ADACEL®

Abbreviated Prescribing Information

See local prescribing information for full details prior to prescribing

This information is intended for Health Care Professional only

TRADE NAME OF THE MEDICINAL PRODUCT AND PRESENTATION

ADACEL® [Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed], Component Pertussis : Pertussis Toxoid, Filamentous Haemagglutinin, Fimbrial agglutinogens 2+3, Pertactin. Excipients : Aluminum Phosphate, 2-phenoxyethanol 0.6%, Residual formaldehyde, Residual glutaraldehyde.

ADACEL® is sterile, uniform, cloudy, white suspension of tetanus and diphtheria toxoids adsorbed separately on aluminum phosphate, combined with acellular pertussis vaccine and suspended in water for injection

THERAPEUTIC INDICATIONS

ADACEL® is indicated for active booster immunization for the prevention of tetanus, diphtheria and pertussis (whooping cough) in person 4 to 6 years of age and 10 years or older.

ADACEL® is indicated for passive protection against pertussis in early infancy following maternal immunization during pregnancy (see sections DOSAGE AND ADMINISTRATION, and WARNING AND PRECAUTION).

ADACEL® should be used in accordance with official recommendations

In accordance with local recommendations, Adacel may be considered as an alternative for the fifth dose of tetanus, diphtheria and acellular pertussis vaccine (Tdap) in children 4 through 6 years of age, concomitantly administered with inactivated Poliomyelitis Vaccine (IPV) at separate sites to complete the vaccination series of this age when indicated.

ADACEL® is not to be used for the treatment of disease caused by Bordetella pertussis, Corynbacterium diphtheriae or Clostridium tetani infections.

PEDIATRICS

ADACEL® is not indicated for immunization of children below the age of 4 years.

TETANUS PROPHYLAXIS IN WOUND MANAGEMENT

The need for active immunization with a tetanus toxoid-containing preparation such as Td adsorbed vaccine or Adacel, with or without passive immunization with tetanus Immune Globulin, depends on both the condition on the wound and the patients vaccination history.

POSOLOGY AND METHOD OF ADMINISTRATION

ADACEL® (0.5 mL) should be administered as a booster injection by the intramuscular route. Re-dosing with ADACEL® can be used to boost immunity to diphtheria, tetanus and pertussis at 5 to 10 years intervals.

The preferred site of injection is the deltoid muscle. Fractional doses (doses <0.5 mL) should not be given. The effect of fractional doses on the safety and efficacy has not been determined.

ADACEL® may be administered to pregnant women from 24 – 36 weeks gestation to provide passive protection of infants against pertussis (see sections INDICATION and WARNINGS AND PRECAUTIONS).

A thorough attempt must be made to determine whether a patient has completed primary immunization. Persons who have completed primary immunization against tetanus and who sustain wounds that are minor and uncontaminated, should receive a booster dose of a tetanus toxoid-containing preparation if they have not received tetanus toxoid within the preceding 10.years. For tetanus-prone wounds (e.g., wounds contaminated with dirt, feces, soil and saliva, puncture wounds, avulsions and wounds resulting from missiles, crushing, burns or frostbite), a booster is appropriate if the patient has not received a tetanus toxoid-containing preparation within the preceding 5 years.

Administration

Inspect for extraneous particulate matter and/or discoloration before use, if these conditions exist, the product should not be administered. Shake the vial well until a uniform, cloudy, suspension results. Cleanse the vial stopper with a suitable germicide prior to withdrawing the dose. Do not remove either the stopper or the metal seal holding it in place. Aseptic technique must be used. Use a separate sterile needle and syringe, or a sterile disposable unit for each individual recipient, to prevent disease transmission. Needles should not be recapped but should be disposed of according to biohazard waste guidelines. Before injection, the skin over the site to be injected should be cleansed with a suitable germicide. Administer the total volume of 0.5 mL intramuscularly (IM). The preferred site of injection is the deltoid muscle.

CONTRA-INDICATIONS

Hypersensitivity

Known systemic hypersensitivity reaction to any component of ADACEL® or a life-threatening reaction after previous administration of the vaccine or a vaccine containing one or more of the same components are contraindications to vaccination.

Because of uncertainty as to which component of the vaccine may be responsible, none of the components should be administered. Alternatively, such persons may be referred to an allergist for evaluation if further immunizations are considered.

Acute Neurological Disorders

Encephalopathy (e.g., coma, decreased level of consciousness, prolonged seizures) within 7 days of a previous dose of a pertussis-containing vaccine not attributable to another identifiable cause is a contraindication to vaccination with any pertussis-containing vaccine, including ADACEL®

SPECIAL WARNINGS AND PRECAUTIONS FOR USE

General: It is extremely important that the recipient, parent or guardian be questioned concerning any signs or symptoms of an adverse reaction after a previous dose of vaccine. The rates and severity of adverse events in recipients of tetanus toxoid are influenced by the number or prior doses and level of pre-existing antitoxins. Syncope (fainting) can occur following, or even before, administration of injectable vaccines, including ADACEL®,. Procedures should be in place to prevent falling injury and manage syncopal reactions.

Data indicate that maternal antibodies may reduce the magnitude of the immune response to some vaccines in infants born to women vaccinated with ADACEL® during pregnancy and showed the lower concentration of antibodies to the antigen pertussis in infants receiving primary and booster vaccine. The clinical relevance of this observation is unknown.

Arthus-type hypersensitivity reactions characterizes by severe local reactions (generally starting 2 to 8 hours after an injection), may follow receipt of tetanus toxoid. Such reactions may be associated with high levels of circulating antitoxin in persons who have had overly frequent injections of tetanus toxoid.

Administration Route Related Precautions: Do not administer ADACEL® by intravascular injection: ensure that the needle does not penetrate a blood vessel.

Intradermal or subcutaneous routes of administration are not to be utilized.

ADACEL® should not be administered into the buttocks.

Febrile and Acute Disease: Vaccination should be postponed in cases of an acute or febrile disease. However, a disease with low-grade fever should not usually be a reason to postpone vaccination.

Hematologic: Because any intramuscular injection can cause an injection site hematoma in persons with any bleeding disorders, such as hemophilia or thrombocytopenia, or in persons on anticoagulant therapy, intramuscular injections with ADACEL® should not be administered to such persons unless the potential benefits outweigh the risk of administration. If the decision is made to administer any product by intramuscular injection to such persons, it should be given with caution, with steps taken to avoid the risk of hematoma formation following injection.

Immune: The possibility of allergic reactions in persons sensitive to components of the vaccine should be evaluated. Hypersensitivity reactions may occur following the use of ADACEL® even in persons with no prior history of hypersensitivity to the product components.

As with all other products, epinephrine hydrochloride solution (1:1,000) and other appropriate agents should be available for immediate use in case an anaphylactic or acute hypersensitivity reaction occurs. Health-care providers should be familiar with current recommendations for the initial management of anaphylaxis in non-hospital settings, including proper airway management. Immunocompromised persons (whether from disease or treatment) may not achieve the expected immune response. If possible, consideration should be given to delaying vaccination until after the completion of any immunosuppressive treatment.

Nevertheless, vaccination of persons with chronic immunodeficiency such as HIV infection is recommended even if the immune response might be limited.

Neurologic: ADACEL® should not be administered to individuals with progressive or unstable neurological disorders, uncontrolled epilepsy or progressive encephalopathy until a treatment regimen has been established, the condition has stabilized, and the benefit clearly outweighs the risk. A review by the US Institute of Medicine (IOM) found evidence for a causal relation between tetanus toxoid and both brachial neuritis and Guillain-Barre syndrome (GBS). If GBS occurred within 6 weeks of receipt of prior vaccine containing tetanus toxoid, the decision to give ADACELR or any vaccine containing tetanus toxoid should be based on careful consideration of the potential benefits and possible risks. A few cases of demyelinating diseases of the central nervous system, peripheral mononeuropathies and cranial mononeuropathies have been reported following vaccines containing tetanus and/or diphtheria toxoids, although the IOM concluded that the evidence is inadequate to accept or reject a causal relation between these conditions and vaccination.

