Drug Safety-related Labeling Changes (SrLC)

Get Email Alerts | Guide

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.

ALHEMO (BLA-761315)

(CONCIZUMAB-MTCI)

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

Download Data

Expand all

07/31/2025 (SUPPL-3)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.1 Thromboembolic Events

Additions and/or revisions underlined:

Alhemo may cause thromboembolic events. Venous and arterial thromboembolic events were reported in 1.9% of patients (6/320) in Alhemo clinical trials. These cases occurred in patients with multiple risk factors for thromboembolism, including the use of high doses or prolonged treatment with factor product or bypassing agent (2 of 6 patients).

. . .

5.2 Hypersensitivity Reactions

Additions and/or revisions underlined:

Alhemo can cause hypersensitivity reaction, including serious cases.

. . .

5.3 Increased Laboratory Values of Fibrin D-dimer and Prothrombin Fragment 1.2

Additions and/or revisions underlined:

Alhemo can cause increased levels of fibrin D-dimer and prothrombin fragment 1.2.

. . .

6 Adverse Reactions

6.1 Clinical Trials Experience

Extensive changes; please refer to label for complete information

7 Drug Interactions

7.1 Breakthrough Bleeding Treatment

Newly added subsection

Take appropriate precautions when treating breakthrough bleeding events in hemophilia patients receiving Alhemo prophylaxis and FVIII or FIX or a bypassing agent [see Dosage and Administration (2.1)]. For mild and moderate bleeds that require additional treatment with FVIII or FIX or bypassing agents (e.g., rFVIIa or aPCC), the lowest-approved dose in the approved product labeling is recommended.

. . .

8 Use in Specific Populations

8.4 Pediatric Use

Additions and/or revisions underlined:

The safety and effectiveness of Alhemo for hemophilia A and B with and without inhibitors have been established in pediatric patients aged 12 years and older. Use of Alhemo for this indication is supported by evidence from adequate and well-controlled studies in adult and pediatric patients aged 12 years and older [see Adverse Reactions (6.1) and Clinical Studies (14)].

The safety and effectiveness of Alhemo for hemophilia A and B with and without inhibitors have not been established in pediatric patients younger than 12 years of age

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

MEDICATION GUIDE

Additions and/or revisions underlined:

. . .

Your healthcare provider may prescribe factor VIII, factor IX or bypassing agents during treatment with Alhemo. Carefully follow your healthcare provider’s instructions regarding when to use on-demand factor VIII, factor IX or bypassing agents, and the recommended dose and schedule for breakthrough bleeds

. . .

What is Alhemo?

Alhemo is a prescription medicine used for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children 12 years of age and older with:

hemophilia A with or without factor VIII inhibitors
hemophilia B with or without factor IX inhibitors

. . .

If you miss a dose of Alhemo after your daily maintenance dose is established:

For 1 missed dose, continue your daily maintenance dose.
For 2 to 6 missed doses, give 2 doses as soon as you remember. Then continue your daily maintenance dose the next day.
For 7 or more missed doses, contact your healthcare provider right away as you will need to receive a new loading dose before continuing your daily maintenance dose.

. . .

Allergic reactions. Alhemo can cause allergic reactions, including reactions that can be serious. Stop using Alhemo and tell your healthcare provider right away if you have redness of the skin, rash, hives, itching, and stomach-area (abdominal) pain. Stop using Alhemo and get emergency medical help right away if you develop any signs or symptoms of a severe allergic reaction, including:

. . .

The most common side effects of Alhemo include:

bruising, redness, bleeding, itching, rash, or lump at the injection site
headache
hives

. . .

05/02/2025 (SUPPL-1)

Approved Drug Label (PDF)

8 Use in Specific Populations

8.6 Body Weight

Additions and/or revisions underlined:

The exposure of concizumab-mtci increased with increasing body weight [see Clinical Pharmacology (12.3)]. However, patients should receive the approved recommended Alhemo dosage titration and concizumab-mtci plasma concentration monitoring regardless of body weight [see Dosage and Administration (2.1)].