Dtap, hepatitis b, poliovirus, and haemophilus b vaccine (Intramuscular)

DTaP, Hepatitis B, Poliovirus, and Haemophilus b combination vaccine is a medicine that helps protect against infections caused by diphtheria, tetanus (lockjaw), pertussis (whooping cough), hepatitis B virus, poliovirus, and Haemophilus influenza type b (Hib) bacteria. The vaccine works by helping your body make its own defense (antibodies) against these diseases.

Diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, and Hib bacterial infections (like pneumonia, meningitis, epiglottitis, pericarditis, septic arthritis) are serious illnesses that can be life-threatening. While some serious side effects can happen after a dose of Vaxelis™ (usually from the pertussis part), this is very rare. The risk of your child getting one of these diseases and suffering serious harm or dying is much higher than the risk of your child having a serious side effect from the vaccine.

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

This vaccine should only be given by or under the direct supervision of your doctor.

It is very important that your child returns 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.

In deciding to use a vaccine, it is important to consider the risks of the vaccine against the benefits it may provide. This decision should be made between you and your doctor. For this vaccine, please consider the following:

Allergies

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

Pediatric

Studies to date show that there are no pediatric-specific problems that would limit the usefulness of Vaxelis™ in children aged 6 weeks to 4 years. Safety and effectiveness have been confirmed.

Geriatric

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

Breast Feeding

Research suggests that this medication poses minimal risk to the infant when used during breastfeeding.

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while in other cases, two different medicines may be used together even if an interaction might happen. In these situations, your doctor may need to adjust the dose, or other precautions may be necessary. When receiving this vaccine, it is very important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions have been identified based on their potential significance and may not include all possible interactions.

Receiving this vaccine with any of the following medicines is usually not recommended but may be necessary in some situations. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Elivaldogene Autotemcel
• Teplizumab-mzwv
• Ublituximab-xiiy

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or 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 about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

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

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

• Guillain-Barré syndrome (a serious nerve and muscle issue), history of after a vaccine with tetanus toxoid—Your doctor will determine 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 containing pertussis, discuss the potential benefits and risks of getting this vaccine with your doctor. Some serious reactions include being less responsive than usual, crying continuously for 3 hours or more, having a seizure with or without a fever, or having a fever of 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 administered until these conditions are treated and under control.

• Weakened immune system—May not be as effective in patients with this condition.

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.

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.