Transcription of HIGHLIGHTS OF PRESCRIBING INFORMATION …
{{id}} {{{paragraph}}}
Example: biology
HIGHLIGHTS OF PRESCRIBING INFORMATION …
HIGHLIGHTS OF PRESCRIBING INFORMATION DOSAGE FORMS AND STRENGTHS . These HIGHLIGHTS do not include all the INFORMATION needed to use LIBTAYO safely Injection: 350 mg/7 mL (50 mg/mL) solution in a single-dose vial. (3). and effectively. See full PRESCRIBING INFORMATION for LIBTAYO. LIBTAYO (cemiplimab-rwlc) injection, for intravenous use CONTRAINDICATIONS . Initial Approval: 2018 None. (4). RECENT MAJOR CHANGES . WARNINGS AND PRECAUTIONS . Immune-Mediated Adverse Reactions ( ). Indications and Usage ( , ) 02/2021. Dosage and Administration ( ) 02/2021 Immune-mediated adverse reactions, which may be severe or fatal, Dosage and Administration ( ) 11/2020 can occur in any organ system or tissue, including the following: immune-mediated pneumonitis, immune-mediated colitis, immune-mediated Warnings and Precautions ( , ) 11/2020 hepatitis, immune-mediated endocrinopathies, immune-mediated Warnings and Precautions ( ) 02/2021 dermatologic adverse reactions, immune-mediated nephritis and renal dysfunction, and solid organ transplant rejection.
• Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT): Fatal and other serious complications can occur in patients who receive allogeneic HSCT before or after being treated with a PD-1/PD-L1 blocking antibody. (5.3) • Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive
Tags:
Information
Domain:
Source:
Link to this page:
Please notify us if you found a problem with this document: