Description
Cefiderocol injection is used to treat complicated urinary tract infection (including pyelonephritis) in patients who have limited or no other treatment options. It is also used to treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP). This medicine is an antibiotic. It works by killing bacteria or preventing their growth. However, this medicine will not work for colds, flu, or other virus infections.
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
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of cefiderocol 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 cefiderocol injection in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving cefiderocol injection.
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:
- Beta-lactam allergy, history of or
- Multiple allergen sensitivity, history of—May increase risk for more serious side effects.
- Diarrhea or
- Seizures, or history of—Use with caution. May make these conditions worse.
- Kidney disease—Use with caution. The effects may be increased because of the slower removal of the medicine from the body.
Proper Use
A nurse or other trained health professional will give you this medicine in a hospital. This medicine is given through a needle placed in one of your veins. The medicine must be injected slowly, so your IV tube will need to stay in place for at least 3 hours.
Precautions
Your doctor will check your progress closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it. Blood and urine tests may be needed to check for unwanted effects.
This medicine may cause serious allergic reactions, including anaphylaxis or certain skin reactions. These reactions can be life-threatening and require immediate medical attention. Tell your doctor right away if you have a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.
This medicine may cause diarrhea, and in some cases it can be severe. It may occur 2 months or more after you stop using this medicine. Do not take any medicine to treat diarrhea without first checking with your doctor. If you have any questions or if mild diarrhea continues or gets worse, check with your doctor.
Before you have any medical tests, tell the medical doctor in charge that you are using this medicine. The results of some tests may be affected by this medicine.
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:
Less common
- Decreased urine
- dizziness
- drowsiness
- dry mouth
- fainting
- fast or irregular heartbeat
- increased thirst
- loss of appetite
- mood or mental changes
- muscle pain, cramps, or spasms
- nausea or vomiting
- numbness or tingling in the hands, feet, or lips
- seizures
- trembling
- trouble breathing
- unusual tiredness or weakness
Incidence not known
- Black, tarry stools
- bleeding gums
- blood in urine or stools
- change in taste
- cough
- diarrhea
- difficulty swallowing
- fever
- gaseous stomach pain
- hives, itching, or skin rash
- indigestion
- loss of taste
- nervousness
- pinpoint red spots on the skin
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- severe stomach cramps and pain
- stomach fullness or tenderness
- swelling or inflammation of the mouth
- tightness in the chest
- unusual bleeding or bruising
- watery and severe diarrhea, which may also be bloody
- weakness or heaviness of legs
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:
Less common
- Difficulty having a bowel movement (stool)
- headache
- redness, itching, swelling, or pain at the injection site
- white patches in the mouth or throat or on the tongue
- white patches with diaper rash
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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