Brand Name
Foscavir
Generic Name
Foscarnet
View Brand Information FDA approval date: July 09, 2012
Classification: Pyrophosphate Analog DNA Polymerase Inhibitor
Form: Injection
What is Foscavir (Foscarnet)?
CMV Retinitis FOSCAVIR is indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome . Combination therapy with FOSCAVIR and ganciclovir is indicated for patients who have relapsed after monotherapy with either drug. SAFETY AND EFFICACY OF FOSCAVIR HAVE NOT BEEN ESTABLISHED FOR TREATMENT OF OTHER CMV INFECTIONS ; CONGENITAL OR NEONATAL CMV DISEASE; OR NONIMMUNOCOMPROMISED INDIVIDUALS. Mucocutaneous Acyclovir Resistant HSV Infections FOSCAVIR is indicated for the treatment of acyclovir-resistant mucocutaneous HSV infections in immunocompromised patients. SAFETY AND EFFICACY OF FOSCAVIR HAVE NOT BEEN ESTABLISHED FOR TREATMENT OF OTHER HSV INFECTIONS ; CONGENITAL OR NEONATAL HSV DISEASE; OR HSV IN NONIMMUNOCOMPROMISED INDIVIDUALS.
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Brand Information
Foscavir (foscarnet sodium)
1DESCRIPTION
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 Na
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 may have been added to adjust the pH of the solution to 7.4. FOSCAVIR INJECTION contains no preservatives.
2CONTRAINDICATIONS
FOSCAVIR is contraindicated in patients with clinically significant hypersensitivity to foscarnet sodium.
3ADVERSE REACTIONS
THE MAJOR TOXICITY OF FOSCAVIR IS RENAL IMPAIRMENT (see
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
FOSCAVIR treatment was associated with seizures in 18/189 (10%) AIDS patients in the initial five controlled studies (see
In five controlled U.S. clinical trials the most frequently reported adverse events in patients with AIDS and CMV retinitis are shown in
From the same controlled studies, adverse events categorized by investigator as “severe” are shown in
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.
3.1Incidence of 5% or Greater
Body as a Whole: fever, fatigue, rigors, asthenia, malaise, pain, infection, sepsis, death
Central and Peripheral Nervous System: headache, paresthesia, dizziness, involuntary muscle contractions, hypoesthesia, neuropathy, seizures including grand mal seizures (see WARNINGS)
Gastrointestinal System: anorexia, nausea, diarrhea, vomiting, abdominal pain
Metabolic and Nutritional: mineral and electrolyte imbalances (see WARNINGS) including hypokalemia, hypocalcemia, hypomagnesemia, hypophosphatemia, hyperphosphatemia
Psychiatric: depression, confusion, anxiety
Respiratory System: coughing, dyspnea
Skin and Appendages: rash, increased sweating
Urinary System: alterations in renal function including increased serum creatinine, decreased creatinine clearance, and abnormal renal function (see WARNINGS)
Special Senses: vision abnormalities
3.2Incidence between 1% and 5%
Application Site: injection site pain, injection site inflammation
Body as a Whole: back pain, chest pain (including reports of transient chest pain as part of infusion reactions), edema, influenza-like symptoms, bacterial infections, moniliasis, fungal infections, abscess
Cardiovascular: hypertension, palpitations, ECG abnormalities including sinus tachycardia, first degree AV block and non-specific ST-T segment changes, hypotension, flushing, cerebrovascular disorder (see WARNINGS)
Central and Peripheral Nervous System: tremor, ataxia, dementia, stupor, generalized spasms, sensory disturbances, meningitis, aphasia, abnormal coordination, leg cramps, EEG abnormalities (see WARNINGS)
Gastrointestinal: constipation, dysphagia, dyspepsia, rectal hemorrhage, dry mouth, melena, flatulence, ulcerative stomatitis, pancreatitis
Hematologic: thrombocytopenia, platelet abnormalities, thrombosis, white blood cell abnormalities, lymphadenopathy
Liver and Biliary: abnormal A-G ratio, abnormal hepatic function, increased SGPT, increased SGOT
Metabolic and Nutritional: hyponatremia, decreased weight, increased alkaline phosphatase, increased LDH, increased BUN, acidosis, cachexia, thirst
Musculo-Skeletal: arthralgia, myalgia
Neoplasms: lymphoma-like disorder, sarcoma
Psychiatric: insomnia, somnolence, nervousness, amnesia, agitation, aggressive reaction, hallucination
Respiratory System: pneumonia, sinusitis, pharyngitis, rhinitis, respiratory disorders, respiratory insufficiency, pulmonary infiltration, stridor, pneumothorax, hemoptysis, bronchospasm
Skin and Appendages: pruritus, skin ulceration, seborrhea, erythematous rash, maculo-papular rash, skin discoloration
Special Senses: taste perversions, eye abnormalities, eye pain, conjunctivitis
Urinary System: albuminuria, dysuria, polyuria, urethral disorder, urinary retention, urinary tract infections, acute renal failure, nocturia, facial edema
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
Selected adverse events from ACTG Study 228 (CRRT) comparing combination therapy with FOSCAVIR or ganciclovir monotherapy are shown in
Adverse events that have been reported in post-marketing surveillance include: administration site extravasation, localized edema, hypersensitivity reactions (including anaphylactic shock, urticaria and angioedema) (see
4OVERDOSAGE
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.
