Trojan horses encapsulated by a TRODELVYᵀᴹ cell membrane in a green, cellular environment.

DOSING AND ADMINISTRATION

TRODELVY IS ADMINISTERED AS AN INTRAVENOUS INFUSION

The recommended dose of TRODELVY is 10 mg/kg on Days 1 and 8 of continuous 21-day treatment cycles

  • Do not administer TRODELVY at doses greater than 10 mg/kg
  • Administer TRODELVY as an intravenous infusion only. Do not administer as an intravenous push or bolus

Continuous 21-day treatment cycles

Treatment bag icons that indicate a treatment on day one, and day 8 of a 21-day treatment cycle

Continue treatment until
disease progression or
intolerance to therapy

Treatment bag icons that indicate a treatment on day one, and day 8 of a 21-day treatment cycle

First infusion

  • Administer infusion over 3 hours
  • Observe patients during the infusion and for at least 30 minutes following the initial dose for signs or symptoms of infusion-related reactions

Subsequent infusions

  • Administer infusion over 1 to 2 hours if prior infusions were tolerated
  • Observe patients during the infusion and for at least 30 minutes after the infusion

Prior to each dose of TRODELVY

  • Premedication for prevention of infusion reactions and prevention of chemotherapy-induced nausea and vomiting (CINV) is recommended
  • Premedicate with antipyretics, H1 and H2 blockers prior to infusion, and corticosteroids may be used for patients who had prior infusion reactions
  • Premedicate with a 2- or 3-drug combination regimen (eg, dexamethasone with either a 5-HT3 receptor antagonist or an NK1 receptor antagonist, as well as other drugs as indicated)
  • Medication to treat infusion-related reactions, as well as emergency equipment, should be available for immediate use

DOSAGE MODIFICATIONS FOR THE MANAGEMENT OF ADVERSE REACTIONS

Withhold or discontinue TRODELVY to manage adverse reactions as described in table below

Dose modifications for adverse reactions

Adverse reactionOccurrenceDose modification

Severe neutropenia

Grade 4 neutropenia ≥7 days,
OR
Grade 3 febrile neutropenia
(absolute neutrophil count <1000/mm3 and fever ≥38.5°C),
OR
At time of scheduled treatment, Grade 3-4 neutropenia, which delays dosing by 2 or 3 weeks for recovery to ≤Grade 1
First25% dose reduction and administer granulocyte-colony stimulating factor (G-CSF)
Second50% dose reduction
ThirdDiscontinue treatment
At time of scheduled treatment, Grade 3-4 neutropenia, which delays dosing beyond 3 weeks for recovery to ≤Grade 1FirstDiscontinue treatment

Severe non-neutropenic toxicity

Grade 4 non-hematologic toxicity of any duration,
OR
Any Grade 3-4 nausea, vomiting, or diarrhea due to treatment that is not controlled with antiemetics and antidiarrheal agents,
OR
Other Grade 3-4 non-hematologic toxicity persisting >48 hours despite optimal medical management,
OR
At time of scheduled treatment, Grade 3-4 non-neutropenic hematologic or non-hematologic toxicity, which delays dose by less than 3 weeks for recovery to ≤Grade 1
First25% dose reduction
Second50% dose reduction
ThirdDiscontinue treatment
In the event of Grade 3-4 non-neutropenic hematologic or non-hematologic toxicity, which does not recover to ≤Grade 1 within 3 weeksFirstDiscontinue treatment
  • Do not re-escalate the TRODELVY dose after a dose reduction for adverse reactions has been made
  • Slow or interrupt the infusion rate of TRODELVY if the patient develops an infusion-related reaction
  • Permanently discontinue TRODELVY for life-threatening infusion-related reactions

2% of patients discontinued due to drug-related adverse reactions

  • Adverse reactions leading to treatment discontinuation were anaphylaxis, anorexia/fatigue, and headache (each: <1%; 1 patient for each event) 
  • 45% of patients experienced an adverse reaction leading to treatment interruption. The most common adverse reaction leading to treatment interruption was neutropenia (33%)
  • Adverse reactions leading to dose reduction occurred in 33% of patients treated with TRODELVY
    • 24% had 1 dose reduction
    • 9% had 2 dose reductions
  • The most common adverse reactions leading to dose reductions were neutropenia and febrile neutropenia

See Important Safety Information below.


Thumbnail image the TRODELVYᵀᴹ Reconstitution Guide

Reconstitution Guide

Get step-by-step instructions on how to reconstitute and administer TRODELVY