WARNINGS
Who should not get CAPVAXIVE?
Do not get CAPVAXIVE if you had an allergic reaction to any of its ingredients, including diphtheria toxoid. (See the list of ingredients in the section ADDITIONAL INFORMATION.)
USES
What is CAPVAXIVE?
CAPVAXIVE is a vaccine for individuals 18 years of age and older to help protect against invasive pneumococcal disease and pneumonia caused by certain types of bacteria called pneumococcus.
These bacteria can cause many types of illnesses, which can be severe, such as infections in:
your lungs (pneumonia)
the area around your brain and spinal cord (meningitis)
your blood (bacteremia)
You cannot get pneumococcal disease from CAPVAXIVE.
CAPVAXIVE might not protect everyone who gets the vaccine.
HOW TO USE
How is CAPVAXIVE given?
• You will get an injection into the muscle (usually in your upper arm).
• You will get one dose of the vaccine.
The most common side effects of CAPVAXIVE are:
Pain, redness, or swelling where you got the injection
Feeling tired
Headache
Muscle aches
Fever
These side effects usually last less than 3 days.
Tell your healthcare provider about these side effects or any unusual symptoms that develop after you get this vaccine. Get medical care right away if you have symptoms of an allergic reaction, which may include:
Wheezing or trouble breathing
Swelling of the face, lips, or tongue
Hives
Rash
There may be side effects not listed here. Ask your healthcare provider for more information. You may also report any side effects to Merck Sharp & Dohme LLC at 1-877-888-4231 or directly to Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number is 1-800-822-7967 or report online to www.vaers.hhs.gov.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
You can also share your drug experience at this web site, under OTHERS and choose Forum.
Medicines are sometimes prescribed for purposes other than those listed in a PATIENT INFORMATION guide. Do not use CAPVAXIVE for a condition for which it was not prescribed. Do not give CAPVAXIVEto other people, even if they have the same symptoms that you have. It may harm them.
You can ask your pharmacist or healthcare provider for information about CAPVAXIVE that is written for healthcare professionals.
What are the ingredients in CAPVAXIVE?
Active ingredient(s): Bacterial sugars from 21 types of pneumococcus; each linked to a protein
(CRM197). The sugars from these bacteria and the protein are not alive and do
not cause disease.
Inactive ingredient(s): L-histidine, polysorbate 20, sodium chloride, water.
CAPVAXIVE does not have any preservatives.
The tip cap and plunger stopper of the prefilled syringe are not made with natural rubber latex.
OVERDOSE
Please call your healthcare provider for more information.
MISSED DOSE
Please call your healthcare provider for more information.
STORAGE
Store refrigerated at 2-degrees C to 8-degrees C (36-degrees F to 46-degrees F).
Do not freeze. Protect from light.
NOTES
Medication Guide: revision date 06/2024
Prescribing Information: revision date 07/2025
Please call your healthcare provider for more information.
Tell your healthcare provider if you:
have had an allergic reaction to any vaccine.
are taking any medications or treatments that might weaken the immune system (like immunosuppressants or steroids).
have a weak immune system (which means your body is less able to fight off infections).
are pregnant or planning to become pregnant.
are breastfeeding or plan to breastfeed.
