Select therapeutic use:

Melanoma and other skin cancers:

Indications for: LIBTAYO

Treatment of metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC in patients who are not candidates for curative surgery or curative radiation. Treatment of metastatic basal cell carcinoma (BCC) or locally advanced BCC in patients previously treated with a hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor is not appropriate.

Adult Dosage:

Give by IV infusion over 30mins. 350mg every 3 weeks until disease progression or unacceptable toxicity. Dose modifications for adverse reactions: see full labeling.

Children Dosage:

Not established.

LIBTAYO Warnings/Precautions:

Severe and fatal immune-mediated adverse reactions can develop. Monitor closely for immune-related pneumonitis, hepatitis, colitis, endocrinopathies (thyroid disorders, adrenal insufficiency, diabetes, hypophysitis/hypopituitarism), nephritis/renal dysfunction, dermatologic reactions, myocarditis, neurological toxicities, others. Withhold or permanently discontinue based on severity and type of adverse reaction; see full labeling for management guidelines. Obtain liver enzymes, creatinine and thyroid function at baseline and periodically during therapy. Monitor for infection. Evaluate for Vogt-Koyanagi-Harada-like syndrome if uveitis in combination with other immune-mediated reactions occur. Interrupt, slow the infusion rate, or permanently discontinue based on severity of infusion-related reactions. Monitor closely for allogeneic HSCT-related complications (eg, graft-versus-host-disease, hepatic veno-occlusive disease, steroid-requiring febrile syndrome) and manage promptly. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for ≥4 months after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for ≥4 months after the last dose).

LIBTAYO Classification:

Human programmed death receptor-1 (PD-1)-blocking antibody.

Adverse Reactions:

Fatigue, rash, diarrhea, nausea, musculoskeletal pain, pruritus, constipation, decreased appetite, Grade 3–4 lab abnormalities (lymphopenia, hyponatremia, hypophosphatemia, increased AST, anemia, hyperkalemia); other immune-mediated adverse reactions (eg, ocular, gastrointestinal, musculoskeletal/connective tissue, hematologic/immune), infusion-related reactions.

Generic Drug Availability:

NO

How Supplied:

Single-dose vial—1

Respiratory and thoracic cancers:

Indications for: LIBTAYO

First-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) in patients who are not candidates for surgical resection or definitive chemoradiation, and whose tumors have high-PD-L1 expression [Tumor Proportion Score (TPS) ≥50%] as determined by an FDA-approved test, with no EGFR, ALK or ROS1 aberrations.

Adult Dosage:

Give by IV infusion over 30mins. 350mg every 3 weeks until disease progression or unacceptable toxicity. Dose modifications for adverse reactions: see full labeling.

Children Dosage:

Not established.

LIBTAYO Warnings/Precautions:

Severe and fatal immune-mediated adverse reactions can develop. Monitor closely for immune-related pneumonitis, hepatitis, colitis, endocrinopathies (thyroid disorders, adrenal insufficiency, diabetes, hypophysitis/hypopituitarism), nephritis/renal dysfunction, dermatologic reactions, myocarditis, neurological toxicities, others. Withhold or permanently discontinue based on severity and type of adverse reaction; see full labeling for management guidelines. Obtain liver enzymes, creatinine and thyroid function at baseline and periodically during therapy. Monitor for infection. Evaluate for Vogt-Koyanagi-Harada-like syndrome if uveitis in combination with other immune-mediated reactions occur. Interrupt, slow the infusion rate, or permanently discontinue based on severity of infusion-related reactions. Monitor closely for allogeneic HSCT-related complications (eg, graft-versus-host-disease, hepatic veno-occlusive disease, steroid-requiring febrile syndrome) and manage promptly. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for ≥4 months after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for ≥4 months after the last dose).

LIBTAYO Classification:

Human programmed death receptor-1 (PD-1)-blocking antibody.

Adverse Reactions:

Fatigue, rash, diarrhea, nausea, musculoskeletal pain, pruritus, constipation, decreased appetite, Grade 3–4 lab abnormalities (lymphopenia, hyponatremia, hypophosphatemia, increased AST, anemia, hyperkalemia); other immune-mediated adverse reactions (eg, ocular, gastrointestinal, musculoskeletal/connective tissue, hematologic/immune), infusion-related reactions.

Generic Drug Availability:

NO

How Supplied:

Single-dose vial—1