Pneumococcal Polysaccharide Vaccine 23-valent, Injection

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KEY POINTS

• This medicine is given by injection to prevent infections caused by 23 types of pneumococcal bacteria.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: vaccine

Generic and brand names: pneumococcal vaccine polyvalent, injection; pneumococcal polysaccharide vaccine 23-valent, injection; PPSV; PPSV23; Pneumovax 23; PPV23

What is this medicine used for?

This medicine is given by injection (a shot) to prevent infections caused by 23 of the most common types of pneumococcal bacteria. These bacteria can infect the lungs, blood, and brain. The vaccine may be given to children over 2 years of age and to adults.

This medicine is recommended for:

• Adults over the age of 65 (in a series along with a second type of pneumococcal vaccine called PCV13)
• Anyone over 2 years of age with medical problems such as diabetes, heart disease, lung disease (including asthma), kidney disease, sickle cell disease, liver disease, or other conditions
• Alcoholics
• Anyone over 2 years of age who has a weakened immune system due to diseases such as HIV, leukemia, lymphoma, Hodgkin’s disease, cancer, organ or bone marrow transplant, or multiple myeloma
• Anyone over 2 years of age who is taking any drug or treatment that lowers the body's resistance to infection, such as long-term steroids, certain cancer drugs, or radiation therapy
• Anyone over 2 years of age whose spleen has been removed or is damaged
• Anyone who smokes cigarettes
• Anyone who lives in a nursing home or other long-term care facility
• Alaska Natives or American Indians aged 50 to 64 years if they live in a high risk area

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine or vaccine
• A bleeding disorder, or if you currently take medicines that reduce the chance of blood clots forming
• A weakened immune system from cancer treatment, diseases such as HIV/AIDS, or from taking steroid medicines or medicines to prevent organ transplant rejection
• Heart disease
• Lung disease

Tell your healthcare provider if you have a fever or infection of any kind. If you are severely ill at the time the shot is scheduled, you may need to wait until you recover before getting this vaccine. If you have a mild cold or mild infection, you may still be able to get your shot.

Tell your healthcare provider about any other immunizations you have recently had or are scheduled to receive, such as the zoster (shingles) vaccine.

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I use it?

Anyone under age 65 with a weakened immune system or certain medical problems, and who has not previously received PCV13 or PPSV23, should receive a dose of PCV13 first followed by a dose of PPSV23 at least 8 weeks later. If you are under the age of 65, you may receive only one PPSV23 shot, depending on your health conditions.

If you are over the age of 65, you will receive a series of shots with both PCV13 and PPSV23 vaccines:

• If you have never received a pneumococcal vaccine, you will receive PCV13 at 65 years, and a PPSV23 vaccine in 6 to 12 months.
• If you are over the age of 65 and have already received a PPSV23 vaccine, you will be given the PCV13 vaccine at least 1 year after you got the PPSV23 shot.

Adults may need another PPSV23 shot at least 5 years after the first PPSV23 vaccine. Your healthcare provider will tell you how many shots you will need and when to get them. Keep all appointments to be sure of full protection. If you miss a shot, get the missed shot as soon as possible.

What should I watch out for?

This vaccine will only protect against diseases caused by certain types of Streptococcus pneumoniae bacteria. It will not protect against infections by other bacteria, viruses, or fungi. Talk to your healthcare provider about this.

You may have some redness, tenderness, or pain where you had the shot. It may last up to 2 days. If symptoms last longer or get worse, contact your healthcare provider.

If you have been taking an antibiotic to prevent pneumococcal infection, keep taking the antibiotic as directed. Do not stop taking the antibiotic after you receive the vaccine.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you have received this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Fever over 102°F, or 38.9°C, joint pain, severe rash, severe irritability, severe headache, unusual weakness, numbness in arms or legs, unusual bruising or bleeding, severe dizziness or fainting, seizures.

Other: Redness, tenderness, swelling, or a hard lump where the shot was given; headache; muscle aches; mild fever; nausea; vomiting; mild weakness or tiredness.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also have an effect. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Cancer medicines such as cisplatin, doxorubicin (Doxil), hydroxyurea (Droxia, Hydrea), vinblastine, and vincristine (Marqibo)
• Corticosteroids such as betamethasone, cortisone, dexamethasone, fludrocortisone, hydrocortisone (A-Hydrocort, Cortef), methylprednisolone (Medrol, Solu-Medrol), prednisolone (Omnipred, Orapred, Prelone), prednisone (Prednisone Intensol), and triamcinolone (Aristospan, Kenalog)
• Everolimus (Afinitor, Zortress)
• Fingolimod (Gilenya)
• Immunosuppressants such as azathioprine (Azasan, Imuran), cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune), tacrolimus (Astagraf, Prograf, Protopic) and temsirolimus (Torisel)
• Medicines to treat psoriasis, rheumatoid arthritis, and other immune disorders such as adalimumab (Humira), belimumab (Benlysta), certolizumab (Cimzia), etanercept (Enbrel), golimumab (Simponi), infliximab (Remicade), and leflunomide (Arava)
• Radiation therapy
• Varicella (chickenpox) vaccine or varicella zoster (shingles) vaccine

Keep a record of all vaccines received and when you received them.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Keep all medicines out of the reach of children.

Do not share medicines with other people.