Human papillomavirus vaccine, bivalent (Intramuscular route)
HUE-man pap-ah-LOH-mah-VYE-rus ree-KOM-bi-nant VAX-een bye-VAY-lent (types 16, 18)
Uses of This Medicine:
Human papillomavirus (HPV) recombinant bivalent vaccine is an active immunizing agent (vaccine) that is used to prevent infection caused by human papillomavirus (types 16 and 18). It works by causing your body to produce its own protection (antibodies) against the virus.
HPV infection is usually a sexually transmitted disease (STD) and is easily spread by having sex with an infected person. This vaccine helps prevent cervical cancer and abnormal or precancerous diseases of the cervix in girls and women 9 to 25 years of age. This vaccine will not treat these diseases or protect you against diseases that are caused by other HPV types. The vaccine will also not protect you against other sexually transmitted diseases that are not caused by HPV.
This vaccine is available only with your doctor's prescription.
Before Using This Medicine:
In deciding to use a vaccine, the risks of taking the vaccine must be weighed against the good it will do. This is a decision you and your doctor will make. For this vaccine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of human papillomavirus bivalent vaccine in children younger than 9 years of age. Safety and efficacy have not been established.
Appropriate studies on the relationship of age to the effects of human papillomavirus bivalent vaccine have not been performed in the geriatric population. Safety and efficacy have not been established.
|All Trimesters||B||Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other medical problems
The presence of other medical problems may affect the use of this vaccine. Make sure you tell your doctor if you have any other medical problems, especially:
- Immune deficiency condition, or family history of This condition may increase the chance and severity of side effects with the vaccine and/or may decrease the useful effects of the vaccine.
- Severe illness with fever The symptoms of this condition may be confused with the possible side effects of the vaccine.
Proper Use of This Medicine:
A nurse or other trained health professional will give you or your child this vaccine. It is given as a shot in the muscle of your upper arm.
To get the best possible protection against infection with the HPV virus, you should complete the vaccine dosing schedule, even if you are not directly exposed to HPV.
This vaccine is usually given as three shots. You will need another dose at 1 month and 6 months after the first dose, unless your doctor tells you otherwise.
This medicine comes with a patient information insert. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.
This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.
Precautions While Using This Medicine:
It is very important that you or your child return to your doctor's office at the right time for all of the doses. Be sure to notify your doctor of any side effects that occur after you or your child receive this vaccine.
This vaccine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you or your child have a rash, itching, swelling of the tongue and throat, or trouble with breathing after you get the injection.
It is important to tell your doctor if you become pregnant. Your doctor may want you to join a pregnancy registry for patients receiving this vaccine.
This vaccine does not replace your routine cervical cancer screening (pap test). You will need to see your doctor for screening tests even after receiving this vaccine.
You or your child may feel faint, lightheaded, or dizzy right after you receive this vaccine. Sitting or lying down for 15 minutes after you receive the vaccine may also help. If any of these side effects occur, do not drive, use machines, or do anything else that could be dangerous if you are not alert. If this problem continues or gets worse, check with your doctor.
The needle cover of the prefilled syringe contains dry natural rubber (a derivative of latex), which may cause allergic reactions in people who are sensitive to latex. Tell your doctor if you or your child have a latex allergy before you receive this vaccine.
Side Effects of This Medicine:
- More common
- Less common
- Bladder pain
- bloody or cloudy urine
- body aches or pain
- change in the color, amount, or odor of vaginal discharge
- difficult, burning, or painful urination
- difficulty with breathing
- ear congestion
- frequent urge to urinate
- general feeling of discomfort or illness
- joint pain
- loss of appetite
- loss of voice
- lower back or side pain
- muscle aches and pains
- nasal congestion
- runny nose
- sore throat
- trouble with sleeping
- unusual tiredness or weakness
- Incidence not known
- Blistering, peeling, or loosening of the skin
- difficulty with swallowing
- fast heartbeat
- joint or muscle pain
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- red, irritated eyes
- shortness of breath
- skin rash
- sores, ulcers, or white spots in the mouth or on the lips
- tightness in the chest
- More common
- Abdominal or stomach cramps, discomfort, or pain
- back pain
- difficulty with moving
- hives or welts
- red streaks on the skin
- redness of the skin
- swelling, tenderness, or pain at the injection site
- swollen joints
- swollen mouth and tongue
- unpleasant taste
- urge to have bowel movement
- Less common
- heavy bleeding
- stuffy or runny nose
- tender, swollen glands in the neck
- trouble with swallowing
- voice changes
- Changes in menstrual periods
- decreased sexual ability in males
- depressed mood
- dry skin and hair
- dry, puffy skin
- feeling cold
- hair loss
- rectal bleeding
- red, scaling, or crusted skin
- sensitivity to heat
- severe abdominal or stomach pain
- severe diarrhea
- slowed heartbeat
- swelling of the front part of the neck
- weight gain
- weight loss
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Last Updated: 12/4/2015