Description of Zostavax
Zostavax is a live attenuated vaccine. It is produced from the same virus strain and by the same process used to produce Varivax, a live varicella zoster virus (VZV) vaccine for prevention of chickenpox. The Drug substance (DS) is equivalent to that in the approved monovalent (VZV) vaccine, (VARIVAX), and the (VZV) component in the tetravalent vaccine, ProQuad. However, Zostavax is manufactured at a higher virus titer than (VARIVAX) and ProQuad. Infection with varicella zoster virus (VZV), an alpha herpes virus, is linked with two distinct diseases; varicella and herpes zoster. Basic infection results in chickenpox (varicella) a generally mild, self-limiting illness usually acquired in childhood or adolescence and affecting almost all individuals. Following initial primary defect with (VZV), the virus remains latent in the dorsal root ganglia. It is assumed that latent virus may frequently reactivate and replicate sub clinically. These episodes of transient sub clinical viremia lead to repeated antigenic stimulation of immunity without clinical manifestations of disease. For a handful of people, however, reactivation and replication of the latent virus result in the clinical manifestation of herpes zoster (HZ), which is often referred to as shingles. HZ is characterized by a unilateral, vesicular rash alongside a dermatomal distribution that generally corresponds to the area of skin innervated by a single spinal or cranial sensory ganglion. Typically, the vesicles crust over in seven to ten days, but may take up to a month to be cured. One of the most significant clinical manifestations of HZ is pain, which is acknowledged to be due to VZV induced neuronal destruction and inflammation.
Possible side effects of Zostavax
Along with its needed effects, a medicine may cause some unwanted effects. Even though not all of these side effects may occur, if they do break up they may need medical attention. Call your doctor or nurse immediatelyif any of the following side effects Zostavax may occur:
i). A more common side effect of Zostavax includes:
- Fever over 39 °C (102 °F)
ii). Less common side effects of Zostavax include:
- Blue lips and fingernails
- Chest pain
- Chickenpox-like skin rash
- Coughing that sometimes produces a pink frothy sputum
- Decreased urine output
- Difficult, fast, or noisy breathing, sometimes with wheezing
- Dilated neck veins
- Extreme fatigue
- Overall sentiment of discomfort or illness
- Increased sweating
- Irregular breathing
- Irregular heartbeat
- Pale skin
- Shortness of breath
- Swelling of the face, lower legs or feet, fingers, ankles
- Tightness in the chest
- Troubled breathing
- Weight gain
- 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
- Common cold
- Cracked, dry, or scaly skin
- Diaper rash
- Disturbed sleep
- Dry skin
- Heat rash or prickly heat
- Lack or loss of strength
- Loss of appetite
- Muscle aching or cramping
- Muscle stiffness
- Runny nose
- Skin rash, encrusted, scaly, and oozing
- Sore throat
- Stuffy nose
- Swollen joints
- Incidence not known
- Bacterial skin infections
- Body aches or pain
- Burning, prickling, crawling, itching, numbness, tingling sentiments or pins and needles
- Difficulty with moving
- Dryness or soreness of the throat
- Pain, swelling, redness, warmth or tenderness of the body
- Red rash with watery, pus filled blisters or yellow-colored,
- Tender, swollen glands in the neck
- Thick yellow to honey-colored crusts
- Voice changes reveals Zostavax side effects
iii). Rare side effects
- Black, tarry stools
- Blood in the urine or stools
- Seizures (convulsions) with high fever
- Difficulty with swallowing or breathing
- 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
- 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 are all indicators of Zostavax side effects
iv). Incidence not known
- Back pain, sudden and severe Zostavax side effects
- Bleeding gums
- Blistering, peeling, or loosening of the skin
- Swelling of the face or bloating, hands, arms, feet or lower legs
- Bloody nose
- Blurred vision
- Bruising more easily
- Convulsions (seizures)
- Fast heartbeat
- 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, throat, tongue, hands, feet or sex organs, legs
- Loss of bladder control
- Muscle jerking or spasm of all extremities
- Painful blisters at the trunk of the body
- Painful knees and ankles
- Pale skin
- Pinpoint red spots on the skin
- Puffiness or swelling of the eyelids or closer the eyes, lips, or tongue, face
- Raised red swellings on the buttocks, skin, ankles or legs
- Rapid weight gain
- Red irritated eyes
- Red skin lesions, often with a purple center
- 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 weakness and numbness in the legs and arms
- Swelling or puffiness of the face
- 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 depicts Zostavax side effects
Some side effects may occur that usually do not need medical attention. These side effects of Zostavax may go away during treatment as your body adjusts to the drug. Equally, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects Zostavax. Check with your health care professional if any of the following side effects of Zostavax continue or are bothersome or if you have any questions about them: Other side effects Zostavax not listed may also occur in a couple of patients. If you realize any other effects, discus with your healthcare professional. Get in touch with your doctor for medical advice about side effects Zostavax. You may report side effects to the FDA at 1-800-FDA-1088.
