Pneumovax 23

• Merck Sharp & Dohme Corp.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Pneumovax 23, there are no specific foods that you must exclude from your diet when receiving this medication. 

Tell your health care provider if you (or your child):

• are allergic to Pneumovax 23
• have heart or lung problems
• have a fever
• have immune problems or are receiving radiation treatment for chemotherapy
• are pregnant or breast-feeding
• are going to receive other vaccines

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor is you are breastfeeding or plan to breastfeed. 

It is not known if Pneumovax 23 crosses into human milk. Because some vaccines can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this vaccine, a choice should be made whether to stop nursing or stop the use of this vaccine. Your doctor and you will decide if the benefits outweigh the risk of using Pneumovax 23. 

PPSV is given as an injection (shot) under the skin or into a muscle of your arm or thigh. You will receive this injection in a doctor's office or other clinic setting.

PPSV is usually given as a routine vaccination in adults who are 65 years and older.

PPSV may also be given to people between the ages 2 and 64 years old who have:

• heart disease, lung disease, or diabetes;

• a cerebrospinal fluid leak, or a cochlear implant (an electronic hearing device);

• alcoholism or liver disease (including cirrhosis);

• sickle cell disease or a disorder of the spleen;

• a weak immune system caused by HIV, AIDS, cancer, kidney failure, organ transplantation, or a damaged spleen; or

• a weak immune system caused by taking steroids or receiving chemotherapy or radiation treatment.

PPSV may also be given to people between the ages 19 and 64 years old who smoke or have asthma.

PPSV should be given at least 2 weeks before the start of any treatment that can weaken your immune system. PPSV is also given at least 2 weeks before you undergo a splenectomy (surgical removal of the spleen).

The timing of this vaccination is very important for it to be effective. Follow your doctor's instructions.

Your doctor may recommend treating fever and pain with an aspirin-free pain reliever such as acetaminophen (Tylenol) or ibuprofen (Motrin, Advil, and others) when the shot is given and for the next 24 hours. Follow the label directions or your doctor's instructions about how much of this medicine to take.

If your doctor has prescribed an antibiotic (such as penicillin) to help prevent infection with pneumococcal bacteria, do not stop using the antibiotic after you receive the PPSV. Take the antibiotic for the entire length of time prescribed by your doctor.

Most people receive only one PPSV shot during their lifetime. However, people in certain age groups or with certain disease conditions that put them at risk of infection may need to receive more than one vaccine. Before receiving this vaccine, tell your doctor if you have received a pneumococcal vaccine within the past 3 to 5 years.

Since PPSV is usually given only one time, you will most likely not be on a dosing schedule. If you are receiving a repeat PPSV shot, be sure to tell your doctor if it has been less than 5 years since you last received a pneumococcal vaccine.

You should not receive a booster vaccine if you had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects you have after receiving this vaccine. If you ever need to receive a booster dose, you will need to tell your doctor if the previous shot caused any side effects.

Becoming infected with pneumococcal disease (such as pneumonia or meningitis) is much more dangerous to your health than receiving this vaccine. However, like any medicine, this vaccine can cause side effects but the risk of serious side effects is extremely low.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• high fever (103 degrees or higher);

• easy bruising or bleeding;

• swollen glands with skin rash or itching, joint pain, and general ill feeling;

• pale or yellowed skin, dark colored urine, confusion or weakness;

• numbness or tingly feeling in your feet and spreading upward, severe lower back pain;

• changes in behavior, problems with vision, speech, swallowing, or bladder and bowel functions; or

• slow heart rate, trouble breathing, feeling like you might pass out.

Less serious side effects are more likely to occur, such as:

• low fever (102 degrees or less), chills, tired feeling;

• swelling, pain, tenderness, or redness anywhere on your body;

• headache, nausea, vomiting;

• joint or muscle pain;

• swelling or stiffness in the arm or leg the vaccine was injected into;

• mild skin rash; or

• mild soreness, warmth, redness, swelling, or a hard lump where the shot was given.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.

