Rezacon 200 mg/10 ml is a Product of the Generic Rezafungin Acetate

What Is Rezacon 200 mg/10 ml Indications and Uses?

Rezacon 200 mg/10 ml (Rezafungin Acetate) is an echinocandin antifungal indicated in patients 18 years of age or older who have limited or no alternative options for the treatment of candidemia and invasive candidiasis.

Pharmacology (Source, Chemical and Physical Composition) Of Rezacon 200 mg/10 ml

Mechanism of Action : Rezacon 200 mg/10 ml (Rezafungin Acetate) is a semi-synthetic echinocandin. inhibits the 1,3-β -D-glucan synthase enzyme complex, which is present in fungal cell walls but not in mammalian cells. This results in inhibition of the formation of 1,3-β -D-glucan, an essential component of the fungal cell wall of many fungi, including Candida species (spp.). Inhibition of 1,3-β -D-glucan synthesis results in concentration-dependent in vitro fungicidal activity against Candida spp., however, the clinical significance of this activity is unknown. Pharmacokinetics : Following single and multiple dosing, the Cmax and AUC of increase in a dose-proportional manner over a dose range of 50 mg (0.125 times the approved maximum recommended loading dose) to 400 mg. The mean AUC0-168h decreased approximately 30% and Cmax decreased approximately 19% in patients with candidemia and IC compared to healthy participants. Distribution : The pharmacokinetics of following IV administration are characterized by a terminal half-life (t1/2) (152±29 hours) and a volume of distribution of 67±28 L. is highly bound to plasma proteins varied from 87.5% to 93.6% in patients. Metabolism : Hepatic metabolism of Rezafungin has not been observed. It is unlikely that is a clinically relevant substrate of CYP450 enzymes Elimin ation: Rezafungin is primarily eliminated via fecal excretion, with the majority of the drug eliminated unchanged. A smaller portion is eliminated in the urine, primarily as inactive metabolites. In healthy human subjects, fecal recovery was significantly higher than urinary recovery. Excretion : The major route of the excretion of Rezafungin is excretion. Approximately 74.3% of the administered radioactive dose was eliminated in the feces and 25.7% of recovered radioactivity, primarily as inactive metabolites was excreted in the urine.

Side Effects of Rezacon 200 mg/10 ml

The following clinically significant adverse reactions are described- Infusion-related Reactions Hepatic Adverse Reactions

Precautions And Warnings for Rezacon 200 mg/10 ml

Infusion-Related Reactions : Infusion-related reactions, including flushing, sensation of warmth, urticaria, nausea, and chest tightness have been observed in clinical trials with Rezacon 200 mg/10 ml (Rezafungin Acetate). If these reactions occur, slow or pause the infusion and restart at a lower rate. Photosensitivity : Rezacon may cause photosensitivity. Patients should be advised to use protection from sun exposure and other sources of UV radiation during Rezacon treatment. Hepatic Adverse Reactions : Abnormalities in liver tests have been seen in clinical trial patients treated with Rezacon. In some patients with serious underlying medical conditions who were receiving multiple concomitant medications along with Rezacon, clinically significant hepatic abnormalities have occurred. Monitor patients who develop abnormal liver tests during Rezacon therapy and evaluate patients for their risk/benefit of continuing Rezacon therapy.

Use During Pregnancy and Lactation

There are no data on the use of Rezacon 200 mg/10 ml (Rezafungin Acetate) during pregnancy to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Therapeutic Class

Other Antifungal preparations

Storage Conditions of It

Unreconstituted vials: Rezacon vials should be stored at 20°C to 25°C. Brief exposure to 15°C to 30°C permitted. Reconstituted vials: Rezacon reconstituted solution can be stored between 5°C and 25°C for up to 24 hours. IV Infusion Solution: Rezacon infusion solution can be stored between 5°C and 25°C or up to 48 hours. Do not freeze. Thanks for using MedEx! How would you rate your experience so far?