Pronunciation:

NOO-moe-KOK-al 20-VAY-lent VAX-een, dif-THEER-ee-a KON-joo-gate

Brand Names:

• Prevnar 20
• Prevnar

Dosage Forms:

• Suspension

Classifications:

Therapeutic—

Vaccine

Uses of This Medicine:

Pneumococcal 20-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.

Before Using This Medicine:

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.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of Prevnar 20™ in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Prevnar 20™ in the elderly.

Breast-feeding—

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.

Other medicines—

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

Receiving this vaccine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Pneumococcal 13-Valent Vaccine, Diphtheria Conjugate
• Pneumococcal Vaccine Polyvalent

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 of This Medicine:

A nurse or other trained health professional will give you this vaccine. It is given as a shot into one of your muscles. This vaccine is given as a single dose.

Precautions While Using This Medicine:

Be sure to notify your doctor of any side effects that occur after you receive this vaccine.

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 will not protect you against all types of pneumococcal infections. It will also not treat an active infection.

Tell your doctor if you have already received another pneumococcal vaccine or using a medicine that causes a weak immune system (eg, radiation treatment, steroid medicine, or cancer medicine).

Side Effects of This Medicine:

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:

More common

Fever

Incidence not known

Blistering, peeling, or loosening of the skin

chest tightness

chills

cough

difficulty swallowing

dizziness

fast heartbeat

hives, itching, skin rash

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

red, irritated eyes

sore throat

sores, ulcers, or white spots in the mouth or on the lips

swollen, painful, or tender lymph glands in the neck, armpit, or groin

trouble breathing

unusual tiredness or weakness

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

difficulty in moving

headache

muscle pain or stiffness

pain in the joints

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.