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Octagam Immune Globulin (Human)

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Overview

What is Octagam Immune Globulin (Human)?

Immune Globulin Intravenous (Human), Octagam 5% liquid, is a solvent/detergent (S/D)-treated, sterile preparation of highly purified immunoglobulin G (IgG) derived from large pools of human plasma. Octagam 5% liquid is a solution for infusion which must be administered intravenously.

All units of human plasma used in the manufacture of Octagam 5% liquid are provided by FDA-approved blood establishments only, and are tested by FDA-licensed serological tests for HBsAg, antibodies to HCV and HIV and Nucleic Acid Test (NAT) for HCV and HIV-1 and found to be non-reactive (negative).

The product is manufactured by the cold ethanol fractionation process followed by ultrafiltration and chromatography. The manufacturing process includes treatment with an organic S/D mixture composed of tri-n-butyl phosphate (TNBP) and Triton X-100 (Octoxynol). The Octagam 5% liquid manufacturing process provides a significant viral reduction in in vitro studies (table 7). These reductions are achieved through a combination of process steps including cold ethanol fractionation, S/D treatment and pH 4 treatment.

Table 7: In vitro reduction factor during Octagam 5% liquid manufacturing

WNV: West Nile Virus

HIV-1: Human Immunodeficiency Virus - 1

PRV: Pseudorabies Virus

SBV: Sindbis Virus

MEV: Mouse Encephalomyelitis Virus

PPV: Porcine Parvovirus



What does Octagam Immune Globulin (Human) look like?



What are the available doses of Octagam Immune Globulin (Human)?

Octagam 5% liquid is supplied in 1.0 g, 2.5 g, 5 g , 10 g or 25 g single use bottles (3, 16)

What should I talk to my health care provider before I take Octagam Immune Globulin (Human)?

Pregnancy: no human or animal data. Use only if clearly needed (8.1).

In patients over age 65 or in any person at risk of developing renal insufficiency, do not exceed the recommended dose, and infuse Octagam 5% liquid at the minimum infusion rate practicable (8.5).

See 17 for PATIENT COUNSELING INFORMATION.

Revised: September 2009

_______________________________________________________________________________________________________________________________________

How should I use Octagam Immune Globulin (Human)?

Octagam is an immune globulin intravenous (human), 5% liquid, indicated for treatment of primary humoral immunodeficiency (PI) (1).

For intravenously use only


What interacts with Octagam Immune Globulin (Human)?

Octagam 5% liquid is contraindicated in patients who have acute severe hypersensitivity reactions to human immunoglobulin.


Octagam 5% liquid contains trace amounts of IgA (not more than 0.2 mg/ml in a 5% solution). It is contraindicated in IgA deficient patients with antibodies against IgA and history of hypersensitivity (See Description [11]).


Octagam 5% liquid is contraindicated in patients with acute hypersensitivity reaction to corn. Octagam 5% liquid contains maltose, a disaccharide sugar which is derived from corn. Patients known to have corn allergies should avoid using Octagam 5% liquid.



What are the warnings of Octagam Immune Globulin (Human)?

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What are the precautions of Octagam Immune Globulin (Human)?

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What are the side effects of Octagam Immune Globulin (Human)?

Adverse Drug Reaction Overview

The most serious adverse reactions observed with Octagam 5% Liquid treatment have been immediate anaphylactic reactions, aseptic meningitis, and hemolytic anemia.

The most common adverse reactions observed with Octagam 5% Liquid treatment during clinical trial (> 5%) were headache and nausea.

Clinical Trials Experience

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

The clinical trial database includes a multi-center, open-label, single arm study in 46 children and adults with PI. Subjects participated in the study for a mean of 346 days and received 300 to 450 mg/kg every 21 days or 400 to 600 mg/kg every 28 days. Infusions were initiated at a rate of 30 mg/kg/hour for the first 30 minutes, and, if tolerated, could be advanced to a maximum tolerated rate not exceeding 200 mg/kg/hour. Over half of the subjects were male (n=28; 61%), and more than half were on the 28-day infusion schedule (n=27; 59%). The mean age of subjects was 31.5 years.

Six subjects experienced a total of 12 SAEs (abdominal pain (2 occurrences), cardiac arrest, pneumonia, cellulitis, coxsackie viral infection, renal calculus (2 occurrences), blood culture positive, ketonuria, gastroenteritis, and colitis pseudomembranosus). Eleven of the 12 SAEs were not suspected to be related to study drug; the other SAE was noted before the subject began receiving the next scheduled infusion, and it was not temporally related to the previous infusion.

Pre-medications were used in 165 (25.2%) out of 654 infusions and in 14 (30.4%) out of 46 patients. Infusions were slowed or interrupted in 9 out of 489 infusions (1.84%) without pre-medication and in 10 out of 165 infusions (6.06%) with pre-medication. Five out of 32 (15.63%) patients who never received any pre-medication had at least one slowed or interrupted infusion, whereas 9 out of 14 (64.29%) patients who received pre-medication at least once also had a slowed or interrupted infusion.

