Complete HIPAA & enrollment forms
Important Safety Information Including Boxed Warning
What is HEPZATO KIT?
HEPZATO KIT consists of a closed circuit of catheters and proprietary filtration technology utilized to deliver HEPZATO (melphalan) to the hepatic artery and to lower the concentration of melphalan in the blood before it is returned to systemic circulation.
HEPZATO (melphalan) for injection is a component of the HEPZATO KIT Hepatic Delivery System (HDS) for intra-arterial use. Initial U.S. approval: 1964
INDICATIONS AND USAGE
HEPZATO is an alkylating drug indicated as a liver-directed treatment for adult patients with uveal melanoma with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation.
DOSAGE AND ADMINISTRATION
HEPZATO, a component of the HEPZATO KIT, is administered by intra-arterial infusion into the hepatic artery (see instructions for use [IFU]). The recommended dose is 3 mg/kg based on ideal body weight (see Table 1), with a maximum absolute dose of 220 mg during a single HEPZATO treatment. The drug is infused over 30 minutes followed by a 30-minute washout period (see IFU). Treatments should be administered every six (6) to eight (8) weeks but can be delayed until recovery from toxicities and as per clinical judgement.
DOSAGE FORMS AND STRENGTHS
For injection: HEPZATO includes 50 mg freeze-dried (lyophilized) melphalan powder per vial in five (5) single dose vials, intended for reconstitution with the supplied diluents.
- 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
- Active cardiac conditions including, but not limited to, unstable coronary syndromes (unstable or severe angina or myocardial infarction), worsening or new-onset congestive heart failure, significant arrhythmias, or severe valvular disease
- History of allergies or known hypersensitivity to melphalan or a component or material utilized within the HEPZATO KIT including natural rubber latex, heparin, and severe hypersensitivity to iodinated contrast not controlled by antihistamines and steroids
WARNINGS AND PRECAUTIONS
- Hypersensitivity reactions, including anaphylaxis, have occurred in patients who received an intravenous (IV) formulation of melphalan. Immediately terminate hepatic arterial melphalan infusion for hypersensitivity reactions and administer supportive care
- Gastrointestinal disturbances such as nausea and vomiting, abdominal pain and diarrhea are common
- Carcinogenic/Mutagenic effects: Secondary malignancies, including acute nonlymphocytic leukemia, myeloproliferative syndrome, and carcinoma, have been reported in patients with cancer treated with alkylating drugs (including melphalan). Melphalan has been shown to cause chromatid or chromosome damage in humans
- Embryo-fetal toxicity: Can cause fetal harm. 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
- Infertility: Melphalan-based chemotherapy regimens have been reported to cause suppression of ovarian function in premenopausal women and testicular suppression in men
Most common (≥20%) adverse reactions or laboratory abnormalities are thrombocytopenia, fatigue, anemia, nausea, musculoskeletal pain, leukopenia, abdominal pain, neutropenia, vomiting, increased alanine aminotransferase, prolonged activated partial thromboplastin time, increased aspartate aminotransferase, increased alkaline phosphatase, and dyspnea.
USE IN SPECIFIC POPULATIONS
- HEPZATO should not be used in patients < 35 kg
- Lactation: Advise not to breastfeed
Complete HIPAA & Enrollment Forms
We aim to minimize the administrative complexities of obtaining prior authorizations and ensure efficient access to the HEPZATO KIT™ for eligible patients, through streamlined processes and dedicated resources.
Procurement & reimbursement
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