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.

CABLIVI (BLA-761112)

(CAPLACIZUMAB-YHDP)

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

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12/23/2025 (SUPPL-18)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.1 Hemorrhage

Additions and/or revisions underlined:

. . .

Avoid concomitant use of CABLIVI with antiplatelet agents, thrombolytic drugs, heparin, or anticoagulants. Interrupt use of CABLIVI if clinically significant bleeding occurs. If needed, von Willebrand factor concentrate may be administered to rapidly correct hemostasis. If CABLIVI is restarted, monitor closely for signs of bleeding.

. . .

6 Adverse Reactions

6.1 Clinical Trials Experience

Additions and/or revisions underlined:

. . .

TITAN and HERCULES

The safety of CABLIVI was evaluated in two placebo-controlled clinical studies (HERCULES, in which 71 patients received CABLIVI; and TITAN, in which 35 patients received CABLIVI). The data described below and in the Warnings and Precautions reflect exposure to CABLIVI during the blinded periods of both studies, which include 106 patients with aTTP who received at least one dose, age 18 to 79 years, of whom 69% were female and 73% were White. The median treatment duration with CABLIVI was 35 days (range 1-77 days).

. . .

Pediatric Patients

The safety of CABLIVI in patients aged less than or equal to 18 years with aTTP was evaluated in an observational, retrospective chart review (OBS17325) [see Clinical Studies (14)]. The most commonly reported events were epistaxis in 4 (13.3%) patients and tachycardia in 4 (13.3%) patients. One serious bleeding adverse reaction (hemorrhage urinary tract) was reported. The adverse reaction profile in pediatric patients 12 years and older with aTTP was consistent with that in adults.

7 Drug Interactions

Concomitant Use of Anticoagulants, Thrombolytic Drugs, Heparin or Antiplatelet Agents

Subsection title revised

Additions and/or revisions underlined:

Concomitant use of CABLIVI with any anticoagulant, thrombolytic drugs, heparin or antiplatelet agent may increase the risk of bleeding. Avoid concomitant use when possible. Assess and monitor closely for bleeding with concomitant use [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.3)].

8 Use in Specific Populations

8.4 Pediatric Use

Additions and/or revisions underlined:

The safety and effectiveness of CABLIVI in pediatric patients 12 years of age and older with acquired thrombotic thrombocytopenic purpura (aTTP), in combination with plasma exchange and immunosuppressive therapy have been established. Use of CABLIVI for this indication is supported by evidence from an observational, retrospective chart review and pharmacokinetic/pharmacodynamic modeling and simulation data [see Adverse Reactions (6), Clinical Pharmacology (12.3) and Clinical Studies (14)].

The safety and effectiveness of CABLIVI in pediatric patients less than 12 years of age have not been established.

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 (Instructions for Use).

Bleeding [see Warnings and Precautions (5.1)]

Advise patients and/or caregivers that bruising and bleeding may occur more easily, that nose bleeds and bleeding of gums may occur, and that it may take them longer than usual to stop bleeding.
Advise patients and/or caregivers to contact their healthcare provider immediately if symptoms of excessive bruising, excessive bleeding, or major bleeding occur. Signs and symptoms of bleeding include pain, swelling or discomfort, prolonged bleeding from cuts, increased menstrual flow or vaginal bleeding, nosebleeds, bleeding of gums from brushing, unusual bleeding or bruising, red or dark brown urine, red or tar black stools, headache, dizziness, or weakness [see Warnings and Precautions (5.1)].
Advise patients and/or caregivers to inform their healthcare provider before scheduling any elective surgery, dental procedure or other invasive interventions.

04/11/2024 (SUPPL-11)

Approved Drug Label (PDF)

6 Adverse Reactions

6.3 Postmarketing Experience

Additions and/or revisions underlined:

The following adverse reactions have been identified during postapproval use of CABLIVI. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to caplacizumab-yhdp exposure.

General disorders and administration site conditions:
Injection site reactions including injection site pain, injection site bruising and injection site erythema

02/23/2022 (SUPPL-9)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.1 Hemorrhage

Additions underlined

…

In the postmarketing setting, cases of life-threatening and fatal bleeding were reported in patients receiving CABLIVI.

…

Avoid concomitant use of CABLIVI with antiplatelet agents or anticoagulants. Interrupt use of CABLIVI if clinically significant bleeding occurs. If needed, von Willebrand factor concentrate may be administered to rapidly correct hemostasis. If CABLIVI is restarted, monitor closely for signs of bleeding.

…

7 Drug Interactions

Additions underlined

Concomitant Use of Anticoagulants or Antiplatelet Agents

Concomitant use of CABLIVI with any anticoagulant or antiplatelet agent may increase the risk of bleeding. Avoid concomitant use when possible. Assess and monitor closely for bleeding with concomitant use [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.3)].

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

PATIENT COUNSELING INFORMATION

Additions underlined

…

Advise patients to contact their healthcare provider immediately if symptoms of excessive bruising, excessive bleeding, or major bleeding occur. Signs and symptoms of bleeding include pain, swelling or discomfort, prolonged bleeding from cuts, increased menstrual flow or vaginal bleeding, nosebleeds, bleeding of gums from brushing, unusual bleeding or bruising, red or dark brown urine, red or tar black stools, headache, dizziness, or weakness [see Warnings and Precautions (5.1)].
…

12/16/2020 (SUPPL-7)

Approved Drug Label (PDF)

6 Adverse Reactions

6.3 Postmarketing Experience

(Newly added subsection)

The following adverse reactions have been identified during postapproval use of CABLIVI. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to caplacizumab-yhdp exposure.

General disorders and administration site conditions:

injection site erythema