Varicella virus vaccine, live (Intramuscular, Subcutaneous)

Varicella virus live vaccine is a treatment that helps protect against infections caused by the varicella-zoster virus (VZV). It helps the body make its own protection (antibodies) against the virus.

Varicella (commonly called chickenpox) is an infection that spreads easily from person to person. Chickenpox is usually mild, but it can sometimes lead to serious issues, such as pneumonia, brain inflammation, and a rare condition known as Reye's syndrome.

It is recommended that anyone 12 months of age and older who has not had chickenpox get vaccinated. Vaccination is not recommended for infants younger than 12 months.

You are considered immune to chickenpox if you have received 2 doses of the varicella vaccine. You are also considered immune if a doctor has diagnosed you with a previous chickenpox infection or if a blood test shows you are immune to the varicella virus.

This vaccine should only be given by or under the supervision of your doctor or another authorized health care professional.

It is very important that you or your child go back to your doctor’s office at the right time if a second dose of the vaccine is needed. Make sure to inform your doctor about any side effects that may happen after you or your child receive this vaccine.

You should not receive this vaccine if you are taking any medicine that weakens the immune system (such as cancer medicine or steroid medicine).

Do not become pregnant for 3 months after getting the varicella virus vaccine. There is a risk that this vaccine may cause issues during pregnancy. If you think you might be pregnant, tell your doctor immediately. Your doctor may want you to join a pregnancy registry for patients who receive this vaccine.

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

• If you are going to have blood transfusions or other blood products within 5 months after receiving this vaccine.
• If you are going to receive any other live virus vaccines within 1 to 3 months after receiving this vaccine.
• If you are going 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 help. 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 receiving the vaccine.

Do not use aspirin or medicines that contain aspirin (for example, 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 ensure it does not contain aspirin or salicylic acid.

You or your child may be able to spread 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. Those at highest risk of catching the virus from you include pregnant women, newborn babies, and people whose bodies cannot fight infections (for example, people with bone marrow disease or AIDS). Discuss this risk with your doctor.

You will need to have a skin test for tuberculosis before the vaccine is given, on the same day the vaccine is given, or at least 4 weeks after you receive this vaccine. Inform 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.

In deciding to use a vaccine, you and your doctor need to consider the risks of the vaccine compared to the benefits it may provide. For this vaccine, please think about the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, including to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Studies so far have not shown any specific problems related to the use of varicella virus vaccine in children aged 1 year and older. However, varicella virus vaccine is not recommended for infants younger than 12 months.

Geriatric

Studies so far have not shown any specific problems related to the use of varicella virus vaccine in elderly patients.

Breast Feeding

Research suggests that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines can be used together even if there may be an interaction. In these situations, your doctor may change the dose, or other precautions may be needed. It is especially important for your healthcare professional to know if you are taking any of the medicines listed below while receiving this vaccine. The following interactions are based on 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 necessary 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
• 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 increase the risk of certain side effects, but using both medicines may be necessary for your treatment. 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

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used around the time of eating food or certain types of food, as interactions may happen. Using alcohol or tobacco with certain medicines may also cause interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect the use of this vaccine. Make sure to inform your doctor if you have any other medical issues, 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—This vaccine should not be used in patients with these conditions.

Along with its necessary effects, a medicine can cause some unwanted effects. Not all of these side effects may happen, but if they do, they might need medical attention.

Check with your doctor right away 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 brings up 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 happen that usually do not need medical attention. These side effects may go away during treatment as your body gets used to the medicine. Also, your health care professional may be able to tell you how 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.

In the U.S.

• Varivax

In Canada

• Varilrix

Available Dosage Forms:

• Powder for Suspension

Therapeutic Class: Vaccine, Live

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.

• Why did I get chickenpox even though I've been vaccinated?