Pronunciation:

pla-zoe-MYE-sin

Brand Names:

• Zemdri

Dosage Forms:

• Solution

Warnings:

Warning: Nephrotoxicity, Ototoxicity, Neuromuscular Blockade and Fetal HarmNephrotoxicity has been reported with plazomicin. 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 CrCl less than 90 mL/min to avoid potentially toxic levels.Ototoxicity, manifested as hearing loss, tinnitus, and/or vertigo, has been reported with plazomicin. 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 plazomicin, 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 plazomicin, can cause fetal harm when administered to a pregnant woman .

Classifications:

Therapeutic—

Antibiotic

Chemical—

Aminoglycoside

Uses of This Medicine:

Plazomicin is used to treat complicated urinary tract infections (cUTI), including pyelonephritis (kidney infection) in patients who have limited or no other treatment options. Plazomicin is an aminoglycoside antibiotic that works by killing bacteria or preventing their growth.

This medicine may be given only by or under the direct supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of plazomicin in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of plazomicin in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution for patients receiving this medicine.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aspirin
• Emtricitabine
• Furosemide
• LetibotulinumtoxinA-wlbg
• Tacrolimus
• Tenofovir Alafenamide

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Hearing loss, family history of or
• Kidney disease or
• Nerve or muscle disorder (eg, myasthenia gravis)—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine. It is given through a needle placed into one of your veins. This medicine must be given slowly, so the needle will have to stay in place for at least 30 minutes.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Urine and hearing tests may be needed to check for unwanted effects.

Check with your doctor right away if you have bloody urine, a decrease in frequency or amount of urine, an increase in blood pressure, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, trouble breathing, unusual tiredness or weakness, vomiting, or weight gain. These could be symptoms of a serious kidney problem.

Check with your doctor right away if you have dizziness, feeling of fullness in the ears, loss of balance, loss of hearing, ringing or buzzing in the ears, or trouble in hearing. These may be symptoms of a serious hearing or balance problem.

Receiving this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while receiving the medicine, tell your doctor right away.

This medicine may cause a serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after receiving this medicine.

Plazomicin may cause diarrhea, and in some cases it can be severe. It may occur 2 months or more after you stop receiving this medicine. Do not take any medicine to treat diarrhea without first checking with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If you have any questions about this or if mild diarrhea continues, or gets worse, check with your doctor.

Side Effects of This Medicine:

Along with its needed effects, a medicine 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:

More common

Blood in the urine

change in the frequency of urination or amount of urine

difficulty in breathing

drowsiness

increased thirst

loss of appetite

nausea

swelling of the feet or lower legs

vomiting

Less common

Blurred vision

cloudy urine

confusion

decrease in urine-concentrating ability

diarrhea

dizziness

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

feeling of fullness in the ears

headache

loss of balance

loss of hearing

nervousness

pounding in the ears

ringing or buzzing in the ears

slow or fast heartbeat

trouble in hearing

unusual tiredness or weakness

Incidence not known

Burning feeling in the chest or stomach

chest tightness

dry mouth

indigestion

irregular heartbeat

mood changes

muscle pain or cramps

numbness or tingling in the hands, feet, or lips

seizures

stomach upset

tenderness in the stomach area

Some side effects 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:

Incidence not known

Constipation

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.