SUSTOL SIDE EFFECTS
- Generic Name: granisetron extended-release injection
- Brand Name: Sustol
- Drug Class: Antiemetics, Selective 5-HT3 Antagonist
SIDE EFFECTS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Injection Site Reactions
- Gastrointestinal Disorders
- Hypersensitivity Reactions
- Serotonin Syndrome
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
SUSTOL
The safety of a 10 mg subcutaneous dose of SUSTOL was evaluated in two double-blind, randomized, active-controlled studies, in which 210 patients (23%) received MEC and 467 patients (51%) received AC combination chemotherapy. The data described below reflect exposure to a single 10 mg dose of SUSTOL in 924 patients whose mean age was 56 years (range 19 to 91 years); 76% of patients were female; 70% of patients were Caucasian, 16%, Asian, 10% Black, and 4% other races. Dexamethasone was co-administered with SUSTOL in Study 1 and Study 2 and an NK1 receptor antagonist was co-administered with SUSTOL in Study 2.
Table 1 lists the most common adverse reactions reported in at least 3% of patients following a single-dose of SUSTOL 10 mg in Study 1 and/or Study 2. Overall, injection site reactions (ISRs) were the most common group of adverse reactions in SUSTOL-treated patients. Specific types of ISRs reported by SUSTOL-treated patients are shown in Table 2.
Table 1. Adverse Reactions Occurring in at Least 3% of Patients Treated with SUSTOL 10 mg in Study 1 and/or Study 2
| Adverse Reaction | Study 1 | Study 2 | ||
| SUSTOL 10 mg subcutaneous (N=468) % | Palonosetron hydrochloride 0.25 mg intravenous (N=463) % | SUSTOL 10 mg subcutaneous (N=456) % | Ondansetron 0.15 mg/kg intravenous (N=459) % | |
| Injection Site Reactions, anya | 37 | 15b | 62 | See footnoteb |
| Constipation | 14 | 11 | 22 | 15 |
| Fatigue | 11 | 10 | 21 | 24 |
| Headache | 9 | 9 | 13 | 19 |
| Diarrhea | 8 | 7 | 9 | 8 |
| Abdominal Pain | 7 | 7 | 7 | 4 |
| Insomnia | 4 | 2 | 5 | 6 |
| Dyspepsia | 3 | 3 | 6 | 7 |
| Dizziness | 3 | 2 | 5 | 5 |
| Asthenia | 4 | 6 | 2 | 2 |
| Gastroesophageal Reflux | 1 | 1 | 5 | 4 |
| a Rates of individual injection site reactions (ISRs) are shown in Table 2 b The placebo subcutaneous injection for Study 1 was normal saline and for Study 2 was a SUSTOL-matched control consisting of the SUSTOL polymer vehicle without active drug. |
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Injection Site Reactions (ISRs)
Injection site reactions occurred in 37% (175/468) in Study 1, Cycle 1 only, and 62% (281/456) in Study 2 of SUSTOL-treated patients. The ISR manifestations included pain, erythema, mass/nodule, swelling/induration, and bleeding. The incidence of individual ISRs is shown in Table 2. Patients may have experienced one or more types of injection site reactions; a total of 213 of 924 patients had three or more.
ISR reporting procedures included both investigator-and patient-reported outcomes in Study 2, while Study 1 used only investigator reporting.
Table 2. Injection Site Adverse Reactions Following a Single 10 mg SUSTOL Dose
| Injection Site Reaction | Study 1 Treatment Arm (Subcutaneous Injection) | Study 2a,b SUSTOL (N=456) % | |
| SUSTOL (N=468) % | Saline Control (N=463) % | ||
| Total Subjects with at least 1 ISR | 37 | 15 | 62 |
| Pain | 3 | 1 | 20 |
| Tenderness | 4 | 1 | 27 |
| Bruising/Hematoma | 22 | 10 | 45 |
| Bleeding | 2 | 1 | 4 |
| Erythema/Redness | 11 | 3 | 17 |
| Swelling/Induration | 1 | 0 | 10 |
| Mass/Nodule | 11 | 1 | 18 |
| Infection at injection site | <1 | 0 | 1 |
| Otherc | 2 | 1 | 1 |
| a Patient diary was used in Study 2 to collect ISR information daily. b The placebo subcutaneous injection for Study 2 was a SUSTOL-matched control consisting of the SUSTOL polymer vehicle without active drug. ISR data for this group are not shown. c Other includes injection site discoloration, vesicles, irritation, lipoma, paresthesia, pruritus, rash, reaction, scab, scar, and warmth. |
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Less common adverse reactions reported in less than 3% of SUSTOL-treated patients in clinical trials are syncope, elevation of serum transaminase levels, pancreatitis, atrial fibrillation, somnolence, flushing, and hypersensitivity reactions (e.g., anaphylaxis, urticaria).
Postmarketing Experience
The following adverse reactions have been identified during post-approval use of other formulations of granisetron. Because they are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
| System Organ Class | Adverse Reactions |
| Cardiovascular | bradycardia, chest pain, palpitations, sick sinus syndrome |
SRC: NLM .