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 used to treat primary immunodeficiency (PI) This includes, but is not limited to, the humoral immune defect in congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.

Hizentra may also be used for purposes not listed in this medication guide.

Important information

You should not use Hizentra subcutaneous if you have a condition called hyperprolinemia (high level of a certain amino acid in the blood).

Hizentra can cause blood clots. A blood clot may be more likely if you have risk factors such as heart disease, blood circulation problems, estrogen use, a history of blood clots, if you are 65 years or older, if you have been bed-ridden, or if you are using a catheter.

Stop using Hizentra and call your doctor at once if you have:

• signs of a blood clot in the brain--sudden numbness or weakness (especially on one side of the body), slurred speech, problems with vision or balance;

• signs of a blood clot in the heart or lung--chest pain, rapid heart rate, sudden cough, wheezing, rapid breathing, coughing up blood; or

• signs of a blood clot in your leg--pain, swelling, warmth, or redness in one or both legs.

Hizentra can also harm your kidneys, especially if you already have kidney disease or if you also use certain other medicines. Many other drugs (including some over-the-counter medicines) can be harmful to the kidneys.

Call your doctor at once if you have signs of a kidney problem, such as swelling, rapid weight gain, and little or no urinating.

Drink plenty of liquids while you are using Hizentra to help improve your blood flow and keep your kidneys working properly.

Before using Hizentra

You should not use Hizentra if you have ever had an allergic reaction to an immune globulin, or if you have:

• immune globulin A (IgA) deficiency with antibody to IgA; or

• a condition called hyperprolinemia (high level of a certain amino acid in the blood).

Hizentra can harm your kidneys or cause blood clots. To make sure this medicine is safe for you, tell your doctor if you have:

• heart disease, blood circulation problems or a blood vessel disorder;

• a history of stroke or blood clot;

• if you use estrogens (birth control pills or hormone replacement therapy);

• kidney disease;

• diabetes;

• if you are dehydrated;

• if you are 65 years or older;

• if you have been bed-ridden due to severe illness; or

• if you are using a catheter.

You may need a dose adjustment if you are exposed to measles, or if you travel to an area where this disease is common.

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 this medicine.

See also: Pregnancy and breastfeeding warnings (in more detail)

It is not known whether immune globulin passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Hizentra is made from human plasma (part of the blood) which may contain viruses and other infectious agents. Donated plasma is tested and treated to reduce the risk of it containing infectious agents, but there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using Hizentra .

How is Hizentra given?

Hizentra subcutaneous is injected under the skin using an infusion pump. The medicine enters the body through a catheter placed under your skin. You may be shown how to use injections at home. Do not self-inject Hizentra 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 can be administered as a weekly or biweekly (every two weeks) infusion. Follow your doctor"s dosing instructions. If you use this medication at home, keep a diary of the days and times you gave the injection and where you injected it on your body.

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.

Do not shake the medication bottle or you may ruin the medicine. Prepare your dose only when you are ready to give an injection. Do not mix Hizentra with other medications in the same infusion. Do not use if the medicine has changed colors or has particles in it. Call your pharmacist for new medicine.

Hizentra subcutaneous should not be injected into a vein.

Before injecting the medicine, test to make sure the infusion pump 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.

Each single-use vial (bottle) of Hizentra is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.

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.

While using Hizentra, you may need frequent blood tests.

This medication can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using Hizentra.

Keep Hizentra in the original carton to protect it from light. Store 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?

Call your doctor for instructions if you miss a dose of this medicine.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid?

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), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) 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.

Stop using this medicine and call your doctor at once if you have:

• signs of a blood clot in the brain--sudden numbness or weakness (especially on one side of the body), slurred speech, problems with vision or balance;

• signs of a blood clot in the heart or lung--chest pain, rapid heart rate, sudden cough, wheezing, rapid breathing, coughing up blood;

• signs of a blood clot in your leg--pain, swelling, warmth, or redness in one or both legs;

• signs of a kidney problem--swelling, rapid weight gain, and little or no urinating;

• liver problems--fast heart rate, tired feeling, dark urine, jaundice (yellowing of the skin or eyes);

• lung problems--chest pain, trouble breathing, blue lips, pale or blue colored appearance in your fingers or toes; or

• signs of new infection--high fever, flu symptoms, mouth sores, severe headache, neck stiffness, increased sensitivity to light, nausea and vomiting.

Common Hizentra side effects may include:

• redness, bruising, itching, and swelling where the medicine was injected;

• nausea, vomiting, diarrhea, bloating, stomach pain;

• tired feeling, headache, migraine;

• mild itching or rash;

• back pain; or

• pain anywhere in your body.

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.

See also: Side effects (in more detail)

What other drugs will affect Hizentra?

Hizentra subcutaneous can harm your kidneys. This effect is increased when you also use certain other medicines, including: antivirals, chemotherapy, injected antibiotics, medicine for bowel disorders, medicine to prevent organ transplant rejection, injectable osteoporosis medication, and some pain or arthritis medicines (including aspirin, Tylenol, Advil, and Aleve).

Other drugs may interact with immune globulin, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.