Octagam 10% 2gm/20ml Inj, 20ml

Manufacturer OCTAPHARMA USA Active Ingredient Immune Globulin (IV)(i MYUN GLOB yoo lin) Pronunciation 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
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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 10% is a medicine made from human blood plasma that contains antibodies. Antibodies are proteins that help your body fight off infections and diseases. It is given directly into your vein (intravenously) to help people whose bodies don't make enough antibodies, or to help calm down an overactive immune system in certain autoimmune conditions.
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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 provided guidelines. This drug is administered via infusion into 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 your infusion to help prevent side effects like headache and kidney problems.
  • Report any unusual symptoms immediately to your healthcare provider during or after the infusion.
  • Avoid live vaccines for several months after receiving Octagam 10%. Discuss your vaccination schedule with your doctor.

Dosing & Administration

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Adult Dosing

Standard Dose: Varies significantly by indication. Examples: Primary Humoral Immunodeficiency (PIDD): 300-600 mg/kg every 3-4 weeks. Immune Thrombocytopenia (ITP): 1 g/kg daily for 1-2 days or 400 mg/kg daily for 2-5 days. Chronic Inflammatory Demyelinating Polyneuropathy (CIDP): Loading dose 2 g/kg divided over 2-5 days, then maintenance 1 g/kg every 3 weeks or 500 mg/kg weekly.
Dose Range: 300 - 2000 mg

Condition-Specific Dosing:

PIDD: 300-600 mg/kg every 3-4 weeks
ITP: 1 g/kg daily for 1-2 days or 400 mg/kg daily for 2-5 days
CIDP: Loading: 2 g/kg over 2-5 days; Maintenance: 1 g/kg every 3 weeks or 500 mg/kg weekly
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Pediatric Dosing

Neonatal: Not established for all indications, use with caution and reduced infusion rates due to renal immaturity.
Infant: Dosing similar to adults for approved indications (e.g., PIDD, ITP) but adjusted by weight. Initial infusion rates should be slower.
Child: Dosing similar to adults for approved indications (e.g., PIDD, ITP) but adjusted by weight. Initial infusion rates should be slower.
Adolescent: Dosing similar to adults for approved indications (e.g., PIDD, ITP) but adjusted by weight.
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Dose Adjustments

Renal Impairment:

Mild: Monitor renal function; consider slower infusion rates.
Moderate: Monitor renal function closely; consider lower doses and/or slower infusion rates. Avoid sucrose-containing IVIG products if possible (Octagam is sucrose-free).
Severe: Use with extreme caution. Monitor renal function closely; consider lower doses and/or slower infusion rates. Avoid sucrose-containing IVIG products. Risk of acute renal failure is higher.
Dialysis: No specific dose adjustment for patients on dialysis, but monitor fluid balance and renal function. Risk of acute renal failure remains.

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 (IVIG) contains antibodies (primarily IgG) that are pooled from the plasma of thousands of healthy donors. Its mechanism of action is complex and multifactorial, varying by indication. In immunodeficiency, it provides passive immunity by replacing deficient IgG antibodies. In autoimmune and inflammatory conditions, it is thought to modulate the immune system through several mechanisms, including: Fc receptor blockade on macrophages, 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: Not applicable (IV administration)
FoodEffect: Not applicable (IV administration)

Distribution:

Vd: Approximately 0.07 L/kg (plasma and extracellular fluid)
ProteinBinding: Not applicable (is a protein)
CnssPenetration: Limited (low levels in CSF, but can have central effects)

Elimination:

HalfLife: Approximately 21-35 days (highly variable depending on patient's condition, IgG levels, and catabolic rate)
Clearance: Variable, depends on individual IgG catabolism
ExcretionRoute: Primarily catabolism; minimal renal excretion of intact IgG
Unchanged: Not applicable (is a protein that is catabolized)
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Pharmacodynamics

OnsetOfAction: Hours to days (for immunomodulatory effects, e.g., ITP, CIDP); immediate (for passive immunity)
PeakEffect: Days to weeks (for immunomodulatory effects); immediate (for passive immunity)
DurationOfAction: Weeks to months (dependent on half-life and indication, typically 3-4 weeks for replacement therapy)

Safety & Warnings

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BLACK BOX WARNING

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 cardiovascular risk factors. For patients at risk of thrombosis, administer Octagam 10% at the minimum dose and 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 while 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

Serious Lung Problems

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

Aseptic Meningitis

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
Severe 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

Contact your doctor right away if you experience any of these symptoms.

