Plazomicin Injection

(pla" zoe mye' sin)

Brand Name(s): Zemdri^®

IMPORTANT WARNING:

Plazomicin injection may cause serious kidney problems. Kidney problems may occur more often in older adults. Tell your doctor if you have or have ever had kidney disease. The risk that you will develop serious kidney problems is greater if you are taking or using certain medications. Tell your doctor and pharmacist what other prescription and nonprescription medications you are taking. If you experience any of the following symptoms, call your doctor immediately: decreased urination; swelling of the face, arms, hands, feet, ankles, or lower legs; or unusual tiredness or weakness.

Plazomicin injection may cause serious hearing problems. Hearing loss may be permanent in some cases. Tell your doctor if you or a family member have hearing loss not related to normal aging or have a history of hearing loss due to use of any medication, or if you have or have ever had dizziness, vertigo, hearing loss, or ringing in the ears. If you experience any of the following symptoms during or after your treatment, call your doctor immediately: hearing loss, roaring or ringing in the ears, loss of balance, or dizziness.

Plazomicin may cause muscle or nerve problems. Tell your doctor if you have or have ever had a neuromuscular disorder such as myasthenia gravis (MG; a disorder of the nervous system that causes muscle weakness) or Parkinson's disease. If you experience any of the following symptoms, call your doctor immediately: burning, tingling, or numbness in the hands, arms, feet, or legs; muscle twitching or weakness; or seizures.

If you are having surgery, including dental surgery, tell the doctor or dentist that you are using plazomicin injection.

Tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while using plazomicin injection, call your doctor immediately. Plazomicin may harm the fetus.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests, including hearing tests, before and during treatment to check your body's response to plazomicin.

WHY is this medicine prescribed?

Plazomicin injection is used to treat serious urinary tract infections, including kidney infections, that are caused by bacteria. Plazomicin injection is in a class of medications called aminoglycoside antibiotics. It works by killing bacteria.

Antibiotics such as plazomicin injection will not work for colds, flu, or other viral infections. Taking or using antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Plazomicin injection comes as a liquid to be injected intravenously (into a vein). When plazomicin is injected intravenously, it is usually infused (injected slowly) over a period of 30 minutes once daily. The length of your treatment is usually 4 to 7 days.

You may receive plazomicin injection in a hospital or you may administer the medication at home. If you will be receiving plazomicin injection at home, your healthcare provider will show you how to use the medication. Be sure that you understand these directions, and ask your healthcare provider if you have any questions.

You should begin to feel better during the first few days of treatment with plazomicin injection. If your symptoms do not improve or get worse, tell your doctor.

Use plazomicin injection until you finish the prescription, even if you feel better. If you stop using plazomicin injection too soon or skip doses, your infection may not be completely treated and the bacteria may become resistant to antibiotics.

What SPECIAL PRECAUTIONS should I follow?

Before using plazomicin injection,

• tell your doctor and pharmacist if you are allergic to plazomicin injection; other aminoglycoside antibiotics such as amikacin, gentamicin, neomycin, streptomycin, or tobramycin; any other medications; or any of the ingredients in plazomicin injection. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you are breastfeeding.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What SIDE EFFECTS can this medicine cause?

Plazomicin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• diarrhea
• nausea
• vomiting
• headache

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:

• rash
• itching
• hives
• swelling of the eyes, face, throat, tongue, or lips
• difficulty breathing or swallowing
• severe diarrhea (watery or bloody stools) that may occur with or without fever and stomach cramps (may occur up to 2 months or more after your treatment)

Plazomicin may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™. © Copyright, 2024. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: April 15, 2023.