Loading…
IVOZFO is a brand name for Fosfomycin, supplied as a powder for solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: IVOZFO™ (fosfomycin for injection) is indicated for the treatment of the following infections in adults and children including neonates: • Bacterial meningitis • Bone and joint infections • Complicated intra-abdominal infections • Complicated skin and soft tissue infections • Complicated urinary tract infections •…
Verbatim from this product's HC label. Tap a section to expand.
(4) 10/2022 WARNINGS AND PRECAUTIONS 10/2022 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ............................................................................................
2 TABLE OF CONTENTS .............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION ......................................................................
4 1 INDICATIONS ............................................................................................................... 5 2 CONTRAINDICATIONS .................................................................................................
5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................ 5 4 DOSAGE AND ADMINISTRATION ................................................................................. 9 5 OVERDOSAGE..............................................................................................................
9
). The action of cardiac glycosides can be potentiated by potassium deficiency. Gastrointestinal Clostridium difficile-associated disease Clostridium difficile-associated disease (CDAD) has been reported with the use of many antibacterial agents, including IVOZFO™ (see 8 ADVERSE REACTIONS).
CDAD may range in severity from mild diarrhea to fatal colitis. It is important to consider this diagnosis in patients who present with diarrhea, symptoms of colitis, pseudomembranous colitis, toxic megacolon, or perforation of the colon subsequent to the administration of any antibacterial agent.
CDAD has been reported to occur over 2 months after the administration of antibacterial agents. Treatment with antibacterial agents may alter the normal flora of the colon and may permit overgrowth of Clostridium difficile. C. difficile produces toxins A and B, which contribute to the development of CDAD.
CDAD may cause significant morbidity and mortality. CDAD can be refractory to antimicrobial therapy. If the diagnosis of CDAD is suspected or confirmed, appropriate therapeutic measures should be initiated. Mild cases of CDAD usually respond to discontinuation of antibacterial agents not directed against C.
difficile. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial agent clinically effective against C. difficile. Surgical evaluation should be instituted as clinically indicated as surgical intervention may be required in certain severe cases.
5 Post market adverse reactions). Therefore, the leukocyte count should be monitored at regular intervals and if such reactions occur, an adequate medical treatment should be initiated. Hepatic/Biliary/Pancreatic Liver injury, usually reversible upon discontinuation of therapy, has been seen with use of fosfomycin, including hepatitis.
10/2022 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ............................................................................................
2 TABLE OF CONTENTS .............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION ......................................................................
4 1 INDICATIONS ............................................................................................................... 5 2 CONTRAINDICATIONS .................................................................................................
5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................ 5 4 DOSAGE AND ADMINISTRATION ................................................................................. 9 5 OVERDOSAGE..............................................................................................................
9 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ............................... 10 7 WARNINGS AND PRECAUTIONS ................................................................................ 13 8 ADVERSE REACTIONS ................................................................................................
13 Product Monograph PrIVOZFOTM (Fosfomycin) COPYRIGHT 2021, Verity Pharmaceuticals Inc. 14 9 DRUG INTERACTIONS ................................................................................................ 15 10 CLINICAL PHARMACOLOGY .......................................................................................
16 11 STORAGE, STABILITY AND DISPOSAL ......................................................................... 18 12 SPECIAL HANDLING INSTRUCTIONS ........................................................................... 18 PART II: SCIENTIFIC INFORMATION .......................................................................................
IVOZFO™ (fosfomycin for injection) is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Fosfomycin in Canada.
Know a brand we are missing in Canada? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
There is no requirement for dosage adjustments in patients with hepatic insufficiency since the pharmacokinetics of fosfomycin remains unaffected in this patient group. Patients with hepatic cirrhosis should be closely monitored for sodium overload.
Immune Acute, potentially life-threatening hypersensitivity reactions (anaphylactic shock) may occur in very rare cases. At the first signs (including sweating, nausea, cyanosis), the infusion of IVOZFO™ Product Monograph PrIVOZFOTM (Fosfomycin) COPYRIGHT 2021, Verity Pharmaceuticals Inc.
