effects of hepatitis a/b vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Inactivated vaccines noted to be safe for administration may not be sufficiently immunogenic during treatment. Suspected adverse events after administration of any vaccine may be reported to Vaccine Adverse Events Reporting System (VAERS), 1-800-822-7967 >10% Soreness (37%) Headache (22%) Fatigue (14%) 1-10% Redness (8%) Diarrhea (5%) Nausea (4%) Fever (4%) Swelling (4%) Contraindications Hypersensitivity to drug or excipients including yeast and neomycin Cautions Contains thimerosal (<1 mcg mercury) The tip caps of the prefilled syringes contain natural rubber latex which may cause allergic reactions Syncope (fainting) can occur in association with administration of injectable vaccines; syncope can be accompanied by transient neurological signs such as visual disturbance, paresthesia, and tonic-clonic limb movements; procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope Prior to immunization, the healthcare provider should review immunization history for possible vaccine sensitivity and previous vaccination-related adverse reactions to allow an assessment of benefits and risks; appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine To avoid diagnostic confusion between manifestations of an acute illness and possible vaccine adverse effects, vaccination should be postponed in persons with moderate or severe acute febrile illness unless they are at immediate risk of hepatitis A or hepatitis B infection Immunocompromised persons, including individuals receiving immunosuppressive therapy, may have a diminished immune response to vaccine Hepatitis A and hepatitis B have relatively long incubation periods; vaccine may not prevent hepatitis A or hepatitis B infection in individuals who have an unrecognized hepatitis A or hepatitis B infection at time of vaccination; additionally, vaccination may not protect all individuals Results from clinical studies indicate that there is no association between hepatitis B vaccination and development of multiple sclerosis and that vaccination with hepatitis B vaccine does not appear to increase the short-term risk of relapse in multiple sclerosis Pregnancy Category: C Lactation: not known if excreted in breast milkPregnancy Categories A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk. B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available. Mechanism of Action Inactivated HAV combined with purified HBsAg induce Ab production Onset: unknown Duration: unknown These products convey active immunity via stimulation of production of endogenously produced antibodies The onset of protection from disease is relatively slow, but duration is long lasting (years) The vaccine should be re-suspended before use; when re-suspended, the vaccine will have a uniform hazy white appearanceUpon storage, a fine white deposit with a clear colorless layer above may be present; re-suspend the vaccine following the following stepsHold the syringe upright in a closed hand; shake syringe by tipping it upside down and back upright again;Repeat this action vigorously for at least 15 seconds; inspect vaccine again; if vaccine appears as a uniform hazy white suspension, it is ready to use – the appearance should not be clearIf the vaccine still does not appear as a uniform hazy white suspension, tip upside down and back upright again for at least another 15 seconds then inspect againParenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permitIf either of these conditions exists, the vaccine should not be administered; for the prefilled syringes, attach a sterile needle and administer intramuscularlyFor 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 contaminatedUse a separate sterile needle and syringe for each individualVaccine should be administered by intramuscular injection only as a 1-mL dose; administer in deltoid regionDo not administer in gluteal region; such injections may result in a 30 suboptimal responseDo not administer this product intravenously, intradermally, or subcutaneously BRAND FORM. UNIT PRICE PILL IMAGE Twinrix (PF) intramuscular- 720 ELISA unit- 20 mcg/mL solutionTwinrix (PF) intramuscular- 720 ELISA unit- 20 mcg/mL solutionCopyright © 2010 First DataBank, Inc.Print Patient Educationhepatitis A and B virus vaccine (PF) intramuscular HEPATITIS-A/HEPATITIS-B VACCINE - INJECTION (HEP-a-TYE-tis/HEP-a-TYE-tis vak-SEEN) COMMON BRAND NAME(S): Twinrix USES: This combination vaccine is used to help prevent infection from the hepatitis A and B viruses. Hepatitis A infection can be mild with no symptoms or a severe illness that can rarely cause liver failure and death. Hepatitis B infection can cause serious problems including liver failure, long-term hepatitis B infection, cirrhosis, and liver cancer. Preventing infection with these viruses can prevent these problems.Hepatitis A/hepatitis B combination vaccine is made from whole, killed hepatitis A virus and a genetically engineered (man-made in the laboratory) piece of hepatitis B virus. It does not contain live virus, so you can not get hepatitis from the vaccine. This vaccine works by helping the body produce immunity (through antibody production) that will prevent you from getting infection from hepatitis A and hepatitis B. This combination vaccine does not protect you from other virus infections (such as HIV virus which causes AIDS, hepatitis C/ hepatitis E, HPV virus which causes genital warts and other problems).The vaccine is recommended for people at an