9.4 Drug-Drug Interactions
Use with Other Vaccines
In infants, NIMENRIX can be given concomitantly with combined diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus and Haemophilus influenzae type B vaccines (DTaP/IPV/Hib/HepB), as well as 10-valent pneumococcal conjugate vaccine (PCV10).
From age 1 year and above, NIMENRIX can be given concomitantly with any of the following vaccines: hepatitis A and hepatitis B vaccines (HAV and HBV), measles-mumps-rubella vaccine (MMR), measles-mumps-rubella-varicella vaccine (MMRV), 10-valent pneumococcal conjugate vaccine or unadjuvanted seasonal influenza vaccine.
NIMENRIX can also be given concomitantly with combined diphtheria-tetanus-acellular pertussis vaccines, including combination DTaP vaccines with hepatitis B, inactivated poliovirus or Haemophilus influenzae type b, such as DTaP/IPV/Hib/HepB vaccine, and 13-valent pneumococcal conjugate vaccine (PCV13) in the second year of life.
In individuals aged 9 to 25 years, NIMENRIX can be given concomitantly with human papillomavirus bivalent [Type 16 and 18] vaccine, recombinant (HPV2).
Safety and immunogenicity of NIMENRIX was evaluated when sequentially administered or co-administered with a DTaP/IPV/Hib/HepB vaccine in the second year of life. The administration of NIMENRIX 1 month after the DTaP/IPV/Hib/HepB vaccine resulted in lower MenA, MenC and MenW-135 rSBA Geometric Mean Titres (GMTs). The clinical relevance of this observation is unknown, since at least 99.4% of subjects (N=178) had rSBA titres ≥ 1:8 for each group (A, C, W-135, and Y). Whenever possible, NIMENRIX and a tetanus toxoid (TT) containing vaccine, such as DTaP/IPV/Hib/HepB vaccine, should be co-administered or NIMENRIX should be administered at least 1 month before the TT-containing vaccine.
One month after co-administration with a 10-valent pneumococcal conjugate vaccine, lower Geometric Mean antibody Concentrations (GMCs) and opsonophagocytic assay (OPA) antibody GMTs were observed for one pneumococcal serotype (18C conjugated to tetanus toxoid carrier protein). The clinical relevance of this observation is unknown. There was no impact of co-administration on the other nine pneumococcal serotypes.
One month after co-administration with a combined tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed (Tdap) in subjects aged 9 to 25 years, lower GMCs were observed to each pertussis antigen (pertussis toxoid [PT], filamentous haemagglutinin [FHA] and pertactin [PRN]). More than 98% of subjects had anti-PT, FHA or PRN concentrations above the assay cut-off thresholds. The clinical relevance of these observations is unknown. There was no impact of co-administration on immune responses to NIMENRIX or the tetanus or diphtheria antigens included in Tdap.
If NIMENRIX is to be given at the same time as another injectable vaccine, the vaccines should always be administered at different injection sites.
Use with Systemic Immunosuppressive Medications
As with other vaccines, it may be expected that in patients receiving immunosuppressive treatment, an adequate response may not be elicited.
9.5 Drug-Food Interactions
Interactions with food have not been established.
9.6 Drug-Herb Interactions
Interactions with herbal products have not been established.
9.7 Drug-Laboratory Test Interactions
Interactions with laboratory tests have not been established.