Ethyol Infusion
Amifostine
500mg
MEDIMMUNE PHARMA BV,
| Pack size | 3 Vials (Lyophilisate) |
|---|---|
| Dispensing mode | POM |
| Source | NETHERLANDS |
| Agent | CITY MEDICAL STORE |
| Retail Price | 3060.00 AED |
Available as:
Indications
Ethyol Infusion is used for:
Nephrotoxicity (Indicated to reduce cumulative renal toxicity associated with repeated administration of cisplatin in patients with advanced ovarian cancer), Xerostomia
Adult Dose
Nephrotoxicity
910 mg/m² IV (15-minute infusion), 30 minutes before chemotherapy
Blood pressure should be followed following its administration and interrupted if systolic blood pressure decreases signficantly from baseline
Xerostomia
200 mg/m² IV (3-minute infusion), 15-30 minutes before radiation therapy
500 mg SC qDay prior to radiation therapy
Child Dose
Safety and efficacy not established
Renal Dose
Administration
Ensure adequate hydration and premedicate with antiemetic treatment
IV Preparation
Reconstitute with 9.5 mL 0.9% NaCl
Amifostine should be further diluted in 0.9% NaCl to a concentration of 5-40 mcg/mL
IV Administration
Infuse over 15 min before chemotherapy
Infuse over 3 min before radiation treatment
Administration as a longer infusion is associated with a higher incidence of adverse effects
Contra Indications
Hypersensitivity to aminothiol, monitor closely during and after IV
Precautions
Patients should be adequately hydrated prior to the Amifostine for Injection infusion and blood pressure should be monitored
Cardiovascular disease, hypocalcemia, hypotension, cutaneous reactions, or nausea/vomiting may occur
Ensure adequate hydration
Do not give to 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; amifostine was studied only with standard fractionated radiotherapy and only when ≥75% of both parotid glands were exposed to radiation
Use caution in hypotension and cerebrovascular disease
Interrupt antihypertensive therapy 24 hr before treatment; patients unable to safely interupt antihypertensive therapy should not recieve amifostine
Lactation: excretion in milk unknown/not recommended
Pregnancy-Lactation
Pregnancy
When used in combination with cisplatin, refer to cisplatin full prescribing information
Verify pregnancy status in females of reproductive potential prior to initiating therapy
Based on findings in animals, therapy can cause fetal harm when administered to a pregnant woman
There are no available data on use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes
Advise pregnant women and females of reproductive potential of the potential risk to a fetus
Animal data
In animal reproduction studies, intravenous administration to pregnant rabbits during organogenesis was embryotoxic at doses approximately sixty percent of recommended dose in humans based on body surface area
Infertility
Based on findings from animal studies, therapy may impair fertility in males of reproductive potential
Lactation
When used in combination with cisplatin, refer to cisplatin full prescribing information for lactation information
There are no data on presence of amifostine or metabolites in human milk, effects on breastfed child, or on milk production
Because of potential for serious adverse reactions in a breastfed child, advise lactating women not to breastfeed during treatment
Interactions
Special consideration should be given to the administration of Amifostine for Injection in patients receiving antihypertensive medications or other drugs that could cause or potentiate hypotension.
Adverse Effects
Side effects of Amifostine :
>10%
Nausea/vomiting (96%), Hypotension (61%) - discontinue infusion if significant BP drop
1-10%
Hypocalcemia (1%), Stevens-Johnson syndrome (1%)
Frequency Not Defined
Chills/feeling of coldness, Flushing/feeling of warmth, Dizziness, Fever, Somnolence, Rash, Malaise, Hiccups, Sneezing
Mechanism of Action
Thiol metabolite binds to reactive metabolites of cisplatin and scavenges free radicals
Note
Ethyol 500mg Infusion manufactured by MEDIMMUNE PHARMA BV,. Its generic name is Amifostine. Ethyol is availble in United Arab Emirates.
Farmaco UAE drug index information on Ethyol Infusion is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.