increased risk of getting these infections. Those at an increased risk include health care personnel, laboratory workers who handle blood and patient specimens, police, fire and emergency medical personnel who give first aid treatment, hemophiliacs, dialysis patients, people who live with or spend much time with people with long-term hepatitis B or active hepatitis A infections, people with multiple sex partners, men who have sex with men, sex workers, injection drug abusers, and people traveling to high-risk areas. HOW TO USE: Read all vaccine information available from your health care professional before receiving the vaccine. If you have any questions, ask your health care professional.This vaccine is usually given by injection into a muscle by a health care professional. Adults and children usually receive the injection in the upper arm, and infants receive it in the upper thigh.A series of 3 injections is usually given over 6 months. Your health care professional will give you a vaccination schedule, which must be followed closely for best effectiveness. If you have an illness with fever at the time a vaccination is scheduled, your health care professional may choose to delay the injection until you are better.Dosage is based on your age. Different brands of hepatitis A/hepatitis B vaccine are available for different ages and may be given differently.For people who cannot get the vaccine before traveling or for whom the vaccine might not work, your health care professional may also give an injection of immune globulin. Immune globulin contains antibodies against the viruses and will immediately help protect you from developing an infection. However, these antibodies last only a few months. For proper protection, it is important to carefully follow your vaccination schedule. SIDE EFFECTS: Pain/redness/swelling at the injection site, fever, tiredness, headache, nausea, and diarrhea may occur. If any of these effects last or get worse, tell your health care professional promptly.Rarely, some people have symptoms such as fainting, dizziness, vision changes, or ringing in the ears just after getting a vaccine injection. Tell your health care professional right away if you have any of these symptoms. Sitting or lying down may help, since these symptoms usually don't last long.Remember that this medication has been prescribed because your health care professional has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your health care professional.Contact the health care professional for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967. In Canada, you may call the Vaccine Safety Section at Public Health Agency of Canada at 1-866-844-0018. PRECAUTIONS: Before getting hepatitis A/hepatitis B vaccine, tell your health care professional if you are allergic to it; or to other vaccines; or if you have any other allergies. This product may contain inactive ingredients (such as latex rubber found in some brands, yeast, neomycin, formalin), which can cause allergic reactions or other problems. Talk to your health care professional for more details.Before using this vaccine, tell your health care professional your medical history, especially of: current illness with fever.If you are a hemodialysis patient, you may not respond as well to the vaccine and will need to have hepatitis A or B antibody levels checked yearly. If antibodies drop too low over time, you may be given another dose of vaccine (often called a booster shot).If you have immune system disorders (such as due to HIV infection, certain cancers such as leukemia/lymphoma, cancer or radiation treatment), your body may not make enough antibodies to protect you from hepatitis A or hepatitis B infection. Antibody levels may be checked after the vaccine series.Older adults may not make as many antibodies to the vaccine. Talk to your health care professional for more details.During pregnancy, this vaccine should be used only when clearly needed. Discuss the risks and benefits with your health care professional.It is unknown if this vaccine passes into breast milk. Consult your health care professional before breast-feeding. DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your health care professional. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this vaccine include: drugs that weaken the immune system (including cyclosporine, tacrolimus, cancer chemotherapy, corticosteroids such as prednisone).Other vaccines may be given at the same time as hepatitis A/hepatitis B vaccine, but should be given with separate syringes and at different injection sites. OVERDOSE: Not applicable. NOTES: As with any vaccine, this vaccine may not fully protect everyone who receives it.Lab and/or medical tests (such as hepatitis A or B antibody levels) may be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.Keep vaccine records for yourself and all of your children, and after your children are grown provide their records to them and their health care professionals. This will prevent unnecessary re-vaccinations. MISSED DOSE: It is important to receive each vaccination as scheduled. Be sure to ask when each dose should be received and make a note on a calendar to help you remember. STORAGE: Store in the refrigerator. Do not freeze. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company. Information last revised May 2023. Copyright(c) 2023 First Databank, Inc. IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs. FormularyPatient DiscountsAdding plans allows you to compare formulary status to