Hizentra
Name: Hizentra
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Immune Globulin Subcutaneous Interactions
Do not receive a "live" vaccine while using immune globulin. 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.
Immune globulin 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.
Warnings
Included as part of the PRECAUTIONS section.
Hizentra Overview
Hizentra is a prescription medicine used to treat primary immune deficiency (PI). 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.
Side Effects of Hizentra
Serious side effects have been reported. See "Precautions" section.
Common side effects of Hizentra include:
- Redness, swelling, itching and/or bruising at 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.
Hizentra and Lactation
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.
Uses For Hizentra
Immune globulin injection is used to prevent or treat diseases that occur when your body has a weak immune system. Immune globulin contains antibodies that make your immune system stronger. It is used for patients who have primary humoral immunodeficiency (PI), idiopathic thrombocytopenic purpura (ITP), chronic immune thrombocytopenic purpura, or chronic inflammatory demyelinating polyneuropathy (CIDP). It is also used to improve muscle strength and disability in patients with multifocal motor neuropathy (MMN). Immune globulin injection belongs to a group of medicines known as immunizing agents.
This medicine is to be given only by or under the supervision of your doctor.
What are some other side effects of Hizentra?
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
- Irritation where Hizentra is given.
- Headache.
- Loose stools (diarrhea).
- Feeling tired or weak.
- Back pain.
- Sore throat.
- Stuffy nose.
- Dizziness.
- Flushing.
- Cramps.
- Upset stomach or throwing up.
- Belly pain.
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
Use in specific populations
Pregnancy
Pregnancy Category C. Animal reproduction studies have not been conducted with Hizentra. It is not known whether Hizentra can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Hizentra should be given to pregnant women only if clearly needed.
Nursing Mothers
Hizentra has not been evaluated in nursing mothers.
Pediatric Use
The safety and effectiveness of Hizentra have been established in the pediatric age groups 2 to 16, as supported by evidence from adequate and well-controlled studies. Hizentra was evaluated in 10 pediatric subjects with PI (3 children and 7 adolescents) in a study conducted in the US (see Clinical Studies [14]) and in 23 pediatric subjects with PI (18 children and 5 adolescents) in Europe. There were no differences in the safety and efficacy profiles as compared with adult subjects. No pediatric-specific dose requirements were necessary to achieve the desired serum IgG levels.
Safety and effectiveness of Hizentra in pediatric patients below the age of 2 have not been established.
Geriatric Use
Of the 49 subjects evaluated in the clinical study of Hizentra, 6 subjects were 65 years of age or older. No overall differences in safety or efficacy were observed between these subjects and younger subjects.
References
- Gabor EP, Meningitis and skin reaction after intravenous immune globulin therapy. Ann Intern Med 1997:127:1130.
- Cayco AV, Perazella MA, Hayslett JP. Renal insufficiency after intravenous immune globulin therapy: a report of two cases and an analysis of the literature. J Am Soc Nephrol 1997;8:1788-1793.
- Dalakas MC. High-dose intravenous immunoglobulin and serum viscosity: risk of precipitating thromboembolic events. Neurology 1994;44:223-226.
- Woodruff RK, Grigg AP, Firkin FC, Smith IL. Fatal thrombotic events during treatment of autoimmune thrombocytopenia with intravenous immunoglobulin in elderly patients. Lancet 1986;2:217-218.
- Wolberg AS, Kon RH, Monroe DM, Hoffman M. Coagulation factor XI is a contaminant in intravenous immunoglobulin preparations. Am J Hematol 2000;65:30-34.
- Copelan EA, Strohm PL, Kennedy MS, Tutschka PJ. Hemolysis following intravenous immune globulin therapy. Transfusion 1986;26:410-412.
- Thomas MJ, Misbah SA, Chapel HM, Jones M, Elrington G, Newsom-Davis J. Hemolysis after high-dose intravenous Ig. Blood 1993;15:3789.
- Wilson JR, Bhoopalam N, Fisher M. Hemolytic anemia associated with intravenous immunoglobulin. Muscle Nerve 1997;20:1142-1145.
- Kessary-Shoham H, Levy Y, Shoenfeld Y, Lorber M, Gershon H. In vivo administration of intravenous immunoglobulin (IVIg) can lead to enhanced erythrocyte sequestration. J Autoimmun 1999;13:129-135.
- Rizk A, Gorson KC, Kenney L, Weinstein R. Transfusion-related acute lung injury after the infusion of IVIG. Transfusion 2001;41:264-268.
- Pierce LR, Jain N. Risks associated with the use of intravenous immunoglobulin. Trans Med Rev 2003;17:241-251.
- Stucki M, Boschetti N, Schäfer W, et al. Investigations of prion and virus safety of a new liquid IVIG product. Biologicals 2008;36:239-247.
