Pronunciation:

sef-toe-BYE-prole me-DOK-a-ril

Brand Names:

• Zevtera

Classifications:

Pharmacologic—

5th Generation Cephalosporin

Uses of This Medicine:

Ceftobiprole medocaril injection is used to treat infections in the bloodstream (bacteremia), including right-sided infective endocarditis. This medicine is also used to treat acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP).

Ceftobiprole medocaril injection belongs to the class of medicines known as cephalosporin antibiotics. It works by killing bacteria or preventing their growth. However, this medicine will not work for colds, flu, or other virus infections.

This medicine is to 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 ceftobiprole medocaril injection to treat CABP in children younger than 3 years of age and to treat ABSSSI and bacteremia in children. 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 ceftobiprole medocaril injection in the elderly.

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.

• Atogepant
• Atorvastatin
• Axitinib
• Bosentan
• Cerivastatin
• Cholera Vaccine, Live
• Docetaxel
• Elagolix
• Eluxadoline
• Exemestane
• Fexofenadine
• Fluvastatin
• Glecaprevir
• Glyburide
• Grazoprevir
• Letermovir
• Lovastatin
• Methotrexate
• Momelotinib
• Nateglinide
• Paclitaxel
• Paritaprevir
• Pitavastatin
• Pravastatin
• Repaglinide
• Revefenacin
• Rosuvastatin
• Selexipag
• Simvastatin
• Valsartan
• Voxilaprevir
• Zavegepant

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:

• Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Seizures, history of—Use with caution. May make this condition worse.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine. This medicine is given through an IV catheter that is placed into one of your veins. The medicine must be injected slowly, so your IV tube will need to stay in place for 2 hours.

To help clear up your infection completely, keep using this medicine for the full time of treatment, even if you begin to feel better after a few days. Also, this medicine works best when there is a constant amount in the blood. To help keep the amount constant, you must receive this medicine on a regular schedule.

Precautions While Using This Medicine:

Your doctor will check your progress closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it. Blood tests may be needed to check for unwanted effects.

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

This medicine may cause brain or nerve problems (eg, seizures). Check with your doctor right away if you have agitation, back pain, blurred vision, change or loss of consciousness, confusion, dizziness, drowsiness, fever, hallucinations, headache, irritability, mood or mental changes, muscle twitching or jerking, shaking or jerking of one area or side of the body, stiff neck, unusual tiredness or weakness, or vomiting.

This medicine 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. If you have any questions or if mild diarrhea continues or gets worse, check with your doctor.

Before you have any medical tests, tell the medical doctor in charge that you or your child are receiving this medicine. The results of some tests (eg, urine tests) may be affected by this medicine.

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

Agitation

bloody urine

blurred vision

chest pain

coma

confusion

dark urine

decreased urine

depression

dizziness

dry mouth

enlarged pupils

headache

hostility

increased sensitivity of the eyes to light

increased sweating, possibly fever or cold, clammy skin

irregular heartbeat

irritability

increased thirst

lethargy

loss of appetite

lower back or side pain

mood changes

muscle pain, cramps, or twitching

nausea or vomiting

nervousness

numbness or tingling in the hands, feet, or lips

pale skin

pounding in the ears

rapid weight gain

seizures

slow or fast heartbeat

stiff or sore neck

stomach cramps, tenderness, or pain

stupor

swelling of the face, ankles, or hands

trouble breathing

unusual bleeding or bruising

unusual tiredness or weakness

watery or bloody diarrhea

yellow eyes or skin

Less common

Black, tarry stools

bleeding gums

bluish color

changes in skin color

chest tightness

chills

cough

difficulty swallowing

hives, itching, skin rash

itching of the genitals

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

painful or difficult urination

pinpoint red spots on the skin

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

sore throat

sores, ulcers, or white spots on the lips or in the mouth

swelling of the foot or leg

swollen glands

thick, white vaginal discharge with mild or no odor

white patches in the mouth or on the tongue

Incidence not known

Feeling of discomfort

increased menstrual flow or vaginal bleeding

joint swelling

muscle jerking

nosebleeds

paralysis

prolonged bleeding from cuts

red or dark brown urine

rhythmic movement of the muscles

swollen lymph glands

unpleasant breath odor

vomiting of blood

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:

More common

Trouble sleeping

unable to sleep

Less common

Anxiety

change in taste

loss of taste

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.