Rezzayo: A Novel Antifungal for Invasive Candidiasis And Candidemia

A newly developed echinocandin antifungal drug called Rezzayo (rezafungin for injection) is prescribed for the treatment of invasive candidiasis and candidemia in people who have few or no other therapeutic alternatives. In this blog, we will discuss the FDA approval, manufacturer details, mechanism of action, dosage information, drug interactions, mode of administration, usage in specific populations including pregnancy, lactation, pediatric, geriatric, side effects, and other information related to Rezzayo.

FDA Approval and Manufacturer Details

Rezzayo (rezafungin) was approved by the FDA on March 22, 2023, for the treatment of candidemia and invasive candidiasis in adult patients. Rezzayo is manufactured by Patheon Italia S.p.A., a Thermo Fisher Scientific company. 

Indication 

Rezzayo, an echinocandin antifungal, is prescribed for individuals aged 18 and older who have limited or no alternative treatment options for candidemia and invasive candidiasis.

Mechanism of Action

Rezzayo works through its mechanism as an echinocandin antifungal. It inhibits the synthesis of beta-(1,3)-D-glucan, an essential component of the fungal cell wall, leading to disruption in cell wall formation and ultimately causing cell death in susceptible fungi.

Dosage Information 

• Administer the medicine through intravenous (IV) infusion, starting with a Rezzayo 400 mg loading dose, followed by a Rezzayo 200 mg dose weekly. 
• Ensure that the treatment does not extend beyond four weekly doses due to the limited establishment of Rezzayo’s safety profile beyond this duration.
• Rezzayo should be administered by a healthcare professional as an intravenous infusion over approximately 1 hour.

Missed Dose

If a scheduled dose is missed (not taken on the assigned day), administer the missed dose at the earliest opportunity.

• If the missed dose is given within 3 days of the assigned day, continue with the regular weekly dosing schedule.
• If the missed dose is given more than 3 days after the assigned day, adjust the dosing schedule to allow for at least 4 days before the next dose.
• If restarting after at least 2 weeks of missed dosing, recommence dosing with the 400 mg loading dose.

Warning And Precaution 

• Infusion-related Responses: Infusion-related reactions, such as flushing, a sense of warmth, urticaria, nausea, or chest tightness, may be induced by Rezzayo. If these reactions occur, consider slowing or temporarily stopping the infusion. 
• Photosensitivity: Rezzayo has the potential to induce photosensitivity. Patients should be advised to take precautions against sun exposure and other sources of UV radiation. It is recommended to use protection from sun exposure and other sources of UV radiation during treatment.
• Hepatic Adverse Reactions: Clinical trial patients treated with Rezzayo have shown abnormalities in liver tests. Regularly monitor patients experiencing abnormal liver test results and assess the risk/benefit ratio of continuing Rezzayo therapy.

Usage in Specific Populations

Rezzayo injection is not recommended for use in patients with known hypersensitivity to rezafungin or other echinocandins. 

Pregnancy: There is a lack of information on the use of Rezzayo during pregnancy, making it challenging to assess the drug-associated risk of significant birth defects, miscarriage, or other adverse outcomes for both the mother and fetus. In studies where rezafungin was administered intravenously to pregnant rats or rabbits during organogenesis, no adverse embryofetal outcomes were observed. The doses used were approximately 5 or 3 times the clinical exposure, as determined by AUC comparison. 

Breastfeeding: It is not known whether Rezzayo is excreted in human milk, and lactating women should either discontinue the medication or discontinue breastfeeding. 

Pediatric: The safety and effectiveness of Rezzayo in pediatric patients have not been established, and it is not recommended for use in patients under 18 years of age. 

Geriatric: The safety and effectiveness of Rezzayo in geriatric patients have not been established.

Side Effects 

The frequent adverse reactions (with an incidence of ≥ 5%) linked to Rezzayo comprise

• Hypokalemia
• Pyrexia
• Diarrhea
• Anemia
• Vomiting
• Nausea
• Hypomagnesemia
• Abdominal pain
• Constipation
• Hypophosphatemia

Other Information

• Rezzayo should be stored at controlled room temperature between 20°C to 25°C (68°F to 77°F) and protected from light. 

• Patients who develop abnormal liver tests should be monitored, and their risk/benefit of continuing Rezzayo therapy should be evaluated. 

• Before starting the treatment with Rezzayo, inform your healthcare provider about all the medicines you take, including prescription, over-the-counter medicines, vitamins, and herbal supplements.

• In general it is advised to not drive a vehicle or to consume alcohol while taking any therapy. For more information on driving and consuming alcohol connect with your doctor. 

Conclusion

In conclusion, Rezzayo, as an echinocandin antifungal, presents a viable treatment option for patients aged 18 and older facing limited or no alternative choices for candidemia and invasive candidiasis. Overall, Rezzayo’s efficacy and safety profile position it as a valuable option in the therapeutic arsenal against candidemia and invasive candidiasis, addressing a critical need in patient care.

FAQs

1. What is invasive candidiasis?

Invasive candidiasis is a severe fungal infection that may pose a life-threatening risk if not identified and treated effectively. This condition arises when Candida, a type of yeast, enters the bloodstream and disseminates to various organs, including the bones, brain, central nervous system, eyes, heart valves, kidneys, liver, and spleen.

2.What is the difference between Candidemia and Invasive candidiasis? 

Candidemia is the presence of Candida yeast in the bloodstream, often characterized by symptoms like fever and low blood pressure. Invasive candidiasis is a more severe stage, where the infection extends beyond the bloodstream to affect critical organs such as kidneys, liver, and brain, potentially leading to localized pain, neurological issues, and organ dysfunction.

3.What are the available dosage forms and strengths of Rezzayo?

Rezzayo is available in the form of an injection, specifically as 200 mg in a solid (cake or powder) state contained within a single-dose vial.

4. How to buy Rezzayo online?

To buy Rezzayo online, contact SANSFRO or similar pharmaceutical procurement firms specializing in medicine importation from the US and Europe. For accurate information tailored to the Indian market, reach out to the dedicated Patient Support Team at (+91) 93157 05373 or help@sansfro.com.    

5. What is the Rezzayo price?

Several factors and product specifications contribute to the pricing of Rezzayo. For accurate and current Rezzayo price information in the Indian market, please contact our Patient Support Team at (+91) 93157 05373 or via email at help@sansfro.com. Our team will provide you with the latest and precise cost details for Rezzayo. 

Reference

1. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217417s000lbl.pdf
2. https://www.drugs.com/pro/Rezzayo.html
3. https://www.cidara.com/news/cidara-therapeutics-and-melinta-therapeutics-announce-fda-approval-of-Rezzayo-rezafungin-for-injection-for-the-treatment-of-candidemia-and-invasive-candidiasis/
4. https://www.Rezzayo.com