Management strategies for immune-mediated pneumonitis ¹

Immune-mediated pneumonitis, defined as requiring use of corticosteroids with no clear alternate etiology, including fatal cases, has been observed in patients receiving LIBTAYO.

Evaluate patients with suspected pneumonitis with radiographic imaging and manage as recommended below:

Management strategies for immune-mediated colitis¹

Immune-mediated diarrhea or colitis, defined as requiring use of corticosteroids with no clear alternate etiology, has been observed in patients receiving LIBTAYO.

Monitor patients for signs and symptoms of diarrhea or colitis and manage as recommended below:

Management strategies for immune-mediated hepatitis ¹

Immune-mediated hepatitis, defined as requiring use of corticosteroids with no clear alternate etiology, including fatal cases, has been observed in patients receiving LIBTAYO.

Monitor patients for abnormal liver tests prior to and periodically during treatment, and manage as recommended below:

Management strategies for immune-mediated hypothyroidism¹

Immune-mediated thyroid disorders have been observed in patients receiving LIBTAYO. Thyroid disorders can occur at any time during the treatment.

Monitor patients for changes in thyroid function at the start of the treatment, periodically during treatment, and as indicated based on clinical evaluation. Manage patients as recommended below:

Management strategies for immune-mediated hyperthyroidism¹

Immune-mediated thyroid disorders have been observed in patients receiving LIBTAYO. Thyroid disorders can occur at any time during the treatment.

Monitor patients for changes in thyroid function at the start of the treatment, periodically during treatment, and as indicated based on clinical evaluation. Manage patients as recommended below:

Management strategies for immune-mediated hypophysitis¹

Immune-mediated hypophysitis has been observed in patients receiving LIBTAYO.

Monitor patients for signs and symptoms of hypophysitis and manage as recommended below:

Management strategies for immune-mediated adrenal insufficiency¹

Immune-mediated hypophysitis has been observed in patients receiving LIBTAYO.

Monitor patients for signs and symptoms of adrenal insufficiency during and after treatment and manage as recommended below:

Management strategies for immune-mediated type 1 diabetes mellitus¹

Immune-mediated type 1 diabetes mellitus, including diabetic ketoacidosis, has been observed in patients receiving LIBTAYO.

Monitor patients for hyperglycemia and signs and symptoms of diabetes and manage as recommended below:

Management strategies for immune-mediated skin adverse reactions¹

Immune-mediated skin adverse reactions, defined as requiring use of corticosteroids with no clear alternate etiology, including rash, erythema multiforme, pemphigoid, and Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN) (some cases with fatal outcome) have been observed in patients receiving LIBTAYO.

Cases of Stevens-Johnson syndrome (SJS), fatal toxic epidermal necrolysis (TEN), and stomatitis occurred following 1 dose of LIBTAYO in patients with prior exposure to idelalisib who were participating in a clinical trial evaluating LIBTAYO in non–Hodgkin’s lymphoma (NHL) and who had recent exposure to sulfa-containing antibiotics.

Monitor patients for signs and symptoms of suspected severe skin reactions and exclude other causes. Manage patients as recommended below:

For recurrent Grade 2, permanently discontinue LIBTAYO. Additional intervention recommended to initiate symptomatic management immediately, including initial dose of 1 to 2 mg/kg/day prednisone or equivalent followed by a taper

For symptoms or signs of SJS or TEN, withhold LIBTAYO and refer the patient for specialized care for assessment and treatment. If SJS or TEN is confirmed, permanently discontinue LIBTAYO.

Skin adverse reactions

Management strategies for skin adverse reactions¹

Cases of Stevens-Johnson syndrome (SJS), fatal toxic epidermal necrolysis (TEN), and stomatitis occurred following 1 dose of LIBTAYO in patients with prior exposure to idelalisib who were participating in a clinical trial evaluating LIBTAYO in non–Hodgkin’s lymphoma (NHL) and who had recent exposure to sulfa-containing antibiotics.¹

Management strategies for immune-mediated nephritis

Immune-mediated nephritis, defined as requiring use of corticosteroids with no clear alternate etiology, has been observed in patients receiving LIBTAYO.

Monitor patients for changes in renal function and manage as recommended below:

Management strategies for other immune-mediated adverse reactions¹

Fatal and life-threatening immune-mediated adverse reactions have been observed with LIBTAYO including in the post-marketing setting (solid organ transplant rejection, myositis, and graft-versus-host disease in association with allogeneic hematopoietic stem cell transplant). These immune-mediated reactions may involve any organ system. Most immune-mediated reactions initially manifest during treatment with LIBTAYO; however, immune-mediated adverse reactions can occur after discontinuation of LIBTAYO.
Immune-related adverse reactions affecting more than one body system can occur simultaneously.

For suspected immune-mediated adverse reactions, evaluate to confirm an immune-mediated adverse reaction and to exclude other causes. Manage patients with treatment modifications, hormone replacement therapy (if clinically indicated), and corticosteroids as recommended below:

Other immune-related adverse reactions include, but are not limited to:¹
meningitis, paraneoplastic encephalomyelitis, arthritis, Guillain-Barre syndrome, encephalitis, chronic inflammatory demyelinating polyradiculoneuropathy, central nervous system inflammation, autoimmune myocarditis, immune thrombocytopenic purpura, myalgia, Sjogren’s syndrome, vasculitis, and myasthenia gravis.

Management strategies for infusion-related reactions¹

LIBTAYO can cause severe or life-threatening infusion-related reactions.¹

Monitor patients for signs and symptoms of infusion-related reactions and manage as recommended below: