Description
Immune globulin-dira 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
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.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of immune globulin-dira injection in children younger than 2 years of age. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of immune globulin-dira 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-dira injection.
Breastfeeding
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.
Drug Interactions
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, Live Non-Replicating
- Smallpox 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
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
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 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 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 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).
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.
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
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
- Body aches or pain
- chills
- cough
- ear congestion
- fever
- headache
- increased blood pressure
- loss of voice
- sneezing
- sore throat
- stuffy or runny nose
- trouble breathing
- unusual tiredness or weakness
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
- 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
- hallucinations
- 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
- 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 sleeping
- unconsciousness
- unusual bleeding or bruising
- 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:
Incidence not known
- Arm or leg pain
- burning sensation
- difficulty in moving
- loss or thinning of the hair
- muscle aches or stiffness
- swollen joints
- unusual drowsiness, dullness, tiredness, weakness or feeling of sluggishness
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.
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