Applies to cefiderocol: intravenous powder for solution.

Serious side effects of Cefiderocol

Along with its needed effects, cefiderocol 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 while taking cefiderocol:

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

Other side effects of Cefiderocol

Some side effects of cefiderocol 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

For Healthcare Professionals

Applies to cefiderocol: intravenous powder for injection.

Hepatic

Very common (10% or more): Elevated liver tests (including increased ALT, increased AST, increased GGT, increased blood alkaline phosphatase, increased hepatic enzyme, increased liver function test, abnormal liver function test, increased transaminases, hypertransaminasemia; up to 16%)

Common (1% to 10%): Increased ALT, increased GGT, increased AST, abnormal hepatic function (including increased liver function test, increased hepatic enzyme, increased transaminases, abnormal liver function test)

Frequency not reported: Cholelithiasis, cholecystitis, gallbladder pain, cholestasis^[Ref]

Metabolic

Very common (10% or more): Hypokalemia (including decreased blood potassium; up to 11%)

Common (1% to 10%): Hypomagnesemia

Frequency not reported: Decreased appetite, hypocalcemia, fluid overload, hyperkalemia^[Ref]

Gastrointestinal

Common (1% to 10%): Diarrhea, vomiting, nausea, constipation, Clostridioides difficile colitis (including pseudomembranous colitis, C difficile infection)

Frequency not reported: Abdominal pain, dry mouth, stomatitis, C difficile-associated diarrhea, oral candidiasis^[Ref]

Cardiovascular

Common (1% to 10%): Atrial fibrillation

Frequency not reported: Congestive heart failure, bradycardia, myocardial infarction, atrial flutter^[Ref]

Local

Common (1% to 10%): Infusion site reactions (including infusion site erythema, inflammation, pain, pruritus, injection site pain, phlebitis, infusion site pain, injection site phlebitis)^[Ref]

Dermatologic

Common (1% to 10%): Rash (including macular rash, maculopapular rash, erythema, skin irritation, erythematous rash, drug eruption)

Frequency not reported: Pruritus

Beta-lactam antibacterial drugs:

-Frequency not reported: Serious skin reactions^[Ref]

Nervous system

Common (1% to 10%): Headache

Frequency not reported: Dysgeusia, seizure

Cephalosporins:

-Frequency not reported: Seizures triggered, nonconvulsive status epilepticus, encephalopathy, coma, asterixis, neuromuscular excitability, myoclonia^[Ref]

Other

Common (1% to 10%): Candidiasis (including oral candidiasis, vulvovaginal candidiasis, candiduria, candida infection)

Frequency not reported: Pyrexia, peripheral edema, C difficile infection, increase in all-cause mortality, death^[Ref]

Respiratory

Common (1% to 10%): Cough

Frequency not reported: Dyspnea, pleural effusion^[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Hypersensitivity (including skin reactions, pruritus)

Frequency not reported: Drug hypersensitivity

Beta-lactam antibacterial drugs:

-Frequency not reported: Serious and sometimes fatal hypersensitivity (anaphylactic) reactions^[Ref]

Hematologic

Frequency not reported: Thrombocytosis, thrombocytopenia, prolonged prothrombin time (PT), prolonged PT-INR, prolonged activated partial thromboplastin time^[Ref]

Renal

Frequency not reported: Acute interstitial nephritis

Psychiatric

Frequency not reported: Insomnia, restlessness^[Ref]

Musculoskeletal

Frequency not reported: Increased creatine phosphokinase^[Ref]

Genitourinary

Frequency not reported: RBC urine positive^[Ref]