SUMMARY CMI

ROTARIX

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about your child receiving this vaccine, speak to your doctor or nurse.

1. Why is my child receiving ROTARIX?

ROTARIX is a live vaccine used to protect your child against gastroenteritis (diarrhoea and vomiting) caused by rotavirus RIX4414 strain. The vaccine works by causing the body to produce its own protection (antibodies) against this disease.

For more information, see Section 1. Why is my child receiving ROTARIX? in the full CMI.

2. What should I know before my child receives ROTARIX?

Your child should not receive ROTARIX if they have had a previous allergic reaction to ROTARIX or to any of the ingredients listed at the end of the CMI.

Talk to your doctor or nurse if your child has any other medical conditions including a history of chronic gastrointestinal disease, a rare illness affecting their immune system known as Severe Combined Immunodeficiency (SCID) or has a severe infection.

For more information, see Section 2. What should I know before my child receives ROTARIX? in the full CMI.

3. What if my child is taking other medicines?

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

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

4. How does my child receive ROTARIX?

• Your doctor or nurse will administer ROTARIX to your child
• The dose is 1.5 mL given into your child's mouth
• Your child will receive 2 doses of ROTARIX. Each dose is given on a separate day with an interval of at least 4 weeks between them.

More instructions can be found in Section 4. How does my child receive ROTARIX? in the full CMI.

5. What should I know after my child receives ROTARIX?

For more information, see Section 5. What should I know after my child receives ROTARIX? in the full CMI.

6. Are there any side effects?

Side effects which have been reported following administration of ROTARIX include diarrhoea, vomiting, abdominal pain, constipation, regurgitation of food, flatulence, fever, chest infection, hoarseness, runny nose, a loss of appetite, dehydration, muscle cramps, feeling tired increased crying, irritability, dermatitis and rash.

If your child develops any symptoms suggestive of a blocked or twisted intestine such as severe abdominal pain, persistent vomiting, bloody stools, an abdominal mass you can feel, abdominal bloating or a high fever seek medical attention immediately.

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

ROTARIX

Active ingredient(s): human rotavirus RIX4414 strain (live attenuated)

Consumer Medicine Information (CMI)

This leaflet provides important information about receiving ROTARIX. You should also speak to your doctor or nurse if you would like further information or if you have any concerns or questions about your child receiving ROTARIX.

Where to find information in this leaflet:

1. Why is my child receiving ROTARIX?
2. What should I know before my child receives ROTARIX?
3. What if my child is taking other medicines?
4. How does my child receive ROTARIX?
5. What should I know after my child receives ROTARIX?
6. Are there any side effects?
7. Product details

1. Why is my child receiving ROTARIX?

ROTARIX is a vaccine used to protect your child against rotavirus infection.

Rotavirus infection is the most common cause of severe diarrhoea and vomiting in infants and young children.

Rotavirus is easily spread by hand-to-mouth contact with the stool of an infected person.

Most children with rotavirus diarrhoea recover on their own. Some children may become very unwell with severe vomiting, diarrhoea and life-threatening loss of fluids that requires hospitalisation.

ROTARIX is a live vaccine that contains the human rotavirus RIX4414 strain which is used to protect against rotavirus gastroenteritis (diarrhoea and vomiting).

The vaccine works by causing your body's natural defences (immune system) to produce its own protection (antibodies) against the most commonly occurring types of rotaviruses.

As with all vaccines, ROTARIX may not completely protect all people who are vaccinated against the disease it is intended to prevent. ROTARIX will not protect against other types of gastroenteritis caused by other types of viruses or organisms.

2. What should I know before my child receives ROTARIX?

Warnings

Your child should not receive ROTARIX if:

• they have had a previous allergic reaction to ROTARIX or any of the ingredients listed at the end of this leaflet. Signs of an allergic reaction include itchy skin rash, shortness of breath and swelling of the face or tongue.
• Always check the ingredients to make sure your child can receive this medicine.
• they have a history of chronic gastrointestinal disease or were born with a defect in the gastrointestinal system.
• they have a rare inherited illness which affects their immune system called Severe Combined Immunodeficiency (SCID).

Check with your doctor or nurse if your child:

• has any other medical conditions.
• has a severe infection with a high fever

In this case, vaccination with ROTARIX may be postponed. A minor infection such as a cold should not be a problem however talk to your doctor or nurse before vaccination.

• currently has severe diarrhoea or is vomiting

In this case, vaccination may be postponed until your child has recovered. Talk to your doctor or nurse before vaccination.

• takes any medicines for any other condition.
• has previously had a part of their intestine blocked or has been twisted (intussusception)

If your child develops any symptoms suggestive of a blocked or twisted intestine such as severe abdominal pain, persistent vomiting, bloody stools, an abdominal mass you can feel, abdominal bloating or a high fever seek medical attention immediately.

During treatment, 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

ROTARIX is not intended to be used in adolescents or adults, therefore use in pregnancy and when breastfeeding is unlikely.

3. What if my child is taking other medicines?

Tell your doctor or nurse if your child is 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 ROTARIX and affect how it works.

4. How does my child receive ROTARIX?

Your doctor or nurse will give your child the vaccine.

How much is given

• The dose of ROTARIX is 1.5 mL.

How is it given

• ROTARIX is given into the mouth.
• Under no circumstances should ROTARIX be injected.

When is ROTARIX given

• Your child will receive 2 doses of ROTARIX.
• Each dose is given on a separate day with an interval of at least 4 weeks between them.
• The first dose is usually given between 6 and 14 weeks of age. The second dose must be given by 24 weeks of age.

If you think your child has been given too much ROTARIX

As this vaccine is given by a doctor or nurse it is unlikely that your child will receive too much.

In the unlikely event that your child spits out or regurgitates most of the vaccine dose, a single replacement dose may be given at the same vaccination visit.

However, if you feel that your child has been given too much ROTARIX, you should immediately:

• phone the Poisons Information Centre
  (by calling 13 11 26), or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

If your child misses a dose of ROTARIX

It is important that you follow the instructions from your doctor or nurse regarding return visits for the second dose.

If you forget to take your child for their second dose, talk to your doctor for advice.

5. What should I know after my child receives ROTARIX?

Things you should do

• keep a record of your child's vaccination history.
• wash your hands immediately after changing nappies and before you prepare and eat food.
• continue to feed your child as normal. There are no restrictions on feeding your child, including breast milk, before or after vaccination with ROTARIX.

Call your doctor straight away if:

• your child experiences severe abdominal pain, persistent vomiting, bloody stools, an abdominal mass that you can feel, abdominal bloating or a high fever.
• experiences wheezing, swelling of the lips/mouth, difficulty in breathing, hay fever, lumpy rash (hives) or faints. These could be symptoms of an allergic reaction.

Remind any doctor, nurse or pharmacist that you see for your child that they have recently been vaccinated with ROTARIX.

Looking after your medicine

• ROTARIX will usually be stored at the doctor's clinic or at the pharmacy.
• If you need to store ROTARIX, it is important to keep it in the refrigerator between 2°C and 8°C.
• Keep ROTARIX in the carton to protect it from light.
• Do not freeze ROTARIX.

Follow the instructions on the carton on how to take care of your medicine properly.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

If your child no longer needs to receive 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 medicines can have side effects. If your child does 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 nurse if you have any further questions about side effects.

Less serious side effects

Serious side effects

Tell your doctor or nurse if you notice anything else that may be making your child 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. By reporting side effects, you can help provide more information on the safety of this medicine.

7. Product details

What ROTARIX contains

Your child should not receive this medicine if they are allergic to any of these ingredients.

The manufacture of this product includes exposure to bovine derived 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 ROTARIX looks like

ROTARIX is a clear, colourless liquid, free of visible particles.

ROTARIX is available in an oral applicator tube with a plunger stopper in packs of 1, 5, 10, 25, 50 or 100 (AUST R 146776).

ROTARIX is available in a squeezable tube in packs of 1 or 10 (AUST R 326141).

Not all pack sizes and container types may be distributed in Australia.

Who distributes ROTARIX

GlaxoSmithKline Australia Pty Ltd
Level 4, 436 Johnston Street,
Abbotsford, Victoria, 3067
Phone: 1800 033 109
www.gsk.com.au

This leaflet was prepared in November 2024.

Version 12.0

Published by MIMS March 2025

1 Name of Medicine

Human Rotavirus (live attenuated oral vaccine).

