Rezafungin

Rezafungin is an antifungal medicine that treats adults with candida (yeast) infections in the blood.

Rezafungin may also be used for other reasons not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets.

Rezafungin is given slowly over 1 hour as an infusion into a vein, usually once per week. A healthcare provider will give you this injection.

Your doctor will perform tests to make sure rezafungin is the right treatment for you.

You will need frequent blood tests to check your liver function.

Follow all storage instructions provided with rezafungin. Your pharmacist can provide more information about how to store this medicine.

Use only as directed. Inform your doctor if you are taking other medicines or have other medical conditions or allergies.

You should not use rezafungin if you are allergic to rezafungin or similar medicines such as:

• anidulafungin;
• caspofungin; or
• micafungin.

Tell your doctor if you have or have ever had liver disease.

It is not known if rezafungin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Ask a doctor if it is safe to breastfeed while using this medicine.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Some side effects may happen during the injection. Tell your medical caregiver if you feel dizzy, nauseous, light-headed, itchy, sweaty, or have a headache, chest tightness, back pain, trouble breathing, or swelling in your face.

Rezafungin may cause serious side effects. Call your doctor right away if you have:

• low blood potassium—leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or feeling limp;
• low blood magnesium—dizziness, irregular heartbeats, feeling jittery, muscle cramps, muscle spasms, cough or feeling like you're choking; or
• low blood phosphate—seizure, confusion, bone pain, or muscle weakness.

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; or
• fever.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Usual Adult Dose for Candidemia:

Loading dose: 400 mg once by IV infusion Maintenance dose: 200 mg once a week by IV infusion Duration of therapy: Safety has not been established beyond 4 weekly dosesComments:-It is recommended to obtain cultures prior to initiating antifungal therapy; adjust treatment appropriately once culture results are known. -For IV use only; reconstitute and dilute prior to administration.-Administer IV infusion over approximately one hour (about 250 mL/hr).-For infusion-related reactions, slow or pause infusion, and restart at a lower rate.Use: For the treatment of candidemia and invasive candidiasis in adult patients with limited or no alternative options; approval based on limited clinical safety and efficacy data

Usual Adult Dose for Systemic Candidiasis:

Loading dose: 400 mg once by IV infusion Maintenance dose: 200 mg once a week by IV infusion Duration of therapy: Safety has not been established beyond 4 weekly dosesComments:-It is recommended to obtain cultures prior to initiating antifungal therapy; adjust treatment appropriately once culture results are known. -For IV use only; reconstitute and dilute prior to administration.-Administer IV infusion over approximately one hour (about 250 mL/hr).-For infusion-related reactions, slow or pause infusion, and restart at a lower rate.Use: For the treatment of candidemia and invasive candidiasis in adult patients with limited or no alternative options; approval based on limited clinical safety and efficacy data

Call your doctor for instructions if you miss a dose.

In a medical setting, an overdose would be treated quickly.

Rezafungin could make you more sensitive to sunburn. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outside.

Other drugs may change how rezafungin works, including prescription and over-the-counter medicines, vitamins, and herbal products. Inform your doctor about all other medicines you are using.