Cervarix, vaccine

Generic Name: human papillomavirus (HPV) vaccine, bivalent (HYOO man pap il OH ma VI
rus vax EEN, bye VAY lent)
Brand Names: Cervarix

What is Cervarix?
Cervarix vaccine is used to prevent cervical cancer caused by human papillomavirus (HPV)
types 16 and 18 in girls and young women ages 10 through 25. Human papillomavirus can
cause genital warts, cancer of the cervix, and various cancers of the vulva or vagina.
Cervarix vaccine is used only in females. Another form of HPV vaccine (Gardasil) is used in
both females and males. This medication guide provides information only for Cervarix.
Cervarix vaccine may also be used for other purposes not listed in this medication guide.

Important information
The bivalent form of HPV vaccine (Cervarix) is used only in females. Another form of HPV
vaccine (Gardasil) is used in both females and males. This medication guide provides
information only for Cervarix.
You should not receive a booster vaccine if you have had a life-threatening allergic reaction
after the first shot.
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Before receiving Cervarix, tell your doctor if you have a weak immune system, or if you are
allergic to latex rubber.

Cervarix should not be used in place of having a routine pelvic exam and Pap smear to screen
for cervical cancer. You may feel faint after receiving this vaccine. Some people have had
seizure-like reactions after receiving this vaccine. Your doctor may want you to remain under
observation during the first 15 minutes after the injection.
Developing cancer from HPV is much more dangerous to your health than receiving the
vaccine to protect against it. However, like any medicine, Cervarix can cause side effects but
the risk of serious side effects is extremely low.
Cervarix will not protect against sexually transmitted diseases such as chlamydia, gonorrhea,
herpes, HIV, syphilis, and trichomoniasis.

Before receiving Cervarix

To make sure you can safely receive Cervarix, tell your doctor if you have any of these other
conditions:

a weak immune system; or

if you are allergic to latex rubber.

FDA pregnancy category B. Cervarix is not expected to be harmful to an unborn baby.

However, you should not receive Cervarix without telling your doctor if you are pregnant or
plan to become pregnant before you have received all doses of this vaccine. It is not known
whether HPV vaccine passes into breast milk or if it could harm a nursing baby. Do not receive
Cervarix vaccine without telling your doctor if you are breast-feeding a baby.
See also: Pregnancy and breastfeeding warnings (in more detail)
Cervarix will not protect against sexually transmitted diseases such as chlamydia, gonorrhea,
herpes, HIV, syphilis, and trichomoniasis.
Cervarix will not prevent diseases caused by HPV types other than types 16 and 18. There are
over 100 different types of HPV.

How is Cervarix given?

Cervarix is given as an injection (shot) into a muscle in your upper arm. You will receive this
injection in a doctor's office or other clinic setting.
Cervarix is given in a series of 3 shots. You may have the first shot at any time as long as you
are between the ages of 10 and 25 years old. Then you will need to receive a second dose 1
month after your first shot, and a third dose 6 months after your first shot.

Be sure to receive all doses of the Cervarix vaccine recommended by your healthcare
provider or your state's health department. You may not be fully protected if you do not
receive the full series.
Cervarix should not be used in place of having a routine pelvic exam and Pap smear to screen
for cervical cancer.

What happens if I miss a dose?

Contact your doctor if you will miss an Cervarix booster dose or if you get behind schedule.
The next dose should be given as soon as possible. There is no need to start over.
Be sure you receive all recommended doses of this vaccine. If you do not receive the full
series of vaccines, you may not be fully protected against the disease.

What happens if I overdose?

An overdose of this vaccine is unlikely to occur.

What should I avoid?

There may be certain other vaccines that should not be given at the same time as the
Cervarix. Until you have completed the series of 3 Cervarixs, do not receive any other vaccine
(including a flu shot) without first asking your doctor.

Cervarix side effects

You should not receive a booster vaccine if you have had a life-threatening allergic reaction
after the first shot of Cervarix.
Developing cancer from HPV is much more dangerous to your health than receiving the
vaccine to protect against it. However, like any medicine, Cervarix 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 Cervarix. Some people have had seizure-like reactions after receiving this vaccine.
Your doctor may want you to remain under observation during the first 15 minutes after the
injection.
Other Cervarix side effects may include:

pain, swelling, or redness where the shot was given;

headache, tired feeling;

joint or muscle pain.

nausea, vomiting, diarrhea, stomach pain;

menstrual pain;

runny or stuffy nose, sore throat, cough; or

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.
See also: Side effects (in more detail)

What other drugs will affect Cervarix?

Before receiving the Cervarix, tell the doctor about all other vaccines you have recently
received.
Also tell the doctor if you have recently received drugs or treatments that can weaken the
immune system, including:

an oral, nasal, inhaled, or injectable steroid medicine;

chemotherapy or radiation;

medications to treat psoriasis, rheumatoid arthritis, or other autoimmune disorders,

such as azathioprine (Imuran), efalizumab (Raptiva), etanercept (Enbrel), leflunomide
(Arava), and others; or

medicines to treat or prevent organ transplant rejection, such as basiliximab (Simulect),

cyclosporine (Sandimmune, Neoral, Gengraf), muromonab-CD3 (Orthoclone),
mycophenolate mofetil (CellCept), sirolimus (Rapamune), or tacrolimus (Prograf).

