Fetroja
- Generic Name: cefiderocol for injection
- Brand Name: Fetroja
Fetroja (Cefiderocol for Injection) side effects drug center
Fetroja Side Effects Center
What Is Fetroja?
Fetroja (cefiderocol) is a cephalosporin antibacterial used to treat patients 18 years of age or older who have limited or no alternative treatment options, for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis caused by susceptible Gram-negative microorganisms.
What Are Side Effects of Fetroja?
Common side effects of Fetroja include:
- diarrhea,
- infusion site reactions,
- constipation,
- rash,
- candidiasis (oral thrush or vaginal yeast infections),
- cough,
- elevations in liver tests,
- headache,
- low blood potassium (hypokalemia),
- nausea, and
- vomiting
Dosage for Fetroja
The dose of Fetroja for injection is 2 grams administered every 8 hours by intravenous (IV) infusion over 3 hours in patients with creatinine clearance (CLcr) 60 to 119 mL/min.
Fetroja In Children
Safety and efficacy of Fetroja in pediatric patients younger than 18 years of age have not been established.
What Drugs, Substances, or Supplements Interact with Fetroja?
Fetroja may interact with other medicines.
Tell your doctor all medications and supplements you use.
Fetroja During Pregnancy and Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant before using Fetroja; it is unknown how it would affect a fetus. It is unknown if Fetroja passes into breast milk. Consult your doctor before breastfeeding.
Additional Information
Tell your doctor if you are pregnant or plan to become pregnant before using Fetroja; it is unknown how it would affect a fetus. It is unknown if Fetroja passes into breast milk. Consult your doctor before breastfeeding.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Fetroja Consumer Information
Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).
Call your doctor at once if you have:
- severe stomach pain, diarrhea that is watery or bloody (even if it occurs months after your last dose);
- tremor, rigid muscles, or a seizure;
- white patches or sores inside your mouth or on your lips; or
- low potassium level--leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling.
Common side effects may include:
- nausea, vomiting, diarrhea, constipation;
- mouth sores;
- cough;
- abnormal liver function tests;
- headache;
- rash; or
- pain, redness, itching, bruising, or swelling around the IV needle.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Fetroja (Cefiderocol for Injection)
Fetroja Professional Information
SIDE EFFECTS
The following serious adverse reactions are described in greater detail in the Warnings and Precautions section:
- Increase in All-Cause Mortality in Patients with Carbapenem-Resistant Gram-Negative Bacterial Infections [see WARNINGS AND PRECAUTIONS]
- Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]
- Clostridioides difficile-Associated Diarrhea (CDAD) [see WARNINGS AND PRECAUTIONS]
- Seizures and Other Central Nervous System Adverse Reactions [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Complicated Urinary Tract Infections (cUTIs), Including Pyelonephritis
FETROJA was evaluated in an active-controlled, randomized clinical trial in patients with cUTI, including pyelonephritis (Trial 1). In this trial, 300 patients received FETROJA 2 grams every 8 hours infused over 1 hour (or a renally-adjusted dose), and 148 patients were treated with imipenem/cilastatin 1 gram/1 gram every 8 hours infused over 1 hour (or a renally-adjusted dose). The median age of treated patients across treatment arms was 65 years (range 18 to 93 years), with approximately 53% of patients aged greater than or equal to 65. Approximately 96% of patients were White, most were from Europe, and 55% were female. Patients across treatment arms received treatment for a median duration of 9 days.
Serious Adverse Reactions And Adverse Reactions Leading To Discontinuation
In Trial 1, a total of 14/300 (4.7%) cUTI patients treated with FETROJA and 12/148 (8.1%) of cUTI patients treated with imipenem/cilastatin experienced serious adverse reactions. One death (0.3%) occurred in 300 patients treated with FETROJA as compared to none treated with imipenem/cilastatin. Discontinuation of treatment due to any adverse reaction occurred in 5/300 (1.7%) of patients treated with FETROJA and 3/148 (2.0%) of patients treated with imipenem/cilastatin. Specific adverse reactions leading to treatment discontinuation in patients who received FETROJA included diarrhea (0.3%), drug hypersensitivity (0.3%), and increased hepatic enzymes (0.3%).
Common Adverse Reactions
Table 4 lists the most common selected adverse reactions occurring in ≥ 2% of cUTI patients receiving FETROJA in Trial 1.
