Twinrix

Indications
Dosage
How Supplied

INDICATIONS

TWINRIX® is indicated for active immunization against disease caused by hepatitis A virus and infection by all known subtypes of hepatitis B virus. TWINRIX is approved for use in persons 18 years of age or older.

DOSAGE AND ADMINISTRATION

Preparation For Administration

Shake well before use. With thorough agitation, TWINRIX is a slightly turbid white suspension. Do not administer if it appears otherwise. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If either of these conditions exists, the vaccine should not be administered.

For the prefilled syringes, attach a sterile needle and administer intramuscularly.

For the vials, use a sterile needle and sterile syringe to withdraw the 1-mL dose and administer intramuscularly. Changing needles between drawing vaccine from a vial and injecting it into a recipient is not necessary unless the needle has been damaged or contaminated. Use a separate sterile needle and syringe for each individual.

Administration

TWINRIX should be administered by intramuscular injection only as a 1-mL dose. Administer in the deltoid region. Do not administer in the gluteal region; such injections may result in a suboptimal response.

Do not administer this product intravenously, intradermally, or subcutaneously.

Recommended Dose And Schedule

Standard dosing schedule consists of 3 doses (1 mL each), given intramuscularly at 0, 1, and 6 months. Alternatively, an accelerated schedule of 4 doses (1 mL each), given intramuscularly on days 0, 7, and 21 to 30 followed by a booster dose at month 12 may be used.

HOW SUPPLIED

Dosage Forms And Strengths

Suspension for injection available in 1-mL single-dose vials and prefilled TIP-LOK® syringes [see DESCRIPTION and Storage and Handling].

Storage And Handling

TWINRIX is available in 1-mL single-dose vials and 1-mL single-dose prefilled disposable TIP-LOK syringes (packaged without needles) (Preservative Free Formulation):

NDC 58160-815-01 Vial in Package of 10: NDC 58160-815-11
NDC 58160-815-05 Syringe in Package of 1: NDC 58160-815-34
NDC 58160-815-43 Syringe in Package of 10: NDC 58160-815-52

Store refrigerated between 2° and 8°C (36° and 46°F). Do not freeze; discard if product has been frozen.

Manufactured by GlaxoSmithKline Biologicals, Rixensart, Belgium, US License No. 1617. Distributed by GlaxoSmithKline, Research Triangle Park, NC 27709. Revised: 12/2013

Last reviewed on RxList: 8/29/2014
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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