RotaTeq

RotaTeq is part of the drug class:

• Rota virus diarrhea vaccines

For up to 15 days after receiving rotavirus vaccine, the child should avoid coming into contact with anyone who has a weak immune system. There is a chance that the virus could be passed from the child to that person.

Avoid receiving the doses of this vaccine in different clinics or from different doctors. Your child should receive the same brand of rotavirus oral vaccine for all doses given. Different brands of this vaccine may not have the same dosing or booster schedule.

It is very important that your child's doctor check your child's progress at regular visits to make sure that this vaccine is working properly and to check for unwanted effects.

Make sure your child's doctor knows if your child has any type of cancer or is receiving medicine or a procedure that may weaken the immune system, such as steroids, cancer medicines, or radiation.

Tell your child's doctor if your child spends time with a person who has an immune system problem or is getting cancer medicines. Your doctor may recommend ways (e.g., proper hand washing after changing of diapers) to help prevent the spread of vaccine virus to other people.

The oral applicator of this vaccine may contain dry natural latex rubber. Make sure your child's doctor knows if your child has had an allergic reaction to latex rubber.

Call your child's doctor right away if your child has diarrhea, blood in the stool, a high fever, severe stomach pain, or vomiting. These could be symptoms of a serious bowel problem called intussusception.

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

• Feeling fussy.
• Runny nose.
• Fever.
• Not hungry.
• Throwing up.
• Crying that is not normal.
• Loose stools (diarrhea).
• Sore throat.

These are not all of the side effects that may occur. If you have questions about side effects, call your child's doctor. Call your child's 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.

A demonstrated history of hypersensitivity to any component of the vaccine.

Infants who develop symptoms suggestive of hypersensitivity after receiving a dose of Rotateq should not receive further doses of Rotateq.

Infants with Severe Combined Immunodeficiency Disease (SCID) should not receive Rotateq. Post-marketing reports of gastroenteritis, including severe diarrhea and prolonged shedding of vaccine virus, have been reported in infants who were administered Rotateq and later identified as having SCID [see Adverse Reactions (6.2)].

Immunosuppressive therapies including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids (used in greater than physiologic doses), may reduce the immune response to vaccines.

Concomitant Vaccine Administration

In clinical trials, Rotateq was administered concomitantly with diphtheria and tetanus toxoids and acellular pertussis (DTaP), inactivated poliovirus vaccine (IPV), H. influenzae type b conjugate (Hib), hepatitis B vaccine, and pneumococcal conjugate vaccine [see Clinical Studies (14)]. The safety data available are in the ADVERSE REACTIONS section [see Adverse Reactions (6.1)]. There was no evidence for reduced antibody responses to the vaccines that were concomitantly administered with Rotateq.

Pregnancy

Pregnancy Category C: Animal reproduction studies have not been conducted with Rotateq. It is also not known whether Rotateq can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Rotateq is not indicated in women of child-bearing age and should not be administered to pregnant females.

Pediatric Use

Safety and efficacy have not been established in infants less than 6 weeks of age or greater than 32 weeks of age.

Data are available from clinical studies to support the use of Rotateq in pre-term infants according to their age in weeks since birth [see Adverse Reactions (6.1)].

Data are available from clinical studies to support the use of Rotateq in infants with controlled gastroesophageal reflux disease.

Overall, 72,324 infants were randomized in 3 placebo-controlled, phase 3 studies conducted in 11 countries on 3 continents. The data demonstrating the efficacy of Rotateq in preventing rotavirus gastroenteritis come from 6,983 of these infants from the US (including Navajo and White Mountain Apache Nations) and Finland who were enrolled in 2 of these studies: REST and Study 007. The third trial, Study 009, provided clinical evidence supporting the consistency of manufacture and contributed data to the overall safety evaluation.

The racial distribution of the efficacy subset was as follows: White (Rotateq 68%, placebo 69%); Hispanic-American (Rotateq 10%, placebo 9%); Black (2% in both groups); Multiracial (Rotateq 4%, placebo 5%); Asian (<1% in both groups); Native American (Rotateq 15%, placebo 14%); and Other (<1% in both groups). The gender distribution was 52% male and 48% female in both vaccination groups.

The efficacy evaluations in these studies included: 1) Prevention of any grade of severity of rotavirus gastroenteritis; 2) Prevention of severe rotavirus gastroenteritis, as defined by a clinical scoring system; and 3) Reduction in hospitalizations due to rotavirus gastroenteritis.

The vaccine was given as a three-dose series to healthy infants with the first dose administered between 6 and 12 weeks of age and followed by two additional doses administered at 4- to 10-week intervals. The age of infants receiving the third dose was 32 weeks of age or less. Oral polio vaccine administration was not permitted; however, other childhood vaccines could be concomitantly administered. Breast-feeding was permitted in all studies.

