Octagam 10% 20g/200ml Inj, 1 Vial

Manufacturer PFIZER U.S. Active Ingredient Immune Globulin (IV)(i MYUN GLOB yoo lin) Pronunciation OK-tah-gam (brand name); IM-yoon GLOB-yoo-lin (active ingredient)
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
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Pharmacologic Class
Immune Globulin (Human)
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Pregnancy Category
Category C
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FDA Approved
May 2004
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Octagam 10% is a medicine made from human blood plasma that contains antibodies (proteins that fight infections). It is given intravenously (into a vein) to help your body fight off infections or to treat certain conditions where your immune system is not working correctly.
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How to Use This Medicine

To use this medication correctly, follow your doctor's instructions and carefully read all accompanying information. Take this medication exactly as directed, and adhere to all guidelines provided. This drug is administered as an intravenous infusion, which means it is given through a vein over a specified period of time.

If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the proper storage procedure.

In the event that you miss a dose, contact your doctor immediately 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 kidney problems and other side effects.
  • Report any unusual symptoms immediately to your healthcare provider during or after the infusion.
  • Avoid live virus vaccines for several months after receiving Octagam 10% as it may make the vaccine less effective. Discuss your vaccination schedule with your doctor.

Dosing & Administration

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Adult Dosing

Standard Dose: Highly variable based on indication. Examples: Chronic Immune Thrombocytopenic Purpura (ITP): 1 g/kg daily for 2 days or 400 mg/kg daily for 5 days. Chronic Inflammatory Demyelinating Polyneuropathy (CIDP): Loading dose 2 g/kg given in divided doses over 2-5 days; Maintenance 1 g/kg every 3 weeks or 0.5 g/kg every week.
Dose Range: 0.4 - 2 mg

Condition-Specific Dosing:

ITP: 1 g/kg/day for 2 days or 400 mg/kg/day for 5 days
CIDP_loading: 2 g/kg over 2-5 days
CIDP_maintenance: 1 g/kg every 3 weeks or 0.5 g/kg every week
Kawasaki_Disease: 2 g/kg as a single infusion over 10-12 hours
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Pediatric Dosing

Neonatal: Not established for all indications; use with caution and reduced infusion rates due to risk of renal dysfunction and fluid overload.
Infant: Dosing is weight-based and indication-specific. Example: Kawasaki Disease: 2 g/kg as a single infusion over 10-12 hours.
Child: Dosing is weight-based and indication-specific. Example: ITP: 1 g/kg/day for 2 days or 400 mg/kg/day for 5 days.
Adolescent: Dosing is weight-based and indication-specific, often similar to adult dosing for specific indications.
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Dose Adjustments

Renal Impairment:

Mild: Use with caution. Consider slower infusion rate and lower concentration.
Moderate: Use with caution. Consider slower infusion rate and lower concentration. Monitor renal function closely.
Severe: Contraindicated in patients with pre-existing renal insufficiency unless the benefit outweighs the risk. If used, administer at the minimum concentration available and at the slowest infusion rate practicable. Monitor renal function closely.
Dialysis: Not specifically studied, but caution is advised. IVIG is not significantly removed by dialysis. Monitor fluid status and renal function.

Hepatic Impairment:

Mild: No specific dose adjustment required.
Moderate: No specific dose adjustment required.
Severe: No specific dose adjustment required, but monitor for fluid overload and other complications.

Pharmacology

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Mechanism of Action

Immune Globulin Intravenous (Human) provides a broad spectrum of opsonizing and neutralizing IgG antibodies against a wide variety of bacterial and viral agents. The precise mechanism of action in various autoimmune and inflammatory conditions is not fully understood but is thought to involve: Fc receptor blockade on macrophages, modulation of cytokine production, inhibition of complement activation, suppression of autoantibody production, and modulation of T-cell and B-cell activity.
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Pharmacokinetics

Absorption:

Bioavailability: 100% (intravenous administration)
Tmax: Not applicable (administered intravenously)
FoodEffect: Not applicable

Distribution:

Vd: Approximately 3.5 L (similar to plasma volume), distributes between intravascular and extravascular compartments.
ProteinBinding: Not applicable (it is a protein itself)
CnssPenetration: Limited

Elimination:

HalfLife: Approximately 21-35 days (variable among individuals and indications)
Clearance: Varies, primarily through catabolism of IgG.
ExcretionRoute: Not excreted intact; catabolized into amino acids.
Unchanged: Not applicable
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Pharmacodynamics

OnsetOfAction: Hours to days, depending on indication (e.g., ITP platelet count may rise within 24-48 hours; CIDP symptom improvement may take weeks).
PeakEffect: Variable, often within days to weeks depending on the condition being treated.
DurationOfAction: Weeks to months, depending on the half-life and indication (e.g., ITP effect may last weeks; CIDP maintenance may be every 3-4 weeks).

