GARDASIL 9: Package Insert and Label Information (Page 5 of 5)

14.6 Studies with Menactra and Adacel

In Study 5, the safety and immunogenicity of co-administration of GARDASIL 9 with Menactra [Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine] and Adacel [Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap)] (same visit, injections at separate sites) were evaluated in 1,237 boys and girls 11 through 15 years of age at enrollment.

One group received GARDASIL 9 in one limb and both Menactra and Adacel, as separate injections, in the opposite limb concomitantly on Day 1 (n = 619). The second group received the first dose of GARDASIL 9 on Day 1 in one limb then Menactra and Adacel, as separate injections, at Month 1 in the opposite limb (n = 618). Subjects in both vaccination groups received the second dose of GARDASIL 9 at Month 2 and the third dose at Month 6. Immunogenicity was assessed for all vaccines one month post vaccination (one dose for Menactra and Adacel and three doses for GARDASIL 9).

Assessments of post-vaccination immune responses included type-specific antibody GMTs for each of the vaccine HPV types at four weeks following the last dose of GARDASIL 9; GMTs for anti-filamentous hemagglutinin, anti-pertactin, and anti-fimbrial antibodies at four weeks following Adacel; percentage of subjects with anti-tetanus toxin and anti-diphtheria toxin antibody concentrations ≥0.1 IU/mL at four weeks following Adacel; and percentage of subjects with ≥4-fold rise from pre-vaccination baseline in antibody titers against N. meningitidis serogroups A, C, Y, and W-135 at four weeks following Menactra. Based on these measures, concomitant administration of GARDASIL 9 with Menactra and Adacel did not interfere with the antibody responses to any of the vaccines when compared with non-concomitant administration of GARDASIL 9 with Menactra and Adacel.

15 REFERENCES

  1. Study 1 NCT00543543
  2. Study 2 NCT00943722
  3. Study 3 NCT01304498
  4. Study 4 NCT01047345
  5. Study 5 NCT00988884
  6. Study 6 NCT01073293
  7. Study 7 NCT01651949
  8. Study 8 NCT01984697

16 HOW SUPPLIED/STORAGE AND HANDLING

Product: 50090-2443

NDC: 50090-2443-0 10 mL in a CARTON

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Inform the patient, parent, or guardian:

  • Vaccination does not eliminate the necessity for women to continue to undergo recommended cervical cancer screening. Women who receive GARDASIL 9 should continue to undergo cervical cancer screening per standard of care.
  • Recipients of GARDASIL 9 should not discontinue anal cancer screening if it has been recommended by a health care provider.
  • GARDASIL 9 has not been demonstrated to provide protection against disease from vaccine and non-vaccine HPV types to which a person has previously been exposed through sexual activity.
  • Since syncope has been reported following HPV vaccination sometimes resulting in falling with injury, observation for 15 minutes after administration is recommended.
  • Vaccine information is required to be given with each vaccination to the patient, parent, or guardian.
  • Provide information regarding benefits and risks associated with vaccination.
  • Safety and effectiveness of GARDASIL 9 have not been established in pregnant women. A pregnancy registry is available. Women exposed to GARDASIL 9 around the time of conception or during pregnancy are encouraged to register by calling 1-800-986-8999. [See Use in Specific Populations (8.1).]
  • It is important to complete the full vaccination series unless contraindicated.
  • Report any adverse reactions to their health care provider.

Manuf. and Dist. by: Merck Sharp & Dohme Corp., a subsidiary of
MERCK & CO., INC., Whitehouse Station, NJ 08889, USA

For patent information: www.merck.com/product/patent/home.html

The trademarks depicted herein are owned by their respective companies.

Copyright © 2006-2018 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. All rights reserved.

uspi-v503-i-1802r007

Patient Information about GARDASIL® 9 (pronounced “gard-Ah-sill nīn”) (Human Papillomavirus 9-valent Vaccine, Recombinant)

Read this information with care before getting GARDASIL® 9. You or your child (the person getting GARDASIL 9) will need 2 or 3 doses of the vaccine, depending on how old you are. It is important to read this information before getting each dose. This information does not take the place of talking with your health care professional about GARDASIL 9.

What is GARDASIL 9?

GARDASIL 9 is a vaccine (injection/shot) given to individuals 9 through 26 years of age to help protect against diseases caused by some types of Human Papillomavirus (HPV).

What diseases can GARDASIL 9 help protect against?

In girls and women 9 through 26 years of age, GARDASIL 9 helps protect against:

  • Cervical cancer
  • Vulvar and vaginal cancers
  • Anal cancer
  • Precancerous cervical, vulvar, vaginal and anal lesions
  • Genital warts

In boys and men 9 through 26 years of age, GARDASIL 9 helps protect against:

  • Anal cancer
  • Precancerous anal lesions
  • Genital warts

These diseases have many causes. Most of the time, these diseases are caused by nine types of HPV: HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58. GARDASIL 9 only protects against diseases caused by these nine types of HPV.

