What is MELPHALAN HYDROCHLORIDE INJECTION used for?

MELPHALAN HYDROCHLORIDE INJECTION (brand name Hepzato Kit) is a Electrolyte / Mineral indicated for 1 INDICATIONS AND USAGE HEPZATO for injection, as a component of the HEPZATO KIT, lymph nodes.

What are the most common side effects of MELPHALAN HYDROCHLORIDE INJECTION?

Reported side effects vary by individual. The side-effects section on this page lists the events most frequently reported to FDA FAERS for MELPHALAN HYDROCHLORIDE INJECTION. FAERS is voluntary reporting, so it reflects what was reported, not absolute incidence.

Is MELPHALAN HYDROCHLORIDE INJECTION the same as Hepzato Kit?

Hepzato Kit is a brand name for MELPHALAN HYDROCHLORIDE INJECTION. They share the same active ingredient and FDA-approved indications. Biosimilars and authorised generics may differ in inactive ingredients such as buffers or preservatives.

MELPHALAN HYDROCHLORIDE INJECTION

Q: How does MELPHALAN HYDROCHLORIDE INJECTION work?

MELPHALAN HYDROCHLORIDE INJECTION works through the following mechanism: 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..

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%

Community Discussions

No community discussions found for MELPHALAN HYDROCHLORIDE INJECTION yet.

Primary sources

Every figure on this page links back to its primary source. See data sources for full provenance.

DailyMed FDA label search → MELPHALAN HYDROCHLORIDE INJECTION openFDA label JSON → MELPHALAN HYDROCHLORIDE INJECTION FAERS adverse-event reports → MELPHALAN HYDROCHLORIDE INJECTION ClinicalTrials.gov → completed Phase 2+ trials of MELPHALAN HYDROCHLORIDE INJECTION

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Formulations

Dosage Forms

Tablet

Route

Intra-arterial