Octagam 5% 10gm/200ml Inj, 200ml

Manufacturer PFIZER U.S. Active Ingredient Immune Globulin (IV)(i MYUN GLOB yoo lin) Pronunciation OK-tah-gam (for brand name); i MYUN GLOB yoo lin (for active ingredient)
WARNING: There is a chance of blood clots with this drug. The chance is raised in older people and in people with thick blood, heart problems, or a history of blood clots. The chance may also be higher if you must be in a bed or chair for some time, if you take estrogen, or if you use certain catheters. However, blood clots can happen even if you do not have any of these health problems. Call your doctor right away if you have numbness or weakness on 1 side of your body; pain, redness, tenderness, warmth, or swelling in the arms or legs; change in color of an arm or leg; chest pain or pressure; shortness of breath; fast heartbeat; or coughing up blood. Talk with your doctor.Kidney problems have happened with human immune globulin. Sometimes, these problems have been deadly. Kidney problems are more common in people using products that have sucrose. Most immune globulin products do not have sucrose. The chance of these problems may be raised if you have kidney problems, high blood sugar (diabetes), fluid loss (dehydration) or low blood volume, a blood infection, or proteins in the blood that are not normal. The chance may be raised if you are 65 or older, or if you take other drugs that may harm the kidneys. Talk with your doctor if you have questions about this information or about if your product has sucrose.You will need to be sure that you are not dehydrated before getting this drug. Check with your doctor to see if you need to drink extra fluids before getting this drug. @ COMMON USES: It is used to help prevent infections or make infections less severe in people with a weak immune system.It is used to treat immune thrombocytopenia (ITP).It is used treat chronic inflammatory demyelinating polyneuropathy (CIDP).It is used to treat Kawasaki disease.It is used to treat a certain muscle problem caused by inflammation (dermatomyositis).It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Immunomodulator; Immunizing Agent
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Pharmacologic Class
Immune Globulin (Human), Intravenous
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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 5% is a medicine made from human blood plasma that contains antibodies (proteins that fight infections). It is given intravenously (into a vein) to help people whose bodies don't make enough antibodies to fight off infections, or to help regulate the 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 medication 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 to your healthcare provider during or after the infusion.

Dosing & Administration

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Adult Dosing

Standard Dose: Highly variable based on indication. Examples: Primary Immunodeficiency (PI): 300-800 mg/kg every 3-4 weeks. Immune Thrombocytopenia (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 divided 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): 300-800 mg/kg every 3-4 weeks
Immune Thrombocytopenia (ITP): 1 g/kg/day for 1-2 days or 400 mg/kg/day for 5 days
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP): Loading: 2 g/kg divided over 2-5 days; Maintenance: 1 g/kg every 3 weeks or 0.5 g/kg every week
Kawasaki Disease: 2 g/kg single dose
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Pediatric Dosing

Neonatal: Not established for all indications; use with caution and reduced infusion rates due to renal risk.
Infant: Dosing is weight-based and indication-specific, similar to adult mg/kg doses but with careful monitoring of fluid status and renal function.
Child: Dosing is weight-based and indication-specific (e.g., PI, ITP, Kawasaki Disease).
Adolescent: Dosing is weight-based and indication-specific, generally similar to adult mg/kg doses.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment, but monitor renal function closely. Consider slower infusion rates.
Moderate: No specific dose adjustment, but monitor renal function closely. Consider slower infusion rates and ensure adequate hydration.
Severe: No specific dose adjustment, but monitor renal function closely. Consider slower infusion rates and ensure adequate hydration. Increased risk of acute renal failure.
Dialysis: Not removed by dialysis. No specific dose adjustment, but monitor renal function and fluid status carefully. Increased risk of acute renal failure.

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 opsonizing and neutralizing IgG antibodies against a wide variety of bacterial and viral agents. The mechanisms of action in immunomodulatory indications (e.g., ITP, CIDP, Kawasaki Disease) are not fully elucidated but are thought to involve: Fc receptor blockade on macrophages, modulation of complement activation, suppression of autoantibody production, anti-idiotypic antibody effects, and modulation of cytokine and chemokine production.
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Pharmacokinetics

Absorption:

Bioavailability: 100%
Tmax: End of infusion (for peak concentration)
FoodEffect: Not applicable (IV administration)

Distribution:

Vd: Approximately 3.5 L (similar to plasma volume)
ProteinBinding: Not applicable (it is a protein)
CnssPenetration: Limited, but can have therapeutic effects in certain neurological conditions.

