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.

ACTHAR GEL (NDA-008372)

(CORTICOTROPIN)

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

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02/29/2024 (SUPPL-74)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.3 Elevated Blood Pressure, Salt and Water Retention, and Hypokalemia

Additions and/or revisions underlined:

Acthar Gel can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium and calcium. Dietary salt restriction and potassium supplementation may be necessary. Caution should be used in the treatment of patients with hypertension or renal insufficiency. Acthar Gel is contraindicated in patients with congestive heart failure [see Contraindications (4)].

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

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

Advise caretakers of patients with infantile spasms to read the FDA-approved patient labeling (Medication Guide

[for infantile spasms]).

Advise caretakers or patients 18 years of age or older to read the FDA-approved Instructions for Use when administering Acthar Gel single-dose pre-filled SelfJect injector.

…

10/29/2021 (SUPPL-71)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.10 Immunogenicity Potential

Additions and/or revisions underlined:

Acthar Gel is immunogenic. Limited available data suggest that a patient may develop antibodies to Acthar Gel after chronic administration and loss of endogenous ACTH and Acthar Gel activity. Prolonged administration of Acthar Gel may increase the risk of hypersensitivity reactions. Cases of anaphylaxis have been reported in the postmarketing setting. Use in patients with sensitivity to porcine protein is contraindicated, and the possibility of sensitivity should be considered during the course of treatment should symptoms arise.

6 Adverse Reactions

6.2 Postmarketing Experience

Additions and/or revisions double underlined:

The following adverse reactions have been identified during post approval use of Acthar Gel.

Because adverse 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.

Allergic Reactions

Allergic responses have presented as dizziness, nausea, and anaphylaxis (anaphylactic shock, hypotension, respiratory compromise, urticaria, edema).

Cardiovascular

Necrotizing angitis (adults only), congestive heart failure, atrial fibrillation, and palpitations.

Dermatologic

Skin thinning (adults only), facial erythema, and increased sweating (adults only).

Endocrine

Decreased carbohydrate tolerance (infants only), hirsutism, and menstrual irregularities.

Gastrointestinal

Pancreatitis (adults only), abdominal distention, and ulcerative esophagitis.

General Disorders and Administration Site Conditions

Injection site reaction and asthenic conditions (including fatigue, malaise, asthenia, and lethargy).

Infections and Infestations

Abscess.

Investigations

Blood glucose increased.

Metabolic

Hypokalemic alkalosis (infants only) and fluid retention (including peripheral swelling).

Musculoskeletal

Muscle weakness and vertebral compression fractures (infants only).

Neurological

Headache (adults only), vertigo (adults only), subdural hematoma, intracranial hemorrhage (adults only), and reversible brain shrinkage (usually secondary to hypertension) (infants only).

Psychiatric Disorders

Insomnia.

8 Use in Specific Populations

8.1 Pregnancy

PLLR conversion:

Risk Summary

Based on Acthar Gel’s pharmacological effect of stimulating an endogenous steroid response [see Clinical Pharmacology (12.1)], Acthar Gel may cause fetal harm when administered to a pregnant woman. The published literature on systemic corticosteroid use during pregnancy, which may be relevant, suggests potential concerns. Intrauterine growth restriction, decreased birth weight, and preterm birth have been reported with maternal use of corticosteroids; however, the underlying maternal condition may also contribute to these risks. Hypoadrenalism has also been reported in infants after high-dose and/or long-term use of corticosteroids during pregnancy (see Clinical Considerations). The potential adverse developmental effects of Acthar Gel have not been adequately assessed in animals.

The estimated background risk of major birth defects and miscarriage for the indicated population(s) is unknown. All pregnancies have a background risk of birth defects, 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.

Clinical Considerations

Fetal-Neonatal Adverse Reactions

Hypoadrenalism has been reported in infants born to mothers treated with systemic corticosteroids during pregnancy. Infants born to mothers treated with Acthar Gel should be carefully observed for signs of hypoadrenalism, such as poor feeding, irritability, weakness, and vomiting, and managed accordingly [see Warnings and Precautions (5.2)].

8.2 Lactation

PLLR conversion:

Risk Summary

There are no available data on the presence of corticotropin in either human or animal milk, the 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 Acthar Gel and any potential adverse effects on the breastfed infant from Acthar Gel or from the underlying maternal condition.

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

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

…

Advise pregnant women of the potential risk to a fetus [see Use in Specific Populations (8.1)]