Vaccine, human Papillomavirus 9-valent: Indication, Dosage, Side Effect, Precaution

Generic Medicine Info Patient Medicine Information

This information is not country-specific. Please refer to the Malaysia prescribing information.

Generic Medicine Info

Indications and Dosage

Intramuscular
Human papillomavirus infection, prevention

Adult: 3 doses of 0.5 mL each given at 0, 2, and 6 months in the deltoid region of the upper arm or in higher anterolateral area of thigh. All doses should be given within a 1-year period.
Child: 9-14 years 2 doses of 0.5 mL each given at 0, and 6-12 months in the deltoid region of the upper arm or in higher anterolateral area of thigh. Administer 3rd dose, if 2nd dose is given at <5 months after the 1st dose. ≥15 years Same as adult dose.

Contraindications

Hypersensitivity.

Special Precautions

Patient with coagulation disorders (including thrombocytopenia), impaired immune responsiveness. Postpone vaccination in patients with severe acute febrile illness. Children. Pregnancy and lactation. Not indicated for the treatment of active HPV infection, cervical cancer, high-grade cervical, vulvar, and vaginal dysplastic lesions or genital warts. Not a substitute for routine cervical or anal cancer screening.

Adverse Reactions

Significant: Inj site reactions (e.g. pain, redness, bruising, swelling); fever, syncope, headache.
Gastrointestinal disorders: Nausea.
General disorders and administration site conditions: Fatigue.
Musculoskeletal and connective tissue disorders: Myalgia.
Nervous system disorders: Dizziness.
Skin and subcutaneous tissue disorders: Pruritus.
Potentially Fatal: Hypersensitivity reactions (e.g. anaphylaxis).

Pregnancy Category (US FDA)

Parenteral: B

Patient Counseling Information

This drug may cause dizziness, if affected, do not drive or operate machinery.

Monitoring Parameters

Monitor for hypersensitivity reactions 15 minutes after admin. Perform gynaecological exam, papillomavirus test, and cervical or anal cancer screening post-vaccination.

Drug Interactions

Increased risk of bleeding with anticoagulants. Decreased immune response with immunosuppressive therapies (e.g. high dose corticosteroids).

Action

Description:
Mechanism of Action: Human Papillomavirus (HPV) 9-valent vaccine is a non-infectious adjuvanted vaccine produced by recombinant technology. It contains inactive virus-like particles (VLP) of the major capsid L1 protein from the same 4 HPV types (6, 11, 16 and 18) found in quadrivalent vaccine and 5 additional types (31, 33, 45, 52, 58) thereby facilitating the production of neutralizing antibodies and development of humoral immune response to prevent premalignant anogenital lesions and cancers, and genital warts caused by HPV.

Storage

Store between 2-8°C. Do not freeze. Protect from light. Stable for 72 hours below 25°C.
Any unused portions or waste material should be disposed of in accordance with local requirements.

MIMS Class

Vaccines, Antisera & Immunologicals

ATC Classification

J07BM - Papillomavirus vaccines ; Used for active immunizations.

References

Anon. Human Papillomavirus Vaccine. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 03/07/2018.

Anon. Papillomavirus (9-Valent) Vaccine (Human, Recombinant). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 03/07/2018.

Buckingham R (ed). Human Papillomavirus Vaccines. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 03/07/2018.

Gardasil 9 (A-S Medication Solutions). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 03/07/2018.

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