Patients Counseling information about Zostavax
- Zostavax is used to prevent shingles. Shingles is a painful, blister, rash. It usually happens in one part of the body and can last for many weeks. It may result in severe and long-lasting pain and scarring. Less known, bacterial skin infections, muscle paralysis, weakness, loss of vision or hearing can happen. Shingles are triggered by the same virus that causes chickenpox. After you have been attacked by chickenpox, the virus that caused it remains in your body in nerve cells. More often, after several years, the virus becomes active again and causes shingles. Therefore the uses of Zostavax are to prevent and not to treat shingles once you have it.
- Zostavax may not prevent everyone who receives it from picking shingles. If you do get shingles after you obtain Zostavax, it may help avert nerve pain that can follow shingles in some people. Dialogue any concerns or questions with your doctor.
- Rarely, people who receive Zostavax may spread the vaccine virus to other people. Keep your doctor informed if you have close contact with anyone who has a weakened immune system, with a newborn baby, or with a woman who may be pregnant and has not had chickenpox or been vaccinated against chickenpox. You will need to share the risk of spreading the vaccine virus to these people.
- Some patients who received Zostavax have reported fever, swollen glands near the position of the injection that lasted a few days to a few weeks, or muscle pain or joint. Inform your doctor if you experience side effects Zostavax that become bothersome or persist. Talk about any concerns or questions with your doctor.
- Zostavax should not be applied in children; effectiveness and safety in children have not been confirmed.
- Pregnancy and breastfeeding: Do not use Zostavax if you are pregnant. Do not get pregnant for at least 3 months after you take Zostavax. If you anticipate that you could be pregnant or if you become pregnant within 3 months after taking Zostavax, call your doctor immediately. It is unknown if this drug is found in breast milk. If you are or will be breastfeeding whereas you are on Zostavax, check with your doctor. Make known any possible risks to your baby.
Warnings and Precautions of Zostavax
i). Hypersensitivity reactions
Serious adverse reactions, including anaphylaxis, have happened with Zostavax. Sufficient treatment provisions, including epinephrine injection (1:1,000), should be available for immediate use should an anaphylactic/anaphylactoid reaction occur.
ii).Transmission of vaccine virus
Transmission of vaccine virus may occur between vaccines and susceptible contacts. In clinical trials with Zostavax, transmission of the vaccine virus has not been reported.
However, post-marketing experience with varicella vaccines suggests that transmission of
vaccine virus may occur rarely between vaccines that develop a varicella-like rash and
susceptible contacts. Transmission of vaccine virus from varicella vaccine recipients without a
(VZV) -like rash has been reported but has not been approved. This is a theoretical danger of
vaccination with Zostavax. The risk of transmitting the attenuated vaccine virus to a
susceptible individual should be weighed against the risk of developing natural zoster that could
be transmitted to a susceptible individual.
iii). Concurrent illness
Deferral should be taken into account in acute illness (for example, in the presence of fever) or in patients with active untreated tuberculosis.
iv). Limitations of vaccine effectiveness
Vaccination with Zostavax does not result in protection of all vaccine beneficiaries. The timeline of protection beyond 4 years after vaccination with Zostavax is not known. The need for revaccination is not being clearly defined.
