Pneumococcal 13-valent vaccine, diphtheria conjugate (Intramuscular)

Pneumococcal 13-valent diphtheria conjugate vaccine is a medicine that helps your body fight off infections caused by pneumococcal bacteria. It helps your body make its own defense (antibodies) against the disease.

Pneumococcal infections can lead to serious issues like pneumonia, which affects the lungs; meningitis, which affects the brain; and bacteremia, a severe infection in the blood. These infections are also a common cause of ear infections in children.

Unless there are specific reasons not to, it is recommended that infants and young children aged 6 weeks to 5 years (before their 6th birthday), children aged 6 to 17 years (before their 18th birthday), and adults aged 18 years and older receive the pneumococcal vaccine.

For infants and young children, 1 to 4 doses of the vaccine are needed, depending on how old they are when they get their first dose. This vaccine can be given at the same time as other routine vaccines.

This vaccine must be given only by your doctor or under their supervision.

It is very important that your child return to your doctor’s office at the right time for all of the doses. Be sure to notify your doctor of any side effects that occur after your child receives this vaccine.

This vaccine may cause a serious 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 13-valent vaccine diphtheria conjugate will not protect you or your child against all types of pneumococcal infections. It will also not treat an active infection.

Make sure the doctor knows if you are receiving a treatment or using a medicine that causes a weak immune system. This includes radiation treatment, steroid medicines (eg, hydrocortisone, methylprednisolone, prednisolone, prednisone), or cancer medicines.

In deciding to use a vaccine, you and your doctor need to consider the risks of the vaccine and the benefits it may provide. Here are some important points to keep in mind:

Allergies

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

Pediatric

The pneumococcal 13-valent diphtheria conjugate vaccine is usually well-tolerated and effective in children. Its safety and effectiveness in children younger than 6 weeks of age have not been established.

Geriatric

Current studies have not shown any specific problems in elderly patients that would limit the use of the pneumococcal 13-valent diphtheria conjugate vaccine.

Breast Feeding

There are no sufficient studies to determine the risk to infants when this medication is used during breastfeeding. Consider the potential benefits and risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if there could be an interaction. If you're receiving this vaccine, it is particularly important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions are noted for their potential significance but are not necessarily all-inclusive.

It is generally not recommended to receive this vaccine with any of the following medicines, but it may be necessary in some situations. If both medicines are prescribed, your doctor may adjust the dose or frequency of use for one or both of the medicines.

• Acetaminophen
• Elivaldogene Autotemcel
• Teplizumab-mzwv
• Ublituximab-xiiy

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

• Pneumococcal 20-Valent Vaccine, Diphtheria Conjugate

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around meal times or with certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional how to use your medicine with food, alcohol, or tobacco.

Other Medical Problems

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

• Apnea in premature babies (breathing stops for short periods)—Use with caution. This condition may worsen.

• Immune system problems (for example, cancer, HIV, kidney or spleen issues, stem cell transplant)—This vaccine may not be as effective in patients with a weakened immune system.

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

Check with your doctor or nurse right away if any of the following side effects happen:

More common

• Fever

Rare

• Chest pain
• chills
• coughing
• difficult or labored breathing
• difficulty with swallowing
• fast heartbeat
• noisy breathing
• seizures
• skin itching, rash, or redness
• sneezing
• sore throat
• swelling of the face, throat, or tongue
• tightness in the chest

Incidence not known

• Bladder pain
• blistering, peeling, or loosening of the skin
• bloody or cloudy urine
• bluish lips or skin
• body aches or pain
• choking
• confusion
• decreased urine output
• diarrhea
• difficult, burning, or painful urination
• dilated neck veins
• ear congestion
• extreme fatigue
• fainting
• frequent urge to urinate
• general feeling of discomfort or illness
• headache
• hives or itching
• irregular breathing
• irregular heartbeat
• joint or muscle pain
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• lightheadedness
• loss of appetite
• loss of voice
• lower back or side pain
• muscle aches and pains
• nasal congestion
• nausea
• not breathing
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rapid, shallow breathing
• red, irritated eyes
• runny nose
• shivering
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips
• sweating
• swelling of the face, fingers, feet, or lower legs
• swollen, painful, or tender lymph glands in the neck, armpit, or groin
• trouble sleeping
• unusual tiredness or weakness
• vomiting
• weight gain

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. Your healthcare professional may also be able to tell you how to prevent or lessen some of these side effects. Check with your healthcare professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

More common

• Decreased appetite
• decreased sleep
• irritability
• red streaks on the skin
• swelling, tenderness, or pain at the injection site

Rare

• Abdominal or stomach pain
• crying
• weakness
• welts

Incidence not known

• Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, rash, redness, scarring, soreness, stinging, tingling, ulceration, or warmth at the injection site
• burning, dry, or itching eyes
• eye discharge or excessive tearing
• pain
• stomach cramps
• tenderness

Other side effects not listed may also happen 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.

In the U.S.

• Prevnar 13

In Canada

• Prevnar

Available Dosage Forms:

• Suspension

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, usually in the thigh or upper arm.

For infants and young children 6 weeks to 5 years of age (prior to the 6th birthday): This vaccine is usually given as 4 separate shots over several months. Your child's doctor will tell you the correct number of shots that are needed and the schedule to be followed for the vaccine.

For children 6 to 17 years of age (prior to 18th birthday): This vaccine is given as a single dose. If your child just recently received a dose of this vaccine, the next dose should be given at least 8 weeks later.

For adults 18 years of age and older: This vaccine is given as a single dose.

It is very important for your child to receive all of the shots for the vaccine.

The vaccine needs to be given on a fixed schedule. Try to keep all of the scheduled appointments. If your child misses a dose, call your child’s doctor for another appointment.