Immune globulin-ifas (Intravenous)

Immune globulin-ifas injection has antibodies that help strengthen your immune system. It is used for patients with primary humoral immunodeficiency (PI), which includes congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and other serious combined immune system issues. It is also used to increase your platelet counts to control or prevent bleeding in patients with chronic immune thrombocytopenia (ITP). Additionally, this medicine is used to help with nerve and muscle problems in patients with chronic inflammatory demyelinating polyneuropathy (CIDP).

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

It is very important that your doctor closely monitors your progress for any problems that may arise from this medicine. Blood and urine tests may be required to check for side 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 had it for more than 8 weeks. Contact your doctor or nurse immediately if you experience any of these symptoms.

This medicine is made from donated human blood. Some human blood products have transmitted certain viruses to people who received them, although the risk is low. Both human donors and donated blood are tested for viruses to minimize the transmission risk. Discuss any concerns about this risk with your doctor.

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

Contact your doctor immediately if you experience a stiff neck, drowsiness, fever, severe headache, nausea, vomiting, painful eye movements, or sensitivity to light. These could indicate a serious condition called aseptic meningitis syndrome (AMS).

This medicine may cause bleeding (hemolysis) or hemolytic anemia. Inform your doctor right away if you experience stomach or back pain, dark urine, decreased urination, difficulty breathing, increased heart rate, tiredness, or yellowing of the eyes or skin after receiving the medicine.

Contact your doctor immediately if you start having chest pain, difficulty breathing, fast or noisy breathing, blue lips and fingernails, fever, pale skin, increased sweating, coughing that sometimes produces pink frothy sputum, or swelling of the legs and ankles after receiving this medicine. These may indicate a serious lung problem.

Contact your doctor right away if you experience red or dark brown urine, lower back or side pain, sudden weight gain, swelling of the face, arms, or legs, decreased urine output, or any urination problems after receiving this medicine. These may be signs of a serious kidney issue.

Your blood pressure may become too high while using this medicine. This could cause headaches, dizziness, or blurred vision. You may need to check your blood pressure at home. If you believe your blood pressure is too high, call your doctor immediately.

Ensure that any doctor or dentist treating you is aware that you are using this medicine. This medicine may affect the results of certain medical tests.

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

In deciding to use a medicine, you need to think about the risks of taking it compared to the benefits it will provide. This is a choice you will make with your doctor. For this medicine, consider the following:

Allergies

Let your doctor know if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also inform your healthcare professional about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies so far have not shown any specific problems in children aged 2 years and older that would limit the use of immune globulin-ifas injection. Safety and effectiveness have not been established in children with ITP or CIDP or in children younger than 2 years of age for treating primary humoral immunodeficiency, congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, or Wiskott-Aldrich syndrome.

Geriatric

Current studies have not indicated any specific issues for elderly patients that would limit the use of immune globulin-ifas injection. However, older adults are more likely to experience age-related blood clotting problems or kidney disease, which may require caution for those receiving immune globulin-ifas injection.

Breast Feeding

There are no sufficient studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits and risks before using this medication during breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if an interaction could happen. In these cases, your doctor may adjust the dose, or other precautions may be needed. When receiving this medicine, it is especially important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions have been chosen for 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 necessary in some cases. If both medicines are prescribed together, your doctor may change the dose or frequency of one or both medicines.

• Pozelimab-bbfg
• Ravulizumab-cwvz

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used near mealtimes or with specific types of food due to potential interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical issues may affect how this medicine works. Be sure to tell your doctor about any other medical problems you have, 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 worsen.

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

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

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.

In the U.S.

• Panzyga

Available Dosage Forms:

• Solution

Therapeutic Class: Immune Serum

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.