Generic Name: immune globulin (human) (i-MUNE GLOB-ue-lin)
Brand Name: Hizentra
Hizentra may increase the risk of blood clots. The risk may be increased in older patients, if you will be confined to a bed or chair for a period of time, if you take estrogen products, or if you have certain catheters. The risk may also be increased if you have a condition that may increase your risk of blood clots, thick blood, heart problems, or a history of blood clots. Blood clots can occur if you do not have any of these conditions. Tell your doctor right away if you develop one-sided numbness or weakness; pain, redness, tenderness, warmth or swelling in the arms or legs; change in color of an arm or leg; chest pain or discomfort; shortness of breath; fast heartbeat; or coughing up blood. Discuss any questions or concerns with your doctor.
Hizentra is used for:
Providing antibodies to help prevent infection in certain patients who have a weakened immune system. It may also be used for other conditions as determined by your doctor.
Hizentra is an immune globulin. It works by providing antibodies, which fight infection.
Do NOT use Hizentra if:
- you are allergic to any ingredient in Hizentra (including polysorbate 80)
- you have had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to blood or products that are produced from blood
- you have high levels of proline in the blood
- you have low immunoglobulin A (IgA) levels, antibodies to IgA, or a history of allergic reaction to IgA
Contact your doctor or health care provider right away if any of these apply to you.
Before using Hizentra:
Some medical conditions may interact with Hizentra. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have low IgA levels or antibodies to IgA
- if you have recently received any vaccinations
- if you have heart problems, blood vessel problems (eg, narrowed arteries), thick blood, a blood clotting disorder, or a history of stroke, heart attack, or blood clots
- if you have kidney problems, diabetes, dehydration or low blood volume, a blood infection, abnormal proteins in the blood, or asthma
- if you have been or may be exposed to measles
- if you will be confined to a bed or a chair for a long period of time
Some MEDICINES MAY INTERACT with Hizentra. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Medicines that may harm the kidney (eg, aminoglycoside antibiotics [eg, gentamicin], amphotericin B, cyclosporine, nonsteroidal anti-inflammatory drugs [NSAIDs] [eg, ibuprofen], tacrolimus, vancomycin) because the risk of kidney side effects may be increased. Ask your doctor if you are unsure if any of your medicines might harm the kidney
- Hydantoins (eg, phenytoin) because unexpected allergic reactions may occur
- Live vaccines (eg, measles, mumps, rubella) because their effectiveness may be decreased by Hizentra
This may not be a complete list of all interactions that may occur. Ask your health care provider if Hizentra may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Hizentra:
Use Hizentra as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Hizentra. Talk to your pharmacist if you have questions about this information.
- Hizentra is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Hizentra at home, a health care provider will teach you how to use it. Be sure you understand how to use Hizentra. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
- Do not use Hizentra if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
- Do not shake Hizentra.
- Do not mix Hizentra with any other medicine.
- Inject Hizentra under the skin, NOT into a muscle or vein. Inject into the abdomen, thigh, upper arm, or outer hip. If more than 1 injection site is used at the same time, be sure there are at least 2 inches between injection sites. Rotate injection sites with each dose of Hizentra.
- Throw away any medicine that is left in the vial after you use a dose of Hizentra.
- Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
- If you miss a dose of Hizentra, contact your doctor right away.
Ask your health care provider any questions you may have about how to use Hizentra.
Important safety information:
- Hizentra may cause dizziness or light-headedness. These effects may be worse if you take it with alcohol or certain medicines. Use Hizentra with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Aseptic meningitis syndrome (AMS) has been reported to occur rarely in association with the use of Hizentra. This usually begins within several hours to 2 days following treatment. Symptoms include severe headache, neck stiffness, unusual drowsiness, fever, painful eye movements, sensitivity to light, nausea, and vomiting.
- Live vaccines (eg, measles, mumps) may not work as well while you are using Hizentra. Talk with your doctor before you receive any vaccine.
- Serious and sometimes fatal kidney problems have happened with human immune globulin products. The risk may be greater if you already have kidney problems or are older than 65 years old. You may also be at increased risk if you have diabetes, dehydration or low blood volume, a blood infection, or abnormal proteins in the blood (paraproteinemia) or if you are taking other medicines that may harm the kidney. Contact your doctor immediately if you experience decreased urination, lower back or flank pain, swelling or bloating, sudden weight gain, shortness of breath, or weakness.
- Hizentra is made from human plasma. There is an extremely low risk of developing a viral infection or Creutzfeldt-Jakob disease (CJD) after using Hizentra. Discuss any questions or concerns with your doctor.
- Hizentra may interfere with certain lab tests. Be sure your doctor and lab personnel know you are using Hizentra.
- Lab tests, including kidney function, blood thickness, and antibody levels, may be performed while you use Hizentra. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use Hizentra with caution in the ELDERLY; they may be more sensitive to its effects, especially kidney failure or blood clots.
- Use Hizentra with extreme caution in NEWBORNS or INFANTS; safety and effectiveness in these children have not been established.
- PREGNANCY and BREAST-FEEDING: It is not known if Hizentra can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Hizentra while you are pregnant. It is not known if this medicine is found in breast milk. If you are or will be breast-feeding while you use Hizentra, check with your doctor. Discuss any possible risks to your baby.
Possible side effects of Hizentra:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Cough; diarrhea; headache; muscle, joint, or back pain; nausea; pain, swelling, redness, heat, or itching at the injection site; stomach upset; tiredness; vomiting.
Severe allergic reactions (rash; itching; hives; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, hands, face, lips, eyes, throat, or tongue); calf pain or tenderness; chest pain or tightness; confusion; coughing up blood; dark urine; dizziness; fainting; fast or irregular heartbeat; fever or chills; numbness of an arm or a leg; one-sided weakness; red, swollen, blistered, or peeling skin; seizures; severe headache or stomach pain; shortness of breath or trouble breathing; speech problems; unusual bruising or bleeding; unusual tiredness or weakness; vision problems; wheezing; yellowing of the skin or eyes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.Proper storage of Hizentra:
Store Hizentra at room temperature up to 77 degrees F (25 degrees C). Do not freeze. Do not use Hizentra if it has been frozen or if the expiration date on the container has passed. Keep Hizentra out of the reach of children and away from pets.
- If you have any questions about Hizentra, please talk with your doctor, pharmacist, or other health care provider.
- Hizentra is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take Hizentra or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Hizentra. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Hizentra. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Hizentra.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.