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GARDASIL® 9 [Human Papillomavirus 9-valent , Recombinant] Consumer Information

What is in this leaflet • genital and the to others without • HPV knowing it. This leaflet answers some In boys and men 9 through 26 What are cervical and common questions about years of age, 9 helps precancerous lesions? GARDASIL 9. It does not contain prevent Cancer of the is a serious all the available information. • and precancerous and sometimes life-threatening It does not take the place of anal lesions . It begins when a female talking to your doctor or catches certain types of HPV. • pharmacist. External genital lesions, These HPV types can cause the including genital warts and All and have cells in the lining of the cervix to • risks and benefits. Your doctor HPV infection change from normal to abnormal has weighed the risks of your GARDASIL 9, helps prevent, but or precancerous lesions. These child or you being given does not treat these . lesions are usually detected GARDASIL 9 against the benefits You cannot get HPV or any of through the cervical screening they expect it will have for your these diseases from program. If these lesions are not child or you. GARDASIL 9. treated, they can turn cancerous. You or your child cannot get What is Human If you have any concerns about without first Papillomavirus? being given this vaccine, ask having a HPV infection. your doctor or pharmacist. HPV is a common virus. Of the What are vulvar and vaginal many different types of HPV, Keep this leaflet. ? some are harmless and others You may need to read it again. can cause diseases of the genital Many vulvar and vaginal cancers areas. While most people clear are caused by HPV. There are no the virus, those who do not can routine screening tests for these cancers. What GARDASIL 9 is develop disease, including cervical cancer, some vaginal, What are anal cancer and used for vulval and anal cancers and precancerous lesions? HPV genital warts. infection is strongly linked to anal GARDASIL 9 is a vaccine that cancer and pre-cancerous anal helps protect against disease Who is at risk for HPV and why lesions. There are no routine caused by the following types of is with GARDASIL screening tests for anal cancer. Human Papillomavirus (HPV): 9 important? 6,11,16,18,31,33,45,52 and 58. Without vaccination, it is What are genital warts? In girls and women 9 through 45 estimated that the majority of Genital warts are caused by years of age, it helps prevent: people who have ever had sex certain types of HPV. They will become infected with HPV commonly appear as skin- • cervical (the lower end of the during their lifetime. A male or coloured, irregular growths. They uterus or womb), vulvar (the female of any age who has taken are found on the inside or outside outside of the female genitals), part in any kind of sexual activity of the genitals in both males and vaginal, and anal cancers that involves genital contact is at females. They can hurt, itch, • abnormal and precancerous risk. bleed, and cause discomfort. (changes in cells which have a Most people who have HPV may Sometimes they can come back risk of turning into cancer) not show any signs or symptoms. after treatment. cervical, vaginal, vulvar and This means that they can pass on anal lesions

Copyright © 2019 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ, USA. All Rights Reserved 1 GARDASIL 9 only protects vaccinated against cervical • had an allergic reaction to a against diseases caused by the cancer and other cancers previous of GARDASIL nine types covered by the (vaginal, vulvar, anal) and or GARDASIL 9 vaccine. GARDASIL 9 works best diseases caused by HPV may be • has a bleeding disorder and when given before you or your very serious. cannot receive injections in the child has become infected with As with any vaccine, GARDASIL arm HPV, but may also be of benefit if 9 may not fully protect everyone • has any illness with a fever you or your child have had a who gets the vaccine. Continue to higher than 37.8°C. Your previous infection. Talk with your follow your doctor or pharmacist’s doctor or pharmacist for more doctor may decide to delay instructions on regular cervical vaccination until the illness information. cancer screening tests. has passed. A mild illness, The GARDASIL 9 vaccine: such as a cold, is not usually a • does not remove the need for reason to delay vaccination. cervical cancer screening; • women should still get routine Before GARDASIL 9 is has a weakened immune cervical cancer screening system, for example due to a given genetic defect or Human • does not protect against Virus (HIV) disease that is caused by When you or your child infection other types of HPV, other must not be given • or take medicines that affect the GARDASIL 9 • does not protect you or your Do not have or let your child • child from HPV types that you takes or plans to take any have GARDASIL 9 if you or may already have (but most medicines, including over the your child have had an people do not have all types counter medicines. to: contained in the vaccine). • is pregnant or is planning to • a previous dose of GARDASIL get pregnant. or GARDASIL 9 How it works Your doctor or pharmacist will • GARDASIL 9 works by causing any of the ingredients in the help decide if you or your child the body to produce its own vaccine listed at the end of this should get the vaccine. leaflet protection against HPV types 6, It is not known whether the 11, 16, 18, 31, 33, 45, 52 and 58 vaccine is harmful to an unborn that cause disease. It does this by Symptoms of allergic reaction baby when administered to a making substances called include swelling of the face, lips, pregnant woman. If you are in the which fight tongue, throat, or other parts of pregnant, you should be HPV. If a vaccinated person the body, shortness of breath, vaccinated with GARDASIL 9 only comes into contact with HPV, the wheezing or difficulty in breathing, if your doctor or health care body is usually ready to destroy it. skin , itching or . professional decides it is clearly needed. It usually takes several weeks Do not use GARDASIL 9 after after vaccination to develop the expiry date printed on the protection against HPV. pack. Women who become pregnant

