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.

CAMPTOSAR (NDA-020571)

(IRINOTECAN HYDROCHLORIDE)

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

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01/27/2022 (SUPPL-53)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.3 Increased Risk of Neutropenia in Patients With Reduced UGT1A1 Activity

Additions and/or revisions underlined:

Published studies have shown that individuals who are homozygous for either the UGT1A1*28 or *6 alleles (*28/*28, *6/*6) or who are compound or double heterozygous for the UGT1A1*28 and *6 alleles (*6/*28) are at increased risk for severe or life-threatening neutropenia during treatment with CAMPTOSAR. These individuals are UGT1A1 poor metabolizers and experience increased systemic exposure to SN-38, an active metabolite of irinotecan. Individuals who are heterozygous for either the UGT1A1*28 or *6 alleles (*1/*28, *1/*6) are intermediate metabolizers and may also have an increased risk of severe or life-threatening neutropenia [see Dosage and Administration (2) and Clinical Pharmacology (12.3, 12.5)].

Consider UGT1A1 genotype testing for the *28 and *6 alleles to determine UGT1A1 metabolizer status [see Clinical Pharmacology (12.5)].

When administering CAMPTOSAR consider a reduction in the CAMPTOSAR starting dose by at least one level for patients known to be homozygous or compound heterozygous for the UGT1A1*28 and/or *6 alleles (*28/*28, *6/*6, *6/*28).

Closely monitor patients with UGT1A1*28 or *6 alleles for neutropenia during and after treatment with CAMPTOSAR. The precise dosage reduction in this patient population is not known. Subsequent dosage modifications may be required based on individual patient tolerance to treatment [see Dosage and Administration (2.1, 2.2)].

01/30/2020 (SUPPL-51)

Approved Drug Label (PDF)

5 Warnings and Precautions

Embryo-Fetal Toxicity

(Newly added information)

Based on its mechanism of action and findings in animals, CAMPTOSAR can cause fetal harm when administered to a pregnant woman. In animal studies, intravenous administration of irinotecan during the period of organogenesis resulted in embryofetal mortality and teratogenicity in pregnant animals at exposures lower than the human exposure based on area under the curve (AUC) at the clinical dose of 125 mg/m2. Advise pregnant women of the potential risk to a fetus.

Advise female patients of reproductive potential to avoid becoming pregnant and to use highly effective contraception during treatment with CAMPTOSAR and for 6 months after the final dose. Advise male patients with female partners of reproductive potential to use condoms during treatment and for 3 months after the final dose of CAMPTOSAR [see Use in Specific Populations (8.1), (8.3) and Nonclinical Toxicology (13.1)].

8 Use in Specific Populations

Females and Males of Reproductive Potential

(PLLR conversion; please refer to label)

Lactation

(PLLR conversion; please refer to label)

Pregnancy

(PLLR conversion; please refer to label)

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

PATIENT COUNSELING INFORMATION

(Newly added information)

· Embryo-Fetal Toxicity [see Warnings and Precautions (5.9), Use in Specific Populations (8.1 and 8.3), Clinical Pharmacology (12.1) and Nonclinical Toxicology (13.1)]

o Advise pregnant women and females of reproductive potential of the potential risk to a fetus and to inform their healthcare provider of a known or suspected pregnancy.

o Advise females of reproductive potential to use effective contraception during treatment with CAMPTOSAR and for 6 months after the final dose.

o Advise male patients with female partners of reproductive potential to use condoms during treatment and for 3 months after the final dose of CAMPTOSAR.

· Lactation

o Advise women not to breastfeed during treatment with CAMPTOSAR and for at least 7 days after the final dose [see Use in Specific Populations (8.2)].

· Infertility

o Advise females and males of reproductive potential that CAMPTOSAR may impair fertility [see Use in Specific Populations (8.3)].

02/22/2019 (SUPPL-50)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.2 Myelosuppression

(Additions and/or revisions are underlined)

CAMPTOSAR can cause severe myelosuppression. Bacterial, viral, and fungal infections have occurred in patients treated with CAMPTOSAR.

…

6 Adverse Reactions

6.2 Postmarketing Experience

….

Infections: fungal and viral infections have been reported.