Okavax (Lyophilisate) Instructions for Use

Marketing Authorization Holder

Research Foundation for Microbial Diseases of Osaka University (BIKEN) (Japan)

ATC Code

J07BK01 (Varicella virus attenuated live)

Active Substance

Varicella vaccine (live) (Ph.Eur.)

Dosage Form

Okavax

Lyophilisate for preparation of solution for subcutaneous administration 1 dose: fl. 1 pc. incl. with solvent (fl. 1 pc.)

Dosage Form, Packaging, and Composition

Solvent water for injections – 0.7 ml.

1 dose (0.5 ml) – vials (1) in a kit with solvent (vial 1 pc.) – cardboard packs.

Clinical-Pharmacological Group

Vaccine for the prevention of chickenpox

Pharmacotherapeutic Group

MIBP-vaccine

Pharmacological Action

The vaccine induces specific humoral and cellular immunity that suppresses the replication of the varicella-zoster virus, thereby preventing the development of the disease. Seroconversion after a single vaccination is observed in more than 90% of cases. Long-lasting post-vaccination immunity is believed to persist for many years.

Indications

• Prevention of chickenpox from 12 months of age in individuals who have not had chickenpox and have not been previously vaccinated;
• Vaccination is particularly indicated for individuals at high risk (see section “Special Precautions”) and for individuals in closed communities (medical hospitals, dormitories, boarding schools, military units, etc.);
• Emergency prevention of chickenpox in individuals who have not previously had the disease and are unvaccinated, as well as individuals at high risk, who have been in direct contact with chickenpox patients (family members, doctors, nursing and junior medical staff; persons involved in patient care).

ICD codes

Dosage Regimen

The drug is administered once subcutaneously into the deltoid muscle region of the shoulder. Intravenous administration of the drug is prohibited!

Immediately before vaccination, the stopper of the vaccine vial is treated with alcohol and, by puncturing with a sterile syringe, 0.7 ml of the supplied solvent (water for injections) is added.

Since the vaccine virus is light-sensitive, the dilution of the vaccine must be carried out under conditions that exclude exposure to direct sunlight.

The time for complete dissolution of the lyophilisate is no more than 2 minutes at a temperature of 20°C (68°F).

After dilution, the contents of the vial must be carefully inspected.

The reconstituted vaccine should be a colorless transparent or slightly whitish liquid without foreign particles.

The vaccine must not be used if foreign particles or other deviations from the normal appearance are detected.

Do not expose to direct light before and after dilution, as the vaccine is light-sensitive and is rapidly inactivated by it.

0.5 ml of the diluted vaccine contains 1 dose of the drug.

Before administering the vaccine, ensure that the needle has not entered a blood vessel.

The diluted vaccine must not be stored.

For emergency prevention of chickenpox, the drug is used in the same dose; it must be administered no later than 72 hours after contact with the source of infection.

Adverse Reactions

Local reactions.

Redness, swelling, and induration may rarely occur at the injection site, resolving on their own within a few days. General reactions.

Sometimes (in 0.1%-5% of cases) in healthy children and adults, 1-3 weeks after vaccination, an increase in body temperature and rash are noted. These symptoms usually disappear on their own within a few days. In rare cases, symptoms of an anaphylactoid reaction (e.g., urticaria, dyspnea, lip edema, laryngeal edema) may develop. In rare cases, other hypersensitivity reactions, such as rash, itching, or increased body temperature, may develop immediately after vaccination and within 24 hours after it. In extremely rare cases (frequency 1:1,000,000), idiopathic thrombocytopenic purpura may develop from several days to three weeks after vaccination. When vaccinating individuals from high-risk groups, a papular and/or vesicular rash accompanied by an increase in body temperature may be observed 14-30 days after vaccination. A similar reaction is observed in approximately 20% of vaccinated individuals with acute lymphocytic leukemia. Vaccination of individuals from high-risk groups may subsequently lead to the development of herpes zoster in them; however, the frequency of its occurrence is equal to or lower than the frequency of this disease in unvaccinated individuals who have had chickenpox.

Contraindications

• History of an anaphylactic reaction to this vaccine or any of its components;
• Severe reaction or post-vaccination complication to a previous administration of this vaccine;
• Pregnancy;
• Primary immunodeficiency with a leukocyte count of less than 1200 cells/μl;
• Secondary immunodeficiency with a leukocyte count of less than 1200 cells/μl (for example, acute myeloid leukemia, T-cell leukemia, or malignant lymphoma – due to the risk of clinical symptoms and the presumed absence of antibody titer increase due to the underlying pathology or chemotherapy for these diseases).

Vaccination is temporarily contraindicated in the following categories of patients

• Individuals with elevated body temperature (from 37.5°C (99.5°F) and above, axillary) – until temperature and clinical picture normalize;
• Individuals with an acute illness – until 2-4 weeks after recovery, and for non-severe acute respiratory viral infections, acute intestinal diseases, etc. – until temperature normalizes. For severe acute diseases of the nervous system (e.g., meningococcal meningitis) until a longer period has elapsed (up to 6 months from the onset of the disease) after stabilization of residual changes;
• During exacerbation of a chronic disease – until complete or maximum achievable remission is achieved, including against the background of maintenance therapy (except for immunosuppressive therapy);
• Before a planned surgical operation – within one month before the date of the operation. 7) Administration of immunosuppressive therapy (see section “Special Precautions”).

