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.

PANDEL (NDA-020453)

(HYDROCORTISONE PROBUTATE)

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

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01/25/2017 (SUPPL-7)

Approved Drug Label (PDF)

4 Contraindications

(Additions and/or revisions are underlined)

None.

5 Warnings and Precautions

5.1 Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression and Other Unwanted Systemic Glucocorticoid Effects

(Additions and/or revisions are underlined; subsection title added)

PANDEL can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during or after withdrawal of treatment. Factors that predispose to HPA axis suppression include the use of high-potency corticosteroids, large treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure, and young age.

Use of topical corticosteroids may require periodic evaluation for HPA axis suppression. Evaluation for HPA axis suppression may be done by using the adrenocorticotropic hormone (ACTH) stimulation test.

If HPA axis suppression is documented, gradually withdraw the drug, reduce the frequency of application, or substitute with a less potent corticosteroid…

In a trial including 15 evaluable subjects 18 years of age or older with psoriasis or atopic dermatitis affecting more than 20% of body surface area, 1 subject (6.7%) had ACTH stimulation test results suggestive of adrenal suppression after treatment with PANDEL twice daily for 21 days. Recovery of HPA axis suppression for this subject is unknown.

Systemic effects of topical corticosteroids may also manifest as Cushing’s syndrome, hyperglycemia, and unmasking latent diabetes mellitus.

5.2 Allergic Contact Dermatitis

(Subsection title added)

6 Adverse Reactions

6.1 Clinical Trials Experience

(Additions and/or revisions are underlined; subsection title added)

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 clinical practice.

The most frequent adverse reactions reported for PANDEL during clinical trials were application site reactions, including burning in 4, stinging in 2, and moderate paresthesia in 1 out of 226 subjects.

6.2 Postmarketing Experience

(Additions and/or revisions are underlined; subsection title added)

The following adverse reactions have been identified during postapproval use of PANDEL because these reactions were 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.

These adverse reactions are as follows:

Skin and Subcutaneous Tissue Disorders: rash, papulovesicular rash

Application Site Reactions: dryness, erythema, pruritus, allergic contact dermatitis.

8 Use in Specific Populations

8.1 Pregnancy

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

Risk Summary

There is no clinical information on PANDEL use in pregnant women to inform any drug-associated risk for major birth defects and miscarriage. In animal reproduction studies, hydrocortisone probutate given by the subcutaneous route during the period of organogenesis was teratogenic at doses equal to or greater than 1 mg/kg/day in rats or 0.1 mg/kg/day in rabbits (12 times and 2 times the human topical dose, respectively).

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 background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Data

Animal Data

Effects on embryo-fetal development were evaluated in rats and rabbits following subcutaneous administration of hydrocortisone probutate during the period of organogenesis. Hydrocortisone probutate was teratogenic in rats when given during the period of organogenesis at subcutaneous doses…

In rabbits, hydrocortisone probutate given by the subcutaneous route was teratogenic at doses…Fetal weight and survival were affected. Delayed ossification and increased incidences of malformations (skeletal abnormalities and cleft palate) were also noted.

No adverse effects were seen in rats following subcutaneous administration of up to 1 mg/kg/day of hydrocortisone probutate during the perinatal and postnatal period (12 times the human average topical dose of PANDEL assuming 3% absorption and an application of 30 g/day on a 70 kg individual).

8.2 Lactation

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

Risk Summary

There is no information on the presence of hydrocortisone probutate in breast milk, or on its effects on the breastfed infant or on milk production… The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for PANDEL and any potential adverse effects on the breastfed infant from PANDEL or from the underlying maternal condition.

Clinical Considerations

To minimize potential exposure to the breastfed infant via breast milk, use PANDEL on the smallest area of skin and for the shortest duration possible while breastfeeding.

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

17 PATIENT COUNSELING INFORMATION

(Additions and/or revisions are underlined)

Advise the patient and/or caregiver to read the FDA-approved patient labeling (Patient Information).

Inform patients and/or caregivers of the following:

1. Discontinue therapy when control is achieved unless directed otherwise by the physician.

5. Report any signs or symptoms of local or systemic adverse reactions to the physician.

8. Advise a woman to use PANDEL on the smallest area of skin and for the shortest duration possible while breastfeeding.

PATIENT INFORMATION

(Newly added section)

Important: PANDEL is for use on skin only (topical). Avoid using PANDEL near or around your eyes.

What is PANDEL?

PANDEL is a prescription corticosteroid medicine used on the skin (topical) for the relief of inflammation and itching caused by certain skin conditions in people 18 years of age or older.

It is not known if PANDEL is safe and effective in children.

Before using PANDEL tell your healthcare provider about all of your medical conditions, including if you:

have adrenal gland problems
have liver problems
have diabetes
have thinning skin (atrophy) at the site to be treated.
are pregnant or plan to become pregnant. It is not known if PANDEL will harm your unborn baby.
are breastfeeding or plan to breastfeed. It is not known if PANDEL can pass into your breast milk and harm your baby.
- If you breastfeed during treatment with PANDEL, clean the treated area of skin on and near your breast, and your nipple before breastfeeding. This will help prevent contact of PANDEL with your baby’s skin.
- You should use PANDEL on the smallest area of skin and for the shortest time possible while breastfeeding.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I use PANDEL?

Use PANDEL exactly as your healthcare provider tells you to use it.
Apply a thin film to the affected skin area. Gently rub PANDEL into your skin until it disappears.
Tell your healthcare provider if your symptoms do not improve after 2 weeks of treatment.
Do not bandage, cover, or wrap the treated area unless your healthcare provider tells you to.
Do not apply PANDEL in the diaper area or use with plastic pants.
Do not use PANDEL on your face, underarms (armpits) or groin areas unless your healthcare provider tells you to.
Wash your hands after applying PANDEL, unless your hands are being treated.

What are possible side effects with PANDEL? PANDEL may cause serious side effects, including:

PANDEL can pass through your skin and may cause adrenal gland problems. This is more likely to happen if you use PANDEL for too long, use it over a large treatment area, use it with other topical medicines that contain corticosteroids, cover the treated area, or have liver failure. Your healthcare provider may do blood tests to check your adrenal gland function during and after treatment with PANDEL.
Skin problems, including skin reactions or thinning of your skin (atrophy), skin infections, and allergic reactions (allergic contact dermatitis) at the treatment site. Tell your healthcare provider if you get any skin reactions such as pain, tenderness, swelling, or healing problems.

The most common side effects of PANDEL include burning and stinging and moderate tingling or prickling feeling. These are not all the possible side effects with PANDEL. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store PANDEL?

Store PANDEL between 68°F to 77°F (20°C to 25°C).

Keep PANDEL and all medicines out of the reach of children.

General information about the safe and effective use of PANDEL.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use PANDEL for a condition for which it was not prescribed. Do not give PANDEL to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or healthcare provider for information about PANDEL that is written for health professionals.

What are the ingredients in PANDEL?

Active ingredient: hydrocortisone probutate

Inactive ingredients: propylene glycol, white petrolatum, light mineral oil, stearyl alcohol, polysorbate 60, sorbitan monostearate, glyceryl monostearate, PEG-20 stearate, glyceryl stearate SE, methylparaben, butylparaben, citric acid, sodium citrate anhydrous, and purified water.

Other

(Physician Labeling Rule (PLR) conversion; please refer to label)