Vivaglobin Side Effects

Generic Name: immune globulin subcutaneous

Please note - some side effects for Vivaglobin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Vivaglobin - for the Consumer

Vivaglobin

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Vivaglobin:

Cough; diarrhea; headache; nausea; pain, swelling, muscle stiffness, or redness at the injection site; sore throat; weakness.

Seek medical attention right away if any of these SEVERE side effects occur when using Vivaglobin:

Severe allergic reactions (rash; itching; hives; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, hands, face, lips, eyes, throat, or tongue); calf pain or tenderness; chest pain or tightness; confusion; coughing up blood; dark urine; eye pain or sensitivity to light; fainting; fast or irregular heartbeat; fever; numbness of an arm or a leg; one-sided weakness; red, swollen, blistered, or peeling skin; seizures; severe headache, dizziness, or stomach pain; shortness of breath or trouble breathing; speech problems; symptoms of kidney problems (eg, decreased urination, lower back or flank pain, swelling or bloating, sudden weight gain); unusual bruising or bleeding; unusual tiredness or weakness; vision problems; wheezing; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Vivaglobin Side Effects - for the Professional

Vivaglobin

The most common adverse reactions (those AEs considered by the investigator to be at least possibly related to Vivaglobin administration) observed in ≥5% of study subjects receiving Vivaglobin were local injection-site reactions (swelling, redness, and itching), headache, nausea, rash, asthenia, and gastrointestinal disorder.

Clinical Studies Experience

Because clinical studies 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 practice.

US-Canada Study

The safety of Vivaglobin was evaluated in a clinical study in the US and Canada for 12 months in 65 subjects with PI who had been previously treated with IGIV every 3 or 4 weeks. After 3 months, subjects were switched from IGIV to weekly subcutaneous administration of Vivaglobin for 12 months. Subjects were treated weekly with Vivaglobin at a mean dose of 158 mg/kg body weight (range: 34 to 352 mg/kg). The 65 subjects received a total of 3,656 infusions of Vivaglobin.

Table 2 shows the number of subjects who withdrew from the US-Canada study due to adverse events (AEs) and the AEs leading to discontinuation.

Table 2: Subjects with Adverse Events (AEs) Leading to Discontinuation, US-Canada Study

AEs	Subjects with AEs At Least Possibly Related	Subjects with AEs Irrespective of Causality	Total Number (%) of Subjects
* One subject experienced hyperventilation and tachycardia.
Subjects with at least 1 AE leading to discontinuation	4	1	5 (8%)
Injection-site reaction	3	–	3 (5%)
Intestinal obstruction	–	1	1 (2%)
Hyperventilation	1*	–	1 (2%)
Tachycardia	1*	–	1 (2%)

Table 3 summarizes the most frequent AEs (experienced by more than 5% of subjects), irrespective of causality. It includes all AEs and those considered temporally associated with the Vivaglobin infusion, i.e., occurring during the infusion or within 72 hours after the end of the infusion.

Table 3: Incidence of Subjects With Adverse Events (AEs)* (Experienced by >5% of Subjects) and Rate† per Infusion, Irrespective of Causality, in the US-Canada Study
	All AEs		AEs Occurring During or Within 72 Hours of Infusion
AEs* (>5% of Subjects)	Number (%) of Subjects (n=65)	Number (Rate†) of AEs per Infusion (n=3656)	Number (%) of Subjects (n=65)	Number (Rate†) of AEs per Infusion (n=3656)
* Excluding infections. † Rate, number of AEs per infusion. ‡ Includes injection-site inflammation.
AEs at the injection site‡	60 (92%)	1789 (0.49)	60 (92%)	1767 (0.4848)
Other AEs
Headache	31 (48%)	159 (0.04)	30 (46%)	104 (0.033)
Gastrointestinal disorder	24 (37%)	35 (0.01)	18 (28%)	24 (0.007)
Fever	16 (25%)	28 (0.008)	12 (8%)	20 (0.005)
Nausea	12 (18%)	18 (0.005)	11 (17%)	15 (0.004)
Rash	11 (17%)	22 (0.006)	10 (15%)	16 (0.004)
Sore throat	10 (15%)	17 (0.005)	8 (12%)	11 (0.003)
Allergic reaction	7 (11%)	8 (0.002)	5 (8%)	5 (0.001)
Pain	6 (9%)	8 (0.002)	4 (6%)	4 (0.001)
Diarrhea	6 (9%)	6 (0.002)	5 (8%)	5 (0.001)
Cough increased	6 (9%)	6 (0.002)	5 (8%)	5 (0.001)
Gastrointestinal pain	5 (8%)	6 (0.002)	4 (6%)	5 (0.001)
Migraine	5 (8%)	5 (0.001)	2 (3%)	2 (0.001)
Skin disorder	5 (8%)	7 (0.002)	3 (5%)	5 (0.001)
Asthma	5 (8%)	8 (0.002)	3 (5%)	4 (0.001)
Arthralgia	4 (6%)	4 (0.001)	3 (5%)	3 (0.001)
Asthenia	4 (6%)	4 (0.001)	2 (3%)	2 (0.001)
Malaise	4 (6%)	5 (0.001)	2 (3%)	2 (0.001)

The total number of AEs, irrespective of causality, including injection-site reactions, that began during or within 72 hours after the end of an infusion was 2262 (a rate of 0.62 AEs per infusion); excluding injection-site reactions, the rate of AEs per infusion was 0.14.

