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FINGOLIMOD .5 mg Capsule, 30-count — NDC 43547-0003-03 package photo

FINGOLIMOD .5 mg Capsule, 30-count

by Solco Healthcare US, LLC · 30 CAPSULE in 1 BOTTLE (43547-003-03)
NDC 43547-0003-03
🏷️ FDA NDC (as labeled) 43547-003-03 billing pads the product segment with a zero
This package
Contains30-count Pack sizes2 compare ↓
Also priced by: Part D plans $24.12/unit — full pricing hub ↓
Also comes in: 90 capsules 43547-0003-09
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 43547-003-03
Product NDC 43547-003
11-digit billing NDC 43547000303
RxCUI 1012895
UNII 3QN8BYN5QF
Application # ANDA208003
SPL Set ID 6c0faf2b-21fb-4830-bb78-5f2dbceb2c82
Established class (EPC) Sphingosine 1-phosphate Receptor Modulator
Mechanism of action Sphingosine 1-Phosphate Receptor Modulators
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-02-17
Route ORAL
Dosage form CAPSULE
Substance FINGOLIMOD
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 43547-003-03 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 43547-0003-03. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Sphingosine 1-phosphate Receptor Modulator class.

Pharmacologic class Sphingosine 1-phosphate Receptor Modulator
Drug family (ATC) Sphingosine-1-phosphate (S1P) receptor modulators
How it works Sphingosine 1-Phosphate Receptor Modulators
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerSolco Healthcare US, LLC
Application holderPRINSTON PHARMACEUTICAL INC
FDA applicationANDA208003 (ANDA)
Labeler code43547
First marketedFeb 2020
Product typeHuman Prescription Drug
Portfolio134 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

📖 What it is MedlinePlus · NLM

Fingolimod is used to treat certain types of multiple sclerosis (MS; a disease that damages nerves causing weakness, numbness, loss of muscle coordination, and problems with vision, speech, and bladder control). Fingolimod is in a class of medications called sphingosine l-phosphate receptor modulators. It works by decreasing the action of immune cells that may cause nerve damage.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Fingolimod works by keeping certain immune cells — the ones that damage your nerves — locked inside your lymph nodes so they can't travel to your brain or spinal cord. This reduces...
  • What exactly is fingolimod doing for my MS?
  • Fingolimod slows your heart rate — especially after that very first dose. The drop can be significant in the first few hours, and in some people it can cause symptoms like dizzines...
  • Why do I have to be monitored for hours after my first dose?
📖 Read our full Fingolimod guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color White
ShapeCapsule
Imprint573;
Size16 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII XM0M87F357
    A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
  • UNII 2G86QN327L
    Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII WZH3C48M4T
    Potassium hydroxide is a strong alkaline chemical used in medicines to adjust and maintain the pH level of liquid formulations, helping keep the product stable and the active ingredients effective.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII 46N107B71O
    Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

9 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $24.12 $723.68 / 30 capsules
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Fingolimod .5 mg 00480-7820-56 Teva 30 capsules $2.097 AB Availability likely —
Fingolimod .5 mg 31722-0889-30 Camber 30 capsules $2.097 AB Availability likely —
Fingolimod .5 mg 43598-0285-30 Dr. 30 capsules $2.097 AB Availability likely —
Fingolimod .5 mg 60505-4332-03 Apotex 30 capsules $2.097 AB Availability likely —
fingolimod .5 mg 64980-0449-03 Rising 30 capsules $2.097 AB Availability likely —
Fingolimod .5 mg 67877-0476-30 Ascend 30 capsules $2.097 AB Availability likely —
Fingolimod .5 mg 82009-0143-30 Quallent 30 capsules $2.097 AB Availability likely —
Fingolimod .5 mg 82249-0385-30 CivicaScript 30 capsules $2.097 AB Availability likely —
Fingolimod Hydrochloride .5 mg 16729-0342-10 Accord 30 capsules $3.563 AB Availability likely —
Gilenya .5 mg 00078-0607-15 Novartis 30 capsules $414.711 AB FDA listed —
Fingolimod .5 mg 42291-0048-30 AvKARE 30 capsules — AB FDA listed —
Fingolimod .5 mgthis 43547-0003-03 Solco 30 capsules — AB FDA listed —
Fingolimod .5 mg 46708-0228-10 Alembic 1000 capsules — AB FDA listed —
Fingolimod .5 mg 62332-0228-10 Alembic 1000 capsules — AB FDA listed —
Fingolimod .5 mg 62756-0064-57 Sun 28 capsules — — FDA listed —
Fingolimod .5 mg 65862-0952-07 Aurobindo 7 capsules — AB FDA listed —
Fingolimod .5 mg 68382-0912-01 Zydus 100 capsules — AB FDA listed —
fingolimod .5 mg 68462-0166-07 Glenmark 49 capsules — AB FDA listed —
Fingolimod .5 mg 70377-0019-11 Biocon 30 capsules — AB FDA listed —
Fingolimod .5 mg 70771-1603-01 Zydus 100 capsules — AB FDA listed —
Fingolimod .5 mg 72865-0257-30 XLCare 30 capsules — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2020
On the market since
Feb 2020
📍
2026
Currently FDA-listed
6 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Fingolimod — the program that covers self-administered drugs. 8 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Fingolimod. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$7.74M
Claims incl. refills
7K
Beneficiaries
2.8K
Spend / beneficiary
$2,754.71
Spend / claim
$1,110.82
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
43547-0003-03 You're viewing this 30 CAPSULE in 1 BOTTLE (43547-003-03) 2021-10-26 Active
43547-0003-09 90 CAPSULE in 1 BOTTLE (43547-003-09) 2021-10-26 Active