Elimination:

HalfLife: Approximately 21-35 days (highly variable depending on patient's IgG levels and catabolism rate)
Clearance: Catabolism of IgG by the reticuloendothelial system
ExcretionRoute: Not excreted renally or hepatically in the traditional sense; catabolized into amino acids.
Unchanged: Not applicable (it is catabolized)
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Pharmacodynamics

OnsetOfAction: Immediate (for antibody replacement); variable (for immunomodulatory effects, can be hours to days)
PeakEffect: Variable, depending on indication and patient response. For antibody replacement, peak IgG levels are at the end of infusion. For immunomodulatory effects, clinical peak may be days to weeks.
DurationOfAction: Weeks to months, depending on half-life and indication (e.g., 3-4 weeks for PI, longer for some autoimmune conditions)
Confidence: Medium

Safety & Warnings

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BLACK BOX WARNING

THROMBOSIS: 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. For patients at risk of thrombosis, administer Octagam 5% 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

Important Side Effects to Report to Your Doctor Right Away

Although rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you experience any of the following symptoms, 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, seek medical attention immediately:

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, seek medical attention immediately:

Headache
Fever
Chills
Nausea or vomiting
Stiff neck
Rash
Sensitivity to light
Feeling sleepy or confused

Other Potential Side Effects

Some patients, especially those receiving immune globulin therapy for the first time or who have not had it within the past 8 weeks, may be at risk for certain side effects, including:

Fever
Chills
Nausea
Vomiting

This may also occur in people who switch brands of immune globulin. If you experience any of these side effects, inform your doctor right away.

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, seek medical attention immediately:

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 Side Effects

Most people do not experience severe side effects, but some may occur. If you experience any of the following side effects, inform your doctor:

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 experience any side effects, inform your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Severe headache, stiff neck, sensitivity to light, nausea, vomiting (signs of aseptic meningitis)
  • Sudden pain, swelling, warmth, or redness in an arm or leg (signs of a blood clot)
  • Sudden shortness of breath, chest pain, coughing up blood (signs of a blood clot in the lung)
  • Sudden numbness or weakness on one side of the body, sudden severe headache, vision changes, slurred speech (signs of a stroke)
  • Decreased urination, swelling in legs or feet, unusual tiredness (signs of kidney problems)
  • Hives, rash, itching, difficulty breathing, wheezing, dizziness, fainting (signs of an allergic reaction)
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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 lacks a specific type of 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 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 discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. This will help ensure your safety while taking this medication. Never start, stop, or adjust the dose of any medication without first 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 with this medication may increase the risk of infection or reduce the vaccine's effectiveness.

Regular blood tests and other laboratory evaluations should be performed as directed by your doctor. Additionally, this medication may interfere with certain lab tests, so it is crucial to notify all your healthcare providers and laboratory personnel that you are taking this drug.

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.

For individuals with high blood sugar (diabetes), it is essential to discuss with your doctor which glucose tests are most suitable for you 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 necessary 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, visual disturbances, or stroke-like symptoms
  • Fluid overload (e.g., shortness of breath, swelling)
  • Acute renal dysfunction

What to Do:

In case of suspected overdose, discontinue the infusion immediately. Management is supportive, focusing on maintaining hydration, monitoring vital signs, renal function, and blood viscosity. 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 these vaccines. Vaccination should be deferred for at least 3 months after IVIG administration. For measles, deferral may be up to 11 months depending on the IVIG dose.
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Moderate Interactions

  • Loop diuretics: Increased risk of acute renal dysfunction, especially in patients with pre-existing renal impairment or risk factors.
  • Nephrotoxic drugs: Concomitant use may increase the risk of acute renal failure.

Monitoring

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Baseline Monitoring

Renal function (BUN, serum creatinine)

Rationale: To assess baseline kidney function and identify patients at risk for acute renal failure.

Timing: Prior to initiation of therapy

Hydration status

Rationale: To ensure adequate hydration, which is crucial to minimize renal risk.

Timing: Prior to and during infusion

Serum IgA levels

Rationale: To identify patients with selective IgA deficiency who are at increased risk of developing anti-IgA antibodies and severe anaphylactic reactions.