Safety & Warnings

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BLACK BOX WARNING

THROMBOSIS: Thrombosis may occur with immune globulin products, including Octagam 10%. Risk factors include advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, and high viscosity. For patients at risk of thrombosis, administer Octagam 10% at the minimum concentration available and at the slowest infusion rate practicable. Ensure adequate hydration in patients prior to administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.
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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or 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
+ Passing out
+ Changes in eyesight
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 eyesight
Shakiness
Excessive sweating
Severe stomach pain
Dark urine or yellow skin and eyes

Severe Lung Problems and Aseptic Meningitis

This medication can cause severe lung problems, which can be life-threatening. If you experience any of the following symptoms, contact your doctor right away:
Trouble breathing
Shortness of breath
New or worsening cough

Additionally, this medication may increase the risk of aseptic meningitis, a severe brain problem. If you experience any of the following symptoms, contact your doctor immediately:
Headache
Fever
Chills
Nausea or vomiting
Stiff neck
Rash
Sensitivity to light
Drowsiness
Confusion

Immune Globulin Therapy and Dehydration

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 can also occur when this medication is administered intravenously. If you experience any of the following symptoms, contact your doctor right away:
Signs of dehydration, such as:
+ Dry skin, mouth, or eyes
+ Thirst
+ Fast heartbeat
+ Dizziness
+ Rapid breathing
+ Confusion
Signs of low sodium levels, such as:
+ Headache
+ Difficulty focusing
+ Memory problems
+ Confusion
+ Weakness
+ Seizures
+ Changes in balance

Other Possible Side Effects

While many people may not experience any side effects or only minor ones, it is essential to be aware of the following possible side effects:
Irritation at the injection site
Dizziness, tiredness, or weakness
Headache
Upset stomach or vomiting
Stomach pain or diarrhea
Back pain
Muscle spasm
Signs of a common cold
Flushing
* Cramps

If you experience any of these side effects or any other symptoms that concern you, contact your doctor or seek medical attention. 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, stiff neck, sensitivity to light, fever, nausea, vomiting (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, coughing up blood (signs of a blood clot in the lung)
  • Sudden weakness or numbness on one side of the body, sudden severe headache, vision changes, slurred speech (signs of a stroke)
  • Decreased urination, swelling in legs or feet, unusual tiredness (signs of kidney problems)
  • Hives, rash, itching, difficulty breathing, wheezing, dizziness, swelling of face/lips/tongue/throat (signs of a severe allergic reaction)
  • Dark urine, yellowing of skin or eyes (signs of hemolysis)
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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 to ensure safe treatment:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reactions you have experienced.
If you have IgA deficiency, a condition where your body lacks a specific antibody.
If you have hyperprolinemia, a condition characterized by elevated levels of proline 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, a type of sugar. Some formulations of this medication contain sorbitol, which may be problematic for individuals with fructose intolerance.

Special Considerations 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 without consulting your doctor.

Additional Precautions:

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. Verify that it is safe to take this medication with your existing treatments and health status. 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 your 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 thoroughly screened, tested, and treated to minimize the risk of infection, there is still a possibility 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. Furthermore, if you have diabetes (high blood sugar), discuss with your doctor which glucose tests are most suitable for you to use.

Individuals 65 years or older should exercise caution when using this medication, as they may be more susceptible to side effects.

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor, as it is crucial to weigh the 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 failure
  • Thrombotic events

What to Do:

Discontinue infusion immediately. Manage symptoms supportively. May require diuretics for fluid overload. Monitor renal function and coagulation parameters. Call 1-800-222-1222 (Poison Control) or seek immediate medical attention.

Drug Interactions

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Major Interactions

  • Live virus vaccines (e.g., measles, mumps, rubella, varicella): Antibodies in IVIG may interfere with the immune response to live virus vaccines. Vaccination should be deferred for at least 3 months after IVIG administration. For measles, deferral may be up to 11 months depending on the IVIG dose.
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Moderate Interactions

  • Loop diuretics: Increased risk of acute renal failure, especially in patients with pre-existing renal impairment or risk factors.
  • Nephrotoxic drugs (e.g., aminoglycosides, NSAIDs): Concomitant use may increase the risk of acute renal failure.
  • ACE inhibitors/ARBs: Potential for increased risk of renal dysfunction in susceptible patients.

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 failure.

Timing: Prior to initiation of therapy

Fluid status/hydration

Rationale: To ensure adequate hydration and prevent fluid overload, especially in patients with cardiac or renal compromise.

Timing: Prior to and during infusion

Serum IgA levels

Rationale: To screen for IgA deficiency, which increases the risk of anaphylactic reactions due to anti-IgA antibodies.

Timing: Prior to first infusion (if not previously known)

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 hourly for several hours post-infusion.

