Allina Health

Pronunciation:

im-MYOON GLOB-yoo-lin

Brand Names:

• Baygam
• Carimune
• Gamimune N
• Gammagard
• Gammar-P
• Hizentra
• Iveegam EN
• Octagam
• Panglobulin NF
• Polygam S/D
• Sandoglobulin
• Vivaglobin

Dosage Forms:

• Solution
• Powder for Solution

Warnings:

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 containing sucrose . Flebogamma(R) 5%, Flebogamma(R) 5% DIF, Flebogamma(R) 10% DIF, Gammagard S/D(R), Gamunex(R), and Previgen(R) do not contain sucrose . Glycine is used as a stabilizer in Gamunex(R) .

Classifications:

Therapeutic—

Immune Serum

Uses of This Medicine:

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), and chronic inflammatory demyelinating polyneuropathy (CIDP).

This medicine is to be administered 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).
• Multifocal motor neuropathy (treatment).
• Relapsing-remitting multiple sclerosis (treatment).

Before Using This Medicine:

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.

Children—

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® in children with PI, and safety and efficacy have not been established for Vivaglobin® in children younger than 2 years of age.

Older adults—

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 kidney disease or heart disease, which may require caution for patients receiving immune globulin injection.

Pregnancy—

Breast-feeding—

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

Other 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.

Other interactions—

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:

• 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 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.

Proper Use of This Medicine:

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 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 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.

To use 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 shake the medicine.
• Follow your doctor's instructions on how to prepare the correct amount of medicine.
• Choose an injection site on your body (e.g., abdomen or stomach area, thigh, upper arm, upper leg or 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. Keep from freezing.

Protect the Hizentra® product from direct light. Keep the medicine in the original package until you are ready to use it.

Store the Vivaglobin® product in the refrigerator, but do not freeze the medicine. Store it in the original container.

Precautions While Using This Medicine:

It is very important that your doctor check the progress of you or your child 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.

This medicine may cause fever, chills, nausea, and vomiting, especially if you will be 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. The risk of getting a virus from medicines made from human blood has been greatly reduced in recent years. This is the result of required testing of human donors for certain viruses, and required testing of the medicine when it is made. Although the risk is low, talk with your doctor if you have concerns.

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 or your child 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 or your child 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 or your child have stomach or back pain, dark urine, decreased urination, an increased heart rate, tiredness, or yellow eyes or skin after you receive the medicine.

Check with your doctor right away if you or your child 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, especially in patients with a history of blood clotting problems, heart disease, or atherosclerosis (hardening of the arteries), and those who stay in bed for a long time because of surgery or illness. Check with your doctor right away if you or your child 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 or your child 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.

Side Effects of This Medicine:

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 immediately if any of the following side effects occur:

More common

Fast or pounding heartbeat

troubled breathing

Less common

Bluish coloring of the lips or nailbeds

burning sensation in the head

faintness or lightheadedness

unusual tiredness or weakness

wheezing

Rare

Difficulty with breathing or 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

unusual tiredness or weakness (sudden and severe)

Incidence not known

Back, leg, or stomach pains

bleeding gums

blistering, peeling, or loosening of the skin

bloody, black, or tarry stools

blurred vision

change in consciousness

chest pain or discomfort

chills

cloudy urine

cold, clammy, or pale skin

confusion

convulsions

coughing that sometimes produces a pink frothy sputum

dark urine

decrease in urine amount

diarrhea

difficult, fast, or noisy breathing, sometimes with wheezing

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

feeling unusually cold

fever with or without chills

general body swelling

headache

high fever

increased sweating

irregular heartbeats

light-colored stools

loss of appetite

loss of bladder control

loss of consciousness

muscle spasm or jerking of all extremities

nausea or vomiting

no blood pressure or pulse

nosebleeds

not breathing

painful or difficult urination

pains in the chest, groin, or legs, especially calves of the legs

red skin lesions, often with a purple center

red, irritated eyes

severe headaches that occur suddenly

shakiness in the legs, arms, hands, or feet

shivering

shortness of breath

shortness of breath that occurs suddenly for no apparent reason

skin blisters

slow heart rate

slurred speech that occurs suddenly

sore throat

sores, ulcers, or white spots in the mouth or on the lips

stomach pain

stopping of the heart

sudden loss of consciousness

sudden loss of coordination

sudden vision changes

sudden, severe weakness or numbness in the arm or leg

sweating

swelling in the legs and ankles

swollen glands

tightness in the chest

tiredness

trembling or shaking of the hands or feet

unconsciousness

unexplained or unusual bleeding or bruising

weakness

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

Joint pain

muscle pain

redness, swelling, itching, or pain at the injection site

Less common

Hip pain

leg cramps

Incidence not known

Feeling of warmth

redness of the face, neck, arms and occasionally, upper chest

skin rash

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.