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amifostine
Overview
What is Ethyol?
ETHYOL (amifostine) is an organic thiophosphate cytoprotective agent known chemically as 2-[(3-aminopropyl)amino]ethanethiol dihydrogen phosphate (ester) and has the following structural formula:
H
N(CH
)
NH(CH
)
S-PO
H
Amifostine is a white crystalline powder which is freely soluble in water. Its empirical formula is CHNOPS and it has a molecular weight of 214.22.
ETHYOL is the trihydrate form of amifostine and is supplied as a sterile lyophilized powder requiring reconstitution for intravenous infusion. Each single-use 10 mL vial contains 500 mg of amifostine on the anhydrous basis.
What does Ethyol look like?
What are the available doses of Ethyol?
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What should I talk to my health care provider before I take Ethyol?
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How should I use Ethyol?
ETHYOL (amifostine) is indicated to reduce the cumulative renal toxicity associated with repeated administration of cisplatin in patient
s 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 (see
).
For the approved indications, the clinical data do not suggest that the effectiveness of cisplatin based chemotherapy regimens or radiation therapy is altered by ETHYOL. There are at present only limited data on the effects of amifostine on the efficacy of chemotherapy or radiotherapy in other settings. ETHYOL should not be administered to patients in other settings where chemotherapy can produce a significant survival benefit or cure, or in patients receiving definitive radiotherapy, except in the context of a clinical study (see ).
The recommended starting dose of ETHYOL is 910 mg/m administered once daily as a 15-minute i.v. infusion, starting 30 minutes prior to chemotherapy.
The 15-minute infusion is better tolerated than more extended infusions. Further reductions in infusion times for chemotherapy regimens have not been systematically investigated.
Patients should be adequately hydrated prior to ETHYOL infusion and kept in a supine position during the infusion. Blood pressure should be monitored every 5 minutes during the infusion, and thereafter as clinically indicated.
The infusion of ETHYOL should be interrupted if the systolic blood pressure decreases significantly from the baseline value as listed in the guideline below:
If the blood pressure returns to normal within 5 minutes and the patient is asymptomatic, the infusion may be restarted so that the full dose of ETHYOL may be administered. If the full dose of ETHYOL cannot be administered, the dose of ETHYOL for subsequent chemotherapy cycles should be 740 mg/m.
It is recommended that antiemetic medication, including dexamethasone 20 mg i.v. and a serotonin 5HT receptor antagonist, be administered prior to and in conjunction with ETHYOL. Additional antiemetics may be required based on the chemotherapy drugs administered.
For Reduction of Moderate to Severe Xerostomia from Radiation of the Head and Neck:
The recommended dose of ETHYOL is 200 mg/m administered once daily as a 3-minute i.v. infusion, starting 15-30 minutes prior to standard fraction radiation therapy (1.8-2.0 Gy).
Patients should be adequately hydrated prior to ETHYOL infusion. Blood pressure should be monitored at least before and immediately after the infusion, and thereafter as clinically indicated.
It is recommended that antiemetic medication be administered prior to and in conjunction with ETHYOL. Oral 5HT receptor antagonists, alone or in combination with other antiemetics, have been used effectively in the radiotherapy setting.
What interacts with Ethyol?
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What are the warnings of Ethyol?
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What are the precautions of Ethyol?
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What are the side effects of Ethyol?
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What should I look out for while using Ethyol?
ETHYOL is contraindicated in patients with known hypersensitivity to aminothiol compounds.
1. Effectiveness of the Cytotoxic Regimen
Limited data are currently available regarding the preservation of antitumor efficacy when ETHYOL is administered prior to cisplatin therapy in settings other than advanced ovarian cancer. Although some animal data suggest interference is possible, in most tumor models the antitumor effects of chemotherapy are not altered by amifostine. ETHYOL should not be used in patients receiving chemotherapy for other malignancies in which chemotherapy can produce a significant survival benefit or cure (e.g., certain malignancies of germ cell origin), except in the context of a clinical study.
