Pronunciation:

var-i-SEL-a VYE-rus VAX-een, lyve

Brand Names:

• Varivax
• Varilrix

Dosage Forms:

• Powder for Suspension

Classifications:

Therapeutic—

Vaccine, Live

Uses of This Medicine:

Varicella virus live vaccine is an active immunizing agent that is given to protect against infection caused by the varicella-zoster virus (VZV). The vaccine works by causing the body to produce its own protection (antibodies) against the virus.

Varicella (commonly known as chickenpox) is an infection that is easily spread from one person to another. Chickenpox is usually a mild infection but sometimes it can cause serious problems, such as pneumonia, inflammation of the brain, and a rare disease called Reye's syndrome.

Immunization against chickenpox is recommended for anyone 12 months of age and older who has not had chickenpox. Immunization against chickenpox is not recommended for infants younger than 12 months of age.

You can be considered to be immune to chickenpox only if you have received 2 doses of the varicella vaccine. You also are considered to be immune if you have a doctor's diagnosis of a previous chickenpox infection or if you have had a blood test showing that you are immune to the varicella virus.

This vaccine is to be administered only by or under the supervision of your doctor or other authorized health care professional.

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:

Allergies—

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.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of varicella virus vaccine in children 1 year of age and older. However, varicella virus vaccine is not recommended for infants younger than 12 months of age.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of varicella virus vaccine in the elderly.

Breast-feeding—

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Other medicines—

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. When you are receiving this vaccine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Receiving this vaccine with any of the following medicines is not recommended. Your doctor may decide not to use this vaccine or change some of the other medicines you take.

• Alemtuzumab
• Bendamustine
• Bortezomib
• Bosutinib
• Cabazitaxel
• Capecitabine
• Carboplatin
• Carfilzomib
• Carmustine
• Chlorambucil
• Cisplatin
• Cladribine
• Clofarabine
• Cyclophosphamide
• Cytarabine
• Cytarabine Liposome
• Dacarbazine
• Dasatinib
• Daunorubicin
• Daunorubicin Citrate Liposome
• Daunorubicin Liposome
• Deflazacort
• Docetaxel
• Doxorubicin
• Epirubicin
• Etoposide
• Fludarabine
• Fluorouracil
• Gemcitabine
• Gemtuzumab Ozogamicin
• Hydroxyurea
• Idarubicin
• Ifosfamide
• Imatinib
• Interferon Alfa
• Irinotecan
• Irinotecan Liposome
• Lomustine
• Mechlorethamine
• Melphalan
• Mercaptopurine
• Methotrexate
• Mitomycin
• Mitoxantrone
• Nelarabine
• Nilotinib
• Ofatumumab
• Oxaliplatin
• Paclitaxel
• Paclitaxel Protein-Bound
• Pemetrexed
• Pentostatin
• Ponatinib
• Procarbazine
• Rituximab
• Temozolomide
• Teniposide
• Thiotepa
• Topotecan
• Tositumomab
• Vinblastine
• Vinorelbine

Receiving this vaccine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adalimumab
• Anifrolumab-fnia
• Ansuvimab-zykl
• Antithymocyte Globulin Rabbit
• Aspirin
• Atoltivimab
• Axicabtagene Ciloleucel
• Azathioprine
• Baricitinib
• Belatacept
• Benorilate
• Betibeglogene Autotemcel
• Bimekizumab-bkzx
• Brexucabtagene Autoleucel
• Brodalumab
• Canakinumab
• Certolizumab Pegol
• Choline Salicylate
• Cyclosporine
• Deucravacitinib
• Dupilumab
• Efgartigimod Alfa-fcab
• Elivaldogene Autotemcel
• Emapalumab-lzsg
• Etanercept
• Etrasimod
• Everolimus
• Fingolimod
• Golimumab
• Guselkumab
• Hyaluronidase
• Immune Globulin
• Inebilizumab-cdon
• Infliximab
• Ixekizumab
• Leflunomide
• Leniolisib
• Lovotibeglogene Autotemcel
• Mesalamine
• Mirikizumab-mrkz
• Mycophenolic Acid
• Ocrelizumab
• Olsalazine
• Ozanimod
• Ponesimod
• Rilonacept
• Risankizumab-rzaa
• Ritlecitinib
• Rozanolixizumab-noli
• Salicylamide
• Salicylic Acid
• Salsalate
• Sarilumab
• Satralizumab-mwge
• Secukinumab
• Siponimod
• Sirolimus
• Sodium Salicylate
• Sodium Thiosalicylate
• Spesolimab-sbzo
• Tacrolimus
• Teplizumab-mzwv
• Teriflunomide
• Tildrakizumab-asmn
• Tocilizumab
• Tofacitinib
• Trabectedin
• Tralokinumab-ldrm
• Trolamine Salicylate
• Ublituximab-xiiy
• Upadacitinib
• Ustekinumab
• Valoctocogene Roxaparvovec-rvox
• Vamorolone
• Voclosporin

Receiving this vaccine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abatacept
• Cytomegalovirus Immune Globulin, Human
• Hepatitis B Immune Globulin
• Rabies Immune Globulin
• Respiratory Syncytial Virus Immune Globulin, Human
• Tetanus Immune Globulin
• Vaccinia Immune Globulin, Human
• Varicella-Zoster Immune Globulin

Other interactions—

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:

• Allergy to gelatin or neomycin, history of or
• Blood disorder (weak immune system) or
• Bone marrow cancer or
• Illness with fever or
• Immune deficiency condition, or family history of or
• Leukemia (cancer of the blood) or
• Lymphoma (cancer of the immune system) or
• Neutropenia (low white blood cell count) or
• Tuberculosis, active and untreated—Should not be used in patients with these conditions.

