Pronunciation:

i-MUNE GLOB-ue-lin - ifas

Brand Names:

• Panzyga

Dosage Forms:

• Solution

Warnings:

Warning: Thrombosis, Renal Dysfunction, and Acute Renal FailureThrombosis may occur with immune globulin intravenous (IGIV) products, including immune globulin-ifas. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors.Renal dysfunction, acute renal failure, osmotic nephropathy, and death may occur with the administration of IGIV products in predisposed patients. Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. Immune globulin-ifas does not contain sucrose.For patients at risk of thrombosis, renal dysfunction, or renal failure, administer immune globulin-ifas at the minimum 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-ifas 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. It is also used to raise your platelet counts to control or prevent bleeding in patients with chronic immune thrombocytopenia (ITP). This medicine is also used to improve nerve and muscle problems in patients with chronic inflammatory demyelinating polyneuropathy (CIDP).

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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of immune globulin-ifas injection in children 2 years of age and older. Safety and efficacy have not been established in children with ITP or CIDP or in children younger than 2 years of age to treat primary humoral immunodeficiency, congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, or Wiskott-Aldrich syndrome.

Older adults—

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

• Pozelimab-bbfg
• Ravulizumab-cwvz

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:

• 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) 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.

• Bleeding problems, history of or
• Hyponatremia (low sodium in the blood) or
• Kidney problems—Use with caution. May make these conditions 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 a needle placed into one of your veins.

While you 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 or more months after receiving immune globulin.

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 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 if you have concerns about this risk.

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, 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.

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.

Your blood pressure might get too high while you are using this medicine. This may cause headaches, dizziness, or blurred vision. You might need to measure your blood pressure at home. If you think your blood pressure is too high, call your doctor right away.

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.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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:

More common

Cough

cough producing mucus

difficulty breathing

fever

headache

pain or tenderness around the eyes and cheekbones

pale skin

stuffy or runny nose

tightness of the chest

trouble breathing

unusual bleeding or bruising

unusual tiredness or weakness

Incidence not known

Agitation

anxiety

back pain

black, tarry stools

blistering, peeling, or loosening of the skin

bloody or cloudy urine

bloody, black, or tarry stools

blue lips and fingernails

bluish lips or skin

blurred vision

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

change in color vision

changes in skin color

chest pain or discomfort

chills

confusion

coughing that sometimes produces a pink frothy sputum

dark urine

decreased frequency or amount of urine

decreased urination

decreased urine output

diarrhea

difficult or painful urination

difficult, fast, noisy breathing

difficulty in speaking

difficulty seeing at night

difficulty swallowing

dizziness or lightheadedness

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

double vision

drowsiness

fainting

fast or irregular heartbeat

hallucinations

high fever

hives, itching, skin rash

inability to move the arms, legs, or facial muscles

inability to speak

increased blood pressure

increased sensitivity of the eyes to sunlight

increased sweating

increased thirst

irritability

joint or muscle pain

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

loss of appetite loss of consciousness

lower back or side pain

mood or mental changes

muscle pain or cramps

nausea

nervousness

noisy breathing

noisy, rattling breathing

pain, redness, or swelling in the arm or leg

painful or difficult urination

pounding in the ears

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

red skin lesions, often with a purple center

red, irritated eyes

seizures

slow heartbeat

slow speech

sore throat

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

stiff neck or back

stomach pain

sudden decrease in the amount of urine

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

swollen glands

tenderness

unusual bleeding or bruising

unusual drowsiness, dullness, or feeling of sluggishness

vomiting

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

Blistering, crusting, irritation, itching, or reddening of the skin

cracked, dry, scaly skin

swelling

upper stomach pain

Incidence not known

Anxiety

bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

bone pain

difficulty in moving

hair loss, thinning of hair

joint swelling

nervousness

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.