Usual Adult Dose for Urothelial Carcinoma

10 mg/kg IV over 60 minutes every 2 weeks until disease progression or unacceptable toxicity

Uses: For the treatment of patients with locally advanced or metastatic urothelial carcinoma who:

• Have disease progression during or following platinum-containing chemotherapy
• Have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy

Usual Adult Dose for Non-Small Cell Lung Cancer

10 mg/kg IV over 60 minutes every 2 weeks until disease progression, unacceptable toxicity, or a maximum of 12 months

Use: For patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy

Usual Adult Dose for Small Cell Lung Cancer

30 kg or less:
20 mg/kg IV every 3 weeks (21 days) for 4 cycles, followed by 20 mg/kg every 4 weeks as a single agent until weight increases to greater than 30 kg
NOTE: When this drug is given in combination with chemotherapy, administer this drug prior to chemotherapy on the same day; refer to the Prescribing Information for etoposide and carboplatin or cisplatin for dosing information.

Greater than 30 kg:
1500 mg IV every 3 weeks (21 days) for 4 cycles, followed by 1500 mg every 4 weeks as a single agent until disease progression or unacceptable toxicity
NOTE: When this drug is given in combination with chemotherapy, administer this drug prior to chemotherapy on the same day; refer to the Prescribing Information for etoposide and carboplatin or cisplatin for dosing information.

Use: This drug in combination with etoposide and either carboplatin or cisplatin, for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC)

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Dose Adjustments

Dose escalation or reduction is not recommended.
Dose withholding or discontinuation may be required based on safety and tolerability.

PNEUMONITIS:

• GRADE 2: Withhold dose; initiate prednisone or equivalent at an initial dose of 1 to 2 mg/kg/day followed by a taper (unless otherwise specified); initiate corticosteroid when adverse reaction improves to less than Grade 1 and continue over at least 1 month; resume therapy when reaction is Grade 1 or less and the corticosteroid dose is less than 10 mg prednisone or equivalent per day
• GRADE 3 OR 4: Permanently discontinue therapy; initiate prednisone or equivalent at an initial dose of 1 to 4 mg/kg/day followed by a taper (unless otherwise specified); initiate corticosteroid when adverse reaction improves to less than Grade 1 and continue over at least 1 month; resume therapy when reaction is Grade 1 or less and the corticosteroid dose is less than 10 mg prednisone or equivalent per day

• GRADE 2 alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 3 to 5 times upper limit of normal (ULN) or total bilirubin greater than 1.5 to 3 x ULN OR Grade 3 ALT or AST less than or equal to 8 x ULN or total bilirubin less than or equal to 5 x ULN: Withhold dose; initiate prednisone or equivalent at an initial dose of 1 to 2 mg/kg/day followed by a taper (unless otherwise specified); initiate corticosteroid when adverse reaction improves to less than Grade 1 and continue over at least 1 month; resume therapy when reaction is Grade 1 or less and the corticosteroid dose is less than 10 mg prednisone or equivalent per day
• GRADE 3 ALT or AST greater than 8 x ULN or total bilirubin greater than 5 x ULN OR concurrent ALT or AST greater than 3 x ULN and total bilirubin greater than 2 x ULN with no other cause: Permanently discontinue therapy; initiate prednisone or equivalent at an initial dose of 1 to 2 mg/kg/day followed by a taper (unless otherwise specified)

• GRADE 2: Withhold dose; initiate prednisone or equivalent at an initial dose of 1 to 2 mg/kg/day followed by a taper (unless otherwise specified); initiate corticosteroid when adverse reaction improves to less than Grade 1 and continue over at least 1 month; resume therapy when reaction is Grade 1 or less and the corticosteroid dose is less than 10 mg prednisone or equivalent per day
• GRADE 3 OR 4: Permanently discontinue therapy; initiate prednisone or equivalent at an initial dose of 1 to 2 mg/kg/day followed by a taper (unless otherwise specified)