People cannot get HPV or any of these diseases from GARDASIL 9.

What important information about GARDASIL 9 should I know?

GARDASIL 9:

  • Does not remove the need for cervical cancer screening; women should still get routine cervical cancer screening.
  • Does not protect the person getting GARDASIL 9 from a disease that is caused by other types of HPV, other viruses or bacteria.
  • Does not treat HPV infection.
  • Does not protect the person getting GARDASIL 9 from HPV types that he/she may already have.

GARDASIL 9 may not fully protect each person who gets it.

Who should not get GARDASIL 9?

Anyone with an allergic reaction to:

  • A previous dose of GARDASIL 9
  • A previous dose of GARDASIL®
  • Yeast (severe allergic reaction)
  • Amorphous aluminum hydroxyphosphate sulfate
  • Polysorbate 80

What should I tell the health care professional before getting GARDASIL 9?

Tell the health care professional if you or your child (the person getting GARDASIL 9):

  • Are pregnant or planning to get pregnant.
  • Have immune problems, like HIV or cancer.
  • Take medicines that affect the immune system.
  • Have a fever over 100°F (37.8°C).
  • Might have had an allergic reaction to a previous dose of GARDASIL 9 or GARDASIL.
  • Take any medicines, even those you can buy over the counter.

The health care professional will help decide if you or your child should get the vaccine.

How is GARDASIL 9 given?

GARDASIL 9 is a shot that is usually given in the arm muscle. GARDASIL 9 may be given as 2 or 3 shots.

For persons who are You will need Given as
*
If the second shot is given earlier than 5 months after the first shot, you will need to get a third shot at least 4 months after the second shot was given.
The need to use a 3-dose schedule instead of a 2-dose schedule will be determined by your health care professional.
9 through 14 years old 2-shots * Dose 1: first shotDose 2: second shot given between 6 and 12 months after the first shot
or 3-shots Dose 1: first shotDose 2: second shot given 2 months after the first shotDose 3: third shot given 6 months after the first shot
15 through 26 years old 3-shots Dose 1: first shotDose 2: second shot given 2 months after the first shotDose 3: third shot given 6 months after the first shot

Make sure that you or your child gets all doses recommended by your health care professional so that you or your child gets the best protection. If the person getting GARDASIL 9 misses a dose, tell the health care professional and they will decide when to give the missed dose. It is important that you follow the instructions of your health care professional regarding return visits for the follow-up doses.

Fainting can happen after getting an HPV vaccine. Sometimes people who faint can fall and hurt themselves. For this reason, the health care professional may ask the person getting GARDASIL 9 to sit or lie down for 15 minutes after getting the vaccine. Some people who faint might shake or become stiff. The health care professional may need to treat the person getting GARDASIL 9.

Can I get GARDASIL 9 if I have already gotten GARDASIL?

If you have already gotten GARDASIL, talk to your health care professional to see if GARDASIL 9 is right for you.

Can I get GARDASIL 9 with other vaccines?

GARDASIL 9 can be given at the same time as:

  • Menactra [Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine]
  • Adacel [Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap)]

What are the possible side effects of GARDASIL 9?

The most common side effects seen with GARDASIL 9 are:

  • pain, swelling, redness, itching, bruising, bleeding, and a lump where you got the shot
  • headache
  • fever
  • nausea
  • dizziness
  • tiredness
  • diarrhea
  • abdominal pain
  • sore throat

Studies show that there was more swelling where the shot was given when GARDASIL 9 was given at the same time as Menactra and Adacel.

Tell the health care professional if you have any of these problems because these may be signs of an allergic reaction:

  • difficulty breathing
  • wheezing (bronchospasm)
  • hives
  • rash

These side effects have been seen with GARDASIL. Because GARDASIL 9 is related to GARDASIL, they may also be seen after getting GARDASIL 9:

  • swollen glands (neck, armpit, or groin)
  • joint pain
  • unusual tiredness, weakness, or confusion
  • chills
  • generally feeling unwell
  • leg pain
  • shortness of breath
  • chest pain
  • aching muscles
  • muscle weakness
  • seizure
  • bad stomach ache
  • bleeding or bruising more easily than normal
  • skin infection
  • fainting

You should contact your health care professional right away if you get any symptoms that bother you.

For a more complete list of side effects, ask the health care professional.

Call your health care professional for medical advice about side effects. You may also report any side effects to your doctor or directly to Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number is 1-800-822-7967 or report online to www.vaers.hhs.gov.

