Marc-Blast Lyophilized Powder

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, 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 to eight weeks but can be delayed until recovery from toxicities and as per clinical judgement
• 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 ]
• Healthcare providers must complete the required HEPZATO KIT REMS training prior to administration of the HEPZATO KIT [see Warnings and Precautions ]
• Discontinue oral anticoagulation and drugs affecting platelet function prior to the procedure [see Warnings and Precautions ]
• Discontinue ACE-inhibitors, calcium channel blockers, or alpha-1-adrenergic blockers prior to the procedure [see Warnings and Precautions ]
• Conduct baseline hematologic testing. …

HEPZATO (melphalan) is supplied in the HEPZATO KIT that contains the following: Melphalan for injection: 5 single dose, clear glass vials for injection, containing 50 mg white to pale yellow lyophilized powder, intended for reconstitution with the supplied diluents For injection: HEPZATO includes 50 mg freeze-dried (lyophilized) melphalan powder per vial in five (5) single dose vials, intended for …

• The safety and effectiveness
• In pediatric patients have not been established

Clinical studies of HEPZATO did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In the FOCUS trial, 30 of the 91 patients (33%) were 65 years and older.

• Advise patients or their caregivers of the following risks of the HEPZATO KIT: Peri-Procedural Complications Advise patients of the severe procedural risks associated with administration of melphalan using the HEPZATO KIT including hemorrhage, hepatic injury, and thromboembolic events
• Advise patients that they will be monitored in a hospital setting following each treatment
• Advise patients taking anti-coagulant and anti-hypertensive medications that these may need to be discontinued prior to treatment with HEPZATO KIT [see Warnings and Precautions ]
• Myelosuppression Advise patients to immediately contact their healthcare provider for a fever, bruising, or bleeding. …

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 infarcti …

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. ( 5.4 ) Gastrointestinal disturbances such as nausea and vomiting, abdominal pain and diarrhea are common. ( 5.5 ) 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. …

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, f …

8.1 Pregnancy Risk Summary Based on animal studies and its mechanism of action, melphalan can cause fetal harm when administered to a pregnant woman, including teratogenicity and/or embryo-fetal lethality [see Clinical Pharmacology ( 12.1 ) ]. Melphalan is a genotoxic drug and can cause chromatid or chromosome damage in humans [see Nonclinical Toxicology ( 13.1 ) ]. …

HEPZATO for injection and its associated diluents including 0.9% sodium chloride must be stored at controlled room temperature 20°C to 25°C (68°F to 77°F). …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.