You're viewing the smallest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 43547-0003-03?
NDC 43547-0003-03 is a 30-count package — 30 capsule in 1 bottle.
What is the difference between NDC 43547-0003-03 and NDC 43547-0003-09?
Both are FINGOLIMOD .5 mg Capsule — the drug itself is identical. NDC 43547-0003-03 is the 30-count package, while NDC 43547-0003-09 is the 90 capsules package.
What NDC number is used to bill for this package of FINGOLIMOD .5 mg Capsule?
Bill NDC 43547-0003-03 — the 11-digit billing format is 43547000303. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 43547-003-03, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 43547-0003-03, written without dashes as 43547000303. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 43547-0003-03, the first segment (43547) is the labeler code FDA assigned to Solco Healthcare US, LLC; the middle segment (0003) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (03) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Solco Healthcare US, LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 90 capsules (43547-0003-09). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Solco Healthcare US, LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide
🎯 Indications and Usage 80 words ▾

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 and Administration ~3 min read ▾

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 ) • Recommended dosage for pediatric patients (10 years of age and above) weighing less than or equal to 40 kg: 0.25 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 de pointes.

( 2.4 , 7.1 )

2.1Assessment Prior to Initiating Fingolimod Capsules Cardiac Evaluation Obtain a cardiac evaluation in patients with certain preexisting conditions [see Warnings and Precautions ( 5.1 )] . Prior to starting treatment, determine whether patients are taking drugs that could slow heart rate or atrioventricular (AV) conduction [see Dosage and Administration ( 2.4 ), Drug Interactions ( 7.5 )] . Complete Blood Count (CBC) Review results of a recent CBC [see Warnings and Precautions ( 5.2 ), Drug Interactions ( 7.6 )] .

Serum Transaminases (ALT and AST) and Total Bilirubin Levels Prior to starting treatment with fingolimod capsules (i.e., within 6 months), obtain serum transaminases [alanine transaminase (ALT) and aspartate transferase (AST)] and total bilirubin levels [see Warnings and Precautions ( 5.5 )] . Ophthalmic Assessment Obtain a baseline evaluation of the fundus, including the macula, near the start of the treatment with fingolimod capsules [see Warnings and Precautions ( 5.4 )] . Skin Examination Obtain a baseline skin examination prior to or shortly after initiation of fingolimod capsules.

If a suspicious skin lesion is observed, it should be promptly evaluated [see Warnings and Precautions ( 5.12 )] . Prior Medications If patients are taking antineoplastic, immunosuppressive, or immune-modulating therapies, or if there is a history of prior use of these drugs, consider possible unintended additive immunosuppressive effects before initiating treatment with fingolimod capsules [see Warnings and Precautions ( 5.2 ), Drug Interactions ( 7.4 )] . Vaccinations Test patients for antibodies to varicella zoster virus (VZV) before initiating fingolimod capsules; VZV vaccination of antibody-negative patients is recommended prior to commencing treatment with fingolimod capsules [see Warnings and Precautions ( 5.2 )] .

It is recommended that pediatric patients if possible, complete all immunizations in accordance with current immunization guidelines prior to initiating fingolimod capsules therapy.

2.2Important Administration Instructions Patients who initiate fingolimod capsules, and those who reinitiate treatment after discontinuation for longer than 14 days, require first-dose monitoring. This monitoring is also recommended when the dose is increased in pediatric patients [see Dosage and Administration ( 2.4 , 2.5 )] . Fingolimod capsules can be taken with or without food.

