Description
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.
This product is available in the following dosage forms:
- Powder for Solution
Before Using
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.
Pediatric
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.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of rezafungin injection in the elderly.
Breastfeeding
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.
Drug Interactions
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
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
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
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.
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