Octagam 5% 5gm/100ml Inj, 1 Vial

Manufacturer PFIZER U.S. Active Ingredient Immune Globulin (IV)(i MYUN GLOB yoo lin) Pronunciation OK-tah-gam (5%) EYE-myoon 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 (Human), Intravenous
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Pregnancy Category
Category C
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FDA Approved
Jul 2004
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Octagam 5% is a medicine made from human blood plasma that contains antibodies (proteins that fight infections). It's given intravenously (into a vein) to help people with weakened immune systems fight off infections or to help regulate an overactive immune system in certain 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 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.

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 kidney problems and other side effects.
  • Report any unusual symptoms immediately during or after the infusion.
  • Avoid live virus vaccines for several months after receiving Octagam 5% as it may make the vaccine less effective. Discuss vaccination schedules with your doctor.

Dosing & Administration

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Adult Dosing

Standard Dose: Highly variable based on indication. For Primary Humoral Immunodeficiency (PI): 300-600 mg/kg every 3-4 weeks. For Idiopathic Thrombocytopenic Purpura (ITP): 1 g/kg/day for 1-2 days or 400 mg/kg/day for 5 days. For Chronic Inflammatory Demyelinating Polyneuropathy (CIDP): Loading dose 2 g/kg over 2-4 days, then maintenance 1 g/kg over 1-2 days every 3 weeks.
Dose Range: 300 - 2000 mg

Condition-Specific Dosing:

Primary Immunodeficiency (PI): 300-600 mg/kg every 3-4 weeks
Idiopathic Thrombocytopenic Purpura (ITP): 1 g/kg/day for 1-2 days or 400 mg/kg/day for 5 days
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP): Loading dose 2 g/kg over 2-4 days, then maintenance 1 g/kg over 1-2 days every 3 weeks
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Pediatric Dosing

Neonatal: Not established for all indications; use with caution, consider lower infusion rates due to immature renal function.
Infant: Dosing is weight-based and indication-specific, similar to adult mg/kg dosing (e.g., PI: 300-600 mg/kg every 3-4 weeks).
Child: Dosing is weight-based and indication-specific, similar to adult mg/kg dosing (e.g., PI: 300-600 mg/kg every 3-4 weeks; ITP: 1 g/kg/day for 1-2 days).
Adolescent: Dosing is weight-based and indication-specific, similar to adult mg/kg dosing.
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Dose Adjustments

Renal Impairment:

Mild: Monitor renal function; ensure adequate hydration; consider slower infusion rates.
Moderate: Monitor renal function closely; ensure adequate hydration; consider slower infusion rates (e.g., <0.01 mL/kg/min for 5% solution).
Severe: Use with extreme caution; monitor renal function closely; ensure adequate hydration; consider slower infusion rates; may be contraindicated in severe pre-existing renal failure unless benefits outweigh risks.
Dialysis: Not removed by dialysis. Use with caution, monitor fluid status and renal function. Consider lower doses or slower infusion rates.

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 (Human) provides a broad spectrum of IgG antibodies against various infectious agents. Its mechanism of action in immunomodulatory conditions (e.g., ITP, CIDP) is not fully elucidated but is thought to involve: Fc receptor blockade on macrophages, modulation of complement activation, suppression of autoantibody production, anti-idiotypic antibody effects, and modulation of cytokine production.
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Pharmacokinetics

Absorption:

Bioavailability: 100%
Tmax: End of infusion
FoodEffect: Not applicable

Distribution:

Vd: Approximately 0.07-0.1 L/kg (similar to plasma volume)
ProteinBinding: Not applicable (it is a protein)
CnssPenetration: Limited under normal conditions; increased in inflammatory states.