2 Qualitative and Quantitative Composition

Rotarix is a liquid suspension of the live attenuated RIX4414 strain of human rotavirus of the G1P(8) type for use in the prevention of rotavirus gastroenteritis. The virus strain derived from the 89-12 strain is obtained by propagation on a well characterised Vero cell line.
Each 1.5 mL dose of the vaccine contains not less than 10^6.0 CCID₅₀ (cell culture infectious dose 50%) of the RIX 4414 strain of human rotavirus.
The manufacture of this product includes exposure to bovine derived materials at the very early steps of the production process. No bovine materials are used in routine production. 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.
The vaccine also contains sucrose. For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Rotarix is presented as a clear, colourless liquid, free of visible particles, for oral administration only.

4 Clinical Particulars

4.1 Therapeutic Indications

Rotarix is indicated for the prevention of rotavirus gastroenteritis. (See Section 5.1 Pharmacodynamic Properties, Clinical trials).

4.2 Dose and Method of Administration

Dosage.

Administration.

Instructions for use and handling.

Instructions for administration of the vaccine in oral applicator (syringe type applicator with a plunger stopper).

Instructions for administration of the vaccine in tube.

1. Pull off the cap.

2. Repeatedly flick the top of the tube until it is clear of any liquid.

3. Position the cap to open the tube.

4. To open the tube.

1. Check the membrane has been pierced.

2. What to do if the membrane has not been pierced.

1. Position the child to give the vaccine.

2. Administer the vaccine.

4.3 Contraindications

Rotarix should not be administered to subjects with known hypersensitivity to any components of the vaccine (see Section 6.1 List of Excipients), or to subjects having shown signs of hypersensitivity after previous administration of rotavirus vaccines.
Rotarix should not be administered to subjects with any history of chronic gastrointestinal disease including any uncorrected congenital malformation (such as Meckel's diverticulum) of the gastrointestinal tract.
Subjects with history of intussusception.
Subjects with severe combined immunodeficiency (SCID) disorder (see Section 4.8 Adverse Effects (Undesirable Effects)).
As with other vaccines, administration of Rotarix should be postponed in subjects suffering from acute severe febrile illness. The presence of a minor infection, such as a cold, is not a contraindication for immunisation.

