Before Using

Drug information provided by: Merative, Micromedex®

In deciding to use a vaccine, the risks of taking the vaccine must be weighed against the good it will do. This is a decision you and your doctor will make. For this vaccine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Vaxelis™ in children 6 weeks to 4 years of age. Safety and efficacy have been established.

Geriatric

Vaxelis™ is not for use in adult or geriatric patients.

Breastfeeding

Hepatitis B Vaccine Recombinant

Diphtheria Toxoid, Adsorbed

Haemophilus B Vaccine

Pertussis Vaccine

Poliovirus Vaccine, Inactivated

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Tetanus Toxoid

Hepatitis B Vaccine Recombinant, Adjuvanted

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.

Drug Interactions

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. When you are receiving this vaccine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Receiving this vaccine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Elivaldogene Autotemcel
  • Teplizumab-mzwv
  • Ublituximab-xiiy

Other Interactions

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

  • Brain disease (eg, encephalopathy)—This includes a loss of consciousness or seizures lasting a long time. Children who have these symptoms within 7 days of receiving a vaccine with pertussis should not get this vaccine.
  • Guillain-Barré syndrome (severe nerve and muscle problem), history of after a vaccine with tetanus toxoid—Your doctor will decide if you should receive this vaccine.
  • Previous serious reaction to a vaccine—If your child had a serious reaction to this vaccine or another vaccine with pertussis in it, you should talk to your doctor about the potential benefits and possible risks of getting this vaccine. Some serious reactions include being less responsive than normal, crying continuously without stopping for 3 hours or more, having a seizure with or without a fever, or having a fever that was 105 degrees F or higher.
  • Progressive neurologic disorder, history of—This includes infantile spasms, progressive brain disease, or uncontrolled seizures. This vaccine should not be given until these conditions are treated and under control.
  • Weakened immune system—May not work as well in patients with this condition.