SUMMARY CMI

ADACEL^®

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I using Adacel?

Adacel is a vaccine. It is used to help prevent whooping cough (pertussis), tetanus and diphtheria in persons aged 10 years and over as a booster following primary immunisation. Use of Adacel during pregnancy allows antibodies to be passed to the baby in the womb from the pregnant woman to protect the baby from whooping cough during the first few months of life.

For more information, see Section 1. Why am I using Adacel? in the full CMI.

2. What should I know before I use Adacel?

Do not use if you have ever had an allergic reaction to Adacel or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use Adacel? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Adacel and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use Adacel?

Adacel is given as an injection, usually into your upper arm muscle by a doctor or nurse.

More instructions can be found in Section 4. How do I use Adacel? in the full CMI.

5. What should I know while using Adacel?

For more information, see Section 5. What should I know while using Adacel? in the full CMI.

6. Are there any side effects?

The most common side effects of Adacel are local reaction around the injection site, headaches, tiredness, fever, chills, soreness, joint pain, nausea and vomiting, diarrhoea, loss of appetite.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

FULL CMI

ADACEL^®

Active ingredients: Diphtheria toxoid, Tetanus Toxoid, Pertactin, Pertussis filamentous haemagglutinin, Pertussis fimbriae 2 + 3, and Pertussis toxoid

Consumer Medicine Information (CMI)

This leaflet provides important information about using Adacel. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Adacel.

Where to find information in this leaflet:

1. Why am I using Adacel?
2. What should I know before I use Adacel?
3. What if I am taking other medicines?
4. How do I use Adacel?
5. What should I know while using Adacel?
6. Are there any side effects?
7. Product details

1. Why am I using Adacel?

Adacel contains the active ingredient Diphtheria toxoid, Tetanus toxoid, Pertactin, Pertussis filamentous haemagglutinin, Pertussis fimbriae 2 + 3, and Pertussis toxoid.

Adacel is a vaccine used to help prevent whooping cough (pertussis), tetanus and diphtheria.

This vaccine is for use as a booster in persons from the age of 10 years who have previously received childhood immunisation. Use of Adacel during pregnancy allows antibodies to be passed to the baby in the womb from the pregnant woman to protect the baby from whooping cough during the first few months of life.

Adacel is not intended for childhood immunisation.

The use of Adacel should be determined on the basis of official recommendations and by your doctor.

Whooping cough, tetanus and diphtheria cause significant sickness and sometimes death in unvaccinated infants, children, and adults.

Adacel works by causing the body to produce its own protection against whooping cough, tetanus, and diphtheria. It does this by making substances called antibodies in the blood, which fight the bacteria and toxins that cause these diseases. If a vaccinated person comes into contact with these bacteria and toxins, the body is usually ready to destroy them.

It usually takes several weeks after vaccination to develop protection against these diseases. Most people will produce enough antibodies against these diseases. However, as with all vaccines, 100% protection cannot be guaranteed. The vaccine will not give you any of these diseases.

The chance of a severe reaction from Adacel is very small, but the risks from not being vaccinated against these diseases may be very serious.

2. What should I know before I use Adacel?

Warnings

Do not use Adacel if:

• you are allergic to the active ingredients, or any of the ingredients listed at the end of this leaflet.
  Always check the ingredients to make sure you can use this medicine.
• a history of severe allergic reaction to a previous dose of this vaccine or another vaccine designed to protect against pertussis, tetanus and diphtheria. Symptoms of an allergic reaction may include:
  - shortness of breath, wheezing or difficulty breathing
  - swelling of the face, lips, tongue or other parts of the body
  - skin rash, itching or hives
• had serious encephalopathy (disease of brain) without an apparent cause within 7 days of a previous pertussis, tetanus or diphtheria vaccination
• moderate or high temperature and/or acute illness

Adacel is not recommended for use in children under 10 years. If you are not sure whether you should have Adacel, talk to your doctor or pharmacist.

