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Hizentra

Generic Name: immune globulin (Intramuscular route, Intravenous route, Subcutaneous route)

i-MUNE GLOB-ue-lin

Intravenous route(Powder for Solution;Solution)

Immune globulin intravenous (IGIV) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Use caution in patients predisposed to acute renal failure and administer at the minimum concentration available and the minimum rate of infusion practicable in such patients. Higher rates of renal failure were associated with IGIV products that contain sucrose . Glucose-free products include Bivigam(TM) , Gammaplex(R), Gammagard Liquid(R), Gammaked(TM), and Gamunex(R)-C, , Flebogamma(R) 5%, Flebogamma(R) 5% DIF, Flebogamma(R) 10% DIF , Octagam(R) 10% , and Privigen(R) . Thrombosis may occur with or without known risk factors. Risk of thrombosis is increased with advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, estrogen use, indwelling central vascular catheters, hyperviscosity, and cardiovascular risk factors. For patients at risk of thrombosis, administer IVIG 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 .

Commonly used brand name(s)

In the U.S.

  • Baygam
  • Bivigam
  • Carimune
  • Flebogamma 10% DIF
  • Flebogamma 5%
  • Gamastan S/D
  • Gamimune N
  • Gammagard
  • Gammagard S/D
  • Gammaplex
  • Gammar-P
  • Gamunex
  • Hizentra
  • Iveegam EN
  • Octagam
  • Octagam 10%
  • Panglobulin NF
  • Polygam S/D
  • Privigen
  • Sandoglobulin
  • Venoglobulin-S
  • Vivaglobin

Available Dosage Forms:

  • Solution
  • Powder for Solution

Therapeutic Class: Immune Serum

Uses For Hizentra

Immune globulin injection belongs to a group of medicines known as immunizing agents. It 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, and chronic inflammatory demyelinating polyneuropathy (CIDP). It is also used as a maintenance treatment to improve muscle strength and disability in patients with multifocal motor neuropathy (MMN).

Slideshow: Flashback: FDA Drug Approvals 2013

This medicine is to be given only by or under the supervision of your doctor.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, immune globulin is used in certain patients with the following medical conditions:

  • Chronic parvovirus B19 infection (treatment).
  • Dermatomyositis (treatment).
  • Guillain-Barré syndrome (treatment).
  • Hyperimmunoglobulinemia E syndrome (treatment).
  • Infections in low-birth-weight preterm high-risk neonates (prophylaxis and treatment adjunct).
  • Lambert-Eaton myasthenic syndrome (treatment).
  • Relapsing-remitting multiple sclerosis (treatment).

Before Using Hizentra

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of immune globulin injection in children. However, safety and efficacy have not been established in children with CIDP, safety and efficacy have not been established for Flebogamma®, Gammagard Liquid®, or Gammaplex® to treat MMN, and subcutaneous injection of Gammaked™ or Gamunex®-C in children with PI. Safety and efficacy have not been established for Gammagard Liquid to treat PI, with Hizentra® or Vivaglobin® in children younger than 2 years of age, use of Gammaplex® in children with PI or ITP, or use of Octagam® in children to treat chronic ITP.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of immune globulin injection in the elderly. However, elderly patients are more likely to have age-related blood clotting problems, kidney disease, or heart disease, which may require caution for patients receiving immune globulin injection.

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Allergy to corn—Use with caution. May cause an allergic reaction to occur again.
  • Anemia, history of or
  • Bleeding problems, history of or
  • Hyponatremia (low sodium in the blood) or
  • Kidney problems—Use with caution. May make these conditions worse.
  • Atherosclerosis (hardening of the arteries), history of or
  • Blood clotting problems, history of or
  • Diabetes or
  • Heart attack or stroke, recent or
  • Heart or blood vessel disease or
  • Hyperproteinemia (high protein in the blood) or
  • Hyperviscosity (thick blood), known or suspected or
  • Hypovolemia (low blood volume or major loss of body fluids) or
  • IgA (immunoglobulin A) deficiency with antibodies against IgA or
  • Paraproteinemia (paraproteins in the blood) or
  • Sepsis (serious infection in the body)—Use with caution. May cause side effects to become worse.
  • Hereditary intolerance to fructose or sucrose or
  • IgA (immunoglobulin A) deficiency with antibodies against IgA—Gammaplex® should not be used in patients with these conditions.
  • Hyperprolinemia (too much proline in the blood) or
  • IgA (immunoglobulin A) deficiency with antibodies against IgA—Hizentra® should not be used in patients with these conditions.
  • IgA (immunoglobulin A) deficiency with antibodies against IgA—Octagam® should not be used in patients with this condition.

