Consumer medicine information

What is in this leaflet

This leaflet answers some common questions about RotaTeq.

It does not contain all the available information.

It does not take the place of talking to your doctor or pharmacist.

All medicines, including vaccines, have risks and benefits. Your doctor has weighed the risks of your child taking RotaTeq against the benefits they expect it will have.

If you have any concerns about this vaccine, ask your doctor, nurse or pharmacist.

Keep this leaflet. You may need to read it again.

What RotaTeq is used for

RotaTeq is a viral vaccine that helps protect your child against gastroenteritis (diarrhoea and vomiting) caused by rotavirus infection.

Rotavirus gastroenteritis may cause fever, vomiting, and diarrhoea. These symptoms can lead to the loss of body fluids (dehydration) and even death.

Rotavirus is the chief cause of severe dehydrating diarrhoea among infants and young children around the world. Before the vaccine was used, the virus was the cause for about 25 million physician visits per year. It also accounted for 2.1 million hospital admissions, and 352,000 to 592,000 deaths per year worldwide.

Rotavirus infects the small intestine and usually starts with fever and vomiting, followed by diarrhoea. The diarrhoea can be mild to severe and generally lasts 3-9 days. Severe vomiting and diarrhoea (more than 5 times each day) lasts an average of 3-6 days. Nearly all children are infected with rotavirus by the time they are 5 years old. This is true even where standards of hygiene are high.

How it works

RotaTeq works by causing your body to produce its own protection (antibodies) against the most common types or "strains" of rotavirus.

As with other vaccines, RotaTeq may not fully protect all those who get it. Some children may already have the virus but not yet show signs of being sick. In those cases, the vaccine may not be able to prevent the illness.

RotaTeq helps protect against diarrhoea and vomiting only if they are caused by rotavirus. It does not protect against them if they are caused by anything else.

Before you take RotaTeq

Before your child starts to take it

Tell your doctor if:

1. Your child has any medical conditions, especially the following:

• diseases which decrease the immune system, for example, HIV infection or AIDS
• cancer
• blood disorders
• diarrhoea or vomiting
• has not been gaining weight
• is not growing as expected
• was born with gastrointestinal problems, or has had an intestinal blockage

Tell your doctor if your child has an infection or a high temperature.
Your doctor may decide to delay giving RotaTeq. A mild fever or upper respiratory infection (cold) by itself is not a reason to delay taking the vaccination.

2. Your child is taking any medicines that may weaken the immune system
3. Your child has regular close contact with a member of the family or household who has a weakened immune system. For example, a person in the house with cancer or one who is taking medicines that may weaken their immune system.
4. Your child has any allergies to any other medicines or vaccines, or any other substances, such as food, preservatives or dyes.

Tell your doctor if your child has had a blood or plasma transfusion in the last 42 days. Your doctor may decide to delay vaccination.

When your child must not take it

Your child should not get the vaccine if :

• He or she has an allergic reaction after getting a dose of the vaccine.
• He or she is allergic to any of the ingredients of the vaccine. A list of the ingredients can be found at the end of this leaflet.
• He or she has Severe Combined Immunodeficiency Disease (SCID)

RotaTeq must be used before the expiry date printed on the pack.

Do not take RotaTeq if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether your child should be given RotaTeq, talk to your doctor.

Use in pregnancy and breast feeding

RotaTeq is a paediatric vaccine not intended for adults and should not be given to pregnant or lactating (breast feeding) women. There are no data available on the use during pregnancy or lactation in humans.

Having other vaccines

Your child may get RotaTeq at the same time as other vaccines, but it should not be mixed with other vaccines or solutions.

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

How RotaTeq is given

How much is given

The entire content of the 2-mL pre-filled unit-dose tube.

How is it given

RotaTeq is given directly to the mouth.

It does not matter if your child is given RotaTeq before or after food.

The vaccine should never be given by injection.

