Pronunciation:

NOO-moe-KOK-al VAX-een pol-ee-VAY-lent

Brand Names:

• Pneumovax 23
• Pnu-Imune 23
• Prevnar

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Vaccine

Uses of This Medicine:

Pneumococcal polyvalent vaccine is an active immunizing agent used to prevent infection by pneumococcal bacteria. It works by causing your body to produce its own protection (antibodies) against the disease.

The following information applies only to the polyvalent 23 pneumococcal vaccine. Other polyvalent pneumococcal vaccines may be available in countries other than the U.S.

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; and possibly death. These problems are more likely to occur in older adults and persons with certain diseases or conditions that make them more susceptible to a pneumococcal infection or more apt to develop serious problems from a pneumococcal infection.

Unless otherwise contraindicated, immunization (vaccination) against pneumococcal disease is recommended for all adults and children 2 years of age and older, especially:

• Older adults, especially those 65 years of age and older.
• Adults and children 2 to 64 years of age with chronic illnesses.
• Adults and children 2 to 64 years of age with sickle cell disease, those with spleen problems or without spleens, and those who are to have their spleens removed.
• Adults and children 2 to 64 years of age who are at increased risk for pneumococcal disease because of another illness (e.g., heart disease, lung disease, asthma, diabetes, alcoholism, liver disease, or kidney disease). People who smoke cigarettes should also receive the vaccine.
• Adults and children 2 to 64 years of age who are living in special environments or social settings (e.g., Alaskan Natives and certain American Indian populations), and residents of nursing homes and other long-term-care facilities.
• Adults and children 2 to 64 years of age with decreased disease-fighting ability (e.g., those with human immunodeficiency virus (HIV) infection, organ or bone marrow transplantations, and cancer).

Immunization (vaccination) against pneumococcal infection is not recommended for infants and children younger than 2 years of age, because these persons cannot produce enough antibodies to the vaccine to protect them against a pneumococcal infection.

This vaccine is to be administered only by or under the supervision of your doctor or other health care professional.

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—

Use of pneumococcal polyvalent vaccine is not recommended in infants and children younger than 2 years of age.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of pneumococcal polyvalent vaccine in the elderly. However, elderly patients are more likely to have unwanted effects which may require caution in patients receiving this vaccine.

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
• Zoster Vaccine, Live

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 20-Valent Vaccine, Diphtheria Conjugate
• Rituximab

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 or
• Immune system problems (e.g., cancer, HIV)—This vaccine may not work as well in patients with these conditions.

• Heart or blood vessel disease or
• Lung disease—Use with caution. May increase risk for more serious side effects.

• Moderate to severe acute illness—Patients with this condition should receive the vaccine at a delayed time.

• Thrombocytopenic purpura (blood disorder)—Use with caution. May make this condition worse.

Proper Use of This Medicine:

A nurse or other trained health professional will give you or your child this vaccine. This vaccine is given as a shot into one of the muscles or under the skin, usually in the thigh or upper arm.

Pneumococcal vaccine is usually given only once to each person. Additional injections are only given for special cases, because of the possibility of more frequent and more severe side effects.

Precautions While Using This Medicine:

If you have more than one doctor, be sure they all know that you have received pneumococcal vaccine polyvalent 23 so that they can put the information into your medical records. This vaccine is usually given only once to each person, except in special cases.

This vaccine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you or your child has a rash, itching, swelling of the tongue and throat, or trouble breathing after receiving the vaccine.

The pneumococcal polyvalent vaccine will not protect you or your child against all types of pneumococcal infections. It will also not treat an active infection.

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

Chills

Less common

Body aches or pain

cough

difficulty with breathing

ear congestion

fever

headache

loss of voice

nasal congestion

runny nose

sneezing

sore throat

unusual tiredness or weakness

Rare

Fever over 102.2 °F (39 °C)

Incidence not known

Black, tarry stools

bleeding gums

bloating or swelling of the face, arms, hands, lower legs, or feet blood in the urine or stools

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

decreased movement of the legs

difficulty with breathing or swallowing

dizziness

eye pain

fast heartbeat

feeling of discomfort

general feeling of discomfort or illness

headache

hives

inflammation of the joints

itching, especially of the feet or hands

itching, pain, redness, swelling, tenderness, or warmth on the skin

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

muscle aches

pinpoint red spots on the skin

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

rapid weight gain

rash

shortness of breath

swollen lymph glands

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

tightness in the chest

tingling of the hands or feet

reddening of the skin, especially around the ears

swelling of the eyes, face, or inside of the nose

unusual bleeding or bruising

unusual tiredness or weakness (sudden and severe)

unusual weight gain or loss

wheezing

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

Difficulty with moving

lack or loss of strength

muscle aching or cramping

muscle pains or stiffness

redness, soreness, hard lump, swelling, tenderness, or pain at the injection site

swollen joints

Less common or rare

Aches or pain in the joints or muscles

fever of 101 °F (38.3 °C) or less

swollen glands

vague feeling of bodily discomfort

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.