Gammaplex

Medical Editor: John P. Cunha, DO, FACOEP Last updated on RxList: 12/13/2021
Gammaplex Side Effects Center

What Is Gammaplex?

Gammaplex (immune globulin intravenous [human], 5% liquid) is an immune globulin intravenous (human) 5% liquid indicated for the treatment of primary humoral immunodeficiency (PI) in adults and pediatric patients two years of age and older and for the treatment of chronic immune thrombocytopenic purpura (ITP).

What Are Side Effects of Gammaplex?

Common side effects of Gammaplex include:

  • headache, fever, nasal congestion, fatigue, nausea, vomiting, high blood pressure (hypertension), low blood pressure (hypotension), rash, infusion site reaction, vomiting, muscle pain, chills, fast heart rate, chest pain/discomfort, pain, dizziness, general feeling of being unwell (malaise), pain or difficultly urinating, dry skin, itching, dehydration, and joint pain.

    Dosage for Gammaplex

    The dose of Gammaplex to treat PI is 300-800 mg/kg (6-16 mL/kg) every 3-4 weeks. The dose of Gammaplex to treat ITP is 1 g/kg (20 mL/kg) for 2 consecutive days.

    What Drugs, Substances, or Supplements Interact with Gammaplex?

    Gammaplex may interact with live virus vaccines. Tell your doctor all medications and supplements you use and all vaccines you recently received.

    Gammaplex During Pregnancy or Breastfeeding

    Tell your doctor if you are pregnant or plan to become pregnant before using Gammaplex. Consult your doctor before breastfeeding.

    Additional Information

    Our Gammaplex (immune globulin intravenous [human], 5% liquid) 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.

Gammaplex Consumer Information

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

Some side effects may occur during the injection. Tell your caregiver if you feel dizzy, nauseated, light-headed, sweaty, or have a headache, pounding in your neck or ears, fever, chills, chest tightness, or warmth or redness in your face.

Call your doctor at once if you have:

  • a blood cell disorder--pale or yellowed skin, dark colored urine, fever, confusion or weakness;
  • dehydration symptoms--feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin;
  • kidney problems--little or no urination, swelling, rapid weight gain, feeling short of breath;
  • lung problems--chest pain, trouble breathing, blue colored lips, fingers, or toes;
  • signs of a new infection--fever with a severe headache, neck stiffness, eye pain, and increased sensitivity to light; or
  • signs of a blood clot--shortness of breath, chest pain with deep breathing, rapid heart rate, numbness or weakness on one side of the body, swelling and warmth or discoloration in an arm or leg.

Common side effects may include:

  • headache, back pain, joint pain;
  • fever, chills, sweating, warmth or tingling;
  • stomach pain, nausea, diarrhea;
  • increased blood pressure, fast heartbeats;
  • dizziness, tiredness, lack of energy;
  • stuffy nose, sinus pain; or
  • pain, swelling, burning, or irritation around the IV needle.

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 Gammaplex (Immune Globulin Intravenous (Human), 5% Liquid )

Gammaplex Professional Information

SIDE EFFECTS

Serious adverse reactions (ARs) observed in clinical trial subjects with primary humoral immunodeficiency (PI) were thrombosis and chest pain. The one event of thrombosis (1 subject, 2%) was reported in an adult who also had a diagnosis of antiphospholipid syndrome which results in increased clotting tendency [see WARNINGS AND PRECAUTIONS].

Serious ARs observed in clinical trial subjects with immune thrombocytopenic purpura (ITP) were headache, vomiting and dehydration. In addition following a review of the data, 4 subjects (11%) were considered to have experienced asymptomatic suspected treatment-emergent hemolysis [see Clinical Trials Experience].

