Octagam 5% Inj, 5gm/100ml

Manufacturer OCTAPHARMA Active Ingredient Immune Globulin (IV)(i MYUN GLOB yoo lin) Pronunciation OK-tah-gam (5% Inj, 5gm/100ml) with active ingredient: i-MYUN GLOB-yoo-lin
WARNING: There is a chance of blood clots with this drug. The chance is raised in older people and in people with thick blood, heart problems, or a history of blood clots. The chance may also be higher if you must be in a bed or chair for some time, if you take estrogen, or if you use certain catheters. However, blood clots can happen even if you do not have any of these health problems. Call your doctor right away if you have numbness or weakness on 1 side of your body; pain, redness, tenderness, warmth, or swelling in the arms or legs; change in color of an arm or leg; chest pain or pressure; shortness of breath; fast heartbeat; or coughing up blood. Talk with your doctor.Kidney problems have happened with human immune globulin. Sometimes, these problems have been deadly. Kidney problems are more common in people using products that have sucrose. Most immune globulin products do not have sucrose. The chance of these problems may be raised if you have kidney problems, high blood sugar (diabetes), fluid loss (dehydration) or low blood volume, a blood infection, or proteins in the blood that are not normal. The chance may be raised if you are 65 or older, or if you take other drugs that may harm the kidneys. Talk with your doctor if you have questions about this information or about if your product has sucrose.You will need to be sure that you are not dehydrated before getting this drug. Check with your doctor to see if you need to drink extra fluids before getting this drug. @ COMMON USES: It is used to help prevent infections or make infections less severe in people with a weak immune system.It is used to treat immune thrombocytopenia (ITP).It is used treat chronic inflammatory demyelinating polyneuropathy (CIDP).It is used to treat Kawasaki disease.It is used to treat a certain muscle problem caused by inflammation (dermatomyositis).It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Immunomodulator; Blood Product Derivative
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Pharmacologic Class
Immune Globulin, Intravenous (Human)
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Pregnancy Category
Category C
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FDA Approved
Jul 2004
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Octagam 5% is a medicine made from human blood plasma that contains antibodies (proteins that fight infections). It is given intravenously (into a vein) to help people with certain immune system problems or autoimmune diseases where their body's immune system attacks itself. It works by providing the body with healthy antibodies or by helping to regulate an overactive immune system.
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How to Use This Medicine

Taking Your Medication Correctly
To ensure safe and effective use, take this medication exactly as directed by your doctor. Carefully review all accompanying information and follow the instructions provided. This medication is administered as an intravenous infusion, which means it is given through a vein over a specified period of time.

Storing and Disposing of Your Medication
If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the proper storage procedure.

Missing a Dose
If you miss a dose, contact your doctor promptly to receive guidance on the appropriate course of action.
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Lifestyle & Tips

  • Stay well-hydrated before, during, and after the infusion to help prevent side effects, especially kidney problems and blood clots.
  • Report any unusual symptoms immediately during or after the infusion.
  • Avoid live virus vaccines for several months after receiving Octagam, as the antibodies can interfere with the vaccine's effectiveness. Discuss vaccination schedules with your doctor.

Dosing & Administration

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Adult Dosing

Standard Dose: Highly variable based on indication. Examples: ITP: 1 g/kg/day for 1-2 days or 400 mg/kg/day for 5 days. CIDP: 0.4 g/kg/day for 5 days every 4 weeks, or 1 g/kg/day for 2 days every 3-4 weeks. Primary Humoral Immunodeficiency (PHI): 300-600 mg/kg every 3-4 weeks.
Dose Range: 0.3 - 2 mg

Condition-Specific Dosing:

Immune Thrombocytopenic Purpura (ITP): 1 g/kg/day for 1-2 days or 400 mg/kg/day for 5 days
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP): Loading dose: 2 g/kg divided over 2-5 days; Maintenance: 1 g/kg every 3 weeks or 0.5 g/kg every week
Primary Humoral Immunodeficiency (PHI): 300-600 mg/kg every 3-4 weeks
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Pediatric Dosing

Neonatal: Not established for all indications; use with caution and specific guidance.
Infant: Dosing similar to adults for approved indications (e.g., Kawasaki disease: 2 g/kg as a single dose over 10-12 hours).
Child: Dosing similar to adults for approved indications (e.g., ITP, PHI, Kawasaki disease).
Adolescent: Dosing similar to adults.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment, but monitor renal function and hydration.
Moderate: Use with caution. Ensure adequate hydration. Monitor renal function closely. Octagam is sucrose-free, which may reduce renal risk compared to sucrose-containing IVIGs.
Severe: Use with caution. Consider lower infusion rates and close monitoring. Avoid in patients with pre-existing renal failure unless benefits outweigh risks. Monitor renal function closely.
Dialysis: Not specifically studied. Consider timing of infusion relative to dialysis. Close monitoring required.

