Pronunciation:

i-MUNE GLOB-ue-lin - stwk

Brand Names:

• Alyglo

Dosage Forms:

• Solution

Warnings:

Thrombosis, Renal Dysfunction and Acute Renal FailureThrombosis may occur with immune globulin (IGIV) products. 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. Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur in predisposed patients who receive IGIV products, including immune globulin-stwk. Patients predisposed to renal dysfunction include those with any degree of preexisting renal insufficiency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs. Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. Immune globulin-stwk does not contain sucrose. For patients at risk of thrombosis, renal dysfunction or acute renal failure, administer immune globulin-stwk 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 .

Classifications:

Therapeutic—

Immune Serum

Uses of This Medicine:

Immune globulin-stwk injection contains antibodies that make your immune system stronger. It is used for patients who have primary humoral immunodeficiency (PI), including congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and other severe combined immune system problems.

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

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 have not been performed on the relationship of age to the effects of immune globulin-stwk injection in children younger than 17 years of age. Safety and efficacy have not been established.

Older adults—

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

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while 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. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adenovirus Vaccine Type 4, Live
• Adenovirus Vaccine Type 7, Live
• Bacillus of Calmette and Guerin Vaccine, Live
• Bumetanide
• Cholera Vaccine, Live
• Dengue Tetravalent Vaccine, Live
• Ebola Zaire Vaccine, Live
• Ethacrynic Acid
• Etozolin
• Furosemide
• Influenza Virus Vaccine, Live
• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Piretanide
• Poliovirus Vaccine, Live
• Pozelimab-bbfg
• Ravulizumab-cwvz
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Smallpox Monkeypox Vaccine
• Torsemide
• Typhoid Vaccine, Live
• Varicella Virus Vaccine, Live
• Yellow Fever Vaccine
• Zoster Vaccine, Live

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:

• Bleeding problems, history of or
• Hyponatremia (low sodium in the blood) or
• Kidney problems—Use with caution. May make these conditions worse.

• Blood clotting problems, history of or
• Diabetes or
• Heart or blood vessel disease or
• Hyperproteinemia (high protein in the blood) or
• Hyperviscosity (thick blood) or
• Hypovolemia (low blood volume or major loss of body fluids) or
• Paraproteinemia (paraproteins in the blood) or
• Sepsis (serious infection in the body)—Use with caution. May cause side effects to become worse.

• IgA (immunoglobulin A) deficiency with antibodies against IgA—Should not be used in patients with this condition.

Proper Use of This Medicine:

A doctor or other trained health professional will give you this medicine in a medical facility. It is given through an IV catheter that is placed into one of your veins.

Precautions While Using This Medicine:

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

This medicine is made from donated human blood. Some human blood products have transmitted certain viruses (eg, Creutzfeldt-Jakob disease) 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 if you have concerns about this risk.

This medicine may cause serious types of allergic reactions, including anaphylaxis, which can be life-threatening and require 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.

This medicine may increase your risk of developing blood clots. Check with your doctor right away if you have swelling and pain in your arms, legs, or stomach, chest pain, loss of sensation, confusion, problems with muscle control or speech, or trouble breathing.

Check with your doctor right away if you start having red or dark brown urine, lower back or side pain, sudden weight gain, 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.

Check with your doctor right away if you start to have a stiff neck, drowsiness, fever, severe headache, nausea, 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, blue lips and fingernails, fever, pale skin, increased sweating, coughing that sometimes produces a pink frothy sputum, or swelling of the legs and ankles after receiving this medicine. These may be symptoms of a serious lung problem, including transfusion-related acute lung injury (TRALI).

While you are being treated with immune globulin injection, do not have any immunizations (vaccines) without your doctor's approval.

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 or nurse immediately if any of the following side effects occur:

Incidence not known

Agitation

anxiety

back pain

black ,tarry stools

blistering, peeling, loosening of the skin

blue lips and fingernails

bluish color of the fingernails, lips, skin, palms, or nail beds

blurred vision

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

change in color vision

changes in skin color

chest pain, discomfort, or tightness

chills

coma

confusion

cough

coughing that sometimes produces a pink frothy sputum

dark urine

decreased urination

depression

diarrhea

difficulty in speaking

difficulty seeing at night

difficulty swallowing

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

double vision

drowsiness

dry mouth

fast, pounding, or irregular heartbeat or pulse

fever

hallucinations

headache

hives, itching, skin rash

hostility

hyperventilation

inability to move the arms, legs, or facial muscles

inability to speak

increased sensitivity of the eyes to sunlight

increased thirst

irritability

joint or muscle pain

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

lethargy

light-colored stools

mood or mental changes

muscle pain, cramps, or twitching

nausea or vomiting

nervousness

no blood pressure or pulse

pain, redness, or swelling in the arm or leg

pain or discomfort in the arms, jaw, back, or neck

painful or difficult urination

pale skin

pounding in the ears

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

restlessness

red irritated eyes

red skin lesions, often with a purple center

seizures

shakiness in the legs, arms, hands, or feet

shaking

slow speech

sore throat

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

stiff neck

stomach pain

stopping of the heart

stupor

sweating

swelling of the face, ankles, or hands

swelling of the fingers, hands, feet, or lower legs

swollen glands

temporary blindness

trembling or shaking of the hands or feet

trouble breathing

trouble sleeping

unconsciousness

unusual bleeding or bruising

unusual tiredness or weakness

weakness in arm and/or leg on one side of the body, sudden and severe

weight gain

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

Stuffy or runny nose

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.