checked often.

Store at room temperature away from moisture and heat.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

In the U.S.

• Xadago

Available Dosage Forms:

• Tablet

Therapeutic Class: Antiparkinsonian

Pharmacologic Class: Monoamine Oxidase Inhibitor, Type B

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Parkinson disease: Adjunctive treatment to levodopa/carbidopa in patients with Parkinson disease (PD) experiencing "off" episodes

Limitations of use: Has not been shown to be effective as monotherapy for the treatment of PD

Parkinson disease: Oral: 50 mg once daily; after 2 weeks may increase to 100 mg once daily.

Discontinuation of therapy: Decrease dose to 50 mg for one week before discontinuing therapy.

>10%: Neuromuscular & skeletal: Dyskinesia (17% to 21%)

1% to 10%:

Cardiovascular: Hypertension (including exacerbation of hypertension: 5% to 7%), orthostatic hypotension (2%)

Central nervous system: Falling (6%), insomnia (4%), anxiety (2%)

Gastrointestinal: Nausea (6%), dyspepsia (2%)

Hepatic: Increased serum ALT (5% to 7%), increased serum AST (6% to 7%)

Respiratory: Cough (2%)

Frequency not defined: Central nervous system: Impulse control disorder

<1% (Limited to important or life-threatening): Sudden onset of sleep (high dose)

Adverse events were observed in animal reproduction studies.

No adjustment recommended

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.