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Zemdri Approval History

Reviewed on Jun 26, 2018 by J.Stewart B.Pharm

FDA Approved: Yes (First approved June 25, 2018)
Brand name: Zemdri
Generic name: plazomicin
Dosage form: Injection
Company: Achaogen, Inc.
Treatment for: Urinary Tract Infection

Zemdri (plazomicin) is an aminoglycoside antibacterial for the treatment of complicated urinary tract infections.

Important Safety Information

BOXED WARNINGS: NEPHROTOXICITY, OTOTOXICITY, NEUROMUSCULAR BLOCKADE AND FETAL HARM

Nephrotoxicity has been reported with Zemdri. The risk of nephrotoxicity is greater in patients with impaired renal function, the elderly, and in those receiving concomitant nephrotoxic medications. Assess creatinine clearance in all patients prior to initiating therapy and daily during therapy. Therapeutic Drug Monitoring (TDM) is recommended for complicated urinary tract infection (cUTI) patients with CLcr less than 90 mL/min to avoid potentially toxic levels.

Ototoxicity, manifested as hearing loss, tinnitus, and/or vertigo, has been reported with Zemdri. Symptoms of aminoglycoside-associated ototoxicity may be irreversible and may not become evident until after completion of therapy. Aminoglycoside-associated ototoxicity has been observed primarily in patients with a family history of hearing loss, patients with renal impairment, and in patients receiving higher doses and/or longer durations of therapy than recommended.

Aminoglycosides have been associated with neuromuscular blockade. During therapy with Zemdri, monitor for adverse reactions associated with neuromuscular blockade particularly in high-risk patients, such as patients with underlying neuromuscular disorders (including myasthenia gravis) or in patients concomitantly receiving neuromuscular blocking agents. Aminoglycosides, including Zemdri, can cause fetal harm when administered to a pregnant woman.

Contraindications: Zemdri is contraindicated in patients with known hypersensitivity to any aminoglycoside.

Additional Warnings and Precautions

Nephrotoxicity: Reported with the use of Zemdri. Most serum creatinine increases were ≤ 1 mg/dL above baseline and reversible. Assess CLcr in all patients prior to initiating therapy and daily during therapy with Zemdri, particularly in those at increased risk of nephrotoxicity, such as those with renal impairment, the elderly and those receiving concomitant potentially nephrotoxic medications. In the setting of worsening renal function, the benefit of continuing Zemdri should be assessed. Adjust the initial dosage regimen in cUTI patients with CLcr ≥ 15 mL/min and < 60 mL/min. For subsequent doses, TDM is recommended for patients with CLcr ≥ 15 mL/min and < 90 mL/min.

Ototoxicity: Reported with Zemdri (manifested as hearing loss, tinnitus, and/or vertigo). Symptoms of aminoglycoside-associated ototoxicity may be irreversible and may not become evident until after completion of therapy. Aminoglycoside-associated ototoxicity has been observed primarily in patients with a family history of hearing loss (excluding age-related hearing loss), patients with renal impairment, and in patients receiving higher doses and/or for longer periods than recommended. The benefit-risk of Zemdri therapy should be considered in these patients.

Neuromuscular Blockade: Aminoglycosides have been associated with exacerbation of muscle weakness in patients with underlying neuromuscular disorders, or delay in recovery of neuromuscular function in patients receiving concomitant neuromuscular blocking agents. During therapy with Zemdri, monitor for adverse reactions associated with neuromuscular blockade, particularly in high-risk patients, such as patients with underlying neuromuscular disorders (including myasthenia gravis) or those patients concomitantly receiving neuromuscular blocking agents.

Fetal Harm: Aminoglycosides, including Zemdri, can cause fetal harm when administered to a pregnant woman. Patients who use Zemdri during pregnancy, or become pregnant while taking Zemdri should be apprised of the potential hazard to the fetus.

Hypersensitivity Reactions: Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving aminoglycoside antibacterial drugs. Before therapy with Zemdri is instituted, careful inquiry about previous hypersensitivity reactions to other aminoglycosides should be made. Discontinue Zemdri if an allergic reaction occurs.

Clostridium difficile-Associated Diarrhea (CDAD): Reported for nearly all systemic antibacterial drugs and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial drugs alters the normal flora of the colon and may permit overgrowth of C. difficile. Careful medical history is necessary. If CDAD is suspected or confirmed, antibacterial drugs not directed against C. difficile may need to be discontinued.

Development of Drug-Resistant Bacteria: Prescribing Zemdri in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. Please click here to see the full Prescribing Information, including BOXED WARNINGS, for additional Important Safety Information.

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Achaogen at (833) AKAO-402.

Development History and FDA Approval Process for Zemdri

DateArticle
Jun 25, 2018Approval Zemdri (plazomicin) Approved by FDA for the Treatment of Adults with Complicated Urinary Tract Infections (cUTI)
May  2, 2018Achaogen Announces FDA Advisory Committee Voted Unanimously in Favor of Plazomicin for Treatment of Adults with Complicated Urinary Tract Infections
Jan  2, 2018Achaogen Announces FDA Acceptance of New Drug Application with Priority Review for Plazomicin for Treatment of Complicated Urinary Tract Infections and Bloodstream Infections
Oct 26, 2017Achaogen Submits Plazomicin New Drug Application (NDA) to the U.S. FDA for Treatment of Complicated Urinary Tract Infections and Bloodstream Infections
Sep  1, 2016Achaogen Completes Patient Enrollment in Phase 3 EPIC Clinical Trial of Plazomicin
Jan 11, 2016Achaogen Announces Enrollment of First Patient in EPIC, a Phase 3 Clinical Trial for the Treatment of Complicated Urinary Tract Infections (cUTI) With Plazomicin
Sep 17, 2014Achaogen Announces First Patient Enrollment in a Phase 3 Clinical Trial of Plazomicin
May 15, 2012Achaogen Announces All Objectives Met in Phase 2 Plazomicin Complicated Urinary Tract Infections Study and Start of First-in-Human Study with ACHN-975

Further information

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