What is Hizentra?
Hizentra (immune globulin) is a sterilized solution made from human plasma. It contains the antibodies to help your body protect itself against infection from various diseases.
Hizentra subcutaneous (for injection under the skin) is a prescription treatment used for replacement therapy in patients with primary humoral immunodeficiency.
Hizentra may also be used for other purposes not listed in this medication guide.
Important information about Hizentra
You should not use Hizentra if you have ever had an allergic reaction to an immune globulin, if you have immune globulin A (IgA) deficiency with antibody to IgA, or if you have a condition called hyperprolinemia (high level of a certain amino acid in the blood).
Before using Hizentra, tell your doctor if you have blood circulation problems or a blood vessel disorder, a history of stroke or blood clot, or if you have been bed-ridden due to severe illness.
Hizentra is usually given once every week. You may be shown how to use injections at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles, tubing, and other items used to inject the medicine.
Subcutaneous Hizentra is for injection only under the skin. Do not inject this medicine into a vein.
If you use Hizentra at home, keep a diary of the days and times you used the medication and where you injected it on your body.
You may need a dose adjustment if you are exposed to measles, or if you travel to an area where this disease is common.
Before using Hizentra
You should not use Hizentra if you have ever had an allergic reaction to an immune globulin, if you have immune globulin A (IgA) deficiency with antibody to IgA, or if you have a condition called hyperprolinemia (high level of a certain amino acid in the blood). Your doctor may need to adjust your dose of Hizentra if you are exposed to measles, or if you travel to an area where this disease is common.
If you have any of these other conditions, you may need a dose adjustment or special tests:
- blood circulation problems or a blood vessel disorder;
- a history of stroke or blood clot; or
- if you have been bed-ridden due to severe illness.
FDA pregnancy category C. It is not known whether Hizentra will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using Hizentra. It is not known whether immune globulin passes into breast milk or if it could harm a nursing baby. Do not use Hizentra without telling your doctor if you are breast-feeding a baby.
How is Hizentra given?
Hizentra subcutaneous is given as an injection using an infusion pump. The medicine enters the body through a needle or catheter placed under your skin. The catheter is attached to the pump with an infusion tube.
You may be shown how to use injections at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles, tubing, and other items used to inject the medicine.
Hizentra comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.
Hizentra must be given slowly, and the infusion can take about 1 hour to complete. You may need to use up to 4 catheters to inject this medicine into different body areas at the same time. Your care provider will show you the best places on your body to inject the medication. Follow your doctor's instructions.
Subcutaneous Hizentra is for injection only under the skin. Do not inject this medicine into a vein. Before injecting the medicine, test to make sure the needle is not in a vein. To do this, gently pull back on the plunger of the syringe connected to the infusion tube. If blood flows back into the syringe, remove the catheter and tubing and throw them away. Start over with a new catheter and syringe, insert the needle in a new place on your body, and test for blood flow-back again.
Hizentra is usually given once every week. Follow your doctor's dosing instructions. If you use Hizentra at home, keep a diary of the days and times you gave the injection and where you injected it on your body.
Do not shake the medication bottle or you may ruin the medicine. Prepare your dose only when you are ready to give yourself an injection. Do not mix Hizentra with other medications in the same infusion. Do not use the medication if it has changed colors, looks cloudy, or has particles in it. Call your doctor for a new prescription.
Use disposable injection items (needle, catheter, tubing) only once. Throw away the used items in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.
To be sure Hizentra is helping your condition, your blood may need to be tested often. Visit your doctor regularly.
Hizentra can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using Hizentra.
Each single use vial (bottle) of this medicine is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.
Store Hizentra in the original carton at room temperature, away from moisture, heat, and light. Do not freeze.
Throw away any Hizentra that has become frozen. Throw away any unused medication after the expiration date on the label has passed.
What happens if I miss a dose?
Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while using Hizentra?
Do not receive a "live" vaccine while using Hizentra The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), oral polio, chickenpox (varicella), BCG (Bacillus Calmette and Guérin), and nasal flu vaccine.
Hizentra side effects
Get emergency medical help if you have any of these signs of an allergic reaction to Hizentra: hives; wheezing, difficulty breathing; dizziness, feeling like you might pass out; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect from Hizentra such as:
- swelling, rapid weight gain, feeling short of breath, urinating less than usual or not at all;
- pain, swelling, redness, warmth, or a lump in your arms or legs;
- pale or yellowed skin, dark colored urine, fast heart rate;
- fever, severe headache, sore throat, neck stiffness, chills, increased sensitivity to light, confusion, and general ill feeling;
- chest pain or tightness, trouble breathing; or
- signs of new infection such as high fever, chills, body aches, flu symptoms, or sores in your mouth and throat.
Less serious Hizentra side effects may include:
- pain, redness, warmth, itching, and swelling of skin where the injection was given;
- nausea, vomiting, diarrhea, stomach pain;
- headache;
- mild skin rash;
- back pain;
- joint or muscle pain; or
- tired feeling;
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
0 comments