Panzyga (Intravenous)

Immune globulin-ifas injection contains 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 help control or prevent bleeding in patients with chronic immune thrombocytopenia (ITP). This medicine is also used to help improve nerve and muscle issues in patients with chronic inflammatory demyelinating polyneuropathy (CIDP).

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

It is very important that your doctor checks 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.

In deciding to use a medicine, you and your doctor must weigh the risks of taking the medicine against the benefits it may provide. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For over-the-counter products, read the label or package ingredients carefully.

Pediatric

Studies have not shown any specific problems that would limit the use of immune globulin-ifas injection in children aged 2 years and older. However, 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

Studies have not shown any specific problems that would limit the use of immune globulin-ifas injection in elderly patients. However, older patients are more likely to have age-related blood clotting issues or kidney disease, which may require caution when using immune globulin-ifas injection.

Breast Feeding

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

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might happen. In these situations, your doctor may need to adjust the dose or take other precautions. When you are receiving this medicine, it is very important for your healthcare professional to know if you are taking any of the following medicines. The following interactions are significant but may not be 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 for one or both medicines.

• Pozelimab-bbfg
• Ravulizumab-cwvz

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used around the time of eating or with certain types of food due to potential interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect how this medicine works. Be sure to tell your doctor if you have any other health issues, 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 fluid loss) or
• Paraproteinemia (paraproteins in the blood) or
• Sepsis (serious infection in the body)—Use with caution. May worsen side effects.

• 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.

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.