FDA

Ethyol

Approved 8 Dec 1995InjectionInjectable

The FDA lists this product in 2 strengths and forms.

Indications

ETHYOL is a cytoprotective agent indicated for: – reduction of cumulative renal toxicity associated with repeated administration of cisplatin in patients with advanced ovarian cancer. ( 1.1 ) – reduction of 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. ( 1.2 ) Limitation of Use Avoid the use of ETHYOL in settings where chemotherapy can produce a significant survival benefit or cure, or in patients receiving definitive radiotherapy.

( 1 , 5.1 , 5.2 )

1.1Reduction of Cumulative Renal Toxicity with Chemotherapy

ETHYOL (amifostine) is indicated to reduce the cumulative renal toxicity associated with repeated administration of cisplatin in patients with advanced ovarian cancer [see Clinical Studies (14.1) ] .

1.2Reduction of Moderate to Severe Xerostomia from Radiation of the Head and Neck

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 Clinical Studies (14.2) ] . Limitation of Use Do not use ETHYOL in other settings where chemotherapy can produce a significant survival benefit or cure [see Warnings and Precautions (5.1) ] , or in patients receiving definitive radiotherapy [see Warnings and Precautions (5.2) ] , except in the context of a clinical study.

Contraindications

ETHYOL is contraindicated in patients with known hypersensitivity to aminothiol compounds. ETHYOL is contraindicated in patients with known hypersensitivity to aminothiol compounds. ( 4 )

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.

At a glance

Brand name: Ethyol
Active substance: amifostine
Route: Injection
Dosage form: Injectable
Applicant: Legacy Pharma
Status: Discontinued
FDA approval: 8 Dec 1995
Application: NDA020221-002

Indications

( 1 , 5.1 , 5.2 )

1.1Reduction of Cumulative Renal Toxicity with Chemotherapy

ETHYOL (amifostine) is indicated to reduce the cumulative renal toxicity associated with repeated administration of cisplatin in patients with advanced ovarian cancer [see Clinical Studies (14.1) ] .

1.2Reduction of Moderate to Severe Xerostomia from Radiation of the Head and Neck

Warnings and precautions

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 .

6.1Clinical 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. Injection site reactions (including rash/erythema, pruritus, urticaria, pain, inflammation, bruising and local swelling) were also observed.

6.2Post-Marketing Experience

The following adverse reactions have been identified during post-approval use of ETHYOL. Because these reactions 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. The following reported post-marketing adverse reactions are described elsewhere in 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) ] Adverse reactions associated with the use of ETHYOL that have been identified in other clinical trials and/or post-marketing reports are described below: Immune system disorders: Hypersensitivity reactions including pruritus, urticaria, laryngeal edema, anaphylactic reactions, anaphylactoid reactions.

Nervous system disorders: Seizure. Cardiac disorders: Myocardial ischemia, myocardial infarction, cardiac arrest, arrhythmias including tachycardia, bradycardia, atrial fibrillation/ flutter, supraventricular tachycardia, extrasystoles. Vascular disorders: Transient hypertension and exacerbations of preexisting hypertension. Respiratory, thoracic and mediastinal disorders: Apnea, dyspnea, hypoxia, respiratory arrest.

Skin and subcutaneous tissue disorders: Erythema multiforme, dermatitis exfoliative, Stevens-Johnson syndrome, toxic epidermal necrolysis. Renal and urinary disorders: Renal failure. General disorders and administration site conditions: Chest discomfort and chest pain.

Ethyol

Indications

1.1Reduction of Cumulative Renal Toxicity with Chemotherapy

1.2Reduction of Moderate to Severe Xerostomia from Radiation of the Head and Neck

Contraindications

Warnings and precautions

At a glance

Two medicines in one question?

Ethyol

Indications

1.1Reduction of Cumulative Renal Toxicity with Chemotherapy

1.2Reduction of Moderate to Severe Xerostomia from Radiation of the Head and Neck

Contraindications

Warnings and precautions

At a glance

Two medicines in one question?

5.1Effectiveness of the Chemotherapy Regimen

5.2Effectiveness of Radiotherapy

5.3Hypotension and Cardiovascular Events

5.4Severe Cutaneous Reactions Fatal

5.5Hypersensitivity

5.6Nausea and Vomiting

Interactions

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary When

Adverse reactions

6.1Clinical Trial Experience

6.2Post-Marketing Experience

Composition

Strengths and forms

Official product information