Timing: Prior to first infusion

Complete Blood Count (CBC)

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

Timing: Prior to initiation of therapy

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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

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

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

Frequency: Continuously during and immediately after infusion

Target: Absence of symptoms

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

Renal function (BUN, serum creatinine)

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

Target: Within patient's normal limits or stable

Action Threshold: Significant increase in creatinine (>0.5 mg/dL or >50% from baseline) warrants immediate investigation and consideration of stopping IVIG.

Urine output

Frequency: During and after infusion, especially in at-risk patients

Target: Adequate

Action Threshold: Oliguria or anuria

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Symptom Monitoring

  • Headache
  • Fever
  • Chills
  • Nausea
  • Vomiting
  • Rash
  • Hives
  • Dyspnea
  • Chest tightness
  • Back pain
  • Muscle cramps
  • Dizziness
  • Fatigue
  • Signs of thrombosis (e.g., pain, swelling, discoloration of limb, shortness of breath, chest pain, neurological deficits)
  • Signs of aseptic meningitis (e.g., severe headache, nuchal rigidity, photophobia, fever, nausea, vomiting)
  • Signs of acute renal failure (e.g., decreased urine output, swelling, fatigue)

Special Patient Groups

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Pregnancy

Category C. Octagam 5% should be given to a pregnant woman only if clearly needed. Human IgG is known to cross the placental barrier, particularly during the third trimester. Clinical experience with IVIG in pregnant women suggests no adverse effects on the course of pregnancy, fetus, or neonate.

Trimester-Specific Risks:

First Trimester: Limited data, but generally considered low risk.
Second Trimester: Limited data, but generally considered low risk.
Third Trimester: Significant placental transfer of IgG occurs, potentially affecting the neonate's immune response to live virus vaccines.
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Lactation

L2 (Likely Compatible). Human IgG is excreted into breast milk. The effects of orally ingested immunoglobulin on the breast-fed infant have not been evaluated. However, immunoglobulins are proteins and are likely to be digested in the infant's gastrointestinal tract. Benefits of breastfeeding should be weighed against the potential risks.

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

Dosing is weight-based and indication-specific. Neonates and infants may be at increased risk for acute renal failure and should receive IVIG at the minimum concentration available and the slowest infusion rate practicable. Close monitoring of renal function and fluid status is essential.

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Geriatric Use

Patients >65 years of age are at increased risk for acute renal failure and thrombotic events. Administer at the minimum dose and infusion rate practicable. Ensure adequate hydration. Monitor renal function and for signs/symptoms of thrombosis.

Clinical Information

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Clinical Pearls

  • Always ensure adequate hydration before, during, and after IVIG infusion to minimize the risk of acute renal failure.
  • Start infusions at a slow rate and gradually increase if tolerated, especially in patients at high risk for adverse reactions (e.g., first-time users, those with IgA deficiency, renal impairment, or cardiovascular disease).
  • Pre-medication (e.g., acetaminophen, antihistamines, corticosteroids) may be considered for patients with a history of infusion-related reactions, but is not routinely required for all patients.
  • Monitor vital signs closely throughout the infusion. Headache, chills, and fever are common infusion-related reactions; slowing the infusion rate often helps manage these.
  • Be vigilant for signs of serious adverse events such as thrombosis, acute renal failure, aseptic meningitis, and hemolytic anemia.
  • Patients with selective IgA deficiency with known antibodies to IgA are at increased risk of severe hypersensitivity reactions, including anaphylaxis. Octagam 5% contains trace amounts of IgA.
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Alternative Therapies

  • Other IVIG products (e.g., Gammagard S/D, Gamunex-C, Privigen, Flebogamma DIF)
  • Subcutaneous Immune Globulin (SCIG) products (e.g., Hizentra, Cuvitru, Xembify) for primary immunodeficiency
  • Corticosteroids (e.g., prednisone) for autoimmune conditions like ITP or CIDP
  • Other immunosuppressants or immunomodulators depending on the specific indication (e.g., rituximab, azathioprine, cyclophosphamide, plasma exchange)
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Cost & Coverage

Average Cost: Not available (highly variable, depends on dose, indication, and contract pricing) per gram
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, 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, who can also inform you about potential drug take-back programs in your area. Some medications may come with an additional patient information leaflet, which your pharmacist can provide. If you have any questions or concerns about your medication, discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the quantity, and the time of ingestion.