Check with your doctor if you:

• have a moderate or high temperature and/or acute illness. Your doctor may decide to delay vaccination until the illness has passed. A mild illness, such as a cold, is not usually a reason to delay vaccination.
• you have, or have had, any medical conditions, especially the following:
  - lowered immunity due to diseases such as some blood disorders, kidney disease requiring dialysis, HIV/AIDS or cancer
  - lowered immunity due to treatment with medicines
  - Guillain-Barre syndrome (temporary inflammation of nerves causing pain, paralysis and sensitivity disorders) after being given a vaccine containing tetanus toxoid (an inactivated form of tetanus toxin). In this case, the decision to give any further vaccine containing tetanus toxoid should be evaluated by your doctor.
  - undiagnosed illness of the brain or epilepsy which is not controlled. Your doctor will assess the potential benefit offered by vaccination
  - bleeding disorder
• have an allergy to latex

After vaccination, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

Your doctor will discuss the possible risk and benefits of having Adacel during pregnancy.

Adacel may be administered during pregnancy for prevention of pertussis in young infants.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

Your doctor will discuss the possible risks and benefits of having Adacel during breastfeeding.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with Adacel and affect how it works.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Adacel.

Having other vaccines

Your doctor will advise you if Adacel is to be given with another vaccine.

4. How do I use Adacel?

How much to use

• The dose of Adacel is a single dose of 0.5mL
• Adacel is given as an injection, usually into your upper arm muscle by a doctor or nurse.
• Adacel should not be injected directly into the veins.

When to use Adacel

• Adacel is generally given whenever a booster dose of whooping cough, tetanus and diphtheria vaccine is required.

If you use too much Adacel

Overdose is most unlikely because your doctor or nurse gives the injections. If you have any concerns, ask your doctor.

5. What should I know while using Adacel?

Things you should do

Call your doctor straight away if you:

• do not feel well after having Adacel

Remind any doctor, dentist or pharmacist you visit that you are using Adacel.

Looking after your medicine

• Adacel is usually stored in the doctor's surgery or clinic, or at the pharmacy.
• However, if you need to store Adacel:
  - Keep Adacel in the original pack until it is time for it to be given.
  - Keep it in the refrigerator, between 2°C and 8°C. If Adacel happens to be stored out of the refrigerator at room temperature, it can be used for up to 72 hours after it was last refrigerated. If Adacel is stored out of the refrigerator for longer than 72 hours, it should be discarded.
  - Do not freeze Adacel. Freezing destroys the vaccine.
  - Do not use Adacel after the expiry date printed on the pack.
  - Do not use Adacel if the packaging is torn or shows signs of tampering

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All vaccines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Serious side effects

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems (Australia) or in New Zealand at https://nzphvc.otago.ac.nz/reporting.

By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription.

What Adacel contains

Do not take this medicine if you are allergic to any of these ingredients.

The manufacture of this product includes exposure to bovine materials. No evidence exists that any case of vCJD (considered to be the human form of bovine spongiform encephalopathy) has resulted from the administration of any vaccine product.

What Adacel looks like

Adacel is a sterile, uniform, cloudy, white suspension for injection.

AUST R number

297685 (syringe)

Who distributes Adacel

Australia:

sanofi-aventis australia pty ltd
12 - 24 Talavera Road
Macquarie Park NSW 2113
Australia
Tel: 1800 818 806

New Zealand:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
PO Box 62027
Sylvia Park Auckland 1644
Freecall: 0800 283 684
Email: [email protected]

This leaflet was prepared in September 2023

ada-ccdsv22-cmiv27-25sep23

Published by MIMS November 2023

1 Name of Medicine

Adacel.
Pertussis vaccine-acellular combined with diphtheria and tetanus toxoids (adsorbed).

