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.

SORILUX (NDA-022563)

(CALCIPOTRIENE)

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

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11/05/2019 (SUPPL-7)

6 Adverse Reactions

6.1 Clinical Trials Experience

Addition of the following information to the end of the subsection:

In an open-label study, 36 pediatric subjects age 4 to less than 12 years applied SORILUX Foam twice daily for up to 8 weeks. Adverse reactions included application site pain and contact dermatitis.

8 Use in Specific Populations

8.4 Pediatric Use

Additions and/or revisions underlined:

The safety and effectiveness of SORILUX Foam have been established in pediatric patients age 4 years and older for topical treatment of plaque psoriasis of the scalp and body.

Use of SORILUX Foam in this age group is supported by two adequate and well controlled 8- week trials in adults and adolescents 12 years of age and older, with additional data from a 15- day open-label safety and pharmacokinetics (PK) study conducted in 19 subjects 12 to less than 17 years of age; and an 8-week open-label safety and PK study in 36 subjects 4 to 11 years of age with psoriasis. Data from 19 subjects aged 12 to less than 17 years and 18 subjects aged 5 to 11 years showed no significant effects on indices of calcium metabolism. Systemic concentrations of calcipotriene were not quantifiable in the two studies in subjects aged 7 years to less than 17 years.

The safety and effectiveness of SORILUX Foam in pediatric patients less than 4 years of age have not been established.

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

PATIENT INFORMATION

Additions and/or revisions underlined:

What is SORILUX Foam?

SORILUX Foam is a prescription medicine used on the skin (topical) to treat plaque psoriasis of the scalp and body in people 4 years of age and older.

It is not known if SORILUX Foam is safe and effective in people under 4 years old.

11/05/2019 (SUPPL-8)

6 Adverse Reactions

Newly added subsection:

6.2 Postmarketing Experience

The following adverse reactions have been identified during post approval use of SORILUX Foam. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Skin and Subcutaneous: application site vesicles

05/06/2019 (SUPPL-6)

Approved Drug Label (PDF)

6 Adverse Reactions

6.1 Clinical Trials Experience

(Additions and/or revisions are underlined)

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

SORILUX Foam was studied in four vehicle-controlled trials. A total of 1094 adult subjects with plaque psoriasis, including 654 exposed to SORILUX Foam, were treated twice daily for 8 weeks. Adverse reactions reported in greater than or equal to 1% of subjects treated with SORILUX Foam and at a higher incidence than subjects treated with vehicle were application site erythema (2%) and application site pain (3%). The incidence of these adverse reactions was similar between the body and scalp.

In an open-label study, 19 pediatric subjects age 12 to less than 17 years applied SORILUX Foam twice daily for 14 days and once on Day 15. Adverse reactions included application site pain, application site pruritus and pruritus.

8 Use in Specific Populations

8.1 Pregnancy

(Pregnancy and Lactation Labeling Rule (PLLR) conversion; Additions and/or revisions are underlined)

Risk Summary

Although there are no available data on the drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes in pregnant women exposed to SORILUX Foam, systemic exposure to calcipotriene is likely to be low.

In animal reproduction studies, oral administration of calcipotriene to pregnant rats and rabbits during the period of organogenesis resulted in an increased incidence of minor skeletal abnormalities, including enlarged fontanelles and extra ribs in rats and an increased incidence of minor skeletal abnormalities, including incomplete ossification of pubic bones and forelimb phalanges in rabbits. The available data do not allow the calculation of relevant comparisons between the systemic exposure of calcipotriene observed in animal studies to the systemic exposure that would be expected in humans after topical use of SORILUX Foam.

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Data

Animal Data

Embryofetal development studies were conducted with calcipotriene after oral administration in rats and rabbits. Pregnant rats received daily oral administration of calcipotriene during the period of organogenesis. Fetuses from dams dosed with 54 mcg/kg/day (318 mcg/m2/day) exhibited a significantly increased incidence of minor skeletal abnormalities consisting primarily of enlarged fontanelles and extra ribs. The enlarged fontanelles are most likely due to calcipotriene’s effect upon calcium metabolism. There were no effects on the incidence of major malformations in fetuses.

Pregnant rabbits received daily oral administration of calcipotriene during the period of organogenesis. Increased rabbit maternal and fetal toxicity was noted at 12 mcg/kg/day (132 mcg/m^2/day). Fetuses from does dosed with 36 mcg/kg/day (396 mcg/m^2/day) exhibited a significantly increased incidence of minor skeletal abnormalities including incomplete ossification of pubic bones and forelimb phalanges. There were no effects on the incidence of major malformations in fetuses.

8.2 Lactation

(Pregnancy and Lactation Labeling Rule (PLLR) Conversion; Additions and/or revisions are underlined)

Risk Summary

There are no data on the presence of topically administered calcipotriene in human or animal milk, the effects on the breastfed infant, or the effects on milk production. After topical administration of SORILUX Foam, concentrations of calcipotriene in plasma are low, and therefore, concentrations in human milk are likely to be low. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for and any potential adverse effects on the breastfed child from SORILUX Foam or from the underlying maternal condition.

8.4 Pediatric Use

(Additions and/or revisions are underlined)

The safety and effectiveness of SORILUX Foam have been established in pediatric patients age 12 years and older for topical treatment of plaque psoriasis of the scalp and body. Use of SORILUX Foam in this age group is supported by two adequate and well controlled 8-week trials in adults and adolescents 12 years of age and older, with additional data from a 15-day open-label safety and pharmacokinetics study conducted in 19 subjects 12 to less than 17 years of age with psoriasis. Data from 17 subjects in the pharmacokinetic study showed no significant effects on indices of calcium metabolism and no quantifiable calcipotriene concentrations in subjects aged 12 to less than 17 years.

The safety and effectiveness of SORILUX Foam in pediatric patients less than 12 years of age have not been established.

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

PATIENT COUNSELING INFORMATION

(Additions and/or revisions are underlined)

Advise the patient to read the FDA-approved patient labeling (Patient Information). Inform the patient to adhere to the following instructions:

Apply SORILUX Foam to the affected skin areas.

Patient Information SORILUX (SOR-i-lux) (calcipotriene) Foam, 0.005%

(Extensive changes; please refer to labeling)