Dosing and Administration

Severity of Adverse Reaction^a

Dose Modification

• Withhold dose until complete or partial resolution (grade 0 to 1) 

• Resume LUTATHERA at 3.7 GBq (100 mCi) in patients with complete or partial resolution. If reduced dose does not result in grade 2, 3, or 4 thrombocytopenia, administer LUTATHERA at 7.4 GBq (200 mCi) as next dose 

• Permanently discontinue LUTATHERA for grade 2 or higher thrombocytopenia requiring a dosing interval beyond 16 weeks 

• For recurrent grade 2, 3, or 4 thrombocytopenia, permanently discontinue LUTATHERA

Severity of Adverse Reaction^a

First occurrence of grade 3 or 4

Dose Modification

• Withhold dose until complete or partial resolution (grade 0, 1, or 2)

• Resume LUTATHERA at 3.7 GBq (100 mCi) in patients with complete or partial resolution. If reduced dose does not result in grade 3 or 4 anemia or neutropenia, administer LUTATHERA at 7.4 GBq (200 mCi) as next dose

• Permanently discontinue LUTATHERA for grade 3 or higher anemia or neutropenia requiring a dosing interval beyond 16 weeks

• For recurrent grade 3 or 4 anemia and neutropenia, permanently discontinue LUTATHERA

Severity of Adverse Reaction^a

First occurrence of:

• Creatinine clearance <40 mL/min; calculated using Cockcroft-Gault with actual body weight, or

• 40% increase in baseline serum creatinine, or

• 40% decrease in baseline creatinine clearance; calculated using Cockcroft-Gault with actual body weight

Dose Modification

• Withhold dose until resolution or return to baseline

• Resume LUTATHERA at 3.7 GBq (100 mCi) in patients with resolution or return to baseline. If reduced dose does not result in renal toxicity, administer LUTATHERA at 7.4 GBq (200 mCi) as next dose

• Permanently discontinue LUTATHERA for renal toxicity requiring a dosing interval beyond 16 weeks

• For recurrent renal toxicity, permanently discontinue LUTATHERA

Severity of Adverse Reaction^a

First occurrence of:

• Bilirubinemia >3 times the upper limit of normal (grade 3 or 4), or

• Serum albumin <30 g/L with international normalized ratio (INR) >1.5

Dose Modification

• Withhold dose until complete resolution or return to baseline

• Resume LUTATHERA at 3.7 GBq (100 mCi) in patients with complete resolution or return to baseline. If reduced LUTATHERA dose does not result in hepatotoxicity, administer LUTATHERA at 7.4 GBq (200 mCi) as next dose

• Permanently discontinue LUTATHERA for hepatotoxicity requiring a dosing interval beyond 16 weeks

• For recurrent hepatotoxicity, permanently discontinue LUTATHERA

Severity of Adverse Reaction^a

First occurrence of grade 3 or 4                                                                                                

Dose Modification

Severity of Adverse Reaction^a

First occurrence of grade 3 or 4

Dose Modification

• Withhold dose until complete or partial resolution (grade 0 to 2)

• Resume LUTATHERA at 3.7 GBq (100 mCi) in patients with complete or partial resolution. If reduced dose does not result in grade 3 or 4 toxicity, administer LUTATHERA at 7.4 GBq (200 mCi) as next dose

• Permanently discontinue LUTATHERA for grade 3 or higher adverse reactions that require a dosing interval beyond 16 weeks

• For recurrent grade 3 or 4 adverse reactions, permanently discontinue LUTATHERA