Protection requires completion of Do not use GARDASIL 9 if the before completion of the vaccine the vaccine series. packaging is torn or shows series should complete their Most people will produce enough signs of tampering. after antibodies against HPV. childbirth. However, as with all vaccines, If you are not sure whether you GARDASIL 9 may be given to 100% protection cannot be or your child should be given women who are breast –feeding guaranteed. GARDASIL 9, talk to your or intend to breast-feed. doctor or pharmacist. The vaccine will not give you or GARDASIL 9 has not been your child HPV or any of the Before you or your child is studied in the elderly. disease listed above. given GARDASIL 9: The chance of a severe reaction Taking other medicines Tell your doctor or health care from GARDASIL 9 is very small, Tell your doctor if you or your provider if you or your child: but the risks from not being child is taking any other

Copyright © 2019 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ, USA. All Rights Reserved 2 medicines, including any that How GARDASIL 9 is This allows you or your child to you buy without a prescription given get the full benefits of GARDASIL from your pharmacy, 9. supermarket or health food GARDASIL 9 is given as an shop. into the muscle in your If you or your child misses a arm or leg. dose Use with other vaccines If you miss a scheduled dose, talk Tell your doctor if you have had How much is given to your doctor or health care any vaccines in the last four Each dose of GARDASIL 9 is provider. See your doctor or Your doctor will advise weeks. 0.5mL. health care provider who will you if GARDASIL 9 is to be given decide when to give the missed with another vaccine. Your doctor When it is given dose. and pharmacist may have more It is important that you follow the You or your child will receive information on medicines and instructions of your doctor or vaccines to be careful with or three doses of the vaccine. health care provider regarding avoid during vaccination with Ideally the doses are given as: return visits for the follow-up GARDASIL 9. • Dose 1: at a date you and your doses. GARDASIL 9 can be given at the doctor or health care provider same time as GARDASIL 9 can choose be given at the same time as: • Dose 2: 2 months after the first • Menactra [Meningococcal dose (not earlier than one After you or your child (Groups A, C, Y and W-135) month after the first dose) has been given Vaccine] • Dose 3: 6 months after the first GARDASIL 9 • Adacel [, Diptheria dose (not earlier than 3 and Acellular Pertussis months after the second dose) Things you must do Vaccine] All three doses should be given Keep follow-up appointments • Repevax [Diptheria, Tetanus, within a 1-year period. Talk to with your doctor or clinic. Pertussis (acellular your doctor for more information. Keep a record of the component) and Poliomyelitis and update this (inactivated) Vaccine]1 after each injection. Alternatively, individuals 9 through 14 years of age may Should I receive GARDASIL receive 2 doses of the vaccine. 9 if I have already received GARDASIL? Side Effects • Dose 1: at a date you and If you have already received your doctor or health care Tell your doctor or pharmacist GARDASIL, talk to your doctor or professional choose as soon as possible if you or pharmacist to see if GARDASIL 9 your child do not feel well is right for you. • Dose 2: given between 5 and 13 months after first dose. during or after having had an GARDASIL 9 contains the same injection of GARDASIL 9. four HPV types (6, 11, 16, 18) If the second vaccine dose is GARDASIL 9 may have unwanted that are in GARDASIL and five given earlier than 5 months after side effects in a few people. All additional HPV types (31, 33, 45, the first dose, a third dose should medicines including vaccines can 52, 58). always be given. have side effects. Sometimes

they are serious, most of the time It is recommended that individuals they are not. You or your child who receive a first dose of may need medical treatment if GARDASIL 9 complete the they get some of the side effects. vaccination course with Ask your doctor or pharmacist GARDASIL 9. to answer any questions you may have. Make sure that you or your child 1 Not currently registered in New gets the complete vaccine series. Zealand

