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.

ALKINDI SPRINKLE (NDA-213876)

(HYDROCORTISONE)

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

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06/05/2024 (SUPPL-5)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.10 Vaccination

Newly added subsection:

Administration of live vaccines may be acceptable in ALKINDI SPRINKLE-treated pediatric patients with adrenocortical insufficiency who receive replacement corticosteroids.

5.2 Immunosuppression and Increased Risk of Infection with Use of a Dosage Greater Than Replacement

Additions and revisions underlined:

Subsection title revised

Use of the recommended dosage of ALKINDI SPRINKLE [see Dosage and Administration (2.1, 2.2)]

as a replacement therapy in pediatric patients with adrenocortical insufficiency is not expected to cause immunosuppression or increase the risk of infection. The use of a greater than replacement dosage can suppress the immune system and increase the risk of infection with any pathogen, including viral, bacterial, fungal, protozoan, or helminthic pathogens. The use of ALKINDI SPRINKLE at greater than replacement dosage can:

Reduce resistance to new infections
Exacerbate existing infections
Increase the risk of disseminated infections
Increase the risk of reactivation or exacerbation of latent infections
Mask some signs of infection

Infections associated with the use of corticosteroids at a greater than replacement dosage range from mild to severe or fatal, and the rate of infectious complications increases with increasing corticosteroid dosages.

Monitor for the development of infection and consider ALKINDI SPRINKLE dosage reduction as needed.

5.9 Risk of Kaposi’s Sarcoma with Use of a Dosage Greater Than Replacement

Newly added subsection:

Kaposi’s sarcoma has been reported to occur in patients receiving corticosteroid therapy, most often for chronic conditions at a dosage greater than replacement (supraphysiologic dosage). If patients take a supraphysiologic chronic dosage of ALKINDI SPRINKLE, they are at increased risk of developing Kaposi’s sarcoma.

6 Adverse Reactions

Additions and revisions underlined:

The following serious adverse reactions are described here and elsewhere in the label:

Adrenal Crisis [see Warnings and Precautions (5.1)]
Immunosuppression and Increased Risk of Infection with Use of a Dosage Greater Than Replacement [see Warnings and Precautions (5.2)]
Growth Retardation [see Warnings and Precautions (5.3)]
Cushing’s Syndrome Due to Use of Excessive Doses of Corticosteroids [see Warnings and Precautions (5.4)]
Decrease in Bone Mineral Density [see Warnings and Precautions (5.5)]
Psychiatric Adverse Reactions [see Warnings and Precautions (5.6)]
Ophthalmic Adverse Reactions [see Warnings and Precautions (5.7)]
Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.8)]
Risk of Kaposi’s Sarcoma with Use of Dosage Greater Than Replacement [see Warnings and Precautions (5.9)]

Vaccinations [see Warnings and Precautions (5.10)]

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

Medication Guide

Additions and revisions underlined:

What are the possible side effects of ALKINDI SPRINKLE? ALKINDI SPRINKLE may cause serious side effects, including:

See “What is the most important information I should know about ALKINDI SPRINKLE?”
Weakened immune system and increased risk of infections. Taking too much ALKINDI SPRINKLE can weaken your body’s immune system and increase your chance of getting infections. Tell your healthcare provider if your child develops any infections or has any of these symptoms:
. . .

Vaccinations. Administration of live vaccine may be acceptable while taking ALKINDI SPRINKLE.

PATIENT COUNSELING INFORMATION

Additions and revisions underlined:

Immunosuppression and Increased Risk of Infections

Advise patients and/or caregivers that greater than replacement dosage of corticosteroids can suppress the immune system and increase the risk of infections.

. . .

Vaccination

Inform patients and/or caregivers that administration of live vaccine may be acceptable [see Warnings and Precautions (5.10)].

12/23/2022 (SUPPL-2)

Approved Drug Label (PDF)

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

Medication Guide

Additions and revisions underlined:

How should I give ALKINDI SPRINKLE?