Elimination:

HalfLife: Approximately 21-35 days (highly variable among individuals and indications)
Clearance: Varies, typically 0.002-0.004 L/kg/day
ExcretionRoute: Not excreted; catabolized
Unchanged: Not applicable
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Pharmacodynamics

OnsetOfAction: Immediate (antibody levels); clinical effect varies by indication (e.g., ITP: hours to days; PI: immediate protection; CIDP: days to weeks).
PeakEffect: End of infusion for antibody levels; clinical peak varies.
DurationOfAction: Weeks to months, depending on half-life and indication (e.g., PI: 3-4 weeks; ITP: days to weeks; CIDP: 3 weeks).
Confidence: Medium

Safety & Warnings

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BLACK BOX WARNING

THROMBOSIS and ACUTE RENAL DYSFUNCTION: Thrombosis may occur with immune globulin products, including Octagam 5%. 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. Acute renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur with immune globulin products, including Octagam 5%. Patients at risk include those with any degree of pre-existing renal insufficiency, diabetes mellitus, age >65, volume depletion, sepsis, paraproteinemia, or concomitant use of nephrotoxic drugs. Administer Octagam 5% at the minimum concentration available and the minimum infusion rate practicable. Ensure adequate hydration in patients at risk for renal dysfunction or thrombosis. Monitor for signs and symptoms of thrombosis and renal dysfunction.
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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 immediate medical attention:

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 immediately:

Trouble breathing
Shortness of breath
New or worsening cough

Additionally, this medication may increase the risk of aseptic meningitis, a severe brain problem. Seek medical help right away if you experience:

Headache
Fever
Chills
Severe 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. Contact your doctor immediately if you experience:

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
+ Confusion
+ Weakness
+ Seizures
+ Changes in balance

Other Side Effects

While many people do not experience side effects or only have minor ones, it is essential to report any concerns to your doctor. Other possible side effects include:

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 side effects that bother you or do not go away, contact your doctor for medical advice. 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 (signs of aseptic meningitis syndrome)
  • Sudden chest pain, shortness of breath, pain/swelling/redness in an arm or leg (signs of blood clot)
  • Decreased urine output, swelling in legs/ankles (signs of kidney problems)
  • Severe allergic reaction (e.g., difficulty breathing, hives, swelling of face/lips/tongue, dizziness)
  • Fever, chills, nausea, vomiting, muscle aches (common infusion-related reactions, usually mild but report if severe)
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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, such as foods or medications. Be sure to describe the symptoms you experienced.
If you have IgA deficiency, a condition where your body does not produce enough immunoglobulin A (IgA), an antibody that plays a key role in your immune system.
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 may contain sorbitol, which can be problematic for individuals with 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 Important Information:

This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. Your healthcare team will assess potential interactions between this medication and your other medications or health conditions to ensure safe treatment. Never start, stop, or modify 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.

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.

If you have diabetes (high blood sugar), consult with your doctor to determine the most suitable glucose tests 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, 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)
  • Hyperviscosity (e.g., headache, dizziness, visual disturbances, stroke-like symptoms)
  • Acute renal dysfunction

What to Do:

Discontinue infusion immediately. Manage symptoms supportively. May require diuretics for fluid overload. 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): May interfere with the immune response to live attenuated virus vaccines. Defer vaccination for at least 3 months after IVIG administration. For measles vaccine, defer for up to 11 months depending on 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 for renal dysfunction. Monitor renal function closely.
  • Nephrotoxic drugs: Concurrent use may increase the risk of acute renal failure. Monitor renal function closely.

Monitoring

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Baseline Monitoring

Renal function (BUN, creatinine)

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

Timing: Prior to initiation of therapy.

Fluid status

Rationale: To assess risk of fluid overload, especially in patients with cardiac or renal impairment.

Timing: Prior to and during 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 for indications like ITP.

Timing: Prior to initiation of therapy.

Vital signs (blood pressure, heart rate, temperature)

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

Timing: Prior to and during infusion.

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Routine Monitoring

Vital signs (blood pressure, heart rate, temperature)

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

Target: Within patient's normal limits; stable.

Action Threshold: Significant changes (e.g., hypotension, tachycardia, fever) warrant temporary cessation or slowing of infusion and assessment.

Signs/symptoms of adverse reactions (e.g., headache, chills, nausea, rash, dyspnea, chest pain)

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

Target: Absence of symptoms.

