the immune responses to vaccines.temsirolimusSerious - Use Alternative (1)temsirolimus decreases effects of human papillomavirus vaccine, nonavalent by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune responses to vaccines.teplizumabSerious - Use Alternative (1)teplizumab decreases effects of human papillomavirus vaccine, nonavalent by Other (see comment). Avoid or Use Alternate Drug. Comment: Administer all age-appropriate vaccinations before starting teplizumab. Inactivated or mRNA vaccines are not recommended within 2 weeks before teplizumab treatment, during treatment, or 6 weeks after completion of treatment.tocilizumabSerious - Use Alternative (1)tocilizumab decreases effects of human papillomavirus vaccine, nonavalent by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune responses to vaccines.tralokinumabMonitor Closely (1)tralokinumab will decrease the level or effect of human papillomavirus vaccine, nonavalent by immunosuppressive effects; risk of infection. Use Caution/Monitor. Limited data are available regarding coadministration with non-live vaccines.triamcinolone acetonide injectable suspensionSerious - Use Alternative (1)triamcinolone acetonide injectable suspension decreases effects of human papillomavirus vaccine, nonavalent by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune responses to vaccines.ublituximabMonitor Closely (1)ublituximab decreases effects of human papillomavirus vaccine, nonavalent by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Administer all immunizations according to immunization guidelines at least 4 weeks before initiating ublituximab for live or live-attenuated vaccines and, whenever possible, at least 2 weeks before initiating for non-live vaccines. Vaccination with live virus vaccines is not recommended during treatment and until B-cell repletion. Do not administer live or live-attenuated vaccines to infants of mothers exposed to ublituximab during pregnancy, before confirming recovery of B-cell counts as measured by CD19+ B cells.ustekinumabMonitor Closely (1)ustekinumab decreases effects of human papillomavirus vaccine, nonavalent by pharmacodynamic antagonism. Use Caution/Monitor. Inactivated vaccinations administered during ustekinumab treatment may not elicit an immune response sufficient to prevent disease.voclosporinMonitor Closely (1)voclosporin decreases effects of human papillomavirus vaccine, nonavalent by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Inactivated vaccines noted to be safe for administration may not be sufficiently immunogenic during treatment. >10% Females aged 16-26 yr Injection site pain (89.9%) Injection site swelling (40%) Injection site erythema (34%) Headache (14.6%) Females aged 9-15 yr Injection site pain (89.3%) Injection site swelling (47.8%) Injection site erythema (34.1%) Headache (11.4%) Males aged 9-26 yr Injection site pain (71.5%) Injection site swelling (26.9%) Injection site erythema (24.9%) Oral temperature ≥100.0°F (10.4%) 1-10% Females aged 16-26 yr Pyrexia (5%) Females aged 9-15 yr Pyrexia (5%) Maled aged 9-26 yr Headache (9.4%) Pyrexia (8.9%) Contraindications Hypersensitivity, including severe allergic reactions to yeast (a vaccine component), or after a previous Gardasil dose Cautions Individuals who develop symptoms indicative of hypersensitivity after first dose should not receive additional doses Monitor for 15 min following vaccination for syncope/convulsive syncope and allergic reactions; when syncope is associated with tonic-clonic movements, activity is usually transient and typically responds to restoring cerebral perfusion by maintaining a supine or Trendelenburg position Not shown to be protective against nonvaccine HPV types Decision to defer administration in patients with febrile illness depends on etiology of the disease and severity of symptoms; do not delay administration in acute illness with or without fever; defer administration in moderate to severe acute illness Bleeding hematoma may occur from IM administration; use caution in patients with history of bleeding disorders, including thrombocytopenia; IM injection may be scheduled shortly after antihemophilia or similar therapy is administered Does not protect against disease not caused by HPV types not included in the vaccine; not for the treatment of active disease; cervical or anal cancer screening is still required following vaccine administration Pregnancy Pregnancy exposure registry: 1-800-986-8999 A five-year pregnancy registry enrolled 2942 women who were inadvertently exposed to HPV vaccine within 1 month before the last menstrual period (LMP) or at any time during pregnancy, 2566 of whom were prospectively followed After excluding elective terminations (n=107), ectopic pregnancies (n=5), and those lost to follow-up (n=814), there were 1,640 pregnancies with known outcomes Rates of miscarriage and major birth defects were 6.8% of pregnancies (111/1640) and 2.4% of live born infants (37/1527), respectively These rates of assessed outcomes in the prospective population were consistent with estimated background rates ACIP recommendations Pregnancy through age 26 years: HPV vaccination not recommended until after pregnancy No intervention needed if vaccinated while pregnant; pregnancy testing not needed before vaccination Lactation Data are not sufficient to assess effects on breastfed infants or on milk production/excretionPregnancy Categories A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk. B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available. Mechanism of Action Induces humoral immune response Recombinant vaccine that targets 9 HPV subtypes: 6, 11, 16, 18, 31, 33, 45, 52, and 58 Pharmacokinetics The peak anti-HPV GMTs occurred at Month 7 in clinical trials; proportions of individuals