Usual Adult Dose for Squamous Cell Carcinoma

350 mg IV over 30 minutes every 3 weeks until disease progression or unacceptable toxicity

Use: For the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation

Usual Adult Dose for Basal Cell Carcinoma

350 mg IV over 30 minutes every 3 weeks until disease progression or unacceptable toxicity

Uses:

• For locally advanced basal cell carcinoma (laBCC) previously treated with a hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor is not appropriate
• For metastatic BCC (mBCC) previously treated with a hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor is not appropriate

Renal Dose Adjustments

No adjustment recommended.

Liver Dose Adjustments

Mild hepatic impairment: No adjustment recommended.
Moderate to severe hepatic impairment: Data not available

Dose Adjustments

No dose reduction for this drug is recommended:

• In general, withhold therapy for severe (Grade 3) immune-mediated adverse reactions.
• Permanently discontinue therapy for life-threatening (Grade 4) or recurrent severe (Grade 3) immune-mediated reactions that require systemic immunosuppressives, or inability to reduce corticosteroid to 10 mg or less prednisone equivalent per day within 12 weeks of initiation.

• Grade 2: Withhold therapy; resume if resolved to Grade 1 or less after corticosteroid taper; permanently discontinue if no complete or partial resolution within 12 weeks of initiating steroids or inability to reduce prednisone to less than 10 mg per day (or equivalent) within 12 weeks of initiation.
• Grade 3 or 4: Permanently discontinue therapy.

• Grade 2 or 3: Withhold therapy; resume if resolved to Grade 1 or less after corticosteroid taper; permanently discontinue if no complete or partial resolution within 12 weeks of initiating steroids or inability to reduce prednisone to less than 10 mg per day (or equivalent) within 12 weeks of initiation
• Grade 4: Permanently discontinue therapy.

• If AST or ALT increases to more than 3 and up to 8 times the upper limit of normal (ULN) OR total bilirubin increases more than 1.5 and up to 3 x ULN: Withhold therapy; resume if resolved to Grade 1 or less after corticosteroid taper; permanently discontinue if no complete or partial resolution within 12 weeks of initiating steroids or inability to reduce prednisone to less than 10 mg per day (or equivalent) within 12 weeks of initiation.
• If AST or ALT increases to more than 8 x ULN OR total bilirubin increases to more than 3 x ULN: Permanently discontinue therapy.

• Baseline AST or ALT is more than 1 and up to 3 x ULN and increases to more than 5 and up to 10 x ULN OR baseline AST or ALT is more than 3 and up to 5 x ULN and increases to more than 8 and up to 10 times ULN: Withhold therapy; resume if resolved to Grade 1 or less after corticosteroid taper; permanently discontinue if no complete or partial resolution within 12 weeks of initiating steroids or inability to reduce prednisone to less than 10 mg per day (or equivalent) within 12 weeks of initiation.
• AST or ALT increases to more than 10 x ULN OR total bilirubin increases to more than 3 x ULN: Permanently discontinue therapy.

• Grade 3 or 4: Withhold until clinically stable or permanently discontinue depending on severity.

• Grade 2 or 3 increased blood creatinine: Withhold therapy; resume if resolved to Grade 1 or less after corticosteroid taper; permanently discontinue if no complete or partial resolution within 12 weeks of initiating steroids or inability to reduce prednisone to less than 10 mg per day (or equivalent) within 12 weeks of initiation.
• Grade 4 increased blood creatinine: Permanently discontinue therapy.

• Suspected SJS, TEN, or DRESS: Withhold therapy; resume if resolved to Grade 1 or less after corticosteroid taper; permanently discontinue if no complete or partial resolution within 12 weeks of initiating steroids or inability to reduce prednisone to less than 10 mg per day (or equivalent) within 12 weeks of initiation.
• Confirmed SJS, TEN, or DRESS: Permanently discontinue therapy.

• Grade 2, 3, or 4: Permanently discontinue therapy.

• Grade 2: Withhold therapy; resume if resolved to Grade 1 or less after corticosteroid taper; permanently discontinue if no complete or partial resolution within 12 weeks of initiating steroids or inability to reduce prednisone to less than 10 mg per day (or equivalent) within 12 weeks of initiation.
• Grade 3 or 4: Permanently discontinue therapy.

• Grade 1 or 2: Interrupt or slow the rate of infusion.
• Grade 3 or 4: Permanently discontinue therapy.

Precautions

CONTRAINDICATIONS:

• None

Dialysis

Data not available

Other Comments

Administration advice:

• Administer this drug by IV infusion over 30 minutes through an IV line containing a sterile, in-line or add-on 0.2-micron to 5-micron filter.

• Store in a refrigerator at 2C to 8C (36F to 46F) in the original carton.
• Protect from light.
• Do not freeze or shake.

• Visually inspect for particulate matter and discoloration prior to administration.
• This drug should be a clear to slightly opalescent, colorless to pale yellow solution that may contain trace amounts of translucent to white particles. Discard the vial if the solution is cloudy, discolored or contains particulate matter.
• Withdraw 7 mL from a vial and dilute with 0.9% sodium chloride injection or 5% dextrose injection, USP to a final concentration between 1 mg/mL to 20 mg/mL.
• Mix diluted solution by gentle inversion. Do not shake.
• Discard any unused product.

• Compatible with 0.9% sodium chloride injection or 5% dextrose injection.

• Monitor for immune-mediated adverse reactions.
• Monitor for hyperglycemia.
• Monitor for infusion reactions.

• This drug can harm a developing fetus. Use effective contraception during therapy and for at least 4 months after.
• Do not breastfeed during therapy and for at least 4 months after.
• Report adverse reactions to your healthcare provider promptly.

Frequently asked questions

• What type of drug is Libtayo?