Zoster Vaccine Recombinant

Zoster Vaccine Recombinant is a vaccine indicated for the prevention of herpes zoster (shingles) in adults aged 50 years and older.

• Zoster Vaccine Recombinant is available under the following different brand names: Shingrix

Adult dosage

Injection, single-dose IM suspension

• 0.5mL

Shingles Prophylaxis

Adult dosage

• Adults above 50 years of age: 0.5 mL IM x2 doses administered 2-6 months apart
• Immunocompromised adults
• Adults aged above 18 years: 0.5 mL IM x2 doses administered 1-2 months apart
•  ACIP recommendation
• Administer 2 doses of recombinant zoster vaccine (RZV) (Shingrix) 2-6 months apart to adults aged above 50 years regardless of past episode of herpes zoster or receipt of zoster vaccine live (ZVL) (Zostavax); as of November 2020, Zostavax is no longer marketed in the United States
• Administer 2 doses of RZV 2-6 months apart to adults who previously received ZVL at least 2 months after ZVL
• Current immunization schedules available at http://www.cdc.gov/vaccines/schedules/hcp/index.html
• Limitations of Use
  • Shingrix is not indicated for the prevention of primary varicella infection (chickenpox) 

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of Zoster Vaccine Recombinant include:

• injection site reactions (pain, redness, and swelling),
• muscle pain,
• fatigue,
• headache,
• shivering,
• fever,
• nausea,
• vomiting,
• diarrhea, and
• abdominal pain.

Serious side effects of Zoster Vaccine Recombinant include:

• signs of an allergic reaction: hives, difficulty breathing, swelling of the face, lips, tongue, or throat.

Rare side effects of Zoster Vaccine Recombinant include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Zoster Vaccine Recombinant has severe interactions with no other drugs.
• Zoster Vaccine Recombinant has serious interactions with the following drugs:
  • ofatumumab SC
  • siponimod
• Zoster Vaccine Recombinant has moderate interactions with at least 65 other drugs.
• Zoster Vaccine Recombinant has minor interactions with the following drug: 
  • ozanimod

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Hypersensitivity (e.g., anaphylaxis) to any component of the vaccine

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Zoster Vaccine Recombinant?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Zoster Vaccine Recombinant?”

Cautions

• Review immunization history for possible vaccine sensitivity and previous vaccination-related adverse reactions; appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration (see Contraindications)
• In a post-marketing observational study, an increased risk of Guillain-Barre syndrome was observed during the 42 days following vaccination
• Syncope can be associated with injectable vaccine administration; may be accompanied by transient neurological signs (visual disturbance, paresthesia, tonic-clonic limb movements); procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope
• Drug interactions overview
  • Use caution with concomitant use of vaccine administration of zoster recombinant with inactivated influenza
  • Immunosuppressive therapies may reduce the effectiveness of the zoster vaccine

Pregnancy and Lactation

• There are no available human data to establish vaccine-associated risks with the vaccine in pregnant women
• Lactation
  • Unknown whether the zoster vaccine is excreted in human milk
  • Data are not available to assess the effects of the zoster vaccine on the breastfed infant or milk production/excretion