Luhan Pharmachem Co., Ltd.

Luhan Pharmachem Co., Ltd. supplies Fingolimod HCl bulk active pharmaceutical ingredient (API) to the pharmaceutical industry. Our Fingolimod HCl is manufactured by cGMP compliant facility. Welcome to contact us for further details including current DMF status for the product and up to date regulatory status of the manufacturing facility. We look forward to assisting you with your research and development projects.

What is Fingolimod HCl?

Fingolimod is a sphingosine 1-phosphate receptor modulator. Chemically, drugstore fingolimod is 2-amino-2-[2-(4-octylphenyl)ethyl]propan-1,3-diol hydrochloride.

Fingolimod hydrochloride is a white to practically white powder that is freely soluble in water and alcohol and soluble in propylene glycol. It has a molecular weight of 343.93.

Fingolimod hydrochloride is indicated for the treatment of patients with relapsing forms of multiple sclerosis (MS) to reduce the frequency of clinical exacerbations and to delay the accumulation of physical disability.

Fingolimod HCl Drug Interaction

QT prolonging drugs

Fingolimod hydrochloride has not been studied in patients treated with drugs that prolong the QT interval. Drugs that prolong the QT interval have been associated with cases of torsades de pointes in patients with bradycardia. Since initiation of Fingolimod hydrochloride treatment results in decreased heart rate and may prolong the QT interval, sovaldi sale patients on QT prolonging drugs with a known risk of torsades de pointes (e.g., citalopram, chlorpromazine, haloperidol, methadone, erythromycin) should be monitored overnight with continuous ECG in a medical facility.

Ketoconazole

The blood levels of fingolimod and fingolimod-phosphate are increased by 1.7-fold when used concomitantly with ketoconazole. Patients who use fingolimod hydrochloride and systemic ketoconazole concomitantly should be closely monitored, as the risk of adverse reactions is greater.

Vaccines

Vaccination may be less effective during and for up to 2 months after discontinuation of treatment with fingolimod hydrochloride. The use of live attenuated vaccines should be avoided during and for 2 months after treatment with Fingolimod hydrochloride because of the risk of infection.

Antineoplastic, immunosuppressive or immunomodulating therapies

Antineoplastic, immunosuppressive or immune modulating therapies are expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects such as natalizumab or mitoxantrone.

Drugs that slow heart rate or atrioventricular conduction (e.g., beta blockers or diltiazem)

Experience with fingolimod hydrochloride in patients receiving concurrent therapy with drugs that slow the heart rate or atrioventricular conduction (e.g., beta blockers, digoxin, or heart-rate slowing calcium channel blockers such as diltiazem or verapamil) is limited. Because initiation of Fingolimod hydrochloride treatment may result in an additional decrease in heart rate, concomitant use of these drugs during fingolimod hydrochloride initiation may be associated with severe bradycardia or heart block. Seek advice from the prescribing physician regarding the possibility to switch to drugs that do not slow the heart rate or atrioventricular conduction before initiating fingolimod hydrochloride. In patients who cannot switch, consider extended monitoring, including overnight, after the first dose.

Laboratory test interaction

Because fingolimod hydrochloride reduces blood lymphocyte counts via redistribution in secondary lymphoid organs, peripheral blood lymphocyte counts cannot be utilized to evaluate the lymphocyte subset status of a patient treated with fingolimod hydrochloride. A recent CBC should be available before initiating treatment with fingolimod hydrochloride.

Precautions Before Using Fingolimod HCl

• Decrease in heart rate and/or atrioventricular conduction after first dose of fingolimod hydrochloride: Monitor patients.
• Infections: fingolimod hydrochloride may increase the risk of infections. A recent CBC should be available before initiating treatment with fingolimod hydrochloride. Monitor for signs and symptoms of infection during treatment and for two months after discontinuation. Do not start fingolimod hydrochloride treatment in patients with active acute or chronic infections.
• Macular edema: Can occur with or without visual symptoms. An ophthalmologic evaluation should be performed before starting fingolimod hydrochloride and at 3-4 months after treatment initiation. Monitor visual acuity at baseline and during routine evaluations of patients. Patients with diabetes mellitus or a history of uveitis are at increased risk and should have regular ophthalmologic evaluations.
• Decrease in pulmonary function tests with fingolimod hydrochloride: Obtain spirometry and diffusion lung capacity for carbon monoxide (DLCO) when clinically indicated.
• Hepatic effects: fingolimod hydrochloride may increase liver transaminases. Recent liver enzyme results should be available before starting fingolimod hydrochloride. Assess liver enzymes if hepatic injury is suspected. Discontinue fingolimod hydrochloride if significant liver injury occurs.
• Fetal risk: Women of childbearing potential should use effective contraception during and for 2 months after stopping fingolimod hydrochloride.

Fingolimod HCl side effects

Most common adverse reactions (incidence ?10% and > placebo): Headache, influenza, diarrhea, back pain, liver transaminase elevations and cough.

Fingolimod HCl overdosage

Fingolimod hydrochloride can induce bradycardia as well as AV conduction blocks (including complete AV block). The decline in heart rate usually starts within one hour of the first dose and is maximal within 6 hours in most patients. In case of fingolimod hydrochloride overdosage, observe patients overnight with continuous ECG monitoring in a medical facility, and obtain regular measurements of blood pressure.

Neither dialysis nor plasma exchange results in removal of fingolimod from the body.

Fingolimod HCl Storage

Store at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF). Protect from moisture.

Disclaimer:

Information on this page is provided for general information purposes. You should not make a clinical treatment decision based on information contained in this page without consulting other references including the package insert of the drug, textbooks and where relevant, expert opinion. We cannot be held responsible for any errors you make in administering drugs mentioned on this page, nor for use of any erroneous information contained on this page.