2.3Recommended Dosage In adults and pediatric patients 10 years of age and older weighing more than 40 kg, the recommended dosage of fingolimod capsules is 0.5 mg orally once-daily. In…

💊 Dosage Forms and Strengths 42 words ▾

3 DOSAGE FORMS AND STRENGTHS Fingolimod capsules are available as: • 0.5 mg hard white opaque capsules printed with "573" in black ink on the cap and "0.5 mg" in black ink on the body. 0.5 mg hard capsules ( 3 )

⛔ Contraindications 209 words ▾

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-arrhythmic treatment with Class Ia or Class III anti-arrhythmic drugs. ( 4 ) • Hypersensitivity to fingolimod or its excipients. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • Infections: Fingolimod capsules may increase the risk. Obtain a complete blood count (CBC) before initiating treatment. Monitor for infection during treatment and for 2 months after discontinuation.

Do not start in patients with active infections. ( 5.2 ) • Progressive Multifocal Leukoencephalopathy (PML): Withhold fingolimod capsules at the first sign or symptom suggestive of PML. ( 5.3 ) • Macular Edema: Increases the risk of macular edema.

Obtain a baseline evaluation of the fundus, including the macula, near the start of treatment with fingolimod capsules. Conduct an evaluation of the fundus, including the macula, 3 to 4 months after treatment start, periodically while on therapy and any time there is a change in vision. Consider discontinuing fingolimod capsules if macular edema develops.

Diabetes mellitus and uveitis increase the risk. ( 5.4 ) • Liver Injury: Obtain liver enzyme results before initiation and periodically during treatment. Closely monitor patients with severe hepatic impairment.

Discontinue if there is evidence of liver injury without other cause. ( 5.5 , 8.6 , 12.3 ) • Posterior Reversible Encephalopathy Syndrome (PRES): If suspected, discontinue fingolimod capsules. ( 5.6 ) • Respiratory Effects: Evaluate when clinically indicated.

( 5.7 ) • Fetal Risk: May cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use an effective method of contraception during treatment and for 2 months after stopping fingolimod capsules. ( 5.8 , 8.1 , 8.3 ) • Severe Increase in Disability After Stopping Fingolimod Capsules: Monitor for development of severe increase in disability following discontinuation and begin appropriate treatment as needed.

( 5.9 ) • Tumefactive MS : Consider when severe MS relapse occurs during treatment or after discontinuation. Obtain imaging and begin treatment as needed. ( 5.10 ) • Increased Blood Pressure (BP): Monitor BP during treatment.

( 5.11 ) • Malignancies : Skin examination prior to or shortly after the start of treatment and periodically thereafter is recommended. Suspicious skin lesions should be evaluated. ( 5.12 )

5.1Bradyarrhythmia and Atrioventricular Blocks Because of a risk for bradyarrhythmia and AV blocks, patients should be monitored during fingolimod capsules treatment initiation [see Dosage and Administration ( 2.4 )] . Reduction in Heart Rate After the first dose of fingolimod capsules, the heart rate decrease starts within an hour. On Day 1, the maximum decline in heart rate generally occurs within 6 hours and recovers, although not to baseline levels, by 8 to 10 hours postdose.

Because of physiological diurnal variation, there is a second period of heart rate decrease within 24 hours after the first dose. In some patients, heart rate decrease during the second period is more pronounced than the decrease observed in the first 6 hours. Heart rates below 40 bpm in adults, and below 50 bpm in pediatric patients occurred rarely.

In controlled clinical trials in adult patients, adverse reactions of symptomatic bradycardia following the first dose were reported in 0.6% of patients receiving fingolimod capsules 0.5 mg and in 0.1% of patients on placebo. Patients who experienced bradycardia were generally asymptomatic, but some patients experienced hypotension, dizziness, fatigue, palpitations, and/or chest pain that usually resolved within the first 24 hours on treatment. Patients with some preexisting conditions (e.g., ischemic heart disease, history of myocardial infarction, congestive heart failure, history of cardiac arrest, cerebrovascular disease, uncontrolled hypertension, history of symptomatic bradycardia, history of recurrent syncope, severe untreated sleep apnea, AV block, sinoatrial heart block) may poorly tolerate the fingolimod capsules-induced bradycardia, or experience serious rhythm disturbances after the first dose of fingolimod capsules.