INTERACTIONS

Immunosuppressive treatments may interfere with the development of the expected immune response. ADACEL® may be administered concurrently with a dose of the trivalent inactivated influenza vaccine and with a dose of hepatitis B vaccine in 11 to 12 year-olds. Vaccines administered simultaneously should be given using separate syringes at separate injection site and preferably in separate limbs. ADACEL® should not be mixed in the same syringe with other parenteral.

PREGNANCY AND LACTATION

Pregnant Woman:

Adacel should be administered between weeks 24 and 36 of pregnant to provide passive protection to young infants.

Safety data from 4 randomized controlled trials (310 pregnancy outcomes), 1 prospective observational study (546 pregnancy outcomes), 5 retrospective observational studies (124,810 pregnancy outcomes), all conducted in pregnant women, and from passive surveillance of women who received ADACEL® or ADACEL-POLIO® (Tdap-IPV; containing the same amounts of tetanus, diphtheria and pertussis antigen as ADACEL®) have shown no vaccine-related adverse effect on pregnancy or on the health of the fetus/newborn child. No unexpected Adverse events were observed following vaccination of pregnant women with Adacel. The most common adverse event were injection site reactions. The adverse event profile for Adacel in pregnancy is similar to the profile when given to non-pregnant women (see section ADVERSE REACTIONS). As with other inactivated vaccines, it is not expected that vaccination with ADACEL® during any trimester would harm the fetus.

Although some observational studies report a slight increase in chorioamnionitis when Tdap vaccine has been given to pregnant women, this has not been associated with adverse outcomes for the pregnant women or their newborns. The causal association between Tdap vaccine and chorioamnionitis has not been established.

Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/fetal development, parturition or postnatal development.

Limited clinical data have shown there is interference with the immune response to other antigens (i.e. diphtheria, tetanus, polio, pneumococcal, meningococcal) in infants born to women vaccinated with ADACEL® during pregnancy. However, in most of the cases, the antibody concentrations remain above the thresholds established as protective. The clinical relevance of this observation is unknown.

Passive protection of neonates and infants against pertussis

Based on findings from multiple studies of ADACEL® and ADACEL-POLIO® administered to pregnant women:

Pertussis antibody responses in pregnant women are generally similar to those in non-pregnant women.
Maternal antibody directed against pertussis antigens persists for 2 to 4 months after birth and may be associated with blunting of the infant immune response to active immunization against pertussis (see section WARNING AND PRECAUTION-General).
The effectiveness of maternal immunization against pertussis in the first 3 months of life has been estimated to be >90%.

Nursing Women: The effect of administration of ADACELR during lactation has not been assessed. As ADACEL® is inactivated, any risk to the mother or the infant is improbable. However, the effect on breast-fed infants of the administration of ADACEL® to their mothers has not been studied. The risks and benefits of vaccination should be assessed before making the decision to immunize a nursing woman

UNDESIRABLE EFFECTS

Hypersensitivity (anaphylactic) reaction (angioedema, edema, rash, hypotension); Nervous System Disorders (paresthesia, hypoesthesia, Guillain-Barre Syndrome, brachial neuritis, facial palsy, convulsion, syncope, myelitis); cardiac disorders (myocarditis); skin and subcutaneous tissue disorders (pruritus, urticarial); musculoskeletal and connective tissue disorders (myositis, muscle spasm; General disorders and administration site conditions (Large injection site reaction (>50mm) and extensive limb swelling from the injection site beyond one or both joints within 24-72 hours after vaccination, maybe associated with erythema, warmth, tenderness, pain at injection site, bruising, sterile abscess at the injection site, injection site bruising, sterile abscess.

PHARMACODYNAMIC PROPERTIES

ATC Code: J07AJ52.

Presentation: Box, 1 Vial @ 0.5 mL (single dose) (DKI1355500343A1)

Date of revision: 23 August 2022 (based on BPOM approval 14 August 2022)