Octagam 20grams Inj, 200ml

Manufacturer OCTAPHARMA Active Ingredient Immune Globulin (IV)(i MYUN GLOB yoo lin) Pronunciation OK-tah-gam (for Octagam); ih-MYUN GLOB-yoo-lin (for Immune Globulin)
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 (IV)
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Pregnancy Category
Category C
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FDA Approved
Jul 2010
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Octagam is a medicine made from human blood plasma that contains antibodies (proteins that fight infections). It's given intravenously (into a vein) to help people with weakened immune systems fight off infections, or to help regulate the immune system in certain autoimmune conditions where the body's immune system mistakenly attacks its own tissues.
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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 slowly 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.

If 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 side effects like headache and kidney problems.
  • Report any unusual symptoms immediately during or after the infusion.
  • Avoid live virus vaccines for several months after receiving Octagam, as the antibodies can make the vaccine less effective. Discuss vaccination schedules with your doctor.

Dosing & Administration

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Adult Dosing

Standard Dose: Varies significantly by indication. For Primary Humoral Immunodeficiency (PI): 300-800 mg/kg every 3-4 weeks. For Chronic Immune Thrombocytopenic Purpura (ITP): 1 g/kg daily for 1-2 days or 400 mg/kg daily for 2-5 days. For Chronic Inflammatory Demyelinating Polyneuropathy (CIDP): Loading dose 2 g/kg over 2-5 days, then maintenance 1 g/kg every 3 weeks or 0.5 g/kg every 3 weeks.
Dose Range: 300 - 2000 mg

Condition-Specific Dosing:

Primary Humoral Immunodeficiency (PI): 300-800 mg/kg (average 400 mg/kg) every 3-4 weeks
Chronic Immune Thrombocytopenic Purpura (ITP): 1 g/kg daily for 1-2 days OR 400 mg/kg daily for 2-5 days
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) - Loading: 2 g/kg given in divided doses over 2-5 days
Chronic Inflammatory Demyelinopathy (CIDP) - Maintenance: 1 g/kg given in divided doses over 1-2 days every 3 weeks OR 0.5 g/kg given in divided doses over 1-2 days every 3 weeks
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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 thrombosis.
Infant: Dosing similar to adult based on weight for approved indications (PI, ITP, CIDP).
Child: Dosing similar to adult based on weight for approved indications (PI, ITP, CIDP).
Adolescent: Dosing similar to adult based on weight for approved indications (PI, ITP, CIDP).
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Dose Adjustments

Renal Impairment:

Mild: Use with caution; ensure adequate hydration. Monitor renal function.
Moderate: Use with caution; ensure adequate hydration. Monitor renal function closely. Consider lower infusion rates.
Severe: Contraindicated in patients with pre-existing renal insufficiency unless the expected benefit outweighs the risk. Ensure adequate hydration. Monitor renal function closely. Consider lower infusion rates and lower doses.
Dialysis: Not specifically studied. Use with extreme caution. IVIG is not significantly removed by dialysis. Monitor for fluid overload and hyperviscosity.

Hepatic Impairment:

Mild: No specific dose adjustment required.
Moderate: No specific dose adjustment required.
Severe: No specific dose adjustment required.

Pharmacology

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Mechanism of Action

Immune Globulin Intravenous (IVIG) contains a broad spectrum of IgG antibodies against various infectious agents and toxins. Its mechanism of action in immunodeficiency is to replace deficient IgG antibodies. In autoimmune and inflammatory conditions (like ITP, CIDP), the mechanisms are complex and include: 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

Distribution:

Vd: Approximately 0.07 L/kg (initial distribution in plasma, then equilibrates with extravascular space)
ProteinBinding: Not applicable (is a protein)
CnssPenetration: Limited

Elimination:

HalfLife: Approximately 21-35 days (highly variable among individuals and indications)
Clearance: Varies, depends on IgG catabolism rate
ExcretionRoute: Catabolism/Degradation
Unchanged: Not applicable (catabolized)
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Pharmacodynamics

