FOSCAVIR (Page 6 of 6)

PATIENT MONITORING

The majority of patients will experience some decrease in renal function due to FOSCAVIR administration. Therefore it is recommended that creatinine clearance, either measured or estimated using the modified Cockcroft and Gault equation based on serum creatinine, be determined at baseline, 2−3 times per week during induction therapy and at least every one to two weeks during maintenance therapy, with FOSCAVIR dose adjusted accordingly (see Dose Adjustment). More frequent monitoring may be required for some patients. It is also recommended that a 24-hour creatinine clearance be determined at baseline and periodically thereafter to ensure correct dosing (assuming verification of an adequate collection using creatinine index). FOSCAVIR should be discontinued if creatinine clearance drops below 0.4 mL/min/kg.

Due to FOSCAVIR’s propensity to chelate divalent metal ions and alter levels of serum electrolytes, patients must be monitored closely for such changes. It is recommended that a schedule similar to that recommended for serum creatinine (see above) be used to monitor serum calcium, magnesium, potassium and phosphorus. Particular caution is advised in patients with decreased total serum calcium or other electrolyte levels before treatment, as well as in patients with neurologic or cardiac abnormalities, and in patients receiving other drugs known to influence serum calcium levels. Any clinically significant metabolic changes should be corrected. Also, patients who experience mild (eg, perioral numbness or paresthesias) or severe (eg, seizures) symptoms of electrolyte abnormalities should have serum electrolyte and mineral levels assessed as close in time to the event as possible.

Careful monitoring and appropriate management of electrolytes, calcium, magnesium and creatinine are of particular importance in patients with conditions that may predispose them to seizures (see WARNINGS ).

HOW SUPPLIED

FOSCAVIR (foscarnet sodium) INJECTION, 24 mg/mL for intravenous infusion, is supplied in glass bottles as follows:

NDC 0186-1906-01500 mL bottles, cases of 12

FOSCAVIR INJECTION should be stored at controlled room temperature, 15 − 30°C (59 − 86°F), and should be protected from excessive heat (above 40°C) and from freezing. FOSCAVIR INJECTION should be used only if the bottle and seal are intact, a vacuum is present, and the solution is clear and colorless.

FOSCAVIR is a trademark of the AstraZeneca group of companies.

AstraZeneca 2006

Manufactured For:

AstraZeneca LP

Wilmington, DE 19850

By: Hospira Inc., Lake Forest, IL 60045 USA

30620–xx Rev. 08/06

FOSCAVIR
foscarnet sodium injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0186-1906
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Foscarnet Sodium (Foscarnet) Foscarnet 24 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
water
sodium hydroxide
hydrochloric acid
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0186-1906-01 12 BOTTLE (12 BOTTLE) in 1 CASE contains a BOTTLE
1 500 mL (500 MILLILITER) in 1 BOTTLE This package is contained within the CASE (0186-1906-01)
Labeler — AstraZeneca LP

Revised: 10/2007 AstraZeneca LP

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