Hepatic Impairment:

Mild: No specific adjustment needed.
Moderate: No specific adjustment needed.
Severe: No specific adjustment needed.

Pharmacology

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Mechanism of Action

Immune Globulin Intravenous (Human) (IVIG) contains a broad spectrum of opsonizing and neutralizing IgG antibodies against a wide variety of bacterial and viral agents. The mechanism of action in various autoimmune and inflammatory disorders is not fully elucidated but is thought to involve: Fc receptor blockade, modulation of complement activation, suppression of autoantibody production, anti-idiotypic antibody effects, modulation of cytokine production, and effects on T-cell and B-cell function.
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Pharmacokinetics

Absorption:

Bioavailability: 100%
Tmax: End of infusion
FoodEffect: Not applicable (IV administration)

Distribution:

Vd: Approximately 0.07 L/kg (primarily intravascular, with some extravascular distribution)
ProteinBinding: Not applicable (it is a protein)
CnssPenetration: Limited (intact IgG does not readily cross the blood-brain barrier, but some penetration occurs in inflammatory conditions)

Elimination:

HalfLife: Approximately 21-35 days (highly variable depending on the individual patient's IgG catabolism and underlying disease state)
Clearance: Variable, dependent on IgG catabolism rate.
ExcretionRoute: Not excreted intact; catabolized.
Unchanged: Not applicable (catabolized)
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Pharmacodynamics

OnsetOfAction: Rapid (within hours to days for some effects like platelet increase in ITP); full immunomodulatory effects may take longer.
PeakEffect: Variable, often within days to weeks depending on the indication.
DurationOfAction: Weeks to months, related to the half-life of IgG and the underlying condition.

Safety & Warnings

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BLACK BOX WARNING

Thrombosis may occur with immune globulin products, including Octagam. Risk factors include advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, and cardiovascular risk factors. For patients at risk of thrombosis, administer Octagam at the minimum dose and infusion rate practicable. Ensure adequate hydration before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.
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Side Effects

Important Side Effects to Report to Your Doctor Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you experience any of the following symptoms, seek medical attention immediately:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of kidney problems, including:
+ Inability to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Signs of high or low blood pressure, such as:
+ Severe headache or dizziness
+ Fainting or near-fainting
+ Changes in vision
Fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling extremely tired or weak
Blue or gray discoloration of the skin, lips, nail beds, fingers, or toes
Seizures
Bloating
Confusion
Swelling
Abnormal heartbeat
Mood changes
Muscle or joint pain
Changes in speech or vision
Shakiness
Excessive sweating
Severe stomach pain
Dark urine or yellowing of the skin or eyes

Serious Lung Problems

This medication can cause severe lung problems, which can be life-threatening. If you experience any of the following symptoms, seek medical attention immediately:

Trouble breathing
Shortness of breath
New or worsening cough

Aseptic Meningitis

This medication may increase the risk of aseptic meningitis, a severe brain problem. If you experience any of the following symptoms, seek medical attention immediately:

Headache
Fever
Chills
Nausea or vomiting
Stiff neck
Rash
Sensitivity to light
Feeling sleepy or confused

Immune Globulin Therapy

If you are receiving immune globulin therapy for the first time, have not had it in the past 8 weeks, or are switching brands, you may be at risk for certain side effects, including:

Fever
Chills
Nausea
Vomiting

Dehydration and Low Sodium Levels

This medication can cause dehydration and low sodium levels when given intravenously. If you experience any of the following symptoms, seek medical attention immediately:

Signs of dehydration, such as:
+ Dry skin, mouth, or eyes
+ Thirst
+ Rapid heartbeat
+ Dizziness
+ Rapid breathing
+ Confusion
Signs of low sodium levels, such as:
+ Headache
+ Difficulty focusing
+ Memory problems
+ Confusion
+ Weakness
+ Seizures
+ Changes in balance

Other Side Effects

Most people do not experience significant side effects, but some may occur. If you experience any of the following side effects, contact your doctor:

Irritation at the injection site
Dizziness, tiredness, or weakness
Headache
Nausea or vomiting
Stomach pain or diarrhea
Back pain
Muscle spasms
Signs of a common cold
Flushing
Cramps

Reporting Side Effects

If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Severe headache, especially with neck stiffness or sensitivity to light (signs of aseptic meningitis)
  • Sudden swelling, pain, redness, or warmth in an arm or leg (signs of a blood clot)
  • Sudden chest pain, shortness of breath, or coughing up blood (signs of a blood clot in the lung)
  • Sudden weakness or numbness on one side of the body, slurred speech, or sudden vision changes (signs of a stroke)
  • Decreased urination, swelling in legs or feet, or unusual fatigue (signs of kidney problems)
  • Severe allergic reaction symptoms like difficulty breathing, hives, swelling of face/lips/tongue/throat, dizziness.
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following conditions before starting this medication:

Any allergies you have, including allergies to this drug, its components, or other substances. Be sure to describe the symptoms you experienced.
If you have IgA deficiency or hyperprolinemia (elevated proline levels in your blood).
If you have excess fluid in your body or have been advised to monitor your fluid intake.
If you are unable to break down fructose, as some products contain sorbitol. Discuss this with your doctor.