Copyright © 2019 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ, USA. All Rights Reserved 3 Tell your doctor if you or your • muscle weakness, abnormal breathing, or swelling of other child have any of the following sensations, tingling in the parts of the body and they worry you: arms, legs and upper body These are very serious side • pain, swelling, redness, itching (Guillain-Barre syndrome) effects. You or your child may and bruising at or around the • confusion need urgent medical attention or injection site • pain or painful, swollen hospitalisation. • headache joint All of these side effects are rare. • fever or high temperature • aching muscles (may appear Other side effects not listed • nausea as muscle weakness or above may also occur in some weakness that is not caused people. Tell your doctor if you • dizziness by exercise) notice anything that is making • fatigue • unusual tiredness, weakness you or your child unwell. Studies show that there was more • chills Do not be alarmed by this list of swelling where the shot was given possible side effects. You or your • when GARDASIL 9 was given at generally feeling unwell child may not experience any of the same time with other vaccines If any of the above symptoms them. such as Repevax or Menactra worsen or you or your child Your doctor or pharmacist has a and/or Adacel. has any unusual or severe more complete list of side effects These are the most common side symptoms after receiving for GARDASIL 9. effects seen with GARDASIL 9. GARDASIL 9, contact your These side effects are usually doctor or healthcare provider. mild and usually improve or Fainting disappear within a few days. Storage As with other vaccines, additional Fainting can happen after getting side effects that have been a vaccine. Sometimes people GARDASIL 9 is usually stored in reported during general use for who faint can fall and hurt the doctor's surgery or clinic, or at GARDASIL 9 are shown below. themselves. For this reason, you the pharmacy. However if you Side effects reported during the or your child may be asked to sit need to store GARDASIL 9: general use of GARDASIL are or lie down for 15 minutes after • Keep it where children also shown below. GARDASIL getting GARDASIL 9. Some cannot reach it. side effects are reported as they people who faint might shake or • Keep it in the fridge where may be relevant to GARDASIL 9 become stiff and may need to be the temperature is 2°C to since the vaccines are similar in treated by the doctor. 8°C. composition. • Do not freeze the vaccine. GARDASIL 9 Allergic Reaction: Freezing destroys the vaccine. • fainting sometimes As with all vaccines given by • Protect the injection from accompanied with seizure-like injection, there is a very small risk light by keeping it in the movements of a serious allergic reaction. original pack until it is time • vomiting Tell your doctor immediately or for it to be given. Additionally, the following side go to Accident and Emergency GARDASIL should be effects have been seen with the at your nearest hospital if you administered as soon as possible general use of GARDASIL. notice any of the following: after being removed from GARDASIL • wheezing, shortness of breath refrigeration. • skin infection (may appear as or difficulty breathing hot, tender and red skin) • pinkish, itchy swellings on the • bleeding or bruising more skin, also called hives or nettlerash Product description easily than normal (may appear as purple or red spots • skin rash, itchiness What it looks like visible through the skin • swelling of the face, lips, • swollen glands in the neck, tongue which may cause GARDASIL 9 is a cloudy white armpit or groin difficulty in swallowing or liquid in a glass syringe or vial.

Copyright © 2019 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ, USA. All Rights Reserved 4 Ingredients The active ingredients of GARDASIL 9 are highly purified inactive from HPV Types 6, 11, 16, 18, 31, 33, 45, 52 and 58. Inactive ingredients: • (as amorphous aluminium hydroxyphosphate sulfate adjuvant) • • L- • Polysorbate 80 • Sodium borate • Residual traces of • Water

Sponsor Merck Sharp & Dohme (NZ) Limited 123 Carlton Gore Road Newmarket Auckland Tel: 0800 500 673

Supplier Seqirus (NZ) Ltd PO Box 62 590 Greenlane AUCKLAND 1546

This leaflet was prepared in March 2020.

CCPPI-V503-I-082019

Copyright © 2019 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ, USA. All Rights Reserved 5