Prior to treatment with fingolimod capsules, th…

🤒 Adverse Reactions ~3 min read ▾

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 Capsules [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 Capsules 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, influenza, sinusitis, back pain, abdominal pain, and pain in extremity.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Solco Healthcare US, LLC at 1-866-257-2597 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adults In clinical trials (Studies 1, 2, and 3), a total of 1,212 patients with relapsing forms of multiple sclerosis received fingolimod capsules 0.5 mg. This included 783 patients who received fingolimod capsules 0.5 mg in the 2-year placebo-controlled trials (Studies 1 and 3) and 429 patients who received fingolimod capsules 0.5 mg in the 1-year active-controlled trial (Study 2).

The overall exposure in the controlled trials was equivalent to 1,716 person-years . Approximately 1,000 patients received at least 2 years of treatment with fingolimod capsules 0.5 mg. In all clinical studies, including uncontrolled extension studies, the exposure to fingolimod capsules 0.5 mg was approximately 4,119 person-years.

In placebo-controlled trials, the most frequent adverse reactions (incidence ≥ 10% and greater than placebo) for fingolimod capsules 0.5 mg were headache, liver transaminase elevation, diarrhea, cough, influenza, sinusitis, back pain, abdominal pain, and pain in extremity. Adverse events that led to treatment discontinuation and occurred in more than 1% of patients taking fingolimod capsules 0.5 mg, were serum transaminase elevations (4.7% compared to 1% on placebo) and basal cell carcinoma (1% compared to 0.5% on placebo).

Table 1 lists adverse reactions in clinical studies in adults that occurred in ≥ 1% of fingolimod capsules-treated patients and ≥ 1% higher rate than for placebo. Table 1: Adverse Reactions Reported in Adult Studies 1 and 3 (Occurring in ≥ 1% of Patients and Reported for Fingolimod Capsules 0.5 mg at ≥ 1% Higher Rate Than for Placebo) Fingolimod Capsules 0.5 mg Placebo Adverse drug reactions N = 783 % N = 773 % Infections Influenza 11 8 Sinusitis 11 8 Bronchitis 8 5 Herpes zoster 2 1 Tinea versicolor 2 < 1 Cardiac disorders Bradycardia 3 1 Nervous system disorders Headache 25 24 Migraine 6 4 Gastrointestinal disorders Nausea 13 12 Diarrhea 13 10 Abdominal pain 11 10 General disorders and administration-site conditions Asthenia 2 1 Musculoskeletal and connective tissue disorders Back pain 10 9 Pain in extremity 10 7 Skin and subcutaneous tissue disorders Alopecia 3 2 Actinic keratosis 2 1 Investigations Liver transaminase elevations (ALT/GGT/AST) 15 4 Blood triglycerides increased 3 1…

🔄 Drug Interactions ~2 min read ▾

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 capsules treatment. ( 5.2 , 7.3 )

7.1QT Prolonging Drugs Fingolimod capsules have 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 capsules 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 )].

7.2Ketoconazole The blood levels of fingolimod and fingolimod-phosphate are increased by 1.7-fold when used concomitantly with ketoconazole. Patients who use fingolimod capsules and systemic ketoconazole concomitantly should be closely monitored, as the risk of adverse reactions is greater.

7.3Vaccines Fingolimod capsules reduce the immune response to vaccination. Vaccination may be less effective during and for up to 2 months after discontinuation of treatment with fingolimod capsules [see Clinical Pharmacology ( 12.2 )] . Avoid the use of live attenuated vaccines during and for 2 months after treatment with fingolimod capsules because of the risk of infection.

It is recommended that pediatric patients, if possible, be brought up to date with all immunizations in agreement with current immunization guidelines prior to initiating fingolimod capsules therapy.

7.4Antineoplastic, Immunosuppressive, or Immune-Modulating Therapies Antineoplastic, immune-modulating, or immunosuppressive therapies, (including corticosteroids) are expected to increase the risk of immunosuppression, and the risk of additive immune system effects must be considered if these therapies are coadministered with fingolimod capsules. When switching from drugs with prolonged immune effects, such as natalizumab, teriflunomide or mitoxantrone, the duration and mode of action of these drugs must be considered to avoid unintended additive immunosuppressive effects when initiating fingolimod capsules [see Warnings and Precautions ( 5.2 )].

7.5Drugs That Slow Heart Rate or Atrioventricular Conduction (e.g., beta blockers or diltiazem) Experience with fingolimod capsules in patients receiving concurrent therapy with drugs that slow the heart rate or AV conduction (e.g., beta blockers, digoxin, or heart rate-slowing calcium channel blockers, such as diltiazem or verapamil) is limited. Because initiation of fingolimod capsules treatment may result in an additional decrease in heart rate, concomitant use of these drugs during fingolimod capsules initiation may be associated with severe bradycardia or heart block.

