Rabix-VC2.5 IU/ml

Rabix-VC is indicated for active immunization against rabies in the following settings:

Pre-exposure prophylaxis (established use)

• Individuals at high occupational or recreational risk of rabies exposure, including veterinarians, animal handlers, wildlife workers, laboratory personnel working with rabies virus, and spelunkers.
• Travelers to rabies-endemic areas, especially where access to prompt medical care and rabies immunoglobulin is limited.
• Children living in or visiting endemic areas, as they are at greater risk of unrecognized animal bites.

Post-exposure prophylaxis (established, guideline-supported use)

• Any person bitten, scratched, or exposed via mucous membrane or open wound to saliva of a potentially rabid animal (e.g., dog, cat, bat, raccoon, fox, or other mammal at risk for rabies), regardless of prior vaccination status.
• In previously unvaccinated individuals, Rabix-VC is given together with human rabies immunoglobulin (as combination therapy) in addition to thorough wound care.
• In previously vaccinated individuals, an abbreviated course of Rabix-VC alone (without immunoglobulin) is used.

Rabies is a medical emergency once exposure has occurred; post-exposure prophylaxis with Rabix-VC should not be delayed while confirming animal rabies status if exposure is significant.

Rabix-VC is a killed (inactivated) virus vaccine that stimulates the body's immune system to produce protective antibodies against the rabies virus, a lyssavirus that causes an almost universally fatal acute encephalomyelitis if untreated after exposure.

Rabix-VC is used both to prevent rabies before a potential exposure occurs (pre-exposure prophylaxis) and to prevent disease after a bite or other exposure to a potentially rabid animal (post-exposure prophylaxis), as part of a defined multi-dose immunization series.

Rabix-VC belongs to the therapeutic class of inactivated viral vaccines, specifically within the vaccines, sera, and immunoglobulins group used for active immunoprophylaxis against rabies.

Rabies Vaccine [Human] contains inactivated (killed) rabies virus antigen that, upon intramuscular injection, is processed by the immune system to stimulate production of rabies virus neutralizing antibodies (RVNA) and a memory immune response, without causing rabies infection.

Protective antibody titers (generally considered adequate at ≥0.5 IU/mL by the rapid fluorescent focus inhibition test) typically develop within 7-14 days of starting the primary series and persist for a variable duration, which is why booster doses or antibody titer monitoring are recommended for individuals with ongoing high risk of exposure. In post-exposure settings, Rabies Vaccine [Human] works together with passively administered rabies immunoglobulin (which provides immediate, temporary antibody coverage at the wound site) to bridge the gap until the person's own active immune response develops.

Rabix-VC is administered by intramuscular injection only.

• Adults and older children: deltoid muscle of the upper arm.
• Infants and young children: anterolateral thigh muscle.
• The gluteal (buttock) region must be avoided, as absorption there is unreliable and may reduce vaccine effectiveness.
• When immunoglobulin is co-administered, it must be given at a different anatomical site from Rabix-VC, using a separate syringe, and never mixed in the same syringe.

Rabix-VC has the following clinically significant interactions:

• Immunosuppressive therapies (e.g., corticosteroids, chemotherapy, biologic immunosuppressants, antimalarials such as chloroquine): may reduce the antibody response to Rabix-VC. If possible, immunosuppressive drugs should be avoided during vaccination and antibody titers should be checked after completion of the series in these patients.
• Human rabies immunoglobulin: when given together for post-exposure prophylaxis in unvaccinated persons, it must be administered at a separate injection site and never in the same syringe as Rabix-VC, as mixing or co-localized injection can blunt the active immune response to the vaccine.
• Other live or inactivated vaccines: can generally be co-administered at different injection sites; no clinically significant interference has been well established.

Side effects of Rabix-VC are generally mild and self-limited.

Common

• Injection site pain, redness, swelling, or itching
• Headache
• Muscle aches (myalgia)
• Low-grade fever
• Dizziness, nausea, abdominal pain

Uncommon/Rare

• Generalized urticaria (hives) or rash, sometimes as an immune-complex-like reaction after booster doses
• Lymphadenopathy
• Anaphylaxis and other serious hypersensitivity reactions
• Neurological events such as Guillain-Barré syndrome or transient neuroparalytic reactions (rare and not conclusively causally linked in all cases)
• Syncope (fainting) around the time of injection

Pregnancy is not a contraindication to Rabix-VC when used for post-exposure prophylaxis, given that untreated rabies is virtually always fatal to both mother and fetus. For pre-exposure prophylaxis during pregnancy, Rabix-VC should be used only if clearly needed, weighing the ongoing risk of exposure against any theoretical risk, and only after consulting a physician.