v). Use in pregnancy (Category B2)
Pregnancy Category B2: Animal reproduction studies have not been conducted with Zostavax. It is also not known whether Zostavax can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. However, naturally-occurring (VZV) infection is known to sometimes cause fetal harm. Therefore, Zostavax should not be administered to pregnant women; additionally, pregnancy should be avoided for three months following vaccination.
vi). Use in lactation
It is not known whether (VZV) is secreted in human milk. Therefore, because some viruses are secreted in human milk, caution should be exercised if Zostavax uses are prescribed to a nursing woman.
vii). Use in the elderly
The mean age of subjects enrolled in the largest (N=38,546) clinical study of Zostavax uses was 69 years (range 59-99 years). Of the 19,270 subjects who were given Zostavax, 10,378 were 60-69 years of age, 7,629 were 70-79 years of age, and 1,263 were 80 years of age and even more stricken in age than that. The safety and efficacy data presented in the Pharmacology, Clinical Trials and adverse effects sections were obtained from these subjects. The uses of Zostavax were demonstrated to be generally safe and effective in this population.
Uses of Zostavax
Zostavax is a live attenuated virus vaccine used for the prevention of herpes zoster (shingles) in
individuals 50 years of age and older.
Limitations on the uses of Zostavax:
- Zostavax is not used for the treatment of zoster or postherpetic neuralgia (PHN).
- Zostavax is not used for prevention of primary varicella infection (Chickenpox).
Zostavax is a vaccine used to help prevent shingles (zoster). It can be prescribed to adults 50 years of age and older. Zostavax uses boost your immune system to help protect you from shingles and its complexities. Zostavax cannot be applied to treat existing shingles or the pain associated with existing shingles. Zostavax can reduce the intensity and length of time your pain from shingles will extend. If you are 70 years old or even older beyond 70 years old and you get shingles even though you have been vaccinated, Zostavax uses can help prevent the long-lasting nerve pain that can follow shingles (a painful acute inflammation of the nerve ganglia, with a skin eruption often developing a girdle around the middle of the body. It triggers the same virus as chickenpox).
Symptoms of shingles include a painful, blister, rash that may lead to scarring. The blisters can persist for many weeks. They often occur in one part of the body. The nerve constraint that comes from shingles can last for months or even years after the rash subside. Shingles are caused by the same virus that causes chickenpox (varicella-zoster virus). After your chickenpox blisters are healed, the virus that caused them remains in your body in nerve cells. The virus may be there for several years and not cause a situation. More often, even though, it may become active again. If this occurs, it can cause a blistering and painful rash that may lead to scarring. The blisters can persist for so many weeks. They often occur in one part of the body.
Dosage of Zostavax
i). Recommended dosage of Zostavax and schedule
Zostavax should be administered as a lone 0.65 mL dose subcutaneously in the deltoid region of the upper arm. Do not inject intramuscularly or intravascularly. Use only sterile syringes void of antiseptics, detergents, preservatives, and for every injection and/or reconstitution of the Zostavax medicine. Detergents and antiseptics, preservatives, may incapacitate the vaccine virus.
ii). Preparation for administration
Zostavax is stored frozen and should be reconstituted immediately upon removal from the rapidly ice formation cooler. The diluent should be stored apart at room temperature or in the refrigerator. Use separate sterile needles for reconstitution and administration of Zostavax. To reconstitute the vaccine: Use only the diluent provision. Stop the entire contents of the diluent into a syringe. Inject all of the diluent in the syringe into the vial of lyophilized vaccine and gently agitate to mix thoroughly. Zostavax when reconstituted is a semi-hazy to translucent, off-white to pale yellow liquid. Withdraw the entire contents of reconstituted vaccine into a syringe and inject the total volume subcutaneously.
• Use only the diluent supplied.
• Stop the entire contents of the diluent into a syringe.
• To avoid excessive foaming, gently inject all of the diluent in the syringe into the vial of lyophilized vaccine and gently agitate to mix thoroughly.
• Stop the entire contents of reconstituted vaccine into a syringe and inject the total volume subcutaneously.
• Administer immediately after reconstitution to minimize loss of strength. Throw off reconstituted vaccine if not used within 30 minutes. Do not stifle reconstituted vaccine.