Proper Use of This Medicine:

A nurse or other trained health professional will give you or your child this vaccine. This vaccine is given as a shot under your skin (usually in the upper arms, or front side of the thighs) or into one of your muscles.

Children 12 months to 12 years of age should receive 2 doses of Varivax® vaccine, with the first dose given between 12 to 15 months and the second between 4 to 6 years. Teenagers and adults should receive 2 doses and wait 4 weeks between the first and second shot.

This vaccine comes with a patient information leaflet. Read and understand carefully all of the information in the insert. Ask your doctor if you have any questions.

Missed dose—

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 if you or your child needs a second dose of the vaccine. Be sure to notify your doctor of any side effects that may occur after you or your child receive this vaccine.

You should not receive this vaccine if you are using medicine that weakens the immune system (including cancer medicine or steroid medicine).

Do not become pregnant for 3 months after receiving varicella virus vaccine. There is a chance that this vaccine may cause problems during pregnancy. If you think you have become pregnant, tell your doctor right away. Your doctor may want you to join a pregnancy registry for patients receiving this vaccine.

Tell your doctor that you or your child have received this vaccine:

• If you are to receive blood transfusions or other blood products within 5 months of receiving this vaccine.
• If you are to receive any other live virus vaccines within 1 to 3 months after receiving this vaccine.
• If you are to receive varicella-zoster immune globulin (VZIG) or other immune globulins within 2 months after receiving this vaccine.

This vaccine may cause a serious allergic reaction, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after you receive the vaccine.

Do not use aspirin or medicines containing aspirin (eg, certain cold medicines) for 6 weeks after receiving this vaccine. Carefully check the label of any pain, headache, or cold medicine you or your child use to be sure it does not contain aspirin or salicylic acid.

You or your child may be able to pass the virus to other people after getting this vaccine. You or your child should avoid close contact with people at high risk for getting chickenpox for 6 weeks after receiving this vaccine. People who are most at risk of catching the virus from you are pregnant women, newborn babies, and people whose bodies cannot fight infection (eg, people with bone marrow disease, AIDS). Talk to your doctor about this risk.

You will need to have a skin test for tuberculosis before the vaccine is given, or on the same day the vaccine is given, or at least 4 weeks after you receive this vaccine. Tell your doctor if you or anyone in your home has ever had a positive reaction to a tuberculosis skin test.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

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 immediately if any of the following side effects occur:

More common

Fever over 39°C (102°F)

Less common

Blue lips and fingernails

chest pain or tightness

chickenpox-like skin rash

coughing that sometimes produces a pink frothy sputum

decreased urine output

difficult, fast, or noisy breathing

dilated neck veins

extreme tiredness or weakness

general feeling of discomfort or illness

increased sweating

irregular breathing

irregular heartbeat

irritability

pale skin

swelling of the ankles, face, fingers, feet, or lower legs

weight gain

Rare

Black, tarry stools

blood in the urine or stools

chills

confusion

cough

difficulty with breathing or swallowing

fever

hives

itching, especially of the feet or hands

muscle or joint pain

pinpoint red spots on the skin

reddening of the skin, especially around the ears

seizures with high fever

severe or continuing headache

stiff neck

swelling of the glands in the neck

thickening of bronchial secretions

unusual bleeding or bruising

unusual tiredness or weakness, sudden and severe

vomiting

Incidence not known

Back pain, sudden and severe

bleeding gums

blistering, peeling, or loosening of the skin

bloating or swelling of the face, arms, hands, lower legs, or feet

bloody nose

blurred vision

bruising more easily

dizziness

fast heartbeat

headache

heavier menstrual periods

inability to move the arms and legs

inability to speak

large, flat, blue, or purplish patches in the skin

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

loss of bladder control

muscle spasm or jerking of all extremities

painful blisters on the trunk of the body

painful knees and ankles

pale skin

pinpoint red spots on the skin

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

raised red swellings on the skin, buttocks, legs, or ankles

red, irritated eyes

red skin lesions, often with a purple center

seizures

shakiness and unsteady walk

skin rash

slurred speech

sores, ulcers, or white spots in the mouth or on the lips

stomach pain

sudden loss of consciousness

sudden numbness and weakness in the arms and legs

swollen or painful glands

temporary blindness

tingling of the hands or feet

unsteadiness, trembling, or other problems with muscle control or coordination

unusual weight gain or loss

weakness in the arm or leg on one side of the body, sudden and severe

weakness of the muscles in your face

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:

More common

Fever of 37.7°C (100°F) or higher, but not above 39°C (102°F)

hives, itching, pain, redness, soreness, tenderness, or warmth at the injection site

Less common

Common cold

congestion

constipation

cracked, dry, or scaly skin

diaper rash

diarrhea

disturbed sleep

dry skin

earache

heat rash or prickly heat

lack or loss of strength

loss of appetite

muscle ache, cramp, or stiffness

nausea

nervousness

runny nose

skin rash, encrusted, scaly, and oozing

sneezing

sore throat

stuffy nose

swelling

swollen joints

teething

Incidence not known

Bacterial skin infections

body aches or pain

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

difficulty with moving

dryness or soreness of the throat

hoarseness

pain, redness, swelling, tenderness, or warmth on the skin

red rash with watery, yellow-colored, or pus-filled blisters

thick yellow to honey-colored crusts

voice changes

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.