Gamimune N 10% Side Effects
Generic Name: immune globulin intravenous
Note: This page contains information about the side effects of immune globulin intravenous. Some of the dosage forms included on this document may not apply to the brand name Gamimune N 10%.
Not all side effects for Gamimune N 10% may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.
For the Consumer
Applies to immune globulin intravenous: powder for solution, solution
In addition to its needed effects, some unwanted effects may be caused by immune globulin intravenous (the active ingredient contained in Gamimune N 10%). In the event that any of these side effects do occur, they may require medical attention.
If any of the following side effects occur while taking immune globulin intravenous, check with your doctor or nurse immediately:More common
- fast, pounding, or irregular heartbeat or pulse
- noisy breathing
- tightness in the chest
- troubled breathing
- unusual tiredness or weakness
- Bluish coloring of the lips or nail beds
- burning sensation in the head
- faintness or lightheadedness
- Difficulty with swallowing
- hives or welts
- itching, especially of the feet or hands
- reddening of the skin, especially around the ears
- swelling of the eyes, face, or inside of the nose
- Back, leg, or stomach pains
- blistering, peeling, or loosening of the skin
- change in vision
- changes in urination
- chest pain or discomfort
- cold, clammy, or pale skin
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- headache that is severe and occurs suddenly
- light-colored stools
- loss of consciousness
- low blood pressure or pulse
- muscle spasm or jerking of all extremities
- nausea or vomiting
- pains in the chest, groin, or legs, especially calves of the legs
- shakiness in the legs, arms, hands, or feet
- skin blisters
- slow breathing
- slurred speech that occurs suddenly
- sores, ulcers, or white spots in the mouth or on the lips
- sudden, severe weakness or numbness in the arm or leg
- swelling in the legs and ankles
- tightness in the chest
- unusual bleeding or bruising
- yellow eyes or skin
Some of the side effects that can occur with immune globulin intravenous may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:More common
- joint pain
- muscle pain
- redness, swelling, itching, or pain at the injection site
- skin rash
- Hip pain
- leg cramps
- Feeling of warmth
- redness of the face, neck, arms, and occasionally, upper chest
- stomach pain
- swollen glands
For Healthcare Professionals
Applies to immune globulin intravenous: intravenous powder for injection, intravenous solution
In general, immune globulin intravenous (the active ingredient contained in Gamimune N 10%) human (IGIV) has been well tolerated. Mild infusion related symptoms of headache, myalgia, backache, fever, pruritus, hypotension/hypertension, tachycardia, chest tightness, chills, flushing, and nausea have been reported. Slowing or temporarily discontinuing the infusion has usually resulted in resolution of symptoms.
Renal side effects have included acute renal failure, acute tubular necrosis, proximal tubular nephropathy, and osmotic nephrosis, primarily in patients with baseline renal impairment. Some patients have required dialysis. Elevations in creatinine and BUN have been noted within 1 to 2 days following infusion. The incidence of adverse reactions may be greater in products containing sucrose as a stabilizer. Maltose containing products may cause mild diuresis. At least one case of reversible oliguria requiring only supportive care and renal failure requiring transplantation in a patient with baseline renal dysfunction has also been reported.
Twenty cases of IGIV related renal impairment have been reported.
Renal impairment, including renal failure, usually occurred in the first 5 days of therapy and more frequently in patients receiving high IGIV dosages for immune thrombocytopenia purpura.
Spontaneous reports to one manufacturer suggest that diabetic patients over the age of 70 years and patients with lupus nephritis receiving dosages greater than 400 mg/kg/day may be at increased risk of renal impairment. The mechanism has not been fully established, but may be related to renal tubular sucrose-induced osmotic injury or an immune mechanism.
Hypersensitivity side effects have included responses in the form of an inflammatory reaction (fever, chills, nausea, vomiting, hypotension) in 10% of patients with agammaglobulinemia or severe hypogammaglobulinemia who have not received IGIV within 8 weeks or who have never received IGIV. True anaphylaxis, rarely resulting in death, has been reported.
Anaphylaxis has occurred more frequently in patients with previous severe hypersensitivity reactions to IGIV, but has been reported in patients without a history of IGIV allergy. Patients previously sensitized to antibodies, such as IgA, may be at increased risk for immediate hypersensitivity reactions. Epinephrine, oxygen, IV antihistamines, and IV corticosteroids should be immediately available as such reactions can occur seconds to hours after the initiation of the infusion.
Limited data suggest that a history of migraine headaches may be associated with an increased risk of aseptic meningitis syndrome.
Nervous system side effects have been reported rarely. Mild, post infusion headache has been reported in 2% of patients with Immune Thrombocytopenic Purpura (ITP) who received dosages equal to or greater than 0.4 g/kg/day. An Aseptic Meningitis Syndrome (AMS), primarily associated with dosages greater than 2 g/kg, has occasionally been reported. Discontinuation of IGIV has resulted in AMS resolution without sequelae. Rarely, seizures have been reported.
Metabolic side effects have been reported rarely. Hyponatremia has been reported in products containing 10% maltose.
Hematologic side effects have been reported rarely. These have included reports of mild hemolysis due to transfer of blood group antibodies, and thrombotic complications. At least 6 cases of disseminated intravascular coagulation (DIC) associated with acute hemoglinemia or hemoglobinuria following immune globulin intravenous (the active ingredient contained in Gamimune N 10%) administration have been reported.
A recent report of two women who received high dose IVIg and subsequently developed thromboembolic complications suggests that high-dose IVIg increases blood viscosity that may last for several weeks, which may increase susceptibility to thromboembolism in predisposed patients.
Out of the 6 patients who developed DIC, 1 child recovered without sequelae and 5 adults all died. The attending or consulting physicians assessed that acute hemolysis or DIC caused or contributed to each death.
Cardiovascular side effects have included rare reports of cardiovascular and cerebrovascular thrombosis.
IGIV products with a more acidic pH have been reported to cause greater vein irritation.
Local side effects have included injection site reactions. These have included erythema, pain, infection, venous thrombosis, thrombophlebitis, and eczema.
Immunologic side effects have been reported rarely. All U.S. immune globulin products undergo viral inactivation and/or removal. However, no method has been totally effective in removing all risk and the potential exists for the presence of unknown infectious agents.
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