- Smith GN, Griffiths B, Mollison D, Mollison PL. Uptake of IgG after intramuscular and subcutaneous injection. Lancet 1972;1:1208-1212.
- Waniewski I, Gardulf A, Hammarström L. Bioavailability of γ-globulin after subcutaneous infusions in patients with common variable immunodeficiency. J Clin Immunol 1994;14:90-97.
- Bavaresco CS, Streck EL, Netto CA, et al. Chronic hyperprolinemia provokes a memory deficit in the Morris Water Maze Task. Metabolic Brain Disease 2005;20:73-80.
Patient Counseling Information
- Self-administration – If self-administration is appropriate, ensure that the patient receives instructions and training on subcutaneous administration in the home or other appropriate setting and has demonstrated the ability to perform subcutaneous infusions.
- Ensure patients understand the importance of adhering to the weekly administration schedule to maintain the steady levels of IgG in their blood.
- Instruct patients to keep their treatment diary/log book current by recording, after each infusion, the time, date, dose, and any reactions, and by removing the peel-off portion of the label (containing the lot number) from the product vial and placing it in the treatment diary/log book.
- Tell patients that mild to moderate local (injection-site) reactions (e.g., swelling and redness) are a common side effect of subcutaneous therapy, but to contact their healthcare professional if a local reaction persists for more than a few days.
- Inform patients of the importance of having an infusion needle long enough to reach the subcutaneous tissue and of changing the actual site of injection with each infusion.
- Inform patients to consider adjusting the injection-site location, volume per site, and rate of infusion based on how infusions are tolerated.
- Dose adjustments – Inform patients that they should be tested regularly to make sure they have the correct levels of Hizentra (IgG) in their blood. These tests may result in adjustments to the Hizentra dose.
- Hypersensitivity – Inform patients of the early signs of hypersensitivity reactions to Hizentra (including hives, generalized urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis), and advise them to notify their physician if they experience any of these symptoms.
- AMS – Inform patients of the signs of AMS, including severe headache, neck stiffness, drowsiness, fever, sensitivity to light, painful eye movements, nausea, and vomiting, and advise them to notify their physician if they experience any of these symptoms.
- Interference with vaccines – Inform patients that administration of IgG may interfere with the response to live virus vaccines (e.g., measles, mumps, rubella, and varicella) and to notify their immunizing physician of recent therapy with Hizentra.
- Reactions reported to occur with IGIV treatment – Advise patients to be aware of and immediately report to their physician symptoms of the following potential reactions:
- Decreased urine output, sudden weight gain, fluid retention/edema, and/or shortness of breath, which may suggest kidney problems
- Shortness of breath, changes in mental status, chest pain, and other manifestations of thrombotic and embolic events
- Fatigue, increased heart rate, yellowing of the skin or eyes, and dark-colored urine, which may suggest hemolysis
- Severe breathing problems, lightheadedness, drops in blood pressure, and fever, which may suggest TRALI (a condition typically occurring within 1 to 6 hours following transfusion)
- Transmissible infectious agents – Inform patients that Hizentra is made from human plasma (part of the blood) and may contain infectious agents that can cause disease (e.g., viruses and, theoretically, the CJD agent). Explain that the risk that Hizentra may transmit an infectious agent has been reduced by screening the plasma donors, by testing the donated plasma for certain virus infections, and by inactivating and/or removing certain viruses during manufacturing.
The attached Hizentra "Information for Patients" contains more detailed instructions for patients who will be self-administering Hizentra.
Hizentra
Immune Globulin Subcutaneous (Human), 20% Liquid
Information for Patients
This patient package insert summarizes important information about Hizentra. Please read it carefully before using this medicine. This information does not take the place of talking with your healthcare professional, and it does not include all of the important information about Hizentra. If you have any questions after reading this, ask your healthcare professional.
What is the most important information I should know about Hizentra?
Hizentra is supposed to be infused under your skin only. DO NOT inject Hizentra into a blood vessel (vein or artery).
What is Hizentra?
Hizentra (Hi – ZEN – tra) is a prescription medicine used to treat primary immune deficiency (PI). Hizentra is made from human plasma. It contains antibodies, called immunoglobulin G (IgG), that healthy people have to fight germs (bacteria and viruses).
People with PI get a lot of infections. Hizentra helps lower the number of infections you will get.
Who should NOT take Hizentra?
Do not take Hizentra if you have too much proline in your blood (called "hyperprolinemia") or if 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.
How should I take Hizentra?
You will take Hizentra through an infusion under your skin. You will put up to 4 needles into different places of your body at one time. The needles are attached to a pump with an infusion tube. It usually takes about 60 minutes to do one infusion. You will need to have infusions once a week.