The following potential serious ARs are described above and/or elsewhere in the labeling:

The most common ARs observed in the PI clinical trials were headache (29 subjects, 39%), pyrexia (11 subjects, 15%), nasal congestion/edema (10 subjects, 13%), fatigue (9 subjects, 12%), nausea (7 subjects, 9%), hypertension (6 subjects, 8%), rash (6 subjects, 8%), hypotension (5 subjects, 7%), infusion site reactions (5 subjects, 7%) vomiting (5 subjects, 7%), myalgia (4 subjects, 5%), chills (4 subjects, 5%), tachycardia (4 subjects, 5%), chest pain/discomfort (4 subjects, 5%), pain (4 subjects, 5%), dizziness (4 subjects, 5%), malaise (4 subjects, 5%), dysuria (4 subjects, 5%), and dry skin (4 subjects, 5%).

The most common ARs observed in the chronic ITP clinical trial were headache (12 subjects, 34%), vomiting (8 subjects, 23%), nausea (5 subjects, 14%), pyrexia (5 subjects, 14%), pruritus (2 subjects, 6%) and arthralgia (2 subjects, 6%).

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Primary Humoral Immunodeficiency Study

In a multicenter, open-label, non-randomized clinical trial, 50 subjects with primary humoral immunodeficiency received doses of Gammaplex ranging from 279 to 799 mg/kg every 21 days (mean dose 465 mg/kg) or 28 days (mean dose 458 mg/kg), for up to 12 months [see Clinical Studies].

Twenty-four subjects (48%) had an AR at some time during the clinical trial that was considered product-related. Of these 24 subjects, three had ARs that were considered definitely related to Gammaplex including headache, pyrexia, tachycardia, chest discomfort, and hypertension. More subjects with the 21-day infusion cycle had at least one AR (14 of 22 subjects, 64%) than subjects with the 28-day infusion cycle (10 of 28 subjects, 36%). The total number of ARs during infusion or within 72 hours of infusion was 237 (a rate of 0.34 ARs per infusion), reflecting that some subjects experienced more than one AR during the observation period. The percentage of Gammaplex infusions with one or more ARs within 72 hours of infusion was 21%. The upper bound of the 1-sided 95% confidence interval for this percentage was 24%, which was below the pre-specified upper limit of 40% for this safety endpoint.

The most common ARs observed in this clinical trial were headache (18 subjects, 36%), fatigue (6 subjects, 12%), nausea (6 subjects, 12%), pyrexia (6 subjects, 12%), pain (4 subjects, 8%), hypertension (3 subjects, 6%), chills (3 subjects, 6%), myalgia (3 subjects, 6%) and vomiting (3 subjects, 6%). Two subjects experienced serious ARs (thrombosis and chest pain).

Forty-seven of the 50 subjects enrolled in this clinical trial had a negative direct antiglobulin test (DAT) at baseline. Of these 47 subjects, 4 (9%) developed a positive DAT at some time during the clinical trial. However, no subjects showed evidence of hemolytic anemia.

There was no evidence of transmission of hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV) or parvovirus B19 during this clinical trial.

Table 2: Adverse Reactions (ARs*) Occurring in > 5% of Subjects with PI**

Adverse Reactions PI studies Subjects (%)
PI [n=75]
Infusions (%)
PI [n=1071]
Headache 29 (39%) 74 (6.9%)
Sinusitis 14 (19%) 17 (1.6%)
Pyrexia 11 (15%) 13 (1.2%)
Nasal Congestion / Edema 10 (13%) 8 (0.7%)
Fatigue 9 (12%) 13 (1.2%)
Nausea 7 (9%) 8 (0.7%)
Hypertension 6 (8%) 8 (0.7%)
Upper respiratory tract infection 6 (8%) 8 (0.7%)
Rash 6 (8%) 6 (0.6%)
Hypotension 5 (7%) 11 (1.0%)
Infusion site reaction 5 (7%) 6 (0.6%)
Vomiting 5 (7%) 4 (0.4%)
Myalgia 4 (5%) 15 (1.4%)
Chills 4 (5%) 9 (0.8%)
Tachycardia 4 (5%) 6 (0.6%)
Rhinitis 4 (5%) 6 (0.6%)
Chest pain/discomfort 4 (5%) 5 (0.5%)
Pain 4 (5%) 5 (0.5%)
Dizziness/ Vertigo 4 (5%) 4 (0.4%)
Malaise / Asthenia / Lethargy 4 (5%) 4 (0.4%)
Dysuria / Cystitis / UTI 4 (5%) 4 (0.4%)
Dry skin / Eczema 4 (5%) 4 (0.4%)
Bronchitis 4 (5%) 4 (0.4%)
* Adverse Reactions (ARs) are defined as treatment emergent adverse events which met any of the following criteria: (a) adverse events which began during an infusion of Gammaplex or within 72 hours of the end of an infusion, (b) adverse events considered by the investigator or sponsor to have been possibly, probably, or definitely related to administration of Gammaplex, (c) adverse events for which the investigator's causality assessment was either missing or indeterminate.
** ARs are presented for the PI studies if occurred in > 5% of subjects. ARs seen in the pediatric study are presented in a separate table if occurred in > 5% of pediatric subjects and were not reported in the major effectiveness study.

