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Durvalumab Dosage

Applies to the following strength(s): 50 mg/mL

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Usual Adult Dose for Bladder Cancer

10 mg/kg IV over 60 minutes every 2 weeks
Duration of therapy: Until disease progression or unacceptable toxicity

Uses: For the treatment of patients with locally advanced or metastatic urothelial carcinoma who:
1) Have disease progression during or following platinum-containing chemotherapy
2) Have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Dose Adjustments

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

Hepatitis:
-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)

Colitis or Diarrhea:
-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)

Hypothyroidism:
Grade 2 to 4: Initiate thyroid hormone replacement as clinically indicated

Hyperthyroidism:
Grade 2 to 4: Withhold dose until clinically stable; initiate symptomatic management

Adrenal Insufficiency, Hypophysitis/Hypopituitarism:
-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

Type 1 Diabetes Mellitus:
-Grade 2 to 4: Withhold dose until clinically stable; initiate therapy with insulin as clinically indicated

Nephritis:
-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)

Rash or Dermatitis:
-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)

Infection:
-Grade 3 or 4: Withhold dose; initiate symptomatic management; treat with anti-infectives for suspected or confirmed infections

Infusion-Related Reactions:
-Grade 1 or 2: Interrupt or slow the rate of infusion; consider premedications with subsequent doses
Grade 3 or 4: Permanently discontinue therapy

Other Adverse Reactions:
-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)

Precautions

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

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.

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

Reconstitution/preparation techniques:
-The manufacturer product information should be consulted.

IV compatibility:
-Do not coadminister other drugs through the same infusion line as this drug.

General:
-The vials do not contain a preservative.

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