Pronunciation:

er-a-va-SYE-kleen

Brand Names:

• Xerava

Dosage Forms:

• Powder for Solution

Classifications:

Therapeutic—

Antibiotic

Chemical—

Tetracycline (class)

Uses of This Medicine:

Eravacycline injection is used to treat complicated intra-abdominal (within the stomach area) infections (cIAI) caused by bacteria.

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 eravacycline injection in the pediatric population. Use is not recommended in children younger than 8 years of age. 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 eravacycline 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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Acitretin

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.

• Abametapir
• Amoxicillin
• Ampicillin
• Bacampicillin
• Bexarotene
• Carbamazepine
• Cloxacillin
• Dicloxacillin
• Enzalutamide
• Etretinate
• Fedratinib
• Fexinidazole
• Fosphenytoin
• Isotretinoin
• Itraconazole
• Lumacaftor
• Magnesium Sulfate
• Mavacamten
• Methicillin
• Methotrexate
• Mitotane
• Nafcillin
• Omaveloxolone
• Oxacillin
• Palovarotene
• Penicillin G
• Penicillin G Benzathine
• Penicillin G Procaine
• Penicillin V
• Phenobarbital
• Phenytoin
• Piperacillin
• Pivampicillin
• Porfimer
• Primidone
• Rifampin
• St John's Wort
• Sultamicillin
• Temocillin
• Tretinoin

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, severe—Use with caution. The effects may be increased because of the slower removal of the medicine from the body.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine. This medicine is given through a needle placed into one of your veins. It must be given slowly, so the needle will have to stay in place for about 60 minutes.

Precautions While Using This Medicine:

It is very important that your doctor check your progress closely while you are receiving this medicine to make sure it is working properly. Blood tests may be needed to check for unwanted effects.

Tell your doctor if you are pregnant or planning to get pregnant. You should not receive this medicine during the second or third part of a pregnancy.

This medicine may cause permanent discoloration of the teeth and slow down the growth of bones in children younger than 8 years of age. Talk with your doctor if you have concerns.

Eravacycline 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.

Avoid overexposing your skin to sunlight. Always use sunscreen or sun blocking lotions and wear protective clothing and hats while you are receiving this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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:

Less common

Bleeding wound

blurred vision

confusion

diarrhea

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

red, tender, or oozing skin at the incision site

sweating

unusual tiredness or weakness

Rare

Black, tarry, stools

bloating

chest pain

chills

constipation

cough

dark urine

difficult or labored breathing

fast, irregular, pounding, or racing heartbeat or pulse

fever

hives, itching, skin rash

hoarseness

indigestion

irritation

joint pain, stiffness or swelling

loss of appetite

lower back or side pain

mood or mental changes

muscle cramps in the hands, arms, feet, legs, or face

nausea

numbness and tingling around the mouth, fingertips, or feet

painful or difficult urination

pains in the stomach, side, or abdomen, possibly radiating to the back

pale skin

redness of the skin

seizures

sore throat

stomach cramps

swelling of the eyelids, face, lips, hands, or feet

tightness in the chest

tremor

troubled breathing or swallowing

ulcers, sores, or white spots in the mouth

unusual bleeding or bruising

vomiting

yellow eyes or skin

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

Dry, red, hot, or irritated skin

Rare

Anxiety

change in taste

discouragement

feeling sad or empty

loss of interest or pleasure

loss of taste

trouble concentrating

trouble sleeping

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.