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Durvalumab Dosage

Medically reviewed by Drugs.com. Last updated on Aug 30, 2019.

Applies to the following strengths: 50 mg/mL

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

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)

HYPERTHYROIDISM OR THYROIDITIS:
-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 premedication with subsequent doses
-GRADE 3 OR 4: Permanently discontinue therapy

OTHER IMMUNE-RELATED 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)

PERSISTENT GRADE 2 OR 3 ADVERSE REACTION (EXCLUDING ENDOCRINOPATHIES):
-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.

INABILITY TO TAPER CORTICOSTEROID:
-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 ADVERSE REACTION:
-RECURRENT GRADE 3 OR 4 (severe or life-threatening) adverse reaction: Permanently discontinue therapy.

Precautions

CONTRAINDICATIONS:
-None

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.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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