Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
ADVERSE REACTIONS The following important adverse reactions are discussed in greater detail in the Warnings and Precautions section: Nephrotoxicity [see Warnings and Precautions (5.1) ] Ototoxicity [see Warnings and Precautions (5.2) ] Neuromuscular Blockade [see Warnings and Precautions (5.3) ] Fetal Harm [see Warnings and Precautions (5.4) ] Hypersensitivity Reactions [see Warnings and Precautions (5.5) ] Clostridium difficile -Associated Diarrhea [see Warnings and Precautions (5.6) ] Most common adverse reactions (≥ 1% of patients treated with ZEMDRI) are decreased renal function, diarrhea, hypertension, headache, nausea, vomiting and hypotension.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Achaogen at 1-833-252-6402 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be compared directly to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
ZEMDRI was evaluated in two comparator-controlled clinical trials (Trial 1, NCT02486627 and Trial 2, NCT01096849) in patients with cUTI, including pyelonephritis.
In both trials, patients with CLcr greater than 60 mL/min received ZEMDRI 15 mg/kg IV once daily as a 30-minute infusion [ see Clinical Studies (14.1) ] .
Trial 1 included 303 patients treated with ZEMDRI and 301 patients treated with meropenem.
Patients were to receive 4 to 7 days of ZEMDRI (mean duration of 5.1 days).
In some patients, parenteral therapy was followed by a switch to an oral antibacterial drug.
The median age of patients treated with ZEMDRI in Trial 1 was 62 years (range 18 to 90 years) and 45.2% of patients were 65 years of age or older.
Patients treated with ZEMDRI were predominantly female (56.1%) and White (99.3%).
WARNINGS AND PRECAUTIONS Hypersensitivity Reactions, including anaphylaxis: Reported for aminoglycosides.
If an allergic reaction occurs, discontinue ZEMDRI.
( 5.4 ) Clostridium difficile -Associated Diarrhea : Reported for nearly all systemic antibacterial drugs.
Evaluate if diarrhea occurs.
( 5.5 ) 5.1 Nephrotoxicity Nephrotoxicity has been reported with the use of ZEMDRI [see Adverse Reactions (6.1) ].
Like all medications, Zemdri (plazomicin) can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: