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.

• CSL Behring GmbH

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.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of this medication, there are no specific foods you must exclude from your diet.

Before receiving this medication, tell your healthcare provider if you:

• are allergic to Hizentra or any of its ingredients 
• have a history of hardening of the arteries (atherosclerosis), stroke, heart attack, or heart failure (low volume of blood pumped by the heart)
• are inactive for long periods of time (such as long bed rest)
• have too much proline in your blood (called "hyperprolinemia")
• have had reactions to polysorbate 80
• 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.
• have a history of heart or blood vessel disease or blood clots
• have thick blood
• if you use estrogens
• have a kidney problem
• have Type II diabetes mellitus
• are older than 65
• are dehydrated
• have a blood infection (sepsis)
• are receiving other medicines that are harmful to your kidneys
• recently received a live vaccine 

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

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. 

Administer Hizentra exactly as prescribed. 

Hizentra is administered under the skin. 

You will place up to 8 needles into different areas of your body each time you use Hizentra.

The needles are attached to a pump with an infusion tube.

• For PI, you can have infusions as often as every day up to every two (2) weeks.
• For CIDP, infusions are given once weekly (in 1 or 2 sessions conducted on 1 day or 2 consecutive days).
  • For weekly infusions, it can take about 1 to 2 hours to complete an infusion; however, this time may be shorter or longer depending on the dose and frequency your doctor has prescribed for you.

During treatment, you will be tested regularly to ensure you have the correct amount of Hizentra in your blood. 

Infuse this medication only after you have been trained by your doctor or healthcare professional. Ask your doctor or healthcare professional about any instructions you do not understand.

• This medication is to be injected into an area on your abdomen, thigh, upper arm, or side of upper leg/hip.
• Use a different site from the last time you infused the medication. New sites should be at least 1 inch from a previous site.
• Never infuse into areas where the skin is tender, bruised, red, or hard. Avoid infusing into scars or stretch marks.
• If you are using more than one injection site, be sure the injection sites are at least 2 inches apart. 
• More than one infusion device can be used at the same time.

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

If you have injected too much medication, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Keep Hizentra in its original carton to protect it from light.
• Each vial label contains a peel-off strip with the vial size and product lot number for use in recording doses in a patient treatment record
• When stored at room temperature (up to 25°C [77°F]), Hizentra is stable for up to 30 months, as indicated by the expiration date printed on the outer carton and vial label.
• Do not shake.
• Do not freeze. Do not use a product that has been frozen.
• Keep this and all medications out of the reach of children.

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.