Pronunciation:

re-za-FUN-jin

Brand Names:

• Rezzayo

Dosage Forms:

• Powder for Solution

Classifications:

Therapeutic—

Antifungal

Pharmacologic—

Glucan Synthesis Inhibitor

Chemical—

Echinocandin

Uses of This Medicine:

Rezafungin injection is used to treat candidemia (fungal infection in the blood) and invasive candidiasis in patients who have limited or no other treatment options.

This medicine is to be given only by or under the direct supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of rezafungin injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of rezafungin injection in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Liver disease—Use with caution. May make this condition worse.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine. It is given through a needle placed into one of your veins. This medicine is given slowly, so the needle will have to remain in place for at least 1 hour once a week.

Missed dose—

This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.

Precautions While Using This Medicine:

It is very important that your doctor check you closely while you are receiving this medicine. This is to make sure the medicine has worked properly. Blood tests may be needed to check for unwanted effects.

This medicine may cause infusion-related reactions. Check with your doctor right away if you have back pain, chest tightness, chills, fever, flushing, headache, nausea and vomiting, trouble breathing, or weakness.

This medicine may make your skin more sensitive to sunlight. Use sunscreen when you are outdoors. Avoid sunlamps and tanning beds.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Bone pain

decreased urine

drowsiness

dry mouth

irregular heartbeat

loss of appetite

mood or mental changes

muscle pain, cramps, or spasms

nausea or vomiting

numbness or tingling in the hands, feet, or lips

pale skin

seizures

trembling

trouble breathing

unusual bleeding or bruising

unusual tiredness or weakness

Less common

Agitation

black, tarry stools

blood in the stools

blood in the urine

back pain

chest tightness

chills

coma

confusion

coughing or vomiting blood

decreased urine output

depression

difficulty swallowing

dizziness

feeling of warmth

fever

headache

hostility

irritability

lethargy

pain, numbness, or tingling of the hands, arms, legs, or feet

persistent bleeding or oozing from puncture sites, mouth, or nose

rash

redness of the face, neck, arms and occasionally, upper chest

stupor

swelling of the face, fingers, hands, feet, ankles, or lower legs

vomiting of blood or material that looks like coffee grounds

weight gain

Incidence not known

Dark urine

increased sensitivity of skin to sunlight

itching, hives, or welts

pain or tenderness in the upper stomach

pale stools

redness or other discoloration of skin

severe sunburn

yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Constipation

diarrhea

stomach pain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.