Pneumococcal vaccine polyvalent (intramuscular route, subcutaneous route)


    Brand Name

    US Brand Name

    Pneumovax 23

    Pnu-Imune 23

    Canadian Brand Name

    Prevnar


    Description

    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

    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

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

    Geriatric

    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.

    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
    • 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

    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

    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

    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.






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