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FOSCAVIR
Overview
What is FOSCAVIR?
FOSCAVIR is the brand name for foscarnet sodium. The chemical name of foscarnet sodium is phosphonoformic acid, trisodium salt. Foscarnet sodium is a white, crystalline powder containing 6 equivalents of water of hydration with an empirical formula of NaCOP•6 H0 and a molecular weight of 300.1. The structural formula is:
FOSCAVIR has the potential to chelate divalent metal ions, such as calcium and magnesium, to form stable coordination compounds. FOSCAVIR INJECTION is a sterile, isotonic aqueous solution for intravenous administration only. The solution is clear and colorless. Each milliliter of FOSCAVIR contains 24 mg of foscarnet sodium hexahydrate in Water for Injection, USP. Hydrochloric acid and/or sodium hydroxide may have been added to adjust the pH of the solution to 7.4. FOSCAVIR INJECTION contains no preservatives.
What does FOSCAVIR look like?
What are the available doses of FOSCAVIR?
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What should I talk to my health care provider before I take FOSCAVIR?
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How should I use FOSCAVIR?
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What interacts with FOSCAVIR?
FOSCAVIR is contraindicated in patients with clinically significant hypersensitivity to foscarnet sodium.
What are the warnings of FOSCAVIR?
Renal Impairment:
THE MAJOR TOXICITY OF FOSCAVIR IS RENAL IMPAIRMENT (see section). Renal impairment is most likely to become clinically evident during the second week of induction therapy, but may occur at any time during FOSCAVIR treatment. Renal function should be monitored carefully during both induction and maintenance therapy (see section). Elevations in serum creatinine are usually, but not always, reversible following discontinuation or dose adjustment of FOSCAVIR. Safety and efficacy data for patients with baseline serum creatinine levels greater than 2.8 mg/dL or measured 24-hour creatinine clearances <50 mL/min are limited.
SINCE FOSCAVIR HAS THE POTENTIAL TO CAUSE RENAL IMPAIRMENT, DOSE ADJUSTMENT BASED ON SERUM CREATININE IS NECESSARY. Hydration may reduce the risk of nephrotoxicity. It is recommended that 750−1000 mL of normal saline or 5% dextrose solution should be given prior to the first infusion of FOSCAVIR to establish diuresis. With subsequent infusions, 750−1000 mL of hydration fluid should be given with 90-120 mg/kg of FOSCAVIR, and 500 mL with 40−60 mg/kg of FOSCAVIR. Hydration fluid may need to be decreased if clinically warranted.
After the first dose, the hydration fluid should be administered concurrently with each infusion of FOSCAVIR.
Mineral and Electrolyte Abnormalities:
FOSCAVIR has been associated with changes in serum electrolytes including hypocalcemia, hypophosphatemia, hyperphosphatemia, hypomagnesemia, and hypokalemia (see section). FOSCAVIR may also be associated with a dose-related decrease in ionized serum calcium which may not be reflected in total serum calcium. This effect is likely to be related to chelation of divalent metal ions such as calcium by foscarnet. Patients should be advised to report symptoms of low ionized calcium such as perioral tingling, numbness in the extremities and paresthesias. Particular caution and careful management of serum electrolytes is advised in patients with altered calcium or other electrolyte levels before treatment and especially in those with neurologic or cardiac abnormalities and those receiving other drugs known to influence minerals and electrolytes (see and sections). Physicians should be prepared to treat these abnormalities and their sequelae such as tetany, seizures or cardiac disturbances. The rate of FOSCAVIR infusion may also affect the decrease in ionized calcium. Slowing the infusion rate may decrease or prevent symptoms.
Seizures:
Seizures related to mineral and electrolyte abnormalities have been associated with FOSCAVIR treatment (see section; ). Several cases of seizures were associated with death. Risk factors associated with seizures included impaired baseline renal function, low total serum calcium, and underlying CNS conditions.
What are the precautions of FOSCAVIR?
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What are the side effects of FOSCAVIR?
THE MAJOR TOXICITY OF FOSCAVIR IS RENAL IMPAIRMENT (see section). Approximately 33% of 189 patients with AIDS and CMV retinitis who received FOSCAVIR (60 mg/kg TID), without adequate hydration, developed significant impairment of renal function (serum creatinine ≥ 2.0 mg/dL). The incidence of renal impairment in subsequent clinical trials in which 1000 mL of normal saline or 5% dextrose solution was given with each infusion of FOSCAVIR was 12% (34/280).