It is not known whether Rabix-VC or its components are excreted in human breast milk; however, breastfeeding is not considered a reason to withhold or delay Rabix-VC when indicated, particularly for post-exposure prophylaxis. A physician should be consulted regarding use during breastfeeding.

The following precautions apply to the use of Rabix-VC:

• In persons with moderate to severe acute febrile illness, elective pre-exposure doses of Rabix-VC may be deferred until recovery; however, post-exposure prophylaxis should never be delayed for this reason, given the fatal nature of untreated rabies.
• Persons on immunosuppressive therapy may have a reduced antibody response; antibody titer testing after the series is advisable in this group (see Interactions).
• Epinephrine and other appropriate medical treatment should be immediately available whenever Rabix-VC is administered, in case of an acute hypersensitivity reaction.
• Vaccinated individuals should be observed for a short period after injection due to the possibility of syncope.
• Post-exposure prophylaxis is time-critical: immediate wound cleansing and prompt initiation of Rabix-VC (with immunoglobulin if indicated) substantially improve effectiveness, and any significant animal exposure should be treated as a medical emergency.
• Rabix-VC should be administered only by or under the supervision of a qualified healthcare professional, exactly as prescribed, completing the full dosing series on schedule.

There is limited data on overdose with Rabix-VC, as it is administered in fixed, individual doses by healthcare professionals. If an excessive dose or dosing frequency is inadvertently given, or if a severe reaction occurs after administration, seek immediate medical attention or contact emergency services/a poison control center. Do not attempt home treatment for a suspected vaccine overdose or severe reaction.

Elderly: No dose adjustment is required for Rabix-VC based on age alone; older adults may occasionally mount a somewhat lower antibody response, so post-vaccination titer checks may be considered in select cases.

Immunocompromised individuals (e.g., HIV infection, organ transplant recipients, those on immunosuppressive therapy): May have a reduced immune response to Rabix-VC; an additional dose (5th dose on Day 28) is recommended for post-exposure prophylaxis in unvaccinated immunocompromised patients, and antibody titer testing after completion of the series is advised.

Renal/Hepatic impairment: No well-established dose adjustment is required for Rabix-VC in renal or hepatic impairment; use per standard schedule with routine clinical judgment.

For pre-exposure prophylaxis, the primary series of Rabix-VC is completed over approximately 21-28 days (3 doses), with booster doses given periodically thereafter based on ongoing risk. For post-exposure prophylaxis, the full course of Rabix-VC is completed over 14-28 days depending on prior vaccination status and immune status; the series must be completed in full even if the biting animal is later found to be healthy, unless testing/observation clearly rules out rabies risk per medical advice.

Rabix-VC is supplied as a lyophilized (freeze-dried) powder that must be reconstituted with the accompanying diluent immediately before administration. Reconstitute by adding the entire volume of diluent to the vial of powder and gently swirling (not shaking vigorously) until the powder is fully dissolved, producing a clear to slightly opalescent solution. Use the reconstituted Rabix-VC immediately; discard if not used promptly or if the solution appears discolored or contains particulate matter.

Inactivated viral vaccine; Rabies immunoprophylaxis agent

Rabies Vaccine [Human] contains inactivated rabies virus antigen that cannot cause rabies infection but is recognized by the immune system as foreign. This triggers production of rabies virus neutralizing antibodies and stimulates memory B- and T-cell responses, so that upon future exposure to live rabies virus, the immune system can rapidly mount a protective antibody response before the virus can travel to the central nervous system and cause disease.

Rabix-VC may be used in infants and children of all ages for both pre-exposure and post-exposure prophylaxis, using the same dose volume per injection as adults (dose is not weight-based or age-based). In infants and young children, Rabix-VC is administered in the anterolateral thigh rather than the deltoid. Given the severity of rabies, post-exposure prophylaxis should never be withheld or delayed in a child with a significant exposure. Formal comparative safety and efficacy data in very young infants are limited, but published experience supports use of Rabix-VC across pediatric age groups when clinically indicated.