Zemdri Generic Name: plazomicin injection, for intravenous use Brand Name: Zemdri Zemdri (Plazomicin Injection, for Intravenous Use) side effects drug center Related Drugs Bactrim Cipro Cipro IV Cipro XR Keflex Levaquin Macrobid Macrodantin Monurol Septra Health Resources Urinary Tract Infection (UTI) Urinary Tract Infection (UTI In Adults) PROFESSIONAL CONSUMER SIDE EFFECTS Overview Professional Information Zemdri Side Effects Center What Is Zemdri? Zemdri (plazomicin) is an aminoglycoside antibacterial indicated for the treatment of patients 18 years of age or older with complicated Urinary Tract Infections (cUTI) including Pyelonephritis. What Are Side Effects of Zemdri? Common side effects of Zemdri include: decreased renal function, diarrhea, high blood pressure (hypertension), headache, nausea, vomiting, and low blood pressure (hypotension) Dosage for Zemdri The recommended dose of Zemdri is 15 mg/kg administered every 24 hours by intravenous (IV) infusion over 30 minutes to patients 18 years of age or older with creatinine clearance greater than or equal to 90 mL/min. The recommended duration of treatment with Zemdri is 4 to 7 days for cUTI, including pyelonephritis. What Drugs, Substances, or Supplements Interact with Zemdri? Zemdri may interact with other drugs. Tell your doctor all medications and supplements you use. Zemdri During Pregnancy and Breastfeeding Tell your doctor if you are pregnant or plan to become pregnant before using Zemdri; it may harm a fetus. It is unknown if Zemdri passes into breast milk. Consult your doctor before breastfeeding. Additional Information Our Zemdri (plazomicin) Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication. Zemdri Consumer Information Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Plazomicin can harm your kidneys, and may also cause nerve damage or hearing loss. 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); dizziness, spinning sensation; a light-headed feeling, like you might pass out; hearing loss, a buzzing or roaring sound in your ears (during or after treatment with plazomicin); muscle weakness; or kidney problems--little or no urination, swelling in your feet or ankles, feeling tired or short of breath. Serious side effects may be more likely in older adults. Common side effects may include: nausea, vomiting, diarrhea; headache; or feeling light-headed. 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 Zemdri (Plazomicin Injection, for Intravenous Use) Zemdri Professional Information SIDE EFFECTSThe following important adverse reactions are discussed in greater detail in the Warnings and Precautions section:Nephrotoxicity [see WARNINGS AND PRECAUTIONS]Ototoxicity [see WARNINGS AND PRECAUTIONS]Neuromuscular Blockade [see WARNINGS AND PRECAUTIONS]Fetal Harm [see WARNINGS AND PRECAUTIONS]Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]Clostridium difficile-Associated Diarrhea [see WARNINGS AND PRECAUTIONS]Clinical Trial ExperienceBecause 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].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%). A majority of patients (68.0%) had mild or moderate renal impairment (CLcr >30 to 90 mL/min) at baseline. Patients with CLcr of 30 mL/min or less were excluded.?Adverse Reactions Leading To Treatment Discontinuations In Trial 1In Trial 1, treatment discontinuation from IV study drug due to an adverse reaction occurred in 2.0% of patients receiving ZEMDRI (6/303) and meropenem (6/301), respectively.Common Adverse Reactions In Trial 1Table 3 lists adverse reactions occurring in 1% or more of patients receiving ZEMDRI in Trial 1.Table 3: Incidence (%) of Adverse Reactions Occurring in 1% or More of cUTI Adult Patients Treated With ZEMDRI in Trial 1Adverse ReactionsZEMDRI(N=303)n (%)Meropenem a(N=301)n (%)Decreased Renal Function b11 (3.6)4 (1.3)Diarrhea7 (2.3)5 (1.7)Hypertension7 (2.3)7 (2.3)Headache4 (1.3)9 (3.0)Nausea4 (1.3)4 (1.3)Vomiting4 (1.3)3 (1.0)Hypotension3 (1.0)2 (0.7)a 1 g IV every 8 hours.b Combined term that corresponds to adverse reactions associated with renal function described in Nephrotoxicity section below.The adverse reactions profile for the cUTI patients in Trial 2 were similar to those observed in Trial 1.Nephrotoxicity Reported In Trial 1In Trial 1, serum creatinine increases of 0.5 mg/dL or greater above baseline occurred in 7.0% (21/300) of ZEMDRI-treated patients compared with 4.0% (12/297) of meropenem-treated patients. Of these, the incidence during IV therapy was 3.7% (11/300) vs 3.0% (9/297) in ZEMDRI- and meropenem-treated patients, respectively. By the last follow-up visit (between 8 to 43 days after completion of IV therapy), the majority of ZEMDRI-treated patients (9/11) and all meropenem treated patients (9/9) with serum creatinine increases while on therapy had fully recovered renal function. Serum creatinine increases of 0.5 mg/dL or greater above baseline were observed following completion of IV therapy. These increases were generally ≤ 1.0 mg/dL above baseline and recovered by the next measurement.In cUTI patients with CLcr of greater than 30 and less than or equal to 90 mL/min, 9.7% (20/207) ZEMDRI-treated and 4.1% (9/217) meropenem-treated patients had serum creatinine increases of 0.5 mg/dL or greater above baseline. In cUTI patients with CLcr greater than 90 mL/min, 1.1% (1/93) ZEMDRI-treated and 3.8% (3/80) of meropenem-treated patients had serum creatinine increases of 0.5 mg/dL or greater above baseline [see Use In Specific Populations].OtotoxicityPure tone audiometry was evaluated in Phase 1 trials and in Trial 2. Treatment associated ototoxicity could not be definitively excluded according to the American Speech-Language- Hearing Association criteria1 in 2.2% (4/182) of ZEMDRI-exposed and 2.0% (1/49) of comparator- or placebo-exposed adults.Other Adverse Reactions Reported With ZEMDRIThe following selected adverse reactions were reported in more than one ZEMDRI-treated patient in Trials 1 and 2 and are not described elsewhere in the labeling:Gastrointestinal disorders:constipation, gastritisLaboratory Investigations: alanine aminotransferase increasedMetabolism and nutrition disorders:hypokalemiaNervous system disorders: dizzinessRenal and urinary disorders: hematuriaRespiratory, thoracic and mediastinal disorders: dyspnea Read the entire FDA prescribing information for Zemdri (Plazomicin Injection, for Intravenous Use) &Copy; Zemdri Patient Information is supplied by Cerner Multum, Inc. and Zemdri Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
