Pneumococcal Conjugate Vaccine13-Valent, Injection

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KEY POINTS

• This medicine is given by injection to prevent infections caused by 13 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 conjugate vaccine 13-valent, injection; PCV13; Prevnar 13

What is this medicine used for?

This medicine is given by injection (a shot) to prevent infections caused by 13 of the most common types of pneumococcal bacteria. These bacteria can infect the lungs, blood, and brain. The vaccine may be given to infants, children, and adults.

This medicine is recommended for:

• Adults over the age of 65 (in a series along with a second type of Pneumococcal Vaccine called PPSV23)
• Children and adults up to 64 years of age with a weakened immune system or medical problems such as:
  • A cochlear implant
  • A spleen that has been removed or is damaged
  • An organ or bone marrow transplant
  • Cancer, leukemia, lymphoma, or multiple myeloma
  • HIV
  • Sickle cell disease
  • Treatment that lowers the body's resistance to infection, such as long-term steroids, certain cancer drugs, or radiation therapy

What should the healthcare provider know before your child receives this medicine?

Before taking this medicine, tell the healthcare provider if your child has ever had:

• An allergy to any medicine or vaccine
• A bleeding disorder
• A weakened immune system from cancer treatment, diseases such as HIV/AIDS, or from taking steroid medicines or medicines to prevent organ transplant rejection

Tell your healthcare provider if you or your child currently have a fever or infection of any kind. Vaccinations should be postponed if you or your child have a moderate to severe infection or fever. If you or your child have a mild cold or other mild infection, you may still be able to get the shot.

Females of childbearing age: Talk with 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?

These shots are given into a muscle of the thigh in babies and the upper arm in toddlers, young children, and adults. These shots may be given at the same time as other routine childhood shots, such as DPT, haemophilus, and polio shots.

This vaccine is usually given to babies as a series of 4 shots. Babies should receive 3 doses (shots) 2 months apart and a fourth dose when they are 12 to 15 months old. The usual age for the first shot is 2 months, but may be given as young as 6 weeks of age.

Older babies and children who have not yet had the shots will need shots according to the following schedule:

• Children 7 to 11 months old: a total of 3 shots, including 2 shots at least 4 weeks apart and then one more shot after 1 year of age and separated from the second shot by at least 2 months
• Children 12 to 23 months old: 2 shots at least 2 months apart
• Children 24 months through 5 years of age: 1 shot
• Children 6 years through 17 years of age: 1 shot

Children 24 to 71 months with certain chronic medical conditions or weakened immune systems may need 2 shots at least 2 months apart. Talk with your healthcare provider about this.

Adults 19 years of age or older with a weakened immune system or certain medical problems, and who have 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 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 or your child will need and when to get them. Keep all appointments to be sure of full protection. If a shot is missed, 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.

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.

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 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 your child has 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; paleness; very fast heartbeat; swelling of your child's lips, tongue, and throat); seizures.

Serious (Report these to your healthcare provider right away.): Fever over 102.2°F, or 39°C.

Other: Irritability; fussiness; drowsiness; restless sleep; decreased appetite; vomiting; diarrhea; fever over 100.2°F, or 37.9°C but less than 102.2°F, or 39°C; headache; muscle pain; redness, tenderness, or swelling at the injection site.

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 interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if your child is 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

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 child's medicines (prescription, nonprescription, supplements, natural remedies, and vitamins) with you. Be sure that you tell all healthcare providers who treat your child about all the products your child is 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.