Pnu-Imune 23 (Intramuscular, Subcutaneous)

Pneumococcal polyvalent vaccine is a type of vaccine that helps your body fight off infections caused by pneumococcal bacteria. It works by making your body produce its own defense (antibodies) against the disease.

The information below specifically refers to the polyvalent 23 pneumococcal vaccine. Other types of polyvalent pneumococcal vaccines may be available in countries outside the U.S.

Pneumococcal infections can lead to serious health issues, such as pneumonia (affecting the lungs), meningitis (affecting the brain), bacteremia (a severe blood infection), and possibly death. These complications are more likely to happen in older adults and people with certain health conditions that make them more vulnerable to pneumococcal infections or more likely to experience serious complications.

Unless there are specific reasons not to, vaccination against pneumococcal disease is recommended for all adults and children aged 2 years and older, especially:

• Older adults, particularly those aged 65 years and older.
• Adults and children aged 2 to 64 years with chronic health problems.
• Adults and children aged 2 to 64 years with sickle cell disease, issues with their spleen, or those who will have their spleen removed.
• Adults and children aged 2 to 64 years who are at higher risk for pneumococcal disease due to another health issue (such as heart disease, lung disease, asthma, diabetes, alcoholism, liver disease, or kidney disease). Those who smoke cigarettes should also get the vaccine.
• Adults and children aged 2 to 64 years living in specific environments or social settings (like Alaskan Natives and certain American Indian groups) and residents of nursing homes or long-term care facilities.
• Adults and children aged 2 to 64 years with weakened immune systems (for example, those with human immunodeficiency virus (HIV), who have had organ or bone marrow transplants, or have cancer).

Vaccination against pneumococcal infection is not recommended for infants and children younger than 2 years old, as they cannot produce enough antibodies from the vaccine to protect themselves against a pneumococcal infection.

This vaccine should only be given by or under the supervision of your doctor or another healthcare professional.

If you see more than one doctor, make sure they all know that you have received the pneumococcal vaccine polyvalent 23 so they can update your medical records. This vaccine is usually given just once to each person, unless there are special circumstances.

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

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

In deciding to use a vaccine, you and your doctor must consider the risks of the vaccine against the benefits it will provide. Here are some important points to think about:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare provider know if you have other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

The use of pneumococcal polyvalent vaccine is not recommended for infants and children younger than 2 years old.

Geriatric

Studies have not shown any specific problems that would limit the use of pneumococcal polyvalent vaccine in elderly patients. However, older adults are more likely to experience unwanted effects, so caution is advised for patients receiving this vaccine.

Interactions with Medicines

Some medicines should never be used together, while others can be used together even if an interaction might happen. In these cases, your doctor may want to adjust the dose or take other precautions. When you receive this vaccine, it is especially important for your healthcare provider to know if you are taking any of the following medicines. The interactions listed below are significant but not exhaustive.

Receiving this vaccine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed, your doctor may adjust the dose or frequency of one or both medicines.

• Elivaldogene Autotemcel
• Teplizumab-mzwv
• Ublituximab-xiiy
• Zoster Vaccine, Live

Receiving this vaccine with any of the following medicines may increase the risk of certain side effects, but using both may be the most effective treatment for you. If both medicines are prescribed, your doctor may adjust the dose or frequency of one or both medicines.

• Pneumococcal 20-Valent Vaccine, Diphtheria Conjugate
• Rituximab

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating food or certain foods due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk to your healthcare provider about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical conditions may affect your use of this vaccine. Be sure to inform your doctor if you have any other medical issues, especially:

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

• Heart or blood vessel disease or
• Lung disease—Use with caution. This may increase the risk of more serious side effects.

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

• Thrombocytopenic purpura (blood disorder)—Use with caution. This may worsen this condition.

Along with its benefits, this medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, you might need medical attention.

Check with your doctor or nurse right away 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
• Reddish 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 happen that usually do not require medical attention. These side effects may go away as your body adjusts to the medicine. Your health care professional may also have ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, 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 can report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Pneumovax 23
• Pnu-Imune 23

In Canada

• Prevnar

Available Dosage Forms:

• Solution

Therapeutic Class: Vaccine

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.