Rezafungin

Rezafungin is a prescription medication used for the treatment of candidemia and invasive candidiasis in adults who have limited or no alternative treatment options.

• Rezafungin is available under the following different brand names: Rezzayo

Common side effects of Rezafungin include:

• diarrhea
• vomiting
• nausea
• abdominal pain
• constipation
• hypokalemia
• hypomagnesemia
• hypophosphatemia
• pyrexia
• anemia

Serious side effects of Rezafungin include:

• hives
• difficulty breathing
• swelling of the face, lips, tongue, or throat
• nausea
• headache
• fast heart rate
• low blood pressure
• rash
• shortness of breath
• tremor
• small purple spots or red spots on the skin
• unusual bleeding
• easy bruising
• confusion
• little or no urine
• swelling
• nausea
• fatigue
• shortness of breath
• yellowed skin and eyes (jaundice)
• abdominal pain
• coughing or choking when eating or drinking
• persistent drooling of saliva
• vomiting
• a black or tarry stool
• blood in vomit
• dizziness
• fainting
• tiredness
• paleness
• rapid weight gain
• high blood pressure
• fatigue
• insomnia
• itching
• joint pain
• fever
• cold sores
• red patches and blisters on the palms of the hands, soles of feet, and face
• dark circles with purple-grey centers on the skin
• headache
• dizziness
• abnormal blood test results
• numbness and tingling in the hands or feet

Rare side effects of Rezafungin include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Injection, lyophilized powder for reconstitution

• 200 mg/single-dose vial

Candida Infections

Adult dosage

• 400 mg IV x 1 dose, THEN
• 200 mg IV every week thereafter
• Safety and efficacy are not established beyond 4 weekly doses

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Rezafungin has no noted severe interactions with any other drugs.
• Rezafungin has no noted serious interactions with any other drugs.
• Rezafungin has no noted moderate interactions with any other drugs.
• Rezafungin has no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Hypersensitivity to rezafungin or other echinocandins 

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Rezafungin?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Rezafungin?”

Cautions

• Infusion-related reactions (eg, flushing, sensation of warmth, urticaria, nausea, chest tightness) observed; if these reactions occur, slow or pause infusion, and restart at a lower rate
• May cause photosensitivity; advise the patient to use protection from sun exposure and other sources of UV radiation during treatment
• Abnormal liver tests observed; monitor patients who develop abnormal liver tests during therapy and evaluate the risk/benefit of continuing therapy

Pregnancy and Lactation

• No data are available on the use of rezafungin during pregnancy to evaluate for drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes
• Infertility
  • Based on rat studies, rezafungin could lead to decreased sperm motility, decreased sperm numbers, and increased incidence of sperm with abnormal morphology
  • The effect on human fertility is unknown
• Lactation
  • There are no data on the presence of rezafungin or its metabolite in human milk, its effects on breastfed infants, or its effects on milk production
  • Rezafungin was present in rat milk
  • The drug is likely to be present in human milk since it is present in animal milk