When will it be given

RotaTeq is given in a series of three doses. The first dose is given as early as 6 weeks of age. The next two doses are given one to two months apart.

RotaTeq has not been adequately studied in infants less than 6 weeks of age and more than 32 weeks of age.

After taking RotaTeq

Things you must do

Wash your hands thoroughly after nappy changes to help prevent the spread of vaccine virus.

Things you must do for your child

Keep an updated record of your child's vaccinations.

Keep follow-up appointments with your child's doctor or clinic. It is important that your child takes the follow-up doses of RotaTeq at the appropriate times to make sure the vaccine has the best chance of providing protection against rotavirus gastroenteritis.

Your doctor or nurse will provide instructions regarding your child's return visits for the follow-up doses.

If you miss a dose

If you forget or are not able to make it to your appointment at the planned time, ask your doctor or nurse for advice.

If you are not sure what to do, ask your doctor or nurse.

Side effects

Tell your doctor or pharmacist as soon as possible if your child does not feel well after having RotaTeq.

RotaTeq may have unwanted side effects in a few people. All medicines, including vaccines, can have side effects. Sometimes they are serious, most of the time they are not.

The side effects of RotaTeq are usually mild and do not last long. In addition, these side effects have not been reported much more frequently than when a placebo (an oral solution without vaccine) was given.

Tell your doctor or pharmacist if you notice any of the following and they worry you:

• diarrhoea
• vomiting
• fever
• runny nose
• sore throat
• wheezing or coughing
• ear infection
• allergic reaction, which may be severe, and can cause swelling of the face or throat, difficulty in breathing, or dizziness; hives
• Kawasaki disease (a serious condition that may cause high fever and may be accompanied by rash, red eyes, red lips and tongue, swollen glands in the neck, swollen hands and feet).

Tell your doctor immediately or go to accident and emergency at your nearest hospital if you notice any of the following:

• Intussusception (a form of blockage of the bowel in which one segment of bowel becomes enfolded within another segment), the symptoms and signs of which may include severe stomach pain, persistent vomiting, blood in stools, a swollen belly and fever.

Other side effects not listed above may occur in some patients. Tell your doctor or pharmacist if you notice any side effects not mentioned in this leaflet.

Storage

RotaTeq is usually stored at the doctor's clinic or at the pharmacy.

If you need to store RotaTeq, always:

• Keep RotaTeq in the refrigerator stored between 2°C to 8°C.
• Keep RotaTeq out of the reach of children.
• Protect the vaccine from light by keeping it in the original pack until it is time for it to be given.

Product description

What it looks like

RotaTeq is a pale yellow clear liquid that may have a pink tint, contained in a dosing tube. Each dosing tube contains a single, 2 mL dose of the vaccine.

Ingredients

The active ingredients of RotaTeq are 5 live rotaviruses.

Each 2 mL dose contains the following rotavirus reassortants: G1, G2, G3, G4, and P1[8]. The minimum dose levels of the reassortants are as follows:

G1 2.2 million infectious units

G2 2.8 million infectious units

G3 2.2 million infectious units

G4 2.0 million infectious units

P1[8] 2.3 million infectious units

Inactive ingredients are

• sucrose
• sodium citrate dihydrate
• monobasic sodium phosphate monohydrate
• sodium hydroxide
• polysorbate 80
• Rotavirus Diluent
• Low Protein Kidney Medium-3

RotaTeq does not contain any preservatives or thiomersal.

The manufacture of this product includes exposure to bovine derive material. 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 contains DNA (very small parts) from porcine circoviruses type 1 and type 2 (viruses that infect pigs). These viruses are not known to cause infection or illness in people and there is no known safety risk in people.

Supplier

RotaTeq is supplied in Australia by:-

Seqirus (Australia) Pty Ltd
63 Poplar Road
Parkville Victoria 3052
Australia

This leaflet was prepared in March 2020.

