Varivax
Name: Varivax
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What Is Varicella Virus Vaccine?
Varicella (commonly known as chickenpox) is a common childhood disease that causes fever, skin rash, and a breakout of fluid-filled blisters on the skin. Most people who receive this vaccine will not get chickenpox, or will get only a mild case and will recover faster.
Chickenpox is usually mild, but it can be serious or even fatal in young infants and in adults. It can lead to severe skin infection, breathing problems, brain damage, or death. A person who has had chickenpox can develop herpes zoster (also called shingles) later in life, which causes painful blisters, skin infections, severe nerve pain, and hearing or vision problems, which may last for months or years.
Chickenpox is spread from person to person through the air, or by coming into contact with the fluid from a chickenpox blister.
Varicella virus vaccine is used to help prevent these diseases in adults and children who are at least 12 months old.
This vaccine works by exposing you to a small dose of the virus or a protein from the virus, which causes the body to develop immunity to the disease. This vaccine will not treat an active infection that has already developed in the body.
Like any vaccine, varicella virus vaccine may not provide protection from disease in every person.
You should not receive this vaccine if you are allergic to gelatin or neomycin.
You should also not receive this vaccine if you have an infection or any illness with fever, active tuberculosis that is not being treated, or severe immune suppression.
You should not receive this vaccine if you are pregnant. Use effective birth control to prevent pregnancy for at least 3 months after receiving a varicella vaccine.
You should not receive this vaccine if you are allergic to gelatin or neomycin, or if you have ever had a life-threatening allergic reaction to any vaccine containing varicella.
You should also not receive this vaccine if you have:
- an infection or any illness with fever;
- active tuberculosis that is not being treated;
- severe immune suppression; or
- if you are pregnant.
It is not known whether this vaccine will harm an unborn baby. However, chickenpox can cause birth defects, low birth weight, or a serious infection in the newborn, and this vaccine exposes you to a small amount of this virus. Tell your doctor if you are pregnant before you receive this vaccine. Use effective birth control to prevent pregnancy for at least 3 months after receiving a varicella vaccine.
To make sure varicella vaccine is safe for you, tell your doctor if:
- you have a weak immune system caused by disease (such as cancer, HIV, or AIDS), or by receiving certain medicines such as steroids, chemotherapy or radiation;
- someone in your household has a weak immune system; or
- you have received an immune globulin or other blood product within the 5 months.
It is not known whether varicella vaccine passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.
Side Effects of Varivax
Serious side effects have been reported with Varivax. See "Varivax Precautions" section.
Common side effects include:
- fever
- pain, swelling, itching, or redness at the site of the shot
- chickenpox-like rash on the body or at the site of the shot
- irritability
Less common side effects include:
- tingling of the skin
- shingles
This is not a complete list of Varivax side effects. Ask your doctor or pharmacist for more information.
Tell your doctor if you have any side effect that bothers you or that does not go away.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
You may also report these events to Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., at 1-877-888-4231, or directly to the Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number is 1-800-822-7967 or report online to www.vaers.hhs.gov.
Varivax and Lactation
Tell your doctor is you are breastfeeding or plan to breastfeed.
It is not known if Varivax crosses into human milk. Because some vaccines can cross into human milk and becuase of the possibility for serious adverse reactions in nursing infants with use of this vaccine, a choice should be made whether to stop nursing or stop the use of this vaccine. Your doctor and you will decide if the benefits outweigh the risk of using Varivax.
What happens if I overdose?
An overdose of this vaccine is unlikely to occur.
Interactions for Varivax
Live Vaccines
Varicella vaccine is a live, attenuated virus vaccine.1 26 27 137 Some oral live vaccines (e.g., rotavirus vaccine live oral, typhoid vaccine live oral, poliovirus vaccine live oral [OPV; no longer commercially available in the US]) can be administered simultaneously with or at any interval before or after varicella vaccine.26 100 However, because of theoretical concerns that the immune response to intranasal live vaccines or other parenteral live virus vaccines might be impaired if given within 28–30 days of another live virus vaccine, if varicella vaccine and these live vaccines are not administered on the same day, they should be administered at least 4 weeks (i.e., 28 days) apart to minimize the potential for interference.26 100 (See Specific Drugs and Laboratory Tests under Interactions.)
Inactivated Vaccines and Toxoids
Varicella vaccine may be administered simultaneously with (using different syringes and different injection sites) or at any interval before or after inactivated vaccines, recombinant vaccines, polysaccharide vaccines, or toxoids.26 27 100 121 137 (See Specific Drugs and Laboratory Tests under Interactions.)