Seek advice from the physician prescribing these drugs regarding the possibility to switch to drugs that do not slow the heart rate or atrioventricular conduction before initiating fingolimod capsules. Patients who cannot switch should have overnight continuous ECG monitoring after the first dose [see Dosage and Administration ( 2.4 ), Warnings and Precautions ( 5.1 )].

7.6Laboratory Test Interaction Because fingolimod capsules reduce 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 capsules. A recent CBC should be available before initiating treatment with fingolimod capsules.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Based on findings from animal studies, fingolimod capsules may cause fetal harm when administered to a pregnant woman. Data from prospective reports to the fingolimod capsules Pregnancy Registry (GPR) are currently not sufficient to allow for an adequate assessment of the drug-associated risk for birth defects and miscarriage in humans. In oral studies conducted in rats and rabbits, fingolimod demonstrated developmental toxicity, including an increase in malformations (rats) and embryolethality, when given to pregnant animals.

In rats, the highest no-effect dose was less than the recommended human dose of 0.5 mg/day on a body surface area (mg/m 2 ) basis. The most common fetal visceral malformations in rats were persistent truncus arteriosus and ventricular septal defect. The receptor affected by fingolimod (sphingosine 1-phosphate receptor) is known to be involved in vascular formation during embryogenesis ( see Data ) .

Advise pregnant women of the potential risk to a fetus. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown.

Clinical Considerations In females planning to become pregnant, fingolimod capsules should be stopped 2 months before planned conception. The possibility of severe increase in disability should be considered in women who discontinue or are considering discontinuation of fingolimod capsules because of pregnancy or planned pregnancy. In many of the cases in which increase in disability was reported after stopping fingolimod capsules, patients had stopped fingolimod capsules because of pregnancy or planned pregnancy [see Warnings and Precautions ( 5.9 )] .

Data Animal Data When fingolimod was orally administered to pregnant rats during the period of organogenesis (0, 0.03, 0.1, and 0.3 mg/kg/day or 0, 1, 3, and 10 mg/kg/day), increased incidences of fetal malformations and embryofetal deaths were observed at all but the lowest dose tested (0.03 mg/kg/day), which is less than the recommended human dose (RHD) on a mg/m 2 basis. Oral administration to pregnant rabbits during organogenesis (0, 0.5, 1.5, and 5 mg/kg/day) resulted in increased incidences of embryofetal mortality and fetal growth retardation at the mid and high doses.

The no-effect dose for these effects in rabbits (0.5 mg/kg/day) is approximately 20 times the RHD on a mg/m 2 basis. When fingolimod was orally administered to female rats during pregnancy and lactation (0, 0.05, 0.15, and 0.5 mg/kg/day), pup survival was decreased at all doses and a neurobehavioral (learning) deficit was seen in offspring at the high dose. The low-effect dose of 0.05 mg/kg/day is similar to the RHD on a mg/m 2 basis.

8.2Lactation Risk Summary There are no data on the presence of fingolimod in human milk, the effects on the breastfed infant, or the effects of the drug on milk production. Fingolimod is excreted in the milk of treated rats. When a drug is present in animal milk, it is likely that the drug will be present in human milk.

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for fingolimod capsules and any potential adverse effects on the breastfed infant from fingolimod capsules or from the underlying maternal condition.

8.3Females and Males of Reproductive Potential Pregnancy Testing The pregnancy status of females of reproductive potential should be verified prior to starting treatment with fingolimod capsule [see Use in Specific Populations ( 8.1 )]. Contraception Before initiation of fingolimod capsules treatment, females of reproductive potential should be counseled on the potential for a serious risk to the fetus and the need for effective contraception during treatment with fingolimod capsules [see Warnings…

🧒 Pediatric Use ~1 min read ▾

8.4Pediatric Use Safety and effectiveness of fingolimod capsules for the treatment of relapsing forms of multiple sclerosis in pediatric patients 10 to less than 18 years of age were established in one randomized, double-blind clinical study in 215 patients (fingolimod capsules n = 107; intramuscular interferon (IFN) beta-1a n = 108) [see Clinical Studies ( 14.2 )] . In the controlled pediatric study, the safety profile in pediatric patients (10 to less than 18 years of age) receiving fingolimod capsules 0.25 mg or 0.5 mg daily was similar to that seen in adult patients.

In the pediatric study, cases of seizures were reported in 5.6% of fingolimod capsules -treated patients and 0.9% of interferon beta-1a-treated patients. It is recommended that pediatric patients, if possible, complete all immunizations in accordance with current immunization guidelines prior to initiating fingolimod capsules therapy. Safety and effectiveness of fingolimod capsules in pediatric patients below the age of 10 years have not been established.