For Children:
If your child is an infant or baby, and it is unclear whether they can break down sucrose or fructose, do not administer this medication.

This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues. Verify that it is safe to take this medication with your existing medications and health conditions. Never start, stop, or adjust the dosage of any medication without consulting your doctor.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you have a latex allergy, be sure to discuss this with your doctor.

Before receiving any vaccinations, consult with your doctor, as certain vaccines may not be effective or may increase the risk of infection when used with this medication.

Regular blood tests and other laboratory evaluations should be performed as directed by your doctor. Additionally, inform all healthcare providers and laboratory personnel that you are taking this medication, as it may affect the results of certain lab tests.

If you have a weakened immune system and have been exposed to measles, consult with your doctor. This medication is derived from human plasma and, although it is screened, tested, and treated to minimize the risk of infection, it may still pose a risk of transmitting viruses. Discuss this with your doctor.

If you are following a low-sodium or sodium-free diet, consult with your doctor, as some formulations of this medication may contain sodium.

For individuals with high blood sugar (diabetes), it is crucial to discuss with your doctor which glucose tests are most suitable for use with this medication.

If you are 65 years or older, exercise caution when using this medication, as you may be more susceptible to side effects.

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor, as it is necessary to discuss the potential benefits and risks of this medication to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Fluid overload (e.g., shortness of breath, swelling)
  • Increased blood viscosity
  • Acute renal dysfunction (rare)

What to Do:

Overdose is rare due to the nature of the product. Management is supportive, focusing on managing fluid overload (e.g., diuretics) and monitoring for adverse effects. In severe cases, plasmapheresis may be considered. Call 1-800-222-1222 (Poison Control) for advice.

Drug Interactions

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Major Interactions

  • Live virus vaccines (e.g., measles, mumps, rubella, varicella): IVIG may interfere with the immune response to live attenuated virus vaccines. Defer vaccination for at least 3 months after IVIG administration. For measles, defer for up to 11 months.
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Moderate Interactions

  • Loop diuretics: Increased risk of renal dysfunction, especially in patients with pre-existing renal impairment or risk factors.
  • Nephrotoxic drugs: Increased risk of renal dysfunction when co-administered with other nephrotoxic agents.

Monitoring

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Baseline Monitoring

Renal function (BUN, serum creatinine)

Rationale: To assess baseline renal status and identify patients at risk for acute renal dysfunction.

Timing: Prior to initiation of therapy

Hydration status

Rationale: To ensure adequate hydration before infusion, which helps prevent renal complications and thrombosis.

Timing: Prior to and during infusion

Serum IgA levels

Rationale: To screen for IgA deficiency, as patients with severe IgA deficiency may develop anti-IgA antibodies and be at increased risk of anaphylactic reactions.

Timing: Prior to first infusion

Vital signs (blood pressure, heart rate, temperature)

Rationale: To establish baseline and monitor for immediate infusion-related reactions.

Timing: Prior to infusion

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Routine Monitoring

Vital signs (blood pressure, heart rate, temperature)

Frequency: Every 15-30 minutes during infusion, then periodically post-infusion.

Target: Within patient's normal limits; report significant changes.

Action Threshold: Significant changes (e.g., hypotension, tachycardia, fever) warrant slowing or stopping infusion and intervention.

Signs and symptoms of adverse reactions (e.g., headache, chills, fever, rash, dyspnea, chest pain, back pain, signs of thrombosis, signs of renal dysfunction)

Frequency: Continuously during infusion and for several hours post-infusion.

Target: Absence of symptoms.

Action Threshold: Any new or worsening symptom warrants immediate assessment and intervention.

Renal function (BUN, serum creatinine)

Frequency: Periodically during therapy, especially in patients with risk factors for renal dysfunction (e.g., pre-existing renal impairment, diabetes, age >65, volume depletion, concomitant nephrotoxic drugs).

Target: Within patient's normal limits.

Action Threshold: Significant increase in BUN/creatinine warrants investigation and potential discontinuation or dose adjustment.