Table 3: ARs* in > 5% of Pediatric Subjects with PI**

Adverse Reactions PI Pediatric Subjects (%)
PI[n=25]
Infusions (%)
PI [n=368]
Dyspnea 2 (8%) 2 (0.5%)
Otitis media acute 2 (8%) 2 (0.5%)
Tonsillar disorder 2 (8%) 2 (0.5%)
* Adverse Reactions (ARs) are defined as treatment emergent adverse events which met any of the following criteria: (a) adverse events which began during an infusion of Gammaplex or within 72 hours of the end of an infusion, (b) adverse events considered by the investigator or sponsor to have been possibly, probably, or definitely related to administration of Gammaplex, (c) adverse events for which the investigator's causality assessment was either missing or indeterminate.
** ARs are presented for the PI studies if occurred in > 5% of subjects. ARs seen in the pediatric study are presented in a separate table if occurred in > 5% of pediatric subjects and were not reported in the major effectiveness study.

Pediatric Primary Humoral Immunodeficiency Study

In a multicenter, open-label, non-randomized clinical trial, 25 children and adolescents with primary humoral immunodeficiency received doses of Gammaplex ranging from 300 to 800 mg/kg every 21 days (mean dose 545 mg/kg) or 28 days (mean dose 521 mg/kg), for up to 12 months [see Clinical Studies].

Fourteen subjects (56%) had an AR at some time during the clinical trial that was considered product-related. Of these 14 subjects, two had ARs that were considered definitely related to Gammaplex including headache, fatigue and myalgia. Seven subjects with the 21-day infusion cycle had at least one AR (7 of 14 subjects, 50%), as did seven subjects with the 28-day infusion cycle (7 of 11 subjects, 64%).

Chronic Immune Thrombocytopenic Purpura Study

In a multicenter, open-label, non-randomized clinical trial, 35 subjects with chronic immune thrombocytopenic purpura were treated with a nominal dose of 1,000 mg/kg on each of two consecutive days (total dose 2,000 mg/kg). Doses of Gammaplex ranged from 482 to 1149 mg/kg on an infusion day. The median total dose per subject was 2035 mg/kg. Pre-medication with antihistamine or analgesic drugs was permitted if required, but corticosteroids were not permitted prior to infusion as pre-medication. Ten subjects received corticosteroids for ITP during the trial and one additional subject received corticosteroids as pre-medication in violation of the protocol. All 35 subjects received at least one infusion of clinical trial drug, and all but one subject completed the first course of treatment.

Twenty-four subjects (69%) reported at least one AR (103 in total); the most commonly reported being headache (12 subjects, 34%), vomiting (8 subjects, 23%), nausea (5 subjects, 14%), pyrexia (5 subjects, 14%), pruritus (2 subjects, 6%), dehydration (2 subjects, 6%) and arthralgia (2 subjects, 6%). Three subjects experienced a total of five serious ARs. Of the five serious ARs, one subject had three concurrently (vomiting, dehydration and headache) and two subjects each had one serious AR (headache). One of these latter two subjects discontinued from the clinical trial because of the severe headache. Table 4 lists the ARs in more than 5% of subjects.