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, contact your doctor immediately:

Signs of dehydration:
+ Dry skin, mouth, or eyes
+ Thirst
+ Fast heartbeat
+ Dizziness
+ Fast breathing
+ Confusion
Signs of low sodium levels:
+ Headache
+ Trouble focusing
+ Memory problems
+ Feeling confused
+ Weakness
+ Seizures
+ Changes in balance

Other Side Effects

Most people do not experience severe side effects, but some may occur. If you experience any of the following symptoms, contact your doctor or seek medical attention if they bother you or do not go away:

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

Reporting Side Effects

If you have questions about side effects or want to report any, contact your doctor or the FDA at 1-800-332-1088 or 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 chest pain, shortness of breath, or coughing up blood (signs of blood clot in lungs)
  • Pain, swelling, warmth, or redness in an arm or leg (signs of blood clot in a vein)
  • Sudden weakness or numbness on one side of the body, slurred speech, or vision changes (signs of stroke)
  • Decreased urination, swelling in legs or feet, or unusual fatigue (signs of kidney problems)
  • Severe allergic reaction symptoms: difficulty breathing, wheezing, hives, swelling of face/lips/tongue, dizziness, fainting.
  • Fever, chills, or shaking during or after infusion.
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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 symptoms you experienced during an allergic reaction.
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 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 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, it may still pose a risk of transmitting viruses.

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

For individuals with high blood sugar (diabetes), consult with your doctor to determine the most suitable glucose tests to use.

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, planning to become pregnant, or breastfeeding, inform your doctor, as it is crucial 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 (leading to headache, dizziness, signs of thrombosis)
  • Acute renal failure

What to Do:

Discontinue infusion immediately. Manage symptoms supportively. May require diuretics for fluid overload or other interventions for severe adverse events. Call 1-800-222-1222 (Poison Control) or seek emergency medical attention.

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. Vaccination should be deferred for at least 3 months after IVIG administration. For measles vaccine, deferral may be up to 11 months depending on the IVIG dose.
  • Loop diuretics (e.g., furosemide): Increased risk of renal dysfunction, especially in patients with pre-existing renal impairment or risk factors for acute renal failure. Monitor renal function closely.
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Moderate Interactions

  • ACE inhibitors: Potential for increased risk of angioedema, though evidence is limited.
  • Nephrotoxic drugs: Concurrent use may increase the risk of acute renal failure, especially in susceptible patients. Monitor renal function closely.

Monitoring

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Baseline Monitoring

Renal function (BUN, creatinine)

Rationale: To identify pre-existing renal impairment and assess risk for acute renal failure.

Timing: Prior to initiation of therapy.

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.

Complete Blood Count (CBC) with differential

Rationale: To assess baseline hematologic status, especially for indications like ITP.

Timing: Prior to initiation of therapy.

Vital signs (blood pressure, heart rate, temperature)

Rationale: To establish baseline and identify immediate reactions.

Timing: Prior to infusion.

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Routine Monitoring

Vital signs (blood pressure, heart rate, temperature)

Frequency: Before, during (at regular intervals, e.g., every 15-30 minutes for the first hour, then hourly), and after infusion.

Target: Within patient's normal limits; stable.

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

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

Frequency: Continuously during and for several hours after infusion.

Target: Absence of symptoms.

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

Renal function (BUN, creatinine)

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

Target: Within patient's normal limits.

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

Fluid balance/urine output

Frequency: During and after infusion, especially in patients at risk for renal dysfunction or fluid overload.

Target: Adequate urine output, no signs of fluid overload.

Action Threshold: Oliguria, anuria, or signs of fluid overload (e.g., edema, dyspnea) require intervention.