Proper Use of immune globulin

This section provides information on the proper use of a number of products that contain immune globulin. It may not be specific to Hizentra. Please read with care.

A doctor or other trained health professional will give you or your child this medicine. This medicine is given through a needle placed in one of your veins, as a shot into one of your muscles, or as a shot under your skin.

This medicine comes with a patient information insert. Read and follow the instructions carefully. Ask your doctor if you have any questions.

While you or your child are being treated with immune globulin injection, do not have any immunizations (vaccines) without your doctor's approval. Live virus vaccines should not be given for 3 months after receiving immune globulin.

The Gammagard Liquid, Gammaked™, Gamunex®-C, Hizentra®, and Vivaglobin® products may sometimes be given at home to patients who do not need to be in the hospital or clinic. They are given as an infusion under your skin once every week. If you or your child are using this medicine at home, your doctor will teach you how to prepare and infuse the medicine. Be sure you understand how to use the medicine.

Do not change the brand or type of your immune globulin unless your doctor tells you to. If you or your child must change the brand or type of medicine, talk to your doctor before giving yourself an injection.

If you or your child are using Gammagard Liquid, Gammaked™, Gamunex®-C, Hizentra®, or Vivaglobin® at home, you will be shown the body areas where the medicine can be given. Use a different body area each time you give yourself an infusion. Keep track of where you give each infusion to make sure you rotate body areas. This will help prevent skin problems.

Allow the Gammagard Liquid, Gammaked™, Gamunex®-C, Octagam®, or Vivaglobin® brand to reach room temperature before using it.

Hizentra® may be given on a weekly (starting this medicine 1 week after the patient's last IGIV infusion) or on a biweekly dosing regimen (starting this medicine 1 or 2 weeks after the patient's last IGIV infusion or 1 week after the last weekly Hizentra® infusion). Your doctor will tell you which dosing regimen is right for you.

To use Gammagard Liquid, Gammaked™, Gamunex®-C, Hizentra®, or Vivaglobin®:

  • First, gather the items you will need on a clean, flat surface using a cloth or towel in a well-lighted area.
  • Wash your hands with soap and water before and after using this medicine.
  • If you have been told to wear gloves when preparing your infusion, put the gloves on.
  • Check the liquid in the vial (glass container). It should be clear and slightly yellow to light brown in color. If it is cloudy, discolored, or contains large flecks (particles), do not use the vial. Select another vial.
  • If the liquid is clear, place it on the clean, flat surface. Do not heat up or shake the medicine.
  • Follow your doctor's instructions on how to prepare the correct amount of medicine.
  • Choose an injection site on your body (eg, abdomen or stomach area, thigh, upper arm, upper leg, hip). Clean the injection site with a fresh alcohol wipe, and let it dry.
  • With two fingers, pinch together the skin at the injection site. Insert the needle with the tube under the skin.
  • Put sterile gauze and tape over the injection site to keep the needle from coming out.
  • Before starting the infusion, make sure no blood is flowing into the infusion tube. If blood is present, remove and throw away the used needle and tube.
  • Follow your doctor's instructions on how to use the infusion pump.
  • Remove the peel-off portion of the label from the used vial. Place this label in your treatment diary or log book. Write down the amount of medicine you used, the date, and the time of your treatment.
  • It usually takes about 60 minutes for each infusion.
  • When all of the medicine has been infused, turn off the pump.
  • Take the gauze off and remove the needle and tube from your skin.
  • Clean and store the infusion pump.
  • Throw away used needles and tubes in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Missed Dose

This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the Hizentra® product at room temperature, away from heat and moisture, for up to 30 months. Keep from freezing. Protect the product from direct light. Keep the medicine in the original package until you are ready to use it.

Store the Gamunex®-C and Vivaglobin® products in the refrigerator, but do not freeze the medicine. Store it in the original container.

You may store the Gammagard Liquid or Gammaked™ product in the refrigerator or at room temperature. Check the box or label of the vials for expiration dates. Store it in the original container. Do not freeze. Talk with your pharmacist if you have questions about storage of this product.

