To Report Suspected Adverse Reactions:
Contact Cumberland Pharmaceuticals Inc. at 1-877-484-2700 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
For Professional Medical Information:
For all questions concerning adverse events associated with the use of this product, please contact Cumberland Pharmaceuticals by phone at (877) 484-2700.
ETHYOL® is stocked in distribution centers (dc) servicing your hospital or physician clinic:
|Wholesaler||Order Entry Number|
|HD Smith (Pharmaceutical)||560-1703|
|Physician Clinics and Centers|
|Wholesaler||Order Entry Number|
|McKesson Specialty Health – Solutions for Oncology||5006777|
|66220-017-03||ETHYOL (amifostine) for Injection||500 mg / vial||Three 500 mg vials per carton (Unit of sale)|
If your distribution center (dc) is temporarily out of ETHYOL:
Request the distribution center immediately contact Cumberland’s Customer Service Center:
Phone: (615) 287-8999
There are two ordering options you can direct the dc to utilize:
– Either –
1. DC orders from Cumberland, ETHYOL arrives at dc, and dc then ships against your P.O.
– Or –
2. DC arranges for drop-shipment directly to your facility, bypassing dc, which saves time.
|HCPCS Code||SHORT DESCRIPTION||HPCS CODE DOSAGE|
For Medicare reimbursement amount, check with your Medicare Part B contractor for maximum allowable limit.
ETHYOL (amifostine) for Injection is supplied as a sterile lyophilized powder in 10 mL single-dose vials (NDC 66220-017-03). Each single-dose vial contains 500 mg of amifostine on the anhydrous basis. The vials are available packaged as follows:
Indication: ETHYOL (amifostine) is indicated to reduce the cumulative renal toxicity associated with repeated administration of cisplatin in patients with advanced ovarian cancer.
ETHYOL is indicated to reduce the incidence of moderate to severe xerostomia in patients undergoing post-operative radiation treatment for head and neck cancer, where the radiation port includes a substantial portion of the parotid glands.
IMPORTANT DOSAGE AND ADMINISTRATION INSTRUCTIONS
Patients should be adequately hydrated prior to ETHYOL infusion. Blood pressure should be monitored prior to, during and immediately after infusion. Antiemetic medication should be administered prior to and in conjunction with ETHYOL.
IMPORTANT SAFETY INFORMATION
ETHYOL is contraindicated in patients with known hypersensitivity to aminothiol compounds.
WARNINGS AND PRECAUTIONS
ETHYOL should not be administered in patients receiving chemotherapy for other malignancies in which chemotherapy can produce a significant survival benefit or cure. ETHYOL should not be administered in patients receiving definitive radiotherapy, since there are at present insufficient data to exclude a tumor-protective effect in this setting.
Patients who are hypotensive or in a state of dehydration should not receive ETHYOL. Patients should have antihypertensive therapy interrupted 24 hours preceding administration of ETHYOL. Patients should not receive ETHYOL where therapy cannot be stopped for 24 hours preceding treatment.
The fluid balance of the patient should be carefully monitored when ETHYOL is administered with highly emetogenic chemotherapy.
Fatal and serious cutaneous reactions such as Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, toxicoderma, exfoliative dermatitis and drug reaction with biopsy-confirmed eosinophilia and systemic symptoms (DRESS) have been reported with ETHYOL treatment. These reactions is higher in patients receiving ETHYOL as a radioprotectant. Serious cutaneous reactions may develop weeks after initiation of ETHYOL administration. Discontinue Ethyol for cutaneous reactions or mucosal lesions appearing outside the injection site or radiation port and for erythematous, edematous or bullous lesions on the palms or soles. Monitor patients carefully prior to, during and after ETHYOL administration. In case of severe acute allergic reactions ETHYOL should be immediately and permanently discontinued. Epinephrine and other appropriate measures should be available for treatment of serious allergic events such as anaphylaxis.
In a randomized study of patients with ovarian cancer given ETHYOL, the most common adverse events included transient hypotension, nausea, vomiting, and a decrease in serum calcium concentrations. Other adverse events reported in clinical studies involving patients with ovarian or head and neck cancers include hypersensitivity and anaphylactic reactions, flushing, chills, malaise, pyrexia, diplopia, blurred vision, rash, dizziness, somnolence, hiccups, diarrhea, and sneezing. Injection site reactions including pruritus and urticaria were also observed.
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