Shingrix 0.5ml Im Vial (10 Pack)
It is used to prevent shingles.
Drug Class
Vaccine
Pharmacologic Class
Recombinant Zoster Vaccine, Adjuvanted
Pregnancy Category
Not available
FDA Approved
Oct 2017
DEA Schedule
Not Controlled
Overview
What is this medicine?
Shingrix is a vaccine given by injection to help prevent shingles (herpes zoster) in adults. Shingles is a painful rash caused by the same virus that causes chickenpox. Shingrix works by helping your body build up protection against this virus.
How to Use This Medicine
To use this medication correctly, follow your doctor's instructions and carefully read all accompanying information. Take this medication exactly as directed, and be sure to follow all instructions provided. This medication is administered via intramuscular injection.
If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the proper storage procedure.
In the event that you miss a dose, contact your doctor to receive guidance on the appropriate course of action.
If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the proper storage procedure.
In the event that you miss a dose, contact your doctor to receive guidance on the appropriate course of action.
Lifestyle & Tips
- Maintain good hygiene to prevent infections.
- Report any severe or unusual side effects to your healthcare provider.
- Keep your vaccination record updated.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
0.5 mL administered intramuscularly in a 2-dose series. The second dose should be administered 2 to 6 months after the first dose.
Dose Range:
0.5 - 0.5 mg
Condition-Specific Dosing:
immunocompromised_18_plus:
0.5 mL administered intramuscularly in a 2-dose series. The second dose should be administered 1 to 2 months after the first dose.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established (approved for 18 years and older)
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Dialysis:
No specific adjustment recommended, but immune response may be attenuated in patients on dialysis.
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Pharmacology
Mechanism of Action
Shingrix is a recombinant subunit vaccine that contains glycoprotein E (gE) antigen, a key protein found on the varicella-zoster virus (VZV), combined with an adjuvant system (AS01B). The gE antigen stimulates the immune system to produce gE-specific CD4+ T-cells and humoral immunity (antibodies) against VZV, providing protection against herpes zoster (shingles). The adjuvant system enhances the immune response, leading to a stronger and more durable immunity.
Pharmacokinetics
Absorption:
Bioavailability:
Not applicable (vaccine, not systemically absorbed in the traditional sense)
Tmax:
Not applicable
FoodEffect:
Not applicable
Distribution:
Vd:
Not applicable
ProteinBinding:
Not applicable
CnssPenetration:
Not applicable
Elimination:
HalfLife:
Not applicable
Clearance:
Not applicable
ExcretionRoute:
Not applicable
Unchanged:
Not applicable
Pharmacodynamics
OnsetOfAction:
Immune response typically develops within weeks after the second dose.
PeakEffect:
Peak antibody and T-cell responses are observed several weeks after the second dose.
DurationOfAction:
Protection has been demonstrated for at least 10 years post-vaccination in clinical trials.
Confidence:
High
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention immediately:
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
Guillain-Barre syndrome, a rare nervous system disorder, 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. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, 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, don't hesitate to contact your doctor. You can also report side effects to the FDA/CDC Vaccine Adverse Event Reporting System (VAERS) online at https://vaers.hhs.gov/reportevent.html or by calling 1-800-822-7967. Your doctor can provide medical advice about side effects and help you manage any concerns.
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention immediately:
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
Guillain-Barre syndrome, a rare nervous system disorder, 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. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, 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, don't hesitate to contact your doctor. You can also report side effects to the FDA/CDC Vaccine Adverse Event Reporting System (VAERS) online at https://vaers.hhs.gov/reportevent.html or by calling 1-800-822-7967. Your doctor can provide medical advice about side effects and help you manage any concerns.
Seek Immediate Medical Attention If You Experience:
- Signs of a severe allergic reaction (anaphylaxis) such as difficulty breathing, wheezing, hives, swelling of the face or throat, dizziness, or weakness. Seek immediate medical attention.
- High fever (above 102°F or 39°C) that does not respond to fever reducers.
- Severe or persistent pain, redness, or swelling at the injection site that worsens or spreads.
- Any new or worsening symptoms after vaccination.
Before Using This Medicine
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.
Potential interactions with other medications or health conditions. To ensure safe use, disclose all medications you are currently taking, including:
+ Prescription medications
+ Over-the-counter (OTC) medications
+ Natural products
+ Vitamins
* Any existing health problems, as they may affect the safety and efficacy of this medication.
To avoid potential interactions, do not start, stop, or modify the dosage of any medication without first consulting your doctor. It is crucial to verify that it is safe to take this medication in conjunction with all your other medications and health conditions.
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.
Potential interactions with other medications or health conditions. To ensure safe use, disclose all medications you are currently taking, including:
+ Prescription medications
+ Over-the-counter (OTC) medications
+ Natural products
+ Vitamins
* Any existing health problems, as they may affect the safety and efficacy of this medication.
To avoid potential interactions, do not start, stop, or modify the dosage of any medication without first consulting your doctor. It is crucial to verify that it is safe to take this medication in conjunction with all your other medications and health conditions.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Certain individuals may experience dizziness or fainting when receiving this drug as an injection. Additionally, some people may notice changes in vision, abnormal sensations such as 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, it is crucial to discuss this with your doctor. You and your doctor will need to weigh the benefits and risks of this medication to both you and your baby.
If you are pregnant, planning to become pregnant, or are breastfeeding, it is crucial to discuss this with your doctor. You and your doctor will need to weigh the benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- No specific symptoms of overdose are known for vaccines, as they are administered in fixed, small doses. However, administration of more than the recommended dose may increase the risk or severity of local or systemic reactions.
What to Do:
Contact a healthcare professional or poison control center (1-800-222-1222) for advice. Symptomatic and supportive care should be provided as needed.
Drug Interactions
Moderate Interactions
- Immunosuppressants (e.g., corticosteroids, chemotherapy, biologics)
Monitoring
Baseline Monitoring
Patient history (age, immunocompromised status, previous zoster episodes)
Rationale: To determine eligibility and appropriate dosing schedule.
Timing: Prior to first dose
Allergy history (especially to vaccine components)
Rationale: To identify potential contraindications.
Timing: Prior to first dose
Routine Monitoring
Injection site reactions (pain, redness, swelling)
Frequency: Within 7 days post-vaccination
Target: Mild to moderate, self-limiting
Action Threshold: Severe or persistent reactions, signs of infection (e.g., pus, spreading redness beyond injection site)
Systemic reactions (myalgia, fatigue, headache, fever, shivering, GI symptoms)
Frequency: Within 7 days post-vaccination
Target: Mild to moderate, self-limiting
Action Threshold: Severe or persistent symptoms, high fever, signs of allergic reaction (e.g., difficulty breathing, hives, swelling of face/throat)
Symptom Monitoring
- Injection site pain
- Injection site redness
- Injection site swelling
- Muscle pain (myalgia)
- Fatigue
- Headache
- Fever
- Shivering
- Gastrointestinal symptoms (nausea, vomiting, diarrhea)
- Rash (rare, but should be reported)
- Signs of allergic reaction (hives, swelling of face/throat, difficulty breathing, dizziness, weakness)
Special Patient Groups
Pregnancy
There are no adequate and well-controlled studies of Shingrix in pregnant women. Shingrix is not a live vaccine, so the theoretical risk to the fetus is low. Vaccination should be considered only if the potential benefits outweigh the potential risks to the mother and fetus. Consult with a healthcare provider.
Trimester-Specific Risks:
First Trimester:
No specific data, theoretical risk low.
Second Trimester:
No specific data, theoretical risk low.
Third Trimester:
No specific data, theoretical risk low.
Lactation
It is not known whether Shingrix is excreted in human milk. 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 infant from Shingrix or from the underlying maternal condition. Consult with a healthcare provider.
Infant Risk:
Not available (theoretical risk low due to non-live vaccine)
Pediatric Use
Safety and effectiveness have not been established in individuals younger than 18 years of age. Not indicated for pediatric use.
Geriatric Use
Approved for adults 50 years of age and older. No dose adjustment is required based on age. Efficacy and immunogenicity remain high in older adults, though local and systemic reactions may be slightly more frequent or severe in younger adults (50-69 years) compared to older adults (70+ years).
Clinical Information
Clinical Pearls
- Shingrix is a non-live, recombinant vaccine, making it safe for immunocompromised individuals (unlike the older live zoster vaccine, Zostavax).
- It requires a 2-dose series for full efficacy. Adherence to the dosing schedule (2-6 months apart for general population, 1-2 months for immunocompromised) is crucial for optimal protection.
- Common side effects are injection site reactions (pain, redness, swelling) and systemic symptoms (fatigue, muscle pain, headache), which are usually mild to moderate and resolve within 2-3 days.
- Despite the side effects, the high efficacy (over 90%) and long-lasting protection make it a highly recommended vaccine for eligible individuals.
- Can be co-administered with other routinely recommended adult vaccines (e.g., influenza, tetanus-diphtheria-acellular pertussis [Tdap], pneumococcal) at different injection sites.
Alternative Therapies
- Zostavax (Zoster Vaccine Live): An older, live attenuated vaccine, less effective than Shingrix and not recommended for immunocompromised individuals. No longer marketed in the US as of July 1, 2020.
- Antiviral medications (e.g., acyclovir, valacyclovir, famciclovir): Used for treatment of acute herpes zoster or postherpetic neuralgia, not for prevention.
Cost & Coverage
Average Cost:
$180 - $220 per dose per 0.5 mL vial
Insurance Coverage:
Often covered by Medicare Part D, Medicare Part B (for certain conditions), and most private insurance plans. Coverage may vary by plan and state.
General Drug Facts
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 to do so by a healthcare professional, avoid flushing medications down the toilet or pouring them down the drain. If you are unsure about the proper disposal method, consult your pharmacist, who can also inform you about potential drug take-back programs in your area. Some medications may come with an additional patient information leaflet, which your pharmacist can provide. 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 medical attention. Be prepared to provide information about the medication taken, the amount, and the time of ingestion.