Meningococcal (Groups A / C / Y and W-135) Diphtheria Conjugate Vaccine

• If you have an allergy to meningococcal (groups A / C / Y and W-135) diphtheria conjugate vaccine or any part of this medicine.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take meningococcal diphtheria conjugate vaccine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Very bad dizziness or passing out.
• Trouble controlling body movements.
• Not able to move face muscles as much.
• Muscle weakness.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

For all patients taking meningococcal diphtheria conjugate vaccine:

• Pain where the shot was given.
• Redness or swelling where the shot is given.
• Headache.
• Feeling tired or weak.
• Muscle or joint pain.
• Loose stools (diarrhea).
• Not hungry.

Children:

• Feeling fussy.
• Feeling sleepy.
• Crying that is not normal.
• Throwing up.
• Fever or chills.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• Menactra
• Menveo

Severe hypersensitivity (eg, anaphylaxis) to other meningococcal-containing vaccines or any component of the formulation including diphtheria toxoid or CRM197 (a diphtheria toxin carrier protein)

Belimumab: May diminish the therapeutic effect of Vaccines (Inactivated). Management: Patients should receive inactivated vaccines prior to initiation of belimumab therapy whenever possible, due to the risk for an impaired response to the vaccine during belimumab therapy. Consider therapy modification

Diphtheria and Tetanus Toxoids, and Acellular Pertussis Vaccine: May diminish the therapeutic effect of Meningococcal (Groups A / C / Y and W-135) Diphtheria Conjugate Vaccine. More specifically, prior administration of the diphtheria and tetanus toxoids, and acellular pertussis vaccine may diminish antibody response to the meningococcal (groups A / C / Y / and W-135) diphtheria conjugate vaccine in some patients. Management: Administer the meningococcal (groups A / C / Y and W-135) diphtheria conjugate vaccine (Menactra brand) before or concurrently with the diphtheria and tetanus toxoids, and acellular pertussis vaccine (Daptacel brand) in children 4 to 6 years of age. Monitor therapy

Fingolimod: May diminish the therapeutic effect of Vaccines (Inactivated). Management: Vaccine efficacy may be reduced. Complete all age-appropriate vaccinations at least 2 weeks prior to starting fingolimod. If vaccinated during fingolimod therapy, revaccinate 2 to 3 months after fingolimod discontinuation. Consider therapy modification

Immunosuppressants: May diminish the therapeutic effect of Vaccines (Inactivated). Management: Vaccine efficacy may be reduced. Complete all age-appropriate vaccinations at least 2 weeks prior to starting an immunosuppressant. If vaccinated during immunosuppressant therapy, revaccinate at least 3 months after immunosuppressant discontinuation. Exceptions: Cytarabine (Liposomal). Consider therapy modification

Pneumococcal Conjugate Vaccine (13-Valent): Meningococcal (Groups A / C / Y and W-135) Diphtheria Conjugate Vaccine may diminish the therapeutic effect of Pneumococcal Conjugate Vaccine (13-Valent). Management: It is recommended to administer PCV13 at least 4 weeks prior to the administration of MenACYW-D vaccine in persons with anatomic asplenia or functional asplenia. Consider therapy modification

Venetoclax: May diminish the therapeutic effect of Vaccines (Inactivated). Monitor therapy

Actual percentages may vary by product and age group:

>10%:

Central nervous system: Drowsiness, excessive crying, fatigue, headache, irritability, malaise

Gastrointestinal: Anorexia, change in appetite, diarrhea, nausea, vomiting

Local: Erythema at injection site, induration at injection site, pain at injection site, swelling at injection site, tenderness at injection site

Neuromuscular & skeletal: Arthralgia, myalgia

Miscellaneous: Fever

1% to 10%:

Central nervous system: Chills

Dermatologic: Skin rash

<1% (Limited to important or life-threatening): Acute disseminated encephalomyelitis, anaphylactoid reaction, anaphylaxis, apnea (premature infants), appendicitis, auditory impairment, Bell’s palsy, blepharoptosis, convulsions (including tonic), Cushing’s syndrome, dehydration, depression, equilibrium disturbance, exfoliation of skin, facial paresis, falling, febrile seizures, gastroenteritis, Guillain-Barre syndrome, hypersensitivity, hypotension, increased serum ALT, inflammation at injection site, injection site cellulitis, Kawasaki Syndrome, ostealgia, pelvic inflammatory disease, pneumonia, pruritus at injection site, seizure, simple partial seizures, staphylococcal infection, suicidal tendencies, syncope (including vasovagal), transverse myelitis, varicella, vertebral disc disease, vestibular disturbance

Monitor for syncope for at least 15 minutes following administration (NCIRD/ACIP 2011). If seizure-like activity associated with syncope occurs, maintain patient in supine or Trendelenburg position to reestablish adequate cerebral perfusion.

• Discuss specific use of vaccine and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience injection site pain, edema, or irritation, headache, loss of strength and energy, muscle pain, joint pain, lack of appetite, diarrhea, irritability (children), fatigue (children), abnormal crying (children), chills (children) or vomiting (children). Have patient report immediately to prescriber severe dizziness, passing out, abnormal movements, facial paralysis, or muscle weakness (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.