Precautions While Using Hizentra

It is very important that your doctor check your progress at regular visits for any problems that may be caused by this medicine. Blood and urine tests may be needed to check for unwanted effects.

Patients with idiopathic thrombocytopenic purpura (ITP) should not be treated with Gammaked™ or Gamunex®-C that is injected under the skin (subcutaneously). Doing so may increase the risk of having a hematoma (buildup of blood under the skin).

This medicine may cause fever, chills, flushing, headaches, nausea, and vomiting, especially if you are receiving it for the first time or if you have not received it for more than 8 weeks. Check with your doctor or nurse right away if you have any of these symptoms.

This medicine is made from donated human blood. Some human blood products have transmitted certain viruses to people who have received them, although the risk is low. Human donors and donated blood are both tested for viruses to keep the transmission risk low. Talk with your doctor about this risk if you are concerned.

This medicine may cause a serious type of allergic reaction, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, hives, chest pain, dizziness or lightheadedness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after receiving this medicine. Certain people, including those with IgA (an immunoglobulin) deficiency and antibodies against IgA and a history of hypersensitivity to human immunoglobulin products should not use this medicine.

Check with your doctor right away if you start to have a stiff neck, drowsiness, fever, severe headache, nausea or vomiting, painful eye movements, or eye sensitivity to light. These could be symptoms of a serious condition called aseptic meningitis syndrome (AMS).

This medicine may cause bleeding (hemolysis) or hemolytic anemia. Tell your doctor right away if you have stomach or back pain, dark urine, decreased urination, difficulty with breathing, an increased heart rate, tiredness, or yellow eyes or skin after you receive the medicine.

Check with your doctor right away if you start having chest pain, difficult, fast, or noisy breathing, sometimes with wheezing, blue lips and fingernails, fever, pale skin, increased sweating, coughing that sometimes produces a pink frothy sputum, shortness of breath, or swelling of the legs and ankles after receiving this medicine. These may be symptoms of a serious lung problem.

This medicine may cause blood clots. This is more likely to occur if you have a history of blood clotting problems, heart disease, or atherosclerosis (hardening of the arteries), or if you are obese, take medicines containing estrogen, or must stay in bed for a long time because of surgery or illness. Check with your doctor right away if you suddenly have chest pain, shortness of breath, a severe headache, leg pain, or problems with vision, speech, or walking. .

Check with your doctor right away if you start having red or dark brown urine, lower back or side pain, a sudden weight gain, a swollen face, arms, or legs, decreased urine output, or any problems with urination after you receive this medicine. These may be symptoms of a serious kidney problem.

Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.

Hizentra Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common
  • Chills
  • cough
  • fast, pounding, or irregular heartbeat or pulse
  • fever
  • noisy breathing
  • tightness in the chest
  • troubled breathing
  • unusual tiredness or weakness
Less common
  • Bluish coloring of the lips or nail beds
  • burning sensation in the head
  • faintness or lightheadedness
Rare
  • Difficulty with swallowing
  • hives or welts
  • itching, especially of the feet or hands
  • reddening of the skin, especially around the ears
  • swelling of the eyes, face, or inside of the nose
Incidence not known
  • Back, leg, or stomach pains
  • blistering, peeling, or loosening of the skin
  • change in vision
  • changes in urination
  • chest pain or discomfort
  • cold, clammy, or pale skin
  • confusion
  • convulsions
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • fever
  • headache that is severe and occurs suddenly
  • light-colored stools
  • loss of consciousness
  • low blood pressure or pulse
  • muscle spasm or jerking of all extremities
  • nausea or vomiting
  • pains in the chest, groin, or legs, especially calves of the legs
  • shakiness in the legs, arms, hands, or feet
  • skin blisters
  • slow breathing
  • slurred speech that occurs suddenly
  • sores, ulcers, or white spots in the mouth or on the lips
  • sudden, severe weakness or numbness in the arm or leg
  • sweating
  • swelling in the legs and ankles
  • tightness in the chest
  • unusual bleeding or bruising
  • yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Diarrhea
  • dizziness
  • headache
  • joint pain
  • muscle pain
  • redness, swelling, itching, or pain at the injection site
  • skin rash
Less common
  • Hip pain
  • leg cramps
Incidence not known
  • Feeling of warmth
  • redness of the face, neck, arms, and occasionally, upper chest
  • stomach pain
  • swollen glands
  • tiredness
  • weakness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

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