The case definition for rotavirus gastroenteritis used to determine vaccine efficacy required that a subject meet both of the following clinical and laboratory criteria: (1) greater than or equal to 3 watery or looser-than-normal stools within a 24-hour period and/or forceful vomiting; and (2) rotavirus antigen detection by enzyme immunoassay (EIA) in a stool specimen taken within 14 days of onset of symptoms. The severity of rotavirus acute gastroenteritis was determined by a clinical scoring system that took into account the intensity and duration of symptoms of fever, vomiting, diarrhea, and behavioral changes.

The primary efficacy analyses included cases of rotavirus gastroenteritis caused by serotypes G1, G2, G3, and G4 that occurred at least 14 days after the third dose through the first rotavirus season post vaccination.

Analyses were also done to evaluate the efficacy of Rotateq against rotavirus gastroenteritis caused by serotypes G1, G2, G3, and G4 at any time following the first dose through the first rotavirus season postvaccination among infants who received at least one vaccination (Intent-to-treat, ITT).

Rotavirus Efficacy and Safety Trial

Primary efficacy against any grade of severity of rotavirus gastroenteritis caused by naturally occurring serotypes G1, G2, G3, or G4 through the first rotavirus season after vaccination was 74.0% (95% CI: 66.8, 79.9) and the ITT efficacy was 60.0% (95% CI: 51.5, 67.1). Primary efficacy against severe rotavirus gastroenteritis caused by naturally occurring serotypes G1, G2, G3, or G4 through the first rotavirus season after vaccination was 98.0% (95% CI: 88.3, 100.0), and ITT efficacy was 96.4% (95% CI: 86.2, 99.6). See Table 8.

The efficacy of Rotateq against severe disease was also demonstrated by a reduction in hospitalizations for rotavirus gastroenteritis among all subjects enrolled in REST. Rotateq reduced hospitalizations for rotavirus gastroenteritis caused by serotypes G1, G2, G3, and G4 through the first two years after the third dose by 95.8% (95% CI: 90.5, 98.2). The ITT efficacy in reducing hospitalizations was 94.7% (95% CI: 89.3, 97.3) as shown in Table 9.

Study 007

Primary efficacy against any grade of severity of rotavirus gastroenteritis caused by naturally occurring serotypes G1, G2, G3, or G4 through the first rotavirus season after vaccination was 72.5% (95% CI: 50.6, 85.6) and the ITT efficacy was 58.4% (95% CI: 33.8, 74.5). Primary efficacy against severe rotavirus gastroenteritis caused by naturally occurring serotypes G1, G2, G3, or G4 through the first rotavirus season after vaccination was 100% (95% CI: 13.0, 100.0) and ITT efficacy against severe rotavirus disease was 100% (95% CI: 30.2, 100.0) as shown in Table 10.

Multiple Rotavirus Seasons

The efficacy of Rotateq through a second rotavirus season was evaluated in a single study (REST). Efficacy against any grade of severity of rotavirus gastroenteritis caused by rotavirus serotypes G1, G2, G3, and G4 through the two rotavirus seasons after vaccination was 71.3% (95% CI: 64.7, 76.9). The efficacy of Rotateq in preventing cases occurring only during the second rotavirus season postvaccination was 62.6% (95% CI: 44.3, 75.4). The efficacy of Rotateq beyond the second season postvaccination was not evaluated.

Rotavirus Gastroenteritis Regardless of Serotype

The rotavirus serotypes identified in the efficacy subset of REST and Study 007 were G1P1A[8]; G2P1[4]; G3P1A[8]; G4P1A[8]; and G9P1A[8].

In REST, the efficacy of Rotateq against any grade of severity of naturally occurring rotavirus gastroenteritis regardless of serotype was 71.8% (95% CI: 64.5, 77.8) and efficacy against severe rotavirus disease was 98.0% (95% CI: 88.3, 99.9). The ITT efficacy starting at dose 1 was 50.9% (95% CI: 41.6, 58.9) for any grade of severity of rotavirus disease and was 96.4% (95% CI: 86.3, 99.6) for severe rotavirus disease.

In Study 007, the primary efficacy of Rotateq against any grade of severity of rotavirus gastroenteritis regardless of serotype was 72.7% (95% CI: 51.9, 85.4) and efficacy against severe rotavirus disease was 100% (95% CI: 12.7, 100). The ITT efficacy starting at dose 1 was 48.0% (95% CI: 21.6, 66.1) for any grade of severity of rotavirus disease and was 100% (95% CI: 30.4, 100.0) for severe rotavirus disease.

Rotavirus Gastroenteritis by Serotype

The efficacy against any grade of severity of rotavirus gastroenteritis by serotype in the REST efficacy cohort is shown in Table 11.