Specific Drugs and Laboratory Tests
| Drug or Test | Interaction | Comments |
|---|---|---|
| Antiviral agents active against Herpesviruses (e.g., acyclovir, famciclovir, valacyclovir) | May reduce efficacy of varicella vaccine26 | Discontinue antiviral agent active against Herpesviruses at least 24 hours before administration of varicella vaccine, if possible26 |
| Blood products (e.g., whole blood, packed RBCs, plasma) | Although specific studies not available, antibodies contained in blood products may interfere with the immune response to varicella vaccine1 26 27 125 | Do not administer varicella vaccine simultaneously with or for specified intervals before or after administration of blood products1 26 27 125 Defer varicella vaccine for ≥3 months following administration of RBCs (with adenine-saline added); for ≥6 months following administration of packed RBCs or whole blood; or for ≥7 months following administration of plasma or platelet products;26 however, because of the importance of postpartum vaccination in women without evidence of varicella immunity, vaccination of such women should not be delayed because they received a blood product26 After administering varicella vaccine, avoid blood products for 2 weeks; if use of a blood product is considered necessary during this period, give a repeat vaccine dose after the recommended interval unless serologic testing is feasible and indicates a response to the vaccine was attained27 |
| Diphtheria and tetanus toxoids and acellular pertussis vaccines adsorbed (DTaP) | Varivax: May be administered concurrently (using different syringes and different injection sites) or at any interval before or after DTaP26 27 100 137 MMRV (ProQuad): Manufacturer states data insufficient to date to recommend concurrent administration with DTaP125 | |
| Haemophilus b (Hib) vaccine | Although specific studies not available, Hib vaccines are inactivated vaccines and interactions are not expected27 100 MMRV (ProQuad): Has been administered concomitantly with Hib vaccine and HepB vaccine at separate injection sites and seroconversion rates and antibody titers for the measles, mumps, rubella, varicella, Hib, and hepatitis B antigens were comparable with results obtained when the vaccines were administered 6 weeks apart125 | Varivax or MMRV (ProQuad): May be administered concurrently with (using different syringes and different injection sites) or at any interval before or after Hib vaccine27 100 121 125 |
| Hepatitis B (HepB) vaccine | Although specific studies not available, HepB vaccine is an inactivated vaccine and interactions are not expected27 100 MMRV (ProQuad): Has been administered concomitantly with HepB and Hib vaccines at separate injection sites and seroconversion rates and antibody titers for measles, mumps, rubella, varicella, anti-PRP, and hepatitis B were comparable with results obtained when the vaccines were administered 6 weeks apart125 | Varivax or MMRV (ProQuad): May be administered concurrently with or at any interval before or after HepB vaccine27 100 121 125 |
| Immune globulin (immune globulin IM [IGIM], immune globulin IV [IGIV]) or specific immune globulin (hepatitis B immune globulin [HBIG], rabies immune globulin [RIG], tetanus immune globulin [TIG], varicella zoster immune globulin [VZIG]) | Although specific studies not available, antibodies contained in immune globulin preparations may interfere with the immune response to varicella vaccine1 26 27 125 | Varivax or MMRV (ProQuad) should not be administered simultaneously with or for specified intervals before or after administration of immune globulin preparations1 26 27 125 Defer administration of varicella vaccine for ≥3 months following administration of tetanus immune globulin (TIG), hepatitis B immune globulin (HBIG), immune globulin IM (IGIM) used for postexposure prophylaxis of hepatitis A virus (HAV);26 for ≥4 months following administration of rabies immune globulin (RIG);26 for ≥5 months following administration of IGIM used for measles prophylaxis in immunocompetent individuals;26 for ≥6 months following administration of cytomegalovirus immune globulin IV (CMV-IGIV) or IGIM for measles prophylaxis in immunocompromised individuals;26 for ≥5–8 months following administration of VZIG or IGIV for postexposure prophylaxis of severe varicella;26 27 126 for≥8 months following administration of immune globulin IV (IGIV) for replacement therapy of immunodeficiencies; for ≥8–10 months following administration of IGIV for treatment of idiopathic thrombocytopenic purpura (ITP);26 or for ≥11 months following administration of IGIV for Kawasaki syndrome26 If varicella vaccine is administered simultaneously with an immune globulin preparation or was administered at less than the recommended interval, consider that vaccine-induced immunity may be compromised; give an additional vaccine dose after the specified interval unless serologic testing is feasible and indicates a response to the vaccine was attained26 After administering varicella vaccine, avoid immune globulin preparations for 2 weeks; if use of an immune globulin is considered necessary during this period, give a repeat vaccine dose after the recommended interval unless serologic testing is feasible and indicates a response to the vaccine was attained26 27 |
