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bezlotoxumab (Intravenous route)

bez-loe-TOX-ue-mab

Commonly used brand name(s)

In the U.S.

  • Zinplava

Available Dosage Forms:

  • Solution

Therapeutic Class: Antitoxin

Pharmacologic Class: Monoclonal Antibody

Uses For bezlotoxumab

Bezlotoxumab injection is used to prevent Clostridium difficile infection (CDI) from coming back in patients who are receiving medicines to treat CDI and are at risk for CDI recurrence. bezlotoxumab is not used to treat CDI.

bezlotoxumab is to be given only by or under the direct supervision of your doctor.

Before Using bezlotoxumab

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 bezlotoxumab, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to bezlotoxumab 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 bezlotoxumab injection in the pediatric population. 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 bezlotoxumab 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.

Interactions with 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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

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 bezlotoxumab. Make sure you tell your doctor if you have any other medical problems, especially:

  • Congestive heart failure, or history of—Use with caution. May make this condition worse.

Proper Use of bezlotoxumab

A nurse or other trained health professional will give you bezlotoxumab in a hospital. bezlotoxumab is given through a needle placed in one of your veins.

bezlotoxumab should come with patient instructions. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Precautions While Using bezlotoxumab

Your doctor will check your progress closely while you are receiving bezlotoxumab. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it.

If you are rapidly gaining weight, having shortness of breath, chest pain, extreme tiredness or weakness, irregular breathing, irregular heartbeat, or excessive swelling of the hands, wrist, ankles, or feet, check with your doctor immediately. These may be symptoms of heart problems or your body keeping too much water.

bezlotoxumab 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:

More common
  • Back pain
  • chest pain
  • chest tightness
  • chills
  • decreased urine output
  • dilated neck veins
  • extreme fatigue
  • fever
  • flushing
  • headache
  • irregular breathing
  • irregular heartbeat
  • nausea and vomiting
  • swelling of face, fingers, feet, or lower legs
  • tightness in the chest
  • troubled breathing
  • weakness
  • weight gain

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
  • Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

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.

Side Effects (complete list)

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