OnsetOfAction: Hours to days (e.g., platelet count increase in ITP within 24-48 hours; clinical improvement in PI/CIDP may take longer)
PeakEffect: Days to weeks (e.g., peak IgG levels immediately post-infusion, but clinical effect may be delayed)
DurationOfAction: Weeks to months (correlates with half-life, typically 3-4 weeks for maintenance dosing)

Safety & Warnings

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BLACK BOX WARNING

THROMBOSIS: 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, hyperviscosity, and cardiovascular risk factors. For patients at risk of thrombosis, administer Octagam 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

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
Feeling sleepy or confused

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
+ Fast breathing
+ Confusion
Signs of low sodium levels, such as:
+ Headache
+ Trouble focusing
+ Memory problems
+ Feeling confused
+ 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, especially with neck stiffness or sensitivity to light (signs of aseptic meningitis)
  • Sudden chest pain, shortness of breath, or pain/swelling in an arm or leg (signs of a blood clot)
  • Decreased urination, swelling in legs or feet, unusual fatigue (signs of kidney problems)
  • Severe allergic reaction symptoms: difficulty breathing, hives, swelling of face/lips/tongue/throat
  • Fever, chills, nausea, vomiting, dizziness, or severe back pain during or shortly 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 with the allergy.
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 products containing this medication may have sorbitol, which can be problematic if you have this condition.

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 the use of certain vaccines in combination with this medication may increase the risk of infection or reduce the vaccine's effectiveness.

Regularly undergo blood tests and other laboratory examinations as directed by your doctor. This medication may interfere with the results of certain lab tests, so it is crucial to notify all your healthcare providers and laboratory personnel that you are taking this medication.

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. 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.

If you have diabetes (high blood sugar), 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, plan to become pregnant, or are breastfeeding, inform your doctor, as you will need to discuss the potential benefits and risks of this medication to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Hyperviscosity (thickening of blood) leading to symptoms like headache, dizziness, confusion, visual disturbances, or stroke-like symptoms
  • Fluid overload (e.g., shortness of breath, swelling)
  • Acute renal failure

What to Do:

In case of suspected overdose, seek immediate medical attention. Call 911 or your local emergency number. Management is supportive, focusing on maintaining hydration, monitoring vital signs, and addressing specific symptoms. In severe cases of hyperviscosity, plasmapheresis may be considered. Call 1-800-222-1222 for Poison Control.

Drug Interactions

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Major Interactions

  • Live virus vaccines (e.g., measles, mumps, rubella, varicella): IVIG can interfere with the immune response to these vaccines. Vaccination should be delayed for at least 3 months, and up to 1 year for measles, after IVIG administration.
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Moderate Interactions

  • Loop diuretics: Increased risk of acute renal failure, especially with sucrose-containing IVIG products (Octagam is sucrose-free, but caution still advised in susceptible patients).
  • 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 higher risk for acute renal failure.

Timing: Prior to initiation of therapy.

Serum IgA levels

Rationale: To screen for IgA deficient patients who may develop anti-IgA antibodies and be at risk for severe anaphylactic reactions.

Timing: Prior to first infusion.

Complete Blood Count (CBC) with differential

Rationale: To assess baseline hematologic status, especially in ITP patients.

Timing: Prior to initiation of therapy.

Vital Signs (Blood Pressure, Heart Rate, Temperature)

Rationale: To establish baseline and identify potential contraindications or risks.

Timing: Immediately 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 1 hour post-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, flushing, chills, fever, nausea, rash, dyspnea, chest pain, back pain)

Frequency: Continuously during and for several hours after infusion.

Target: Absence of symptoms.

Action Threshold: Presence of symptoms warrants slowing/stopping infusion and appropriate management.

Urine output and signs of fluid overload

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

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

Action Threshold: Decreased urine output or signs of fluid overload (e.g., dyspnea, edema) require immediate assessment.

