Hepzato Dosage
Generic name: Melphalan Hydrochloride 50mg in 10mL; ; Sodium Chloride 0.9mg in 100mL
Dosage form: injection, powder, lyophilized, for solution
Drug class: Alkylating agents
Medically reviewed by Drugs.com. Last updated on Nov 22, 2024.
Important Pre-Treatment and Administration Information
HEPZATO is a component of the HEPZATO KIT Hepatic Delivery System [HDS]. Refer to the HEPZATO KIT Hepatic Delivery System Instructions for Use (IFU) for additional instructions including pre-infusion evaluation, hydration, premedication, anticoagulation, and supportive care.
Caution: The double balloon catheter component of the HDS contains natural rubber latex which may cause allergic reactions .
- Healthcare providers must complete the required HEPZATO KIT REMS training prior to administration of the HEPZATO KIT.
- Discontinue oral anticoagulation and drugs affecting platelet function prior to the procedure.
- Discontinue ACE-inhibitors, calcium channel blockers, or alpha-1-adrenergic blockers prior to the procedure.
- Conduct baseline hematologic testing. Administer intra-hepatic HEPZATO with the HEPZATO KIT only to patients with the following.
- Hemoglobin ≥ 10 g/dL
- Platelets ≥ 100,000/microliter
- Neutrophils > 2000/microliter
Recommended Dosage
- Administer HEPZATO via the HEPZATO KIT Hepatic Delivery System only to patients weighing 35 kg or greater due to potential size limitations with respect to percutaneous catheterization.
- HEPZATO, a component of the HEPZATO KIT, is administered by infusion into the hepatic artery (see IFU) every 6 to 8 weeks for up to 6 total infusions.
- The recommended HEPZATO dose is 3 mg/kg based on ideal body weight (IBW), as calculated per Table 1 below, with a maximum of 220 mg during a single treatment.
Height | Ideal Body Weight | |
---|---|---|
Men | ≥ 152 cm | 52 kg + (0.75 kg/cm of height greater than 152 cm) |
< 152 cm | 52 kg – (0.75 kg/cm of height less than 152 cm) | |
Women | ≥ 152 cm | 49 kg + (0.67 kg/cm of height greater than 152 cm) |
< 152 cm | 49 kg – (0.67 kg/cm of height less than 152 cm) |
Dosage Modifications for Adverse Reactions
A dosage reduction to 2 mg/kg is recommended for subsequent treatments for the following reasons:
- Grade 4 neutropenia of > 5 days duration despite growth factor support or associated with neutropenic fever;
- Grade 4 thrombocytopenia of > 5 days duration or associated with a hemorrhage that required a transfusion;
HEPZATO administered with the HEPZATO KIT should be discontinued if patients have life threatening or HEPZATO-related persistent toxicity that has not resolved to Grade 2 or less by 8 weeks following treatment.
Preparation and Administration
Refer to the HEPZATO KIT Hepatic Delivery System IFU for further details and instructions.
Reconstitute and dilute melphalan immediately prior to beginning intra-arterial infusion.
Reconstituted and diluted solutions of HEPZATO are unstable. No more than 60 minutes should elapse from reconstitution and completion of the intra-hepatic infusion of the diluted HEPZATO solution. A citrate derivative of melphalan has been detected in reconstituted HEPZATO in 30 minutes, and nearly 1% of labeled strength of melphalan hydrolyzes every 10 minutes when reconstituted HEPZATO is further diluted in 0.9% Sodium Chloride. A precipitate forms if the reconstituted solution is stored at 5°C. Do not refrigerate HEPZATO once reconstituted.
HEPZATO is a hazardous drug1. Follow applicable special handling and disposal procedures.
Reconstitution and Dilution Instructions:
- Rapidly (in 5 seconds or less) inject 10 mL of the supplied sterile diluent into the HEPZATO 50 mg vial using a sterile needle (20-gauge or larger) and syringe. The resulting solution will contain melphalan 5 mg/mL
- Immediately shake the vial vigorously until a clear solution is obtained. No more than five (5) seconds should elapse between the discharge of the syringe and the commencement of shaking.
- Immediately further dilute the required dose with the provided 0.9% sodium chloride injection, United States Pharmacopeia (USP), to a concentration not greater than 0.45 mg/mL, as follows
- HEPZATO doses up to 110 mg:
Dilute in 250 mL of 0.9% sodium chloride injection - HEPZATO doses 111 mg to 220 mg:
Divide the total dose equally into 2 and dilute each in 250 mL of 0.9% sodium chloride injection (for example, if the total dose is 200 mg, dilute 100 mg in each 250 mL 0.9% sodium chloride injection)
- HEPZATO doses up to 110 mg:
- Visually inspect parenteral drug products for particulate matter and discoloration prior to administration, whenever solution and container permit. If particulates and discolorations are noted, the product should not be used.
- Administer diluted HEPZATO intra-arterially as described in the IFU. Complete the infusion within 30 minutes, followed by a 30-minute washout period. Refer to the IFU for additional administration procedures.
More about Hepzato (melphalan)
- Check interactions
- Compare alternatives
- Pricing & coupons
- Side effects
- During pregnancy
- FDA approval history
- Drug class: alkylating agents
- En español
Patient resources
Other brands
Professional resources
Other brands
Related treatment guides
See also:
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.