fingolimod 0.5 mg

1 INDICATIONS AND USAGE Fingolimod capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older. Fingolimod capsules are a sphingosine 1-phosphate receptor modulator indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older. ( 1 )

mylan pharmaceuticals inc.

FDA Reported Adverse Reactions
`[1] neutropenia` `[2] drug ineffective` `[3] off label use` `[4] fatigue` `[5] nausea` `[6] headache` `[7] hospitalisation` `[8] death` `[9] dyspnoea` `[10] pain`

2 years ago

CAPSULE BROWN Mylan FD 0 5

16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied

FINGOLIMOD capsules contain 0.56 mg

FINGOLIMOD hydrochloride, USP equivalent to 0.5 mg

FINGOLIMOD. The 0.5 mg capsules are hard-shell gelatin capsules with a brown-orange opaque cap and white opaque body filled with white to off-white powder. The capsules are axially printed with MYLAN over FD 0.5 in black ink on both the cap and body. They are available as follows: NDC 0378-4525-93 bottles of 30 capsules NDC 0378-4525-71 carton of 7 capsules (1 x 7) 16.2 Storage and Handling Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.

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fingolimod 0.5 mg

FDA Reported Adverse Reactions [1] neutropenia [2] drug ineffective [3] off label use [4] fatigue [5] nausea [6] headache [7] hospitalisation [8] death [9] dyspnoea [10] pain

CAPSULE BROWN Mylan FD 0 5

More pills like CAPSULE Mylan FD 0 5

FDA Reported Adverse Reactions
`[1] neutropenia` `[2] drug ineffective` `[3] off label use` `[4] fatigue` `[5] nausea` `[6] headache` `[7] hospitalisation` `[8] death` `[9] dyspnoea` `[10] pain`