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.

ROLVEDON (BLA-761148)

(EFLAPEGRASTIM-XNST)

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

Download Data

06/16/2023 (SUPPL-2)

Approved Drug Label (PDF)

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

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Inform patients to contact their healthcare provider with any questions.

…

Instruct patients who self-administer Rolvedon using the single-dose prefilled syringe of the:

Importance of following the Instructions for Use
Dangers of reusing syringes
Importance of following local requirements for proper disposal of used syringes.

PATIENT INFORMATION

Additions and/or revisions underlined:

How will I receive Rolvedon?

Rolvedon is given as an injection under your skin (subcutaneous injection) by a healthcare provider. If your healthcare provider decides that the subcutaneous injections can be given at home by you or your caregiver, follow the detailed “Instructions for Use” that comes with your Rolvedon for information on how to prepare and inject a dose of Rolvedon.
You and your caregiver will be shown how to prepare and inject Rolvedon before you use it.
…
What are the possible side effects of Rolvedon?
…

Serious allergic reactions. Rolvedon can cause serious allergic reactions. These reactions can cause a rash all over your whole body, shortness of breath, wheezing, dizziness, swelling around your mouth or eyes, fast heart rate, and sweating. If you have any of these symptoms, stop using Rolvedon and call your healthcare provider or get emergency medical help right away.
…

Decreased platelet count (thrombocytopenia). Your healthcare provider will check your blood during treatment with Rolvedon. Tell your healthcare provider if you have unusual bleeding or bruising during treatment with Rolvedon. This could be a sign of decreased platelet counts, which may reduce the ability of your blood to clot.

…

How should I store Rolvedon?

Store Rolvedon in the refrigerator between 36°F to 46°F (2°C to 8°C).
Do not freeze Rolvedon. Throw away (dispose of) any Rolvedon that has been frozen.
Store Rolvedon in the original carton to protect from light.
Do not shake Rolvedon.
Take the carton out of the refrigerator and place the sealed blister tray on a clean flat surface for at least 30 minutes to allow it to reach room temperature before use.
Throw away (dispose of) any Rolvedon that has been left at room tempterature, 68ºF to 77ºF (20ºC to 25ºC), for more than 12 hours.

Keep Rolvedon and all medicines out of the reach of children.

General information about the safe and effective use of Rolvedon.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Rolvedon for a condition for which it was not prescribed. Do not give Rolvedon to other people, even if they have the same symptom that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about Rolvedon that is written for health professionals.