Australian Register Number:

AUST R 120245

Published by MIMS May 2020

1 Name of Medicine

Rotavirus G1 human-bovine reassortant.
Rotavirus G2 human-bovine reassortant.
Rotavirus G3 human-bovine reassortant.
Rotavirus G4 human-bovine reassortant.
Rotavirus P1 [8] human-bovine reassortant.

6.7 Physicochemical Properties

Chemical structure.

CAS number.

2 Qualitative and Quantitative Composition

RotaTeq is a live, oral pentavalent reassortant vaccine for use in the prevention of rotavirus gastroenteritis.
Each 2 mL dose of RotaTeq contains the following rotavirus reassortants: G1, G2, G3, G4 and P1A[8] derived from rotaviruses infecting human and bovine species. The minimum dose levels of the reassortants are as follows:
G1: 2.2 x 10⁶ infectious units;
G2: 2.8 x 10⁶ infectious units;
G3: 2.2 x 10⁶ infectious units;
G4: 2.0 x 10⁶ infectious units;
P1A[8]: 2.3 x 10⁶ infectious units.
The reassortants are propagated in Vero cells using standard tissue culture techniques in the absence of antifungal agents.
The reassortants are suspended in a buffered stabilizer solution.

List of excipients with known effect.

3 Pharmaceutical Form

RotaTeq is a pale yellow clear liquid that may have a pink tint.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Rotavirus is the leading cause of severe acute gastroenteritis in infants and young children, with potentially severe consequences including hospitalisation and death. The greatest proportion of hospitalisations occurs among infants and young children between 6 months and 23 months of age. If left untreated without prompt oral or intravenous administration of fluids, rotavirus gastroenteritis may cause dehydration that is fatal.

Mechanism of action.

Clinical trials.

Efficacy.

Infants with hospitalisations, emergency department visits and non-urgent visits.

Efficacy between doses.

Efficacy through multiple rotavirus seasons.

Safety and efficacy in pre-term infants.

Effectiveness.

Safety, efficacy and immunogenicity with concomitant administration of RotaTeq and other vaccines.

Immunogenicity.

5.2 Pharmacokinetic Properties

Absorption.

Distribution.

Metabolism.

Excretion.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

4 Clinical Particulars

4.1 Therapeutic Indications

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

4.3 Contraindications

Hypersensitivity to any component of the vaccine.
Individuals who develop symptoms suggestive of hypersensitivity after receiving a dose of RotaTeq should not receive further doses of RotaTeq.
Individuals with Severe Combined Immunodeficiency Disease (SCID). Cases of gastroenteritis associated with vaccine virus have been reported post-marketing in infants with SCID.
Individuals with a history of intussusception.

