Shingrix 0.5ml Im Vial (1pack)

Shingrix is a recombinant zoster vaccine that contains glycoprotein E (gE) antigen from the varicella zoster virus (VZV) and an adjuvant system, AS01B. The gE antigen is critical for VZV replication and spread. The AS01B adjuvant system, composed of QS-21 and MPL, enhances the immune response to the gE antigen, leading to robust and sustained cell-mediated and humoral immunity against VZV.

Urgent Side Effects: Seek Medical Attention Immediately
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical help right away:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
A nervous system problem called Guillain-Barre syndrome, which may cause:
+ Weakness
+ Burning, numbness, or tingling sensations that are not normal

Other Possible Side Effects
Like all medications, this drug can cause side effects. Although many people do not experience any side effects or only have mild ones, it is essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or do not go away, contact your doctor or seek medical help:

Pain, redness, or swelling at the injection site
Muscle pain
Feeling tired or weak
Headache
Shivering
Fever
Upset stomach or vomiting
Stomach pain or diarrhea

Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA/CDC Vaccine Adverse Event Reporting System (VAERS) at https://vaers.hhs.gov/reportevent.html or by calling 1-800-822-7967.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, any of its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist identify potential interactions between this medication and other substances.
* Any existing health problems, as this medication may interact with certain conditions.

To ensure your safety, it is crucial to verify that this medication can be taken with all your current medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

When receiving this drug as an injection, such as a vaccine, some individuals may experience dizziness or fainting. Additionally, other possible side effects include changes in vision, abnormal sensations like burning, numbness, or tingling, or stiffening or jerking muscle movements. If you experience any of these symptoms, notify your doctor immediately.

If you are pregnant, planning to become pregnant, or are breastfeeding, you must discuss this with your doctor. This conversation will help you understand the benefits and risks of taking this medication to both you and your baby, allowing you to make an informed decision.

• Immunosuppressive therapies (e.g., high-dose corticosteroids, chemotherapy, biologics): May reduce the immune response to the vaccine.

• Other vaccines: Can be co-administered with other routinely recommended adult vaccines (e.g., influenza vaccine, pneumococcal vaccines) at different injection sites.

• Injection site reactions (pain, redness, swelling)
• Systemic reactions (myalgia, fatigue, headache, fever, shivering, gastrointestinal symptoms)
• Signs of allergic reaction (rash, hives, swelling of face/throat, difficulty breathing, dizziness, weakness)

Shingrix is not routinely recommended during pregnancy. While it is a non-live vaccine, there are no adequate and well-controlled studies in pregnant women. Vaccination should generally be deferred until after pregnancy unless the potential benefits outweigh the potential risks.

It is not known whether Shingrix is excreted in human milk. However, because Shingrix is not a live vaccine, it is generally considered compatible with breastfeeding. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Shingrix and any potential adverse effects on the breastfed child from Shingrix or from the underlying maternal condition.

Shingrix is not indicated for use in individuals younger than 18 years of age.

Shingrix is indicated for adults 50 years of age and older. This population is the primary target for vaccination due to increased risk of shingles and postherpetic neuralgia with age. No dose adjustment is needed for geriatric patients.

• Shingrix is a non-live, recombinant vaccine, making it safe for immunocompromised individuals.
• The AS01B adjuvant system contributes to the vaccine's high efficacy but also to higher rates of local and systemic reactogenicity compared to other vaccines.
• Completion of the 2-dose series is crucial for achieving and maintaining high levels of protection.
• Can be co-administered with other adult vaccines (e.g., flu, pneumococcal) at separate injection sites.
• Patients should be advised about the expected reactogenicity (pain, redness, swelling at injection site, muscle aches, fatigue, headache) which are generally mild to moderate and resolve within 2-3 days.

• No other currently marketed shingles vaccine in the US (Zostavax, a live attenuated vaccine, was discontinued in 2020).
• Antiviral medications (e.g., acyclovir, valacyclovir, famciclovir) for treatment of acute shingles episodes.

If your symptoms or health problems persist or worsen, it is essential to contact your doctor for further guidance. To ensure safe use, never share your medication with others, and do not take medication prescribed to someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly. Unless instructed otherwise, do not flush medications down the toilet or pour them down the drain. If you are unsure about the correct disposal method, consult your pharmacist for advice. Many communities have drug take-back programs, which your pharmacist can help you locate. Some medications may come with an additional patient information leaflet; check with your pharmacist to see if this applies to your prescription. If you have any questions or concerns about your medication, discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time it was taken to ensure prompt and effective treatment.