Important Administration Instructions

• For subcutaneous injection only.
• SUSTOL is intended for administration by a health care provider.
• SUSTOL is supplied as a refrigerated kit consisting of a single-dose, pre-filled, sterile syringe, a special thin walled 18 Ga 5/8" administration needle, two syringe warming pouches, and a Point Lok® needle protection device. See the SUSTOL Instructions for Use included in the kit for complete administration instructions with illustrations.
• Do not substitute non-kit components for any of the components from the kit for administration.

Preparation

1. At least 60 minutes prior to administration, remove the SUSTOL kit from refrigeration.
2. Unpack the kit to allow the SUSTOL syringe and all other contents to warm to room temperature.
3. Activate one of the syringe warming pouches, and wrap the SUSTOL syringe in the warming pouch for 5 to 6 minutes to warm SUSTOL to body temperature.
4. Prior to administration, inspect the SUSTOL syringe visually for particulate matter and discoloration. Note that the syringe is amber colored glass. SUSTOL should not be administered if particulate matter or discoloration is observed, the tip cap is missing or has been tampered with, or if the Luer fitting is missing or dislodged.

Administration

1. Use standard aseptic technique when performing the injection.
2. Administer SUSTOL as a single subcutaneous injection in the skin of the back of the upper arm or in the skin of the abdomen at least one inch away from the umbilicus. Avoid injecting SUSTOL anywhere the skin is burned, hardened, inflamed, swollen, or otherwise compromised [see Warnings and Precautions (5.1)]. Topical anesthetic may be used at the injection site prior to administration of SUSTOL.
3. Due to the viscosity of SUSTOL, the time required for injection is greater than most medications administered subcutaneously. SUSTOL requires a slow, sustained injection which may take up to 20 to 30 seconds. Pressing the plunger harder will NOT expel SUSTOL faster.

Recommended Dosage

The recommended dosage of SUSTOL is 10 mg administered subcutaneously. Administer SUSTOL in combination with dexamethasone at least 30 minutes before the initiation of MEC or AC combination chemotherapy. Administer SUSTOL on Day 1 of chemotherapy and not more frequently than once every 7 days because of the extended-release properties of the formulation.

For patients receiving MEC, the recommended dexamethasone dosage is 8 mg intravenously on Day 1. For patients receiving AC combination chemotherapy regimens, the recommended dexamethasone dosage is 20 mg intravenously on Day 1, followed by 8 mg orally, twice a day, on Days 2, 3 and 4.

If SUSTOL is administered with an NK1 receptor antagonist, see the prescribing information of the NK1 receptor antagonist for the recommended dexamethasone dosage.

Dosage Adjustment in Renal Impairment

In patients with moderate renal impairment (creatinine clearance of 30 to 59 mL/min), administer SUSTOL on Day 1 of chemotherapy and not more frequently than once every 14 days. Avoid SUSTOL in patients with severe renal impairment (creatinine clearance of less than 30 mL/min) [see Use in Specific Populations (8.6)].