Octagam 10% 30mg/300ml Inj, 300ml

Manufacturer PFIZER U.S. Active Ingredient Immune Globulin (IV)(i MYUN GLOB yoo lin) Pronunciation IM-yoon 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; Immunoglobulin
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Pharmacologic Class
Immune Globulin Intravenous (Human)
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Pregnancy Category
Category C
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FDA Approved
Aug 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 by infusion into a vein to help people with weakened immune systems fight off infections, or to treat certain autoimmune diseases 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 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, especially kidney problems.
  • Report any unusual symptoms immediately to your healthcare provider during or after the infusion.
  • Discuss any planned vaccinations with your doctor, as this medication can affect the effectiveness of live virus vaccines.

Dosing & Administration

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Adult Dosing

Standard Dose: Highly variable based on indication. Examples: Primary Immunodeficiency (PI): 300-600 mg/kg every 3-4 weeks. Immune Thrombocytopenia (ITP): 400 mg/kg/day for 2-5 days or 1000 mg/kg/day for 1-2 days. 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 week.
Dose Range: 300 - 2000 mg

Condition-Specific Dosing:

Primary Immunodeficiency (PI): 300-600 mg/kg every 3-4 weeks
Immune Thrombocytopenia (ITP): 400 mg/kg/day for 2-5 days or 1000 mg/kg/day for 1-2 days
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP): Loading: 2 g/kg over 2-5 days; 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 renal immaturity.
Infant: Dosing is weight-based (mg/kg) and indication-specific, similar to adult mg/kg doses but with careful monitoring of fluid balance and renal function.
Child: Dosing is weight-based (mg/kg) and indication-specific, similar to adult mg/kg doses.
Adolescent: Dosing is weight-based (mg/kg) and indication-specific, similar to adult mg/kg doses.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment, but monitor renal function closely.
Moderate: Use with caution. Consider lower infusion rates and ensure adequate hydration. Monitor renal function.
Severe: Contraindicated or use with extreme caution. Risk of acute renal failure. Consider alternative therapies or significant dose reduction/slower infusion rates with close monitoring.
Dialysis: Not removed by dialysis. Use with caution, monitor fluid balance and renal function. Consider lower doses or slower infusion rates.

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 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 diseases, the mechanism is complex and multifactorial, including: Fc receptor blockade on macrophages, modulation of complement activation, suppression of autoantibody production, anti-idiotypic antibody activity, modulation of cytokine production, and effects on T-cell and B-cell function.
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Pharmacokinetics

Absorption:

Bioavailability: 100%
Tmax: Immediately after infusion
FoodEffect: Not applicable (IV administration)

Distribution:

Vd: Approximately 0.07 L/kg (primarily intravascular, with some extravascular distribution)
ProteinBinding: Not applicable (is a protein)
CnssPenetration: Limited (does not readily cross intact blood-brain barrier)

Elimination:

HalfLife: Highly variable, typically 21-35 days (can be shorter in patients with high IgG turnover or certain disease states)
Clearance: Variable, depends on individual IgG catabolism rate
ExcretionRoute: Not excreted renally as intact protein; catabolized into amino acids
Unchanged: Not applicable (is catabolized)
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Pharmacodynamics

OnsetOfAction: Immediate (antibody levels rise rapidly); clinical effect may take hours to days depending on indication.
PeakEffect: Within hours to days after infusion, depending on the clinical indication.
DurationOfAction: Weeks to months, depending on half-life and indication (e.g., 3-4 weeks for PI, longer for some autoimmune conditions).

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. Acute renal dysfunction and acute renal failure may occur. For patients at risk, administer Octagam 10% at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients prior to administration. Monitor renal function, including blood urea nitrogen (BUN) and serum creatinine.
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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 immediately or seek emergency medical attention:

Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness or 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 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 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
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 administered intravenously. If you experience any of the following symptoms, contact your doctor 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

While many people may not experience any side effects or only minor ones, it is essential to contact your doctor if you notice any of the following:

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

If you have any questions or concerns about side effects, contact your doctor. You can also report side effects to 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, stiff neck, sensitivity to light, nausea, vomiting (signs of aseptic meningitis)
  • Sudden chest pain, shortness of breath, pain or swelling in an arm or leg, numbness or weakness on one side of the body (signs of blood clot)
  • Decreased urination, swelling in legs or feet, unusual tiredness (signs of kidney problems)
  • Hives, rash, itching, swelling of the face/lips/tongue, difficulty breathing, dizziness, fainting (signs of allergic reaction)
  • Fever, chills, body aches, fatigue (common infusion-related reactions, but report if severe or persistent)
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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, a type of sugar. Some products containing this medication may have sorbitol, which can be problematic for individuals with this condition.

For Parents or Caregivers of Infants and Babies:

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 Considerations:

This medication may interact with other drugs or health conditions. Therefore, it is crucial to provide your doctor and pharmacist with a comprehensive list of:
+ All prescription and over-the-counter medications you are taking.
+ Any natural products, vitamins, or supplements you are using.
+ Your existing health problems.
* Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to ensure your safety.
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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 taken with this drug.

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 taking 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
  • Acute renal dysfunction
  • Increased risk of thrombosis

What to Do:

In case of suspected overdose, stop the infusion immediately. Management is supportive, focusing on maintaining hydration, monitoring vital signs, renal function, and managing any adverse reactions. 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): IVIG may impair the immune response to these vaccines. Vaccination should be deferred for at least 3 months (up to 11 months for some vaccines) after IVIG administration.
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Moderate Interactions

  • Loop diuretics: Increased risk of acute renal failure when co-administered with IVIG, especially in patients with pre-existing renal impairment.
  • Nephrotoxic drugs: Increased risk of renal dysfunction when co-administered with IVIG, particularly 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 higher risk for acute renal failure.

