Rezzayo

Generic Name/API: Rezafungin
Manufacturer: Patheon Italia S.p.A., a Thermo Fisher Scientific company
Packaging: Injection form
Storage: Store at 20°C to 25°C
Dosage: 200 mg intravenous injection
Strength: 200 mg in a single-dose vial
Indication: Rezzayo (Rezafungin) is a prescription medication used to treat candidemia and invasive candidiasis.
No Indian generic option is available.
 
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About Rezzayo 

  • Rezzayo, is an antifungal which belongs to the pharmacological class known as Echinocandins. 
  • The US FDA administration granted approval to the drug on Mar 23, 2023.
  • Rezzayo is used to treat candidemia and invasive candidiasis in patients aged 18 and older when other treatment options are limited or unavailable.
  • Candidemia refers to a bloodstream infection caused by Candida, whereas invasive candidiasis is a more comprehensive term for infections that result from Candida spreading throughout the body, including the bloodstream, organs, and deep tissues. This condition can be life-threatening, particularly in individuals with compromised immune systems.
  • The symptoms of candidemia and invasive candidiasis can vary but often include fever and chills. Additional symptoms can depend on which parts of the body are affected and may include localized pain, organ dysfunction, and other signs of severe infection. It’s essential to consult a healthcare provider for a proper diagnosis and treatment if you experience such symptoms.
  • Before starting the treatment inform the healthcare provider with all the pre-existing health conditions. 

Strength: 

Injection: The injection is available in Rezzayo 200 mg single-dose vials


Recommended Dosage

Administering intravenous (IV) injections is a medical procedure that should be performed by trained healthcare professionals. Use proper aseptic technique when handling equipment and performing the injection. This includes washing hands, wearing gloves, and cleaning the injection site. Continuously monitor the patient during and after the injection for any adverse reactions. Properly dispose of all used equipment and materials according to medical waste disposal guidelines.

  • Administer Rezzayo via intravenous (IV) infusion with an initial 400 mg loading dose, followed by a 200 mg dose once weekly. Note that the safety of Rezzayo hasn’t been confirmed for more than four weekly doses.

Important

Gently swirl to dissolve the white to pale yellow cake or powder. Avoid shaking to reduce foaming. The solution should be clear to pale yellow after dissolving. Prior to administration, visually inspect parenteral drug products for particulate matter and discoloration, if possible. Do not use if the reconstituted solution is cloudy or has precipitated. The reconstituted solution should not be directly injected and must be diluted before intravenous infusion.


Warnings & Precautions

  • Rezzayo is not suitable for individuals with known hypersensitivity to Rezafungin or echinocandins. 
  • During treatment, if patients experience infusion-related reactions, including flushing, warmth sensation, urticaria, nausea, or chest tightness, they should promptly inform their healthcare provider. 
  • Additionally, Rezzayo may lead to photosensitivity, so patients are advised to take precautions against sun exposure and UV radiation. 
  • Patients with underlying medical conditions taking multiple concomitant medications should inform their doctor about any abnormalities in liver tests, as clinically significant hepatic adverse reactions have been observed in such cases. 
  • Healthcare providers will assess the risk and benefit of continuing Rezzayo therapy in these circumstances.

Common Rezzayo Side Effects:

  • Hypokalemia 
  • Pyrexia
  • Hypomagnesemia
  • Abdominal pain
  • Constipation
  • Hypophosphatemia
  • Urinary tract infection (UTI)
  • Upper respiratory tract infection (URTI)
  • Headache
  • Nasopharyngitis
  • Diarrhea
  • Back pain
  • Arthralgia
  • Nasal congestion
  • Sinusitis

Use in Specific Population

  • There is limited information regarding the use of Rezzayo during pregnancy, and its potential risks, such as major birth defects, miscarriage, and adverse maternal or fetal outcomes, have not been adequately evaluated. 
  • Similarly, there is a lack of data concerning the presence of Rezafungin or its metabolites in human breast milk, the effects on breastfed infants, or their impact on milk production. 
  • Notably, rat studies indicate that Rezafungin may affect male fertility by reducing sperm motility, sperm numbers, and increasing the incidence of abnormal sperm morphology. 
  • However, the influence of Rezzayo on human fertility remains uncertain. It is important for individuals who are pregnant, planning pregnancy, or suspect they might be pregnant, as well as those who are breastfeeding, to consult with their healthcare provider for guidance on the use of this medication. 
  • The safety and efficacy of Rezzayo have not been confirmed in pediatric patients.
  • Clinical trials with Rezzayo did not involve an adequate number of older adult participants to determine potential differences in treatment response compared to younger adults.

