Human Papillomavirus 9-valent Vaccine, Recombinant

Human Papillomavirus 9-valent Vaccine, Recombinant is approved for the prevention of certain diseases caused by nine types of Human Papillomavirus (HPV). 

Human Papillomavirus 9-valent Vaccine, Recombinant is a vaccine approved for use in females and males ages 9 through 26. It is approved for the prevention of cervical, vulvar, vaginal and anal cancers caused by 9 types of HPV. 

This vaccine is administered as three separate shots, with the initial dose followed by additional shots given two and six months later. For all of the indications for use approved by the FDA, the vaccine's full potential for benefit is obtained by those who are vaccinated prior to becoming infected with the HPV strains covered by the vaccine.

The most commonly reported adverse reactions were injection site pain, swelling, redness, and headaches. 

Human Papillomavirus 9-valent Vaccine, Recombinant is a vaccine approved for use in females and males ages 9 through 26. It is approved for the prevention of cervical, vulvar, vaginal and anal cancers caused by HPV types 16, 18, 31, 33, 45, 52 and 58, and for the prevention of genital warts caused by HPV types 6 or 11.

This vaccine adds protection against five additional HPV types—31, 33, 45, 52 and 58— which cause approximately 20 percent of cervical cancers and are not covered by previously FDA-approved HPV vaccines.

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

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

In boys 9 through 26 years of age, this vaccine 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.

Human Papillomavirus 9-valent Vaccine, Recombinant may be found in some form under the following brand names:

• Gardasil 9

The most common side effects include:

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

Contact your health care provider right away if you get any symptoms that concern you, even several months after getting the vaccine.

This is not a complete list of side effects. Ask your health care provider for more information.

Tell your doctor about all the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements. Especially tell your doctor if you are taking:

• Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids

This is not a complete list of drug interactions. Ask your doctor or pharmacist for more information. 

This vaccine 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)].
  • Studies have shown that there is more swelling at the injection site when Human Papillomavirus 9-valent Vaccine, Recombinant was given at the same time as Menactra and Adacel

Tell your health care provider if you have:

• 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. 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 receiving this vaccine 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 receiving Human Papillomavirus 9-valent Vaccine, Recombinant.

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

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

It is important to know that Human Papillomavirus 9-valent Vaccine, Recombinant:

• Does not remove the need for cervical cancer screening; women should still get routine cervical cancer screening.
• Does not protect the person 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 from HPV types that he/she may already have.

You should not get this vaccine if you have, or have had:

• an allergic reaction after getting a dose of Human Papillomavirus 9-valent Vaccine, Recombinant
• a severe allergic reaction to yeast, amorphous aluminum hydroxyphosphate sulfate, polysorbate 80.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of this vaccine, there are no specific foods that you must exclude from your diet when receiving this medication. 

Tell your healthcare provider if you: 

• Are allergic to Human Papillomavirus 9-valent Vaccine, Recombinant or to any of its ingredients as well as if you have had an allergic reaction to a previous dose of this vaccine or Gardasil.
• 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).

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications and vaccines based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This vaccine falls into category B. There are no well-done studies that have been done in humans. In animal studies, pregnant animals were given this vaccine, and the babies did not show any medical issues related to this medication. This vaccine should not be given during pregnancy. This vaccine should be given during pregnancy only if clearly needed. 

Tell your doctor is you are breastfeeding or plan to breastfeed. 

It is not known if this vaccine crosses into human milk. Because some vaccines can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this vaccine, a choice should be made whether to stop nursing or stop the use of this vaccine. Your doctor and you will decide if the benefits outweigh the risk of receiving this vaccine.  

• This vaccine is usually injected in the arm muscle.
• You must receive 3 doses.
• Make sure you get all 3 doses on time so that you get the best protection. If you miss a dose, talk to your healthcare provider.

This vaccine is usually given in the arm muscle.

You will need 3 vaccines given on the following schedule:

• Dose 1: at a date you and your health care provider choose.
• Dose 2: after two months
• Dose 3: after four months (6 months after Dose 1)

This vaccine is administered by a healthcare provider in a medical setting. It is unlikely that an overdose will occur in this setting. However, if overdose is suspected, seek emergency medical attention.