Description
Pneumococcal 15-valent conjugate vaccine is an active immunizing agent used to prevent infection caused by certain types of pneumococcal bacteria (Streptococcus pneumoniae). It works by causing your body to produce its own protection (antibodies) against the disease.
Pneumococcal infection can cause serious problems, such as pneumonia (which affects the lungs), meningitis (which affects the brain), bacteremia (which is a severe infection in the blood).
This vaccine is to be given only by or under the supervision of your doctor.
This product is available in the following dosage forms:
- Suspension
Before Using
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 have not been performed on the relationship of age to the effects of Vaxneuvance™ in children younger than 6 weeks of age. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Vaxneuvance™ in the elderly.
Breastfeeding
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.
- Atidarsagene Autotemcel
- Elivaldogene Autotemcel
- Ocrelizumab
- 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:
- Immune system problems—This vaccine may not work as well in patients with a weak immune system.
Proper Use
A nurse or other trained health professional will give you this vaccine. It is given as a shot into one of your muscles.
For adults: This vaccine is given as a single dose.
For children at least 6 weeks of age: This vaccine is given as a 4-dose series at 2, 4, 6, and 12 to 15 months of age (at least 2 months after the third dose). If your child did not receive the complete series according to this schedule, your healthcare provider may suggest a catch-up schedule.
Precautions
Be sure to notify your doctor of any side effects that occur after you receive this vaccine.
This vaccine will not protect you against all types of pneumococcal infections. It will also not treat an active infection.
This vaccine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have a rash, itching, a fast heartbeat, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after receiving the vaccine.
This vaccine may cause breathing problems (eg, apnea) in premature babies. Check with your doctor right away if your baby has bluish lips or skin or not breathing.
Tell your doctor if you are using a medicine that causes a weak immune system.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur:
Less common
- Fever
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
- decreased appetite
- difficulty in moving
- headache
- joint pain or swelling
- muscle aches, cramps, pains, or stiffness
- unusual tiredness or weakness
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
DRG-20518750