Juvenile Animal Toxicity Data In a study in which fingolimod (0.3, 1.5, or 7.5 mg/kg/day) was orally administered to young rats from weaning through sexual maturity, changes in bone mineral density and persistent neurobehavioral impairment (altered auditory startle) were observed at all doses. Delayed sexual maturation was noted in females at the highest dose tested and in males at all doses. The bone changes observed in fingolimod-treated juvenile rats are consistent with a reported role of S1P in the regulation of bone mineral homeostasis.

When fingolimod (0.5 or 5 mg/kg/day) was orally administered to rats from the neonatal period through sexual maturity, a marked decrease in T-cell dependent antibody response was observed at both doses. This effect had not fully recovered by 6 to 8 weeks after the end of treatment. Overall, a no-effect dose for adverse developmental effects in juvenile animals was not identified.

🧓 Geriatric Use 62 words ▾

8.5Geriatric Use Clinical MS studies of fingolimod capsules did not include sufficient numbers of patients aged 65 years and over to determine whether they respond differently than younger patients. Fingolimod capsules should be used with caution in patients aged 65 years and over, reflecting the greater frequency of decreased hepatic, or renal, function and of concomitant disease or other drug therapy.

🆘 Overdosage 91 words ▾

10 OVERDOSAGE Fingolimod capsules can induce bradycardia as well as AV conduction blocks (including complete AV block). The decline in heart rate usually starts within 1 hour of the first dose and is maximal within 6 hours in most patients [see Warnings and Precautions ( 5.1 )]. In case of fingolimod capsules overdosage, observe patients overnight with continuous ECG monitoring in a medical facility, and obtain regular measurements of blood pressure [see Dosage and Administration ( 2.4 )].

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

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Fingolimod is metabolized by sphingosine kinase to the active metabolite, fingolimod-phosphate. Fingolimod-phosphate is a sphingosine 1-phosphate receptor modulator, and binds with high affinity to sphingosine 1-phosphate receptors 1, 3, 4, and 5. Fingolimod-phosphate blocks the capacity of lymphocytes to egress from lymph nodes, reducing the number of lymphocytes in peripheral blood.

The mechanism by which fingolimod exerts therapeutic effects in multiple sclerosis is unknown, but may involve reduction of lymphocyte migration into the central nervous system.

12.2Pharmacodynamics Heart Rate and Rhythm Fingolimod causes a transient reduction in heart rate and AV conduction at treatment initiation [see Warnings and Precautions ( 5.1 )] . Heart rate progressively increases after the first day, returning to baseline values within 1 month of the start of chronic treatment. Autonomic responses of the heart, including diurnal variation of heart rate and response to exercise, are not affected by fingolimod treatment.

Fingolimod treatment is not associated with a decrease in cardiac output. Potential to Prolong the QT Interval In a thorough QT interval study of doses of 1.25 or 2.5 mg fingolimod at steady-state, when a negative chronotropic effect of fingolimod was still present, fingolimod treatment resulted in a prolongation of QTc, with the upper boundary of the 90% confidence interval (CI) of 14.0 msec. There is no consistent signal of increased incidence of QTc outliers, either absolute or change from baseline, associated with fingolimod treatment.

In MS studies, there was no clinically relevant prolongation of the QT interval, but patients at risk for QT prolongation were not included in clinical studies. Immune System Effects on Immune Cell Numbers in the Blood In a study in which 12 adult subjects received fingolimod capsules 0.5 mg daily, the lymphocyte count decreased to approximately 60% of baseline within 4 to 6 hours after the first dose. With continued daily dosing, the lymphocyte count continued to decrease over a 2-week period, reaching a nadir count of approximately 500 cells/mcL or approximately 30% of baseline.

In a placebo-controlled study in 1,272 MS patients (of whom 425 received fingolimod 0.5 mg daily and 418 received placebo), 18% (N = 78) of patients on fingolimod 0.5 mg reached a nadir of < 200 cells/mcL on at least 1 occasion. No patient on placebo reached a nadir of < 200 cells/mcL. Low lymphocyte counts are maintained with chronic daily dosing of fingolimod capsules 0.5 mg daily.

Chronic fingolimod dosing leads to a mild decrease in the neutrophil count to approximately 80% of baseline. Monocytes are unaffected by fingolimod. Peripheral lymphocyte count increases are evident within days of stopping fingolimod treatment and typically normal counts are reached within 1 to 2 months.

