Hepzato Kit
melphalan hydrochloride injection, powder, lyophilized, for solution · KIT · Delcath Systems, Inc.
Hepzato Kit is a kit containing melphalan hydrochloride injection, powder, lyophilized, for solution, taken intra-arterial. Manufactured by Delcath Systems, Inc..
Key Facts
- Brand Name
- Hepzato Kit
- Generic Name
- melphalan hydrochloride injection, powder, lyophilized, for solution
- NDC Code (Product)
75833-601- Manufacturer
- Delcath Systems, Inc.
- Dosage Form
- KIT
- Route
- INTRA-ARTERIAL
- Marketing Status
- Application #
- NDA201848
- Marketing Start
- 12/04/2023
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE HEPZATO for injection, as a component of the HEPZATO KIT, is 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. 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.( 1 )
Dosage & Administration
2 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. ( 2.2 ). 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. ( 2.3 ) 2.1 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 [see Contraindications ( 4 ) ]. Healthcare providers must complete the required HEPZATO KIT REMS training prior to administration of the HEPZATO KIT [see Warnings and Preca…
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, 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 History of allergies or known hypersensitivity to a component or material utilized within the HEPZATO KIT including History of allergy to natural rubber latex History of allergy or hypersensitivity to heparin or presence of heparin-induced thrombocytopenia (HIT) History of severe allergic reaction to iodinated contrast not controlled by premedication with antihistamines and steroids Active intracranial metastases or brain lesions with a propensity to bleed Liver failure, portal hypertension, or known varices …
Adverse Reactions
6 ADVERSE REACTIONS Below are adverse reactions associated with HEPZATO KIT. Additional adverse reactions related to the procedure and/or medical device are described in further detail in the HEPZATO KIT IFU. The following clinically significant adverse reactions are described elsewhere in the labeling: Peri-procedural complications [see Warnings and Precautions ( 5.1 )] Myelosuppression [see Warnings and Precautions ( 5.3 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.4 )] Gastrointestinal Adverse Reactions [see Warnings and Precautions ( 5.5 )] Secondary Malignancies [see Warnings and Precautions ( 5.6 )] 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. 6.1 Clinical Trials Experience Because clinical trials are conduc…
Frequently Asked Questions
What is Hepzato Kit used for?
Hepzato Kit contains melphalan hydrochloride injection, powder, lyophilized, for solution. It is a kit taken intra-arterial. Consult your doctor for specific uses.
Is Hepzato Kit a controlled substance?
Hepzato Kit is not classified as a controlled substance by the DEA.
What is the generic name for Hepzato Kit?
The generic name for Hepzato Kit is melphalan hydrochloride injection, powder, lyophilized, for solution. There are no other listed brand versions of melphalan hydrochloride injection, powder, lyophilized, for solution.
What is the NDC code for Hepzato Kit ?
The NDC (National Drug Code) for Hepzato Kit is 75833-601, listed by Delcath Systems, Inc..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)