2 Qualitative and Quantitative Composition

Each 0.5 mL dose of Adacel contains:
Diphtheria toxoid ≥ 2 IU (2 Lf);
Tetanus toxoid ≥ 20 IU (5 Lf)*;
Pertussis toxoid 2.5 micrograms;
Pertussis filamentous haemagglutinin 5 micrograms;
Pertactin 3 micrograms;
Pertussis fimbriae 2 + 3 5 micrograms;
Adsorbed on aluminium phosphate 1.5 mg (0.33 mg aluminium).
*The formulated content of 5 Lf of tetanus toxoid per 0.5 mL dose is the same as the related product Tripacel.
This vaccine may contain traces of formaldehyde and glutaral which are used during the manufacturing process.
For the full list of excipients, see Section 6.1 List of Excipients.
The vaccine is prepared from: purified, formaldehyde-detoxified and adsorbed diphtheria and tetanus toxins; purified, glutaral-detoxified and adsorbed pertussis toxin (pertussis toxoid or PT); purified, formaldehyde-treated and adsorbed filamentous haemagglutinin (FHA); purified and adsorbed pertactin (PRN) and co-purified and adsorbed fimbriae types 2 and 3 (FIM).
Adacel is an adult/adolescent formulation diphtheria-tetanus-acellular pertussis (dTpa) combination vaccine with reduced content of pertussis toxoid, filamentous haemagglutinin and diphtheria toxoid compared to paediatric diphtheria-tetanus-acellular pertussis (DTPa) formulations.
The manufacture of this product includes exposure to bovine materials. No evidence exists that any case of vCJD (considered to be the human form of bovine spongiform encephalopathy) has resulted from the administration of any vaccine product.

3 Pharmaceutical Form

Sterile suspension for injection. Adacel appears as a sterile, uniform, cloudy, white suspension.

4 Clinical Particulars

4.1 Therapeutic Indications

Adacel is indicated for active immunisation against tetanus, diphtheria and pertussis in persons aged 10 years and over as a booster following primary immunisation.
Adacel may be administered during pregnancy for prevention of pertussis in young infants via transplacental antibody transfer from the pregnant woman to the fetus.

4.2 Dose and Method of Administration

Adacel (0.5 mL) should be administered by intramuscular route.
Booster doses of Adacel should be given according to the official national recommendations as per the current Immunisation Handbook.
Consistent with the official national recommendations, in adolescents or adults with an unknown or incomplete vaccination against diphtheria, tetanus and pertussis, one dose of dTpa vaccine should be administered as part of a vaccination series against diphtheria, tetanus, and pertussis. Two additional doses of a diphtheria and tetanus containing vaccine should also be given.
Adacel can be used for repeat vaccination, after a previous dose of dTpa or dTpa-IPV to boost immunity to diphtheria, tetanus and pertussis at 5- to 10-year intervals. Repeat vaccination should be performed taking into account official national recommendations.
If Adacel is administered to a pregnant woman, it should be done according to official national recommendations for pertussis vaccination of a pregnant woman.
For further information, refer to the current Immunisation Handbook.

Administration.

4.3 Contraindications

Hypersensitivity.

Febrile or acute disease.

Neurological disorders.

4.4 Special Warnings and Precautions for Use

Hypersensitivity.

Administration route related precautions.

Serious and severe adverse events related precautions.

Syncope.

Latex.

Neurological disorders.

Altered immune status.

Protection.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Adacel can be administered concomitantly with hepatitis B vaccine, using a separate limb for the site of injection.
In a clinical trial conducted in adolescents 11 to 17 years of age, when Adacel was administered concomitantly with Menactra, antibody responses to pertussis (with the exception of PRN and FIM), tetanus and diphtheria antigens were non-inferior to those observed when each vaccine was administered separately. Geometric mean concentrations (GMCs) of antibodies to the pertussis antigens PRN and FIM were lower when Adacel was administered concomitantly with Menactra than when Adacel was administered alone. Given the strong response to all pertussis antigens across the treatment groups, and since there are no widely accepted serological correlates of protection for pertussis, the clinical significance of these lower pertussis antibody responses is unknown. The immunogenicity profile of Menactra was similar when administered concomitantly with Adacel or separately.
Separate injection sites and separate syringes must be used in case of concomitant administration.
Immunosuppressive treatment may interfere with the development of the expected immune response to Adacel, see Section 4.4 Special Warnings and Precautions for Use.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

(Category A)
(Category A - definition: drugs which have been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed.)