• GRADE 2 TO 4: Withhold dose until clinically stable; initiate symptomatic management

• GRADE 2 TO 4: Withhold dose until clinically stable; initiate prednisone or equivalent at an initial dose of 1 to 2 mg/kg/day followed by a taper (unless otherwise specified) and hormone replacement as clinically indicated

• GRADE 2 TO 4: Withhold dose until clinically stable; initiate therapy with insulin as clinically indicated

• GRADE 2 creatinine greater than 1.5 to 3 x ULN: Withhold dose; initiate prednisone or equivalent at an initial dose of 1 to 2 mg/kg/day followed by a taper (unless otherwise specified); initiate corticosteroid when adverse reaction improves to less than Grade 1 and continue over at least 1 month; resume therapy when reaction is Grade 1 or less and the corticosteroid dose is less than 10 mg prednisone or equivalent per day
• GRADE 3 creatinine greater than 3 to 6 x ULN OR Grade 4 creatinine greater than 6 x ULN: Permanently discontinue therapy; initiate prednisone or equivalent at an initial dose of 1 to 2 mg/kg/day followed by a taper (unless otherwise specified)

• GRADE 2 for longer than 1 week OR Grade 3: Withhold dose; consider initiating prednisone or equivalent at an initial dose of 1 to 2 mg/kg/day followed by a taper (unless otherwise specified); initiate corticosteroid when adverse reaction improves to less than Grade 1 and continue over at least 1 month; resume therapy when reaction is Grade 1 or less and the corticosteroid dose is less than 10 mg prednisone or equivalent per day
• GRADE 4: Permanently discontinue therapy; consider initiating prednisone or equivalent at an initial dose of 1 to 2 mg/kg/day followed by a taper (unless otherwise specified)

• GRADE 3 OR 4: Withhold dose; initiate symptomatic management; treat with anti-infectives for suspected or confirmed infections

• GRADE 1 OR 2: Interrupt or slow the rate of infusion; consider premedication with subsequent doses
• GRADE 3 OR 4: Permanently discontinue therapy

• GRADE 3: Withhold dose; initiate symptomatic management (Based on severity of the adverse reaction, therapy should be withheld and a corticosteroid taper administered; consider increasing dose of corticosteroids and/or other systemic immunosuppressants if there is worsening or no improvement; initiate corticosteroid when adverse reaction improves to less than Grade 1 and continue over at least 1 month; resume therapy when reaction is Grade 1 or less and the corticosteroid dose is less than 10 mg prednisone or equivalent per day

• GRADE 4: Permanently discontinue therapy; consider initiating prednisone or equivalent at an initial dose of 1 to 4 mg/kg/day followed by a taper (unless otherwise specified)

• GRADE 2 OR 3 adverse reaction that does not recover to Grade 0 or 1 within 12 weeks after the last dose: Permanently discontinue therapy.

• GRADE 2 OR 3 adverse reaction that does not recover to Grade 0 or 1 within 12 weeks after the last dose: Permanently discontinue therapy.

• RECURRENT GRADE 3 OR 4 (severe or life-threatening) adverse reaction: Permanently discontinue therapy.

Precautions

CONTRAINDICATIONS:

• None

Dialysis

Data not available

Other Comments

Administration advice:

• Administer IV over 60 minutes through an IV line containing a sterile, low-protein binding 0.2 or 0.22 micron in-line filter.
• Administer infusion solution immediately after preparing; if the infusion is not administered immediately and needs to be stored, the total time from vial puncture to the start of the administration should not exceed 24 hours in a refrigerator at 2C to 8C (36F to 46F) or 4 hours at room temperature up to 25C (77F).
• Do not shake the prepared solution.

• Store unused vials in a refrigerator at 2C to 8C (36F to 46F) in original carton to protect from light.
• Do not freeze.

• The manufacturer product information should be consulted.

• Do not coadminister other drugs through the same infusion line as this drug.

• The vials do not contain a preservative.

Frequently asked questions

• What type of drug is Imfinzi?