2. Effectiveness of Radiotherapy
ETHYOL should not be administered in patients receiving definitive radiotherapy, except in the context of a clinical trial, since there are at present insufficient data to exclude a tumor-protective effect in this setting. ETHYOL was studied only with standard fractionated radiotherapy and only when ≥75% of both parotid glands were exposed to radiation. The effects of ETHYOL on the incidence of xerostomia and on toxicity in the setting of combined chemotherapy and radiotherapy and in the setting of accelerated and hyperfractionated therapy have not been systematically studied.
3. Hypotension
Patients who are hypotensive or in a state of dehydration should not receive ETHYOL. Patients receiving ETHYOL at doses recommended for chemotherapy should have antihypertensive therapy interrupted 24 hours preceding administration of ETHYOL. Patients receiving ETHYOL at doses recommended for chemotherapy who are taking antihypertensive therapy that cannot be stopped for 24 hours preceding ETHYOL treatment, should not receive ETHYOL.
Prior to ETHYOL infusion patients should be adequately hydrated. During ETHYOL infusion patients should be kept in a supine position. Blood pressure should be monitored every 5 minutes during the infusion, and thereafter as clinically indicated. It is important that the duration of the 910 mg/m infusion not exceed 15 minutes, as administration of ETHYOL as a longer infusion is associated with a higher incidence of side effects. For infusion durations less than 5 minutes, blood pressure should be monitored at least before and immediately after the infusion, and thereafter as clinically indicated. If hypotension occurs, patients should be placed in the Trendelenburg position and be given an infusion of normal saline using a separate i.v. line. During and after ETHYOL infusion, care should be taken to monitor the blood pressure of patients whose antihypertensive medication has been interrupted since hypertension may be exacerbated by discontinuation of antihypertensive medication and other causes such as i.v. hydration.
Guidelines for interrupting and restarting ETHYOL infusion if a decrease in systolic blood pressure should occur are provided in the section. Hypotension may occur during or shortly after ETHYOL infusion, despite adequate hydration and positioning of the patient (see and ). Hypotension has been reported to be associated with dyspnea, apnea, hypoxia, and in rare cases seizures, unconsciousness, respiratory arrest and renal failure.
4. Cutaneous Reactions
Fatal and serious cutaneous reactions have been reported with ETHYOL treatment, including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, toxicoderma, exfoliative dermatitis and drug reaction with biopsy-confirmed eosinophilia and systemic symptoms (DRESS). These reactions have been reported more frequently when ETHYOL is used as a radioprotectant (see ). Serious cutaneous reactions may develop weeks after initiation of ETHYOL administration. Monitor patients carefully prior to, during and after ETHYOL administration. Discontinue ETHYOL for cutaneous reactions or mucosal lesions appearing outside of the injection site or radiation port and for erythematous, edematous or bullous lesions on the palms or soles.
5. Hypersensitivity
Allergic manifestations including anaphylaxis and severe cutaneous reactions have been associated with ETHYOL administration.
6. Nausea and Vomiting
Antiemetic medication should be administered prior to and in conjunction with ETHYOL (see ). When ETHYOL is administered with highly emetogenic chemotherapy, the fluid balance of the patient should be carefully monitored.
7. Hypocalcemia
Serum calcium levels should be monitored in patients at risk of hypocalcemia, such as those with nephrotic syndrome or patients receiving multiple doses of ETHYOL (see ). If necessary, calcium supplements can be administered.
What might happen if I take too much Ethyol?
In clinical trials, the maximum single dose of ETHYOL was 1300 mg/m. No information is available on single doses higher than this in adults. In the setting of a clinical trial, pediatric patients have received single ETHYOL doses of up to 2700 mg/m. At the higher doses, anxiety and reversible urinary retention occurred.
Administration of ETHYOL at 2 and 4 hours after the initial dose has not led to increased nausea and vomiting or hypotension. The most likely symptom of overdosage is hypotension, which should be managed by infusion of normal saline and other supportive measures, as clinically indicated.
