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Important Safety Information - bebtelovimab

The following provides essential safety information on the unapproved use of bebtelovimab under the Emergency Use Authorization.

WARNINGS AND PRECAUTIONS

There are limited clinical data available for bebtelovimab. Serious and unexpected adverse events may occur that have not been previously reported with bebtelovimab use.

Hypersensitivity Including Anaphylaxis and Infusion-Related Reactions

Serious hypersensitivity reactions, including anaphylaxis, have been observed with administration of other SARS-CoV-2 monoclonal antibodies and could occur with administration of bebtelovimab. If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration, and initiate appropriate medications and/or supportive care.

Infusion-related reactions, which may occur up to 24 hours after the injection, have been observed in clinical trials of bebtelovimab when administered with other monoclonal antibodies and may occur with use of bebtelovimab alone. These reactions may be severe or life-threatening. Signs and symptoms of infusion-related reactions may include:

fever, difficulty breathing, reduced oxygen saturation, chills, fatigue, arrhythmia (e.g. atrial fibrillation, sinus tachycardia, bradycardia), chest pain or discomfort, weakness, altered mental status, nausea, headache, bronchospasm, hypotension, hypertension, angioedema, throat irritation, rash including urticaria, pruritus, myalgia, vasovagal reactions (e.g. pre-syncope, syncope), dizziness, and diaphoresis

Administer appropriate medications and/or supportive care if an infusion-related reaction occurs.

Hypersensitivity reactions occurring more than 24 hours after the injection have also been reported with the use of SARS-CoV-2 monoclonal antibodies under Emergency Use Authorization.

Clinical Worsening After Monoclonal Antibody Administration

Clinical worsening of COVID-19 after administration of SARS-CoV-2 monoclonal antibody treatment has been reported and may include signs or symptoms of fever, hypoxia or increased respiratory difficulty, arrhythmia (e.g., atrial fibrillation, sinus tachycardia, bradycardia), fatigue, and altered mental status. Some of these events required hospitalization. It is not known if these events were related to SARS-CoV-2 monoclonal antibody use or were due to progression of COVID-19.

Limitations of Benefit and Potential Risk in Patients with Severe COVID-19

Treatment with bebtelovimab has not been studied in patients hospitalized due to COVID-19. Monoclonal antibodies, such as bebtelovimab, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high-flow oxygen or mechanical ventilation. See Limitations of Authorized Use.

Adverse Reactions

Adverse reactions observed in those who have received bebtelovimab, alone or in combination with bamlanivimab and etesevimab, at the authorized dose or higher, are infusion-related reactions (n=2, 0.3%), pruritus (n=2, 0.3%) and rash (n=5, 0.8%). The most common treatment-emergent adverse events observed in subjects treated with bebtelovimab, alone or in combination with bamlanivimab and etesevimab, at the authorized dose or higher, included nausea (0.8%) and vomiting (0.7%).

USE IN SPECIFIC POPULATIONS

Pregnancy

Severe hypersensitivity reactions and infusion-related reactions, have been observed with administration of bebtelovimab, including in pregnant patients. Pregnant patients who develop severe hypersensitivity and infusion-related reactions should be managed appropriately, including obstetrical care.

There are insufficient data to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Bebtelovimab should only be used during pregnancy if the potential benefit outweighs the potential risk for the mother and the fetus.

Breastfeeding

There are no available data on the presence of bebtelovimab in human or animal milk, the effects on the breastfed infant, or the effects on milk production. Breastfeeding individuals with COVID-19 should follow practices according to clinical guidelines to avoid exposing the infant to COVID-19.

Please see Fact Sheet for Healthcare Providers and Fact Sheet for Patients, Parents and Caregivers (English) or Fact Sheet for Patients, Parents and Caregivers (Spanish) Please also see the FDA Letter of Authorization on the authorized use of bebtelovimab.

BB HCP EUA ISI 14SEP2022

Important Safety Information - baricitinib

The following provides essential safety information on the unapproved use of baricitinib under the Emergency Use Authorization.

WARNINGS

There are limited clinical data available for baricitinib in pediatric patients 2 to less than 18 years of age hospitalized with COVID-19 requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO.

Serious Infections

There is limited information regarding use of baricitinib in patients with COVID-19 and concomitant active serious infections.

Serious infections, including viral reactivation, have occurred in patients with COVID-19 receiving baricitinib. Avoid the use of baricitinib with known active tuberculosis. Consider if the potential benefits outweigh the potential risks of baricitinib treatment in patients with active serious infections other than COVID-19 or chronic/recurrent infections.

Thrombosis

Serious venous thrombosis, including pulmonary embolism have been observed in COVID-19 patients treated with baricitinib and are known adverse drug reactions of baricitinib. If clinical features of deep vein thrombosis or pulmonary embolism occur, patients should be evaluated promptly and treated appropriately.

Abnormal Laboratory Values

There is limited information regarding use of baricitinib in patients with COVID-19 and any of the following clinical findings: absolute neutrophil count (ANC) <1000 cells/mm³, absolute lymphocyte count (ALC) <200 cells/mm³, and hemoglobin <8 g/dL.

Evaluate estimated glomerular filtration rate (eGFR), liver enzymes, and complete blood count at baseline and thereafter according to local patient management practice. Monitor closely when treating patients with abnormal baseline and post-baseline laboratory values. Follow dosage modifications as recommended in the Fact Sheet for Healthcare Providers for patients with abnormal renal, hematological and hepatic laboratory values. Manage patients according to routine clinical guidelines.

Vaccinations

Avoid use of live vaccines with baricitinib.

Hypersensitivity

If a serious hypersensitivity occurs, discontinue baricitinib while evaluating the potential causes of the reaction.

See Warnings and Precautions in the FDA-approved full Prescribing Information and Medication Guide for additional information on risks associated with baricitinib treatment.

SERIOUS SIDE EFFECTS

Serious venous thrombosis, including pulmonary embolism, and serious infections have been observed in COVID-19 patients treated with baricitinib and are known adverse drug reactions of baricitinib.

ADVERSE REACTIONS

During the first 29 days in COVID-19 clinical trials, adverse reactions that occurred in ≥1% of patients treated with baricitinib 4mg vs placebo, respectively, were alanine aminotransferase (ALT) ≥3 x upper limit of normal (ULN) (18.1% vs 16.0%), aspartate aminotransferase (AST) ≥3 x ULN (11.8% vs 9.4%), thrombocytosis >600,000 cells/mm³ (7.9% vs 4.6%), creatine phosphokinase (CPK) >5 x ULN (4.5% vs 4.7%), neutropenia <1000 cells/mm³ (2.2% vs 1.8%), deep vein thrombosis (1.5% vs 1.4%), pulmonary embolism (1.5% vs 0.8%), and urinary tract infection (1.5% vs 1.0%).

USE IN SPECIFIC POPULATIONS

Pregnancy

Baricitinib should be used during pregnancy only if the potential benefit justifies the potential risk for the mother and the fetus.

Renal Impairment

There are limited data for baricitinib in patients with severe renal impairment. Baricitinib is not recommended for patients who are on dialysis, have end-stage renal disease, or have acute kidney injury.

Hepatic Impairment

Baricitinib has not been studied in patients with severe hepatic impairment. Baricitinib should only be used in patients with severe hepatic impairment if the potential benefit outweighs the potential risk.

Please see Fact Sheet for Healthcare Providers and Fact Sheet for Patients, Parents and Caregivers (English) or Fact Sheet for Patients, Parents and Caregivers (Spanish). Please also see the FDA Letter of Authorization on the authorized use of baricitinib.

BC HCP EUA ISI 11MAY2022