SKYZoster

SKYZoster

vaccine, varicella-zoster

Manufacturer:

SK Bioscience

Distributor:

Biogenetech

Marketer:

Biogenetech
Full Prescribing Info
Contents
Live, attenuated varicella-zoster virus (in-house) (virus strain: Oka/SK, Cell line: MRC-5).
Description
Each 0.5 mL of reconstituted vaccine contains Live, attenuated varicella-zoster virus (In-house) (Virus strain: Oka/SK, Cell line: MRC-5) ≥ 27,400 PFU.
Appearance: Lyophilized white crystalline pellet in a clear colorless vial. Colorless or pale yellow liquid in the vial when reconstituted to a suspension.
Excipients/Inactive Ingredients: Stabilizers: Sucrose (Ph. Eur.) 25.00 mg, Hydrolyzed gelatin (NF) 12.50 mg, Urea (Ph. Eur.) 1.20 mg, Monosodium glutamate (NF) 0.55 mg, Disodium edetate (Ph. Eur.) 0.25 mg, L-cysteine (JP) 0.25 mg, Glycine (Ph. Eur.) 2.50 mg.
Other excipients: Sodium dihydrogen phosphate dihydrate, Disodium phosphate dodecahydrate, Sodium chloride, Potassium chloride, Sodium hydroxide.
Each diluent contains Sterilized water for injection (Ph. Eur.) 0.7 mL.
Indications/Uses
Prevention of herpes zoster (shingles) in individuals aged 50 years and older.
Dosage/Direction for Use
Administer total reconstituted vaccine volume (about 0.5 mL) as a single dose subcutaneously in the deltoid region of the upper arm. Do not inject intravascularly or intramuscularly.
Reconstitution and Administration instructions: Vial presentation: To reconstitute the vaccine, inject the entire content of the provided diluent into the vial of lyophilized vaccine using enclosed 23G needle and syringe.
Prefilled syringe presentation: To reconstitute the vaccine, inject the entire content of the provided diluent into the vial of lyophilized vaccine using enclosed 23G needle.
Gently agitate to dissolve completely. Withdraw the entire content (approximately 0.5 mL) of the reconstituted vaccine and inject the vaccine subcutaneously using enclosed 25G needle. The vaccine should be administered immediately after reconstitution, in order to minimize loss of potency. Discard reconstituted vaccine, if not used within 30 minutes.
Contraindications
Individuals with a history of hypersensitivity reaction to gelatin or any other component in SKYZoster.
Individuals with a history of anaphylactic/anaphylactoid reaction to neomycin (trace amount of neomycin is present in the reconstituted vaccine).
Individuals with primary and acquired immunodeficiency states due to conditions such as acute and chronic leukemias; lymphoma; other conditions affecting the bone marrow or lymphatic system; immunosuppression due to HIV/AIDS; and cellular immune deficiencies.
Individuals on immunosuppressive therapy (including high-dose corticosteroids). However, SKYZoster is not contraindicated for use in individuals who are receiving topical/inhaled corticosteroids or low-dose systemic corticosteroids or in patients who are receiving corticosteroids as replacement therapy for adrenal insufficiency. SKYZoster may cause disseminated diseases in individuals with immunodeficiency or on immunosuppressive therapy, as the vaccine is live, attenuated zoster virus vaccine.
Individuals with untreated active tuberculosis.
SKYZoster should not be administered to women who are or may be pregnant (see Use in Pregnancy & Lactation).
Special Precautions
The physicians should interview a recipient on post-vaccination experiences of live, attenuated varicella virus vaccine, before administrating SKYZoster.
SKYZoster should be administered only for prevention of herpes zoster (shingles) in individuals aged 50 years and older.
SKYZoster is not indicated for prevention of primary varicella infection (Chickenpox).
SKYZoster should be administered only to a recipient who can induce an adequate immune response.
SKYZoster is not indicated for treatment of zoster or post-herpetic neuralgia.
As with other vaccines, serious adverse reactions, including anaphylaxis, might occur with SKYZoster. Adequate treatment provisions, including epinephrine injection (1:1,000), should be available for immediate use.
Deferral should be considered in acute illness (for example, in the presence of fever, > 38.0°C).
As with other vaccines, vaccination with SKYZoster does not result in protection of all vaccine recipients.
Effectiveness of the multiple-dose of SKYZoster has not been evaluated. The need for a boost dose is not defined.
Transmission of the vaccine virus has not been reported from SKYZoster clinical studies. However with live, attenuated varicella-zoster virus vaccines, transmission of vaccine virus may occur rarely between vaccinees with breakthrough infections and susceptible contacts.
No studies on the effects on the ability to drive or use machines have been performed.
Use in Children: SKYZoster is not indicated for prevention of primary varicella infection (Chickenpox) and should not be used in children and adolescents.
Use in the Elderly:
The median age of subjects enrolled in the clinical studies (N=845), whom were administrated with SKYZoster, was 59 years (range 50~82 years). Of the subjects, 440 were 50~59 years of age, 298 were 60-69 years of age and 107 were 70 years and older. A total number of elderly subjects over 65 years of age was 229.
Use In Pregnancy & Lactation
Safety of SKYZoster has not been evaluated in pregnant women. Direct and/or indirect adverse effect related to reproduction and developmental toxicity has not been observed in animal studies. However, SKYZoster should not be administered to pregnant women since naturally occurring varicella-zoster virus infection is known to sometimes cause fetal harm. Pregnancy should be avoided for 3 months following administration of SKYZoster (refer to Contraindications).
It is not known whether varicella-zoster vaccine virus is excreted in human milk. However, since human milk transmission of maternal viral infection is established for some viruses, SKYZoster should not be administered to nursing mothers.
Adverse Reactions
Local (injection site) reaction: Pain, erythema/redness, and induration/swelling may occur.
Systemic reaction: Myalgia, fatigue/malaise, headache, diarrhea, vomiting and fever may occasionally occur after vaccination.
Safety of SKYZoster was evaluated in 842 subjects aged 50 years and older and 401 subjects (47.62%) experienced adverse drug reactions.
Solicited adverse drug reactions (local and systemic reactions) are summarized in Table 1 as follows. (See Table 1.)

