Evomela Dosage

Recommended Dosage for Conditioning Treatment

The recommended dose of Evomela for conditioning treatment is 100 mg/m 2/day administered over 30 minutes by intravenous infusion for 2 consecutive days (Day -3 and Day -2) prior to autologous stem cell transplantation (ASCT, Day 0). For patients who weigh more than 130% of their ideal body weight, body surface area should be calculated based on adjusted ideal body weight.

Administer prophylactic antiemetics [see Warnings and Precautions ( 5.2)] .

Preparation and Administration

Evomela is a hazardous drug. Follow applicable special handling and disposal procedures 1.

Evomela is light sensitive. Retain in original carton until use.

Do not mix Evomela with other melphalan hydrochloride for injection drug products.

Reconstitution and Infusion Instructions:

1. Use normal saline solution (0.9% Sodium Chloride Injection, USP) (8.6 mL as directed) to reconstitute Evomela and make a 50 mg/10 mL (5 mg/ mL) nominal concentration of melphalan.

The reconstituted Evomela drug product is stable for 24 hours at refrigerated temperature (5 oC) without any precipitation due to the high solubility.

The reconstituted Evomela drug product is stable for 1 hour at room temperature.

2. Calculate the required volume of Evomela needed for a patient’s dose and withdraw that volume from the vial(s).

3. Add the required volume of Evomela to the appropriate volume of 0.9% Sodium Chloride Injection, USP to a final concentration of 0.45 mg/mL.

The Evomela admixture solution is stable for 4 hours at room temperature in addition to the 1 hour following reconstitution.

4. Infuse over 30 minutes via an injection port or central venous catheter.

Evomela may cause local tissue damage should extravasation occur. Do not administer by direct injection into a peripheral vein. Administer Evomela by injecting slowly into a fast-running IV infusion via a central venous access line.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.