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Gardasil 9 Generic Name & Formulations
Legal Class
Rx
General Description
9-valent human papillomavirus (HPV) types 6, 11, 16, 18, 31, 33, 45, 52, and 58 vaccine; recombinant; aluminum adsorbed, susp for IM inj; preservative-free.
Pharmacological Class
HPV.
How Supplied
Single-dose vials—10; Prefilled syringes (w. tip caps)—10
Manufacturer
Generic Availability
NO
Gardasil 9 Indications
Indications
In females 9–45yrs old, to prevent cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by HPV types 16, 18, 31, 33, 45, 52, and 58; genital warts caused by HPV types 6 and 11; cervical intraepithelial neoplasia (CIN) grades 2 and 3 and cervical adenocarcinoma in situ (AIS), cervical intraepithelial neoplasia (CIN) grade 1, vulvar intraepithelial neoplasia (VIN) grades 2 and 3, vaginal intraepithelial neoplasia (VaIN) grades 2 and 3, and anal intraepithelial neoplasia (AIN) grades 1, 2, and 3 caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58. In males 9–45yrs old, to prevent anal, oropharyngeal and other head and neck cancers caused by HPV types 16, 18, 31, 33, 45, 52, and 58; genital warts caused by HPV types 6 and 11; and anal intraepithelial neoplasia (AIN) grades 1, 2, and 3 caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58.
Limitations of Use
Vaccination does not eliminate the necessity to undergo screening for cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers as recommended. Not for protection against disease from HPV types through exposure to sexual activity or diseases due to HPV types other than 6, 11, 16, 18, 31, 33, 45, 52, and 58. Not for treating external genital lesions; cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers; CIN; VIN; VaIN; or AIN. May not protect all vaccine recipients.
Gardasil 9 Dosage and Administration
Adults and Children
Give by IM inj in deltoid or upper thigh. Each dose is 0.5mL. <9yrs: not established. 9–14yrs: 2-dose regimen: give 1st dose at elected date, 2nd dose 6–12mos after the 1st dose (if the 2nd dose is given earlier than 5mos after the 1st dose, administer a 3rd dose at least 4mos after the 2nd dose). Or, 9–45yrs: 3-dose regimen: give 1st dose at elected date, 2nd dose 2mos after the 1st dose, and 3rd dose 6mos after the 1st dose. Monitor patients for 15mins after administration.
Gardasil 9 Contraindications
Contraindications
Yeast allergy.
Gardasil 9 Boxed Warnings
Not Applicable
Gardasil 9 Warnings/Precautions
Warnings/Precautions
Immunocompromised. Have treatment available to manage anaphylactic reactions. Pregnancy. Nursing mothers.
Gardasil 9 Pharmacokinetics
See Literature
Gardasil 9 Interactions
Interactions
Immunosuppressants: may get suboptimal response.
Gardasil 9 Adverse Reactions
Adverse Reactions
Inj site reactions (eg, swelling, erythema, pain), headache; post-administration syncope (may be associated with tonic-clonic movements and other seizure-like activity).
Gardasil 9 Clinical Trials
See Literature
Gardasil 9 Note
Notes
Register pregnant patients exposed to Gardasil 9 by calling (800) 986-8999.
Gardasil 9 Patient Counseling
See Literature
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