Papillomavirus (Types 16, 18) Vaccine (Human, Recombinant)

• If you have an allergy to papillomavirus (types 16, 18) vaccine (human, recombinant) or any part of this medicine.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take papillomavirus vaccine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• If you have a latex allergy, talk with your doctor.
• This medicine may not protect all people who use it. Talk with the doctor.
• Women taking papillomavirus vaccine need to be sure to have regular gynecology check-ups. Your doctor will tell you how often to have these. Talk with your doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• Cervarix [DSC]

Contains inactive human papillomavirus (HPV) proteins HPV 16 L1, and HPV 18 L1 which produce neutralizing antibodies to prevent cervical cancer, cervical adenocarcinoma, and cervical neoplasia cause by HPV.

Efficacy: Moderate- to high-grade cervical intraepithelial neoplasia (CIN 2/3) and adenocarcinoma in situ (AIS) are the immediate and necessary precursors of squamous cell carcinoma and adenocarcinoma of the cervix, respectively. Vaccination with 2vHPV reduced the incidence of CIN 2/3 and AIS by 87% to 98% in several randomized clinical trials. (CDC/ACIP [Markowitz, 2014]).

Not well defined; >8 to 10 years (CDC/ACIP [Markowitz, 2014])

There are no dosage adjustments provided in the manufacturer's labeling.

Adverse events were not observed in animal reproduction studies. In clinical trials, pregnancy testing was conducted prior to each vaccine administration and vaccination was discontinued if the woman was found to be pregnant; women were also instructed to avoid pregnancy for 2 months after receiving the vaccine. Pregnancies with vaccination within 1 month of their last menstrual period (LMP) had a higher rate of spontaneous abortions. The association between vaccination and spontaneous abortion occurring between gestation weeks 1 to 19 was evaluated in a postmarketing study. Women who were vaccinated within 1 month of their LMP were compared to women vaccinated 18 months prior to and 120 days after their LMP. The rate of spontaneous abortion was not statistically significant (HR 1.26, 95% CI 0.77 to 2.09). Based on available registry data, the rate of major birth defects is within the reported background rates (CDC/ACIP [Markowitz 2014]).

Administration of the vaccine in pregnancy is not recommended; until additional information is available, the vaccine series (or completion of the series) should be delayed until pregnancy is completed. Pregnancy testing is not required prior to administration of the vaccine (CDC/ACIP [Petrosky 2015]).

• Discuss specific use of vaccine and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience loss of strength and energy, headache, muscle pain, joint pain, nausea, vomiting, diarrhea, abdominal pain, or injection site pain or irritation. Have patient report immediately to prescriber severe dizziness, passing out, difficulty with motor activity, seizures, or enlarged lymph nodes (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.