Papillomavirus (9-Valent) Vaccine (Human, Recombinant)

• If you have an allergy to papillomavirus (9-valent) vaccine (human, recombinant) or any part of this medicine.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take papillomavirus vaccine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Very bad dizziness or passing out.
• Trouble controlling body movements.
• Seizures.
• Joint pain.
• Swollen gland.
• Feeling very tired or weak.
• Feeling confused.
• Chills.
• Leg pain.
• Shortness of breath.
• Chest pain.
• Muscle pain or weakness.
• Very bad belly pain.
• Any unexplained bruising or bleeding.
• Signs of skin infection like oozing, heat, swelling, redness, or pain.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Dizziness.
• Headache.
• Mild fever.
• Upset stomach.
• Loose stools (diarrhea).
• Sore throat.
• Belly pain.
• Feeling tired or weak.
• Pain where the shot was given.
• Redness or swelling where the shot is given.
• Irritation where the shot is given.
• Small bump where the shot is given.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• 9-Valent HPV
• 9vHPV
• HPV Vaccine (9-valent)
• HPV9
• Human Papillomavirus Vaccine (9-valent)

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Suspension, Intramuscular [preservative free]:

Gardasil 9: (0.5 mL) [contains polysorbate 80, yeast extract]

Suspension Prefilled Syringe, Intramuscular [preservative free]:

Gardasil 9: (0.5 mL) [contains polysorbate 80, yeast extract]

• Gardasil 9

Immunization:

Manufacturer’s labeling:

Children ≥9 years and Adolescents <15 years:

2-dose series: IM: 0.5 mL at 0, and 6 to 12 months. If the second dose is inadvertently administered earlier than 5 months after the first dose, then patient should be converted to a 3-dose series.

3-dose series: IM: 0.5 mL at 0, 2, and 6 months

Adolescents ≥15 years: 3-dose series: IM: 0.5 mL at 0, 2, and 6 months

CDC/ACIP recommended immunization schedule: Routine vaccination at 11 to 12 years of age; may start as early as 9 years of age. In a 2-dose schedule, minimum interval between first and second doses is 5 months. In a 3-dose schedule, minimum interval between first and second doses is 4 weeks; the minimum interval between the second and third dose is 12 weeks; the minimum interval between first and third doses is 5 months. (CDC/ACIP [Meites 2016]).

Non-immunocompromised patients and certain medical conditions: Asplenia, asthma, chronic granulomatous disease, chronic liver disease, chronic lung disease, chronic renal disease, CNS anatomic barrier defects (eg, cochlear implant), complement deficiency, diabetes, heart disease, or sickle cell disease:

Children ≥9 years and Adolescents <15 years: 2-dose series: IM: 0.5 mL at 0, and 6 to 12 months. Administer first dose at age 11 to 12 years. For patients with any history of sexual abuse or assault, vaccination should be started at 9 years.

Adolescents ≥15 years: 3-dose series: IM: 0.5 mL at 0, 1 to 2, and 6 months

Immunocompromised patients: Children ≥9 years and Adolescents: 3-dose series: IM: 0.5 mL at 0, 1 to 2, and 6 months. Note: Includes immunocompromising conditions that might reduce cell-mediated or humoral immunity (eg, lymphocyte antibody deficiencies, T lymphocyte complete or partial defects, HIV infection, malignant neoplasms, transplantation, autoimmune disease, immunosuppressive therapy).

Shake suspension well before use. Do not use if discolored or if contains particulate matter, or if syringe is cracked. Inject the entire dose IM into the deltoid region of the upper arm or higher anterolateral thigh area. Do not mix with other vaccines or injections; separate needles and syringes should be used for each injection (ACIP [Kroger 2017]). To prevent syncope related injuries, adolescents and adults should be vaccinated while seated or lying down (ACIP [Kroger 2017]). US law requires that the date of administration, the vaccine manufacturer, lot number of vaccine, and the administering person's name, title, and address be entered into the patient's permanent medical record.

For patients at risk of hemorrhage following intramuscular injection, the vaccine should be administered intramuscularly if, in the opinion of the physician familiar with the patient's bleeding risk, the vaccine can be administered by this route with reasonable safety. If the patient receives antihemophilia or other similar therapy, intramuscular vaccination can be scheduled shortly after such therapy is administered. A fine needle (23 gauge or smaller) can be used for the vaccination and firm pressure applied to the site (without rubbing) for at least 2 minutes. The patient should be instructed concerning the risk of hematoma from the injection. Patients on anticoagulant therapy should be considered to have the same bleeding risks and treated as those with clotting factor disorders (ACIP [Kroger 2017]).