Eravacycline (intravenous route)


    Brand Name

    US Brand Name

    Xerava


    Description

    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.

    This product is available in the following dosage forms:

    • Powder for Solution

    Before Using

    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.

    Pediatric

    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.

    Geriatric

    Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of eravacycline injection in the elderly.

    Breastfeeding

    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.

    Drug Interactions

    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
    • Avacopan
    • Bacampicillin
    • Bexarotene
    • Carbamazepine
    • Clarithromycin
    • Cloxacillin
    • Dicloxacillin
    • Enzalutamide
    • Ethinyl Estradiol
    • Etretinate
    • Fedratinib
    • Fexinidazole
    • Fosphenytoin
    • Isotretinoin
    • Itraconazole
    • Levonorgestrel
    • 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

    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

    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

    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

    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.






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