With caution

When deciding on vaccination of individuals from the following groups, their general state of health and physical examination data should be taken into account

• Patients with chronic diseases of the cardiovascular system, kidneys, liver;
• Patients with hematological diseases;
• Patients who had fever or symptoms of an allergic reaction (e.g., rash) within two days before any previous immunization;
• Patients with a history of convulsive syndrome;
• Patients suffering from diseases accompanied by impaired immune system function;
• Patients suspected of having an allergy to any components of the vaccine.

Use in Pregnancy and Lactation

Vaccination is contraindicated during pregnancy.

The decision to vaccinate during lactation should be made by a doctor, taking into account the ratio of the expected benefit and the possible risk. According to a clinical study, in 12 seronegative breastfeeding mothers vaccinated, no traces of the virus contained in the vaccine were found in breast milk; all children remained seronegative.

Use in Hepatic Impairment

With caution: patients with chronic liver diseases.

Use in Renal Impairment

With caution: patients with chronic kidney diseases.

Geriatric Use

Since physiological functions are reduced in elderly individuals, their health status should be carefully assessed before vaccination.

Special Precautions

1. As with other injections, the vaccination procedure requires the availability of all medications and instruments to manage a possible anaphylactic reaction. The vaccinated person should remain under the supervision of a healthcare professional for 30 minutes after vaccination.

The vaccinated person is advised to refrain from mental and physical stress on the day of vaccination and the next day, and also not to contaminate the injection site. Parents of the vaccinated child should receive the same instructions.

2. When vaccinating patients with acute lymphocytic leukemia, the following conditions must be met

1) Remission lasting at least 3 months;

2) Lymphocyte count not less than 500/mm³;

3) Positive reactions in the delayed-type hypersensitivity test using tuberculin, dinitrochlorobenzene, or phytohemagglutinin (PHA, 5 μg/0.1 ml);

4) Discontinuation of chemotherapy (except for 6-mercaptopurine) for at least 1 week before immunization and 1 week after immunization;

5) The time of immunization does not coincide with the period of intensification of therapy for leukemia or other therapy with immunosuppressive action, such as radiation therapy. Even if the above conditions are not met (except for cases of pronounced decrease in immune status, in particular, with a lymphocyte count of less than 500/mm³), the vaccine can be administered as an emergency prevention measure in case a patient with leukemia has been in contact with a chickenpox patient.

Clinical data show that under such circumstances, the severity of the natural infection is much higher than the possible side effects of the vaccine. In such cases, the vaccine must be administered within 72 hours after contact.

3. Vaccination of patients with solid tumors should be carried out only under the condition of tumor growth inhibition as a result of chemotherapy or surgery. The conditions described for patients with leukemia also apply to patients from this group.

4. Vaccination of patients receiving ACTH or corticosteroids for nephrosis or severe bronchitis should be carried out provided the clinical condition is stable. In cases of suspected secondary immunodeficiency (see “Contraindications”) caused by drug therapy, delayed-type hypersensitivity tests (see section 2.3) of this section) should be performed before vaccine administration.

5. Since physiological functions are reduced in elderly individuals, their health status should be carefully assessed before vaccination.

6. Women of childbearing age are recommended to use contraception for 1 month before vaccination and 2 months after vaccination.

Drug Interactions

Transfusion of blood components and administration of immunoglobulins

The vaccine may be ineffective in patients receiving blood component transfusions or immunoglobulin preparations because the vaccine virus may be neutralized by antibodies to the Varicella Zoster virus. Vaccination of such patients should be postponed for at least 3 months from the last receipt of immunoglobulin or blood components. In patients receiving high-dose immunoglobulin therapy (200 mg/kg and more), for example, for idiopathic thrombocytopenic purpura or Kawasaki disease, vaccination should be postponed for at least 6 months from the end of immunoglobulin therapy.

If human immunoglobulin was administered within 14 days after the administration of Okavax, the vaccination may be ineffective. Such patients should be revaccinated no earlier than 3 months after the previous vaccination.

Other live vaccines

For individuals who have received live vaccines (polio vaccine, measles, mumps, rubella, BCG, yellow fever vaccine), vaccination with Okavax should be carried out no earlier than 4 weeks later.

Inactivated vaccines

With the exception of the anti-rabies vaccine, simultaneous administration of Okavax and inactivated vaccines from the national immunization schedule and the immunization schedule for epidemic indications is permitted, provided they are administered with different syringes into different parts of the body.

Storage Conditions

Store and transport at a temperature from 2 to 8°C (46.4°F), in a light-protected place. Keep out of reach of children.

Shelf Life

Shelf life – 2 years.

Dispensing Status

By prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.