Zinplava

Bezlotoxumab is a human monoclonal antibody that binds to C. difficile toxin B and neutralizes its effects. Bezlotoxumab is an IgG1 immunoglobulin with an approximate molecular weight of 148.2 kDa.

ZINPLAVA (bezlotoxumab) Injection is a sterile, preservative-free, clear to moderately opalescent, colorless to pale yellow solution that requires dilution for intravenous infusion. The product is provided in a 50 mL vial that contains 1000 mg of bezlotoxumab in 40 mL of solution. Each mL of solution contains bezlotoxumab (25 mg), citric acid monohydrate (0.8 mg), diethylenetriaminepentaacetic acid (0.0078 mg), polysorbate 80 (0.25 mg), sodium chloride (8.77 mg), sodium citrate dihydrate (4.75 mg), and Water for Injection, USP. The vial may contain sodium hydroxide to adjust the pH to 6.0.

Pregnancy

Adequate and well-controlled studies of bezlotoxumab have not been conducted in pregnant women

No animal reproductive and developmental studies have been conducted

Lactation

Unknown if distributed in human breast milk

Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

Zinplava is a prescription medication used to prevent Clostridium difficile (C-diff) infections from coming back in adults. Zinplava belongs to a group of drugs called human monoclonal antibodies. These prevent the infection from coming back again by blocking the activity of C-diff toxin B.

This medication is available in an injectable form to be given directly into a vein (IV) by a healthcare professional. Zinplava is administered as a single dose infusion over 60 minutes. You do not need to do anything to prepare for receiving Zinplava.

Common side effects of Zinplava include nausea, fever, and headache. Zinplava can also cause drowsiness or dizziness. Do not drive or operate heavy machinery until you know how Zinplava affects you.

Bezlotoxumab is a monoclonal antibody. Monoclonal antibodies are made to target only certain cells in the body. Bezlotoxumab works by binding to a specific toxin produced by the Clostridium difficile bacteria, to help neutralize the toxin's effects.

Bezlotoxumab is used together with antibiotic medicine in adults with Clostridium difficile (C. difficile), an infection that can cause life-threatening diarrhea. Bezlotoxumab may help keep this infection from coming back after treatment.

Bezlotoxumab is not an antibiotic and will not treat the infection itself.

Bezlotoxumab may also be used for purposes not listed in this medication guide.

Before you receive bezlotoxumab, tell your doctor about all your medical conditions or allergies, and all the medicines you are using. Also make sure your doctor knows if you are pregnant or breast-feeding.

To make sure bezlotoxumab is safe for you, tell your doctor if you have:

• congestive heart failure.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant.

It is not known whether bezlotoxumab passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Bezlotoxumab is not approved for use by anyone younger than 18 years old.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Other drugs may interact with bezlotoxumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Bezlotoxumab is injected into a vein through an IV. A healthcare provider will give you this injection.

This medicine must be given slowly, and the IV infusion can take about 60 minutes to complete.

Bezlotoxumab has no antibacterial effects and will not treat the underlying infection. You must use antibiotic medication to treat C. difficile infection.

Use your antibiotic medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses of your antibiotic may also increase your risk of further infection that is resistant to antibiotics.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

General

• Administer only while patient is receiving an anti-infective regimen for treatment of CDI.1

Administration

Administer by IV infusion;1 do not administer by IV injection.1

IV Infusion

For solution compatibility information, see Compatibility under Stability.

Must be diluted prior to IV infusion.1

After dilution, administer through a separate IV line using an in-line or add-on, low-protein-binding filter with a pore size of 0.2–5 µm.1

May be infused via a central line or peripheral catheter.1

Vials contain no preservatives;1 for single use only.1

Withdraw appropriate dose from vial(s) containing 25 mg/mL of bezlotoxumab and transfer into IV infusion bag containing 0.9% sodium chloride injection or 5% dextrose injection to provide a final concentration of 1–10 mg/mL.1 Gently invert IV bag to mix solution.1

Do not shake vials or final infusion solution.1

Discard any unused portion remaining in vial.1

Complete the infusion within 16 hours following dilution if stored at room temperature or within 24 hours if stored in refrigerator.1

If IV bag containing diluted solution is refrigerated, allow it to come to room temperature prior to IV infusion.1

Administer by IV infusion over 60 minutes.1

Dosage

Adults

10 mg/kg as a single dose.1

Safety and efficacy of >1 dose of bezlotoxumab not evaluated.1

Special Populations

Geriatric Patients

Dosage adjustments not needed in patients ≥65 years of age.1

Specific drug interaction studies not performed.4

Drug interactions not expected because bezlotoxumab is eliminated by catabolism (see Elimination under Pharmacokinetics).1

Not a substrate for and does not inhibit or induce CYP isoenzymes.4

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Zinplava, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Zinplava. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Zinplava.

Review Date: October 4, 2017

Injection: 1,000 mg/40 mL (25 mg/mL) clear to moderately opalescent, colorless to pale yellow solution in a single-dose vial.

There is no clinical experience with overdosage of Zinplava. In case of overdose, patients should be closely monitored for signs or symptoms of adverse reactions, and appropriate symptomatic treatment should be instituted.

Before you receive Zinplava, tell your doctor about all your medical conditions or allergies, and all the medicines you are using. Also make sure your doctor knows if you are pregnant or breast-feeding.

Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.