ZINPLAVA 25 mg/mL concentrate for solution for infusion
Merck Sharp & Dohme Limited
1. Name of the medicinal product
ZINPLAVA® 25 mg/mL concentrate for solution for infusion
2. Qualitative and quantitative composition
Each mL of concentrate contains 25 mg bezlotoxumab.
One 40 mL vial contains 1,000 mg of bezlotoxumab.
Bezlotoxumab is a human monoclonal antibody produced in Chinese hamster ovary cells by recombinant DNA technology. It binds to C. difficile toxin B.
Excipient with known effect
Each mL of concentrate contains 0.2 mmol sodium, which is 4.57 mg sodium.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Concentrate for solution for infusion.
Clear to moderately opalescent, colourless to pale yellow liquid.
4. Clinical particulars
4.1 Therapeutic indications
ZINPLAVA is indicated for the prevention of recurrence of Clostridium difficile infection (CDI) in adults at high risk for recurrence of CDI (see sections 4.2, 4.4 and 5.1).
4.2 Posology and method of administration
Posology
ZINPLAVA should be administered during the course of antibacterial therapy for CDI (see sections 4.4 and 5.1).
ZINPLAVA should be administered as a single intravenous infusion of 10 mg/kg (see below and section 6.6).
The experience with ZINPLAVA in patients is limited to a single CDI episode and single administration (see section 4.4).
Special populations
Elderly
No dose adjustment is necessary in patients ≥ 65 years of age (see section 5.2).
Renal impairment
No dose adjustment is necessary for patients with renal impairment (see section 5.2).
Hepatic impairment
No dose adjustment is necessary for patients with hepatic impairment (see section 5.2).
Paediatric population
The safety and efficacy of ZINPLAVA in patients below 18 years of age have not been established. No data are available.
Method of administration
• Administer the diluted solution for infusion intravenously over 60 minutes using a sterile, non-pyrogenic, low-protein binding 0.2 micron to 5 micron in-line or add-on filter. ZINPLAVA should not be administered as an intravenous push or bolus.
• The diluted solution can be infused via a central line or peripheral catheter.
• ZINPLAVA must not be co-administered with other medicinal products simultaneously through the same infusion line.
For instructions on dilution of the medicinal product before administration, see section 6.6.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4 Special warnings and precautions for use
ZINPLAVA is not a treatment for CDI and has no effect on the current CDI episode. ZINPLAVA should be administered during the course of antibacterial therapy for CDI. There is no data regarding the efficacy of ZINPLAVA if given after the initial 10- to 14-days of antibacterial therapy for CDI.
ZINPLAVA should not be administered as an intravenous push or bolus.
There is no experience with repeat administration of ZINPLAVA in patients with CDI. In clinical trials, patients with CDI were only administered a single dose of ZINPLAVA (see section 5.1).
4.5 Interaction with other medicinal products and other forms of interaction
No formal interactions studies with other medicinal products were conducted. Therapeutic monoclonal antibodies do not typically have significant drug-drug interaction potenti