Target: Within patient's normal range

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

Signs/symptoms of infusion reactions (headache, chills, fever, nausea, flushing, rash)

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

Target: Absence of symptoms

Action Threshold: Presence of symptoms warrants slowing/stopping infusion and symptomatic treatment.

Renal function (BUN, serum creatinine)

Frequency: Daily during infusion, then as clinically indicated, especially in at-risk patients.

Target: Within normal limits or patient's baseline

Action Threshold: Increase in creatinine by >0.5 mg/dL or significant percentage increase from baseline warrants investigation and potential discontinuation.

Signs/symptoms of thrombosis (pain, swelling, discoloration of limb, chest pain, dyspnea)

Frequency: Continuously during and after infusion.

Target: Absence of symptoms

Action Threshold: Any new or worsening symptoms warrant immediate medical evaluation.

Urine output

Frequency: Daily, especially in at-risk patients.

Target: Adequate for hydration status

Action Threshold: Oliguria or anuria warrants immediate investigation.

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Symptom Monitoring

  • Headache
  • Fever
  • Chills
  • Nausea
  • Vomiting
  • Flushing
  • Rash
  • Hives
  • Dyspnea
  • Chest tightness
  • Back pain
  • Muscle cramps
  • Dizziness
  • Signs of thrombosis (e.g., swelling, pain, redness in an extremity; sudden chest pain; shortness of breath; sudden vision changes)
  • Signs of renal dysfunction (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. Use only if clearly needed and the potential benefits outweigh the potential risks to the fetus. Human IgG is known to cross the placental barrier, particularly during the third trimester.

Trimester-Specific Risks:

First Trimester: Limited data, theoretical risk low.
Second Trimester: Limited data, theoretical risk low.
Third Trimester: Significant placental transfer of IgG occurs, potential for interference with neonatal live virus vaccines.
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Lactation

Human IgG is excreted into breast milk. However, antibodies in breast milk are generally considered beneficial to the infant. Oral absorption of intact IgG by the infant is unlikely. Use is generally considered compatible with breastfeeding, but caution is advised.

Infant Risk: Low risk of adverse effects to the breastfed infant. May provide passive immunity.
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Pediatric Use

Dosing is weight-based and indication-specific. Pediatric patients, especially neonates and infants, may be at increased risk for acute renal failure and fluid overload. Use lower concentrations and slower infusion rates. Monitor closely for adverse reactions.

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Geriatric Use

Elderly patients (â‰Ĩ65 years) are at increased risk for acute renal failure and thrombotic events. Administer at the minimum concentration available and at the slowest infusion rate practicable. Ensure adequate hydration. Monitor renal function and for signs/symptoms of thrombosis closely.

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.
  • Infusion rate should be started slowly and gradually increased if tolerated. Patients at high risk for adverse events (e.g., renal impairment, cardiovascular disease, elderly) should receive the slowest possible infusion rate and lowest concentration.
  • Pre-medication with antihistamines, acetaminophen, or corticosteroids may be considered for patients with a history of infusion-related reactions.
  • Screen for IgA deficiency before the first infusion. Patients with severe IgA deficiency and known antibodies to IgA are at increased risk of severe hypersensitivity reactions, including anaphylaxis.
  • Monitor for signs of aseptic meningitis syndrome (AMS), which can occur hours to days after infusion and typically resolves spontaneously within several days.
  • Be vigilant for signs and symptoms of thrombosis, especially in patients with risk factors. Consider prophylactic anticoagulation in high-risk patients if appropriate.
  • IVIG can interfere with serological tests (e.g., Coombs test) due to passive transfer of antibodies.
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Alternative Therapies

  • Corticosteroids (e.g., prednisone, methylprednisolone) for autoimmune conditions like ITP, CIDP.
  • Other immunomodulators (e.g., rituximab, azathioprine, mycophenolate mofetil, cyclophosphamide) depending on the specific autoimmune indication.
  • Plasma exchange (plasmapheresis) for certain neurological or autoimmune conditions.
  • Specific disease-modifying therapies for primary immunodeficiencies (e.g., subcutaneous immune globulin for maintenance therapy).
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Cost & Coverage

Average Cost: Highly variable, typically several thousand to tens of thousands of dollars per infusion, depending on dose and patient weight. per gram or per vial
Insurance Coverage: Specialty tier, often requires prior authorization and medical necessity documentation due to high cost and specific indications.
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General Drug Facts

If your symptoms or health problems persist or worsen, it is essential to contact your doctor for further guidance. To ensure safe use, never share your medication with others, and do not take medication prescribed to someone else. 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. Unless instructed otherwise, do not flush medications down the toilet or drain. If you are unsure about the proper disposal method, consult your pharmacist, who can also inform you about potential drug take-back programs in your area. Some medications may come with an additional patient information leaflet, 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 amount, and the time of the incident to ensure prompt and effective treatment.