Gardasil Injection

GARDASIL 9 is a vaccine (injection/shot) that helps protect against some diseases caused by some types of Human Papillomavirus (HPV). GARDASIL 9 contains the same 4 HPV types (6, 11, 16, 18) as in GARDASIL with 5 additional HPV types (31, 33, 45, 52, 58). In girls and women 9 years of age onward, GARDASIL 9 helps protect against:

• Cervical (the lower end of the uterus or womb), vulvar (the outside of the female genitals), vaginal and anal cancer.
• Pre-cancerous (changes in cells which have a risk of turning into cancer) cervical, vulvar (the outside of the female genitals), vaginal and anal lesions.
• Genital warts.
• HPV persistent infection.

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

• Anal cancer
• Pre-cancerous anal lesions
• Genital warts
• HPV persistent infection.

These diseases have many causes. Most of the time, these diseases are caused by 9 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. You or your child cannot get HPV or any of the above diseases from GARDASIL 9. GARDASIL 9 helps prevent, but does not treat these diseases.

Who should receive GARDASIL 9?

Persons from 9 years of age onward can receive GARDASIL 9. GARDASIL 9 works best when given before you or your child (the person getting GARDASIL 9) has any contact with HPV. The person getting GARDASIL 9 can still receive benefit if not previously or currently infected with all the HPV types covered by the vaccine. Therefore, you should talk with your doctor or healthcare professional to find out if GARDASIL 9 is right for you or your child.

Who should not receive GARDASIL 9?

Anyone who:

• is allergic to any of the ingredients in the vaccine (including any of the ingredients listed under inactive ingredients).
• has an allergic reaction after receiving a previous dose of GARDASIL 9.
• has an allergic reaction after receiving a previous dose of GARDASIL.

What should I tell my doctor or healthcare provider before I or my child is vaccinated with GARDASIL 9?

Your doctor or healthcare provider will decide if you or your child should receive GARDASIL 9.

Warnings and precautions

You should tell your doctor or healthcare provider if you or your child:

• has had an allergic reaction to GARDASIL or GARDASIL 9.
• has a bleeding disorder and cannot receive injections in the arm.
• has any illness with a fever higher than 37,8 °C.
• is pregnant or is planning to get pregnant.
• takes or plans to take any medicines, including over-the-counter medicines.
• has a weakened immune system e.g. due to Human Immunodeficiency Virus (HIV) infection or a genetic defect, or if you take medicines that affect your immune system.

GARDASIL 9 is given as an injection usually in the arm muscle. GARDASIL 9 should be administered as soon as possible after being removed from refrigeration. You or your child will receive 3 doses of the vaccine. Ideally the doses are given as:

• First dose: at a date you and your doctor or healthcare provider choose.
• Second dose: 2 months after the first dose.
• Third dose: 6 months after the first dose.

The second dose should be administered at least one month after the first dose and the third dose should be administered at least 3 months after the second dose. All 3 doses should be given within a 1-year period. Please speak to your doctor for more information. It is recommended that individuals who receive a first dose of GARDASIL 9 complete the vaccination course with GARDASIL 9. Make sure that you or your child gets all doses. This allows you or your child to get the full benefits of GARDASIL 9. If you or your child misses a dose, your doctor or healthcare provider will decide when to give the missed dose. What should I do if my child or I miss a dose? Your doctor or healthcare provider will decide when to give the missed dose. It is important that you follow the instructions of your doctor or healthcare provider regarding return visits for the follow-up doses.

GARDASIL 9 can have side effects. Any medicine may have unintended or undesirable effects, so - called side effects. The most frequent side effects seen with GARDASIL 9 are:

• pain, swelling, redness, itching and bruising, where you got the shot
• headache
• fever
• nausea
• dizziness
• fatigue.

Studies show that there was more swelling where the shot was given when GARDASIL 9 was given at the same time as Repevax or Menactra and/or Adacel. Tell the doctor or healthcare professional if you have any of these problems because these may be signs of an allergic reaction:

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

As with other vaccines, additional side effects that have been reported during general use for GARDASIL 9 are shown below. Side effects reported during the general use of GARDASIL are also shown below. GARDASIL 9:

• fainting sometimes accompanied with seizure-like movements
• vomiting
• lump where you got the shot.

Additionally, the following side effects have been seen with the general use of GARDASIL. GARDASIL:

• skin infection
• bleeding or bruising more easily than normal
• swollen glands (neck, armpit or groin)
• Guillain-Barré syndrome (muscle weakness, abnormal sensations, tingling in the arms, legs and upper body)
• confusion
• joint pain
• aching muscles
• unusual tiredness, weakness
• chills
• generally feeling unwell.

Fainting can happen after getting a HPV vaccine. Sometimes people who faint can fall and hurt themselves. For this reason, your doctor or healthcare 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 doctor or healthcare professional may need to treat the person getting GARDASIL 9. Other side effects may also occur rarely, and as with any vaccine, some side effects may be serious. If you or your child has any unusual or severe symptoms after receiving GARDASIL 9, contact your doctor or healthcare provider right away. Your doctor or healthcare provider has a more complete list of side effects for GARDASIL 9. Not all side effects reported for GARDASIL 9 are included in this leaflet. Should your general health worsen or if you experience any untoward effects while using GARDASIL 9, please consult your doctor, pharmacist or other healthcare professional for advice.

Store all medicines out of reach of children. Store refrigerated at 2 to 8 °C. Protect from light. Do not remove from carton until required for use. GARDASIL 9 remains stable for up to 72 hours at 25 °C. DO NOT FREEZE. DISCARD IF THE VACCINE HAS BEEN FROZEN. Do not use GARDASIL 9 after the month and year following EXP.: on the container. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets). Discard the empty vial or syringe in approved biological waste containers according to local regulations.