In a separate post hoc analysis of health care utilization data from 68,038 infants (Rotateq 34,035 and placebo 34,003) in REST, using a case definition that included culture confirmation, hospitalization and emergency departments visits due to G9P1A[8] rotavirus gastroenteritis were reduced (Rotateq 0 cases: placebo 14 cases) by 100% (95% CI: 69.6%, 100.0%).

Immunogenicity

A relationship between antibody responses to Rotateq and protection against rotavirus gastroenteritis has not been established. In phase 3 studies, 92.9% to 100% of 439 recipients of Rotateq achieved a 3-fold or more rise in serum anti-rotavirus IgA after a three-dose regimen when compared to 12.3%-20.0% of 397 placebo recipients.

[See FDA-Approved Patient Labeling (17.2).]

Information for Parents/Guardians

Parents or guardians should be given a copy of the required vaccine information and be given the “Patient Information” appended to this insert. Parents and/or guardians should be encouraged to read the patient information that describes the benefits and risks associated with the vaccine and ask any questions they may have during the visit. See PRECAUTIONS and Patient Information.

FDA-Approved Patient Labeling

Patient Information
Rotateq®2 (pronounced "RŌ-tuh-tek")
rotavirus vaccine, live, oral, pentavalent

Read this information carefully before your child receives each dose of Rotateq in case any information about the vaccine changes. Your child will need 3 doses of the vaccine over the course of a few months. This leaflet is a summary of certain information about Rotateq and does not take the place of talking with your child’s doctor, who can give you more complete information written for health care professionals.

What is Rotateq?

Rotateq is an oral vaccine used to help prevent rotavirus infection in children. Rotavirus infection can cause fever, vomiting, and diarrhea that can be severe and can lead to loss of body fluids (dehydration), hospitalization and even death in some children. Rotateq may not fully protect all children that get the vaccine, and if your child already has the virus it will not help them.

Who should not receive Rotateq?

Your child should not get Rotateq if:

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

What should I tell the doctor before my child gets Rotateq?

Tell your doctor if your child:

• Has illness with fever. A mild fever or cold by itself is not reason to delay taking the vaccine.
• Has diarrhea or has been vomiting.
• Has not been gaining weight or is not growing as expected.
• Has a blood disorder.
• Has any type of cancer.
• Has a weak immune system because of a disease (this includes HIV/AIDS).
• Gets treatment or takes medicines that may weaken the immune system (such as high doses of steroids) or has received a blood transfusion or blood products within the past 42 days.
• Was born with gastrointestinal problems, or has had a blockage or abdominal surgery.
• Has regular close contact with a member of family or household who has a weak immune system such as someone with cancer or someone taking medicines that weaken their immune system.

What are the possible side effects of Rotateq?

The most common side effects reported after taking Rotateq were diarrhea, vomiting, fever, runny nose and sore throat, wheezing or coughing, and ear infection.

Other reported side effects include: hives; Kawasaki disease (a serious condition that can affect the heart; symptoms may include fever, rash, red eyes, red mouth, swollen glands, swollen hands and feet and, if not treated, death can occur).

Call your doctor right away if your child has any side effects that concern you or seem to get worse.

These are NOT all the possible side effects of Rotateq. You can ask your doctor for a more complete list.

You, as a parent or guardian, may also report any adverse reactions to your child’s doctor or directly to the Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number is 1-800-822-7967 or report online to www.vaers.hhs.gov.

What other important information should I know?

Call your child's doctor or go to the emergency department right away if, following any dose of Rotateq, your child has vomiting, diarrhea, severe stomach pain, blood in their stool or change in their bowel movements. These symptoms may be signs of a serious and life-threatening problem, called intussusception, that happens when a part of the intestine gets blocked or twisted. Intussusception can happen even when no vaccine has been given and the cause is usually unknown.

Since FDA approval, reports of infants with intussusception have been received by Vaccine Adverse Event Reporting System (VAERS). Intussusception occurred days and sometimes weeks after vaccination. Some infants needed hospitalization, surgery on their intestines, or a special enema to treat this problem. Death due to intussusception has occurred.

Contact your doctor or go to the emergency department right away if your child has any symptoms of intussusception, even if it has been several weeks since the last vaccine dose.

Since FDA approval, the spread of vaccine virus to non-vaccinated contacts has been reported. Tell your doctor if you have someone in your household who has a weak immune system, cancer or is taking medications that can weaken the immune system so that your doctor can provide further advice. Hand washing is recommended after diaper changes to help prevent the spread of vaccine virus.

Can Rotateq be given with other vaccines?

Your child may get Rotateq at the same time as other childhood vaccines.

How is Rotateq given?

