Gardasil

Tell your doctor about all the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements. Especially tell your doctor if you are taking:

• Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids 

This is not a complete list of Gardasil drug interactions. Ask your doctor or pharmacist for more information. 

Gardasil can be given at the same time as:

• Recombivax HB 1 [hepatitis B vaccine (recombinant)]
• Menactra [Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine]
• Adacel [Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap)]

• Gardasil is a shot that is usually given in the arm muscle.
• Make sure that you get all 3 doses on time so that you get the best protection. If you miss a dose, talk to your health care provider.

Human papillomavirus (HPV) can cause genital warts, cancer of the cervix, and various cancers of the vulva or vagina.

The quadrivalent (kwa-dri-VAY-lent) form of HPV vaccine (Gardasil) is used in both females and males. Another form of HPV vaccine (Cervarix) is used only in females. This medication guide provides information only for Gardasil.

HPV quadrivalent vaccine (Gardasil) is used to prevent genital warts and cervical/vaginal/anal cancers caused by certain types of HPV (types 6, 11, 16, and 18) in girls and young women ages 9 through 26.

HPV quadrivalent vaccine is also used to prevent genital warts caused by HPV types 6 and 11 in boys and young men ages 9 through 26.

The Centers for Disease Control and Prevention (CDC) recommends HPV vaccine for all girls ages 11 or 12 years old. The vaccine is also recommended in girls and women ages 13 through 26 years old who have not already received the vaccine or have not completed all booster shots.

You may receive this vaccine even if you have already had genital warts, or had a positive HPV test or abnormal pap smear in the past. However, this vaccine will not treat active genital warts or HPV-related cancers, and it will not cure HPV infection.

HPV vaccine may also be used for other purposes not listed in this medication guide.

Your doctor or pharmacist can provide more information about this vaccine. Additional information is available from your local health department or the Centers for Disease Control and Prevention.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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• If you have an allergy to this medicine or any part of Gardasil.
• 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 this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• If you need to store this medicine at home, talk with your doctor, nurse, or pharmacist about how to store it.

Hypersensitivity, including severe allergic reactions to yeast (a vaccine component), or after a previous dose of Gardasil. [See Description (11).]

There have been reports of administration of higher than recommended doses of Gardasil.

In general, the adverse event profile reported with overdose was comparable to recommended single doses of Gardasil.

Gardasil, Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant, is a non-infectious recombinant quadrivalent vaccine prepared from the purified virus-like particles (VLPs) of the major capsid (L1) protein of HPV Types 6, 11, 16, and 18. The L1 proteins are produced by separate fermentations in recombinant Saccharomyces cerevisiae and self-assembled into VLPs. The fermentation process involves growth of S. cerevisiae on chemically-defined fermentation media which include vitamins, amino acids, mineral salts, and carbohydrates. The VLPs are released from the yeast cells by cell disruption and purified by a series of chemical and physical methods. The purified VLPs are adsorbed on preformed aluminum-containing adjuvant (Amorphous Aluminum Hydroxyphosphate Sulfate). The quadrivalent HPV VLP vaccine is a sterile liquid suspension that is prepared by combining the adsorbed VLPs of each HPV type and additional amounts of the aluminum-containing adjuvant and the final purification buffer.

Gardasil is a sterile suspension for intramuscular administration. Each 0.5-mL dose contains approximately 20 mcg of HPV 6 L1 protein, 40 mcg of HPV 11 L1 protein, 40 mcg of HPV 16 L1 protein, and 20 mcg of HPV 18 L1 protein.

Each 0.5-mL dose of the vaccine contains approximately 225 mcg of aluminum (as Amorphous Aluminum Hydroxyphosphate Sulfate adjuvant), 9.56 mg of sodium chloride, 0.78 mg of L-histidine, 50 mcg of polysorbate 80, 35 mcg of sodium borate, <7 mcg yeast protein/dose, and water for injection. The product does not contain a preservative or antibiotics.

After thorough agitation, Gardasil is a white, cloudy liquid.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Gardasil has not been evaluated for the potential to cause carcinogenicity or genotoxicity.

Gardasil administered to female rats at a dose of 120 mcg total protein, which is equivalent to the recommended human dose, had no effects on mating performance, fertility, or embryonic/fetal survival.

The effect of Gardasil on male fertility has been studied in male rats at an intramuscular dose of 0.5 mL/rat/occasion (120 mcg total protein which is equivalent to the recommended human dose). One group of male rats was administered Gardasil once, 3 days prior to cohabitation, and a second group of male rats was administered Gardasil three times, at 6 weeks, 3 weeks, and 3 days prior to cohabitation. There were no treatment-related effects on reproductive performance including fertility, sperm count, and sperm motility. There were no treatment-related gross or histomorphologic and weight changes on the testes.