Instructions for using Hizentra are at the end of this patient package insert (see "How do I use Hizentra?"). Do not use Hizentra by yourself until you have been taught how by your doctor or healthcare professional.
What should I avoid while taking Hizentra?
Vaccines may not work well for you while you are taking Hizentra. Tell your doctor or healthcare professional that you are taking Hizentra before you get a vaccine.
Tell your doctor or healthcare professional if you are pregnant or plan to become pregnant, or if you are nursing.
What are possible side effects of Hizentra?
The most common side effects with Hizentra are:
- Redness, swelling, and itching at the injection site
- Headache/migraine
- Vomiting
- Pain (including pain in the back, joints, arms, legs)
- Fatigue
- Bruising
- Diarrhea
- Stomach ache
- Nausea
- Rash
Tell your doctor right away or go to the emergency room if you have hives, trouble breathing, wheezing, dizziness, or fainting. These could be signs of a bad allergic reaction.
Tell your doctor right away if you have any of the following symptoms. They could be signs of a serious problem.
- Reduced urination, sudden weight gain, or swelling in your legs. These could be signs of a kidney problem.
- Pain, swelling, warmth, redness, or a lump in your legs or arms. These could be signs of a blood clot.
- Bad headache with nausea, vomiting, stiff neck, fever, and sensitivity to light. These could be signs of a brain swelling called meningitis.
- Brown or red urine, fast heart rate, yellow skin or eyes. These could be signs of a blood problem.
- Chest pains or trouble breathing.
- Fever over 100ºF. This could be a sign of an infection.
Tell your doctor about any side effects that concern you. You can ask your doctor to give you more information that is available to healthcare professionals.
How do I use Hizentra?
Infuse Hizentra only after you have been trained by your doctor or healthcare professional. Below are step-by-step instructions to help you remember how to use Hizentra. Ask your doctor or healthcare professional about any instructions you do not understand.
Instructions for use
Hizentra comes in single-use vials.
Keep Hizentra in the storage box at room temperature.
| Step 1: Assemble supplies Gather the Hizentra vial(s), the following disposable supplies (not provided with Hizentra), and other items (infusion pump, sharps or other container, treatment diary or log book): Infusion administration tubing Needle or catheter sets (for subcutaneous infusion) Y-site connectors (if needed) Alcohol wipes Antiseptic skin preps Syringes Transfer needles Gauze and tape, or transparent dressing Gloves (if recommended by your doctor) | |
Step 2: Wash hands
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| Step 3: Clean surface Thoroughly clean a table or other flat surface using one of the alcohol wipes. | |
| Step 4: Check vials Carefully look at the liquid in each vial of Hizentra (Figure 2). It should look clear and be pale yellow to light brown. Check for particles or color changes. Do not use the vial if:
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Step 5: Transfer Hizentra from vial(s) to syringe
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| When using multiple vials to achieve the desired dose, repeat this step. | |
| Step 6: Prepare infusion pump and tubing Prepare the infusion pump (following the manufacturer's instructions) and prime (fill) the infusion tubing. To prime the tubing, connect the syringe filled with Hizentra to the infusion tubing and gently push on the syringe plunger to fill the tubing with Hizentra (Figure 7). | |
Step 7: Prepare injection site(s)
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Step 8: Insert needle(s)
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| Step 9: Start infusion Follow the manufacturer's instructions to turn on the infusion pump (Figure 13). | |
| Step 10: Record treatment (Figure 14) Peel off the removable part of the label of the Hizentra vial. Put this label in your treatment diary or log book with the date and time of the infusion. Also include the exact amount of Hizentra that you infused. | |
Step 11: Clean up
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Be sure to tell your doctor about any problems you have doing your infusions. Your doctor may ask to see your treatment diary or log book, so be sure to take it with you each time you visit the doctor's office.
Call your doctor for medical advice about side effects. You can also report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Manufactured by:
CSL Behring AG
Bern, Switzerland
US License No. 1766
Distributed by:
CSL Behring LLC
Kankakee, IL 60901 USA
PRINCIPAL DISPLAY PANEL - 5 mL Vial Label
NDC 44206-451-01
A5614/876
Immune Globulin Subcutaneous
(Human), 20% Liquid
Hizentra™
Subcutaneous use only
Rx only
Each Hizentra single-use vial
contains 1 g IgG. Store Hizentra
up to 25°C (77°F). Do not freeze.
PRINCIPAL DISPLAY PANEL - 5 mL Vial Carton
NDC 44206-451-01
1 g
5 mL
Immune Globulin
Subcutaneous (Human),
20% Liquid
Hizentra™
Single-use vial
For Subcutaneous Administration
Only
Rx only
CSL Behring
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| Labeler - CSL Behring AG (481152762) |
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| CSL Behring AG | 481152762 | MANUFACTURE | |