RotaTeq (rotavirus vaccine, live, oral, pentavalent) ¹ is indicated for the prevention of rotavirus gastroenteritis in infants and children caused by the serotypes G1, G2, G3, and G4 when administered as a 3-dose series to infants between the ages of 6 to 32 weeks. The first dose of RotaTeq (rotavirus vaccine, live, oral, pentavalent) should be administered between 6 and 12 weeks of age [see DOSAGE AND ADMINISTRATION].

FOR ORAL USE ONLY. NOT FOR INJECTION.

The vaccination series consists of three ready-to-use liquid doses of RotaTeq (rotavirus vaccine, live, oral, pentavalent) administered orally starting at 6 to 12 weeks of age, with the subsequent doses administered at 4- to 10-week intervals. The third dose should not be given after 32 weeks of age [see Clinical Studies].

There are no restrictions on the infant's consumption of food or liquid, including breast milk, either before or after vaccination with RotaTeq (rotavirus vaccine, live, oral, pentavalent) .

Do not mix the RotaTeq (rotavirus vaccine, live, oral, pentavalent) vaccine with any other vaccines or solutions. Do not reconstitute or dilute [see DOSAGE AND ADMINISTRATION].

For storage instructions [see How Supplied/Storage and Handling].

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. The dosing tube is contained in a pouch [see DOSAGE AND ADMINISTRATION].

Use with Other Vaccines

In clinical trials, RotaTeq (rotavirus vaccine, live, oral, pentavalent) was administered concomitantly with other licensed pediatric vaccines [see ADVERSE REACTIONS , DRUG INTERACTIONS, and Clinical Studies].

Instructions For Use

To administer the vaccine:

Tear open the pouch and remove the dosing tube.

Clear the fluid from the dispensing tip by holding tube vertically and tapping cap.

Open the dosing tube in 2 easy motions:

1. Puncture the dispensing tip by screwing cap clockwise until it becomes tight.

2. Remove cap by turning it counterclockwise.

Administer dose by gently squeezing liquid into infant's mouth toward the inner cheek until dosing tube is empty. (A residual drop may remain in the tip of the tube.)

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.

Discard the empty tube and cap in approved biological waste containers according to local regulations.

Dosage Forms And Strengths

RotaTeq (rotavirus vaccine, live, oral, pentavalent) , 2 mL for oral use, is a ready-to-use solution of live reassortant rotaviruses, containing G1, G2, G3, G4 and P1A[8] which contains a minimum of 2.0 - 2.8 x 10⁶ infectious units (IU) per individual reassortant dose, depending on the serotype, and not greater than 116 x 10⁶ IU per aggregate dose.

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. The dosing tube is contained in a pouch.

Storage And Handling

No. 4047 - RotaTeq (rotavirus vaccine, live, oral, pentavalent) , 2 mL, a solution for oral use, is a pale yellow clear liquid that may have a pink tint. It is supplied as follows:

NDC 0006-4047-31 package of 1 individually pouched single-dose tube

NDC 0006-4047-41 package of 10 individually pouched single-dose tubes.

Storage and Handling

Store and transport refrigerated at 2-8°C (36-46°F). RotaTeq (rotavirus vaccine, live, oral, pentavalent) should be administered as soon as possible after being removed from refrigeration. For information regarding stability under conditions other than those recommended, call 1-800-MERCK-90.

Protect from light.

RotaTeq (rotavirus vaccine, live, oral, pentavalent) should be discarded in approved biological waste containers according to local regulations.

The product must be used before the expiration date.

REFERENCES

3. Parashar UD et al. Global illness and deaths caused by rotavirus disease in children. Emerg Infect Dis 2003;9(5):565-572.

4. Parashar UD, Holman RC, Clarke MJ, Bresee JS, Glass RI. Hospitalizations associated with rotavirus diarrhea in the United States, 1993 through 1995: surveillance based on the new ICD-9-CM rotavirus-specific diagnostic code. J Infect Dis 1998;177:13-7.

¹Registered trademark of MERCK & CO., Inc., Whitehouse Station, New Jersey 08889 USA COPYRIGHT © 2006, 2007 MERCK & CO., Inc. All rights reserved

Issued April 2008. MERCK & Co., Inc., Whitehouse Station, NJ, 08889, USA. FDA rev date: 04/30/08

Last reviewed on RxList: 8/28/2008
This monograph has been modified to include the generic and brand name in many instances.