Pronunciation:

NOO-moe-KOK-al 13-VAY-lent VAX-een, dif-THEER-ee-a KON-joo-gate

Brand Names:

• Prevnar 13
• Prevnar

Dosage Forms:

• Suspension

Classifications:

Therapeutic—

Vaccine

Uses of This Medicine:

Pneumococcal 13-valent diphtheria conjugate 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.

Pneumococcal infection can cause serious problems, such as pneumonia, which affects the lungs; meningitis, which affects the brain; and bacteremia, which is a severe infection in the blood. Pneumococcal infection is also an important cause of ear infections in children.

Unless otherwise contraindicated, immunization (vaccination) against pneumococcal disease is recommended for infants and young children 6 weeks to 5 years of age (prior to the 6th birthday), children 6 to 17 years of age (prior to the 18th birthday), or to adults 18 years of age and older.

For infants and young children, immunization requires 1 to 4 doses of the vaccine, depending on the age at the first dose. This vaccine can be given at the same time as other routine vaccinations.

This vaccine is to be given only by or under the supervision of your doctor.

Before Using This Medicine:

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.

Children—

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

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of pneumococcal 13-valent diphtheria conjugate vaccine in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

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.

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

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

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:

• Apnea in premature babies (breathing stops for short periods)—Use with caution. May make this condition worse.

• Immune system problems (eg, cancer, HIV, kidney or spleen problems, stem cell transplant)—This vaccine may not work as well in patients with a weak immune system.

Proper Use of This Medicine:

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.

Precautions While Using This Medicine:

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 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 13-valent diphtheria conjugate vaccine 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. .

Side Effects of This Medicine:

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

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. 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

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 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.