SUSTOL

SUSTOL- granisetron injection
Heron Therapeutics

1 INDICATIONS AND USAGE

SUSTOL is indicated in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens.

2 DOSAGE AND ADMINISTRATION

2.1 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.

2.2 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.

2.3 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)].

3 DOSAGE FORMS AND STRENGTHS

SUSTOL is supplied as a clear, colorless to slightly yellow, viscous liquid and is available as an:

  • Extended-Release Injection: 10 mg/0.4 mL in a single-dose pre-filled syringe.

4 CONTRAINDICATIONS

SUSTOL is contraindicated in patients with hypersensitivity to granisetron, any of the components of SUSTOL, or to any of the other 5-HT3 receptor antagonists [see Warnings and Precautions (5.3), Description (11)].

5 WARNINGS AND PRECAUTIONS

5.1 Injection Site Reactions (ISRs)

Infections

Infections at the injection site occurred in 0.4% (7 of 1814) of patients with cancer and 0.2% (1 of 412) of healthy subjects in clinical trials. Infections had a median onset of 9 days (range 7 to 16 days) following SUSTOL administration. One patient who was neutropenic at the time of the infection was hospitalized. All patients with infection were treated with antibiotics and had complete resolution.

Bruising and/or hematomas

Bruising and/or hematomas at the injection site occurred in 426 of 1131 (38%) patients treated with SUSTOL 10 mg with a median time to onset of 2 days. Bruising and/or hematomas with a delayed onset (onset 5 or more days following SUSTOL administration) were reported in 175 (15%) patients. Severe bruising or hematoma (e.g., greater than 4 cm bruise or hematoma) occurred in 3% of patients. Patients receiving concomitant anticoagulant and antiplatelet medications were at greater risk for severe injection site bruising and hematomas.

Bleeding

Bleeding at the injection site occurred in 70 of 1814 (4%) patients treated with SUSTOL. One patient required emergency management. Bleeding for longer than 5 days was reported in 23 (1%) patients.

Pain and Tenderness

In a clinical trial that collected information about injection site pain and tenderness from patient diaries, pain with or without tenderness at the injection site was reported by 91 of 456 (20%) of patients treated with SUSTOL 10 mg, and an additional 50 of 456 (11%) of patients reported tenderness without pain. Pain and/or tenderness severe enough to require taking pain medication, interfere with patient activity level, or cause significant discomfort at rest was reported in 2% of patients. Among all patients who reported pain and/or tenderness with SUSTOL 10 mg in clinical trials, the median duration was 5 days, and pain lasting longer than 7 days occurred in 6% of patients.

Nodules

Nodules at the injection site occurred in 203 of 1131 (18%) of patients treated with SUSTOL 10 mg. Nodules persisted for a median of 15 days and 73 patients (6%) had nodules with durations longer than 21 days.

Management of ISRs

  • Monitor patients for ISRs following SUSTOL injection. Some ISRs (infections, bruising, and hematoma) may occur up to 2 weeks or more after SUSTOL administration.
  • In patients receiving antiplatelet agents or anticoagulants, consider the increased risk of bruising or severe hematoma prior to the use of SUSTOL.
  • In patients with ongoing or unresolved ISRs, administer SUSTOL at a site away from areas affected by ISRs [see Dosage and Administration (2.1)].

5.2 Gastrointestinal Disorders

Constipation

In clinical trials, 224 of 1131 (20%) of patients treated with SUSTOL 10 mg reported constipation compared to 13% to 15% in the 5-HT3 receptor antagonist control arms. Hospitalization due to constipation or fecal impaction was reported in 5 SUSTOL-treated patients (0.3%). Monitor patients for the development of constipation while receiving treatment with SUSTOL taking into consideration the extended-release properties of the SUSTOL polymer formulation over at least 5 to 7 days, particularly in patients receiving opioid medications. Consider optimizing bowel regimens in patients using SUSTOL.

Progressive Ileus and Gastric Distention

SUSTOL may mask a progressive ileus and/or gastric distention. This should be particularly considered before use of SUSTOL in patients who have had recent abdominal surgery. Monitor for decreased bowel activity, particularly in patients with risk factors for gastrointestinal obstruction.

5.3 Hypersensitivity Reactions

Hypersensitivity reactions, including anaphylaxis, have been reported in granisetron-treated patients who have exhibited hypersensitivity to other 5-HT3 receptor antagonists [see Contraindications (4)]. Avoid SUSTOL in patients who have had hypersensitivity reactions to other 5-HT3 receptor antagonists [see Contraindications (4)].

Due to the extended-release properties of the SUSTOL polymer formulation, exposure to granisetron may continue for 5 to 7 days following administration. Hypersensitivity reactions may occur up to 7 days or longer following SUSTOL administration and may have an extended course. Inform patients of the signs and symptoms of anaphylaxis, and instruct them to seek immediate medical care should signs and symptoms occur. If hypersensitivity reactions occur, administer appropriate treatment and monitor patients until signs and symptoms resolve.

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