4.4 Special Warnings and Precautions for Use

Adequate treatment provisions, including adrenaline (epinephrine) injection (1:1000), should be available for immediate use should an anaphylactic reaction occur.
No safety or efficacy data are available from clinical trials regarding the administration of RotaTeq to immunocompromised patients such as individuals with malignancies or who are otherwise immunocompromised; individuals receiving immunosuppressive therapy; individuals infected with HIV; or individuals who have received a blood transfusion or blood products, including immunoglobulins within 42 days.
No fecal shedding of vaccine strains was seen in a small subset of infants with serious medical conditions (e.g. cystic fibrosis, failure to thrive, cancer, congenital heart disease and neutropenia) that were diagnosed after enrolment in the study. Health care providers may want to consider these data when assessing the benefits and potential risks of administering RotaTeq to infants with serious medical conditions while keeping in mind nearly all children are infected with naturally occurring rotavirus by age 5 years.
In clinical trials, RotaTeq was not administered to infants known to have immunodeficient household members. In these trials, RotaTeq was shed in the stools of 8.9% of vaccine recipients almost exclusively in the week after dose 1 and in only one vaccine recipient (0.3%) after dose 3. Transmission of vaccine virus strains to non-vaccinated contacts has been observed post-marketing. RotaTeq should be administered with caution to individuals with immunodeficient close contacts such as:
individuals with malignancies or who are otherwise immunocompromised; or
individuals receiving immunosuppressive therapy.
However, because nearly all children are infected with naturally occurring rotavirus by the age of 5 years, vaccination of infants may decrease the risk of exposure of immunodeficient household contacts to naturally occurring rotavirus. The health care provider should assess the potential risks and benefits of administering RotaTeq to infants known to have immunodeficient close contacts.
Infants with active gastrointestinal illness, chronic diarrhoea or growth retardation, or a history of congenital abdominal disorders or intussusception were not to be included in the clinical studies. Administration of RotaTeq may be considered with caution in such infants when, in the opinion of the physician, withholding the vaccine entails a greater risk.
Any acute infection or febrile illness may be reason for delaying use of RotaTeq except when, in the opinion of the physician, withholding the vaccine entails a greater risk. Low-grade fever itself and mild upper respiratory infection are not contraindications to vaccination with RotaTeq.
As with any vaccine, vaccination with RotaTeq may not result in complete protection in all recipients.
The clinical studies were not designed to assess the level of protection provided by only 1 or 2 doses of RotaTeq. Post hoc analyses of data from a large clinical study suggest that RotaTeq provides protection against hospitalisations and emergency department visits for rotavirus gastroenteritis during administration of the 3-dose vaccination series starting from 14 days post dose 1 (see Section 5.1 Pharmacodynamic Properties, Clinical trials, Efficacy between doses).
No clinical data are available for RotaTeq when administered after exposure to rotavirus.
In worldwide post-marketing surveillance, cases of intussusception have been reported in temporal association with RotaTeq. (See Section 4.8 Adverse Effects (Undesirable Effects), Post-marketing reports.)
Post-marketing safety data from Australia have identified an increased risk of intussusception shortly after the administration of the first dose and second dose of RotaTeq. No increased risk of intussusception was observed among infants receiving RotaTeq in two large post-marketing safety studies conducted in the United States. No increased risk of intussusception was observed in clinical trials following administration of RotaTeq compared with placebo. (See Section 4.8 Adverse Effects (Undesirable Effects)).
As a precaution, healthcare professionals should follow-up on any symptoms suggestive of intussusception (severe abdominal pain or distress, persistent vomiting, bloody stools, abdominal bloating and/or high fever). Parents/guardians should be advised to seek medical advice promptly where these signs/symptoms are evident.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

There are no known drug interactions. (See Section 4.2 Dose and Method of Administration, Use with other vaccines.)

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.8 Adverse Effects (Undesirable Effects)

71,725 infants were evaluated in 3 placebo-controlled clinical trials including 36,165 infants who received RotaTeq and 35,560 infants who received placebo. Parents/guardians were contacted on days 7, 14 and 42 after each dose regarding intussusception and any other serious adverse events.
The vaccine is generally well tolerated.
In the large-scale (34,837 vaccine recipients and 34,788 placebo recipients), placebo-controlled Rotavirus Efficacy and Safety Trial (REST), RotaTeq did not increase the risk of intussusception relative to placebo (see Table 1). Active surveillance was employed to identify potential cases of intussusception at days 7, 14 and 42 after each dose and every 6 weeks thereafter for 1 year after dose one. There were no confirmed cases of intussusception during the 42-day period after dose one, and there was no clustering of cases among vaccine recipients at any time period after any dose.
Following the 1-year safety follow-up period, 4 cases of intussusception were reported in children who had received placebo during the study.
Kawasaki's disease was reported in the phase III clinical trials in < 0.1% (5/36,150) of vaccine recipients and < 0.1% (1/35,536) of placebo recipients within 42 days of any dose (not statistically significant).
In 11,711 infants (6,138 recipients of RotaTeq) from the 3 studies, a Vaccination Report Card was used by parents/guardians to record the child's temperature and any episodes of diarrhoea and vomiting on a daily basis during the first week following each vaccination. Table 2 summarizes the frequencies of these adverse events, regardless of cause.
Parents/guardians of the 11,711 infants were also asked to report the presence of other events on the Vaccination Report Card for 42 days after each dose. The following vaccine-related adverse experiences were observed among recipients of RotaTeq at a frequency at least 0.3% greater than that observed among placebo recipients.
Very common (≥ 1/10); Common (≥ 1/100, < 1/10); Uncommon (≥ 1/1,000, < 1/100); Rare (≥ 1/10,000, < 1/1,000); Very rare (< 1/10,000).