How should I store and handle Ethyol?
Store at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) ETHYOL (amifostine) for Injection is supplied as a sterile lyophilized powder in 10 mL single-use vials (NDC 66220-017-03). Each single-use vial contains 500 mg of amifostine on the anhydrous basis. The vials are available packaged as follows:3 pack - 3 vials per carton (NDC 66220-017-03)Store the lyophilized dosage form at Controlled Room Temperature 20°-25°C (68°-77°F) [See USP].U.S. Patent 5,994,409Manufactured for: Cumberland Pharmaceuticals Inc.Nashville, TN 37203ETHYOL is a registered trademark owned by the Clinigen Group.For product information, please call Cumberland Pharmaceuticals Inc. Medical Information at 1 877 484 2700.Revision Date 05/2017ETHYOL (amifostine) for Injection is supplied as a sterile lyophilized powder in 10 mL single-use vials (NDC 66220-017-03). Each single-use vial contains 500 mg of amifostine on the anhydrous basis. The vials are available packaged as follows:3 pack - 3 vials per carton (NDC 66220-017-03)Store the lyophilized dosage form at Controlled Room Temperature 20°-25°C (68°-77°F) [See USP].U.S. Patent 5,994,409Manufactured for: Cumberland Pharmaceuticals Inc.Nashville, TN 37203ETHYOL is a registered trademark owned by the Clinigen Group.For product information, please call Cumberland Pharmaceuticals Inc. Medical Information at 1 877 484 2700.Revision Date 05/2017ETHYOL (amifostine) for Injection is supplied as a sterile lyophilized powder in 10 mL single-use vials (NDC 66220-017-03). Each single-use vial contains 500 mg of amifostine on the anhydrous basis. The vials are available packaged as follows:3 pack - 3 vials per carton (NDC 66220-017-03)Store the lyophilized dosage form at Controlled Room Temperature 20°-25°C (68°-77°F) [See USP].U.S. Patent 5,994,409Manufactured for: Cumberland Pharmaceuticals Inc.Nashville, TN 37203ETHYOL is a registered trademark owned by the Clinigen Group.For product information, please call Cumberland Pharmaceuticals Inc. Medical Information at 1 877 484 2700.Revision Date 05/2017ETHYOL (amifostine) for Injection is supplied as a sterile lyophilized powder in 10 mL single-use vials (NDC 66220-017-03). Each single-use vial contains 500 mg of amifostine on the anhydrous basis. The vials are available packaged as follows:3 pack - 3 vials per carton (NDC 66220-017-03)Store the lyophilized dosage form at Controlled Room Temperature 20°-25°C (68°-77°F) [See USP].U.S. Patent 5,994,409Manufactured for: Cumberland Pharmaceuticals Inc.Nashville, TN 37203ETHYOL is a registered trademark owned by the Clinigen Group.For product information, please call Cumberland Pharmaceuticals Inc. Medical Information at 1 877 484 2700.Revision Date 05/2017ETHYOL (amifostine) for Injection is supplied as a sterile lyophilized powder in 10 mL single-use vials (NDC 66220-017-03). Each single-use vial contains 500 mg of amifostine on the anhydrous basis. The vials are available packaged as follows:3 pack - 3 vials per carton (NDC 66220-017-03)Store the lyophilized dosage form at Controlled Room Temperature 20°-25°C (68°-77°F) [See USP].U.S. Patent 5,994,409Manufactured for: Cumberland Pharmaceuticals Inc.Nashville, TN 37203ETHYOL is a registered trademark owned by the Clinigen Group.For product information, please call Cumberland Pharmaceuticals Inc. Medical Information at 1 877 484 2700.Revision Date 05/2017ETHYOL (amifostine) for Injection is supplied as a sterile lyophilized powder in 10 mL single-use vials (NDC 66220-017-03). Each single-use vial contains 500 mg of amifostine on the anhydrous basis. The vials are available packaged as follows:3 pack - 3 vials per carton (NDC 66220-017-03)Store the lyophilized dosage form at Controlled Room Temperature 20°-25°C (68°-77°F) [See USP].U.S. Patent 5,994,409Manufactured for: Cumberland Pharmaceuticals