Action Threshold: Presence of symptoms warrants slowing or stopping infusion, and appropriate management (e.g., pre-medication, symptomatic treatment).

Renal function (BUN, creatinine)

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

Target: Stable or within acceptable limits.

Action Threshold: Significant increase in creatinine warrants investigation, potential dose adjustment, or discontinuation.

Signs/symptoms of thrombosis (e.g., pain, swelling, discoloration of limb, shortness of breath, chest pain)

Frequency: Continuously during and for several days to weeks post-infusion.

Target: Absence of symptoms.

Action Threshold: Suspicion of thrombosis warrants immediate medical evaluation.

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Symptom Monitoring

  • Headache
  • Fever
  • Chills
  • Nausea
  • Vomiting
  • Rash
  • Hives
  • Dyspnea
  • Chest tightness
  • Back pain
  • Flushing
  • Dizziness
  • Signs of thrombosis (e.g., swelling, pain, redness in limb; sudden shortness of breath, chest pain, vision changes)
  • Signs of acute renal dysfunction (e.g., decreased urine output, swelling)

Special Patient Groups

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Pregnancy

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

Trimester-Specific Risks:

First Trimester: Limited data, but generally considered low risk as IgG transfer is minimal.
Second Trimester: Limited data, but generally considered low risk.
Third Trimester: Significant placental transfer of IgG occurs, potentially providing passive immunity to the neonate. No known adverse effects on the fetus.
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Lactation

L1 - Safest. Immune globulins are naturally present in breast milk and are considered compatible with breastfeeding. No adverse effects on the breastfed infant are expected.

Infant Risk: Low risk; compatible with breastfeeding.
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Pediatric Use

Dosing is weight-based and indication-specific. Infusion rates should be carefully monitored, especially in infants and young children, due to potential for fluid overload and renal considerations. Safety and efficacy in pediatric patients are established for approved indications.

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Geriatric Use

Use with caution in patients >65 years of age due to increased risk of acute renal dysfunction and thrombotic events. Ensure adequate hydration and monitor renal function closely. Consider slower infusion rates.

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 thrombosis.
  • Start infusion slowly and gradually increase rate if tolerated, especially for the first infusion or in patients at risk for adverse reactions.
  • Pre-medication (e.g., acetaminophen, antihistamines, corticosteroids) may be considered for patients with a history of infusion-related reactions.
  • Test for IgA deficiency prior to first infusion. Patients with selective IgA deficiency and known anti-IgA antibodies are at increased risk of severe allergic reactions, including anaphylaxis.
  • Monitor vital signs closely throughout the infusion and for a period afterward.
  • Be vigilant for signs and symptoms of thrombosis (e.g., DVT, PE, stroke, MI) and acute renal dysfunction, especially in at-risk patients.
  • Octagam 5% has a lower osmolarity compared to 10% solutions, which may be advantageous for patients at risk of renal impairment or fluid overload, but vigilance is still required.
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Alternative Therapies

  • Other intravenous immune globulin (IVIG) products (e.g., Gammagard S/D, Gamunex-C, Privigen, Flebogamma DIF, Bivigam, Asceniv, Panzyga)
  • Subcutaneous immune globulin (SCIG) products (e.g., Hizentra, Cuvitru, Xembify, Gamunex-C/Gammagard S/D for subcutaneous use) for primary immunodeficiency.
  • For specific indications, other immunosuppressants or immunomodulators may be alternatives (e.g., corticosteroids, rituximab, thrombopoietin receptor agonists for ITP).
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Cost & Coverage

Average Cost: Highly variable, typically several hundred to thousands of dollars per vial depending on dose and market. per 100ml vial (5gm)
Insurance Coverage: Specialty Tier; often requires prior authorization and is covered under medical benefit for 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 promptly. To ensure safe use, never share your medication with others, and do not take medication prescribed for 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, avoid flushing medications down the toilet or pouring them down the drain. If you are unsure about the correct disposal method, consult your pharmacist for guidance. Many communities offer drug take-back programs, which your pharmacist can help you locate. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist. 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 emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time it occurred.