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Privigen

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Privigen

Privigen Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Privigen Immune Globulin Intravenous (Human), 10% Liquid is a sterilized solution made from human plasma that contains the antibodies to help your body protect itself against infection from various diseases. It is used to treat patients with primary immunodeficiency (PI) associated with defects in humoral immunity. It is also used to treat patients with chronic immune thrombocytopenic purpura (ITP) to rapidly raise platelet counts to prevent bleeding. Common side effects include headache, pain, nausea, fatigue, chills, fever, and anemia.

The usual dose of Privigen for patients with PI is 200 to 800 mg/kg, administered every 3 to 4 weeks. Privigen may interact with "live" vaccines. Tell your doctor all medications and supplements you use and all vaccines you recently received. During pregnancy, Privigen should be used only if prescribed. Consult your doctor before breastfeeding.

Our Privigen Immune Globulin Intravenous (Human), 10% 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.

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.

Privigen 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;
  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
  • black or tarry stools, coughing up blood or vomit that looks like coffee grounds;
  • red or pink urine;
  • sudden numbness or weakness, sudden severe headache, confusion, problems with vision or speech;
  • chest pain, sudden cough, wheezing, rapid breathing, warmth or swelling in one or both legs;
  • 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 Privigen (Immune Globulin Intravenous) »

What is Prescribing information?

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

Privigen FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The most serious adverse reaction observed in clinical study subjects receiving Privigen™ (immune globulin intravenous) for PI was hypersensitivity in one subject. The most serious adverse reactions observed in subjects receiving Privigen™ (immune globulin intravenous) for chronic ITP were aseptic meningitis syndrome in one subject and hemolysis in two subjects. Six other subjects in the ITP study experienced hemolysis as documented from clinical laboratory data. (WARNINGS and PRECAUTIONS).

The most common adverse reactions observed in subjects with PI were headache, pain, nausea, fatigue, and chills. The most common adverse reactions observed in subjects with chronic ITP were headache, pyrexia/hyperthermia, and anemia.

In general, reported adverse reactions to Privigen™ (immune globulin intravenous) in subjects with either PI or chronic ITP were similar in kind and frequency to those observed with other IGIV products.

Clinical Studies Experience

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

Treatment of Primary Immunodeficiency

In a prospective, open-label, single-arm, multicenter clinical study, 80 subjects with PI received median doses of Privigen™ (immune globulin intravenous) ranging from 200 to 888 mg/kg every 3 weeks (median dose 428.3 mg/kg) or 4 weeks (median dose 440.6 mg/kg) for up to 12 months (see CLINICAL STUDIES).

Routine premedication was not allowed. However, subjects who experienced two consecutive infusion-related adverse events (AEs) that were likely to be prevented by premedication were permitted to receive antipyretics, antihistamines, NSAIDs, or antiemetic agents. During the study, 8 (10%) subjects received premedication prior to 51 (4.9%) of the 1038 infusions administered.

Temporally associated AEs are those occurring during or within 72 hours after the end of an infusion, irrespective of causality. In this study, the upper bound of the 1-sided 97.5% confidence interval for the proportion of Privigen™ (immune globulin intravenous) infusions with temporally associated AEs was 23.8% (actual proportion: 20.8%). This is below the target of 40% for this safety endpoint.11 The total number of temporally associated AEs was 397 (a rate of 0.38 AEs per infusion).

Table 1 lists the temporally associated AEs that occurred in more than 5% of subjects within 72 hours after the end of a Privigen™ (immune globulin intravenous) infusion, irrespective of causality.

Table 1: Temporally Associated Adverse Events* (TAAEs) in > 5% of Subjects With PI
Within 72 Hours After the End of a Privigen™ (immune globulin intravenous) Infusion, Irrespective of Causality

TAAE No. Subjects Reporting
TAAE (% of Subjects
[n=80])
No. TAAEs Reported (as
% Rate of Infusions
[n=1038])
No. Infusions With
TAAE (% of Infusions
[n=1038])
Headache 35 (43.8) 90 (8.7) 82 (7.9)
Pain 20 (25.0) 51 (4.9) 44 (4.2)
Fatigue 13 (16.3) 29 (2.8) 27 (2.6)
Nausea 10 (12.5) 22 (2.1) 19 (1.8)
Chills 9 (11.3) 15 (1.4) 15 (1.4)
Vomiting 7 (8.8) 13 (1.3) 13 (1.3)
Pyrexia 6 (7.5) 11 (1.1) 10 (1.0)
Cough 5 (6.3) 5 (0.5) 5 (0.5)
Diarrhea 5 (6.3) 5 (0.5) 5 (0.5)
Stomach discomfort 5 (6.3) 5 (0.5) 5 (0.5)
*Excluding infections.

Of the 397 temporally associated AEs reported for the 80 subjects with PI, the investigators judged 192 to be related to the infusion of Privigen™ (immune globulin intravenous) (including 5 serious, severe AEs described below). Of the 187 non-serious AEs related to the infusion of Privigen™ (immune globulin intravenous) , 91 were mild, 81 were moderate, 14 were severe, and 1 was of unknown severity. The most common temporally associated AEs judged by the investigators to be “at least possibly” related to the infusion were headache (29% of subjects), pain (14% of subjects), nausea (11% of subjects), fatigue (11% of subjects), and chills (11% of subjects).