FOSCAVIR has been associated with changes in serum electrolytes including hypocalcemia (15−30%), hypophosphatemia (8−26%) and hyperphosphatemia (6%), hypomagnesemia (15−30%), and hypokalemia (16−48%) (see section). The higher percentages were derived from those patients receiving hydration.
FOSCAVIR treatment was associated with seizures in 18/189 (10%) AIDS patients in the initial five controlled studies (see section). Risk factors associated with seizures included impaired baseline renal function, low total serum calcium, and underlying CNS conditions predisposing the patient to seizures. The rate of seizures did not increase with duration of treatment. Three cases were associated with overdoses of FOSCAVIR (see section).
In five controlled U.S. clinical trials the most frequently reported adverse events in patients with AIDS and CMV retinitis are shown in Table 5. These figures were calculated without reference to drug relationship or severity.
From the same controlled studies, adverse events categorized by investigator as “severe” are shown in Table 6. Although death was specifically attributed to FOSCAVIR in only one case, other complications of FOSCAVIR (ie, renal impairment, electrolyte abnormalities, and seizures) may have contributed to patient deaths (see section).
From the five initial U.S. controlled trials of FOSCAVIR, the following list of adverse events has been compiled regardless of causal relationship to FOSCAVIR. Evaluation of these reports was difficult because of the diverse manifestations of the underlying disease and because most patients received numerous concomitant medications.
| n = 189 | n = 189 | ||||||
| Fever | 65% | Abnormal Renal Function | 27% | ||||
| Nausea | 47% | Vomiting | 26% | ||||
| Anemia | 33% | Headache | 26% | ||||
| Diarrhea | 30% | Seizures | 10% | ||||
| n = 189 | |||||||
| Death | 14% | ||||||
| Abnormal Renal Function | 14% | ||||||
| Marrow Suppression | 10% | ||||||
| Anemia | 9% | ||||||
| Seizures | 7% |
Incidence 5% or Greater
Body as a Whole:
Central and Peripheral Nervous System:
Gastrointestinal System:
Hematologic:
Metabolic and Nutritional:
Psychiatric:
Respiratory System
Skin and Appendages:
Urinary:
Special Senses:
Incidence between 1% and 5%
Application Site:
Body as a Whole:
Cardiovascular:
Central and Peripheral Nervous System:
Gastrointestinal:
Hematologic:
Liver and Biliary:
Metabolic and Nutritional:
Musculo-Skeletal:
Neoplasms:
Psychiatric:
Respiratory System:
Skin and Appendages:
Special Senses:
Urinary System:
Selected adverse events occurring at a rate of less than 1% in the five initial U.S. controlled clinical trials of FOSCAVIR include: syndrome of inappropriate antidiuretic hormone secretion, pancytopenia, hematuria, dehydration, hypoproteinemia, increases in amylase and creatinine phosphokinase, cardiac arrest, coma, and other cardiovascular and neurologic complications.
Selected adverse event data from the Foscarnet vs. Ganciclovir CMV Retinitis Trial (FGCRT), performed by the Studies of the Ocular Complications of AIDS (SOCA) Research Group, are shown in Table 7 (see section).
Selected adverse events from ACTG Study 228 (CRRT) comparing combination therapy with FOSCAVIR or ganciclovir monotherapy are shown in Table 8. The most common reason for a treatment change in patients assigned to either FOSCAVIR or ganciclovir was retinitis progression. The most frequent reason for a treatment change in the combination treatment group was toxicity.
Adverse events that have been reported in post-marketing surveillance include: ventricular arrhythmia, prolongation of QT interval, gamma GT increased, diabetes insipidus (usually nephrogenic), renal calculus, and muscle disorders including myopathy, myositis, muscle weakness and rare cases of rhabdomyolysis. Cases of vesiculobullous eruptions including erythema multiforme, toxic epidermal necrolysis, and Stevens-Johnson Syndrome have been reported. In most cases, patients were taking other medications that have been associated with toxic epidermal necrolysis or Stevens-Johnson Syndrome.
