MELPHALAN HYDROCHLORIDE INJECTION

Electrolyte / Mineral

Brand names: Hepzato Kit

Intra-arterial

Mechanism of Action

12.1 Mechanism of Action Melphalan is an alkylating drug of the bischloroethylamine type. As a result, its cytotoxicity appears to be related to the extent of its interstrand cross-linking with DNA, probably by binding at the N7 position of guanine. It is active against both resting and rapidly dividing tumor cells.

Indications

1 INDICATIONS AND USAGE HEPZATO for injection

as a component of the HEPZATO KIT

lymph nodes

subcutaneous tissues

or extrahepatic disease limited to the bone

lymph nodes

Contraindications

• 4 CONTRAINDICATIONS HEPZATO and the HEPZATO KIT are contraindicated in patients with: Active intracranial metastases or brain lesions with a propensity to bleed Liver failure
• portal hypertension
• or known varices at risk for bleeding Surgery or medical treatment of the liver in the previous 4 weeks Uncorrectable coagulopathy Inability to safely undergo general anesthesia
• including active cardiac conditions including
• but not limited to

FDA Warnings

5 WARNINGS AND PRECAUTIONS Hypersensitivity reactions, including anaphylaxis, have occurred in patients who received an intravenous (IV) formulation of melphalan
Advise females of reproductive potential and males with female partners of reproductive potential of the potential risk to a fetus and to use effective contraception
Administration of HEPZATO requires general anesthesia and extracorporeal bypass of circulation which may cause life threatening or fatal adverse effects
To mitigate the risk of thromboembolic events, administer anticoagulation as described in the IFU during the procedure

Known Side Effects

3 documented side effects by frequency

Drug Not Working

1-10%

Fever

1-10%

Diarrhea

1-10%

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Formulations

Dosage Forms

Tablet

Route

Intra-arterial