Is Rezafungin approved by the FDA?
Rezafungin, marketed under the brand name Rezzayo, was approved by the FDA on March 22, 2023, for the treatment of candidemia and invasive candidiasis in adult patients with limited or no alternative treatment options. This approval was based on limited clinical safety and efficacy data.
Usage and Dosage
Rezafungin is administered as an intravenous infusion, usually once per week. The standard dosing regimen involves an initial loading dose of 400 mg followed by a maintenance dose of 200 mg once a week. Each infusion is given slowly over approximately one hour.
Side Effects
Common side effects of rezafungin may include:
- Low blood levels of potassium, phosphate, or magnesium
- Diarrhea, nausea, vomiting
- Constipation, stomach pain
- Pale skin, tiredness, feeling light-headed or short of breath, cold hands and feet
- Fever
Some side effects may occur during the injection, such as dizziness, nausea, light-headedness, itching, sweating, headache, chest tightness, back pain, trouble breathing, or swelling in the face.
Serious side effects requiring immediate medical attention include:
- Severe allergic reactions
- Low blood potassium or magnesium levels
- Low blood phosphate levels
Warnings and Precautions
Before starting rezafungin, it is important to inform your doctor if you have:
- A history of liver disease
- Any allergies to rezafungin or similar medications (anidulafungin, caspofungin, micafungin)
It is not known if rezafungin will harm an unborn baby, so pregnant women should consult their doctor. Breastfeeding women should also seek medical advice before using this medication.
Interactions
Rezafungin can interact with other medications, including prescription and over-the-counter medicines, vitamins, and herbal products. It is crucial to inform your healthcare provider about all the medications you are currently taking to avoid potential interactions.
Storage
Rezafungin should be stored as per the instructions provided with the medication. Your pharmacist can provide detailed storage information.
Rezafungin offers a promising treatment option for adults with serious candida infections, especially those with limited alternatives. Always follow your healthcare provider's instructions and report any side effects or concerns promptly.
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