Posted on October 15th, 2010 by
Class: Biologic agent
Generic Name: Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine Recombinant
Trade Name: Gardasil®
How is this drug used? Gardasil® is FDA approved for the prevention of some diseases or pre-cursors to diseases caused by the human papillomavirus (HPV) types 6, 11, 16, or 18. Gardasil is approved for females ages 9 to 26. It is important for patients to remember that physicians have the ability to prescribe medication for conditions other than those for which the drug has been approved by the FDA. Patients who have received a prescription of this drug for a condition other than which it is approved may wish to discuss this issue with their physician.
What is the mechanism of action? Gardasil stimulates the immune system to produce antibodies against the HPV types 6, 11, 16 and 18, creating immunity to HPV. Gardasil is not intended to treat HPV among patients already infected with the virus.
How is Gardasil given (administered)? Gardasil is administered as an injection into a muscle in three separate doses. Following the initial dose, a second is administered two months later, and a third is administered six months after the first dose.
How are patients monitored? Patients will be monitored approximately 15 minutes following administration of the vaccine to monitor for fainting or muscle spasms while fainting. Patients should continue to undergo regular screening for cervical cancer and other cancers.
What are the common side effects of treatment with Gardasil?
• Pain at injection site
• Headache, fever, nausea (occurrence of less than 2%)
This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.
Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.
Are there any special precautions patients should be aware of before starting treatment?
• Patients should inform their physician if they are pregnant, breastfeeding, or have already been infected with HPV.
• Patients should inform their physician of any other medication they are taking (whether prescription or over-the-counter, including vitamins, herbs, etc.), as they may interfere with treatment.
• Patients should check with their physician before starting any new drug or nutritional supplement.
• Patients should inform their physician of any known drug or food allergies or any reactions to medications they have experienced in the past.
What is a package insert?
A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics, and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.
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