Cervarix Intramuscular

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:

• Fever

• Anxiety
• back, leg, or stomach pains
• bleeding gums
• chest pain
• chills
• cough
• dark urine
• difficulty with breathing
• difficulty with swallowing
• dizziness or lightheadedness
• fainting
• fast heartbeat
• general body swelling
• headache
• hives or welts, itching, or skin rash
• loss of appetite
• nausea or vomiting
• nosebleeds
• pale skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• redness of the skin
• seizures
• sore throat
• sudden shortness of breath or troubled breathing
• swollen, painful, or tender lymph glands in the neck, armpit, or groin
• tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over affected area
• tightness in the chest
• unusual tiredness or weakness
• yellowing of the eyes or skin

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:

• Headache

• Diarrhea
• difficulty with moving
• joint pain
• muscle aching or cramping
• muscle pains or stiffness
• sore throat
• swollen joints
• upper abdominal or stomach pain

• Body aches or pain
• ear congestion
• loss of voice
• nasal congestion
• runny nose
• sneezing

• Bloating
• constipation
• darkened urine
• difficulty with moving
• fast heartbeat
• indigestion
• loss of appetite
• muscle pain or stiffness
• pain in the joints pain, swelling, or redness at the injection site
• pains in the stomach, side, or abdomen, possibly radiating to the back

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.

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

To make sure Cervarix is safe for you, tell your doctor if you have:

• a weak immune system;

• an allergic to latex rubber; or

• if you are being treated with cancer medicine, steroids, or other drugs that can weaken your immune system.

Cervarix is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether human papillomavirus vaccine passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

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

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 9 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 you receive all recommended doses. If you do not receive the full series of vaccines, you may not be fully protected against the disease.

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

Applies to human papillomavirus vaccine: intramuscular suspension

General

The most common adverse events were injection site reactions, fatigue, headache, and myalgia.[Ref]

Local

Very common (10% or more): Injection site pain (91.9%), injection site swelling (49%), injection site erythema (48.4%)
Common (1% to 10%): Injection site pruritus, injection site hematoma, injection site induration, injection site hemorrhage, injection site warmth, injection site mass, injection site reaction
Postmarketing reports: Injection site cellulitis[Ref]

Other

Very common (10% or more): Fatigue (54.6%), headache (53.4%), pyrexia (13%), fever of 99.5F or higher (12.9%)
Common (1% to 10%): Chlamydia infection, malaise
Uncommon (0.1% to 1%): Death
Postmarketing reports: Asthenia, chills[Ref]

Deaths occurred during clinical trials which were generally assessed as not vaccine related: car accidents, suicides, acute lymphocytic leukemia, hypovolemic septic shock, airplane crash, cerebral hemorrhage, gunshot wound, stomach adenocarcinoma, pulmonary embolus/deep vein thrombosis, sepsis, pancreatic cancer, arrhythmia, pulmonary tuberculosis, hyperthyroidism, post-operative pulmonary embolism and acute renal failure, traumatic brain injury/cardiac arrest, systemic lupus erythematosus, cerebrovascular accident, breast cancer, nasopharyngeal cancer, autoimmune disease, infectious disease, homicide, and 1 unexplained sudden death 678 days following the last vaccine dose.[Ref]

Musculoskeletal

Very common (10% or more): Myalgia (48.8%), arthralgia (20.7%)
Common (1% to 10%): Back pain
Postmarketing reports: Pain in extremity[Ref]

Gastrointestinal

Common (1% to 10%): Nausea, diarrhea, vomiting, abdominal pain upper, toothache
Rare (less than 0.1%): Appendicitis, gastroenteritis
Postmarketing reports: Pancreatitis[Ref]

Respiratory

Common (1% to 10%): Nasopharyngitis, oropharyngeal pain, influenza, cough, nasal congestion, upper respiratory tract infection, pharyngitis
Rare (0.01% to 0.1%): Pneumonia, pulmonary embolism, asthma
Very rare (less than 0.01%): Bronchospasm
Frequency not reported: Asthmatic crisis
Postmarketing reports: Pulmonary embolus[Ref]

Nervous system

Common (1% to 10%): Dizziness, migraine
Postmarketing reports: Acute disseminated encephalomyelitis, Guillain-Barre syndrome, motor neuron disease, paralysis, seizures, syncope (including syncope associated with tonic-clonic movements and other seizure-like activity) sometimes resulting in falling with injury, transverse myelitis[Ref]

Immunologic

New medical conditions potentially indicative of systemic autoimmune disorders included: arthralgia/arthritis/arthropathy, autoimmune thyroiditis, celiac disease, diabetes mellitus insulin dependent, erythema nodosum, hyperthyroidism, hypothyroidism, inflammatory bowel disease, multiple sclerosis, nephritis, optic neuritis, pigmentation disorder, psoriasis, Raynaud's phenomenon, rheumatoid arthritis, scleroderma/morphea, Stevens-Johnson syndrome, systemic lupus erythematosus, uveitis, alopecia areata, ankylosing spondylitis, autoimmune thrombocytopenia, myocarditis, proteinuria, skin depigmentation, dermatomyositis, vasculitis, and vitiligo.[Ref]

Common (1% to 10%): New medical conditions potentially indicative of systemic autoimmune disorders
Postmarketing reports: Autoimmune diseases[Ref]

Hypersensitivity

Common (1% to 10%): Injection site hypersensitivity
Frequency not reported: Allergy to vaccine
Postmarketing reports: Hypersensitivity reactions (including anaphylactic/anaphylactoid reactions, bronchospasm, and urticaria)[Ref]

Hematologic

Uncommon (0.1% to 1%): Lymphadenopathy
Postmarketing reports: Autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura[Ref]

Psychiatric

Common (1% to 10%): Insomnia[Ref]

Genitourinary

Common (1% to 10%): Dysmenorrhea, vaginal infection, urinary tract infection
Rare (less than 0.1%): Pelvic inflammatory disease, pyelonephritis[Ref]

Dermatologic

Common (1% to 10%): Rash, urticaria, itching/pruritus
Postmarketing reports: Cellulitis, angioedema, erythema multiforme[Ref]

Cardiovascular

Postmarketing reports: Deep vein thrombosis[Ref]

Some side effects of Cervarix may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Use is not recommended. AU TGA pregnancy category: B2 US FDA pregnancy category: B Comments: -Women who are pregnant or trying to become pregnant are advised to postpone vaccination until the completion of pregnancy.

Animal studies showed no adverse effects on the offspring and no effects on fertility. There are no adequate and well-controlled studies in pregnant women. Human pregnancies that occurred during clinical trials (study drug administration was delayed until resolution of pregnancy during clinical trials) had adverse event (spontaneous abortion, late fetal death, or congenital anomaly) rates that were similar in both the active drug and placebo groups. AU TGA pregnancy category B2: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage. US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

Use is considered acceptable; caution is recommended. Excreted into human milk: Unknown Excreted into animal milk: Probable