Reconstitution
Instructions

ISTODAX is a cytotoxic drug.
Use appropriate handling procedures.

  • Step 1: Gather necessary materials

    ISTODAX Reconstitution Step 1: Gather the necessary materials

    1. Calculate the number of vials needed for your patient1
    2. Gather materials needed for reconstitution
    —A sufficient number of ISTODAX kits
    —Suitably sized needle and syringe (3 mL or greater)24
    —Gloves and alcohol wipes24
    —500 mL bag or bottle of 0.9% Sodium Chloride for Injection, USP1
    3. Open an ISTODAX kit for reconstitution. The kit includes a 10 mg single-dose vial of ISTODAX and a single-dose vial with 2.2 mL (deliverable volume) of diluent1
    4. ISTODAX must be reconstituted with the supplied diluent and further diluted with 0.9% Sodium Chloride Injection, USP before intravenous infusion1
    5. ISTODAX and diluent vials contain an overfill to ensure the recommended volume can be withdrawn at a concentration of 5 mg/mL

  • Step 2: Choose an appropriately sized needle

    ISTODAX Reconstitution Step 2: Choose an appropriately sized needle

    1. Choose a suitably sized needle for the reconstitution process2
    2. Attach the suitably sized needle to a 3-mL syringe or larger24

  • Step 3: Draw up the diluent

    ISTODAX Reconstitution Step 3: Draw up the diluent

    1. Remove the tamper-evident cap from the vial of diluent and expose the rubber stopper24
    2. Using appropriate aseptic technique, insert the needle through the center of the stopper24
    Each 10 mg single-dose vial of ISTODAX must be reconstituted with 2.2 mL of supplied diluent1
    3. Withdraw 2.2 mL from the diluent vial1

  • Step 4: Slowly inject the diluent while angling the stream

    ISTODAX Reconstitution Step 4: Slowly inject the diluent while angling the stream

    1. Remove the tamper-evident seal from the ISTODAX vial to expose the rubber stopper24
    2. Using appropriate aseptic technique, insert the needle through the center of the stopper24
    3. Slowly inject 2.2 mL of the diluent into the ISTODAX vial1

  • Step 5: Swirl the vial

    ISTODAX Reconstitution Step 5: Swirl the vial

    1. Swirl the contents of the vial until there are no visible particles in the resulting solution1
    2. The reconstituted ISTODAX vial will contain 2 mL of deliverable volume of drug product at a concentration of 5 mg/mL and is chemically stable for up to 8 hours at room temperature defined as 20° to 25°C (68° to 77°F)1,26
    3. Reconstitute the number of ISTODAX vials needed for your patient based on the appropriate dosage required1
    4. Parenteral drug products should be inspected visually for particulate matter and discoloration before administration whenever solution and container permit1

  • Step 6: Further dilute with 0.9% Sodium Chloride Injection, USP

    ISTODAX Reconstitution Step 6: Further dilute with 0.9% sodium chloride injection, USP

    1. Remove the tamper-resistant seal from the bag of 500 mL of 0.9% Sodium Chloride Injection, USP using appropriate aseptic technique1
    2. Withdraw the appropriate amount of reconstituted ISTODAX from the vials; inject it into the 0.9% Sodium Chloride Injection, USP bag1
    3. The diluted solution is compatible with polyvinyl chloride (PVC), ethylene vinyl acetate (EVA), and polyethylene (PE) infusion bags as well as glass bottles and is chemically stable for up to 24 hours when stored at room temperature. However, administer as soon after dilution as possible1
    4. Infuse intravenously over 4 hours1

Procedures for proper handling and disposal of anticancer drugs should be considered. See Full Prescribing Information for a reference on this subject. In addition, refer to your institutional guidelines for the preparation and administration of cytotoxic drugs.

NEXT: HOW ISTODAX IS ADMINISTERED

Important Safety Information

WARNINGS AND PRECAUTIONS

ADVERSE REACTIONS

Cutaneous T-Cell Lymphoma
The most common Grade 3/4 adverse reactions (>5%) regardless of causality in Study 1 (N=102) were infections (11%) and asthenia/fatigue (8%), and in Study 2 (N=83) were lymphopenia (37%), infections (33%), neutropenia (27%), leukopenia (22%), anemia (16%), asthenia/fatigue (14%), thrombocytopenia (14%), hypophosphatemia (10%), vomiting (10%), dermatitis/exfoliative dermatitis (8%), hypermagnesemia (8%), hyperuricemia (8%), hypocalcemia (6%), nausea (6%), and pruritus (6%).

Infections were the most common type of serious adverse event reported in both Study 1 (N=102) and Study 2 (N=83) with 8 patients (8%) in Study 1 and 26 patients (31%) in Study 2 experiencing a serious infection.

The most common adverse reactions regardless of causality in Study 1 (N=102) were nausea (56%), asthenia/fatigue (53%), infections (46%), vomiting (34%), and anorexia (23%), and in Study 2 (N=83) were nausea (86%), asthenia/fatigue (77%), anemia (72%), thrombocytopenia (65%), ECG ST-T wave changes (63%), neutropenia (57%), lymphopenia (57%), infections (54%), anorexia (54%), vomiting (52%), hypocalcemia (52%), hyperglycemia (51%), hypoalbuminemia (48%), leukopenia (46%), dysgeusia (40%), and constipation (39%).

DRUG INTERACTIONS

USE IN SPECIFIC POPULATIONS

Please click here for Full Prescribing Information.

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