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Gammagard Liquid

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Gammagard Liquid

Gammagard Liquid

Gammagard Liquid Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Gammagard Liquid [Immune Globulin Intravenous (Human)] 10% is a preparation of highly purified and concentrated immunoglobulin G (IgG) antibodies used to treat primary immune deficiency, and to reduce the risk of infection in individuals with poorly functioning immune systems such as those with chronic lymphocytic leukemia (CLL). It is also used to increase platelets (blood clotting cells) in people with idiopathic thrombocytopenic purpura (ITP) and to prevent aneurysm caused by a weakening of the main artery in the heart associated with Kawasaki syndrome. Gammagard is also used to treat chronic inflammatory demyelinating polyneuropathy (CIDP), a debilitating nerve disorder that causes muscle weakness and can affect daily activities. Common side effects include flushing, headache, dizziness, chills, muscle cramps, back/joint pain, fever, nausea, or vomiting. Pain, redness, and swelling at the injection site may also occur.

Gammagard Liquid is administered intravenously under physician supervision. For patients with Primary Immunodeficiency, monthly doses of approximately 300 - 600 mg/kg infused at 3 to 4 week intervals are commonly used. Gammagard may interact with lithium, methotrexate, pain or arthritis medicines, medicines used to treat ulcerative colitis, medicines used to prevent organ transplant rejection, IV antibiotics, antiviral medicines, or cancer medicines. Tell your doctor all medications and supplements you use. During pregnancy, Gammagard should be used only if prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Gammagard Liquid [Immune Globulin Intravenous (Human)] 10% Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Gammagard Liquid in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • urinating less than usual or not at all;
  • drowsiness, confusion, mood changes, increased thirst, loss of appetite, nausea and vomiting;
  • swelling, weight gain, feeling short of breath;
  • wheezing, chest tightness;
  • feeling like you might pass out;
  • fever with headache, neck stiffness, chills, increased sensitivity to light, purple spots on the skin, and/or seizure (convulsions); or
  • pale or yellowed skin, dark colored urine, fever, confusion or weakness.

Less serious side effects may include:

  • mild headache;
  • dizziness;
  • tired feeling;
  • back pain, muscle cramps;
  • minor chest pain; or
  • flushing (warmth, redness, or tingly feeling).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Gammagard Liquid (Immune Globulin Intravenous (Human) 10%) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Gammagard Liquid Overview - Patient Information: Side Effects

SIDE EFFECTS: Flushing, headache, dizziness, chills, muscle cramps, back/joint pain, fever, nausea, or vomiting may occur. Tell your doctor or other health care professional immediately if any of these effects occur, persist, or worsen. Pain, redness, and swelling at the injection site may also occur. If these effects continue or become bothersome, tell your doctor.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: easy bleeding/bruising, fainting, fast/irregular heartbeat, unusual tiredness.

This medication may rarely cause blood clots (such as pulmonary embolism, stroke, heart attack, deep vein thrombosis). You may be at increased risk for blood clots if you are severely dehydrated, or have a history of blood clots, heart/blood vessel disease, heart failure, stroke, or if you are immobile (such as very long plane flights or bedridden). If you use estrogen-containing products, these may also increase your risk. Before using this medication, if you have any of these conditions report them to your doctor or pharmacist. Get medical help right away if any of these side effects occur: shortness of breath/rapid breathing, chest/jaw/left arm pain, unusual sweating, confusion, sudden dizziness/fainting, pain/swelling/warmth in the groin/calf, sudden/severe headaches, slurred speech, weakness on one side of the body, sudden vision changes.

Rarely, this product may contain substances that could cause infections because it is made from human blood. Though the risk is very low due to careful screening of blood donors, discuss the risks and benefits with your doctor. Tell your doctor immediately if you develop any signs of infection such as persistent sore throat/fever, yellowing eyes/skin, or dark urine.

Treatment with this medication may rarely cause a serious inflammation of the brain (aseptic meningitis syndrome) several hours to 2 days after your treatment. Get medical help right away if you develop severe headache, stiff neck, drowsiness, high fever, sensitivity to light, eye pain, or severe nausea/vomiting.

Lung problems may rarely occur 1 to 6 hours after your treatment. You will be monitored closely for any lung problems after your treatment.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Gammagard Liquid (Immune Globulin Intravenous (Human) 10%)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Gammagard Liquid FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

General

Various mild and moderate reactions, such as headache, fever, fatigue, chills, flushing, dizziness, urticaria, wheezing or chest tightness, nausea, vomiting, rigors, back pain, chest pain, muscle cramps, and changes in blood pressure may occur with infusions of Immune Globulin Intravenous (Human). In general, reported adverse reactions to GAMMAGARD LIQUID (immune globulin intravenous (human) 10%) in patients with Primary Immunodeficiency are similar in kind and frequency to those observed with other IGIV products. Slowing or stopping the infusion usually allows the symptoms to disappear promptly. Although hypersensitivity reactions have not been reported in the clinical studies with GAMMAGARD LIQUID (immune globulin intravenous (human) 10%) immediate anaphylactic and hypersensitivity reactions are a remote possibility. Epinephrine and antihistamines should be available for treatment of any acute anaphylactic reactions (see WARNINGS).