Infections and infestations.

Gastrointestinal disorders.

General disorders and administration site conditions.

Other adverse events.

Post-marketing reports.

Immune system disorders.

Skin and subcutaneous tissue disorders.

Gastrointestinal disorders.

Post-marketing safety surveillance studies.

Australian case series analysis of intussusception.

U.S. post-marketing observational safety surveillance study.

U.S. vaccine safety datalink study.

Reporting suspected adverse effects.

4.2 Dose and Method of Administration

For oral use only. Not for injection.
The vaccination series consists of three ready-to-use liquid doses of RotaTeq administered orally to infants.
The first dose of RotaTeq should be administered at 6 to 12 weeks of age; the subsequent doses at a minimum interval of 4 weeks. The third dose should be administered by 32 weeks of age (see Section 4.4 Special Warnings and Precautions for Use, Paediatric use).
There are no restrictions on the infant's consumption of food or liquid, including breast milk, either before or after vaccination with RotaTeq.
RotaTeq may be given to pre-term infants according to their chronological age.
If for any reason an incomplete dose is administered (e.g. infant spits or regurgitates the vaccine), a replacement dose is not recommended, since such dosing was not studied in the clinical trials. The infant should continue to receive any remaining doses in the recommended series.
The vaccine is to be administered orally without mixing with any other vaccines or solutions. Do not reconstitute or dilute.
Each dose is supplied in a container consisting of a squeezable plastic, latex-free dosing tube with a twist-off cap, allowing for direct oral administration.
Refer to the package insert for instructions on administration of the vaccine.

Use with other vaccines.

4.7 Effects on Ability to Drive and Use Machines

Not applicable.

4.9 Overdose

There have been reports of administration of higher than recommended doses of RotaTeq. In general, the adverse event profile reported with overdose was comparable to that observed with recommended doses of RotaTeq.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

7 Medicine Schedule (Poisons Standard)

S4.

6 Pharmaceutical Particulars

6.1 List of Excipients

Sucrose, sodium citrate dihydrate, monobasic sodium phosphate monohydrate, sodium hydroxide, polysorbate 80, Rotavirus diluent, Low Protein Kidney Medium-3.
There are no preservatives or thiomersal present.

6.2 Incompatibilities

Please see Section 4.2 Dose and Method of Administration; Section 4.5 Interactions with Other Medicines and Other Forms of Interactions for further information.

6.3 Shelf Life

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

6.4 Special Precautions for Storage

Store and transport refrigerated at 2°C to 8°C. Protect from light.
The product must be used before the expiration date.
RotaTeq should be administered as soon as possible after being removed from refrigeration. When out of refrigeration at room temperature at or below 25°C, administration may be delayed for up to 48 hours. After this time, the vaccine should be discarded in approved biological waste containers according to local regulations.

6.5 Nature and Contents of Container

RotaTeq is available as a single, pre-filled 2 mL unit dose in a plastic dosing tube with a twist-off cap. The dosing tube is contained in a pouch. The container and delivery system are latex-free.
RotaTeq is supplied as:
(1) a single-dose pre-filled dosing tube of vaccine.
(2) a box of ten single-dose pre-filled dosing tubes of vaccine.

6.6 Special Precautions for Disposal

The vaccine should be discarded in approved biological waste containers according to local regulations.

Summary Table of Changes