Page 12 of 28 (fosfomycin for injection) must be immediately discontinued. The intravenous line should be left in place. Depending upon the clinical situation, appropriate emergency measures may need to be initiated. Monitoring and Laboratory Tests One vial with 2 g of IVOZFO™ contains 28 mmol (640 mg) sodium, one vial with 4 g IVOZFO™ contains 56 mmol (1,280 mg) sodium and one vial with 8 g of IVOZFO™ contains 111 mmol (2,560 mg) sodium.
A high sodium load associated with the use of IVOZFO™ may result in decreased levels of potassium in serum or plasma. Serum electrolytes (particularly sodium, potassium, and phosphate) and water balance must be monitored regularly during therapy, in particular when using the high-dose regimens (>16 g/day in adults; > 300 mg/kg/day in children), and for all doses in neonates and premature infants due to variable renal sodium excretion (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular; and 8 ADVERSE REACTIONS).
2 Recommended dose and dosage adjustment, Renal Impairment). Fosfomycin is primarily excreted unchanged by the kidneys. In patients with severe renal insufficiency (creatinine clearance ≤ 40mL/min), the elimination of IVOZFO™ (fosfomycin for injection) is substantially slowed.
(See Dosage in renal insufficiency). Data on fosfomycin clearance by continuous veno-venous hemofiltration is very limited and fosfomycin clearance may be extensive. Patients undergoing renal replacement therapy should be closely monitored for clinical efficacy and for adverse events.
Reproductive Health Fertility To date, in humans no reduction in fertility after therapy with fosfomycin has been reported. In male and female rats, reduced fertility was observed after the oral administration of fosfomycin at supra- therapeutic doses (see 16 NON-CLINICAL TOXICOLOGY).
Sensitivity/Resistance Development of Drug-Resistant Bacteria and Need for Combination Therapy Prescribing IVOZFO in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and risks the development of drug-resistant bacteria.
In vitro, fosfomycin has been found to rapidly select for resistant mutants. Also, the use of intravenous fosfomycin alone has been associated with selection of resistance in clinical studies. Whenever possible, it is recommended that fosfomycin is administered as part of a combination antibacterial drug regimen to reduce the risk of selecting for resistance.
Product Monograph PrIVOZFOTM (Fosfomycin) COPYRIGHT 2021, Verity Pharmaceuticals Inc. 1 Pregnant Women No clinical studies of fosfomycin use in pregnant women are available. Fosfomycin crosses the placental barrier. IVOZFO™ should therefore not be prescribed to pregnant women unless the benefit to the mother outweighs the risk to the fetus.
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see 16 NON-CLINICAL TOXICOLOGY). 2 Breast-feeding After the administration of fosfomycin, low quantities were found in human milk.
Only scarce information about fosfomycin use during breastfeeding is available, therefore this treatment is not recommended as first choice for a breastfeeding […]
18 13 PHARMACEUTICAL INFORMATION ............................................................................ 18 14 CLINICAL TRIALS ........................................................................................................
19 15 MICROBIOLOGY ........................................................................................................ 19 16 NON-CLINICAL TOXICOLOGY .....................................................................................
21 PATIENT MEDICATION INFORMATION .................................................................................. 23 Product Monograph PrIVOZFOTM (Fosfomycin) COPYRIGHT 2021, Verity Pharmaceuticals Inc.
Page 4 of 28 PART I:
HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS IVOZFO™ (fosfomycin for injection) is indicated for the treatment of the following infections in adults and children including neonates: • Bacterial meningitis • Bone and joint infections • Complicated intra-abdominal infections • Complicated skin and soft tissue infections • Complicated urinary tract infections • Hospital-acquired pneumonia, including ventilator-associated pneumonia • Infective endocarditis • Bacteremia that occurs in association with, or is suspected to be associated with, any of the infections listed above IVOZFO™ should be used only when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of the infections listed above, or when these alternative antibacterial agents have failed to demonstrate efficacy (see 7 WARNINGS AND […]