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.

H.P. ACTHAR GEL (NDA-008372)

(CORTICOTROPIN)

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

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03/02/2021 (SUPPL-68)

Approved Drug Label (PDF)

4 Contraindications

Additions and/or revisions underlined:

Acthar Gel is contraindicated:

for intravenous administration.
in infants under 2 years of age who have suspected congenital infections.
with concomitant administration of live or live attenuated vaccines in patients receiving immunosuppressive doses of Acthar Gel.
in patients with scleroderma, osteoporosis, systemic fungal infections, ocular herpes simplex …

5 Warnings and Precautions

Additions and/or revisions underlined:

The adverse effects of Acthar Gel are related primarily to its steroidogenic effects. Not all of the adverse events described below have been seen after treatment with Acthar Gel, but they might be expected to occur because they are steroidogenic effects [see Adverse Reactions (6.3)].

5.7 Behavioral and Mood Disturbances

… Also, existing emotional instability or psychotic tendencies may be aggravated. These effects are reversible once Acthar Gel therapy is stopped.

5.10 Immunogenicity Potential

… Prolonged administration of Acthar Gel may increase the risk of hypersensitivity reactions. 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.

5.12 Negative Effects on Growth and Physical Development

Long-term use of Acthar Gel may have negative effects on growth and physical development in pediatric patients. Changes in appetite …

6 Adverse Reactions

Newly added bulleted line listing:

The following clinically significant adverse reactions are described elsewhere in the labeling:

Infections [see Warnings and Precautions (5.1)]
Cushing’s Syndrome and Adrenal Insufficiency Upon Withdrawal [see Warnings and Precautions (5.2)]
Elevated Blood Pressure, Salt and Water Retention, and Hypokalemia [see Warnings and Precautions (5.3)]
Masking Symptoms of Other Diseases [see Warnings and Precautions (5.5)]
Gastrointestinal Perforation and Bleeding [see Warnings and Precautions (5.6)]
Behavioral and Mood Disturbances [see Warnings and Precautions (5.7)]
Ophthalmic Effects [see Warnings and Precautions (5.9)]
Immunogenicity Potential [see Warnings and Precautions (5.10)]
Negative Effects on Growth and Physical Development [see Warnings and Precautions (5.12)]
Decrease in Bone Density [see Warnings and Precautions (5.13)]
Use in Pregnancy [see Warnings and Precautions (5.14)]

Additions and/or revisions underlined:

6.1 Clinical Trials Experience

Additions and/or revisions underlined:

Adverse Reactions in Infants and Children Under 2 Years of Age

… The number of patients in controlled trials at the recommended dose was too few to provide meaningful incidence rates or to permit a meaningful comparison to the control groups. The most common adverse reactions (5% or greater in the recommended twice daily dosing group) for the treatment of infantile spasms are increased risk of infections, convulsions, hypertension, irritability, and pyrexia. TABLE: Incidence (%) of Adverse Reactions Occurring in greater than or equal to 2% of Infants and Children Under 2 Years of Age Treated with Acthar Gel

6.2 Postmarketing Experience

Additions and/or revisions 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.

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.

6.3 Possible Additional Steroidogenic Effects

Additions and/or revisions underlined:

… Metabolic

Negative nitrogen balance due to protein catabolism and alteration in glucose tolerance.

8 Use in Specific Populations

8.4 Pediatric Use

Additions and/or revisions underlined:

Acthar Gel is indicated as monotherapy for the treatment of infantile spasms in infants and children less than 2 years of age. Both serious and other adverse reactions can occur in this population [see Warnings and Precautions (5) and Adverse Reactions (6.1)].

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

MEDICATION GUIDE

Newly added; please refer to label for complete information.

PATIENT COUNSELING INFORMATION

Extensive changes; please refer to label for complete information.

04/26/2018 (SUPPL-57)

Approved Drug Label (PDF)

6 Adverse Reactions

6.2: Postmarketing Experience

(Additions and/or revisions are underlined)

6.2.6 Injection site reactions.