Totect

Managing an anthracycline extravasation with TOTECT® (dexrazoxane) for injection1

Administer TOTECT within 6 hours of the extravasation.

It must be re-administered as follows:
Second dose, day 2: 24 (±3) hours after day 1
Third dose, day 3: 48 (±3) hours after day 1

Pharmacist: TOTECT Preparation

TOTECT solution can be prepared with EITHER Sterile Water for Injection, USP and Lactated Ringer’s Injection OR 0.167M sodium lactate injection and 0.9% Sodium Chloride Injection– refer carefully to the instructions below.

Preparation of Totect Solution using Sterile Water for Injection, USP and Lactated Ringer’s Injection, USP

Step 1. Reconstitute each Totect vial with 50 mL of Sterile Water for Injection, USP. Once reconstituted, the reconstituted Totect solution contains 
10 mg/mL of Totect.

Step 2. Calculate the volume of the 10 mg/mL reconstituted Totect solution needed for the recommended dose. In order to obtain the required dose, more than one vial may be needed. The reconstituted solution should be further diluted within 30 minutes after initial reconstitution. It contains no antibacterial preservative.

Step 3. Withdraw the calculated volume from the reconstituted Totect solution and further dilute into an infusion bag containing 1000 mL of Lactated Ringer’s Injection. Do not mix Totect with any other drugs.

Preparation of Totect Solution using 0.167M Sodium Lactate Injection and 0.9% Sodium Chloride Injection

Step 1. Reconstitute each Totect vial with 50 mL of 0.167M sodium lactate injection solution.

Preparation of 0.167M sodium lactate injection solution
Dilution of sodium lactate injection to 0.167M is required before using it to reconstitute Totect. Add 1.67 mL of 5 mEq/mL sodium lactate injection to 50 mL Sterile Water for Injection, USP to make 50 mL of 0.167M sodium lactate injection solution.

Once reconstituted, the reconstituted Totect solution contains 10 mg/mL of Totect.

Step 2. Calculate the volume of the 10 mg/mL reconstituted Totect solution needed for the recommended dose. In order to obtain the required dose, more than one vial may be needed. The reconstituted solution should be further diluted within 30 minutes after initial reconstitution. It contains no antibacterial preservative.

Step 3. Withdraw the calculated volume from the reconstituted Totect solution and further dilute into an infusion bag containing 1000 mL of 0.9% Sodium Chloride Injection. Do not mix Totect with any other drugs.

Use the Totect infusion bag immediately after preparation. If not used immediately, the product is stable for 4 hours from the time of preparation when stored at room temperature or for up to 12 hours when stored refrigerated between 2-8ºC (36-46°F).

Nurse: TOTECT Administration

Remove any local cooling at least 15 minutes prior to administration.

Administer TOTECT as an intravenous infusion over 1-2 hours. Infusion should be in a large vein of an extremity or area other than the one affected by the extravasation, as soon as possible within the first 6 hours after the incident. Treatment on Day 2 and Day 3 should start at the same hour (+/- 3 hours) as on the first day.

As TOTECT is a hazardous drug, follow all hazardous drug safety precautions.

References:
1. TOTECT® [prescribing information]. Nashville, TN; Cumberland Pharmaceuticals; November 2018.

INDICATION: TOTECT® (dexrazoxane) is indicated for the treatment of extravasation resulting from intravenous anthracycline chemotherapy.

IMPORTANT DOSAGE AND ADMINISTRATION INSTRUCTIONS
Reconstitute and further dilute Totect before use [see Prescribing Information- Dosage and Administration]. The Totect dose should be reduced by 50% in patients with creatinine clearance values < 40 mL/min.

IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS

None.

WARNINGS AND PRECAUTIONS
Myelosuppression: TOTECT is associated with leukopenia, neutropenia, and thrombocytopenia. Perform hematological monitoring during treatment with TOTECT and cytotoxic chemotherapy as the myelosuppression and cytotoxic potential may be additive to that of chemotherapy alone.

Anaphylactic/Hypersensitivity Reactions: Hypersensitivity reactions including anaphylactic reaction, angioedema, skin reactions, bronchospasm, respiratory distress, hypotension and loss of consciousness have occurred in patients treated with dexrazoxane products and anthracyclines. Previous history of allergy to dexrazoxane products should be carefully considered prior to administration. Consider permanent discontinuation in patients with severe hypersensitivity reactions.

Embryo-Fetal Toxicity: TOTECT can cause fetal harm when administered to a pregnant woman. Advise patients of potential risk and to use effective contraception during treatment and 6 months following the last dose of TOTECT. Use in patients with hepatic impairment is not recommended.

DRUG INTERACTIONS
TOTECT is not recommended for use with dimethyl sulfoxide (DMSO).

ADVERSE REACTIONS
In the clinical studies, TOTECT was administered to patients also receiving chemotherapeutic agents for cancer, and the adverse reaction profile reflects the combination of TOTECT, underlying disease, and already administered chemotherapy. The most common adverse reactions (≥15%) are nausea, fever, injection site pain, vomiting, and postoperative infection.

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