This list is not complete and other drugs may interact with this vaccine. Tell your doctor about
all medications you use. This includes prescription, over-the-counter, vitamin, and herbal
products. Do not start a new medication without telling your doctor.

Not all side effects for Cervarix may be reported. You should always consult a doctor or
healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to human papillomavirus vaccine: intramuscular suspension

In addition to its needed effects, some unwanted effects may be caused by human
papillomavirus vaccine (the active ingredient contained in Cervarix). In the event that any of
these side effects do occur, they may require medical attention.
If any of the following side effects occur while taking human papillomavirus
vaccine, check with your doctor or nurse immediately:
More common

Fever
Less common

Black, tarry stools

bleeding gums

blood in urine or stools

blurred vision

body aches or pain

chills

constipation

cough

depressed mood

difficulty with breathing

dry mouth

dry skin and hair

ear congestion

feeling cold

flushed, dry skin

fruit-like breath odor

headache

hoarseness or husky voice

increased hunger

increased thirst

increased urination

loss of consciousness

loss of voice

muscle cramps and stiffness

nasal congestion

nausea

pinpoint red spots on skin

runny nose

slowed heartbeat

sneezing

sore throat

stomachache

sweating

troubled breathing

unexplained weight loss

unusual bleeding or bruising

unusual tiredness or weakness

vomiting

Rare

Difficulty with swallowing

dizziness

fast heartbeat

hives

itching

noisy breathing

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

shortness of breath

skin rash

tightness in the chest

wheezing

Incidence not known

Anxiety

back pain, sudden and severe

back, leg, or stomach pains

bloating

chest pain

convulsions (seizures)

dark urine

fainting

general body swelling

hives or welts

hoarseness

inability to move the arms and legs

indigestion

irritation

joint pain, stiffness, or swelling

loss of appetite

loss of bladder control

muscle spasm or jerking of all extremities

muscle weakness, sudden and progressing

nosebleeds

pain in the stomach, side, or abdomen, possibly radiating to the back

pain, redness, or swelling in the arm or leg

pale skin

paralysis

rash

redness of the skin

shakiness and unsteady walk, unsteadiness, trembling, or other problems with muscle
control or coordination

sudden loss of consciousness

sudden numbness and weakness in the arms and legs

sudden shortness of breath or troubled breathing

swelling of the eyelids, face, lips, hands, or feet

swollen, painful, or tender lymph glands in the neck, armpit, or groin

yellowing of the eyes or skin

Some of the side effects that can occur with human papillomavirus vaccine may not need
medical attention. As your body adjusts to the medicine during treatment these side effects
may go away. Your health care professional may also be able to tell you about ways to reduce
or prevent some of these side effects. If any of the following side effects continue, are
bothersome or if you have any questions about them, check with your health care
professional:
More common

Red streaks on the skin, swelling, tenderness, pain, or itching at the injection site
Less common

Changes in skin coloring

cloudy urine

diarrhea

difficulty with moving

general feeling of discomfort or illness

hair loss, thinning of hair

muscle pain or stiffness

pain in the joints

sleeplessness

toothache

trouble with sleeping

unable to sleep

For Healthcare Professionals

Applies to human papillomavirus vaccine: intramuscular suspension

Local
Local side effects have included injection site pain, swelling, erythema, and pruritus.[Ref]

Gastrointestinal
Gastrointestinal side effects have included nausea, diarrhea, vomiting, and toothache. [Ref]

General
General side effects have included fever, dizziness, malaise, and insomnia. Postmarketing
reports have included asthenia and fatigue.[Ref]

Respiratory
Respiratory side effects have included cough, nasal congestion, nasopharyngitis, and upper
respiratory tract infection.[Ref]

Musculoskeletal
Musculoskeletal side effects have included myalgia and arthralgia.[Ref]
References
1. "Product Information. Gardasil (human papillomavirus vaccine)." Merck & Company Inc, West Point, PA.

Dosage

The information at Drugs.com is not a substitute for medical advice. ALWAYS consult your doctor or pharmacist.

Preparation for Administration

Shake vial or syringe well before withdrawal and use. Parenteral drug products should be
inspected visually for particulate matter and discoloration prior to administration, whenever
solution and container permit. If either of these conditions exists, the vaccine should not be
administered. With thorough agitation, CERVARIX is a homogeneous, turbid, white suspension.
Do not administer if it appears otherwise.

Dose and Schedule

Immunization with CERVARIX consists of 3 doses of 0.5-mL each, by intramuscular injection
according to the following schedule: 0, 1, and 6 months. The preferred site of administration
is the deltoid region of the upper arm.
Do not administer this product intravenously, intradermally, or subcutaneously.

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