If you have more than one doctor, be sure they all know that you have received pneumococcal vaccine polyvalent 23 so that they can put the information into your medical records. This vaccine is usually given only once to each person, except in special cases.

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 polyvalent vaccine will not protect you or your child against all types of pneumococcal infections. It will also not treat an active infection.

• It is used to prevent pneumococcal disease.

• Tell all of your health care providers that you take Pneumovax 23. This includes your doctors, nurses, pharmacists, and dentists.
• This medicine may not protect all people who use it. Talk with the doctor.
• Do not give to a child younger than 2 years of age.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

General

Caution and appropriate care should be exercised in administering PNEUMOVAX 23 to individuals with severely compromised cardiovascular and/or pulmonary function in whom a systemic reaction would pose a significant risk.

Any febrile respiratory illness or other active infection is reason for delaying use of PNEUMOVAX 23, except when, in the opinion of the physician, withholding the agent entails even greater risk.

In patients who require penicillin (or other antibiotic) prophylaxis against pneumococcal infection, such prophylaxis should not be discontinued after vaccination with PNEUMOVAX 23.

PNEUMOVAX 23 may not be effective in preventing pneumococcal meningitis in patients who have chronic cerebrospinal fluid (CSF) leakage resulting from congenital lesions, skull fractures, or neurosurgical procedures.

Routine revaccination of immunocompetent persons previously vaccinated with a 23-valent vaccine is not recommended. However, revaccination once is recommended for persons aged ≥ 2 years who are at highest risk for serious pneumococcal infections and those likely to have a rapid decline in pneumococcal antibody levels. (See INDICATIONS AND USAGE, Revaccination.)

Instructions to Health Care Provider

The health care provider should determine the current health status and previous vaccination history of the vaccinee. (See INDICATIONS AND USAGE, Revaccination.)

The health care provider should question the patient, parent or guardian about reactions to a previous dose of PNEUMOVAX 23 or other pneumococcal vaccine.

Information for Patients

The health care provider should inform the patient, parent or guardian of the benefits and risks associated with vaccination. For risks associated with vaccination, see WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS. Patients, parents, or guardians should be told that vaccination with Pneumovax 23 may not offer 100% protection from pneumococcal infection.

Patients, parents and guardians should be instructed to report any serious adverse reactions to their health care provider who in turn should report such events to the vaccine manufacturer or the U.S. Department of Health and Human Services through the Vaccine Adverse Event Reporting System (VAERS), 1-800-822-7967.{37}

Pregnancy

Animal reproduction studies have not been conducted with PNEUMOVAX 23. It is also not known whether PNEUMOVAX 23 can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. PNEUMOVAX 23 should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when PNEUMOVAX 23 is administered to a nursing woman.

Pediatric Use

Pneumovax 23 is not indicated in children less than 2 years of age. Safety and effectiveness in children below the age of 2 years have not been established. Children in this age group respond poorly to the capsular types contained in this polysaccharide vaccine. (See CLINICAL PHARMACOLOGY, Immunogenicity.)

Geriatric Use

Persons 65 years of age or older were enrolled in several clinical studies of Pneumovax 23 that were conducted pre- and post-licensure. In the largest of these studies, the safety of Pneumovax 23 in adults 65 years of age and older was compared to the safety of Pneumovax 23 in adults 50 to 64 years of age. Of 1007 subjects enrolled in this study, 433 subjects were 65 to 74 years of age, and 195 subjects were 75 years of age or older. No overall difference in safety was observed between these subjects and younger subjects. However, since elderly individuals may not tolerate medical interventions as well as younger individuals, a higher frequency and/or a greater severity of reactions in some older individuals cannot be ruled out.

NDC 0006-4739-00

5 Dose Vial

Pneumococcal
Vaccine
Polyvalent
PNEUMOVAX® 23

Do not use in children less than 2 years of age.

Each 0.5 mL dose contains 25 mcg of polysaccharide from each pneumococcal capsular type.

Contains phenol 0.25% added as preservative.

FOR SYRINGE USE ONLY

Rx only

Manuf. and Dist. by:
MERCK & CO., INC.
Whitehouse Station, NJ 08889, USA