Gardasil 9

Brand Name

Gardasil 9

Common Name

human papillomavirus 9-valent vaccine

In this drug factsheet:

• How does this medication work? What will it do for me?
• How should I use this medication?
• What form(s) does this medication come in?
• Who should NOT take this medication?
• What side effects are possible with this medication?
• Are there any other precautions or warnings for this medication?
• What other drugs could interact with this medication?

How does this medication work? What will it do for me?

This medication belongs to the family of medications known as vaccines. It is used to prevent certain diseases caused by infection with human papillomavirus (HPV; types 6, 11, 16, 18, 31, 33, 45, 52, and 58) for individuals 9 to 45 years of age. These diseases include genital warts, cervical cancer, vaginal, vulvar, and anal cancers, and certain abnormal growths in the vagina, vulva, and cervix that may lead to cancer.

The HPV vaccine works by helping the immune system prevent HPV infection.

HPV infections are sexually transmitted. The HPV vaccine does not help prevent other types of sexually transmitted infections (STIs).

Human papillomavirus 9-valent vaccine has also been granted a notice of compliance with conditions (NOC/c) by Health Canada. This means that Health Canada has approved this medication to be marketed based on promising evidence of effectiveness, but additional results of studies are needed to verify its effectiveness. An NOC/c is used to allow access to products that are used to treat or prevent serious, life-threatening, or severely debilitating illness.

The notice of compliance with conditions applies to the use of the vaccine to prevent cancer in the mouth and throat, as well as other head and neck cancers, caused by HPV types 16, 18, 31, 33, 45, 52, and 58.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are receiving this medication, speak to your doctor. Do not stop using this medication without consulting your doctor.

How should I use this medication?

This medication is given as 3 separate 0.5 mL injections into the upper arm or thigh muscle. The second dose is given 2 months after the first dose, and the third dose is given 6 months after the first dose. The injections are given by a health care professional in a clinic or similar setting.

Children and adolescents between the ages of 9 and 14 may be given the vaccine as a 2-dose series. In this case, the second dose is given between 5 and 13 months after the first dose.

It is important to use this medication exactly as recommended by your doctor. If you miss an appointment to receive a dose, contact your doctor as soon as possible to reschedule your appointment.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are using the medication without consulting your doctor.

Store this medication in the refrigerator and do not allow it to freeze. Protect it from light and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

What form(s) does this medication come in?

Each 0.5 mL dose of sterile suspension contains 30 μg of HPV 6 L1 protein, 40 μg of HPV 11 L1 protein, 60 μg of HPV 16 L1 protein, 40 μg of HPV 18 L1 protein, 20 μg of HPV 31 L1 protein, 20 μg of HPV 33 L1 protein, 20 μg of HPV 45 L1 protein, 20 μg of HPV 52 L1 protein, and 20 μg of HPV 58 L1 protein. Nonmedicinal ingredients: aluminum (as amorphous aluminum hydroxyphosphate sulfate adjuvant), L-histidine, polysorbate 80, sodium borate, sodium chloride, and water for injection.

Who should NOT take this medication?

HPV vaccine should not be used by anyone who is allergic to the HPV vaccine or to any of the ingredients of the medication.

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• a general feeling of discomfort or illness
• abdominal pain
• diarrhea
• dizziness
• fever
• fainting
• headache
• muscle aches
• nausea and vomiting
• pain, swelling, itching, or redness at the place of injection
• sore throat
• swollen glands
• tiredness
• vomiting
• weakness

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• bruising or bleeding more easily
• chills
• confusion
• hives
• joint pain
• muscle weakness
• rash
• skin infection
• swollen glands

Stop taking the medication and seek immediate medical attention if any of the following occur:

• seizures
• signs of a severe allergic reaction such as itching, rash, hives, swelling of the face or lips, chest tightness, shortness of breath, or wheezing
• symptoms of Guillain-Barre syndrome (e.g., abnormal sensations; muscle weakness; tingling in the arms, legs, or upper body)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Adults older than 45 years: The safety and efficacy of this medication have not been established for adults over 45 years of age.

Bleeding disorders: If you have any bleeding problems (such as hemophilia) or are taking blood thinners such as warfarin, tell your doctor before receiving this medication.

Fever: A doctor may decide to delay this vaccine if the person receiving the vaccine has an acute infection or fever.

Health exams: You will still need to have regular health exams after having the vaccine, including Pap tests, HPV DNA tests, or other tests as recommended by your doctor.

Human papillomavirus vaccine is not intended to be used as a treatment for the cancers that it may help to prevent.

Immune system: People with weakened immune systems (e.g., those who have cancer or HIV, or taking immunosuppressive therapy) may not get the full benefits of the vaccine.

Vaccine protection: This vaccine protects only against certain types of HPV and, as with other vaccines, may not provide 100% protection for everyone who receives the vaccine. The HPV vaccine should not be used for treatment of active genital warts or cancers. It does not prevent any other STIs, such as chlamydia, gonorrhea, or HIV. Condoms should still be used to prevent STIs even after you have received the vaccine.

Pregnancy: This medication is not recommended during pregnancy.

Breast-feeding: It is not known if the HPV vaccine passes into breast milk. However, this vaccine may be given to those who are breast-feeding or are planning to breast-feed.

Children: The safety and effectiveness of this medication have not been established for children less than 9 years of age.

What other drugs could interact with this medication?

There may be an interaction between human papillomavirus vaccine and any of the following:

• acetaminophen
• acetylsalicylic acid (ASA)
• immunosuppressive therapy medications that weaken the immune system (e.g., certain cancer medications, transplant medications, medications for rheumatoid arthritis, multiple sclerosis, corticosteroids)
• non-steroidal anti-inflammatory drugs (NSAIDs; celecoxib, diclofenac, ibuprofen, ketorolac)
• certain other vaccines

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2024. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Gardasil-9