Immunoglobulins, Normal Human, For Extravascular Adm.

Immunoglobulins, Normal Human, For Extravascular Adm. Overview

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Immunoglobulins 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.

This medication comes as a liquid to be injected just under the skin (subcutaneously) using an infusion pump. It is usually given once 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.

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Immunoglobulins, Normal Human, For Extravascular Adm. Cautionary Labels

precautionsprecautionsprecautionsprecautionsprecautionsprecautions

Uses of Immunoglobulins, Normal Human, For Extravascular Adm.

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

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

Immunoglobulins, Normal Human, For Extravascular Adm. Brand Names

Immunoglobulins, Normal Human, For Extravascular Adm. may be found in some form under the following brand names:

Immunoglobulins, Normal Human, For Extravascular Adm. Drug Class

Immunoglobulins, Normal Human, For Extravascular Adm. is part of the drug class:

Side Effects of Immunoglobulins, Normal Human, For Extravascular Adm.

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

Side effects are generally mild and tolerable and may include:

  • Redness, swelling and itching at injection site
  • Headache
  • Blood pressure changes 
  • Nausea
  • Vomiting
  • Dizziness
  • Fever
  • Fatigue
  • Chills 
  • Pain in the back, joints, arms and 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.

Immunoglobulins, Normal Human, For Extravascular Adm. Interactions

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 interefere 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.

Immunoglobulins, Normal Human, For Extravascular Adm. Precautions

Serious side effects have been reported including:

  • Anaphylaxis (a life-threatening allergic reaction)
  • Serious Kidney Disease
  • Pulmonary Embolism (blood clot to the lung)
  • Aseptic Meningitis Syndrome (a type of brain inflammation)
  • Hemolytic Anemia (a serious blood problem)
  • Serious lung problems

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 rare, but serious problem.

  • Decreased urination, sudden weight gain, fluid retention/swelling in your legs, and/or shortness of breath. They could be signs of a serious kidney problem called renal failure.
  • 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. These could be signs of a blood clot in your body (thrombosis). Immediately report symptoms of thrombosis.
  • Severe headache, stiff neck, fatigue, fever, sensitivity to light, painful eye movements, nausea and vomiting. These could be signs of a type of brain inflammation called aseptic meningitis.
  • Increased heart rate, fatigue, yellow skin or eyes, and dark colored urine. These could be signs of a type of blood problem called hemolytic anemia.
  • Chest pains, trouble breathing, blue lips or extremities, and fever. These could be signs of a lung problem called TRALI (transfusion-related acute lung injury).
  • Fever over 100°F. This could be a sign of an infection. 

Do not take this medication 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.

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. Also tell your doctor what drugs you are using, as some drugs, such as those that contain the hormone estrogen (for example, birth control pills), may increase your risk of developing a blood clot.

 

Immunoglobulins, Normal Human, For Extravascular Adm. Food Interactions

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.

Inform MD

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

  • have a history of hardening of the arteries (atherosclerosis), stroke, heart attack, or heart failure (low volume of blood pumped by the heart)
  • have a blood clotting disorder
  • are inactive for long periods of time (such as long bed rest)
  • if you use estrogens
  • if you have thickening of your blood
  • have a kidney problem
  • have Type II diabetes mellitus
  • are older than 65
  • are dehydrated
  • have a blood infection (sepsis)
  • have high protein content in your blood
  • are receiving other medicines that are harmful to your kidneys
  • have an allergy to immune globulin

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

Immunoglobulins, Normal Human, For Extravascular Adm. and Pregnancy

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 or can affect reproduction capacity. Immune globulins cross the placenta from maternal circulation increasingly after 30 weeks of gestation. This medication should be given to a pregnant woman only if clearly indicated.

Immunoglobulins, Normal Human, For Extravascular Adm. 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, caution should be exercised when it is administered to a nursing woman.

Immunoglobulins, Normal Human, For Extravascular Adm. Usage

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 should 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.
  • During an infusion, do not use more than 4 injection sites at the same time.
  • You will need to have infusions once a week or every two weeks. It usually takes about 1 to 2 hours to complete one infusion; however, the infusion may take longer depending on what your doctor has prescribed for you.

 

Immunoglobulins, Normal Human, For Extravascular Adm. Dosage

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. 

You should be tested regularly to make sure you have the correct levels of IgG in your blood. These tests may result in adjustments to the dose.

 

Immunoglobulins, Normal Human, For Extravascular Adm. Overdose

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

 

Other Requirements

Store at room temperature.

Keep this and all medications out of the reach of children.

Immunoglobulins, Normal Human, For Extravascular Adm. FDA Warning

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.