| Immunosuppressive agents (e.g., alkylating agents, antimetabolites, corticosteroids, radiation) | Use of varicella vaccine in individuals receiving immunosuppressive therapy may result in more extensive vaccine-associated rash or disseminated disease1 27 125 Corticosteroid therapy (prednisone or equivalent) in a dosage ≥2 mg/kg daily or ≥20 mg daily given for ≥2 weeks is considered immunosuppressive26 137 Short-term (<2 weeks), low- to moderate-dose systemic corticosteroid therapy; long-term, alternate-day systemic corticosteroid therapy using low to moderate doses of short-acting drugs; topical corticosteroid therapy (e.g., nasal, cutaneous, ophthalmic); or intra-articular, bursal, or tendon injections with corticosteroids should not be immunosuppressive in usual dosages26 63 70 | Defer varicella vaccine until immunosuppressive therapy is discontinued1 27 125 137 Optimum interval between discontinuance of immunosuppressive therapy and subsequent administration of a live viral vaccine not determined;26 137 live viral vaccines generally should not be administered for at least 3 months after immunosuppressive therapy is discontinued26 63 70 137 In patients who received corticosteroid therapy that is considered immunosuppressive,26 63 70 delay administration of varicella vaccine for at least 1 month after the corticosteroid is discontinued26 27 137 MMRV (ProQuad): Manufacturer states this vaccine may be used in individuals receiving topical corticosteroids or low-dose corticosteroids for asthma prophylaxis or replacement therapy (e.g., for Addison’s disease)125 |
| Influenza vaccine | Intranasal live influenza vaccine: Studies using seasonal intranasal live influenza vaccine indicate simultaneous administration with varicella vaccine in children 12–15 months of age did not interfere with the immune response to either vaccine and did not increase the frequency of adverse effects;142 safety and immunogenicity of concomitant administration not evaluated in infants >15 months of age142 Parenteral inactivated influenza vaccine: Interactions with live vaccines such as varicella vaccine unlikely26 | Intranasal live influenza vaccine: If not given simultaneously, give at least 4 weeks apart, if possible26 Parenteral inactivated influenza vaccine: May be administered simultaneously with (using different syringes and different injection sites) or at any interval before or after varicella vaccine26 |
| Measles, mumps, and rubella vaccine (MMR) | Simultaneous administration of monovalent varicella vaccine and MMR does not interfere with the immune response to either vaccine;1 26 76 varicella vaccine may be less effective if given <30 days after MMR26 121 The fixed-combination vaccine containing varicella vaccine and MMR (MMRV; ProQuad) results in antibody responses similar to those obtained after simultaneous administration of a single dose of MMR and a single dose of Varivax90 | Monovalent varicella vaccine and MMR may be given simultaneously (using different syringes and different injection sites);1 5 7 26 27 87 100 if not administered simultaneously, give at least 1 month apart26 27 100 Alternatively, may be given simultaneously as the fixed-combination vaccine containing varicella vaccine and MMR (MMRV; ProQuad)90 |
| Pneumococcal vaccine | Although specific studies not available, pneumococcal vaccines are inactivated vaccines and interactions with varicella vaccine are not expected26 119 120 Manufacturer states data not available to date regarding concurrent administration of MMRV (ProQuad) and PCV7 (Prevnar)125 | Pneumococcal vaccine may be administered concurrently with (using different syringes and different injection sites) or at any interval before or after varicella vaccine26 27 100 121 |
| Poliovirus vaccine inactivated (IPV) | Although specific studies not available, IPV is an inactivated vaccine and interactions with varicella vaccine are not expected26 Manufacturer states data not available to date regarding concurrent administration of MMRV (ProQuad) and IPV125 | Varicella vaccine may be administered concurrently with (using different syringes and different injection sites) or any time before or after IPV26 27 100 121 |
| Rho(D) immune globulin | Specific studies not available evaluating whether passively acquired antibodies from Rho(D) immune globulin interfere with the immune response to varicella vaccine26 | Because of the importance of postpartum varicella vaccination in women who do not have evidence of varicella immunity, vaccination of such women should not be delayed because they received Rho(D) immune globulin26 |
