Immune globulin-slra (Intravenous)

Immune globulin-slra injection contains antibodies that help boost your immune system. It is used for patients with primary humoral immunodeficiency (PI), including congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and other serious combined immune system issues.

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

It is very important that your doctor monitors you or your child's progress closely for any problems that may arise from this medicine. Blood and urine tests may be necessary to check for unwanted effects.

This medicine may cause a serious allergic reaction, including anaphylaxis, which can be life-threatening and needs immediate medical attention. Tell your doctor right away if you have a rash, itching, hives, chest pain, dizziness or lightheadedness, trouble breathing or swallowing, or any swelling of your hands, face, or mouth after using 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. Contact your doctor immediately if you or your child experience swelling and pain in your arms, legs, or stomach, chest pain, shortness of breath, loss of sensation, confusion, or issues with muscle control or speech.

Immediately check with your doctor if you start to experience a stiff neck, drowsiness, fever, severe headache, nausea, vomiting, painful eye movements, or sensitivity to light. These could be signs of a serious condition called aseptic meningitis syndrome (AMS).

Contact your doctor right away if you notice red or dark brown urine, lower back or side pain, sudden weight gain, swollen face, arms, or legs, decreased urine output, or any issues with urination after receiving this medicine. These may indicate a serious kidney problem.

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

Immediately check with your doctor if you experience chest pain, difficulty breathing, rapid 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 signs of a serious lung problem.

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 keep the risk of transmission low. Talk with your doctor if you have concerns about this risk.

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. 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.

While you are receiving immune globulin injection, do not get any immunizations (vaccines) without your doctor's approval.

In deciding to use a medicine, you and your doctor need to consider the risks of taking the medicine compared to the benefits it may provide. The following points should be taken into account for this medicine:

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, like to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies have not been done on how age affects the use of immune globulin-slra injection in children younger than 3 years old. Safety and effectiveness have not been established for this age group.

Geriatric

Current studies have not shown any specific problems for older adults that would limit the use of immune globulin-slra injection. However, older patients are more likely to have age-related liver, kidney, or heart issues, which may require extra caution and a change in the dose for those receiving this medicine.

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 against the potential risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be taken together at all, while in other cases, two different medicines may be used together even if an interaction could happen. If you are receiving this medicine, it is very important that your healthcare professional knows if you are taking any of the following medicines. The interactions listed below are significant and are not all-inclusive.

Using this medicine with the following medicines is usually not recommended, but may be necessary in some cases. If both are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Pozelimab-bbfg
• Ravulizumab-cwvz

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around mealtime or with certain foods due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect the use of this medicine. Be sure to tell your doctor if you have any medical problems, especially:

• Blood clotting problems 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 worsen side effects.

• History of bleeding problems 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, Immune globulin-slra (Intravenous) may cause some unwanted effects. Although not all of these side effects may occur, if they do, they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

• Body aches or pain
• chills
• cough
• cough producing mucus
• diarrhea
• ear congestion
• fever
• headache
• loss of appetite
• loss of voice
• muscle aches
• nausea
• pain or tenderness around the eyes and cheekbones
• sneezing
• sore throat
• stomach pain
• stuffy or runny nose
• tightness of the chest
• troubled breathing
• unusual tiredness or weakness

Less common

• Nosebleed

Incidence not known

• Blistering, peeling, or loosening of the skin
• bloody, black, or tarry stools
• bluish color of the fingernails, lips, skin, palms, or nail beds
• chest pain
• dark urine
• feeling unusually cold
• high fever
• itching skin
• joint or muscle pain
• light-colored stools
• loss of consciousness
• painful or difficult urination
• pale skin
• red skin lesions, often with a purple center
• red, irritated eyes
• seizures
• shivering
• sores, ulcers, or white spots in the mouth or on the lips
• swollen glands
• tremor
• unexplained bleeding or bruising
• unusual bleeding or bruising
• vomiting
• 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 Immune globulin-slra. 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

• Muscle spasms

Less common

• Arm or leg pain
• mouth or throat pain

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.

• Asceniv

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.