| EVENT | GANCICLOVIR | FOSCARNET | |||||||||||||||||
| No. of Events | No. of Patients | Rates | No. of Events | No. of Patients | Rates | ||||||||||||||
| 63 | 41 | 1.30 | 31 | 17 | 0.72 | ||||||||||||||
| 6 | 4 | 0.12 | 13 | 9 | 0.30 | ||||||||||||||
| 21 | 13 | 0.37 | 19 | 13 | 0.37 | ||||||||||||||
| 49 | 27 | 1.26 | 51 | 28 | 1.46 | ||||||||||||||
| Hospitalization | 209 | 91 | 4.74 | 202 | 75 | 5.03 | |||||||||||||
| Anemia(Hgb <70 g/L) | 11 | 7 | 0.20 | 9 | 7 | 0.14 | 19 | 15 | 0.33 | ||||||||||
| Seizures | 6 | 6 | 0.17 | 7 | 6 | 0.15 | 10 | 5 | 0.18 | ||||||||||
| Hospitalizations | 86 | 53 | 1.86 | 111 | 59 | 2.36 | 118 | 64 | 2.36 |
What should I look out for while using FOSCAVIR?
FOSCAVIR is contraindicated in patients with clinically significant hypersensitivity to foscarnet sodium.
What might happen if I take too much FOSCAVIR?
In controlled clinical trials performed in the United States, overdosage with FOSCAVIR was reported in 10 out of 189 patients. All 10 patients experienced adverse events and all except one made a complete recovery. One patient died after receiving a total daily dose of 12.5 g for three days instead of the intended 10.9 g. The patient suffered a grand mal seizure and became comatose. Three days later the patient expired with the cause of death listed as respiratory/cardiac arrest. The other nine patients received doses ranging from 1.14 times to 8 times their recommended doses with an average of 4 times their recommended doses. Overall, three patients had seizures, three patients had renal function impairment, four patients had paresthesias either in limbs or periorally, and five patients had documented electrolyte disturbances primarily involving calcium and phosphate.
Overdose (up to 20 times the recommended dose) has been reported in post-marketing use of FOSCAVIR. Some of these post-marketing reports were relative overdoses in that the dose of FOSCAVIR had not been adjusted in patients with a reduced renal function. The pattern of adverse events associated with a FOSCAVIR overdose is consistent with the known adverse event profile of the drug.
There is no specific antidote for FOSCAVIR overdose. Hemodialysis and hydration may be of benefit in reducing drug plasma levels in patients who receive an overdosage of FOSCAVIR, but the effectiveness of these interventions has not been evaluated. The patient should be observed for signs and symptoms of renal impairment and electrolyte imbalance. Medical treatment should be instituted if clinically warranted.
How should I store and handle FOSCAVIR?
Store the kit at 2°-8°C (36°-46°F) and protect from light.ArrayStore the kit at 2°-8°C (36°-46°F) and protect from light.ArrayFOSCAVIR (foscarnet sodium) INJECTION, 24 mg/mL for intravenous infusion, is supplied in glass bottles as follows:NDC 0186-1906-01500 mL bottles, cases of 12FOSCAVIR 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 2006Manufactured For:AstraZeneca LPWilmington, DE 19850By: Hospira Inc., Lake Forest, IL 60045 USA30620–xx Rev. 08/06FOSCAVIR (foscarnet sodium) INJECTION, 24 mg/mL for intravenous infusion, is supplied in glass bottles as follows:NDC 0186-1906-01500 mL bottles, cases of 12FOSCAVIR 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 2006Manufactured For:AstraZeneca LPWilmington, DE 19850By: Hospira Inc., Lake Forest, IL 60045 USA30620–xx Rev. 08/06FOSCAVIR (foscarnet sodium) INJECTION, 24 mg/mL for intravenous infusion, is supplied in glass bottles as follows:NDC 0186-1906-01500 mL bottles, cases of 12FOSCAVIR 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 2006Manufactured For:AstraZeneca LPWilmington, DE 19850By: Hospira Inc., Lake Forest, IL 60045 USA30620–xx Rev. 08/06FOSCAVIR (foscarnet sodium) INJECTION, 24 mg/mL for intravenous infusion, is supplied in glass bottles as follows:NDC 0186-1906-01500 mL bottles, cases of 12FOSCAVIR 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 2006Manufactured For:AstraZeneca LPWilmington, DE 19850By: Hospira Inc., Lake Forest, IL 60045 USA30620–xx Rev. 08/06FOSCAVIR (foscarnet sodium) INJECTION, 24 mg/mL for intravenous infusion, is supplied in glass bottles as follows:NDC 0186-1906-01500 mL bottles, cases of 12FOSCAVIR 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 2006Manufactured For:AstraZeneca LPWilmington, DE 19850By: Hospira Inc., Lake Forest, IL 60045 USA30620–xx