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Heplisav-b Generic Name & Formulations
Legal Class
Rx
General Description
Hepatitis B vaccine (recombinant), adjuvanted (formulated to contain HBsAg 20mcg + CpG 1018 3000mcg) per 0.5mL dose; soln for IM inj; preservative-free.
Pharmacological Class
HB.
How Supplied
Single-dose vials—1, 5
Manufacturer
Generic Availability
NO
Heplisav-b Indications
Indications
Hepatitis B immunization.
Heplisav-b Dosage and Administration
Adult
Give IM inj in deltoid muscle. ≥18yrs: 2 doses (0.5mL each) 1 month apart.
Children
<18yrs: not established.
Heplisav-b Contraindications
Contraindications
Yeast hypersensitivity.
Heplisav-b Boxed Warnings
Not Applicable
Heplisav-b Warnings/Precautions
Warnings/Precautions
Have appropriate medical treatment available to manage possible anaphylactic reactions. Immunocompromised. Pregnancy. Nursing mothers.
Heplisav-b Pharmacokinetics
See Literature
Heplisav-b Interactions
Interactions
Concomitant immunosuppressants: may get sub-optimal response. Concomitant immune globulin; give separately using different syringes at different inj sites. May interfere with lab tests.
Heplisav-b Adverse Reactions
Adverse Reactions
Local reactions (eg, pain, redness, swelling), fatigue, headache, malaise; anaphylaxis.
Heplisav-b Clinical Trials
See Literature
Heplisav-b Note
Notes
To register pregnant patients, call (844) 443-7734.
Heplisav-b Patient Counseling
See Literature
