GARDASIL 9 VACCINE PRE-FILLED SYRINGE  (0.5 ML)

Generic Name: human papillomavirus 9-valent vaccine
Brand Name: Gardasil 9
Drug class: Viral vaccines

WHAT IS THE DOSAGE OF THIS MEDICATION?

Each pre-filled syringe of Gardasil 9 contains approximately 20 µg of HPV 6 L1 protein, 40 µg of HPV 11 L1 protein, 40 µg of HPV 16 L1 protein, and 20 µg of HPV 18 L1 protein.

WHAT IS THIS MEDICATION USED FOR?

Gardasil 9 is a HPV (human papillomavirus) vaccine used to protect young children, and adults from illness caused by infection with certain strains of the human papillomavirus. Infected with the human papillomavirus can lead certain types of cancers for men including: penile, anal, tonsils, base of tongue, anogenital warts, and back of throat. For women, this includes: cervical, vaginal, vulvar, anal, cancers of tonsils, base of tongue, back of throat, and anogenital warts. Gardasil 9 protects an individual against 9-types of HPV (6, 11, 16, 18, 31, 33, 45, 52, 58).

This vaccine is also used to prevent certain diseases caused by infection with HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 for boys and men aged 9 to 45 years of age. It is used to prevent genital warts caused by HPV types 6 and 11. It is also used to protect against anal cancer caused by HPV types 16, 18, 31, 33, 45, 52 and 58, as well as certain abnormal growths in the anus 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).

Gardasil 9 is given as three injections over a six month period. The second injection is two months after the first, and the third injection is six months after the first.

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.

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.

WHO SHOULD NOT TAKE THIS MEDICATION

Do not use medication if you:

• are allergic to the HPV vaccine or to any of the ingredients of the medication.
  

POTENTIAL INTERACTION WITH OTHER 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.

Inform your doctor about all prescription, over-the-counter (non-prescription), and herbal medications that 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.

The following medications could potentially interact with this medication:

• acetaminophen

• immunosuppressive therapy medications that weaken the immune system (e.g., certain cancer medications, transplant medications, medications for rheumatoid arthritis, multiple sclerosis, corticosteroids)

• certain other vaccines

WHAT ARE THE SIDE EFFECTS OF 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.

Inform your doctor about all prescription, over-the-counter (non-prescription), and herbal medications that 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.

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.

This is not a complete list of possible side effects. If you notice other effects not listed, please contact your doctor or pharmacist.

Possible side effects include:

• Injection site reactions (such as redness, itching, swelling, bruising, pain)

• muscle/joint aches

• fever

• drowsiness

• tiredness

• headache

• restless sleep

• vomiting

• skin rash

• irritability

• loss of appetite

• nausea

• diarrhea

• fatigue

• hives

• rash

• skin infection

• swollen glands

• 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)

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