Renal function (BUN, serum creatinine)

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

Target: Within baseline limits.

Action Threshold: Significant increase warrants investigation and potential discontinuation.

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Symptom Monitoring

  • Headache
  • Fever
  • Chills
  • Nausea
  • Vomiting
  • Rash
  • Flushing
  • Dizziness
  • Fatigue
  • Muscle cramps
  • Back pain
  • Chest pain
  • Dyspnea
  • Signs of thrombosis (e.g., pain, swelling, discoloration of limb, sudden shortness of breath, chest pain, neurological deficits)
  • Signs of acute renal failure (e.g., decreased urine output, edema, 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. It is not known whether Octagam can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Octagam should be given to a pregnant woman only if clearly needed. However, IVIG is often used in pregnancy for certain autoimmune conditions (e.g., ITP, recurrent pregnancy loss) and is generally considered relatively safe.

Trimester-Specific Risks:

First Trimester: Limited data, but generally considered low risk for major malformations.
Second Trimester: Generally considered safe, often used for maternal autoimmune conditions.
Third Trimester: Generally considered safe, may provide passive immunity to the neonate.
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Lactation

L2 (Safer). 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. Consider the benefits of breastfeeding along with the mother's clinical need for Octagam.

Infant Risk: Low risk. No known adverse effects on breastfed infants.
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Pediatric Use

Dosing for PI, ITP, and CIDP is weight-based and similar to adults. Use with caution in neonates and infants due to potential for renal dysfunction and thrombosis, especially with higher concentrations or rapid infusion rates. Ensure adequate hydration.

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Geriatric Use

Use with caution due to increased risk of thrombosis and acute renal failure. Ensure adequate hydration. Administer at the minimum dose and infusion rate practicable. Monitor renal function closely. Patients over 65 years of age are at higher risk for thrombotic events.

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 headache.
  • Infuse slowly initially, especially for the first infusion or in patients at high risk for adverse reactions, and gradually increase the rate if tolerated.
  • Pre-medication (e.g., acetaminophen, antihistamines, corticosteroids) may be considered for patients with a history of infusion-related reactions.
  • Monitor vital signs frequently during the infusion, particularly during the first hour.
  • Be vigilant for signs of thrombosis (e.g., stroke, MI, DVT, PE) and acute renal failure, especially in high-risk patients.
  • Octagam is sucrose-free, which may reduce the risk of osmotic nephrosis compared to sucrose-containing IVIG products, but renal dysfunction can still occur.
  • Patients with selective IgA deficiency with known antibodies to IgA are at increased risk of severe hypersensitivity reactions, including anaphylaxis. Octagam contains trace amounts of IgA.
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Alternative Therapies

  • Other Immune Globulin Intravenous (IVIG) brands (e.g., Gammagard, Privigen, Flebogamma, Gamunex-C, Panzyga, Asceniv)
  • Subcutaneous Immune Globulin (SCIG) for PI (e.g., Hizentra, Cuvitru, Xembify, HyQvia)
  • Immunosuppressants (e.g., corticosteroids, rituximab, azathioprine, mycophenolate mofetil) for autoimmune conditions where IVIG is used.
  • Splenectomy (for refractory ITP)
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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 weight. per infusion
Insurance Coverage: Specialty Tier / Medical Benefit (often requires prior authorization and is covered under medical benefit for approved indications)
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General Drug Facts

If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure safe use, never share your prescription medications with others, and do not take medications that have been prescribed to someone else.

Store all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion. Proper disposal of unused or expired medications is crucial. Unless instructed otherwise by a healthcare professional or pharmacist, do not dispose of medications by flushing them down the toilet or pouring them down the drain. Instead, consult with your pharmacist to determine the best disposal method, as some communities may have designated drug take-back programs.

Some medications may come with an additional patient information leaflet, so it is a good idea to check with your pharmacist for more information. 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 critical information, including the name of the medication taken, the amount, and the time it was taken, to ensure prompt and effective treatment.