4.4 Special Warnings and Precautions for Use

Rotarix should under no circumstances be injected.
It is good clinical practice that vaccination should be preceded by a review of the medical history (especially with regard to previous vaccination and possible occurrence of undesirable events) and a clinical examination.
The administration of Rotarix should be postponed in subjects suffering from diarrhoea or vomiting.
Administration of Rotarix may be considered with caution in infants with gastrointestinal illnesses, when, in the opinion of the physician, the risk of rotavirus infection by withholding the vaccine entails a greater risk to the infant. No safety or efficacy data are available for the administration of Rotarix to infants with gastrointestinal illnesses.
Administration of Rotarix in immunosuppressed infants, including infants on immunosuppressive therapy, should be based on careful consideration of potential benefits and risks.
The risk of intussusception has been evaluated in a large safety trial (including 63,225 infants) conducted in Latin America and Finland. No increased risk of intussusception was observed in this clinical trial following administration of Rotarix when compared with placebo (see Section 4.8 Adverse Effects (Undesirable Effects)).
Data from postmarketing studies indicate an increased incidence of intussusception shortly after the administration of the first dose and second dose of Rotarix (see Section 4.8 Adverse Effects (Undesirable Effects)). Whether vaccination with Rotarix affects the overall risk of intussusception has not been established. The overall incidence of intussusception remains rare.
Therefore, healthcare professionals should follow up on any symptoms suggestive of intussusception after rotavirus vaccine administration. These symptoms can include severe abdominal pain or distress, persistent vomiting, bloody stools, palpable abdominal mass, abdominal bloating and/or high fever.
Parents/ guardians should be advised to seek medical advice promptly where these signs/ symptoms are evident.
Rotarix should not be administered in subjects with a predisposition for intussusception (see Section 4.3 Contraindications).
Excretion of the vaccine virus in the stools occurs after vaccination and lasts for 10 days on average with peak excretion around the 7th day. Viral antigen particles detected by ELISA were found in 50% of stools after the first dose and 4% of stools after the second dose. When these stools were tested for the presence of live vaccine strain, 17% were positive. In two comparative controlled trials, vaccine shedding after vaccination with Rotarix liquid formulation was comparable to that observed after vaccination with Rotarix lyophilised formulation.
In clinical trials, cases of transmission of excreted vaccine virus to seronegative contacts of vaccinees have been observed without causing any clinical symptoms.
There is a potential risk for transmission to nonvaccinated contacts. Therefore, Rotarix should be administered with caution to infants with close contacts who are immunodeficient, such as household members with malignancies or who are otherwise immunocompromised or receiving immunosuppressive therapy. Contacts of recent vaccines should be advised to observe personal hygiene (e.g. washing their hands when changing children's nappies).
As with any vaccine, a protective immune response may not be elicited in all vaccinees (see Section 5.1 Pharmacodynamic Properties, Clinical trials).
The extent of protection that Rotarix might provide against rotavirus strains that have not been circulating in clinical trials is currently unknown (see Section 5.1 Pharmacodynamic Properties, Clinical trials).
Rotarix does not protect against gastroenteritis due to pathogens other than rotavirus.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Coadministration studies have demonstrated that Rotarix can be given concomitantly with any of the following administered either as monovalent or as combination vaccines: diphtheria tetanus acellular pertussis vaccine (DTPa), Haemophilus influenzae type b vaccine (Hib), inactivated polio vaccine (IPV), hepatitis B vaccine (HBV), hexavalent vaccines DTPa-HBV-IPV/Hib, pneumococcal conjugate vaccine and meningococcal serogroup C conjugate vaccine. The studies demonstrated that the immune responses and the safety profiles of the administered vaccines were unaffected.
Clinical studies, involving more than 2,000 subjects, were performed where Rotarix and oral polio vaccine (OPV) were administered two weeks apart. The immune response to Rotarix and OPV was unaffected. In three immunogenicity studies, involving approximately 1,200 subjects, Rotarix was concomitantly administered with OPV. The immune response to OPV, as well as the response to Rotarix after the second dose, were unaffected. Rotarix can be concomitantly administered with OPV if this is in accordance with local recommendations. In the absence of local recommendations, an interval of two weeks between the administration of OPV and Rotarix should be respected.
Although antibodies to rotavirus may be detected in breast milk, the available data show no reduction in efficacy when Rotarix is administered to breastfed infants.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

Clinical trial experience.

Solicited adverse events.

Unsolicited adverse events.

Serious adverse events.

Safety in preterm infants.

Safety in infants with human immunodeficiency (HIV) infection.

Post marketing data.

Gastrointestinal disorders.

Blood and lymphatic disorders.

Vascular disorders.

Reporting suspected adverse effects.

4.9 Overdose

Some cases of overdose have been reported. In general, the adverse event profile reported in these cases was similar to that observed after administration of the recommended dose of Rotarix.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Rotavirus is likely to affect all children up to the age of five years of age. The peak incidence of rotavirus gastroenteritis is between 6 to 24 months of age. Dehydration from rotavirus gastroenteritis can lead to hospitalisation, which is most common in children under 2 years of age.

Mechanism of action.

Clinical trials.

Protective efficacy in Europe.

Between dose efficacy.

Protective efficacy in Latin America.

Protective efficacy in Africa.

^# Note.

5.2 Pharmacokinetic Properties

Not relevant to vaccines.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Rotarix also contains sucrose, di-sodium adipate, Dulbecco's Modified Eagle Medium and sterile water.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine. See Section 4.5 Interactions with Other Medicines and Other Forms of Interactions.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store at 2°C to 8°C. (Refrigerate. Do not freeze.) Store in the original package, in order to protect from light.

6.5 Nature and Contents of Container

1.5 mL of oral suspension in an oral applicator (Type I, Ph. Eur.) with a plunger stopper (butyl rubber). Pack sizes of 1, 5, 10, 25, 50 or 100.
1.5 mL of oral suspension in a squeezable tube Low Density Polyethylene (LDPE) fitted with a membrane and a cap (polypropylene). Pack sizes of 1 or 10.
Not all pack sizes and container types may be distributed in Australia.

6.6 Special Precautions for Disposal

Discard the empty tube and cap according to local regulations.

6.7 Physicochemical Properties

Not relevant to vaccines.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicine.

Summary Table of Changes