KADCYLA dosing and administration
Guidelines for dosing, administering, preparing, and storing
Read more below to see KADCYLA dosing regimen options, administration
information, and dose modification. For additional information,
download the KADCYLA Dosing and Administration Guide.
Preparing and storing KADCYLA
Calculating the correct dose1
Dosing for KADCYLA is based on weight (3.6 mg/kg; actual body
Selecting the appropriate vial1
KADCYLA is supplied as a sterile powder for concentrate and comes in
2 vial types. Vials will reconstitute to 20 mg/mL.
Instructions for reconstitution1
Use aseptic technique for reconstitution and preparation of dosing solution. Use appropriate procedures for the preparation of chemotherapeutic drugs.
1. To yield a single-use reconstituted solution of 20 mg/mL of KADCYLA for IV infusion, using a sterile syringe, slowly inject:
a. 8 mL of sterile water for injection (SWFI) into the 160 mg vial
b. 5 mL of SWFI into the 100 mg vial
2. Gently swirl the vial until solution is completely dissolved. DO NOT FREEZE OR SHAKE
a. Do not use if the reconstituted solution contains visible particulates or is cloudy or discolored
Instructions for dilution1
1. Add reconstituted KADCYLA solution to an infusion bag containing 250 mL of 0.9% sodium chloride injection
a. Do not use Dextrose (5%) solution to dilute KADCYLA
2. Mix diluted solution by gentle inversion to avoid foaming. DO NOT FREEZE OR SHAKE
3. Administer the infusion immediately after preparation, using a 0.22 micron in-line PES filter
a. Do not mix or dilute KADCYLA with other drugs during preparation
- Store vials in a refrigerator at 2°C-8°C (36°F-46°F) until time of use
- Reconstituted vials with SWFI and diluted KADCYLA
infusion solution should be used immediately or may be stored in a
refrigerator at 2°C-8°C (36°F-46°F) for up to 24 hours prior to
use. DO NOT FREEZE OR SHAKE
- Storage time for KADCYLA infusion solution is additional to the time allowed for the reconstituted vials
- Discard any unused solution after 24 hours
Single IV infusion every 3 weeks1
- Administer at a dose of 3.6 mg/kg via IV infusion
- Do not administer KADCYLA as an intravenous push or bolus
- An in-line PES filter (0.2 or 0.22 micron) is required
- No loading dose
Dosing schedule for KADCYLA1
Monitoring for infusion-related reactions (IRRs)
IRRs have been reported in clinical trials with KADCYLA. In most patients, these reactions resolved over the course of several hours to a day after completing the infusion.
- Monitor patients for IRRs, especially during the first infusion
- Slow or interrupt the infusion and administer appropriate medical therapies if severe IRRs occur
- Permanently discontinue treatment in the event of life-threatening infusion reactions
Dose modifications and reductions for select adverse reactions1
Severe adverse reactions have been reported in clinical studies with KADCYLA. Before beginning treatment with KADCYLA, review the Preadministration Guidelines and the Dose Modifications and Reductions Guidelines, which can be found in the full Prescribing Information. For an additional resource, download the Dosing and Administration Guide.
When multiple dose-modification events occur, always use the most conservative guideline.
ALT=alanine aminotransferase; AST=aspartate
aminotransferase; CHF=congestive heart failure; LVEF=left
ventricular ejection fraction; ULN=upper limit of normal.
- Pulmonary toxicity: Permanently discontinue in patients diagnosed with interstitial lung disease (ILD) or pneumonitis
- Peripheral neuropathy: Hold treatment in patients with severe to life-threatening peripheral neuropathy (Grades ≥3) until resolution to Grades ≤2
Dose reduction guidelines for KADCYLA1*
- Dose reductions should be made in decrements of 0.6 mg/kg
- A maximum of 2 dose reductions should occur before discontinuation
- KADCYLA dose should never be re-escalated after a dose reduction has been made
*Dose reduction guidelines based on KADCYLA full
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Informative materials about KADCYLA for yourself, your practice, and
View and save the full Prescribing Information for KADCYLA.