Applies to immune globulin intramuscular: intramuscular injectable.
Warning
- The chance of blood clots may be raised with this drug. The chance may be higher in older people, if you have to be in a bed or chair for a long time, if you take estrogen products, or if you have certain catheters. Some health problems like thick blood, heart problems, or a history of blood clots raise the chance of having blood clots. Blood clots can happen if you do not have any of these health problems. Call your doctor right away if you have numbness or weakness on 1 side of your body; pain, redness, tenderness, warmth, or swelling in the arms or legs; change in color of an arm or leg; chest pain or pressure; shortness of breath; fast heartbeat; or coughing up blood. Talk with your doctor.
- Kidney problems have happened with human immune globulin. Sometimes, these problems have been deadly. Kidney problems are more common in people using products that have sucrose. Most immune globulin products do not have sucrose. The chance of these problems may be raised if you have kidney problems, high blood sugar (diabetes), fluid loss (dehydration) or low blood volume, a blood infection, or proteins in the blood that are not normal. The chance may be raised if you are 65 or older, or if you take other drugs that may harm the kidneys. Talk with your doctor if you have questions about this information or about if your product has sucrose.
- You will need to be sure that you are not dehydrated before getting this drug. Check with your doctor to see if you need to drink extra fluids before getting this drug.
Serious side effects
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
- Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
Other side effects
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
- Irritation where this drug is given.
- Feeling tired or weak.
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.
For Healthcare Professionals
Applies to immune globulin intramuscular: intramuscular solution.
Local
Frequency not reported: Injection site pain, injection site tenderness, injection site erythema, injection site stiffness, induration, local warmth/heat when touched, local bruising, local irritation[Ref]
Hypersensitivity
Frequency not reported: Anaphylaxis, allergic response
Anaphylaxis is more likely if this product is given intravenously.[Ref]
Nervous system
Frequency not reported: Drowsiness, headache, dizziness, convulsions[Ref]
Dermatologic
Frequency not reported: Urticaria, angioedema, sweating[Ref]
Gastrointestinal
Frequency not reported: Nausea[Ref]
Musculoskeletal
Frequency not reported: Chills[Ref]
Other
Frequency not reported: Malaise, sensation of fever, mild pyrexia[Ref]
