Gardasil 9: Side Effects & Dosing

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

HPV 9-valent vaccine, recombinant

Indications/Uses

Prevention of cervical, vulvar, vag & anal cancer, precancerous or dysplastic lesions & genital warts caused by HPV in girls & women 9-45 yr. Prevention of anal cancer, anal precancerous or dysplastic lesions & external genital lesions (ie, genital warts) caused by HPV in boys & men 9-45 yr.

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Dosage/Direction for Use

3-dose schedule: 0.5 mL IM inj at 0, 2 & 6 mth. Alternative schedule: Administer 2nd dose between 5 & 13 mth after 1st dose & administer 3rd dose if 2nd dose is administered earlier than 5 mth after 1st dose.

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Overdosage

View Gardasil 9 overdosage for action to be taken in the event of an overdose.

Contraindications

Hypersensitivity.

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Special Precautions

Anaphylactic reactions. Not to be inj intravascularly, SC or intradermally. Not to be used for treatment of active external genital lesions; cervical, vulvar, vag or anal cancers; CIN, VIN, VaIN or AIN. Not intended for prevention of other established HPV-related lesions progression. Not for protection against diseases not caused by HPV. Syncope, current or recent febrile illness, impaired immune responsiveness, thrombocytopenia or any coagulation disorder. Avoid use during pregnancy. Childn <9 yr. Elderly ≥65 yr.

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Use In Pregnancy & Lactation

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Adverse Reactions

Inj site pain, swelling, erythema, pruritus, bruising; headache, pyrexia, nausea, dizziness; fatigue; syncope w/ tonic-clonic movements sometimes, vomiting, inj site nodule.

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Drug Interactions

Reduced immune responses w/ immunosuppressive therapies ie, irradiation, antimetabolites, alkylating agents, cytotoxic drugs, corticosteroids.

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Storage

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Description

View Gardasil 9 description for details of the chemical structure and excipients (inactive components).

Action

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MIMS Class

Vaccines, Antisera & Immunologicals

ATC Classification

J07BM03 - papillomavirus (human types 6, 11, 16, 18, 31, 33, 45, 52, 58) ; Belongs to the class of papillomavirus vaccines.

Regulatory Classification

Presentation/Packing

Form

Gardasil 9 susp for inj (pre-filled syringe)

Packing/Price

0.5 mL x 1's

Gardasil 9

human papillomavirus 9-valent recombinant vaccine

Manufacturer:

Merck Sharp & Dohme

Distributor:

Zuellig Pharma