Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of the labeling: – Hypotension and Cardiovascular Events [see Warnings and Precautions (5.3) ] – Severe Cutaneous Reactions [see Warnings and Precautions (5.4) ] – Hypersensitivity [see Warnings and Precautions (5.5) ] – Nausea and Vomiting [see Warnings and Precautions (5.6) ] – Hypocalcemia [see Warnings and Precautions (5.7) ] Most common adverse reactions are hypotension, nausea and vomiting.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Legacy Pharma Inc.
at 1-800-727-7151 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trial 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.
ETHYOL was administered to patients receiving chemotherapeutic agents for advanced ovarian cancer (WR-1 study) or who were receiving standard fractionated radiotherapy for head and neck cancer (WR-38 study) [see Clinical Studies (14) ] .
In the WR-38 study of patients with head and neck cancer, 17% (26/150) discontinued ETHYOL due to adverse reactions.
All but one of these patients continued to receive radiation treatment until completion.
Table 2 summarizes adverse reactions reported in patients from the WR-1 and WR-38 clinical trials.
Table 2: Incidence of Common Adverse Reactions in Patients Receiving ETHYOL Ovarian Cancer (WR-1 Trial) 910 mg/m 2 Head and Neck Cancer (WR-38 Trial) 200 mg/m 2 Per Patient Per Infusion Per Patient Per Infusion Nausea/Vomiting ≥Grade 3 36/122 (30%) 53/592 (9%) 12/150 (8%) 13/4314 (<1%) All Grades 117/122 (96%) 520/592 (88%) 80/150 (53%) 233/4314 (5%) Hypotension ≥Grade 3 10/122 (8%) 4/150 (3%) All Grades 75/122 (62%) 159/592 (27%) 22/150 (15%) 46/4314 (1%) Other clinically relevant adverse reactions reported in patients in the WR-1 and WR-38 trials include the following: Infusion-related Reactions: flushing/feeling of warmth, chills/feeling of coldness, malaise, pyrexia, rash, dizziness, somnolence, hiccups, diarrhea, sneezing, diplopia and blurred vision.
These effects have not generally precluded the completion of therapy.
5 WARNINGS AND PRECAUTIONS – Hypotension and Cardiovascular Events: Patients who are hypotensive or dehydrated should not receive ETHYOL.
If interruption of antihypertensive therapy is possible, interrupt antihypertensive therapy 24 hours prior to ETHYOL administration.
Monitor blood pressure during infusion;
interrupt and restart infusion if decrease in systolic blood pressure is observed.
Do not administer ETHYOL to hypotensive patients who are taking antihypertensive therapy that cannot be stopped for 24 hours prior to ETHYOL administration.
Like all medications, Ethyol can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: