Recommended dosage 1.9 mg/kg (up to a maximum of 190 mg for patients ≥100 kg) administered every 2 weeks until disease progression or unacceptable toxicity
Dosing & Administration
EMRELIS dosing schedule:
EMRELIS is an IV infusion administered over 30 minutes
- EMRELIS contains a hazardous component. Follow applicable special handling and disposal procedures in accordance with local requirements
- Reconstitute and further dilute EMRELIS prior to IV infusion
Please see Section 2.5 Instructions for Preparation and Administration of the Prescribing Information for more detailed instructions on preparation, reconstitution, and administration.
Strong CYP3A4 Inhibitors:
- Concomitant use with strong CYP3A inhibitors may increase unconjugated MMAE AUC, which may increase the risk of EMRELIS adverse reactions. Monitor patients for adverse reactions when EMRELIS is given concomitantly with strong CYP3A inhibitors.1
No specific dose adjustment required for:
Mild hepatic impairment1*
Avoid use of EMRELIS in patients with moderate or severe hepatic impairment†
Preparing EMRELIS for administration1
- Available in 2 sizes: 20 mg single-dose vial and 100 mg single-dose vial
- EMRELIS contains a hazardous component. Follow applicable special handling and disposal procedures in accordance with local requirements
Preparing EMRELIS for IV infusion
1Before reconstitution, allow the vial to reach room temperature after removal from refrigerator
2Calculate recommended dose based on patient’s weight to determine number of vials needed
- For patients weighing ≥100 kg, use 190 mg dose; more than one vial may be needed to reach calculated dose
3Using a sterile syringe, slowly inject sterile water for injection, using the volume provided in the table below, into the EMRELIS dose vial to obtain a concentration of 20 mg/mL EMRELIS
Reconstitution volumes
- Swirl the vial gently until completely dissolved. Do not shake
- Inspect the reconstituted solution for particulate matter and discoloration. The solution should appear clear to slightly opalescent, colorless to slightly yellow. Do not use if the reconstituted solution is discolored, is cloudy, or contains visible particulates
4 Use reconstituted EMRELIS immediately
- If not used immediately, store reconstituted vials in refrigerator at 36° to 46° F for up to 24 hours from time of reconstitution. Do not freeze
5Each vial of EMRELIS is intended for single dose only; discard any unused drug remaining in vial
Dilution in Infusion Bag
- Calculate the required dose volume (mL) of reconstituted EMRELIS solution needed
- Withdraw the calculated dose volume (mL) of reconstituted solution from the EMRELIS vial using a sterile syringe. Discard any unused portion left in the vial in accordance with local requirements
- Inject the calculated amount of reconstituted solution into 0.9% Sodium Chloride Injection infusion bag so that the final EMRELIS concentration is between 1 mg/mL and 10 mg/mL. Use only 0.9% Sodium Chloride Injection
- Gently invert the infusion bag to thoroughly mix the solution. Do not shake
- After preparing the dose for infusion, visually inspect the bag content for particulates and discard if present
- If not used immediately, the diluted solution can be stored in a refrigerator at 2° to 8° C (36° to 45° F) for up to 24 hours and an additional 4 hours at room temperature (9° to 30° C, 47° to 86° F) until the end of administration. Do not freeze
Method of Administration
If the prepared infusion solution was stored refrigerated (2° to 8° C [36° to 46° F]), allow the solution to reach room temperature prior to administration.
- Administer by intravenous infusion over 30 minutes using a dedicated infusion line with a 0.20 or 0.22 micron in-line filter made of polyether sulfone (PES), polyvinylidene fluoride (PVDF), or Polyamide (PA)
- Do not mix EMRELIS with other drugs or administer other drugs through the same intravenous line
*Total bilirubin ≤ULN and AST >ULN or total bilirubin >ULN and ≤1.5 x ULN and any AST.
†Total bilirubin >1.5 x ULN and any AST.
AUC=area under the curve; IV=intravenous.