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Drug Safety-related Labeling Changes (SrLC)

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TYENNE (BLA-761275)

(TOCILIZUMAB-AAZG)

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

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12/13/2024 (SUPPL-13)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.2 Gastrointestinal Perforations

Additions and revisions underlined:

Events of gastrointestinal perforation have been reported in clinical trials, primarily as complications of diverticulitis in patients treated with tocilizumab. Use TYENNE with caution in patients who may be at increased risk for gastrointestinal perforation. Promptly evaluate patients presenting with fever, new onset abdominal symptoms, and a change in bowel habits for early identification of gastrointestinal perforation [see Adverse Reactions (6.1)].

8 Use in Specific Populations

8.1 Pregnancy

Additions and revisions underlined:

Risk Summary

The available data with tocilizumab products from a pregnancy exposure registry, retrospective cohort study, pharmacovigilance, and published literature are insufficient to draw conclusions about a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. These studies had methodological limitations, including small sample size of tocilizumab exposed groups, missing exposure and outcomes information, and lack of adjustment for cofounders.

. . .

Disease-associated Maternal Risk

Published data suggest that the risk of adverse pregnancy outcomes in women with rheumatoid arthritis is associated with increased disease activity. Adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth weight (less than 2500 g) infants, and small for gestational age at birth.

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

Medication Guide

Additions and revisions underlined:

Your healthcare provider should monitor you closely for signs and symptoms of TB during and after treatment with TYENNE.

. . .

  • Tell your healthcare provider right away if you have fever and new onset stomach-area pain that does not go away, and a change in your bowel habits.
PATIENT COUNSELING INFORMATION

Additions and revisions underlined:

. . .

  • Gastrointestinal Perforation

Inform patients that some patients who have been treated with TYENNE have had serious side effects in the stomach and intestines [see Warnings and Precautions (5.2)]. Instruct the patient of the importance of contacting their doctor immediately when symptoms of fever, severe, persistent abdominal pain, and change in bowel habits appear to assure rapid evaluation and appropriate treatment.

12/03/2024 (SUPPL-11)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.6 Hypersensitivity Reactions, Including Anaphylaxis

Additions and/or revisions underlined:

In the postmarketing setting, events of hypersensitivity reactions, including anaphylaxis and death have occurred in patients treated with a range of doses of intravenous tocilizumab products, with or without concomitant therapies. Events have occurred in patients who received premedication. Hypersensitivity, including anaphylaxis events, have occurred both with and without previous hypersensitivity reactions and as early as the first infusion of tocilizumab products. In addition, serious cutaneous reactions, including Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), have been reported in patients with autoinflammatory conditions treated with tocilizumab products.

TYENNE for intravenous use should only be infused by a healthcare professional with appropriate medical support to manage anaphylaxis. For TYENNE subcutaneous injection, advise patients to seek immediate medical attention if they experience any symptoms of a hypersensitivity reaction. If a hypersensitivity reaction occurs, immediately discontinue TYENNE; treat promptly and monitor until signs and symptoms resolve.

6 Adverse Reactions

6.9 Postmarketing Experience

Additions and/or revisions underlined:

Hypersensitivity Reactions: Fatal anaphylaxis, Stevens-Johnson Syndrome, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) [see Warnings and Precautions (5.6)]

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

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

  • Hypersensitivity and Serious Allergic Reactions

    Inform patients that some patients who have been treated with TYENNE have developed serious allergic reactions, including anaphylaxis and serious skin reactions [see Warnings and Precautions (5.6)]. Advise patients to stop taking TYENNE and seek immediate medical attention if they experience any symptom of serious allergic reactions (including rash, hives, and swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing).

    MEDICATION GUIDE

    Additions and/or revisions underlined:

    What are the possible side effects with TYENNE?

    TYENNE can cause serious side effects, including:

  • Serious Allergic Reactions. Serious allergic reactions, including death, can happen with TYENNE. These reactions can happen with any infusion or injection of TYENNE, even if they did not occur with an earlier infusion or injection. Stop taking TYENNE, contact your healthcare provider, and get emergency help right away if you have any of the following signs of a serious allergic reaction:

     

    • trouble breathing

    • swelling of your mouth, lips, tongue, or face

    • wheezing

    • severe itching

    • skin rash, hives, redness, or swelling outside of the injection site area

    • dizziness or fainting

    • fast heartbeat or pounding in your chest (tachycardia)

    • sweating

      Tell your healthcare provider about any side effect that bothers you or does not go away. These are not all the possible side effects of TYENNE. For more information, ask your healthcare provider or pharmacist.