Table 4 : Selected Adverse Reactions Occurring in ≥ 2% of cUTI Patients Receiving FETROJA in Trial 1
| Adverse Reaction | FETROJAa (N = 300) | Imipenem/Cilastatinb (N = 148) |
| Diarrhea | 4% | 6% |
| Infusion site reactionsc | 4% | 5% |
| Constipation | 3% | 4% |
| Rashd | 3% | < 1% |
| Candidiasise | 2% | 3% |
| Cough | 2% | < 1% |
| Elevations in liver testsf | 2% | < 1% |
| Headache | 2% | 5% |
| Hypokalemiag | 2% | 3% |
| Nausea | 2% | 4% |
| Vomiting | 2% | 1% |
| cUTI = complicated urinary tract infection. a 2 grams IV over 1 hour every 8 hours (with dosing adjustment based on renal function). b 1 gram IV over 1 hour every 8 hours (with dosing adjustment based on renal function and body weight). c Infusion site reactions include infusion site erythema, inflammation, pain, pruritis, injection site pain, and phlebitis. d Rash includes rash macular, rash maculopapular, erythema, skin irritation. e Candidiasis includes oral or vulvovaginal candidiasis, candiduria. f Elevations in liver tests include alanine aminotransferase, aspartate aminotransferase, gamma-glutamyl transferase, blood alkaline phosphatase, hepatic enzyme increased. g Hypokalemia includes blood potassium decreased. | ||
Other Adverse Reactions Of FETROJA In The cUTI Patients (Trial 1)
The following selected adverse reactions were reported in FETROJA-treated cUTI patients at a rate of less than 2% in Trial 1:
Blood and lymphatic disorders: thrombocytosis
Cardiac disorders: congestive heart failure, bradycardia, atrial fibrillation
Gastrointestinal disorders: abdominal pain, dry mouth, stomatitis
General system disorders: pyrexia, peripheral edema
Hepatobiliary disorders: cholelithiasis, cholecystitis, gallbladder pain
Immune system disorders: drug hypersensitivity
Infections and infestations: C. difficile infection
Laboratory investigations: prolonged prothrombin time (PT) and prothrombin time international normalized ratio (PT-INR), red blood cells urine positive, creatine phosphokinase increase
Metabolism and nutrition disorders: decreased appetite, hypocalcemia, fluid overload
Nervous system disorders: dysgeusia, seizure
Respiratory, thoracic, and mediastinal disorders: dyspnea, pleural effusion
Skin and subcutaneous tissue disorders: pruritis
Psychiatric disorders: insomnia, restlessness
Hospital-acquired Bacterial Pneumonia And Ventilator-associated Bacterial Pneumonia (HABP/VABP)
FETROJA was evaluated in an active-controlled clinical trial in patients with HABP/VABP (Trial 2). In this trial, 148 patients received FETROJA 2 grams every 8 hours infused over 3 hours, and 150 patients received meropenem 2 grams every 8 hours infused over 3 hours. Doses of study treatments were adjusted based on renal function. The median age was 67 years, approximately 59% of patients were 65 years of age and older, 69% were male, and 68% were White. Overall, approximately 60% were ventilated at randomization, including 41% with VABP and 14% with ventilated HABP. The mean Acute Physiology And Chronic Health Evaluation (APACHE II) score was 16. All patients received empiric treatment for Gram-positive organisms with linezolid for at least 5 days.
Serious Adverse Reactions And Adverse Reactions Leading To Discontinuation
In Trial 2, serious adverse reactions occurred in 54/148 (36.5%) HABP/VABP patients treated with FETROJA and 45/150 (30%) of HABP/VABP patients treated with meropenem. Adverse reactions leading to death were reported in 39/148 (26.4%) patients treated with FETROJA and 35/150 (23.3%) patients treated with meropenem. Adverse reactions leading to discontinuation of treatment occurred in 12/148 (8.1%) of patients treated with FETROJA and 14/150 (9.3%) of patients treated with meropenem. The most common adverse reactions leading to discontinuation in both treatment groups were elevated liver tests.
Common Adverse Reactions
Table 5 lists the most common selected adverse reactions occurring in ≥ 4% of patients receiving FETROJA in the HABP/VABP trial.
Table 5 : Selected Adverse Reactions Occurring in ≥ 4% of HABP/VABP Patients Receiving FETROJA in Trial 2
| Adverse Reaction | FETROJAa N = 148 | Meropenemb N = 150 |
| Elevations in liver testsc | 16% | 16% |
| Hypokalemiad | 11% | 15% |
| Diarrhea | 9% | 9% |
| Hypomagnesemia | 5% | < 1% |
| Atrial fibrillation | 5% | 3% |
| HABP/VABP = hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia. a 2 grams IV over 3 hours every 8 hours (with dosing adjustment based on renal function). b 2 grams IV over 3 hours every 8 hours (with dosing adjustment based on renal function). c Elevations in liver tests include the following terms: aspartate aminotransferase increased, alanine aminotransferase increased, gamma-glutamyl transferase increased, liver function test increased, liver function test abnormal, hepatic enzyme increased, transaminases increased, hypertransaminesemia. d Hypokalemia includes blood potassium decreased. | ||
Other Adverse Reactions Of FETROJA In HABP/VABP Patients In Trial 2
The following selected adverse reactions were reported in FETROJA-treated HABP/VABP patients at a rate of less than 4% in Trial 2:
Blood and lymphatic disorders: thrombocytopenia, thrombocytosis
Cardiac disorders: myocardial infarction, atrial flutter
Gastrointestinal disorders: nausea, vomiting, abdominal pain
Hepatobiliary disorders: cholecystitis, cholestasis
Infections and infestations: C. difficile infection, oral candidiasis
Laboratory investigations: prolonged prothrombin time (PT) and prothrombin time international normalized ratio (PT-INR), and activated partial thromboplastin time (aPTT)
Metabolism and nutrition disorders: hypocalcemia, hyperkalemia
Nervous system disorders: seizure
Renal and genitourinary disorders: acute interstitial nephritis
Respiratory, thoracic, and mediastinal disorders: cough
Skin and subcutaneous tissue disorders: rash including rash erythematous
Read the entire FDA prescribing information for Fetroja (Cefiderocol for Injection)
&Copy; Fetroja Patient Information is supplied by Cerner Multum, Inc. and Fetroja Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.