Call your healthcare provider if granules come back up into your child’s mouth (regurgitation) or your child has vomiting after swallowing ALKINDI SPRINKLE. Your child may not have received the full dose of ALKINDI SPRINKLE and another dose of ALKINDI SPRINKLE may be needed.

PATIENT COUNSELING INFORMATION

Additions and revisions underlined:

Advise patients and/or caregivers to contact their healthcare provider if the full dose was not administered due to regurgitation or vomiting of granules as a repeat dose may be required [see Dosage and Administration (2.3)].

02/03/2022 (SUPPL-1)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.1 Adrenal Crisis

Newly added information:

When switching patients to ALKINDI SPRINKLE from another oral hydrocortisone formulation, consider the potential for dosing inaccuracy if the other oral hydrocortisone formulation has been manipulated (e.g., split or crushed tablets, compounded formulations). Manipulation of oral hydrocortisone formulations may result in a relative difference in hydrocortisone exposure when using the same dosage to initiate ALKINDI SPRINKLE treatment. Closely monitor patients after switching to ALKINDI SPRINKLE to ensure ALKINDI SPRINKLE is providing the same level of hydrocortisone exposure as the previously used oral hydrocortisone formulation. If symptoms of adrenal insufficiency occur, increase the total daily dosage of ALKINDI SPRINKLE.

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 ALKINDI SPRINKLE? ALKINDI SPRINKLE may cause serious side effects, including:

Adrenal gland problems. Not giving enough ALKINDI SPRINKLE, stopping ALKINDI SPRINKLE, or switching to ALKINDI SPRINKLE after taking another hydrocortisone medicine (the same class of medicines as ALKINDI SPRINKLE) by mouth, can cause serious and life-threatening adrenal gland problems including death. Do not stop giving ALKINDI SPRINKLE without talking to your healthcare provider. Tell your healthcare provider if your child has any of these symptoms:

Problems with body salt (electrolyte) levels (replaces dehydration)

Your healthcare provider will change the dose of ALKINDI SPRINKLE depending on your child’s size. Tell your healthcare provider if your child cannot swallow medicines by mouth. During episodes of acute infections, surgery, major trauma or if your child cannot take medicines by mouth, your healthcare provider may recommend increased doses of ALKINDI SPRINKLE or use of corticosteroid medicines given directly into the bloodstream instead.

The amount of hydrocortisone in a dose of ALKINDI SPRINKLE may not be the same as in previous hydrocortisone medicines that your child takes by mouth if these oral hydrocortisone medicines have been manipulated (e.g., crushed, compounded). When switching to ALKINDI SPRINKLE, your healthcare provider may need to prescribe a starting dose of ALKINDI SPRINKLE that is different from previous hydrocortisone medicines that your child may have been taking by mouth. Watch your child closely after being switched to ALKINDI SPRINKLE and contact your healthcare provider if your child has any symptoms of adrenal gland problems. Your healthcare provider may need to change the dose of ALKINDI SPRINKLE.

PATIENT COUNSELING INFORMATION

Adrenal Crisis

Additions and/or revisions underlined:

Inform the patient or caregiver that undertreatment or sudden discontinuation of ALKINDI SPRINKLE, or switching to ALKINDI SPRINKLE from another oral hydrocortisone formulation, may lead to adrenocortical insufficiency, adrenal crisis, and death. Inform the caregiver that potential dosing inaccuracy of the manipulated oral hydrocortisone formulation (e.g., split or crushed tablets, compounded formulations) may result in dosing differences when switching to ALKINDI SPRINKLE which may require dose adjustments. Advise caregivers to watch the patient for symptoms of adrenocortical insufficiency during the days after the switching to ALKINDI SPRINKLE. Inform the patient or caregiver to contact their healthcare provider if they have symptoms of adrenocortical insufficiency, prolonged vomiting, are severely ill or are unable to take oral medications [see Warnings and Precautions (5.1)].