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Zinplava is a monoclonal antibody, used to prevent recurrence of Clostridium difficile infection in adult patients at high risk of recurrence. So what are the uses, doses and precautions during the use of Zinplava?
1. What is Zinplava?
Zinplava has the active ingredient Bezlotoxumab, a monoclonal antibody. Bezlotoxumab has the ability to bind to Clostridium difficile toxin B and neutralize toxin B to prevent toxic effects. Bezlotoxumab does not bind to Clostridium difficile toxin A. Zinplava is indicated for the prevention of recurrence of Clostridium difficile infection (CDI) in adults at high risk of recurrence. Zinplava is not a cure for CDI and is not effective against Clostridium difficile.
2. Dosage and how to use Zinplava
Dosage:
Zinplava should be given intravenously at a dose of 10mg/kg. Treatment with Zinplava in patients should be limited to one episode of Clostridium difficile infection. The drug is administered in a single dose. Elderly: No dose adjustment of Zinplava is required in patients ≥ 65 years of age. Renal Impairment: No dose adjustment of Zinplava is required for patients with renal impairment. Hepatic impairment: No dose adjustment of Zinplava is required for patients with hepatic impairment. Children: The safety and effectiveness of Zinplava have not been established in patients younger than 18 years of age. Therefore, this drug should not be used. How to use:
Use diluted Zinplava solution for intravenous infusion for 60 minutes. Zinplava should not be used intravenously. The diluent may be administered via a central or peripheral line. Zinplava should not be used concurrently with other medicinal products through the same infusion line. Instructions on how to dilute the drug before use are as follows:
Need to dilute the solution immediately after removing the vial from the storage place. Check for colors and irregularities in the potion. Do not use the vial if the solution is discolored or has visible particles. Do not shake the vial. Withdraw the required volume from the vial based on the patient's weight and transfer to an infusion bag containing 0.9% Sodium Chloride or 5% Dextrose, to dilute the drug solution to a final concentration of 1 to 10 mg. /ml. Mix the diluted solution by gentle stirring.
3. Contraindications of Zinplava
Zinplava is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients listed in the formulation.
4. What are the side effects of Zinplava?
Patients using Zinplava may experience unwanted effects including:
Heart failure; Headache; Nausea ; Infusion-related reactions include vomiting, fatigue, fever, dizziness, headache, dyspnea, increased blood pressure; Ventricular tachyarrhythmia.
5. Notes when using Zinplava
Zinplava is not an antibiotic that is effective against Clostridium difficile and will not affect the current CDI episode. Current antibiotics indicated in the treatment of CDI include Metronidazole, Vancomycin (oral use), Fidaxomicin, and Rifaximin. Patients must use antibiotics according to the doctor's prescription and dosage to reduce the risk of CDI recurrence. Zinplava should be used during antibacterial treatment for CDI. There are no data on the efficacy of Zinplava if used after 10 to 14 days of initial antibacterial therapy for CDI. Heart failure has been reported in some patients treated with Bezlotoxumab and occurred mainly in patients with pre-existing heart failure. In addition, higher rates of death from heart failure, infection, and respiratory failure were observed in patients with a history of heart failure who received Bezlotoxumab. In patients with a history of heart failure, Bezlotoxumab should be used only in cases where the potential benefits outweigh the risks. As with all other therapeutic proteins, the patient developed immunity following the administration of Zinplava. Antibody formation can affect the therapeutic effect of the drug. Lactation: It is not known whether Bezlotoxumab is excreted in human milk. According to the manufacturer, the decision to continue or stop breastfeeding during treatment should take into account the risks to the infant, the benefits of breastfeeding, and the benefits of therapy to the mother. Pregnancy: There are no clinical data on the effects of this on pregnant women. Zinplava should not be used during pregnancy unless the patient's clinical condition requires treatment with Bezlotoxumab. Drug Interactions: Therapeutic monoclonal antibodies generally do not pose a significant risk of drug-drug interactions because they do not directly affect cytochrome P450 enzymes and are not substrates of hepatic or renal metabolites. . Storage: Dilutions of Zinplava can be stored at room temperature for up to 16 hours or refrigerated at 2°C to 8°C for up to 24 hours. If the diluent is stored in the refrigerator, it should be allowed to return to room temperature before administering to the patient. Do not freeze the diluted solution of Zinplava. The article has provided an overview of the drug Zinplava. The above information is for reference only, patients need to contact their doctor or pharmacist for specific advice before using Zinplava.
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