Six of the 46 subjects in the trial (13%) were withdrawn from the study: 2 on the subjects' request; 1 because of investigator's decision (non-compliance); 1 because of loss to follow-up; 1 death (cardiac arrest, not suspected to be related to study drug); and 1 by error of the study coordinator.

All adverse events in trial OCTA-06, irrespective of the causality assessment, reported by at least 5% of subjects during the 12-months treatment are given in the table below.

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Table 2: Subjects and Infusions with at least one Adverse Event Irrespective of Causality (Study OCTA-06)

The adverse reactions in trial OCTA-06 reported by at least 5% of subjects during the 12-month treatment are given in the table below.

Table 3: Subjects and Infusions with At Least One Adverse Reaction (Study OCTA-06)

The following table provides an overview on the temporally associated adverse events (TAAEs) during and within different time-points after the end of Octagam infusion.

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Table 4: Overview on TAAEs Occurring During and Over a Specified Number of Hours after the End of Infusion, Irrespective of Causality (Study OCTA-06)

All temporally associated adverse events (TAAEs) in trial OCTA-06, irrespective of the causality assessment, reported by at least 5% of subjects within 72 hours after the end of the infusion are given in the table below.

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Table 5: TAAEs During and Over 72 Hours After End of Infusion, Irrespective of Causality (Study OCTA-06)

The subset of drug related temporally associated adverse events (TAAEs) in trial OCTA-06 reported by at least 5% of subjects within 72 hours after the end of the infusion is given in the table below.

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Table 6: Drug-Related TAAEs During and Over 72 Hours After End of Infusion (Study OCTA-06)

Laboratory Abnormalities

Standard clinical laboratory evaluations were performed Study OCTA-06. Three subjects (7%) had incidences of AST (>2.5 x ULN) which were all assessed as clinically non-significant. Four subjects (9%) had incidences of serum creatinine increases being stable throughout the course of the study. Therefore, these observations were not regarded as indicative of acute renal dysfunction.

Octagam 5% liquid
No. of subjects (%) No. of infusions (%)
 Total 46 (100%) 654 (100%)
Nasal congestion 24 (52%) 39 (6%)
Sinusitis NOS 23 (50%) 45 (7%)
Headache NOS 22 (48%) 62 (9%)
Cough 20 (43%) 46 (7%)
Sore throat NOS 16 (35%) 25 (4%)
Fever 15 (33%) 19 (3%)
Vomiting NOS 12 (26%) 15 (2%)
Diarrhoea NOS 11 (24%) 22 (3%)
Bronchitis NOS 10 (22%) 14 (2%)
Abdominal pain upper 9 (20%) 11 (2%)
Arthralgia 9 (20%) 15 (2%)
Nasopharyngitis 8 (17%) 14 (2%)
Rhinorrhoea 8 (17%) 9 (1%)
Upper respiratory tract infection NOS 8 (17%) 13 (2%)
Fatigue 7 (15%) 9 (1%)
Nausea 7 (15%) 8 (1%)
Pain in limb 7 (15%) 10 (2%)
Sinus congestion 7 (15%) 9 (1%)
Back pain 5 (11%) 10 (2%)
Injection site reaction NOS 5 (11%) 11 (2%)
Wheezing 5 (11%) 8 (1%)
Asthma NOS 4 (9%) 5 (0.8%)
Asthma aggravated 4 (9%) 10 (2%)
Chest pain NEC 4 (9%) 4 (0.6%)
Conjunctivitis NEC 4 (9%) 4 (0.6%)
Dyspepsia 4 (9%) 5 (0.8%)
Earache 4 (9%) 6 (0.9%)
Ecchymosis 4 (9%) 7 (1%)
Fungal infection NOS 4 (9%) 4 (0.6%)
Injection site pain 4 (9%) 4 (0.6%)
Insomnia NEC 4 (9%) 4 (0.6%)
Sinusitis acute NOS 4 (9%) 8 (1%)
Urinary tract infection NOS 4 (9%) 8 (1%)
Vaginal candidiasis 4 (9%) 7 (1%)
Abdominal pain NOS 3 (7%) 3 (0.5%)
Dizziness (exc vertigo) 3 (7%) 4 (0.6%)
Dyspnoea NOS 3 (7%) 3 (0.5%)
Epistaxis 3 (7%) 5 (0.8%)
Eye discharge 3 (7%) 3 (0.5%)
Eye irritation 3 (7%) 3 (0.5%)
Hypertension NOS 3 (7%) 5 (0.8%)
Otitis media NOS 3 (7%) 4 (0.6%)
Pain NOS 3 (7%) 4 (0.6%)
Postnasal drip 3 (7%) 3 (0.5%)
Productive cough 3 (7%) 3 (0.5%)
Rigors 3 (7%) 4 (0.6%)
Throat irritation 3 (7%) 3 (0.5%)
Urticaria NOS 3 (7%) 8 (1%)
Octagam 5% liquid
No. of subjects (%) No. of infusions (%)
Total 46 (100%) 654 (100%)
Headache NOS 7 (15%) 18 (3%)
Nausea 3 (7%) 4 (0.6%)
Total # of infusions (N=654) Time-Points
  24 hrs 48hrs 72hrs
Total # of TAAEs 172 183 189
Proportion of infusions with TAAEs 26.3% 28.0% 28.9%
Upper bound 1 sided 97.5% CI for proportion of TAAEs 29.7% 31.4% 32.4%
TAAE Subjects (%)n=46 Infusion (%)N=654
Headache NOS 15 (32.6%) 28 (4.3%)
Sinusitis NOS 12 (26.1%) 13 (2.0%)
Nasal congestion 10 (21.7%) 11 (1.7%)
Arthralgia 7 (15.2%) 10 (1.5%)
Cough 7 (15.2%) 7 (1.1%)
Injection site reaction NOS 5 (10.9%) 11 (1.7%)
Sore throat NOS 5 (10.9%) 5 (0.8%)
Vomiting NOS 5 (10.9%) 5 (0.8%)
Back pain 4 (8.7%) 6 (0.9%)
Diarrhoea NOS 4 (8.7%) 5 (0.8%)
Ecchymosis 4 (8.7%) 5 (0.8%)
Injection site pain 4 (8.7%) 4 (0.6%)
Nausea 4 (8.7%) 5 (0.8%)
Upper respiratory tract infection NOS 4 (8.7%) 5 (0.8%)
Wheezing 4 (8.7%) 6 (0.9%)
Asthma aggravated 3 (6.5%) 4 (0.6%)
Eye irritation 3 (6.5%) 3 (0.5%)
Fungal infection NOS 3 (6.5%) 3 (0.5%)
Pain in limb 3 (6.5%) 5 (0.8%)
Rhinorrhoea 3 (6.5%) 3 (0.5%)
Urinary tract infection NOS 3 (6.5%) 3 (0.5%)
TAAE Subjects (%)n=46 Infusion (%)N=654
 Headache NOS  6 (13.0%)  15 (2.3%)
 Nausea  3 (6.5%)  4 (0.6%)