Inc.Nashville, TN 37203ETHYOL is a registered trademark owned by the Clinigen Group.For product information, please call Cumberland Pharmaceuticals Inc. Medical Information at 1 877 484 2700.Revision Date 05/2017ETHYOL (amifostine) for Injection is supplied as a sterile lyophilized powder in 10 mL single-use vials (NDC 66220-017-03). Each single-use vial contains 500 mg of amifostine on the anhydrous basis. The vials are available packaged as follows:3 pack - 3 vials per carton (NDC 66220-017-03)Store the lyophilized dosage form at Controlled Room Temperature 20°-25°C (68°-77°F) [See USP].U.S. Patent 5,994,409Manufactured for: Cumberland Pharmaceuticals Inc.Nashville, TN 37203ETHYOL is a registered trademark owned by the Clinigen Group.For product information, please call Cumberland Pharmaceuticals Inc. Medical Information at 1 877 484 2700.Revision Date 05/2017ETHYOL (amifostine) for Injection is supplied as a sterile lyophilized powder in 10 mL single-use vials (NDC 66220-017-03). Each single-use vial contains 500 mg of amifostine on the anhydrous basis. The vials are available packaged as follows:3 pack - 3 vials per carton (NDC 66220-017-03)Store the lyophilized dosage form at Controlled Room Temperature 20°-25°C (68°-77°F) [See USP].U.S. Patent 5,994,409Manufactured for: Cumberland Pharmaceuticals Inc.Nashville, TN 37203ETHYOL is a registered trademark owned by the Clinigen Group.For product information, please call Cumberland Pharmaceuticals Inc. Medical Information at 1 877 484 2700.Revision Date 05/2017
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Clinical pharmacokinetic studies show that ETHYOL is rapidly cleared from the plasma with a distribution half-life of < 1 minute and an elimination half-life of approximately 8 minutes. Less than 10% of ETHYOL remains in the plasma 6 minutes after drug administration. ETHYOL is rapidly metabolized to an active free thiol metabolite. A disulfide metabolite is produced subsequently and is less active than the free thiol. After a 10-second bolus dose of 150 mg/mof ETHYOL, renal excretion of the parent drug and its two metabolites was low during the hour following drug administration, averaging 0.69%, 2.64% and 2.22% of the administered dose for the parent, thiol and disulfide, respectively. Measurable levels of the free thiol metabolite have been found in bone marrow cells 5-8 minutes after intravenous infusion of ETHYOL. Pretreatment with dexamethasone or metoclopramide has no effect on ETHYOL pharmacokinetics.
Non-Clinical Toxicology
ETHYOL is contraindicated in patients with known hypersensitivity to aminothiol compounds.1. Effectiveness of the Cytotoxic Regimen
Limited data are currently available regarding the preservation of antitumor efficacy when ETHYOL is administered prior to cisplatin therapy in settings other than advanced ovarian cancer. Although some animal data suggest interference is possible, in most tumor models the antitumor effects of chemotherapy are not altered by amifostine. ETHYOL should not be used in patients receiving chemotherapy for other malignancies in which chemotherapy can produce a significant survival benefit or cure (e.g., certain malignancies of germ cell origin), except in the context of a clinical study.
2. Effectiveness of Radiotherapy
ETHYOL should not be administered in patients receiving definitive radiotherapy, except in the context of a clinical trial, since there are at present insufficient data to exclude a tumor-protective effect in this setting. ETHYOL was studied only with standard fractionated radiotherapy and only when ≥75% of both parotid glands were exposed to radiation. The effects of ETHYOL on the incidence of xerostomia and on toxicity in the setting of combined chemotherapy and radiotherapy and in the setting of accelerated and hyperfractionated therapy have not been systematically studied.
