Hizentra

Hizentra is a prescription medicine used to treat primary immune deficiency (PI) and chronic inflammatory demyelinating polyneuropathy (CIDP). 

 It contains antibodies from human plasma, called immunoglobulin G (IgG), that healthy people have to fight germs (bacteria and viruses).

This medication works by temporarily providing the antibodies necessary to fight infection. Hizentra lowers the number of infections one will get. 

This medication comes as a liquid to be injected just under the skin (subcutaneously). It can be given once daily, every week, or once every 2 weeks.

Common side effects include redness, swelling and itching at the injection site as well as headaches, nausea, and fatigue.

Hizentra is a prescription medication approved as antibody replacement therapy for primary immunodeficiency (PI) in adults and children 2 years of age and older.

This medication is also used to treat adults with inflammatory demyelinating polyneuropathy (CIDP). 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

The dose your healthcare provider recommends may be based on several factors including:

• the condition being treated
• other medical conditions you have
• your body's response to this medication

Over time, the dose may need to be adjusted to achieve the desired clinical response and serum IgG trough level. 

WARNING: THROMBOSIS

• Thrombosis may occur with immune globulin products1-3, including this medication. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity, and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors.
• For patients at risk of thrombosis, administer at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.

Serious side effects have been reported including:

• Allergic reactions. Tell your doctor right away or go to the emergency room if you have hives, trouble breathing, wheezing, dizziness, or fainting. 
• Kidney problems including renal failure. Tell your doctor right away if you experience decreased urination, sudden weight gain, fluid retention/swelling in your legs, and/or shortness of breath. 
• Blood clots. Immediately report symptoms of thrombosis which include:
  • Pain and/or swelling of an arm or leg with warmth over the affected area
  • Discoloration of an arm or leg
  • Unexplained shortness of breath
  • Chest pain or discomfort that worsens on deep breathing
  • Unexplained rapid pulse
  • Numbness or weakness on one side of the body
• Infection in the brain (meningitis). Tell your doctor right away if you experience severe headaches, stiff neck, fatigue, fever, sensitivity to light, painful eye movements, and nausea and vomiting.
• Blood problems. Tell your doctor right away if you experience fast heart rate, fatigue, yellow skin or eyes, and dark colored urine. 
• Lung problems. Tell your doctor if you experience chest pains, trouble breathing, blue lips or extremities, and fever. 
• Infections. Tell your doctor if you notice signs and symptoms of an infection such as a Fever over 100°F. 

Do not take this medication if:

• you are allergic to Hizentra or any of its ingredients
• you have too much proline in your blood (called "hyperprolinemia")
• you have had reactions to polysorbate 80

Tell your doctor if you have had a serious reaction to other immune globulin medicines or if you have been told that you also have a deficiency of the immunoglobulin called IgA.

Tell your doctor if you have a history of heart or blood vessel disease or blood clots, have thick blood, or have been immobile for some time. These things may increase your risk of having a blood clot after using Hizentra.

Serious side effects have been reported. See "Precautions" section.

Common side effects of Hizentra include:

• Redness, swelling, itching and/or bruising at the injection site
• Headache
• Diarrhea
• Fatigue
• Back pain
• Nausea
• Cough
• Rash (including hives)
• Itching
• Fever and/or chills
• Vomiting
• Stomach pain
• Pain (including pain in the chest, back, joints, arms, legs)

Tell your healthcare provider if any side effect is bothersome or does not go away. These are not all the possible side effects of this medication. 

You may report side effects to the FDA at 1-800-FDA-1088.

Tell your healthcare provider about the medications you take including prescription and non-prescription medications, vitamins, and herbal supplements.

Especially tell your healthcare provider if you have recently received a live vaccine as this medication may interfere with your body's response to live vaccines.

Also, medications that contain the hormone estrogen (for example, birth control pills), may increase your risk of developing a blood clot. Be sure to tell your healthcare provider if you are taking one of these medications.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category C. Animal reproduction studies have not been conducted. It is also not known whether this medication can cause fetal harm when administered to a pregnant woman. This medication should be given to a pregnant woman only if clearly indicated.

Tell your healthcare provider if you are breastfeeding or planning to breastfeed.

It is not known whether this medication is excreted in human milk. Because many drugs are excreted in human milk and may cause harm, your doctor will decide if you will continue to take Hizentra or stop breastfeeding. 

This medication is for subcutaneous infusion only, and must not be injected into a blood vessel.

The antibodies in this medication may prevent certain vaccines from working. Before you get a vaccine, tell the doctor or nurse that you are taking this medication. 

Your infusions may take several hours. Side effects tend to decrease the more slowly this mediction is infused.

Unless otherwise instructed, drink plenty of fluids to stay hydrated for your infusions.