FINGOLIMOD .5 mg/1
fingolimod · CAPSULE · Solco Healthcare US, LLC
FINGOLIMOD is a capsule containing fingolimod at .5 mg/1, taken oral. Manufactured by Solco Healthcare US, LLC.
Key Facts
- Brand Name
- FINGOLIMOD
- Generic Name
- fingolimod
- NDC Code (Product)
43547-003- Manufacturer
- Solco Healthcare US, LLC
- Strength
- .5 mg/1
- Dosage Form
- CAPSULE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA208003
- Drug Class
- Sphingosine 1-phosphate Receptor Modulator [EPC]
- Marketing Start
- 02/17/2020
Recall History
Ascend Laboratories, LLC
Failed Dissolution Specifications
Full Prescribing Information
Indications & Usage
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 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION · Assessments are required prior to initiating fingolimod capsules. ( 2.1 ) · Recommended dosage for adults and pediatric patients (10 years of age and older) weighing more than 40 kg: 0.5 mg orally once daily, with or without food. ( 2.2 , 2.3 ) · First-Dose Monitoring (including reinitiation after discontinuation greater than 14 days and dose increases): o Observe all patients for bradycardia for at least 6 hours; monitor pulse and blood pressure hourly. Electrocardiograms (ECGs) prior to dosing and at end of observation period required. ( 2.4 ) o Monitor until resolution if heart rate < 45 beats per minute (bpm) in adults, < 55 bpm in patients aged 12 years and above, or < 60 bpm in pediatric patients aged 10 to below 12 years, atrioventricular (AV) block, or if lowest postdose heart rate is at the end of the observation period. ( 2.4 ) o Monitor symptomatic bradycardia with ECG until resolved. Continue overnight if intervention is required; repeat first-dose monitoring for second dose. ( 2.4 ) o Observe patients overnight if at higher risk of symptomatic bradycardia, heart block, prolonged QTc interval, or if taking drugs with known risk of torsades …
Contraindications
4 CONTRAINDICATIONS Fingolimod capsules are contraindicated in patients who have: in the last 6 months experienced myocardial infarction, unstable angina, stroke, transient ischemic attack (TIA), decompensated heart failure requiring hospitalization or Class III/IV heart failure a history or presence of Mobitz Type II second-degree or third-degree AV block or sick sinus syndrome, unless patient has a functioning pacemaker [see Warnings and Precautions ( 5.1 )] a baseline QTc interval ≥500 msec cardiac arrhythmias requiring anti-arrhythmic treatment with Class Ia or Class III anti-arrhythmic drugs had a hypersensitivity reaction to fingolimod or any of the excipients in fingolimod capsules. Observed reactions include rash, urticaria and angioedema upon treatment initiation [see Warnings and Precautions ( 5.14 )]. Recent myocardial infarction, unstable angina, stroke, transient ischemic attack (TIA), decompensated heart failure with hospitalization, or Class III/IV heart failure. ( 4 ) History of Mobitz Type II 2 nd degree or 3 rd degree AV block or sick sinus syndrome, unless patient has a pacemaker. ( 4 ) Baseline QTc interval ≥500 msec. ( 4 ) Cardiac arrhythmias requiring anti-arr…
Drug Interactions
7 DRUG INTERACTIONS • Systemic Ketoconazole: Monitor during concomitant use. ( 7.2 , 12.3 ) • Vaccines: Avoid live attenuated vaccines during, and for 2 months after stopping fingolimod treatment. ( 5.2 , 7.3 ) 7.1 QT Prolonging Drugs Fingolimod 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 treatment results in decreased heart rate and may prolong the QT interval, 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 [ see Dosage and Administration ( 2.4 ), Warnings and Precautions ( 5.1 ) ]. 7.2 Ketoconazole The blood levels of fingolimod and fingolimod-phosphate are increased by 1.7-fold when used concomitantly with ketoconazole. Patients who use fingolimod and systemic ketoconazole concomitantly should be closely monitored, as the risk of adverse reactions is increased. 7.3 Vaccines Fingolimod reduces the immune response to vaccinatio…
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in labeling: Bradyarrhythmia and Atrioventricular Blocks [see Warnings and Precautions ( 5.1 )] Infections [see Warnings and Precautions ( 5.2 )] Progressive Multifocal Leukoencephalopathy [see Warnings and Precautions ( 5.3 )] Macular Edema [see Warnings and Precautions ( 5.4 )] Liver Injury [ see Warnings and Precautions ( 5.5 ) ] Posterior Reversible Encephalopathy Syndrome [ see Warnings and Precautions ( 5.6 ) ] Respiratory Effects [ see Warnings and Precautions ( 5.7 ) ] Fetal Risk [see Warnings and Precautions ( 5.8 )] Severe Increase in Disability After Stopping Fingolimod [see Warnings and Precautions ( 5.9 )] Tumefactive Multiple Sclerosis [see Warnings and Precautions ( 5.10 )] Increased Blood Pressure [see Warnings and Precautions ( 5.11 )] Malignancies [see Warnings and Precautions ( 5.12 ) ] Immune System Effects Following fingolimod Discontinuation [see Warnings and Precautions ( 5.13 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.14 )] Most common adverse reactions (incidence ≥10% and greater than placebo): Headache, liver transaminase elevation, diarrhea, cough, inf…
Frequently Asked Questions
What is FINGOLIMOD used for?
FINGOLIMOD contains fingolimod. It is a capsule taken oral. Consult your doctor for specific uses.
Is FINGOLIMOD a controlled substance?
FINGOLIMOD is not classified as a controlled substance by the DEA.
What is the generic name for FINGOLIMOD?
The generic name for FINGOLIMOD is fingolimod. There are 9 other brand versions of fingolimod.
What is the NDC code for FINGOLIMOD .5 mg/1?
The NDC (National Drug Code) for FINGOLIMOD .5 mg/1 is 43547-003, listed by Solco Healthcare US, LLC.