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.

RIVFLOZA (NDA-215842)

(NEDOSIRAN SODIUM)

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

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03/27/2025 (SUPPL-2)

Approved Drug Label (PDF)

6 Adverse Reactions

6.1 Clinical Trials Experience

Additions and/or revisions underlined:

. . .

The safety of RIVFLOZA has additionally been evaluated in one single-arm clinical study (PHYOX8) in 15 pediatric patients 2 to less than 12 years of age with PH1 and an eGFR greater than or equal to 30 mL/min/1.73 m2. Injection site reactions were reported in 2 patients (13%). Overall, the RIVFLOZA safety profile was similar to that seen in PHYOX2.

. . .

8 Use in Specific Populations

8.4 Pediatric Use

Additions and/or revisions underlined:

The safety and effectiveness of RIVFLOZA have been established in pediatric patients aged 2 years and older. Use of RIVFLOZA in these age groups is supported by evidence from an adequate and well-controlled trial in adult and pediatric patients 9 years of age and older (PHYOX2), and a single-arm study in pediatric patients 2 to less than 12 years of age (PHYOX8) [see Clinical Studies (14)].

The safety and effectiveness of RIVFLOZA in patients younger than 2 years of age have not been established.

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

PATIENT INFORMATION

Additions and/or revisions underlined:

. . .

How should I use RIVFLOZA?

Read the detailed Instructions for Use that comes with RIVFLOZA about the right way to prepare and inject RIVFLOZA.
Use RIVFLOZA exactly as your healthcare provider tells you to.
Inject RIVFLOZA under your skin (subcutaneous injection).
Use RIVFLOZA 1 time each month.
Your healthcare provider will prescribe the dose of RIVFLOZA that is right for you or your child based on your or your child’s body weight.
RIVFLOZA comes as a single-dose Pre-filled Syringe and as a single-dose vial.
Your healthcare provider will show you or your caregiver how to prepare and inject RIVFLOZA. Do not try to inject RIVFLOZA until you or your caregiver have been shown the right way by your healthcare provider.
In children 2 years of age to less than 12 years of age weighing 86 pounds (39 kilograms) or more, it is recommended that RIVFLOZA Pre-filled Syringe be given by a healthcare provider or caregiver.
If you miss a dose of RIVFLOZA, inject the dose as soon as possible. If you miss a dose of RIVFLOZA by more than 7 days, inject the dose as soon as possible and resume monthly dosing from the most recently injected dose. If you have any questions about a missed dose, call your healthcare provider or pharmacist.

. . .