Dosage Forms and Strengths of Zostavax
Zostavax is a lyophilized putting together of live, attenuated varicella-zoster virus (Oka/Merck) to be reconstituted with sterile diluent to give a single dosage of Zostavax suspension with a minimum of 19,400 PFU (plaque forming units) when stored at room temperature for up to 30 minutes.
Overdose of Zostavax
Zostavax is administered by a healthcare provider in a medical setting. It is most probably not possible that an overdose will occur in this setting. However, if overdose is suspected, consult emergency medical attention. Furthermore, if an overdose is noticed with Zostavax, call 1-800-222-1222 (the American Association of Poison Regulatory Centers), your local poison regulatory center, or emergency room immediately. However, it should be noted that the administration of a higher than recommended dose of Zostavax was reported rarely and the adverse reaction profile was comparable to that observed with the recommended dosage of Zostavax.
Storage conditions of Zostavax
- Before reconstitution, Zostavax should be stored frozen at a temperature between -58°F and +5°F (-50°C and -15°C) until it is reconstituted for injection.
- Any freezer, alongside frost-free, that has a separate sealed freezer door and reliably maintains a temperature between -58°F and +5°F (-50°C and -15°C) is acceptable for storing Zostavax.
- Zostavax may be stored and/or transported at refrigerator temperature between 36°F and 46°F (2°C to 8°C) for up to 72 continuous hours prior to reconstitution.
- Vaccine stored between 36°F and 46°F (2°C to 8°C) that is not used within 72 hours of removal from +5°F (-15°C) storage should be discarded.
- Zostavax should be reconstituted immediately upon removal from the freezer. The diluent should be stored apart at room temperature (68°F to 77°F, 20°C to 25°C), or in the refrigerator.
Use in specific populations
Pregnancy Category C: Animal reproduction studies have not been conducted with Zostavax. It is also not known whether Zostavax can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. However, naturally occurring (VZV) infection is known to sometimes cause fatal consequences. Zostavax is not used in women of childbearing age and should not be administered to pregnant females. Vaccines and health care providers are encouraged to report any exposure to Zostavax during pregnancy by calling (800) 986-8999. Available data on the inadvertent administration of Zostavax to pregnant women are insufficient to inform vaccine-associated risks in pregnancy. All pregnancies have a risk of birth defect, loss, or other adverse results. In the overall American population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Zostavax is contraindicated for use in pregnant women because the vaccine is made up of live, attenuated varicella-zoster virus, and it is known that severe-type varicella-zoster virus, if contracted during pregnancy, can result to the congenital varicella syndrome.
Risk Summary: It is not known whether varicella-zoster vaccine virus is excreted in human milk. The developmental and health merits of breastfeeding should be considered along with the mother’s clinical need for Zostavax, and any predominant adverse effects on the breastfed child from Zostavax or from the underlying maternal situation. For preventive vaccines, the vectors of maternal condition are susceptible to disease prevented by the vaccine.
iii). Nursing Mothers
Zostavax is not indicated in women who are breastfeeding. It is unknown whether (VZV) is secreted in human milk. Therefore, because some viruses are secreted in human milk, caution should be exercised if Zostavax is administered to a nursing woman.
iv). Pediatric Use
Zostavax is not indicated for prevention of primary varicella infection (Chickenpox) and should not be used in children and adolescents.
v). Geriatric Use
The median age of subjects enrolled in the largest (N=38,546) clinical study of Zostavax was 69 years (range 59-99 years). Of the 19,270 subjects who obtained Zostavax, 10,378 were 60-69 years of age, 7,629 were 70-79 years old, and 1,263 were 80 years old and even beyond. Above all, there are some important things you have to tell your healthcare provider before attempting Zostavax. These include: have or have had any medical problems. Have taken any medicines, including non-prescription drugs, and dietary supplements. Have any allergies, combining allergies to neomycin or gelatin. Had an allergic reaction to another vaccine. Are pregnant or plan to get pregnant. And are consequently nursing.
A disclaimer: All the contents and information in this article acts as a guide that gives you a packaged clue on what the medicine Zostavax is all about. However, it should be made abundantly clear here that on no account should the information in this article be rated above the doctor’s prescription.