Clinical Study

Adverse experiences were examined among a total of 61 enrolled subjects with Primary Immunodeficiency who received at least one infusion of GAMMAGARD LIQUID (immune globulin intravenous (human) 10%) during the Phase 3 multicenter clinical study. For this study, temporally associated adverse events are defined by the FDA as those occurring during or within 72 hours of completion of an infusion. Adverse drug reactions (ADR's) are those adverse events that were deemed by the investigators as causally related to the infusion of GAMMAGARD LIQUID (immune globulin intravenous (human) 10%) .

Of all adverse experiences, 15 events in 8 subjects were serious. Two serious events, two episodes of aseptic meningitis in one patient, were deemed to be possibly related to the infusion of GAMMAGARD LIQUID (immune globulin intravenous (human) 10%) .

Among the 896 non-serious adverse experiences, 258 were judged by the investigator to be possibly or probably related to the infusion of GAMMAGARD LIQUID (immune globulin intravenous (human) 10%) . Of these, 136 were mild, 106 were moderate, and 16 were severe. All of the severe non-serious adverse experiences were transient, did not lead to hospitalization, and resolved without complication. One subject withdrew from the study due to a non-serious adverse experience (papular rash).

Of the 345 temporally related adverse experiences, those occurring in > 5% of subjects are shown in Table 5. Of these events, only headache occurred in association with more than 5% of infusions. All events were expected based on past experiences with intravenous gammaglobulin products.

Table 5: Adverse Events*, Regardless of Causality, that Occurred within 72 Hours of Infusion

Event By Infusion By Subject
  Number Percentage Number Percentage
Headache 57 6.90 22 36.1
Fever 19 2.30 13 21.3
Fatigue 18 2.18 10 16.4
Vomiting 10 1.21 9 14.8
Chills 14 1.69 8 13.1
Infusion site events 8 0.97 8 13.1
Nausea 9 1.09 6 9.8
Dizziness 7 0.85 6 9.8
Pain in Extremity 7 0.85 5 8.2
Diarrhea 7 0.85 5 8.2
Cough 5 0.61 5 8.2
Pruritus 5 0.61 4 6.5
Pharyngeal Pain 5 0.61 4 6.5
* Excluding Infections

The majority (227/258) of the non-serious adverse experiences deemed related to study product were considered expected based on previous experience with IGIV products and 31 were considered unexpected. In virtually every case, these unexpected events were either consistent with the subject's specific type of immunodeficiency or with the subject's medical history prior to entering the study. A total of 14 hospitalizations occurred during the study but none were related to infection. Hematology and clinical chemistry parameters were monitored in all subjects prior to each infusion throughout the 12-month period of study. Mean values for all laboratory parameters remained consistent throughout the study period. Three of the hematology values in one subject were outside of the normal range and reported as non-serious adverse experiences that resolved completely. These were a red cell count of 3.9 x106/jL, hematocrit of 31%, and white cell count of 3.88 x 103/jL. All spontaneously returned to baseline. One subject had an elevated BUN (45 mg/dL) and creatinine (1.4 mg/dL) on one occasion that were reported as non-serious adverse experiences and resolved completely. These values improved to 30 mg/dL and 0.8 mg/dL, respectively, by the next infusion. Six of the patients had a single, transient elevation in serum transaminases. Two additional patients had persistent elevations in transaminases, ALT and AST, which were present at the initiation of the study, prior to the infusion of GAMMAGARD LIQUID (immune globulin intravenous (human) 10%) . There was no other evidence of liver abnormalities. None of the hematology or chemistry laboratory abnormalities that occurred during the course of the study required clinical intervention and none had clinical consequences. During the Phase 3 clinical study, viral safety was assessed by serological screening for HBsAg and antibodies to HCV and HIV-1 and HIV-2 prior to, during, and at the end of the study and by Polymerase Chain Reaction (PCR) tests for HBV, HCV, and HIV-1 genomic sequences prior to and at the end of the study. None of the 61 treated subjects were positive prior to study entry and none converted from negative to positive during the 12-month period of study.

Postmarketing:

The following is a list of adverse reactions that have been identified and reported during the post-approval use of IGIV products:

Respiratory
cyanosis, hypoxemia, pulmonary edema, dyspnea, bronchospasm
Cardiovascular
thromboembolism, hypotension
Neurological
seizures, tremor
Hematologic
hemolysis, positive direct antiglobulin (Coombs) test
General/Body as a Whole
pyrexia, rigors
Musculoskeletal
back pain
Gastrointestinal
hepatic dysfunction, abdominal pain

Rare and Uncommon Adverse Events:

Respiratory
apnea, Acute Respiratory Distress Syndrome (ARDS), Transfusion Related Acute Lung Injury (TRALI)
Integumentary
bullous dermatitis, epidermolysis, erythema multiforme, Stevens-Johnson syndrome
Cardiovascular
cardiac arrest, vascular collapse
Neurological
coma, loss of consciousness
Hematologic
pancytopenia, leukopenia

Because postmarketing reporting of these reactions is voluntary and the at-risk populations are of uncertain size, it is not always possible to reliably estimate the frequency of the reaction to establish a causal relationship to exposure to the product. Such is also the case with literature reports authored independently45 (see PRECAUTIONS).

Read the entire FDA prescribing information for Gammagard Liquid (Immune Globulin Intravenous (Human) 10%) »

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Gammagard Liquid - User Reviews

Gammagard Liquid User Reviews

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Here is a collection of user reviews for the medication Gammagard Liquid sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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