Table 4 summarizes the severity of local AEs by infusion, irrespective of causality.

Table 4: Severity of Local Adverse Events (AEs) by Infusion, Irrespective of Causality, in the US-Canada Study
AEs	Number (Rate*) of AEs	Number (Rate*) of AEs Occurring During or Within 72 Hours of Infusion
(Number of infusions: 3656)
* Rate, number of AEs per infusion. † Defined as those reactions that did not interfere with routine activities. ‡ Defined as those reactions that interfered with routine activities. § Defined as those reactions that made it impossible to perform routine activities.
AEs at the injection site	1789 (0.49)	1767 (0.48)
Mild†	1112 (0.30)	1100 (0.30)
Moderate‡	601 (0.16)	593 (0.16)
Severe§	65 (0.02)	64 (0.02)
Unknown severity	11 (<0.01)	10 (<0.01)
Discontinuations due to AEs at the injection site	3 subjects

Of the three subjects who discontinued the study due to injection-site reactions, one withdrew on Day 1 (Infusion 1) of the wash-in/wash-out period after a moderate injection-site reaction and a mild headache; one withdrew on Day 22 (Infusion 4) of the wash-in/wash-out period following severe injection-site reactions for two weeks; and one withdrew on Day 78 following a mild injection-site reaction.

Local reactions decreased substantially after repeated use.

Table 5 summarizes the most frequent adverse reactions (experienced by at least 3% of subjects) and considered by the investigator to be at least possibly related to Vivaglobin administration.

Table 5: Incidence of Subjects With Adverse Reactions (Experienced in ≥3% of Subjects) and Rate* per Infusion in the US-Canada Study

Related Adverse Reactions (≥3% Subjects)	Number (%) of Subjects (n=65)	Number (Rate*) of Adverse Reactions per Infusion (n=3656)
* Rate, number of adverse reactions per infusion. † Includes injection-site inflammation.
Adverse reactions at the injection site†	60 (92%)	1787 (0.49)
Other Adverse reactions
Headache	21 (32%)	59 (0.016)
Nausea	7 (11%)	9 (0.002)
Rash	4 (6%)	9 (0.002)
Asthenia	3 (5%)	3 (0.001)
Gastrointestinal disorder	3 (5%)	3 (0.001)
Fever	2 (3%)	2 (0.001)
Skin disorder	2 (3%)	3 (0.001)
Tachycardia	2 (3%)	2 (0.001)
Urine abnormality	2 (3%)	3 (0.001)

Europe-Brazil Study

In a clinical study conducted in Europe and Brazil, the efficacy and safety of Vivaglobin were evaluated for 10 months in 60 subjects with PI. Subjects were treated weekly with Vivaglobin at a mean dose of 89 mg/kg body weight (range: 51 to 147 mg/kg), which was 101% of their previous weekly IGIV or IGSC dose. Study subjects received a total of 2,297 infusions of Vivaglobin.

The AEs and their rates reported in this study were similar to those reported in the US-Canada study, with two exceptions: no episodes of headache were reported; and 18 (a rate of 0.008 per infusion) episodes of fever were judged to be related to the administration of Vivaglobin. One subject discontinued due to repeated local reactions of moderate severity.

Postmarketing Experience

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.

Vivaglobin

Adverse reactions identified during worldwide postmarketing use of Vivaglobin for treatment of PI are allergic-anaphylactic reactions (including dyspnea, pruritus, urticaria, rash, edema and other cutaneous reactions, wheezing, syncope, hypotension, and throat swelling), generalized reactions (including flu-like symptoms, myalgia, chills, fever, tachycardia, arthralgia, nausea and vomiting, diarrhea, gastrointestinal cramping, stomach pain, back pain, headache, headache possibly caused by increased blood pressure, and chest tightness), migraine, and injection-site reactions.

General

The following adverse reactions have been identified and reported during the postmarketing use of IGIV products11:

• 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, bullous dermatitis
• Hematologic: Pancytopenia, leukopenia, hemolysis, positive direct antiglobulin (Coombs') test
• General/Body as a Whole: Pyrexia, rigors
• Musculoskeletal: Back pain
• Gastrointestinal: Hepatic dysfunction, abdominal pain

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Side Effects by Body System - for Healthcare Professionals

Local

Local side effects have been reported the most frequently. Up to 92% of patients reported adverse events at the injection site.

Gastrointestinal

Gastrointestinal side effects have been reported often (37%), including nausea (18%) and diarrhea (10%).

Dermatologic

Dermatologic side effects have included rash (17%).

Hypersensitivity

Hypersensitivity side effects have rarely included immediate anaphylactoid and hypersensitivity reactions. Allergic reactions (11%) have also been reported.

General

General side effects have included headache (48%), fever (25%), sore throat (17%), and pain (10%).

Respiratory

Respiratory side effects have included an increase in cough (10%).

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