Human data.

Multiple studies involving numerous pregnant women and their offspring have generated considerable safety, immunogenicity and effectiveness data on the use of Adacel and Adacel Polio, which contains the same tetanus, diphtheria and acellular pertussis components as Adacel, primarily during the second and third trimesters of pregnancy.
Safety data are available from 4 randomised controlled trials (310 pregnancy outcomes), 6 observational studies (84,371 pregnancy outcomes) and from passive surveillance:
Adacel and Adacel Polio led to no more than the expected (generally mild or moderate, and usually self-limited) adverse events for pregnant women who receive it. Safety outcomes for pregnant women were very similar to those seen when these vaccines were given to non-pregnant women of childbearing age;
Adacel and Adacel Polio have not been shown to cause harm to the fetus or newborn;
Although some observational studies report a slight increase in chorioamnionitis when dTpa vaccine has been given to pregnant women, this has not been associated with adverse outcomes for the pregnant women or their newborns.
Immunogenicity data from 13 studies and effective data from 3 studies have shown:
Pertussis antibody responses following vaccination with Adacel are robust in most pregnant women, are amplified when measured in newborn cord blood, persist for 2 to 4 months in the infant, but appear to blunt (reduce) the infant's antibody responses to her or his own pertussis vaccinations later in infancy. There is no evidence to suggest that this blunting is clinically relevant in protection against pertussis;
Adacel and Adacel Polio are > 90% effective when given to women during pregnancy in preventing pertussis disease and hospitalisation in their infants younger than 3 months of age as details in Table 1.
The decision to administer Adacel to a pregnant woman should be made according to the official national recommendations for pertussis vaccination of a pregnant woman.

4.7 Effects on Ability to Drive and Use Machines

No studies on the effects on the ability to drive and use machines have been performed.

4.8 Adverse Effects (Undesirable Effects)

The reactions are listed within body systems and categorised by frequency according to the following definitions: very common (≥ 1/10), common (< 1/10 and ≥ 1/100), uncommon (< 1/100 and ≥ 1/1,000).

Clinical trial experience.

Safety following repeat vaccination.

Post-marketing experience.

Immune system disorders.

Nervous system disorders.

Cardiac disorders.

Skin and subcutaneous tissue disorders.

Musculoskeletal and connective tissue disorders.

General disorders and administration site conditions.

Reporting suspected adverse reactions.

4.9 Overdose

For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Pertussis, purified antigens, combinations with toxoids.
ATC code: J07AJ52.

Clinical trials.

Duration of immunity.

Immunogenicity following repeat vaccination.

5.2 Pharmacokinetic Properties

Evaluation of pharmacokinetic properties is not required for vaccines.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Aluminium phosphate, phenoxyethanol, water for injections, other ingredients per dose include ≤ 5 micrograms residual formaldehyde and < 50 nanogram residual glutaral.

6.2 Incompatibilities

The vaccine must not be mixed with other vaccines or medicinal products.

6.3 Shelf Life

48 months.

6.4 Special Precautions for Storage

Store at 2°C to 8°C. Refrigerate. Do not freeze. Do not use after expiry date.

Pre-filled syringe.

6.5 Nature and Contents of Container

0.5 mL of suspension in pre-filled syringe - pack size of 1 or 10 syringes with or without separate needles.

6.6 Special Precautions for Disposal

After use, any remaining vaccine and container must be disposed of safely according to locally agreed procedures.

6.7 Physicochemical Properties

No data available.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes