Drug Safety-related Labeling Changes (SrLC)

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Drug Safety-related Labeling Changes (SrLC) Database

ANDA	Abbreviated New Drug Application
BLA	Biologics License Application
CDER	Center for Drug Evaluation and Research
MG	Medication Guide
NDA	New Drug Application
PCI	Patient Counseling Information
PI	Patient Information
PLR	Physician Labeling Rule
PLLR	Pregnancy and Lactation Labeling Rule
Italics	For the most part, italics indicate an FDA comment such as: Additions and/or revisions underlined These italics usually appear at the beginning of the section. In some cases, italics may be an inherent part of the label, and will most often appear in the body of the section.
Underlines	Any text that is underlined indicates text that has been added or revised. There are exceptions where underlining occurs in a section subtitle or heading. This is the case when there is just one word underlined in the body of the text.

Sections

BW	Box Warning
WP	Warnings and Precautions all in one section (PLR-format) Warnings as one section (pre-PLR format) Precautions as one section (pre-PLR format)
AR	Adverse Reactions (in pre-PLR format, this may be a subheading under precautions).
DI	Drug Interactions (in pre-PLR format, this may be a subheading under precautions).
USP	Use in Specific Populations (Inclusive on one or more of the following: Pregnancy; Lactation (PLLR- format); Nursing Mothers (pre-PLLR format); Females and Males of Reproductive Potential (PLLR format only); Pediatric Use, Geriatric Use, Renal Impairment, Hepatic Impairment, Sex, Race (these last six may be a subheading of precautions if label in pre-PLLR format.
PCI/PI/MG	Patient Counseling Information (PLR format only) - summarizes the information that a health care provider should convey to a patient (or caregiver when applicable) when a counseling discussion is taking place (e.g., a physician prescribing a drug during an office visit, a nurse providing discharge instructions at a hospital, or a pharmacist conveying information at a pharmacy). Patient Information - FDA approved patient labeling. Medication Guide - paper handouts that come with many prescription medicines. The guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events.

Only NDAs and CDER regulated BLAs are included in this database. ANDAs are not included.

Applications that remain active, even if the product has been discontinued, undergo safety-related labeling changes.

TASCENSO ODT (NDA-214962)

(FINGOLIMOD LAURYL SULFATE)

Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)

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01/28/2025 (SUPPL-3)

Approved Drug Label (PDF)

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

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Administration

Tell patients not to discontinue TASCENSO ODT without first discussing this with the prescribing healthcare provider. Advise patients to contact their healthcare provider if they accidently take more TASCENSO ODT than prescribed. Advise patients to use dry hands when opening the blister pack. Instruct patients to not push the ODT through the lidding foil, but to peel back the lidding foil and then push the underside [see Dosage and Administration (2.2)].

MEDICATION GUIDE

Extensive additions and/or revisions, please refer to label for complete information.

06/05/2024 (SUPPL-2)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.12 Malignancies

Additions and/or revisions underlined:

Cutaneous Malignancies

The risk of cutaneous malignancies (including basal cell carcinoma (BCC), squamous cell carcinoma (SCC), and melanoma) is increased in patients treated with S1P receptor modulators. Use of fingolimod, the active moiety in TASCENSO ODT, has been associated with an increased risk of BCC and melanoma.

In two-year placebo-controlled trials in adult patients, the incidence of BCC was 2% in patients on fingolimod 0.5 mg capsules and 1% in patients on placebo [see Adverse Reactions (6.1)]. Melanoma, basal cell carcinoma, squamous cell carcinoma, Kaposi’s sarcoma [see Warnings and Precautions (5.2)], and Merkel cell carcinoma have been reported with fingolimod in the postmarketing setting.

Skin examinations are recommended prior to or shortly after the start of treatment and periodically thereafter for all patients, particularly those with risk factors for skin cancer. Providers and patients are advised to monitor for suspicious skin lesions. If a suspicious skin lesion is observed, it should be promptly evaluated. As usual for patients with increased risk for skin cancer, exposure to sunlight and ultraviolet light should be limited by wearing protective clothing and using a sunscreen with a high protection factor.

Concomitant phototherapy with UV-B radiation or PUVA photochemotherapy is not recommended in patients taking TASCENSO ODT.

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5.3 Progressive Multifocal Leukoencephalopathy

Additions and/or revisions underlined:

… Longer treatment duration increases the risk of PML in fingolimod-treated patients; the majority of cases have occurred in patients treated with fingolimod for at least 18 months.

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5.4 Macular Edema

Additions and/or revisions underlined:

S1P receptor modulators, including TASCENSO ODT, have been associated with an increased risk of macular edema. Obtain a baseline evaluation of the fundus, including the macula, near the start of treatment with TASCENSO ODT. Perform an examination of the fundus, including the macula, 3 to 4 months after starting treatment, periodically while on therapy, and any time there is a change in vision.

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Continuation of TASCENSO ODT in patients who develop macular edema has not been evaluated. Macular edema over an extended period of time (i.e., 6 months) can lead to permanent visual loss. Consider discontinuing TASCENSO ODT if macular edema develops; this decision should include an assessment of the potential benefits and risks for the individual patient. The risk of recurrence after rechallenge has not been evaluated.

Macular Edema in Patients with History of Uveitis or Diabetes Mellitus

Patients with a history of uveitis and patients with diabetes mellitus are at increased risk of macular edema during TASCENSO ODT therapy. In the combined clinical trial experience in adult patients with all doses of fingolimod capsules, the rate of macular edema was higher in MS patients with a history of uveitis compared to those without a history of uveitis (approximately 20% versus 0.6%, respectively). Fingolimod, the active moiety in TASCENSO ODT, has not been tested in MS patients with diabetes mellitus.

6 Adverse Reactions

6.2 Postmarketing Experience

Additions and/or revisions underlined:

…

Neoplasms, benign, malignant, and unspecified (including cysts and polyps): melanoma, Merkel cell carcinoma, cutaneous T- cell lymphoma (including mycosis fungoides), Kaposi’s sarcoma, squamous cell carcinoma [see Warnings and Precautions (5.12)]

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17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

…

Macular Edema

Advise patients that TASCENSO ODT may cause macular edema, and that they should obtain an eye exam near the start of treatment with TASCENSO ODT, 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 TASCENSO ODT. Inform patients with diabetes mellitus or a history of uveitis that their risk of macular edema is increased [see Warnings and Precautions (5.4)].

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Malignancies

Advise patients that the risk of basal cell carcinoma and melanoma is increased with use of fingolimod, the active moiety in TASCENSO ODT, and that cases of squamous cell carcinoma, Merkel cell carcinoma, and Kaposi’s sarcoma have been reported. Advise patients that any suspicious skin lesions should be promptly evaluated. Advise patients to limit exposure to sunlight and ultraviolet light by wearing protective clothing and using a sunscreen with a high protection factor. Inform patients that lymphoma has also occurred in patients receiving fingolimod [see Warnings and Precautions (5.12)].

…

MEDICATION GUIDE

Additions and/or revisions underlined:

…

What is the most important information I should know about TASCENSO ODT?

TASCENSO ODT may cause serious side effects, including:

…

5.A problem with your vision called macular edema. Macular edema can cause some of the same vision symptoms as a multiple sclerosis (MS) attack (optic neuritis). You may not notice any symptoms with macular edema. If macular edema happens, it usually starts in the first 3 to 4 months after you start taking fingolimod, the active ingredient in TASCENSO ODT, but can happen at any time. Your doctor should test your vision around the time you start taking TASCENSO ODT, 3 to 4 months after you start taking TASCENSO ODT, periodically while you continue taking TASCENSO ODT, and any time you notice vision changes during treatment with TASCENSO ODT. Your risk of macular edema is higher if you have diabetes or have had an inflammation of your eye called uveitis.

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08/10/2023 (SUPPL-1)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.1 Bradyarrhythmia and Atrioventricular Blocks

Additions and/or revisions underlined:

…

Heart Rate

After the first dose of TASCENSO ODT, 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 beats per minute (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 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.

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Since initiation of TASCENSO ODT treatment results in decreased heart rate and may prolong the QT interval, patients with a prolonged QTc interval (> 450 msec adult and pediatric males, > 470 msec adult females, or > 460 msec pediatric females) before dosing or during 6-hour observation, or at additional risk for QT prolongation (e.g., hypokalemia, hypomagnesemia, congenital long- QT syndrome), or on concurrent therapy with 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

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5.3 Progressive Multifocal Leukoencephalopathy

Additions and/or revisions underlined:

…

If PML is confirmed, treatment with TASCENSO ODT should be discontinued.

Immune reconstitution inflammatory syndrome (IRIS) has been reported in patients treated with S1P receptor modulators, including fingolimod, who developed PML and subsequently discontinued treatment. IRIS presents as a clinical decline in the patient’s condition that may be rapid, can lead to serious neurological complications or death, and is often associated with characteristic changes on MRI. The time to onset of IRIS in patients with PML was generally within a few months after S1P receptor modulator discontinuation. Monitoring for development of IRIS and appropriate treatment of the associated inflammation should be undertaken.

5.4 Macular Edema

Additions and/or revisions underlined:

…

Macular Edema in Patients with History of Uveitis or Diabetes Mellitus

Patients with a history of uveitis and patients with diabetes mellitus are at increased risk of macular edema during TASCENSO ODT therapy. The incidence of macular edema is also increased in MS patients with a history of uveitis. In the combined clinical trial experience in adult patients with all doses of fingolimod capsules, the rate of macular edema was approximately 20% in MS patients with a history of uveitis versus 0.6% in those without a history of uveitis. Fingolimod, the active moiety in TASCENSO ODT, has not been tested in MS patients with diabetes mellitus. In addition to the examination of the fundus including the macula prior to treatment and at 3 to 4 months after starting treatment, MS patients with diabetes mellitus or a history of uveitis should have regular follow-up examinations.

5.9 Severe Increase in Disability After Stopping TASCENSO ODT

Additions and/or revisions underlined:

…

After stopping TASCENSO ODT in the setting of PML, monitor for development of immune reconstitution inflammatory syndrome (PML-IRIS) [see Warnings and Precautions (5.3)].

6 Adverse Reactions

6.1 Clinical Trials Experience

Additions and/or revisions underlined:

Pediatric Patients 10 Years of Age and Older

In the controlled pediatric trial (Study 4), the safety profile in pediatric patients receiving fingolimod 0.25 mg or 0.5 mg capsules daily was similar to that seen in adult patients.

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8 Use in Specific Populations

8.1 Pregnancy

Additions and/or revisions underlined:

Risk Summary

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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 ) basis.

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Data

Animal Data

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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 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 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 basis.

8.5 Geriatric Use

Additions and/or revisions underlined:

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. TASCENSO ODT 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.

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

MEDICATION GUIDE

Additions and/or revisions underlined:

…

What is the most important information I should know about TASCENSO ODT?

TASCENSO ODT may cause serious side effects, including:

…

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

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

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Human Papilloma Virus (HPV). Due to risk of HPV infection please consult your doctor for routine pap smear.

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What is TASCENSO ODT?

TASCENSO ODT is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults and children 10 years of age and older.

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