Influenza A H1N1 Intranasal

FOR INTRANASAL ADMINISTRATION BY A HEALTH CARE PROVIDER.

2.1 Dosing Information

Clinical studies are ongoing with Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal to determine the optimal number of doses.

Available data show that children 9 years of age and younger are largely serologically naïve to the pandemic (H1N1) 2009 virus [1]. Based upon these data Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal should be administered as follows:

Each 0.2 mL dose is administered as 0.1 mL per nostril. 

2.2 Administration Instructions

Each sprayer contains a single dose; approximately one-half of the contents should be administered into each nostril. Refer to the administration diagram (Figure 1) for step-by-step administration instructions. Once the vaccine has been administered, the sprayer should be disposed of according to the standard procedures for medical waste (e.g., sharps container or biohazard container).

Figure 1

Pre-filled, single-dose intranasal sprayer containing 0.2 mL suspension [See Description (11)].

4.1 Hypersensitivity 

Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal is contraindicated in individuals with a history of hypersensitivity, especially anaphylactic reactions, to eggs, egg proteins, gentamicin, gelatin, or arginine or with life-threatening reactions to previous influenza vaccinations.

4.2 Concomitant Pediatric and Adolescent Aspirin Therapy and Reye’s Syndrome

Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal is contraindicated in children and adolescents (2-17 years of age) receiving aspirin therapy or aspirin-containing therapy, because of the association of Reye’s syndrome with aspirin and wild-type influenza infection.

MedImmune’s Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal and seasonal trivalent Influenza Vaccine Live, Intranasal (FluMist) are manufactured by the same process. Available information for FluMist is provided in this section.

7.1 Aspirin Therapy

Do not administer Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal or FluMist to children or adolescents who are receiving aspirin therapy or aspirin-containing therapy [see Contraindications (4.2)].

7.2 Antiviral Agents Against Influenza A and/or B 

The concurrent use of Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal or FluMist with antiviral agents that are active against influenza A and/or B viruses has not been evaluated. However, based upon the potential for antiviral agents to reduce the effectiveness of Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal, do not administer this vaccine until 48 hours after the cessation of antiviral therapy and antiviral agents should not be administered until two weeks after administration of this vaccine unless medically indicated. If antiviral agents and Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal or FluMist are administered concomitantly, revaccination should be considered when appropriate.

7.3 Concomitant Inactivated Vaccines 

There are no data on the concomitant administration of Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal and seasonal trivalent Influenza Virus Vaccines.

The safety and immunogenicity of Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal or FluMist when administered concurrently with inactivated vaccines have not been determined. Studies of FluMist excluded subjects who received any inactivated or subunit vaccine within two weeks of enrollment. Therefore, healthcare providers should consider the risks and benefits of concurrent administration of Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal with inactivated vaccines.

7.4 Concomitant Live Vaccines

There are no data on the concomitant administration of Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal and FluMist.

Concurrent administration of FluMist with the measles, mumps and rubella vaccine and the varicella vaccine was studied in 1245 children 12-15 months of age. Adverse events were similar to those seen in other clinical trials with FluMist [see Adverse Reactions (6.1)]. No evidence of interference with immune responses to measles, mumps, rubella, varicella and FluMist vaccines was observed. Concurrent administration of FluMist with the measles, mumps and rubella vaccine and the varicella vaccine in children >15 months of age has not been studied.

7.5 Intranasal Products

There are no data regarding co-administration of Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal or FluMist with other intranasal preparations.

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Neither Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal nor FluMist have been evaluated for carcinogenic or mutagenic potential or potential to impair fertility.

Vaccine recipients or their parents/guardians should be informed by the health care provider of the potential benefits and risks of Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal, and should be advised that there are two influenza vaccine formulations for this influenza season, the monovalent vaccine against disease caused by pandemic (H1N1) 2009 virus and seasonal trivalent influenza vaccine.

17.1 Asthma and Recurrent Wheezing 

Ask the vaccinee or their parent/guardian if the vaccinee has asthma. For children <5 years of age, also ask if the vaccinee has recurrent wheezing since this may be an asthma equivalent in this age group.

17.2 Vaccination with a Live Virus Vaccine

Vaccine recipients or their parents/guardians should be informed by the health care provider that Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal is an attenuated live virus vaccine and has the potential for transmission to immunocompromised household contacts.

17.3 Adverse Event Reporting

The vaccine recipient or the parent/guardian accompanying the vaccine recipient should be told to report any suspected adverse events to the physician or clinic where the vaccine was administered.

FluMist® is a registered trademark of MedImmune, LLC.

Manufactured by:

MedImmune, LLC

Gaithersburg, MD 20878

1-877-633-4411

Issue Date: February 2010                                           RAL-FLUV9H2

U.S. Government License No. 1799

PRINCIPAL DISPLAY PANEL

Influenza A (H1N1) 2009

Monovalent Vaccine Live,

Intranasal

For Intranasal Administration Only

Contents: 10 pre-filled sprayers

One 0.2 mL dose each (0.1 mL per nostril)

STORE REFRIGERATED at 2°-8°C (35°-46°F)

Rx Only