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.

HYDREA (NDA-016295)

(HYDROXYUREA)

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

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11/28/2023 (SUPPL-58)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.10 Laboratory Test Interference

Additions and/or revisions underlined:

Interference with Uric Acid, Urea, or Lactic Acid Assays is possible, rendering falsely elevated results of these in patients treated with hydroxyurea [see Drug Interactions (7.2)].

Hydroxyurea may falsely elevate sensor glucose results from certain continuous glucose monitoring (CGM) systems and may lead to hypoglycemia if sensor glucose results are relied upon to dose insulin.

If a patient using a CGM is to be prescribed hydroxyurea, consult with the CGM prescriber about alternative glucose monitoring methods [see Drug Interactions (7.2)].

7 Drug Interactions

7.2 Laboratory Test Interference

Additions and/or revisions underlined:

Interference with Uric Acid, Urea, or Lactic Acid Assays

Studies have shown that there is an analytical interference of hydroxyurea with the enzymes (urease, uricase, and lactate dehydrogenase) used in the determination of urea, uric acid, and lactic acid, rendering falsely elevated results of these in patients treated with hydroxyurea.

Interference with Continuous Glucose Monitoring Systems

Hydroxyurea may falsely elevate sensor glucose results from certain continuous glucose monitoring (CGM) systems and may lead to hypoglycemia if sensor glucose results are relied upon to dose insulin.

If a patient using a CGM is to be prescribed hydroxyurea, consult with the CGM prescriber about alternative glucose monitoring methods.

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

MEDICATION GUIDE

Additions and/or revisions underlined:

…

Before taking DROXIA, tell your healthcare provider about all of your medical conditions, including if you:

are using a continuous glucose monitor (CGM) to test your blood glucose. Hydroxyurea may affect your sensor glucose results and may lead to low blood sugar (hypoglycemia). Talk to the healthcare provider that prescribed your CGM about whether it is safe to use while you are taking DROXIA.

…

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

…

Advise patients to notify their healthcare provider if they are using a continuous glucose monitoring system while taking DROXIA [see Warnings and Precautions (5.10)].

…

06/07/2023 (SUPPL-57)

Approved Drug Label (PDF)

Boxed Warning

Additions and/or revisions underlined:

WARNING: MYELOSUPPRESSION AND MALIGNANCIES Myelosuppression: DROXIA may cause severe myelosuppression. Do not give if bone marrow function is markedly depressed. Monitor blood counts at baseline and throughout treatment. Interrupt treatment and reduce dose as necessary [see Warnings and Precautions (5.1)].
Malignancies: DROXIA is carcinogenic. Advise sun protection and monitor patients for malignancies [see Warnings and Precautions (5.3)].

12/18/2017 (SUPPL-50)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.8 Laboratory Test Interference

(Newly added subsection)

Interference with Uric Acid, Urea, or Lactic Acid Assays is possible, rendering falsely elevated results of these in patients treated with hydroxyurea.

6 Adverse Reactions

6.1 Postmarketing Experience

(Additions and/or revisions are underlined)

Skin and subcutaneous tissue disorders: maculopapular rash, skin ulceration, dermatomyositis-like skin changes, peripheral and facial erythema, hyperpigmentation, nail hyperpigmentation...

Hypersensitivity: Drug-induced fever (pyrexia) (>39°C, >102°F) requiring hospitalization has been reported concurrently with gastrointestinal, pulmonary, musculoskeletal, hepatobiliary, dermatological or cardiovascular manifestations. Onset typically occurred within 6 weeks of initiation and resolved upon discontinuation of hydroxyurea. Upon re- administration fever re-occurred typically within 24 hours.

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

Medication Guide DROXIA (drock-SEE-yuh) (hydroxyurea) capsules

(Extensive changes; please refer to label)

03/23/2016 (SUPPL-48)

Approved Drug Label (PDF)

5 Warnings and Precautions

Embryo-Fetal Toxicity

Based on the mechanism of action and findings in animals, HYDREA/DROXIA can cause fetal harm when administered to a pregnant woman. Hydroxyurea was embryotoxic and teratogenic in rats and rabbits at doses 0.8 times and 0.3 times, respectively, the maximum recommended human daily dose on a mg/m2 basis. Advise pregnant women of the potential risk to a fetus
Advise females of reproductive potential to use effective contraception during and after treatment with HYDREA for at least 6 months after therapy. Advise males of reproductive potential to use effective contraception during and after treatment with HYDREA for at least 1 year after therapy.

Live Vaccinations

Avoid use of live vaccine in patients taking HYDREA. Concomitant use of Hydrea/Droxia with a live virus vaccine may potentiate the replication of the virus and/or may increase the adverse reaction of the vaccine because normal defense mechanisms may be suppressed by HYDREA/DROXIA. Vaccination with live vaccines in a patient receiving HYDREA/DROXIA may result in severe infection. Patient’s antibody response to vaccines may be decreased. Consider consultation with a specialist.

6 Adverse Reactions

Postmarketing Experience

Reproductive System and Breast disorders: azoospermia, and oligospermia

Metabolism and Nutrition disorders: anorexia, tumor lysis syndrome

Hepatobiliary disorders: cholestasis, and hepatitis

Adverse reactions observed with combined hydroxyurea and irradiation therapy are similar to those reported with the use of hydroxyurea or radiation treatment alone. These effects primarily include bone marrow depression (anemia and leukopenia), gastric irritation, and mucositis. Almost all patients receiving an adequate course of combined hydroxyurea and irradiation therapy will demonstrate concurrent leukopenia. Platelet depression (<100,000 cells/mm3) has occurred in the presence of marked leukopenia. HYDREA may potentiate some adverse reactions usually seen with irradiation alone, such as gastric distress and mucositis.