Click on icon to see table/diagram/image

Unsolicited adverse drug reactions were reported in 19 (2.26%) out of 842 subjects during 6 weeks post-vaccination of SKYZoster. The most frequently reported unsolicited adverse drug reaction was skin and subcutaneous tissue disorders with 6 subjects (0.71%) reporting 7 cases. With regard to the outcomes of adverse drug reactions, all subjects were recovered without sequelae. Adverse drug reactions occasionally observed (≥ 0.1 and < 5%) during the study period are shown as follows. (See Table 2.)

Click on icon to see table/diagram/image

6 cases of serious adverse events were reported in 6 (0.71%) out of 842 subjects during 6 weeks post-vaccination reporting period (gastric cancer, bronchitis, contusion, lower limb fracture, pancreatitis, ligament sprain). All of these serious adverse events were determined to not have a causal relationship with SKYZoster.
Varicella-like and zoster-like rashes were diagnosed in 3 out of 842 subjects vaccinated with SKYZoster during 6 weeks post-vaccination reporting period and their causal relationship with SKYZoster could not be ruled out.
In phase I clinical trial, no subjects from the SKYZoster group and Zostavax group reported varicella-like or zoster-like rash during 6 weeks post-vaccination reporting period.
In phase II/III clinical trial, 2 subjects reported varicella-like and zoster-like rash within 6 weeks post-vaccination. The specimen acquired from the subjects with zoster-like rash could not be determined as the specimen was inadequate for Polymerase Chain Reaction (PCR) testing. From the PCR testing result of the varicella-like rash specimen, varicella-zoster virus was detected, but not able to determine the virus strain (wild type or Oka/SK strain).
In phase III clinical trial, one subject from each SKYZoster and Zostavax group reported varicella-like and zoster-like rashes. Of the reported cases, one case of varicella-like rash was reported in the SKYZoster group and while the PCR testing detected varicella-zoster virus, it could not determine virus strain (wild type or Oka/SK strain). The PCR testing on one case of zoster-like rash reported in Zostavax group also detected varicella-zoster virus but the virus strain (wild type or Oka/Merck) could not be determined.
Drug Interactions
Concurrent administration of SKYZoster and anti-viral medications known to be effective against varicella-zoster virus has not been evaluated.
Caution For Usage
Store SKYZoster refrigerated at 2°C to 8°C.
SKYZoster should be reconstituted immediately upon removal from the refrigerator. After reconstitution, the vaccine should be used right away or up to 30 minutes when stored at room temperature. Do not freeze reconstituted vaccine.
To reconstitute and administer the vaccine in vial presentation, use the sterile syringe and needles provided. Dispose used needles appropriately to prevent being re-used to other individuals.
To reconstitute and administer the vaccine in prefilled syringe presentation, use the needles provided in the package. Dispose used needles appropriately to prevent being re-used to other individuals.
Store in the original package and this medicinal product must not be mixed with other medicinal products in one syringe.
Storage
Keep refrigerated at 2°C to 8°C in a hermetic container away from light. Do not freeze.
ATC Classification
J07BK - Varicella zoster vaccines ; Used for active immunizations.
Presentation/Packing
Inj (single dose lyo vial + 0.7 mL diluent in pre-filled syringe) ≥27,400 PFU (lyophilized white crystalline pellet) x 0.5 mL x 1's.
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