GARDASIL 9 was not studied in women who knew they were pregnant. A pregnancy registry is available. You are encouraged to contact the registry as soon as you become aware of your pregnancy by calling 1-800-986-8999, or ask your health care professional to contact the registry for you.

What is in GARDASIL 9?

GARDASIL 9 contains:

  • Proteins of HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
  • Amorphous aluminum hydroxyphosphate sulfate
  • Yeast protein
  • Sodium chloride
  • L-histidine
  • Polysorbate 80
  • Sodium borate
  • Water

This document is a summary of information about GARDASIL 9.

To learn more about GARDASIL 9, please talk to the health care professional or visit www.GARDASIL9.com.

Manuf. and Dist. by: Merck Sharp & Dohme Corp., a subsidiary of
MERCK & CO., INC., Whitehouse Station, NJ 08889, USA

For patent information: www.merck.com/product/patent/home.html

The trademarks depicted herein are owned by their respective companies.

Copyright © 2006-2016 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. All rights reserved.

Revised: 10/2016

usppi-v503-i-1610r002

Human Papillomavirus 9-valent Vaccine, Recombinant

Label ImageLabel Image
GARDASIL 9 human papillomavirus 9-valent vaccine, recombinant injection, suspension
Product Information
Product Type VACCINE Item Code (Source) NDC:50090-2443(NDC:0006-4119)
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HUMAN PAPILLOMAVIRUS TYPE 6 L1 CAPSID PROTEIN ANTIGEN (HUMAN PAPILLOMAVIRUS TYPE 6 L1 CAPSID PROTEIN ANTIGEN) HUMAN PAPILLOMAVIRUS TYPE 6 L1 CAPSID PROTEIN ANTIGEN 30 ug in 0.5 mL
HUMAN PAPILLOMAVIRUS TYPE 11 L1 CAPSID PROTEIN ANTIGEN (HUMAN PAPILLOMAVIRUS TYPE 11 L1 CAPSID PROTEIN ANTIGEN) HUMAN PAPILLOMAVIRUS TYPE 11 L1 CAPSID PROTEIN ANTIGEN 40 ug in 0.5 mL
HUMAN PAPILLOMAVIRUS TYPE 16 L1 CAPSID PROTEIN ANTIGEN (HUMAN PAPILLOMAVIRUS TYPE 16 L1 CAPSID PROTEIN ANTIGEN) HUMAN PAPILLOMAVIRUS TYPE 16 L1 CAPSID PROTEIN ANTIGEN 60 ug in 0.5 mL
HUMAN PAPILLOMAVIRUS TYPE 18 L1 CAPSID PROTEIN ANTIGEN (HUMAN PAPILLOMAVIRUS TYPE 18 L1 CAPSID PROTEIN ANTIGEN) HUMAN PAPILLOMAVIRUS TYPE 18 L1 CAPSID PROTEIN ANTIGEN 40 ug in 0.5 mL
Human Papillomavirus Type 31 L1 Capsid Protein Antigen (Human Papillomavirus Type 31 L1 Capsid Protein Antigen) Human Papillomavirus Type 31 L1 Capsid Protein Antigen 20 ug in 0.5 mL
Human Papillomavirus Type 33 L1 Capsid Protein Antigen (Human Papillomavirus Type 33 L1 Capsid Protein Antigen) Human Papillomavirus Type 33 L1 Capsid Protein Antigen 20 ug in 0.5 mL
Human Papillomavirus Type 45 L1 Capsid Protein Antigen (Human Papillomavirus Type 45 L1 Capsid Protein Antigen) Human Papillomavirus Type 45 L1 Capsid Protein Antigen 20 ug in 0.5 mL
Human Papillomavirus Type 52 L1 Capsid Protein Antigen (Human Papillomavirus Type 52 L1 Capsid Protein Antigen) Human Papillomavirus Type 52 L1 Capsid Protein Antigen 20 ug in 0.5 mL
Human Papillomavirus Type 58 L1 Capsid Protein Antigen (Human Papillomavirus Type 58 L1 Capsid Protein Antigen) Human Papillomavirus Type 58 L1 Capsid Protein Antigen 20 ug in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE 9.56 mg in 0.5 mL
HISTIDINE 0.78 mg in 0.5 mL
POLYSORBATE 80 50 ug in 0.5 mL
SODIUM BORATE 35 ug in 0.5 mL
WATER
Product Characteristics
Color WHITE (white, cloudy) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50090-2443-0 10 mL in 1 CARTON None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125508 12/10/2014
Labeler — A-S Medication Solutions (830016429)
Establishment
Name Address ID/FEI Operations
A-S Medication Solutions 830016429 RELABEL (50090-2443)

Revised: 02/2018 A-S Medication Solutions

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2019. All Rights Reserved.