Urine output

Frequency: Monitor during and after infusion, especially in at-risk patients.

Target: Adequate urine output.

Action Threshold: Oliguria or anuria.

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Symptom Monitoring

  • Headache
  • Fever
  • Chills
  • Nausea
  • Vomiting
  • Fatigue
  • Rash
  • Hives
  • Dyspnea
  • Chest tightness
  • Back pain
  • Flank pain
  • Signs of thrombosis (e.g., swelling, pain, redness in limb; sudden chest pain, shortness of breath, slurred speech, weakness on one side of body)
  • Signs of acute renal failure (e.g., decreased urine output, swelling, fatigue)
  • Signs of aseptic meningitis (e.g., severe headache, nuchal rigidity, photophobia, fever, nausea, vomiting)

Special Patient Groups

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Pregnancy

Category C. Animal reproduction studies have not been conducted. However, immune globulins are known to cross the placental barrier, particularly during the third trimester. Clinical experience with IVIG in pregnant women suggests no harmful effects on the course of pregnancy, the fetus, or the neonate. Use only if clearly needed and the potential benefits outweigh the potential risks.

Trimester-Specific Risks:

First Trimester: Limited data, but generally considered low risk as IgG transfer is minimal.
Second Trimester: Limited data, but generally considered low risk.
Third Trimester: Significant placental transfer of IgG occurs, potentially affecting the neonate's immune response to live vaccines. No known direct teratogenic effects.
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Lactation

L3 (Moderately Safe). IgG is naturally present in human milk and is transferred to the infant. Oral absorption of intact IgG is minimal. No adverse effects on the breastfed infant are expected. IVIG is generally considered compatible with breastfeeding.

Infant Risk: Low risk. IgG is a normal component of breast milk and provides passive immunity to the infant. Oral absorption of intact IgG is minimal.
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Pediatric Use

Dosing for pediatric patients is typically weight-based and similar to adults for approved indications (e.g., ITP, PHI, Kawasaki disease). Safety and efficacy have been established in pediatric patients for these indications. Close monitoring for adverse reactions is important, especially for infusion rate and hydration.

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Geriatric Use

Use with caution in patients aged 65 years and older, especially those with pre-existing renal impairment, diabetes mellitus, volume depletion, or cardiovascular disease, due to increased risk of acute renal dysfunction and thrombotic events. Ensure adequate hydration and use the minimum dose and infusion rate practicable.

Clinical Information

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Clinical Pearls

  • Always ensure adequate hydration before, during, and after IVIG infusion to minimize the risk of renal dysfunction and thrombosis.
  • Start infusions at a slow rate and gradually increase if tolerated, especially for the first infusion or in patients at risk for adverse reactions.
  • Pre-medication (e.g., acetaminophen, antihistamines) may be considered for patients with a history of infusion-related reactions, but is not routinely required for all patients.
  • Screen patients for IgA deficiency before the first infusion. Patients with severe IgA deficiency may be at higher risk of anaphylactic reactions due to anti-IgA antibodies.
  • Monitor for signs of aseptic meningitis (severe headache, neck stiffness, photophobia) which can occur hours to days after infusion.
  • Be vigilant for signs and symptoms of thrombosis (e.g., DVT, PE, stroke, MI), particularly in at-risk patients. Octagam is sucrose-free, which may reduce renal risk compared to some other IVIG products, but renal monitoring is still crucial.
  • IVIG can interfere with serological tests (e.g., Coombs test, blood typing) due to passive transfer of antibodies.
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Alternative Therapies

  • Other IVIG brands (e.g., Gammagard, Privigen, Flebogamma, Gamunex)
  • Subcutaneous Immune Globulin (SCIG) for primary immunodeficiencies (e.g., Hizentra, Cuvitru, Xembify)
  • Corticosteroids (e.g., prednisone) for autoimmune conditions like ITP, CIDP
  • Other immunosuppressants (e.g., rituximab, azathioprine, mycophenolate mofetil) depending on the specific autoimmune indication
  • Splenectomy for refractory ITP
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Cost & Coverage

Average Cost: Highly variable, typically $50-$150 per gram per gram
Insurance Coverage: Specialty Tier / Medical Benefit (often covered under medical benefit for infusions)
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General Drug Facts

If your symptoms or health problems persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly; do not flush them down the toilet or pour them down the drain unless instructed to do so by a healthcare professional or pharmacist. If you are unsure about the correct disposal method, consult your pharmacist, who can also inform you about potential drug take-back programs in your area. Some medications may have additional patient information leaflets, which your pharmacist can provide. If you have any questions or concerns about your medication, discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately contact your local poison control center or seek medical attention. Be prepared to provide information about the medication taken, the quantity, and the time of ingestion.