Gardasil 9

HPV 9-valent vaccine is given as an injection (shot) into a muscle in your upper arm or thigh. You will receive this injection in a doctor's office or other clinic setting.

HPV 9-valent vaccine is given in a series of 3 shots. You may have the first shot at any time as long as you are between the ages of 9 and 26 years old. Then you will need to receive a second dose 2 months after your first shot, and a third dose 6 months after your first shot.

Be sure you receive all recommended doses of this vaccine. If you do not receive the full series of vaccines, you may not be fully protected against the disease.

HPV 9-valent vaccine should not be used in place of having a routine pelvic exam, Pap smear, or anal exam to screen for cervical or anal cancer.

An overdose of this vaccine is unlikely to occur.

Contact your doctor if you will miss a booster dose or if you get behind schedule. The next dose should be given as soon as possible. There is no need to start over.

Gardasil 9 is approved for the prevention of certain diseases caused by nine types of Human Papillomavirus (HPV). 

Gardasil 9 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. 

Gardasil 9 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, Gardasil 9’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. 

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 Gardasil 9 drug interactions. Ask your doctor or pharmacist for more information. 

Gardasil 9 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 Gardasil 9 was given at the same time as Menactra and Adacel

• Gardasil 9 is a vaccine that is usually injected in the arm muscle.
• You must receive 3 doses of Gardasil 9.
• 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.

Gardasil 9 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. 

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

• Fever

• Anxiety
• back, leg, or stomach pains
• bleeding gums
• chest pain
• chills
• cough
• dark urine
• difficulty with breathing
• difficulty with swallowing
• dizziness or lightheadedness
• fainting
• fast heartbeat
• general body swelling
• headache
• hives or welts, itching, or skin rash
• loss of appetite
• nausea or vomiting
• nosebleeds
• pale skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• redness of the skin
• seizures
• sore throat
• sudden shortness of breath or troubled breathing
• swollen, painful, or tender lymph glands in the neck, armpit, or groin
• tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over affected area
• tightness in the chest
• unusual tiredness or weakness
• yellowing of the eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Headache

• Diarrhea
• difficulty with moving
• joint pain
• muscle aching or cramping
• muscle pains or stiffness
• sore throat
• swollen joints
• upper abdominal or stomach pain

• Body aches or pain
• ear congestion
• loss of voice
• nasal congestion
• runny nose
• sneezing

• Bloating
• constipation
• darkened urine
• difficulty with moving
• fast heartbeat
• indigestion
• loss of appetite
• muscle pain or stiffness
• pain in the joints pain, swelling, or redness at the injection site
• pains in the stomach, side, or abdomen, possibly radiating to the back

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Cervarix(R):
Females, up to 25 years old: 0.5 mL, IM, at 0, 1, and 6 months

Gardasil(R) and Gardasil 9(R):
Females and males, up to 26 years old: 0.5 mL, IM, at 0, 2, and 6 months

Uses: For the prevention of cervical, vulvar, and anal cancer caused by Human Papillomavirus (HPV) in females, and prevention of anal cancer, genital warts, and anal intraepithelial neoplasia cause by HPV in males.

Data not available

Minimum interval between the first and second dose of vaccine is 4 weeks; minimum interval between the second and third dose of vaccine is 12 weeks, minimum interval between first and third dose of the vaccine is 24 weeks.

If the vaccine series is interrupted and only one dose was given, administer the second dose as soon as possible and give the third dose at least 12 weeks later. If the vaccine series is interrupted and the first two doses were given, administer the third dose as soon as possible. Inadequate doses or doses received following a shorter than recommended dosing interval should be repeated. The HPV vaccine series should be completed with the same product whenever possible.

You should not receive a booster vaccine if you have had a life-threatening allergic reaction after the first shot.

To make sure HPV 9-valent vaccine is safe for you, tell your doctor if you have:

• a weak immune system;

• an allergy to yeast; or

• if you are being treated with cancer medicine, steroids, or other drugs that can weaken your immune system.

This vaccine is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of HPV 9-valent vaccine on the baby.

It is not known whether HPV 9-valent vaccine passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

HPV 9-valent vaccine will not protect against sexually transmitted diseases such as chlamydia, gonorrhea, herpes, HIV, syphilis, and trichomoniasis.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.