9-valent HPV vaccine
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| ID | DRUG-GARDASIL-9 |
|---|---|
| Тип | Препарат |
| Синоніми | 9-валентна вакцина проти ВПЛ9vHPVGardasil 9Gardasil-9HPV9Human papillomavirus (HPV) 9-valent vaccine, recombinantRecombinant 9-valent HPV vaccine |
| Статус | переглянуто 2026-05-18 |
| Хвороби | DIS-CERVICAL |
| Джерела | SRC-ESMO-CERVICAL-2024 SRC-NCCN-CERVICAL-2025 |
Дані про препарат
| Клас | Recombinant subunit vaccine (virus-like particles, L1 protein) — prophylactic against HPV |
|---|---|
| Механізм дії | Recombinant non-infectious nine-valent HPV vaccine. Each dose contains virus-like particles (VLPs) assembled from the L1 major capsid protein of nine HPV types — 6, 11, 16, 18, 31, 33, 45, 52, and 58 — produced in Saccharomyces cerevisiae and adjuvanted with amorphous aluminium hydroxyphosphate sulfate (AAHS). L1 VLPs are immunogenic but contain no viral DNA — cannot cause HPV infection. Vaccination elicits high-titer neutralizing IgG that prevents incident infection by the covered HPV types. Cancer-prevention pathway: prevents persistent infection with the HPV types responsible for ~90% of cervical cancers, ~90% of anal cancers, ~70% of vaginal/vulvar cancers, ~60% of penile cancers, and a growing fraction of oropharyngeal cancers. |
| Типове дозування | Routine schedule (age 9-14 at first dose, immunocompetent): 2-dose schedule — 0 and 6-12 months. Catch-up schedule (age 15-45, or any age if immunocompromised): 3-dose schedule — 0, 2, 6 months (months 0, 2, 6 from first dose). Each dose: 0.5 mL IM in deltoid (preferred) or anterolateral thigh. Do NOT inject IV, SC, or intradermally. Series interruption: resume from where left off — do not restart. Catch-up in adults to age 45 is supported by FDA / NCCN; benefit is highest before HPV exposure but residual benefit exists at any age. Hepatic / renal impairment: no dose adjustment. Pregnancy: avoid initiating series in pregnancy (insufficient data, not a known teratogen); complete after delive... |
| Зареєстровано в Україні | True |
| Відшкодовується НСЗУ | False |
| Остання перевірка для України | 2026-05-18 |
Нотатки
STUB — v0.2 prevention-workstream authoring; pending two-Clinical-Co-Lead signoff per CHARTER §6.1 dev-mode. Gardasil-9 is the only HPV vaccine currently available in most markets (Gardasil-4 and Cervarix-2 are discontinued). Recommended by WHO, ACIP, ESMO, NCCN for routine HPV immunization, ideally before sexual debut (age 9-14, 2 doses). Catch-up through age 45 supported with shared-decision making in adults. Prevents HPV-driven cancers: cervical (Path A v0.2-A scope — primary prevention for the largest infectious-etiology cancer attributable fraction globally), anal, vaginal, vulvar, penile, oropharyngeal, and certain head/neck cancers. Vaccine modality — no standard pharmacology block; immunogenicity data captured in separate `immunogenicity` field (preserved as extra under permissive schema; render layer can ignore or surface). NDC 0006-4119; vaccines are tracked by NDC and CVX codes, not by RxNorm — rxnorm_id intentionally null. Ukraine-specific: Gardasil-9 is NOT on the national vaccination schedule and is NOT reimbursed by NSZU as of 2026-05; available out-of-pocket at private centers (~₴5000-8000/dose × 2-3 doses) — a substantial cost barrier in the Ukrainian context. Fun...
Де використовується
Access Pathways
AP-GARDASIL-9-OUT-OF-POCKET- HPV-9 vaccine (Gardasil-9) — private pay in Ukraine
Contraindications
CI-GARDASIL-9-PREGNANCY- CI-GARDASIL-9-PREGNANCY
Indications
IND-CHRONIC-HPV-PREVENTION-VACCINATION-SCREENING- IND-CHRONIC-HPV-PREVENTION-VACCINATION-SCREENING
Regimens
REG-HPV-GARDASIL-9- HPV nonavalent vaccination (Gardasil-9) — 3-dose series