Sixteen subjects (20%) experienced 41 serious AEs. Five of these were related severe AEs (hypersensitivity, chills, fatigue, dizziness, and increased body temperature) that occurred in one subject and resulted in the subject's withdrawal from the study. Two other subjects withdrew from the study due to AEs related to Privigen™ (immune globulin intravenous) (chills and headache in one subject; vomiting in the other).

Seventy-seven of the 80 subjects enrolled in this study had a negative direct antiglobulin test (DAT) at baseline. Of these 77 subjects, 36 (46.8%) developed a positive DAT at some time during the study. However, no subjects showed evidence of hemolytic anemia.

During this study, no subjects tested positive for infection due to human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), or B19 virus (B19V).

Treatmentof Chronic Immune Thrombocytopenic Purpura

In a prospective, open-label, single-arm, multicenter clinical study, 57 subjects with chronic ITP received a 2 g/kg dose of Privigen™ (immune globulin intravenous) administered daily as two 1 g/kg intravenous infusions for 2 consecutive days (see CLINICAL STUDIES).

Concomitant medications affecting platelets or other treatments for chronic ITP were not allowed. Thirty-two (56.1%) subjects received premedication with acetaminophen and/or an antihistamine.

Table 2 lists the temporally associated AEs that occurred in more than 5% of subjects with chronic ITP within 72 hours after the end of a treatment cycle (two consecutive infusions) with Privigen™ (immune globulin intravenous) , irrespective of causality.

Table 2: Temporally Associated Adverse Events (TAAEs) in > 5% Subjects With Chronic
ITP Within 72 hours After the End of a Treatment Cycle* With Privigen™ (immune globulin intravenous) ,
Irrespective of Causality

TAAE No. Subjects Reporting
TAAE (% of Subjects
[n=57])
No. TAAEs Reported
(as % Rate of
Infusions [n=114])
No. Infusions With
TAAE (% of Infusions
[n=114])
Headache 37 (64.9) 48 (42.1) 41 (36.0)
Pyrexia/hyperthermia 21 (36.8) 23 (20.2) 22 (19.3)
Nausea 6 (10.5) 8 (7.0) 6 (5.3)
Epistaxis 6 (10.5) 8 (7.0) 6 (5.3)
Vomiting 6 (10.5) 7. (6.1) 6 (5.3)
Blood unconjugated bilirubin increased 6 (10.5) 6 (5.3) 6 (5.3)
Blood conjugated bilirubin increased 5 (8.8) 5 (4.4) 5 (4.4)
Blood total bilirubin increased 4 (7.0) 4 (3.5) 4 (3.5)
Hematocrit decreased 3 (5.3) 3 (2.6) 3 (2.6)
* Two consecutive daily infusions.

Of the 183 temporally associated AEs reported for the 57 subjects with chronic ITP, the investigators judged 150 to be related to the infusion of Privigen™ (immune globulin intravenous) (including the one serious AE described below). Of the 149 non-serious AEs related to the infusion of Privigen™ (immune globulin intravenous) , 103 were mild, 37 were moderate, and 9 were severe. The most common temporally associated AEs judged by the investigators to be “at least possibly” related to the infusion were headache (65% of subjects) and pyrexia/hyperthermia (35% of subjects).

Three subjects experienced three serious AEs, one of which (aseptic meningitis) was related to the infusion of Privigen™ (immune globulin intravenous) .

One subject withdrew from the study due to gingival bleeding, which was not related to Privigen™ (immune globulin intravenous) .

Eight subjects, all of whom had a positive DAT, experienced transient drug-related hemolytic reactions, which were associated with elevated bilirubin, elevated lactate dehydrogenase, and a decrease in hemoglobin level within two days after the infusion of Privigen™ (immune globulin intravenous) . Two of the eight subjects were clinically anemic but did not require clinical intervention.

Four other subjects with active bleeding were reported to have developed anemia without evidence of hemolysis.

In this study, there was a decrease in hemoglobin after the first Privigen™ (immune globulin intravenous) infusion (median decrease of 1.2 g/dL by Day 8) followed by a return to near baseline by Day 29.

Fifty-six of the 57 subjects in this study had a negative DAT at baseline. Of these 56 subjects, 12 (21.4%) developed a positive DAT during the 29-day study period.

Postmarketing Experience

The following mild to moderate reactions may occur with the administration of IGIV products: headache, diarrhea, tachycardia, fever, fatigue, dizziness, malaise, chills, flushing, skin reactions, wheezing or chest tightness, nausea, vomiting, rigors, back pain, chest pain, myalgia, arthralgia, and changes in blood pressure. Immediate hypersensitivity and anaphylactic reactions are also a possibility.

The following adverse reactions have been identified and reported during the postapproval use of IGIV products.12

Because postmarketing reporting of adverse reactions is voluntary and from a population of uncertain size, it is not always possible to reliably estimate the frequency of these reactions or establish a causal relationship to product exposure. Evaluation and interpretation of these postmarketing reactions is confounded by underlying diagnosis, concomitant medications, preexisting conditions, and inherent limitations of passive surveillance.

Read the entire FDA prescribing information for Privigen (Immune Globulin Intravenous) »

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