5DOSAGE AND ADMINISTRATION
CAUTION - DO NOT ADMINISTER FOSCAVIR BY RAPID OR BOLUS INTRAVENOUS INJECTION. THE TOXICITY OF FOSCAVIR MAY BE INCREASED AS A RESULT OF EXCESSIVE PLASMA LEVELS. CARE SHOULD BE TAKEN TO AVOID UNINTENTIONAL OVERDOSE BY CAREFULLY CONTROLLING THE RATE OF INFUSION. THEREFORE, AN INFUSION PUMP MUST BE USED. IN SPITE OF THE USE OF AN INFUSION PUMP, OVERDOSES HAVE OCCURRED.
6DOSAGE
THE RECOMMENDED DOSAGE, FREQUENCY, OR INFUSION RATES SHOULD NOT BE EXCEEDED. ALL DOSES MUST BE INDIVIDUALIZED FOR PATIENTS' RENAL FUNCTION.
6.1Induction Treatment
The recommended initial dose of FOSCAVIR for patients with normal renal function is:
- For CMV retinitis patients, either 90 mg/kg (1-1/2 to 2 hour infusion) every twelve hours or 60 mg/kg (minimum one hour infusion) every eight hours over 2-3 weeks depending on clinical response.
- For acyclovir-resistant HSV patients, 40 mg/kg (minimum one hour infusion) either every 8 or 12 hours for 2-3 weeks or until healed.
An infusion pump must be used to control the rate of infusion. Adequate hydration is recommended to establish a diuresis (see
6.2Maintenance Treatment
Following induction treatment the recommended maintenance dose of FOSCAVIR for CMV retinitis is 90 mg/kg/day to 120 mg/kg/day (individualized for renal function) given as an intravenous infusion over 2 hours. Because the superiority of the 120 mg/kg/day has not been established in controlled trials, and given the likely relationship of higher plasma foscarnet levels to toxicity, it is recommended that most patients be started on maintenance treatment with a dose of 90 mg/kg/day. Escalation to 120 mg/kg/day may be considered should early reinduction be required because of retinitis progression. Some patients who show excellent tolerance to FOSCAVIR may benefit from initiation of maintenance treatment at 120 mg/kg/day earlier in their treatment.
An infusion pump must be used to control the rate of infusion with all doses. Again, hydration to establish diuresis both prior to and during treatment is recommended to minimize renal toxicity, provided there are no clinical contraindications (see
Patients who experience progression of retinitis while receiving FOSCAVIR maintenance therapy may be retreated with the induction and maintenance regimens given above or with a combination of FOSCAVIR and ganciclovir (see
6.3Use in Patients with Abnormal Renal Function
FOSCAVIR should be used with caution in patients with abnormal renal function because reduced plasma clearance of foscarnet will result in elevated plasma levels (see
Renal function must be monitored carefully at baseline and during induction and maintenance therapy with appropriate dose adjustments for FOSCAVIR as outlined below (see
FOSCAVIR is not recommended in patients undergoing hemodialysis because dosage guidelines have not been established.
6.4Dose Adjustment
FOSCAVIR dosing must be individualized according to the patient's renal function status. Refer to
To use this dosing guide, actual 24-hour creatinine clearance (mL/min) must be divided by body weight (kg), or the estimated creatinine clearance in mL/min/kg can be calculated from serum creatinine (mg/dL) using the following formula (modified Cockcroft and Gault equation):
For males:
7PATIENT 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 once weekly during maintenance therapy, with FOSCAVIR dose adjusted accordingly (see
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 (e.g., perioral numbness or paresthesias) or severe (e.g., 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
8HOW SUPPLIED
FOSCAVIR (foscarnet sodium) INJECTION, 24 mg/mL for intravenous infusion, is supplied in 250 mL glass bottles or polypropylene based infusion bags containing 6000 mg foscarnet sodium (24 mg/mL) as follows:
NDC 76310-024-11 250 mL bottle
Single-dose. Discard unused portion.
Store between 20° and 25°C (68° and 77°F) [See USP Controlled Room Temperature]. Protect from excessive heat (above 40°C) and from freezing. If refrigerated or exposed to temperatures below the freezing point, precipitation may occur. By keeping the bottle or infusion bag at room temperature with repeated shaking, the precipitate can be brought into solution again.
FOSCAVIR INJECTION should be used only if the bottle or infusion bag and its seal(s) are intact, a vacuum is present, and the solution is clear and colorless. Do not remove the infusion bag from the overwrap until ready for use.
Manufactured for:
Distributed by: Hospira, Inc., Lake Forest, IL 60045 USA
FOSCAVIR is a trademark of Clinigen Healthcare Ltd.
Date of revision: October 2020
Novaplus is a registered trademark of Vizient, Inc.
9BOTTLE LABEL – PRINCIPAL DISPLAY PANEL
NDC 76310-024-11
Foscavir
6000 mg/250 mL (24 mg/mL)
6000 mg/250 mL (24 mg/mL)
For Central Intravenous Infusion Only
Must Be Diluted for Peripheral Intravenous Infusion
Must Be Diluted for Peripheral Intravenous Infusion
Rx only
Single-dose. Discard unused portion.
Single-dose. Discard unused portion.
Mfd. for: Clinigen Healthcare Ltd., DE14 2WW, UK.
(Clinigen and Novaplus logos)
Novaplus is a registered trademark of Vizient, Inc.
10INNER CARTON LABEL – PRINCIPAL DISPLAY PANEL
NDC 76310-024-11
Foscavir ®
(foscarnet sodium)
(foscarnet sodium)
injection
6000 mg/250 mL
6000 mg/250 mL
(24 mg/mL)
For Central Intravenous Infusion Only
Must Be Diluted for Peripheral
Intravenous Infusion
Must Be Diluted for Peripheral
Intravenous Infusion
Single-dose. Discard unused portion.