Effect on Antibody Response Fingolimod capsules reduce the immune response to vaccination, as evaluated in 2 studies. In the first study, the immunogenicity of keyhole limpet hemocyanin (KLH) and pneumococcal polysaccharide vaccine (PPV-23) immunization were assessed by IgM and IgG titers in a steady-state, randomized, placebo-controlled study in healthy adult volunteers. Compared to placebo, antigen-specific IgM titers were decreased by 91% and 25% in response to KLH and PPV-23, respectively, in subjects on fingolimod capsules 0.5 mg.

Similarly, IgG titers were decreased by 45% and 50%, in response to KLH and PPV-23, respectively, in subjects on fingolimod capsules 0.5 mg daily compared to placebo. The responder rate for fingolimod capsules 0.5 mg as measured by the number of subjects with a > 4-fold increase in KLH IgG was comparable to placebo and 25% lower for PPV-23 IgG, while the number of subjects with a > 4-fold increase in KLH and PPV-23 IgM was 75% and 40% lower, respectively, compared to placebo. The capacity to mount a skin delayed-type hypersensitivity reaction to Can…

🧬 Mechanism of Action 80 words ▾

12.1Mechanism of Action Fingolimod is metabolized by sphingosine kinase to the active metabolite, fingolimod-phosphate. Fingolimod-phosphate is a sphingosine 1-phosphate receptor modulator, and binds with high affinity to sphingosine 1-phosphate receptors 1, 3, 4, and 5. Fingolimod-phosphate blocks the capacity of lymphocytes to egress from lymph nodes, reducing the number of lymphocytes in peripheral blood.

The mechanism by which fingolimod exerts therapeutic effects in multiple sclerosis is unknown, but may involve reduction of lymphocyte migration into the central nervous system.

📦 How Supplied / Storage and Handling 81 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied 0.5 mg fingolimod capsules are supplied as follows: hard white opaque capsules printed with "573" in black ink on the cap and "0.5 mg" in black ink on the body. Bottles of 30 (NDC 43547-003-03) Bottles of 90 (NDC 43547-003-09)

16.2Storage and Handling Fingolimod capsules should be stored at 20ºC to 25ºC (68ºF to 77ºF); excursions permitted to 15ºC to 30ºC (59ºF to 86ºF) [see USP Controlled Room Temperature]. Protect from moisture.

📋 Description 108 words ▾

11 DESCRIPTION Fingolimod is a sphingosine 1-phosphate receptor modulator. Chemically, fingolimod is 2-amino-2-[2-(4-octylphenyl)ethyl]propan-1,3-diol hydrochloride. Its structure is shown below: Fingolimod hydrochloride, USP 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 g/mol. Fingolimod capsules are provided as 0.5 mg hard gelatin capsules for oral use. Each 0.5 mg capsule contains 0.56 mg of fingolimod hydrochloride, equivalent to 0.5 mg of fingolimod.

Each 0.5 mg fingolimod capsule contains the following inactive ingredients: black iron oxide, gelatin, magnesium stearate, potassium hydroxide, propylene glycol, silicified microcrystalline cellulose, shellac and titanium dioxide. chemically structure

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Tell patients not to discontinue fingolimod capsules without first discussing this with the prescribing physician. Advise patients to contact their physician if they accidently take more fingolimod capsules than prescribed.

Cardiac Effects Advise patients that initiation of fingolimod capsules treatment results in a transient decrease in heart rate. Inform patients that they will need to be observed in the doctor's office or other facility for at least 6 hours after the first dose, after reinitiation if treatment is interrupted or discontinued for certain periods, and after the dosage is increased [see Dosage and Administration ( 2.4 ), Warnings and Precautions ( 5.1 )] . Risk of Infections Inform patients that they may have an increased risk of infections, some of which could be life-threatening, when taking fingolimod capsules, and that they should contact their physician if they develop symptoms of infection.

Advise patients that the use of some vaccines should be avoided during treatment with fingolimod capsules and for 2 months after discontinuation. Recommend to patients that they delay treatment with fingolimod capsules until after VZV vaccination if they have not had chickenpox or a previous VZV vaccination. Inform patients that prior or concomitant use of drugs that suppress the immune system may increase the risk of infection [see Warnings and Precautions ( 5.2 )] .

Progressive Multifocal Leukoencephalopathy Inform patients that cases of progressive multifocal leukoencephalopathy (PML) have occurred in patients who received fingolimod capsules. Inform the patient that PML is characterized by a progression of deficits and usually leads to death or severe disability over weeks or months. Instruct the patient of the importance of contacting their doctor if they develop any symptoms suggestive of PML.