The vaccine is given by mouth. Your child will receive 3 doses of the vaccine. The first dose is given when your child is 6 to 12 weeks of age, the second dose is given 4 to 10 weeks later and the third dose is given 4 to 10 weeks after the second dose. The last (third) dose should be given to your child by 32 weeks of age.

Your doctor will gently squeeze the vaccine into your child’s mouth (see Figure 1). Your infant may spit out some or all of it. If this happens, the dose does not need to be given again during that visit.

Figure 1

What do I do if my child misses a dose of Rotateq?

All 3 doses of the vaccine should be given to your child by 32 weeks of age. Your doctor will tell you when your child should come for the follow-up doses. It is important to keep those appointments. If you forget or are not able to go back at the planned time, ask your doctor for advice.

What else should I know about Rotateq?

This leaflet gives a summary of certain information about the vaccine. If you have any questions or concerns about Rotateq, talk to your doctor.

What are the ingredients in Rotateq?

5 live rotavirus strains (G1, G2, G3, G4, and P1).

Sucrose, sodium citrate, sodium phosphate monobasic monohydrate, sodium hydroxide, polysorbate 80 and also fetal bovine serum.

Parts of porcine circovirus (a virus that infects pigs) types 1 and 2 have been found in Rotateq. Porcine circovirus type 1 (PCV-1) and porcine circovirus type 2 (PCV-2) are not known to cause disease in humans.

Rx only

Issued September 2010

Manuf. and Dist. by:
MERCK & CO., INC., Whitehouse Station, NJ 08889, USA

9714311

Registered trademark of MERCK & Co., Inc., Whitehouse Station, NJ, 08889 USA
COPYRIGHT © 2008, 2009 MERCK & Co., Inc.
All rights reserved

This is a representative sample of the packaging. Please see How Supplied section for a complete list of available packaging.

PRINCIPAL DISPLAY PANEL - Carton 10 Single-Dose 2 mL Tubes

Manuf. and Dist. by:
MERCK & CO., INC.
Whitehouse Station, NJ 08889, USA

NDC 0006-4047-41

10 Single-Dose
2 mL Tubes

Rotavirus Vaccine, Live, Oral, Pentavalent
Rotateq®

FOR ORAL USE ONLY. NOT FOR INJECTION.
Administer orally without mixing with any other vaccines or solutions.

Each 2 mL oral dose contains 5 rotavirus reassortants that have been propagated in Vero cells. The minimum dose levels (infectious units, IU) are as follows:
G1 (2.2 x 106) IU; G2 (2.8 x 106) IU; G3 (2.2 x 106) IU; G4 (2.0 x 106) IU and P1 (2.3 x 106) IU.

Rotateq contains no preservatives.

Rx only

RotaTeq (rotavirus oral vaccine) contains up to five strains of rotavirus. It is made from both human and animal sources.

Infection with rotavirus can affect the digestive system of babies and young children, causing severe stomach or intestinal illness.

RotaTeq oral vaccine is used to help prevent this disease in children.

RotaTeq works by exposing your child to a small dose of the virus, which causes the body to develop immunity to the disease. This vaccine will not treat an active infection that has already developed in the body.

RotaTeq is for use in children between the ages of 6 weeks and 32 weeks old.

Like any vaccine, RotaTeq may not provide protection from disease in every person.

Get emergency medical help if your child has any of these signs of an allergic reaction to RotaTeq: hives; difficulty breathing; swelling of the face, lips, tongue, or throat.

Your child should not receive a booster vaccine if he or she had a life threatening allergic reaction after the first shot. Keep track of any and all side effects your child has after receiving RotaTeq. When the child receives a booster dose, you will need to tell the doctor if the previous shot caused any side effects.

RotaTeq may cause intussusception in some people. Intussusception is when a section of the intestine folds over into itself, creating an obstruction in the bowel. Call your doctor as soon as possible if your child has stomach pain or bloating, vomiting (especially if it is golden-brown to green in color), bloody stools, grunting or excessive crying, and eventually weakness and shallow breathing.

Becoming infected with rotavirus is much more dangerous to your child's health than receiving this vaccine. However, like any medicine, this vaccine can cause side effects but the risk of serious side effects is extremely low.

Call your doctor at once if the child has:

• seizure (black-out or convulsions);

• severe or ongoing diarrhea;

• ear pain, swelling, or drainage;

• fever, chills, cough with yellow or green mucus;

• stabbing chest pain, wheezing, feeling short of breath;

• pain or burning with urination; or

• high fever, redness of the skin or eyes, swollen hands, peeling skin rash, chapped or cracked lips.

Common rotavirus oral vaccine side effects may include:

• mild fussiness or crying;

• mild diarrhea;

• vomiting; or

• stuffy nose, sinus pain, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report vaccine side effects to the US Department of Health and Human Services at 1 800 822 7967.