| Rotavirus vaccine | No evidence to date that parenterally administered live vaccines such as varicella vaccine interfere with the immune response to oral rotavirus vaccine26 | May be administered concomitantly with or at any interval before or after varicella vaccine26 |
| Salicylates | Reye’s syndrome has been reported in children and adolescents who received salicylates during natural varicella infection;1 100 125 an association between Reye’s syndrome, administration of varicella vaccine, and use of salicylates has not been established1 27 42 100 | Because Reye’s syndrome has been reported in children and adolescents who received salicylates during natural varicella infection, manufacturer of Varivax and MMRV (ProQuad) recommends that salicylates be avoided for 6 weeks following vaccination1 125 ACIP states that children with rheumatoid arthritis or other conditions requiring therapeutic salicylate therapy probably should receive the vaccine in conjunction with subsequent close monitoring since risk for serious salicylate-associated complications is likely to be greater in children who develop natural varicella than in those who receive varicella vaccine27 In children receiving long-term salicylate therapy, AAP suggests that the theoretical risks associated with varicella vaccine be weighed against the known risks of the wild-type virus100 |
| Tuberculin | Effect of varicella vaccine, if any, on tuberculin testing has not been determined;26 100 another live virus vaccine (measles vaccine) has been reported to temporarily suppress tuberculin skin sensitivity26 100 125 | Tuberculin tests (if required) should be administered before, simultaneously with, or 4–6 weeks after administration of Varivax or MMRV (ProQuad)26 125 ACIP states that vaccination with varicella vaccine should not be delayed based only on a theoretical concern about a possible interaction with tuberculin skin testing26 |
| Typhoid vaccine | Oral live typhoid vaccine (Vivotif): Specific data not available regarding immunogenicity when administered concurrently with or within 30 days of varicella vaccine26 Parenteral inactivated typhoid vaccine (Typhim Vi): Since this typhoid vaccine is an inactivated vaccine, interactions with live vaccines such as varicella vaccine are unlikely26 | Oral live typhoid vaccine (Vivotif): May be administered simultaneously with or at any interval before or after varicella vaccine26 Parenteral inactivated typhoid vaccine (Typhim Vi): May be administered simultaneously with (using different syringes and injection sites) or at any interval before or after varicella vaccine26 |
| Yellow fever vaccine | Data regarding nonsimultaneous administration not available26 | Yellow fever vaccine and varicella vaccine may be given simultaneously (using different syringes and different injection sites)26 If not given simultaneously, give at least 4 weeks apart, if possible26 |
Commonly used brand name(s)
In the U.S.
- Varivax
- Zostavax
In Canada
- Varilrix
Available Dosage Forms:
- Powder for Solution
Therapeutic Class: Vaccine
Precautions While Using Varivax
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 occur after your child receive this vaccine.
Do not become pregnant for 3 months after receiving varicella virus vaccine without first checking with your doctor. 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.
Zostavax® should not be used in place of Varivax®.
Zostavax® should not be used in children.
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 varicella-zoster immune globulin (VZIG) or other immune globulins within 2 months after receiving this vaccine.
- If you are to receive any other live virus vaccines within 1 month of receiving this vaccine.
This vaccine may cause serious types of allergic reactions, including anaphylaxis. Anaphylaxis 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 take aspirin or medicines that contain aspirin (such as 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 (such as with bone marrow disease, cancer drug treatment, or AIDS). Talk to your doctor about this risk.
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.
How do I store and/or throw out Varivax?
- If you need to store Varivax at home, talk with your doctor, nurse, or pharmacist about how to store it.
- Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
- Check with your pharmacist about how to throw out unused drugs.
PRINCIPAL DISPLAY PANEL - Carton 10 Single-dose 0.5 mL Vials
10 Single-dose 0.5 mL Vials
NDC 0006-4827-00
VARICELLA VIRUS VACCINE LIVE
Varivax®
STORE FROZEN
Oka/Merck Strain. Human cell tissue culture origin containing trace quantities of neomycin.
Contains no preservatives.
Rx only
A
Manuf. and Dist. by:
MERCK & CO., INC.