Inform the patient that typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes [see Warnings and Precautions ( 5.3 )] . Macular Edema Advise patients that fingolimod capsules may cause macular edema, and that they should obtain an eye exam near the start of treatment with fingolimod capsules, have their eyes monitored periodically by an eye care professional while receiving therapy, and contact their healthcare provider if they experience any changes in their vision while taking fingolimod capsules.

Inform patients with diabetes mellitus or a history of uveitis that their risk of macular edema is increased [see Warnings and Precautions ( 5.4 )]. Hepatic Effects Inform patients that fingolimod capsules may cause liver injury. Advise patients that they should contact their physician if they have any unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, or jaundice and/or dark urine [see Warnings and Precautions ( 5.5 )].

Posterior Reversible Encephalopathy Syndrome Advise patients to immediately report to their healthcare provider any symptoms involving sudden onset of severe headache, altered mental status, visual disturbances, or seizure. Inform patients that delayed treatment could lead to permanent neurological sequelae [see Warnings and Precautions ( 5.6 )] . Respiratory Effects Advise patients that they should contact their physician if they experience new onset or worsening of dyspnea [see Warnings and Precautions ( 5.7 )] .

Fetal Risk • Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females to inform their healthcare provider of a known or suspected pregnancy [ see Warnings and Precautions (5.8) and Use in Specific Populations ( 8.1 , 8.3 )]. • Advise female patients of reproductive potential to use effective contraception…

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE Dispense with Medication Guide available at: www.solcohealthcare.com/medguide/fingolimod-capsules.pdf Fingolimod Capsules (fin gol’ i mod) for oral use Read this Medication Guide before you start taking fingolimod capsules and each time you get a refill. There may be new information. If you are the parent of a child who is being treated with fingolimod capsules, the following information applies to your child.

This information does not take the place of talking to your doctor about your medical condition or your treatment. What is the most important information I should know about fingolimod capsules? Fingolimod capsules may cause serious side effects, including: 1.

Slow heart rate (bradycardia or bradyarrhythmia) when you start taking fingolimod capsules. Fingolimod capsules can cause your heart rate to slow down, especially after you take your first dose. You will have a test, called an electrocardiogram (ECG), to check the electrical activity of your heart before you take your first dose of fingolimod capsules.

All adults and children will be observed by a healthcare professional for at least 6 hours after taking their first dose of fingolimod capsules. Children should also be observed by a healthcare professional for at least 6 hours after taking their first dose of 0.5 mg of fingolimod capsules when switching from the 0.25 mg dose. After you take your first dose of fingolimod capsules, and after a child takes their first dose of 0.5 mg of fingolimod capsules when switching from the 0.25 mg dose: • Your pulse and blood pressure should be checked every hour. • You should be observed by a healthcare professional to see if you have any serious side effects.

If your heart rate slows down too much, you may have symptoms, such as: o dizziness o tiredness o feeling like your heart is beating slowly or skipping beats o chest pain • If you have any of the symptoms of slow heart rate, they will usually happen during the first 6 hours after your first dose of fingolimod capsules. Symptoms can happen up to 24 hours after you take your first fingolimod capsules dose. • 6 hours after you take your first dose of fingolimod capsules you will have another ECG. If your ECG shows any heart problems or if your heart rate is still too low or continues to decrease, you will continue to be observed. • If you have any serious side effects after your first dose of fingolimod capsules, especially those that require treatment with other medicines, you will stay in the medical facility to be observed overnight.

You will also be observed for any serious side effects for at least 6 hours after you take your second dose of fingolimod capsules the next day. • If you have certain types of heart problems, or if you are taking certain types of medicines that can affect your heart, you will be observed overnight after you take your first dose of fingolimod capsules. Your slow heart rate will usually return to normal within 1 month after you start taking fingolimod capsules. Call your doctor or go to the nearest hospital emergency room right away if you have any symptoms of a slow heart rate.

If you miss 1 or more doses of fingolimod capsules, you may need to be observed by a healthcare professional when you take your next dose. Call your doctor if you miss a dose of fingolimod capsules. See “How should I take fingolimod capsules?” 2.

Pregnancy. Please consult your doctor before getting pregnant. You should avoid becoming pregnant while taking fingolimod capsules or in the two months after you stop taking it because of the risk of harm to the baby.

3. Infections. Fingolimod capsules can increase your risk of serious infections that can be life-threatening and cause death.

You should not receive live vaccines during treatment with fingolimod capsules and for 2 months after you stop taking fingolimod capsules. Talk to your doctor before you receive a vaccine during treatment and for 2 months after treatment with fingolimod capsules. If you rece…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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