Based on a review of clinical and laboratory data, 4/35 subjects (11%) with drops in hemoglobin exceeding 2 g/dL following administration of Gammaplex were considered to have experienced suspected treatment-emergent hemolysis. Milder treatment-emergent hemolysis could not be excluded for an additional 7 subjects, giving a total of 11 of 35 subjects (31%) for whom hemolysis could not be excluded (not including an additional two subjects who lacked follow-up testing for hemolysis, so their hemolysis status was considered unassessable). Data for two subjects were consistent with possible intravascular hemolysis, including one subject who may also have had an element of extravascular hemolysis. Nine of the possible hemolysis cases were mild and appeared consistent with possible extravascular hemolysis.

There was no evidence of transmission of HBV, HCV, HIV and parvovirus B19 during this clinical trial.

Table 4: Adverse Reactions (ARs*) Occurring in > 5% of Subjects with ITP

Adverse Reactions Subjects (%)
ITP [n=35]
Infusions (%)
ITP [n=94]
Headache 12 (34%) 15 (16%)
Vomiting 8 (23%) 9 (9.6%)
Nausea 5 (14%) 5 (5.3%)
Pyrexia 5 (14%) 7 (7.4%)
Pain 2 (6%) 2 (2.1%)
Abdominal pain upper 2 (6%) 2 (2.1%)
Gastritis 2 (6%) 2 (2.1%)
Contusion 2 (6%) 2 (2.1%)
Arthralgia 2 (6%) 2 (2.1%)
Cough 2 (6%) 2 (2.1%)
Anemia 2 (6%) 1 (1.1%)
Ecchymosis 2 (6%) 3 (3.2%)
Pruritus 2 (6%) 2 (2.1%)
Dehydration 2 (6%) 2 (2.1%)
Hypertension 2 (6%) 1 (1.1%)
Neck pain 2 (6%) 1 (1.1%)
* Adverse Reactions (ARs) are defined as treatment emergent adverse events which met any of the following criteria: (a) adverse events which began during an infusion of Gammaplex or within 72 hours of the end of an infusion, (b) adverse events considered by the investigator or sponsor to have been possibly, probably, or definitely related to administration of Gammaplex, (c) adverse events for which the investigator's causality assessment was either missing or indeterminate. 

Postmarketing Experience

Because adverse reactions are voluntarily reported post-approval from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to product exposure.

In addition to the adverse reactions identified in clinical studies [see ADVERSE REACTIONS], the following adverse reactions have been identified during postmarketing use of Gammaplex:

The following adverse reactions have been identified during post-marketing use of intravenous immune globulins9:

  • Infusion reactions: Hypersensitivity (e.g., anaphylaxis), headache, diarrhea, tachycardia, fever, fatigue, dizziness, malaise, chills, flushing, urticaria or other skin reactions, wheezing or other chest discomfort, nausea, vomiting, rigors, back pain, myalgia, arthralgia, and changes in blood pressure
  • Renal: Acute renal dysfunction/failure, osmotic nephropathy
  • Respiratory: Apnea, Acute Respiratory Distress Syndrome (ARDS), TRALI, cyanosis, hypoxemia, pulmonary edema, dyspnea, bronchospasm
  • Cardiovascular: Cardiac arrest, thromboembolism, vascular collapse, hypotension
  • Neurological: Coma, loss of consciousness, seizures, tremor, aseptic meningitis syndrome
  • Integumentary: Stevens-Johnson syndrome, epidermolysis, erythema multiforme, dermatitis (e.g., bullous dermatitis)
  • Hematologic: Pancytopenia, leukopenia, hemolysis, positive direct antiglobulin (Coombs') test
  • Gastrointestinal: Hepatic dysfunction, abdominal pain
  • General/Body as a Whole: Pyrexia, rigors

Read the entire FDA prescribing information for Gammaplex (Immune Globulin Intravenous (Human), 5% Liquid )

© Gammaplex Patient Information is supplied by Cerner Multum, Inc. and Gammaplex Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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