Description and Brand Names

Drug information provided by: Micromedex

US Brand Name

  1. Prevnar 13

Canadian Brand Name

  1. Prevnar

Descriptions


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 50 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 administered only by or under the supervision of your doctor.

This product is available in the following dosage forms:

  • Suspension

Before Using

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.

Pediatric

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.

Geriatric

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.

Pregnancy

Information about this pneumococcal-13-valent-vaccine-diphtheria-conjugate-intramuscular-route
Pregnancy Category Explanation
All Trimesters B Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breastfeeding

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.

Drug Interactions

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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 (e.g., 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

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 50 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

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 (such as hydrocortisone, methylprednisolone, prednisolone, prednisone), or cancer medicines. .

Side Effects

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

  1. Fever

Rare

  1. Chest pain
  2. chills
  3. coughing, wheezing, or shortness of breath
  4. difficult or labored breathing
  5. difficulty with swallowing
  6. fast heartbeat
  7. noisy breathing
  8. seizures
  9. skin itching, rash, or redness
  10. sneezing
  11. sore throat
  12. swelling of the face, throat, or tongue
  13. tightness in the chest

Incidence not known

  1. Bladder pain
  2. blistering, peeling, or loosening of the skin
  3. bloody or cloudy urine
  4. bluish lips or skin
  5. body aches or pain
  6. choking
  7. confusion
  8. decreased urine output
  9. diarrhea
  10. difficult, burning, or painful urination
  11. dilated neck veins
  12. ear congestion
  13. extreme fatigue
  14. fainting
  15. frequent urge to urinate
  16. general feeling of discomfort or illness
  17. headache
  18. hives
  19. irregular breathing
  20. irregular heartbeat
  21. itching
  22. joint or muscle pain
  23. large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  24. lightheadedness
  25. loss of appetite
  26. loss of voice
  27. lower back or side pain
  28. muscle aches and pains
  29. nasal congestion
  30. nausea
  31. not breathing
  32. puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  33. rapid, shallow breathing
  34. red, irritated eyes
  35. runny nose
  36. shivering
  37. sore throat
  38. sores, ulcers, or white spots in the mouth or on the lips
  39. sweating
  40. swelling of the face, fingers, feet, or lower legs
  41. swollen, painful, or tender lymph glands in the neck, armpit, or groin
  42. trouble sleeping
  43. troubled breathing
  44. unusual tiredness or weakness
  45. vomiting
  46. 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

  1. Decreased appetite
  2. decreased sleep
  3. irritability
  4. red streaks on the skin
  5. swelling, tenderness, or pain at the injection site

Rare

  1. Abdominal or stomach pain
  2. crying
  3. hives or welts
  4. weakness

Incidence not known

  1. 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
  2. burning, dry, or itching eyes
  3. eye discharge or excessive tearing
  4. pain
  5. stomach cramps
  6. 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.