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Gardasil 9
Generic Name: Human Papillomavirus Vaccine
Drug Category: Vaccine
Litigation Alert Level: High
This drug has been approved for use by males and females over the age of 9 years old and under the age of 45 years old for a maximum duration of 6 months.
| Approved Uses |
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GARDASIL 9 is a vaccine indicated for: Girls and Women (9 through 45 years of age): The prevention of the following diseases: • Cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by Human Papillomavirus (HPV) types 16, 18, 31, 33, 45, 52, and 58 • Genital warts (condyloma acuminata) caused by HPV types 6 and 11 • And the following precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52,
Boys and Men (9 through 45 years of age): The prevention of the following diseases: • Anal, oropharyngeal and other head and neck cancers caused by HPV types 16, 18, 31, 33, 45, 52, and 58 • Genital warts (condyloma acuminata) caused by HPV types 6 and 11 • And the following precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, The oropharyngeal and head and neck cancer indication is approved under accelerated approval based on effectiveness in preventing HPV-related anogenital disease. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. GARDASIL 9 has not been demonstrated to provide protection against disease caused by:
GARDASIL 9 is not a treatment for external genital lesions; cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers; CIN; VIN; VaIN; or AIN. Not all vulvar, vaginal, anal, oropharyngeal and other head and neck cancers are caused by HPV, and GARDASIL 9 protects only against those vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by HPV 16, 18, 31, 33, 45, 52, and 58. GARDASIL 9 does not protect against genital diseases not caused by HPV. Vaccination with GARDASIL 9 may not result in protection in all vaccine recipients. Safety and effectiveness of GARDASIL 9 have not been assessed in individuals older than 45 years of age or in children below the age of 9 years. Hypersensitivity, including severe allergic reactions to yeast (a vaccine component), or after a previous dose of GARDASIL 9 or GARDASIL. Because vaccines may develop syncope, sometimes resulting in falling with injury, observation for 15 minutes after administration is recommended. Syncope, sometimes associated with tonic-clonic movements and other seizure-like activity, has been reported following HPV vaccination. The vaccine-related serious adverse reactions were pyrexia, allergy to vaccine, asthmatic crisis, and headache. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune responses to vaccines. There are no adequate and well-controlled studies of GARDASIL 9 in pregnant women. Available data are not sufficient to assess the effects of GARDASIL 9 on the breastfed infant or on milk production/excretion. |
| Off-label Uses |
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• Use in patients under 9 years of age. GoToSource • Use in patients over 45 years of age. GoToSource • Cutaneous warts. GoToSource • Recurrent respiratory papillomatosis. GoToSource |
| Adverse Events |
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Systemic lupus erythematosus. GoToSource Premature ovarian failure. GoToSource Study finding that clinical trials data have not demonstrated, to date, that the vaccines have actually prevented cervical cancer and/or cervical cancer death. GoToSource Generalized urticaria (hives), eyelid angioedema, rhino-conjunctivitis and dyspnoea (shortness of breath). GoToSource Erythema nodosum (skin inflammation). GoToSource Facial paralysis. GoToSource Guillain-barré syndrome (autoimmune disorder). GoToSource Venous thromboembolic events, autoimmune disorders, anaphylaxis (life-threatening allergic reaction), death, transverse myelitis (inflammation of the spinal cord), pancreatitis and syncope (loss of consciousness). GoToSource Paraesthesia (abnormal skin sensations) and chronic fatigue syndrome. GoToSource Involutional lipoatrophy (loss of subcutaneous fat). GoToSource Postural orthostatic tachycardia syndrome. GoToSource |
| Litigation |
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Claims filed for death, blood clots, anaphylactic shock, pulmonary embolism, guillain-barré syndrome, miscarriage and paralysis. |
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