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Symptom Monitoring

  • Headache
  • Chills
  • Fever
  • Nausea
  • Vomiting
  • Fatigue
  • Dizziness
  • Rash
  • Hives
  • Flushing
  • Chest pain or tightness
  • Shortness of breath or difficulty breathing
  • Swelling (especially face, lips, tongue, throat)
  • Signs of thrombosis (e.g., pain, swelling, warmth, redness in a limb; sudden chest pain, shortness of breath, vision changes, slurred speech)
  • Signs of renal dysfunction (e.g., decreased urine output, swelling, fatigue)
  • Signs of aseptic meningitis (e.g., severe headache, neck stiffness, photophobia, nausea, vomiting)

Special Patient Groups

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Pregnancy

Category C. Animal reproduction studies have not been conducted. It is not known whether Octagam 10% can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Octagam 10% should be given to a pregnant woman only if clearly needed. IgG antibodies are known to cross the placenta, particularly in the third trimester.

Trimester-Specific Risks:

First Trimester: Limited data, theoretical risk of immune modulation in early fetal development.
Second Trimester: Limited data, generally considered low risk if clinically indicated.
Third Trimester: IgG antibodies are actively transported across the placenta, potentially affecting fetal immune system. Generally considered safe if clinically indicated, but monitor for neonatal effects.
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Lactation

Human IgG is excreted into breast milk and may contribute to the transfer of protective antibodies to the neonate. No adverse effects on the breastfed infant are expected. Use is generally considered compatible with breastfeeding.

Infant Risk: Low
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Pediatric Use

Dosing is weight-based and varies by indication. Infusion rates should be initiated slowly, especially in infants and young children, and carefully titrated. Monitor for adverse reactions, particularly renal function and fluid balance, as pediatric patients may be more susceptible to certain side effects.

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Geriatric Use

Use with caution in elderly patients (â‰Ĩ65 years) due to increased risk of acute renal failure and thrombotic events. Ensure adequate hydration and administer at the minimum dose and infusion rate practicable. Monitor renal function and signs of thrombosis closely.

Clinical Information

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Clinical Pearls

  • Always ensure adequate hydration before, during, and after infusion to minimize the risk of renal dysfunction and other adverse events.
  • Infusion rate should be started slowly and gradually increased if tolerated. Patients who have not received IVIG before, or who are switching brands, or who have underlying risk factors (e.g., renal impairment, cardiovascular disease) should receive a slower initial infusion rate.
  • 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.
  • Patients with IgA deficiency who have antibodies to IgA are at increased risk of severe hypersensitivity reactions, including anaphylaxis. Octagam 10% contains trace amounts of IgA. Screen for IgA deficiency prior to first infusion.
  • Monitor for signs and symptoms of thrombosis (e.g., DVT, PE, stroke, MI) and acute renal failure, especially in high-risk patients. These are serious but rare complications.
  • Aseptic meningitis syndrome (AMS) is a known but rare side effect, typically occurring within hours to 2 days post-infusion. Symptoms include severe headache, neck stiffness, photophobia, nausea, and vomiting. It is usually reversible upon discontinuation.
  • Octagam 10% is sucrose-free, which may be advantageous for patients at risk of renal dysfunction compared to sucrose-stabilized IVIG products.
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Alternative Therapies

  • Other IVIG products (e.g., Gammagard, Gamunex-C, Privigen, Flebogamma DIF)
  • Subcutaneous Immune Globulin (SCIG) products (e.g., Hizentra, Gammaked, Cuvitru, Xembify) for primary immunodeficiency
  • For ITP: Corticosteroids, anti-D immunoglobulin, thrombopoietin receptor agonists (e.g., romiplostim, eltrombopag), splenectomy, rituximab.
  • For CIDP: Corticosteroids, plasma exchange (PLEX).
  • For PIDD: Prophylactic antibiotics, hematopoietic stem cell transplantation (for severe cases).
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Cost & Coverage

Average Cost: Varies widely, typically $50-$150 per gram per gram
Insurance Coverage: Specialty Tier (requires prior authorization, often administered in hospital or infusion center)
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General Drug Facts

If your symptoms or health issues 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. Unless instructed otherwise, do not flush medications down the toilet or pour them down the drain. If you are unsure about the correct disposal method, consult your pharmacist, as they can provide guidance on the best approach. Additionally, you may want to inquire about potential drug take-back programs in your area. Some medications may come with a separate patient information leaflet, so be sure to check with your pharmacist. If you have any questions or concerns about your medication, do not hesitate to 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 emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time it occurred, as this will aid in prompt and effective treatment.