Storage and Handling

  • Store Rezzayo vials at temperatures between 20°C to 25°C (68°F to 77°F), with brief exposure to 15°C to 30°C (59°F to 86°F) permitted. 
  • Once reconstituted, the solution can be stored at temperatures between 5°C (41°F) and 25°C (77°F) for up to 24 hours. 
  • The IV infusion solution can be stored at temperatures between 5°C (41°F) and 25°C (77°F) for up to 48 hours, but do not freeze it.

Sansfro follows a simple four-step protocol to ensure that patients can access the prescription medications they need:

  1. Medication Inquiry: When a patient makes an inquiry, our Sansfro Named Access Programme Support team responds within 24 hours to offer assistance.
  2. Verification Process: We verify the availability and approval of medications, ensuring patients can access treatments that might not be readily available in their home countries. We also review the patient’s prescription and medical records for accuracy and compliance.
  3. Medication Procurement: Once the verification process is complete, our staff contacts our network of suppliers to acquire the required medication promptly and at competitive prices.
  4. Safe Delivery: After the final quote is accepted, we arrange for the secure delivery of the consignment. Our logistics team assists with tracking shipments and strictly follows standard operating procedures to ensure the safe and authorized distribution of medications.

To facilitate the import of medication, the Sansfro team initiates the process by requesting specific documentation from patients, which includes:

  1. A valid copy of the prescription.
  2. Proof of patient’s identity.
  3. Information about the prescribing physician.
  4. Current home address.

Upon receiving these documents, the Sansfro team proceeds to prepare and submit the import license application. This license is a crucial prerequisite for obtaining the required medication and is obtained following government approval.

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About Sansfro

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FAQ'S

What is Rezzayo?
Rezzayo, also known as rezafungin, is a prescription medicine used to treat serious Candida fungal infections, specifically candidemia, and invasive candidiasis, in adults aged 18 years or older. Rezzayo is administered as a once-weekly intravenous infusion and is available in powder for injection form.

What is candidemia and invasive candidiasis? 

Candidemia is a bloodstream infection caused by Candida, while invasive candidiasis refers to Candida infections that have spread to different body parts, including the bloodstream and organs. Both conditions are especially severe in people with weakened immune systems.

How does Rezzayo work?

Rezzayo (Rezafungin) involves inhibiting the synthesis of a key component of the fungal cell wall called beta-(1,3)-D-glucan. By interfering with the formation of this essential cell wall component, Rezzayo weakens the fungal cell wall, making it more susceptible to rupture and ultimately leading to the death of the fungal cells. This disruption in cell wall formation hinders the growth and proliferation of the fungus, contributing to the antifungal effect of Rezzayo.

What is the difference between Rezzayo and Rezafungin

Rezzayo is the brand name of the medication, while Rezafungin is the active pharmaceutical ingredient (API) or the generic name of the drug. Essentially, Rezzayo and Rezafungin refer to the same medication, with Rezzayo being its brand name.

What are the common adverse reactions to Rezafungin injection?

Common side effects of Rezafungin injection may include hypokalemia (low potassium levels), pyrexia (fever), and diarrhea, which have been reported in more than 10% of patients. These side effects are relatively common, and it’s important to discuss any concerns or symptoms with your healthcare provider while undergoing treatment with Rezzayo. They can provide guidance on managing these side effects and ensuring your overall well-being during your treatment.

How to buy Rezzayo Online?

Acquiring Rezzayo online has become increasingly convenient. To obtain this medication, which is currently available exclusively in the US and Europe, you can contact the SANSFRO team or similar companies that specialize in importing medicines from these regions.

What is the Rezzayo price in India?

Rezzayo price in India depends on specific product requirements, Regulatory Framework, Import duties and taxes, currency fluctuation, etc . For more information, please reach out to our Patient Support Team at ‎(+91) 93157 05373 or contact us via email at help@sansfro.com.

Dr Anchal Aryan

Medical counselor

Patient Support Head Detail

Dr Anchal Aryan

Medical counselor

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