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Evomela Dosage

Generic name: MELPHALAN HYDROCHLORIDE 50mg in 10mL
Dosage form: injection, powder, lyophilized, for solution

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Recommended Dosage for Conditioning Treatment

The recommended dose of Evomela for conditioning treatment is 100 mg/m2/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)].

Recommended Dosage for Palliative Treatment

The recommended dose of Evomela for palliative treatment is 16 mg/m2 administered as a single intravenous infusion over 15-20 minutes at 2-week intervals for 4 doses, then, after adequate recovery from toxicity, at 4‑week intervals.

Administer prophylactic anti-emetics [see Warnings and Precautions (5.2).

Dose Modification for Renal Impairment

For Conditioning Treatment: No dose adjustment is necessary.

For Palliative Treatment: Dosage reduction of up to 50% should be considered in patients with renal impairment (BUN ≥30 mg/dL) [see Use in Specific Populations (8.6)].

Preparation and Administration

Evomela is a cytotoxic drug. Follow applicable special handling and disposal procedures1.

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 normal saline used to reconstitute each vial should appear to be assisted or pulled into the vial by the negative pressure (partial vacuum) present in the vial. Discard any vial (and replace with another vial) if there is no vacuum present when reconstituting the vial with normal saline.
 
 
 
The reconstituted Evomela drug product is stable for 24 hours at refrigerated temperature (5oC) 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.
 
 
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