3. Hypotension
Patients who are hypotensive or in a state of dehydration should not receive ETHYOL. Patients receiving ETHYOL at doses recommended for chemotherapy should have antihypertensive therapy interrupted 24 hours preceding administration of ETHYOL. Patients receiving ETHYOL at doses recommended for chemotherapy who are taking antihypertensive therapy that cannot be stopped for 24 hours preceding ETHYOL treatment, should not receive ETHYOL.
Prior to ETHYOL infusion patients should be adequately hydrated. During ETHYOL infusion patients should be kept in a supine position. Blood pressure should be monitored every 5 minutes during the infusion, and thereafter as clinically indicated. It is important that the duration of the 910 mg/m infusion not exceed 15 minutes, as administration of ETHYOL as a longer infusion is associated with a higher incidence of side effects. For infusion durations less than 5 minutes, blood pressure should be monitored at least before and immediately after the infusion, and thereafter as clinically indicated. If hypotension occurs, patients should be placed in the Trendelenburg position and be given an infusion of normal saline using a separate i.v. line. During and after ETHYOL infusion, care should be taken to monitor the blood pressure of patients whose antihypertensive medication has been interrupted since hypertension may be exacerbated by discontinuation of antihypertensive medication and other causes such as i.v. hydration.
Guidelines for interrupting and restarting ETHYOL infusion if a decrease in systolic blood pressure should occur are provided in the section. Hypotension may occur during or shortly after ETHYOL infusion, despite adequate hydration and positioning of the patient (see and ). Hypotension has been reported to be associated with dyspnea, apnea, hypoxia, and in rare cases seizures, unconsciousness, respiratory arrest and renal failure.
4. Cutaneous Reactions
Fatal and serious cutaneous reactions have been reported with ETHYOL treatment, including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, toxicoderma, exfoliative dermatitis and drug reaction with biopsy-confirmed eosinophilia and systemic symptoms (DRESS). These reactions have been reported more frequently when ETHYOL is used as a radioprotectant (see ). Serious cutaneous reactions may develop weeks after initiation of ETHYOL administration. Monitor patients carefully prior to, during and after ETHYOL administration. Discontinue ETHYOL for cutaneous reactions or mucosal lesions appearing outside of the injection site or radiation port and for erythematous, edematous or bullous lesions on the palms or soles.
5. Hypersensitivity
Allergic manifestations including anaphylaxis and severe cutaneous reactions have been associated with ETHYOL administration.
6. Nausea and Vomiting
Antiemetic medication should be administered prior to and in conjunction with ETHYOL (see ). When ETHYOL is administered with highly emetogenic chemotherapy, the fluid balance of the patient should be carefully monitored.
7. Hypocalcemia
Serum calcium levels should be monitored in patients at risk of hypocalcemia, such as those with nephrotic syndrome or patients receiving multiple doses of ETHYOL (see ). If necessary, calcium supplements can be administered.
Special consideration should be given to the administration of ETHYOL in patients receiving anti-hypertensive medications or other drugs that could cause or potentiate hypotension.
Patients should be adequately hydrated prior to the ETHYOL infusion and blood pressure should be monitored (see
).
The safety of ETHYOL administration has not been established in elderly patients, or in patients with preexisting cardiovascular or cerebrovascular conditions such as ischemic heart disease, arrhythmias, congestive heart failure, or history of stroke or transient ischemic attacks. ETHYOL should be used with particular care in these and other patients in whom the common ETHYOL adverse effects of nausea/vomiting and hypotension may be more likely to have serious consequences.
Prior to chemotherapy, ETHYOL should be administered as a 15-minute infusion (see ). Blood pressure should be monitored every 5 minutes during the infusion, and thereafter as clinically indicated.
Prior to radiation therapy, ETHYOL should be administered as a 3-minute infusion (see ). Blood pressure should be monitored at least before and immediately after the infusion, and thereafter as clinically indicated.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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