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

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.

More pills like CAPSULE Mylan FD 0 5

DISCLAIMER:

"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."

"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."

"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."

PillSync may earn a commission via links on our site

fingolimod 0.5 mg

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

CAPSULE BROWN Mylan FD 0 5

More pills like CAPSULE Mylan FD 0 5

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