Whitehouse Station, NJ 08889, USA
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| Labeler - Merck Sharp & Dohme Corp. (001317064) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Merck Sharp & Dohme Corp. | 002387926 | MANUFACTURE | |
For Healthcare Professionals
Applies to varicella virus vaccine: subcutaneous powder for injection
General
The most common adverse events were injection site reactions and fever.[Ref]
Other
Very common (10% or more): Fever (27%), otitis media (12%)
Uncommon (0.1% to 1%): Otitis, viral infection, asthenia, hematoma, malaise
Rare (less than 0.1%): Ear pain, infection, candidiasis, non-venomous bite/sting, heaviness
Frequency not reported: Insect bites[Ref]
Local
Very common (10% or more): Injection site complaints (pain/soreness, swelling and/or erythema, rash, pruritus, hematoma, induration, stiffness) (32.5%)
Common (1% to 10%): Varicella-like rash (injection site)
Uncommon (0.1% to 1%): Injection site ecchymosis, induration
Rare (less than 0.1%): Extravasation, injection site eczema, lump, warmth, stiffness, pain/tenderness/soreness, warm sensation, warm to touch, venipuncture site hemorrhage[Ref]
Respiratory
Very common (10% or more): Upper respiratory infection (26.9%), cough (11%)
Common (1% to 10%): Rhinorrhea
Uncommon (0.1% to 1%): Nasal congestion, respiratory congestion, influenza, pharyngitis
Rare (less than 0.1%): Pneumonitis, sinusitis, sneezing, pulmonary congestion, epistaxis, rhinitis, wheezing, bronchitis, respiratory infection, pneumonia, flu-like illness
Frequency not reported: Upper respiratory illness, lower respiratory illness[Ref]
Dermatologic
Common (1% to 10%): Varicella-like rash (generalized), rash, measles/rubella-like rash
Uncommon (0.1% to 1%): Varicella, viral exanthema, contact dermatitis, diaper rash, erythema, miliaria rubra, pruritus, urticaria
Rare (less than 0.1%): Flushing, vesicle, atopic dermatitis, eczema, acne, herpes simplex, contusion, dermatitis, drug eruption, impetigo, skin infection, measles, sunburn, lump, warmth, discoloration, inflammation, roughness/dryness, hive-like rash, hyperpigmentation
Postmarketing reports: Varicella (vaccine strain), Stevens-Johnson syndrome, erythema multiforme, Henoch-Schonlein purpura, secondary bacterial infections of skin and soft tissue including cellulitis, herpes zoster[Ref]
Psychiatric
Common (1% to 10%): Irritability
Uncommon (0.1% to 1%): Crying, insomnia, sleep disorder
Rare (less than 0.1%): Apathy, nervousness, agitation, dream abnormality, emotional changes
Frequency not reported: Disturbed sleep[Ref]
Gastrointestinal
Uncommon (0.1% to 1%): Gastroenteritis, diarrhea, vomiting
Rare (less than 0.1%): Abdominal pain, nausea, flatulence, hematochezia, mouth ulcer, lip abnormality
Frequency not reported: Constipation, cold/canker sore[Ref]
Nervous system
Uncommon (0.1% to 1%): Headache, somnolence, fatigue
Rare (less than 0.1%): Febrile seizures, hypersomnia, gait abnormality, tremor
Postmarketing reports: Encephalitis, cerebrovascular accident, transverse myelitis, Guillain-Barré syndrome, Bell's palsy, ataxia, non-febrile seizures, aseptic meningitis, dizziness, paresthesia[Ref]
Hematologic
Rare (less than 0.1%): Lymphadenopathy, lymphadenitis, thrombocytopenia
Postmarketing reports: Aplastic anemia, idiopathic thrombocytopenic purpura[Ref]
Hypersensitivity
Frequency not reported: Allergic reactions (including allergic rash, hives)
Postmarketing reports: Anaphylaxis (including anaphylactic shock) and related phenomena such as angioneurotic edema, facial edema, and peripheral edema; anaphylaxis in individuals with or without an allergic history[Ref]
Ocular
Uncommon (0.1% to 1%): Conjunctivitis
Rare (less than 0.1%): Acute conjunctivitis, tearing, edema of the eyelid, irritation
Frequency not reported: Eye complaints
Postmarketing reports: Necrotizing retinitis (in immunocompromised individuals)[Ref]
Metabolic
Uncommon (0.1% to 1%): Anorexia[Ref]
Musculoskeletal
Rare (less than 0.1%): Musculoskeletal pain, myalgia, stiffness, pain of the hip, leg, or neck
Frequency not reported: Chills, stiff neck, arthralgia[Ref]
Some side effects of Varivax may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.