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.

Octagam 5% liquid Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Octagam 5% liquid. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or to establish a causal relationship to Octagam 5% liquid.

General

The following adverse reactions have been identified during post-approval use of IGIV products. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or to establish a causal relationship to IGIV products:




What should I look out for while using Octagam Immune Globulin (Human)?

Octagam 5% liquid is contraindicated in patients who have acute severe hypersensitivity reactions to human immunoglobulin.

Octagam 5% liquid contains trace amounts of IgA (not more than 0.2 mg/ml in a 5% solution). It is contraindicated in IgA deficient patients with antibodies against IgA and history of hypersensitivity (See Description [11]).

Octagam 5% liquid is contraindicated in patients with acute hypersensitivity reaction to corn. Octagam 5% liquid contains maltose, a disaccharide sugar which is derived from corn. Patients known to have corn allergies should avoid using Octagam 5% liquid.


What might happen if I take too much Octagam Immune Globulin (Human)?

Overdose may lead to fluid overload and hyperviscosity, particularly in the elderly and in patients with impaired renal function.


How should I store and handle Octagam Immune Globulin (Human)?

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Octagam 5% liquid supplies a broad spectrum of opsonic and neutralizing IgG antibodies against bacteria or their toxins. The mechanism of action in PI has not been fully elucidated.

Non-Clinical Toxicology
Octagam 5% liquid is contraindicated in patients who have acute severe hypersensitivity reactions to human immunoglobulin.

Octagam 5% liquid contains trace amounts of IgA (not more than 0.2 mg/ml in a 5% solution). It is contraindicated in IgA deficient patients with antibodies against IgA and history of hypersensitivity (See Description [11]).

Octagam 5% liquid is contraindicated in patients with acute hypersensitivity reaction to corn. Octagam 5% liquid contains maltose, a disaccharide sugar which is derived from corn. Patients known to have corn allergies should avoid using Octagam 5% liquid.

Severe hypersensitivity reactions may occur [ ] (See Contraindications [4.1]). In case of hypersensitivity, Octagam 5% liquid infusion should be immediately discontinued and appropriate treatment instituted. Epinephrine should be immediately available for treatment of acute severe hypersensitivity reaction. IgA deficient patients with antibodies against IgA are at greater risk of developing severe hypersensitivity and anaphylactoid reactions when administered Octagam 5% liquid (See Contraindications [4.2]). Patients known to have corn allergies should avoid using Octagam 5% liquid (See Contraindications [4.3]).

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

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Tips

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Interactions

Interactions

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