Hepatitis B immune globulin (Injection)

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Chest pain, shortness of breath, or coughing up blood
• Lightheadedness, dizziness, or fainting
• Numbness or weakness in your arm or leg, or on one side of your body
• Pain in your lower leg (calf)
• Sudden or severe headache, or problems with vision, speech, or walking

If you notice these less serious side effects, talk with your doctor:

• Pain, itching, burning, swelling, or a lump under your skin where the needle or shot is placed

Introduction

Hepatitis B Immune Globulin (hep-a-TYE-tis B i-MUNE-GLOB-ue-lin)

Prevents hepatitis B from occurring again in HBsAg-positive patients after a liver transplant. It is also used preventatively after exposed to hepatitis B virus.

Brand Name(s)

Nabi-HB, Bayhep B, HyperHEP B S/D, HepaGam B

When This Medicine Should Not Be Used

Warnings While Using This Medicine

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you have a history of blood clotting problems, diabetes, or heart problems (such as atherosclerosis).
• This medicine may affect the results of blood sugar tests. If you are also using insulin or other medicine for diabetes, know the symptoms of hypoglycemia (confusion, irritability, double or blurred vision, and in severe cases, seizures or loss of consciousness). Tell your doctor if you experience hypoglycemia on a regular basis while receiving this medicine.
• This medicine is made from donated human blood. Human donors are tested for viruses, and the medicine is tested when it is made. Still, there is a very low risk that you could get a virus from a medicine made from human blood. Talk with your doctor if you have concerns.
• This medicine may cause blood clots. This is more likely to occur if you have a history of blood clotting problems, heart disease, or atherosclerosis (hardening of the arteries), or if you must stay in bed for a long time because of surgery or illness. Check with your doctor right away if you suddenly have chest pain, shortness of breath, a severe headache, leg pain, or problems with vision, speech, or walking.
• Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.
• Your doctor will need to check your blood at regular visits while you are using this medicine. Be sure to keep all appointments.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

How to Use This Medicine

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot into a muscle or a vein.
• A nurse or other trained health professional will give you this medicine.
• If you are using this medicine to prevent hepatitis B from occurring again after a liver transplant, this medicine is given through a needle placed in one of your veins.
• If you are using this medicine for prevention of hepatitis B after exposure to hepatitis B virus, it should be given as a shot into one of your muscles.
• This medicine works best if you receive it soon after exposure to hepatitis B. If you had sexual contact with a person who has hepatitis B, you should receive this medicine within 14 days. If you were exposed some other way, you should receive this medicine within 24 hours of exposure to hepatitis B.
• You may need a second dose of medicine 1 month after the first dose. Make sure you understand the schedule if you need a second dose.
• This medicine may be given to a newborn if the baby's mother has hepatitis B. The baby is often given the medicine within 12 hours after birth.
• Hepatitis B vaccine is often used in addition to hepatitis B immune globulin. Make sure you understand if you also need the vaccine.

If a dose is missed:

• Call your doctor, pharmacist, treatment clinic, or home health caregiver for instructions.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• You should wait 3 months after receiving hepatitis B immune globulin before you get flu shots or other vaccines. It is okay to get the hepatitis B vaccine, but other vaccines may not work as well while you are using this medicine.