Gardasil

DRUG DESCRIPTION

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 (quadrivalent human papillomavirus types 6, 11, 16, 18 recombinant vaccine) 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 (quadrivalent human papillomavirus types 6, 11, 16, 18 recombinant vaccine) is a white, cloudy liquid.

What are the possible side effects of human papillomavirus vaccine (Gardasil)?

You should not receive a booster vaccine if you have had a life-threatening allergic reaction after the first shot.

Becoming infected with HPV is much more dangerous to your health than receiving the vaccine to protect against it. However, like any medicine, this vaccine can cause side effects but the risk of serious side effects is extremely low.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

You...

Read All Potential Side Effects and See Pictures of Gardasil

What are the precautions when taking quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine (Gardasil)?

Before receiving this medication, tell your doctor or pharmacist if you are allergic to it; or to other vaccines; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before receiving this vaccination, tell your doctor or pharmacist your medical history, especially of: immune system problems (e.g., HIV infection), bleeding disorders (e.g., hemophilia, thrombocytopenia), current fever/illness.

This vaccine can cause fainting in some patients, which could result in falling and injury. To reduce the risk of this side effect, your doctor may recommend that you stay in a sitting or lying position for 15 minutes after the injection. Infrequently, fainting...

Read All Potential Precautions of Gardasil


Gardasil Consumer (continued)

SIDE EFFECTS: Redness, itching, swelling, bruising, and pain at the injection site may occur. Fever may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Fainting has also occurred in some patients after receiving this vaccine. See the Precautions section for more details.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these rare but very serious side effects occur: joint pain/swelling.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US, you may report side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967. In Canada, you may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before receiving this medication, tell your doctor or pharmacist if you are allergic to it; or to other vaccines; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before receiving this vaccination, tell your doctor or pharmacist your medical history, especially of: immune system problems (e.g., HIV infection), bleeding disorders (e.g., hemophilia, thrombocytopenia), current fever/illness.

This vaccine can cause fainting in some patients, which could result in falling and injury. To reduce the risk of this side effect, your doctor may recommend that you stay in a sitting or lying position for 15 minutes after the injection. Infrequently, fainting along with seizure-like movements have occurred, and usually have resolved after placing the patient in a lying position.

This vaccine is not recommended for use during pregnancy. Consult your doctor for more details.

It is not known if this drug passes into breast milk. Consult your doctor before breast-feeding.


Gardasil Patient Information Including Side Effects

Brand Names: Gardasil

Generic Name: human papillomavirus (HPV) vaccine, quadrivalent (Pronunciation: HYOO man pap il OH ma VI rus vax EEN, kwa dri VAY lent)

  • What is human papillomavirus vaccine (Gardasil)?
  • What are the possible side effects of human papillomavirus vaccine (Gardasil)?
  • What is the most important information I should know about human papillomavirus vaccine (Gardasil)?
  • What should I discuss with my health care provider before receiving human papillomavirus vaccine (Gardasil)?
  • How is human papillomavirus vaccine given (Gardasil)?
  • What happens if I miss a dose (Gardasil)?
  • What happens if I overdose (Gardasil)?
  • What should I avoid while receiving human papillomavirus vaccine (Gardasil)?
  • What other drugs will affect human papillomavirus vaccine (Gardasil)?
  • Where can I get more information?

What is human papillomavirus vaccine (Gardasil)?

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 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.

What are the possible side effects of human papillomavirus vaccine (Gardasil)?

You should not receive a booster vaccine if you have had a life-threatening allergic reaction after the first shot.

Becoming infected with HPV is much more dangerous to your health than receiving the vaccine to protect against it. However, like any medicine, this vaccine can cause side effects but the risk of serious side effects is extremely low.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

You may feel faint after receiving this vaccine. Your doctor may want you to remain under observation during the first 15 minutes after the injection.

Other side effects may include:

  • pain, swelling, redness, or itching where the shot was given;
  • mild fever, dizziness, tired feeling;
  • nausea, vomiting, diarrhea;
  • sleep problems (insomnia);
  • runny or stuffy nose, sore throat, cough; or
  • tooth pain, joint or muscle pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.

What is the most important information I should know about human papillomavirus vaccine (Gardasil)?

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.

You should not receive a booster vaccine if you have had a life-threatening allergic reaction after the first shot.

Before receiving HPV quadrivalent vaccine, tell your doctor if you have a high fever or signs of infection, a weak immune system, a bleeding disorder such as hemophilia, or if you are taking a blood thinner such as warfarin (Coumadin).

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.

HPV vaccine should not be used in place of having a routine pelvic exam and Pap smear to screen for cervical cancer.

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.

You may feel faint after receiving this vaccine. Your doctor may want you to remain under observation during the first 15 minutes after the injection.

Becoming infected with HPV is much more dangerous to your health than receiving the vaccine to protect against it. However, like any medicine, this vaccine can cause side effects but the risk of serious side effects is extremely low.

HPV vaccine will not protect against sexually transmitted diseases such as chlamydia, gonorrhea, herpes, HIV, syphilis, and trichomoniasis.

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