Pronunciation:

dif-THEER-ee-a TOX-oyd, ad-SORBD, TET-a-nus TOX-oyd, per-TUS-iss VAX-een, a-SELL-yoo-lar, POE-lee-oh VYE-rus VAX-een, in-AK-ti-vated, hee-MOF-i-lus B KON-joo-gate VAX-een, hep-a-TYE-tis B VAX-een

Uses of This Medicine:

DTaP, Hepatitis B, Poliovirus, and Haemophilus b combination vaccine is an active immunizing agent used to prevent infections caused by diphtheria, tetanus (lockjaw), pertussis (whooping cough), hepatitis B virus, poliovirus, and Haemophilus influenza type b (Hib) bacteria. The vaccine works by causing your body to produce its own protection (antibodies) against the disease.

Diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, and Hib bacterial infection (eg, pneumonia, meningitis, epiglottitis, pericarditis, septic arthritis) are serious diseases that can cause life-threatening illnesses. Although some serious side effects can occur after a dose of Vaxelis™ (usually from the pertussis vaccine part), this rarely happens. The chance of your child catching one of these diseases, and being permanently injured or dying as a result, is much greater than the chance of your child getting a serious side effect from the vaccine.

This vaccine is recommended for children 6 weeks through 4 years of age (before the child's 5th birthday).

This vaccine is to be given only by or under the direct 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—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Vaxelis™ in children 6 weeks to 4 years of age. Safety and efficacy have been established.

Older adults—

Vaxelis™ is not for use in adult or geriatric patients.

Breast-feeding—

Studies in women suggest that this medication poses minimal risk to the infant when used during 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.

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.

• Atidarsagene Autotemcel
• Elivaldogene Autotemcel
• Ocrelizumab
• Teplizumab-mzwv
• Ublituximab-xiiy

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:

• Brain disease (eg, encephalopathy)—This includes a loss of consciousness or seizures lasting a long time. Children who have these symptoms within 7 days of receiving a vaccine with pertussis should not get this vaccine.

• Guillain-Barré syndrome (severe nerve and muscle problem), history of after a vaccine with tetanus toxoid—Your doctor will decide if you should receive this vaccine.

• Previous serious reaction to a vaccine—If your child had a serious reaction to this vaccine or another vaccine with pertussis in it, you should talk to your doctor about the potential benefits and possible risks of getting this vaccine. Some serious reactions include being less responsive than normal, crying continuously without stopping for 3 hours or more, having a seizure with or without a fever, or having a fever that was 105 degrees F or higher.

• Progressive neurologic disorder, history of—This includes infantile spasms, progressive brain disease, or uncontrolled seizures. This vaccine should not be given until these conditions are treated and under control.

• Weakened immune system—May not work as well in patients with this condition.

Proper Use of This Medicine:

A nurse or other trained health professional will give your child this vaccine in a medical facility. It is given as a shot into a muscle.

This vaccine is usually given as a series of 3 shots. It is important that your child receive all of the shots in this series. Try to keep all scheduled appointments. Make another appointment as soon as possible if your child misses a dose of this vaccine.

After the 3-dose series of this vaccine, you may need another dose of a pertussis vaccine to complete the primary series to prevent whooping cough.

This vaccine is used to complete the first 3 doses of the 5-dose DTaP series in babies and young children who have received 1 or 2 doses of other vaccines (eg, Pentacel® or Daptace®).

This vaccine is given to babies with HBsAg-negative mothers and who have received a dose of any hepatitis B vaccine, before or at 1 month of age. It may also be used to complete the hepatitis B vaccination series after 1 or 2 doses of other hepatitis B vaccines.

This vaccine is given to infants and young children who have received 1 or 2 doses of inactivated poliovirus and Haemophilus influenzae type b conjugate vaccine.

Your child may also receive other vaccines at the same time as this one. You should receive information sheets on all of the vaccines. Make sure you understand all of the information given to you.

Precautions While Using This Medicine:

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

Check with your doctor right away if your child has sudden weakness in the arms and legs or numbness or tingling of the arms. This could be a sign of a serious condition called Guillain-Barré syndrome or brachial neuritis.

This vaccine will not treat an active infection. If your child has an infection due to diphtheria, tetanus, pertussis, hepatitis, poliovirus, or Hib bacteria, your child will need medicines to treat these infections.

Be sure to tell your child's doctor about any side effects that occur after your child receives the vaccine. This may include seizures, a high fever, crying that will not stop, or severe redness or swelling where the shot was given.

This vaccine may cause apnea (breathing stops for short periods) in some premature babies. Talk with your child's doctor if you have concerns.

Make sure any doctor who treats your child knows that he or she is using this medicine. This medicine may affect the results of certain medical tests.

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 over 100.4 degrees F (38 degrees C)

Less common

Prolonged crying lasting more than 3 hours

Rare

Bluish lips or skin

chills

confusion

dizziness

drowsiness

fainting

fast heartbeat

fever

headache

lightheadedness

loss of consciousness

pale skin

rapid, shallow breathing

unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

Incidence not known

Cold, clammy skin

fast, weak pulse

hives, itching, skin rash

hoarseness

irritation

joint pain, stiffness, or swelling

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals

redness of the skin

seizures

sweating

swelling of the eyelids, face, lips, hands, or feet

tightness in the chest

troubled breathing or swallowing

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

Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

decreased appetite

sleepiness

vomiting

Rare

Fever less than 100.4 degrees F (38 degrees C)

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.