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3. Have you ever wondered & ask your self if there is a certain vaccine capable of protecting against cancer?!

4. Presented by: Amal AlZahrani Pharma. D Candidate

5. Out lines I. Human papilloma virus II. gardasil ® & its preparation III. Indications & Recommendation IV. Side effects & precautions V. Roles of pharmacists in Gardasil ® delivery VI. Gardasil ’ s acceptance by the community VII. Conclusion

6. Human papilloma viruses HPV: Are a group of more than 120 different strains. Are a group of more than 120 different strains. Approximately 40 types of these viruses pass from one person to another through sexual contact. Approximately 40 types of these viruses pass from one person to another through sexual contact. Genital (HPV) infection is the most common sexually transmitted infection. Genital (HPV) infection is the most common sexually transmitted infection.

7. … cont ’ d … cont ’ d Most of genital HPV infections cause no symptoms. Most of genital HPV infections cause no symptoms. However, some of genital HPV may persist inside the body & lead to genital warts or cervical cancer. However, some of genital HPV may persist inside the body & lead to genital warts or cervical cancer. HPV has also been implicated in other cancers such as oral, laryngeal and skin cancer. HPV has also been implicated in other cancers such as oral, laryngeal and skin cancer.

8. … cont ’ d

9. Who can get genital HPV?  Anyone is susceptible to HPV. What makes a person more likely to get genital HPV?  Having multiple sex partnersor  Having a sex partner who has had many partners

10. Incidence of HPV Parkin, D. M. (2006) "The global health burden of infection-associated cancers in the year 2002." Int J Cancer 118(12): 3030-44. PMID 16404738PMID 16404738

11. … cont ’ d Source: Globocan 2002

12. … cont ’ d EEEEach year over 470.000 women around the world have contracted cervical cancer due to this virus.  G G G Genital HPV is more common among the women with low socioeconomic status & in developing countries.

13. What is Gardasil ® ? It is a new vaccine that has been licensed to be safely used on June 8, 2006, by FDA Gardasil®, manufactured by Merck Company, is the first vaccine targeted specifically to prevent cervical cancer.

14. … cont ’ d  This vaccine protect against infection from four genotypes of (HPV).  HPV-16 & HPV-18, account for about 70% of cervical cancers  HPV- 6 & HPV-11, account for about 90% of genital warts.  Gardasil ® covers the most offending & common strains of HPV that cause cervical cancer.

15. … cont ’ d  Gardasil ® may not effective when used in females older than 26 years old.  Males may benefit from this vaccine in prevention genital warts but gardasil is still not approved for males.  Gardasil® was 100% effective.  Gardasil® safe and caused no serious side effects.

16. Gardasil® opens a new era in cancer prevention, it is a major health break through & is approved to prevent not only cervical cancer but also genital warts.

17. Preparation of Gardasil ® : Preparation of Gardasil ® :  GARDASIL® is a recombinant, quadrivalent vaccine prepared by genetic engineering from the highly purified virus- like particles (VLPs) of the major capsid (L1) protein of HPV Types 6, 11, 16, and 18.

18. Genome structure of HPV:

19. L1 of HPV 6,11,16&18 Expressed in Yeast Self assembled as VLPs

20. Important of Gardasil ® : Important of Gardasil ® : To reduce cervical cancer deaths around the world To reduce cervical cancer deaths around the world HPV is a silent infectious disease HPV is a silent infectious disease Cervical screening test like Pap test & HPV DNA tests cannot tell us the specific type of HPV. Cervical screening test like Pap test & HPV DNA tests cannot tell us the specific type of HPV.

21. INDICATIONS & USES: Gardasil ® is a prophylactic vaccine indicated for females to prevent the following diseases caused by HPV types 6, 11, 16 & 18: cervical cancer cervical cancer genital warts genital warts

22. Dose Regimen:  First dose: at selected date.  Second dose: 2 months after the first dose.  Third dose: 6 months after the first dose

23. Method of administration: Gardasil ® is administered intramuscularly I.M.:  Deltoid region of the upper arm.  Higher anterolateral area of the thigh.

24. Recommendation: According to The Advisory committee on Immunization Practices ACIPs: Gardasil Gardasil should be routinely given to girls when they are 11 or 12 12 years old. The The advisory committee, noted that the vaccination series can be started as early as nine years years old at the discretion of the physician or health care provider.

25. … cont ’ d The The recommendation also includes girls and women 13-26 13-26 years old. The The vaccine should be administered before any sexual contact. (i.e., before women are exposed to the viruses)

26. Why is Gardasil ® recommended to be given in early age?

27. This is because:  Vaccination early in life appears to make good biological sense.  Theoretically, girls in early age have not any sexual contact so, the vaccine will be effective.

28. woman has been vaccinated she still needs cervical cancer screening

29. … cont ’ d 1) There 1) There are more than 15 15 different types of HPV are associated with development of 30 %of cervical cancer and 10 %of genital warts. 2) Gardasil® 2) Gardasil® does not protect against all types types of cervical cancer.

30. Side effects: Pain, swelling, redness or itching at the site of infection Nausea, vomiting, diarrhea, Dizziness Runny or stuffy nose, sore throat, cough Muscle pain.

31. … cont ’ d Hives Hives Difficulty breathing Difficulty breathing Swelling of the face, lip, tong or throat Swelling of the face, lip, tong or throat Sever stomach pain Sever stomach pain Pain, swelling, or stiffness in joints Pain, swelling, or stiffness in joints

32. Precautions: Who should avoid Gardasil? Pregnant women or women planning to get pregnant People with history of immediate hypersensitivity to yeast or to any vaccine component. People with any illness with a fever more than 37ċ People with bleeding or blood clotting disorder or if they are taking warfarin People that have a weakened immune system due to a genetic defect or HIV infections.

33. Drug interaction:  Cancer treatments  Steroid medicine, including inhaled steroids must be avoided because they may reduce the immune response to the vaccine.  All the prescription and over-the-counter medications can affect Gardasil.

34. … cont ’ d But there are a few exceptions: Use Use of hormonal contraceptives. GARDASIL® GARDASIL® may be administered concomitantly at separate injection sites with hepatitis B vaccine.

35. Roles of pharmacist in Gardasil ® delivery

36.  The pharmacists should ask the person for history of immediate hypersensitivity to yeast or to any vaccine component.  The pharmacists should notify vaccinated women that they should do not using any medication without telling their doctor & they should continue to receive regular cervical cancer screening.

37. Future plane of HPV vaccine:

38. … cont ’ d  CERVARIX ® from GlaxoSmithkline company, CERVARIX ® targets only two HPV strains, HPV-16 & HPV-18.  There are clinical trials going on evaluating & developing Gardasil ™ to be used effectively and safely in males & women older than 26 years of age.

39. Gardasil’s acceptance by the community: 1111st: Encouraging Promiscuity 2222nd: Parents’ Acceptance 3333rd: Gsrdasil’s cost

40. To solve these problems: I- The fedral & state have discussing subsidization of Gardasil's high price & adding Gardasil to Vaccines for Children contract.

41. II- Responsibility of Medical community gardasil does not protect from all STDs, it simply provides protection against certain types of HPV that cause cervical cancer. Gardasil considered as a childhood vaccine. Gardasil aims to eradicate HPV type 6, 11, 16 & 18.

42. Conclusion

43. As a pharmacist We should update our knowledge

44. Thank you