Timing: Prior to initiation of therapy.

Fluid status/hydration

Rationale: To ensure adequate hydration before, during, and after infusion to minimize risk of renal adverse events.

Timing: Prior to and throughout infusion.

Serum IgA levels

Rationale: To identify patients with selective IgA deficiency who 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 in patients with ITP or other hematologic conditions.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Vital signs (blood pressure, heart rate, temperature)

Frequency: Before, during (every 15-30 minutes for the first hour, then periodically), and after 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 assessing for adverse reaction.

Signs and symptoms of adverse reactions (e.g., headache, chills, fever, rash, dyspnea, chest pain, back pain, nausea, vomiting)

Frequency: Continuously during and for several hours after infusion.

Target: Absence of symptoms.

Action Threshold: Any new or worsening symptom warrants slowing or stopping infusion and appropriate management.

Urine output and signs of renal dysfunction (e.g., oliguria, anuria, edema)

Frequency: During and for several days after infusion, especially in at-risk patients.

Target: Normal urine output.

Action Threshold: Decreased urine output or signs of fluid overload/renal impairment.

Signs of thrombosis (e.g., localized pain/swelling, dyspnea, chest pain, neurological deficits)

Frequency: During and for several days after infusion, especially in at-risk patients.

Target: Absence of symptoms.

Action Threshold: Any new or worsening symptom suggestive of thrombosis.

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Symptom Monitoring

  • Headache
  • Chills
  • Fever
  • Nausea
  • Vomiting
  • Fatigue
  • Dizziness
  • Rash
  • Hives
  • Dyspnea
  • Chest pain
  • Back pain
  • Muscle cramps
  • Joint pain
  • Signs of allergic reaction (e.g., swelling of face/throat, difficulty breathing)
  • Signs of acute renal failure (e.g., decreased urine output, swelling)
  • Signs of thrombosis (e.g., pain, swelling, warmth in limb; sudden chest pain, shortness of breath; sudden neurological changes)
  • 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. IVIG is known to cross the placental barrier, particularly in the third trimester. It is generally considered safe for use in pregnancy when clinically indicated, as IgG is a natural component of human plasma and provides passive immunity to the fetus. Use only if the potential benefit justifies the potential risk to the fetus.

Trimester-Specific Risks:

First Trimester: Limited data, but unlikely to cause major malformations as IgG is a large molecule and placental transfer is minimal early in pregnancy.
Second Trimester: Placental transfer increases, but generally considered low risk.
Third Trimester: Significant placental transfer of IgG occurs, providing passive immunity to the neonate. No known specific risks to the fetus from IVIG itself, but underlying maternal condition and potential for infusion-related reactions should be considered.
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Lactation

L3 (Moderately safe). IgG is naturally present in breast milk and provides passive immunity to the infant. Oral absorption of intact IgG by the infant is minimal. No adverse effects on breastfed infants have been reported. Considered compatible with breastfeeding.

Infant Risk: Low risk.
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Pediatric Use

Dosing is weight-based and indication-specific. Infusion rates should be carefully controlled, especially in neonates and infants, due to potential for fluid overload and renal immaturity. Close monitoring for adverse reactions is crucial.

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Geriatric Use

Use with caution. Elderly patients are at increased risk for acute renal failure, thrombosis, and fluid overload due to age-related decline in renal function, pre-existing cardiovascular disease, and other comorbidities. Administer at the minimum dose and infusion rate practicable, ensuring adequate hydration and close monitoring of renal function and fluid status.

Clinical Information

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Clinical Pearls

  • Always ensure adequate hydration before, during, and after IVIG infusion to minimize the risk of renal adverse events and thrombosis.
  • Start infusions slowly and gradually increase the rate if tolerated, especially for the first infusion or in patients at high risk for adverse reactions.
  • Pre-medication (e.g., acetaminophen, antihistamines, corticosteroids) may be considered for patients with a history of infusion-related reactions.
  • Monitor vital signs frequently, particularly during the initial phase of infusion.
  • Patients with selective IgA deficiency are at higher risk for anaphylactic reactions due to anti-IgA antibodies; consider IgA-depleted products if available and necessary.
  • Be vigilant for signs of thrombosis (e.g., headache, neurological symptoms, chest pain, limb pain/swelling) and acute renal failure (e.g., decreased urine output) for several days post-infusion.
  • Inform patients about the potential interference with live virus vaccines and advise them to discuss vaccination schedules with their healthcare provider.
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Alternative Therapies

  • Subcutaneous Immune Globulin (SCIG) for primary immunodeficiency (e.g., Hizentra, Gammaked, Cuvitru, Xembify)
  • Corticosteroids (e.g., prednisone) for autoimmune conditions like ITP or CIDP
  • Other immunosuppressants (e.g., azathioprine, mycophenolate mofetil, rituximab) depending on the specific autoimmune indication
  • Plasma exchange (plasmapheresis) for certain acute neurological or autoimmune conditions
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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 frequency. per 300ml (30g) vial
Insurance Coverage: Specialty Tier; typically 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 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. Properly dispose of unused or expired medications by checking with your pharmacist for the recommended disposal method. Unless instructed to do so, avoid flushing medications down the toilet or pouring them down the drain, as this can harm the environment. Many communities have drug take-back programs; your pharmacist can provide information on these programs. Some medications may come with an additional patient information leaflet; check with your pharmacist for more details. If you have any questions or concerns about your medication, consult with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. Be prepared to provide information about the medication taken, the amount, and the time it was taken to ensure prompt and effective treatment.