Cytoprotective and supportive care agents:

Indications for ETHYOL:

To reduce cumulative renal toxicity associated with repeated administration of cisplatin in patients with advanced ovarian cancer. To reduce xerostomia in patients undergoing post-op radiation therapy for head and neck cancer where the radiation port includes a substantial portion of the parotid glands.

Adult Dosage:

Pretreat with antiemetics. Reduction of renal toxicity: 910mg/m2 by IV infusion over 15mins once daily, starting 30mins before chemotherapy; monitor BP every 5mins during infusion and thereafter; if full dose cannot be given, then give dose of 740mg/m2 for subsequent cycles. Xerostomia: 200mg/m2 by IV infusion over 3mins once daily, starting 15–30mins before standard fraction radiation therapy; monitor BP before and immediately after infusion. Both: interrupt infusion if systolic BP decreases significantly from baseline (see full labeling); may restart if BP returns to normal after 5mins.

Children Dosage:

Not established.

ETHYOL Contraindications:

Hypersensitivity to aminothiol compounds.

ETHYOL Warnings/Precautions:

Permanently discontinue if severe infusion-related reactions occur. Do not use in patients receiving chemotherapy for other malignancies in which chemotherapy can produce a significant survival benefit or in patients receiving definitive radiotherapy (except in a clinical trial). Not recommended for hypotensive or dehydrated patients. Stop BP medication 24hrs before therapy when using as a chemoprotectant (do not give to patients unable to stop antihypertensives). Monitor prior to, during and after therapy; discontinue if severe cutaneous reactions, mucosal lesions, or allergic reactions occur. Ensure adequate hydration. Keep patient in supine position. Hypocalcemia risk (eg, nephrotic syndrome, multiple doses of Ethyol); monitor serum calcium. Elderly. Embryo-fetal toxicity. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended.

ETHYOL Classification:

Cytoprotective agent.

ETHYOL Interactions:

Caution with antihypertensives or other drugs that can cause hypotension; monitor closely.

Adverse Reactions:

Hypotension, nausea, vomiting; infusion-related reactions, cardiovascular events, inj site reactions, hypersensitivity reactions; rare: severe cutaneous reactions (eg, erythema multiforme, SJS, TEN, DRESS).

How Supplied:

Single-dose vials—3