Personalized Support for HEPZATO KIT™
HEPZATO KIT™ Access is a personalized support program offered to patients, providers, and facilities while navigating the payor authorization process. Our dedicated reimbursement experts will provide status updates while coverage and product access details are finalized.
Patient Support
Complete HIPAA & enrollment forms
Service Provider Support
Access 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
WARNING: SEVERE PERI-PROCEDURAL COMPLICATIONS, MYELOSUPPRESSION
See full prescribing information for complete boxed warning.
- Severe peri-procedural complications including hemorrhage, hepatocellular injury, and thromboembolic events may occur with intra-hepatic administration of HEPZATO. Assess patients for these adverse reactions during and for 72 hours following administration of HEPZATO.
- HEPZATO is available only through a restricted program under a Risk Evaluation and Mitigation Strategy called the HEPZATO KIT REMS.
- Myelosuppression with resulting severe infection, bleeding, or symptomatic anemia may occur with HEPZATO. Monitor hematologic laboratory parameters and delay additional cycles of HEPZATO therapy until blood counts have improved.
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.
CONTRAINDICATIONS
- 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
ADVERSE REACTIONS
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.
To report SUSPECTED ADVERSE REACTIONS, contact Delcath at 1-833-632-0458 and www.Delcath.com or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
- HEPZATO should not be used in patients < 35 kg
- Lactation: Advise not to breastfeed
Patient Support
Complete HIPAA & Enrollment Forms
Service Provider Support
Access HIPAA & Enrollment Forms
Expedited access
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
We assist facilities with navigating procurement processes, charge entry, and reimbursement-related support.
Collaborative partnership
As part of the Patient Access Program, Delcath’s dedicated team of experts will collaborate closely with your center to address any queries and provide ongoing support to ensure a smooth patient and provider experience.