who remained seropositive to each vaccine HPV type at Month 24 were similar to the corresponding seropositive proportions at Month 7 IM Preparation Shake well before use Thoroughly agitate immediately before administration is necessary to maintain suspension of the vaccine Do not diluted or mix with other vaccine After thorough agitation, appears as a white, cloudy liquid Inspect visually for particulate matter and discoloration prior to administration, whenever solution and container permit Do not use the product if particulates are present or if it appears discolored IM Administration Administer IM in the deltoid region of the upper arm or in the higher anterolateral area of the thigh Observe patients for 15 minutes after administration Storage Store refrigerated at 2-8°C (36-46°F) Do not freeze Protect from light Administer as soon as possible after being removed from refrigeration Can be administered provided total (cumulative multiple excursion) time out of refrigeration (at temperatures between 8-25°C) does not exceed 72 hr Cumulative multiple excursions between 0-2°C are also permitted as long as the total time between 0°C and 2°C does not exceed 72 hr BRAND FORM. UNIT PRICE PILL IMAGE Gardasil 9 (PF) intramuscular- 0.5 mL solutionGardasil 9 (PF) intramuscular- 0.5 mL vialCopyright © 2010 First DataBank, Inc.Print Patient Educationhuman papillomavirus vaccine,9-valent (PF) intramuscular HUMAN PAPILLOMAVIRUS VACCINE - INJECTION COMMON BRAND NAME(S): Gardasil, Gardasil 9 USES: This medication is a vaccine used to prevent cancer of the anus, abnormal tissue growth of the anus, genital warts, or certain head and neck cancers. In girls and women, it is also used to prevent cancer of the cervix/vagina/vulva and abnormal tissue growth in these areas that can lead to cancer. These conditions are commonly caused by certain types of human papillomavirus (HPV). Vaccines work by increasing the body's natural defense (immunity) against the virus.This vaccine does not protect against all types of HPV, only the types in the vaccine. It is used to prevent the diseases and will not treat active anal/cervical/head/neck/vaginal/vulvar cancer, genital warts, or other diseases caused by the types of HPV in the vaccine. HOW TO USE: Read all vaccine information available from your health care professional before receiving the vaccine. If you have any questions, ask your health care professional.This vaccine is given by injection into the muscle of the thigh or upper arm by a health care professional.This vaccine is usually given as 3 separate doses. The second dose should be given 2 months after the first dose, and the third dose should be given 6 months after the first dose. For children younger than 15 years, this vaccine may also be given as 2 separate doses with the second dose given 6 to 12 months after the first dose. The vaccination schedule should be followed closely for the vaccine to be most effective. SIDE EFFECTS: Redness, itching, swelling, bruising, and pain at the injection site may occur. Fever and headache may also occur. If any of these effects last or get worse, tell your health care professional promptly.Rarely, some people have symptoms such as fainting, dizziness, vision changes, or ringing in the ears just after getting a vaccine injection. Seizure-like movements may also rarely happen after injection with this vaccine. Tell your health care professional right away if you have any of these symptoms. Sitting or lying down may help, since these symptoms usually don't last long.Remember that this medication has been prescribed because your health care professional has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your health care professional.Contact the health care professional for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967. In Canada, you may call the Vaccine Safety Section at Public Health Agency of Canada at 1-866-844-0018. PRECAUTIONS: Before receiving this vaccine, tell the health care professional if you are allergic to it; or to yeast; or to other vaccines; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your health care professional for more details.Before receiving this vaccination, tell your health care professional your medical history, especially of: immune system disorders (such as due to HIV infection, certain cancers such as leukemia/lymphoma, cancer or radiation treatment), current fever/illness.This vaccine is not recommended for use during pregnancy. Consult your health care professional for more details.It is unknown if this vaccine passes into breast milk. Consult your health care professional before breast-feeding. DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your health care professional. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this vaccine include: drugs that weaken the immune system (including cyclosporine, tacrolimus, cancer chemotherapy, corticosteroids such as prednisone).This vaccine can be given at the same time as other vaccines, using separate injection sites and separate syringes. OVERDOSE: Not applicable. NOTES: As with any vaccine, this vaccine may not fully protect everyone who receives it.Getting this vaccine does not replace cervical cancer screening. Continue to have regular obstetrician/gynecologist checkups. MISSED DOSE: If you miss a dose in the vaccination schedule, contact your health care professional right away. STORAGE: Store in the refrigerator. Do not freeze. Protect from light. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company. Information last revised January 2022. Copyright(c) 2023 First Databank, Inc. IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs. FormularyPatient DiscountsAdding plans allows you to compare formulary status to other drugs in the same class.To view formulary information