Rev. 08/06FOSCAVIR (foscarnet sodium) INJECTION, 24 mg/mL for intravenous infusion, is supplied in glass bottles as follows:NDC 0186-1906-01500 mL bottles, cases of 12FOSCAVIR 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 2006Manufactured For:AstraZeneca LPWilmington, DE 19850By: Hospira Inc., Lake Forest, IL 60045 USA30620–xx Rev. 08/06FOSCAVIR (foscarnet sodium) INJECTION, 24 mg/mL for intravenous infusion, is supplied in glass bottles as follows:NDC 0186-1906-01500 mL bottles, cases of 12FOSCAVIR 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 2006Manufactured For:AstraZeneca LPWilmington, DE 19850By: Hospira Inc., Lake Forest, IL 60045 USA30620–xx Rev. 08/06FOSCAVIR (foscarnet sodium) INJECTION, 24 mg/mL for intravenous infusion, is supplied in glass bottles as follows:NDC 0186-1906-01500 mL bottles, cases of 12FOSCAVIR 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 2006Manufactured For:AstraZeneca LPWilmington, DE 19850By: Hospira Inc., Lake Forest, IL 60045 USA30620–xx Rev. 08/06FOSCAVIR (foscarnet sodium) INJECTION, 24 mg/mL for intravenous infusion, is supplied in glass bottles as follows:NDC 0186-1906-01500 mL bottles, cases of 12FOSCAVIR 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 2006Manufactured For:AstraZeneca LPWilmington, DE 19850By: Hospira Inc., Lake Forest, IL 60045 USA30620–xx Rev. 08/06FOSCAVIR (foscarnet sodium) INJECTION, 24 mg/mL for intravenous infusion, is supplied in glass bottles as follows:NDC 0186-1906-01500 mL bottles, cases of 12FOSCAVIR 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 2006Manufactured For:AstraZeneca LPWilmington, DE 19850By: Hospira Inc., Lake Forest, IL 60045 USA30620–xx Rev. 08/06
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
The pharmacokinetics of foscarnet has been determined after administration as an intermittent intravenous infusion during induction therapy in AIDS patients with CMV retinitis. Observed plasma foscarnet concentrations in four studies (FOS-01, ACTG-015, FP48PK, FP49PK) are summarized in Table 3:
Non-Clinical Toxicology
FOSCAVIR is contraindicated in patients with clinically significant hypersensitivity to foscarnet sodium.THE MAJOR TOXICITY OF FOSCAVIR IS RENAL IMPAIRMENT (see section). Approximately 33% of 189 patients with AIDS and CMV retinitis who received FOSCAVIR (60 mg/kg TID), without adequate hydration, developed significant impairment of renal function (serum creatinine ≥ 2.0 mg/dL). The incidence of renal impairment in subsequent clinical trials in which 1000 mL of normal saline or 5% dextrose solution was given with each infusion of FOSCAVIR was 12% (34/280).
FOSCAVIR has been associated with changes in serum electrolytes including hypocalcemia (15−30%), hypophosphatemia (8−26%) and hyperphosphatemia (6%), hypomagnesemia (15−30%), and hypokalemia (16−48%) (see section). The higher percentages were derived from those patients receiving hydration.
FOSCAVIR treatment was associated with seizures in 18/189 (10%) AIDS patients in the initial five controlled studies (see section). Risk factors associated with seizures included impaired baseline renal function, low total serum calcium, and underlying CNS conditions predisposing the patient to seizures. The rate of seizures did not increase with duration of treatment. Three cases were associated with overdoses of FOSCAVIR (see section).
In five controlled U.S. clinical trials the most frequently reported adverse events in patients with AIDS and CMV retinitis are shown in Table 5. These figures were calculated without reference to drug relationship or severity.
From the same controlled studies, adverse events categorized by investigator as “severe” are shown in Table 6. Although death was specifically attributed to FOSCAVIR in only one case, other complications of FOSCAVIR (ie, renal impairment, electrolyte abnormalities, and seizures) may have contributed to patient deaths (see section).
From the five initial U.S. controlled trials of FOSCAVIR, the following list of adverse events has been compiled regardless of causal relationship to FOSCAVIR. Evaluation of these reports was difficult because of the diverse manifestations of the underlying disease and because most patients received numerous concomitant medications.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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