Octagam 1gm/20ml Inj, 1 Vial

Manufacturer OCTAPHARMA Active Ingredient Immune Globulin (IV)(i MYUN GLOB yoo lin) Pronunciation i MYUN GLOB yoo lin
WARNING: There is a chance of blood clots with this drug. The chance is raised in older people and in people with thick blood, heart problems, or a history of blood clots. The chance may also be higher if you must be in a bed or chair for some time, if you take estrogen, or if you use certain catheters. However, blood clots can happen even if you do not have any of these health problems. Call your doctor right away if you have numbness or weakness on 1 side of your body; pain, redness, tenderness, warmth, or swelling in the arms or legs; change in color of an arm or leg; chest pain or pressure; shortness of breath; fast heartbeat; or coughing up blood. Talk with your doctor.Kidney problems have happened with human immune globulin. Sometimes, these problems have been deadly. Kidney problems are more common in people using products that have sucrose. Most immune globulin products do not have sucrose. The chance of these problems may be raised if you have kidney problems, high blood sugar (diabetes), fluid loss (dehydration) or low blood volume, a blood infection, or proteins in the blood that are not normal. The chance may be raised if you are 65 or older, or if you take other drugs that may harm the kidneys. Talk with your doctor if you have questions about this information or about if your product has sucrose.You will need to be sure that you are not dehydrated before getting this drug. Check with your doctor to see if you need to drink extra fluids before getting this drug. @ COMMON USES: It is used to help prevent infections or make infections less severe in people with a weak immune system.It is used to treat immune thrombocytopenia (ITP).It is used treat chronic inflammatory demyelinating polyneuropathy (CIDP).It is used to treat Kawasaki disease.It is used to treat a certain muscle problem caused by inflammation (dermatomyositis).It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Immunoglobulin; Immunomodulator
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Pharmacologic Class
Immune Globulin Intravenous (Human)
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Pregnancy Category
Category C
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FDA Approved
Jul 2004
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Octagam 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 calm down an overactive immune system in certain autoimmune diseases.
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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 like kidney problems and blood clots.
  • Report any unusual symptoms immediately to your healthcare provider during or after the infusion.
  • Avoid live virus vaccines (like MMR or chickenpox) for several months after receiving Octagam, as it can make the vaccine less effective. Discuss your vaccination schedule with your doctor.

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. Idiopathic Thrombocytopenic Purpura (ITP): 400 mg/kg/day for 2-5 days OR 800-1000 mg/kg for 1-2 days. Chronic Inflammatory Demyelinating Polyneuropathy (CIDP): Loading dose 2 g/kg divided over 2-5 days; maintenance 1 g/kg every 3 weeks or 0.5 g/kg every week.
Dose Range: 300 - 2000 mg

Condition-Specific Dosing:

Primary Immunodeficiency: 300-800 mg/kg every 3-4 weeks
ITP: 400 mg/kg/day for 2-5 days or 800-1000 mg/kg for 1-2 days
CIDP: Loading: 2 g/kg over 2-5 days; Maintenance: 1 g/kg every 3 weeks or 0.5 g/kg every week
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Pediatric Dosing

Neonatal: Not established for all indications; use with caution, lower infusion rates. For specific conditions like neonatal alloimmune thrombocytopenia, doses similar to ITP may be used.
Infant: Dosing similar to adult based on weight for specific indications (e.g., PI, ITP, Kawasaki disease).
Child: Dosing similar to adult based on weight for specific indications (e.g., PI, ITP, Kawasaki disease).
Adolescent: Dosing similar to adult based on weight for specific indications.
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Dose Adjustments

Renal Impairment:

Mild: Use with caution; ensure adequate hydration; consider lower infusion rates and minimum effective dose.
Moderate: Increased risk of acute renal dysfunction; ensure adequate hydration; consider lower infusion rates and minimum effective dose; monitor renal function closely.
Severe: Increased risk of acute renal dysfunction; ensure adequate hydration; consider lower infusion rates and minimum effective dose; monitor renal function closely. Avoid sucrose-containing formulations if possible.
Dialysis: No specific dose adjustment for patients on dialysis, but monitor for fluid overload and hyperviscosity. Administer post-dialysis.

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 is complex and multifactorial, depending on the indication. In immunodeficiency, it provides passive immunity by replacing deficient IgG antibodies. In autoimmune and inflammatory conditions, proposed mechanisms include: Fc receptor blockade on macrophages, modulation of cytokine production and function, suppression of autoantibody production, anti-idiotypic antibody activity, complement pathway modulation, and regulation of T-cell and B-cell activity.
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Pharmacokinetics

Absorption:

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

Distribution:

Vd: Approximately 0.07 L/kg (similar to plasma volume)
ProteinBinding: Not applicable (it is a protein)
CnssPenetration: Limited, but can cross the blood-brain barrier in conditions of inflammation or increased permeability.

Elimination:

HalfLife: Approximately 21-35 days (highly variable depending on patient's underlying condition and IgG catabolism rate)
Clearance: Varies with individual and disease state
ExcretionRoute: Catabolism
Unchanged: Not applicable
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Pharmacodynamics

OnsetOfAction: Variable; immediate for passive immunity, days to weeks for immunomodulatory effects (e.g., platelet count increase in ITP, neurological improvement in CIDP).
PeakEffect: Variable; depends on indication and individual response.
DurationOfAction: Weeks to months, correlating with the half-life of IgG.

Safety & Warnings

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BLACK BOX WARNING

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 before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.

Acute renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur with immune globulin intravenous (IGIV) products in predisposed patients. Patients at risk include those with any degree of pre-existing renal insufficiency, diabetes mellitus, age >65, volume depletion, sepsis, paraproteinemia, or concomitant nephrotoxic drugs. Administer Octagam at the minimum concentration available and the minimum infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor renal function, including blood urea nitrogen (BUN) and serum creatinine, and urine output in patients at risk.
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Side Effects

Important Side Effects to Report to Your Doctor Immediately

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

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
+ Fainting or near-fainting
+ 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 or eyes

Serious Lung Problems

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

Aseptic Meningitis

This medication may increase the risk of aseptic meningitis, a severe brain problem. If you experience any of the following symptoms, seek medical attention right away:

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

Dehydration and Low Sodium Levels

This medication can cause dehydration and low sodium levels when given intravenously. If you experience any of the following symptoms, seek medical attention 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
+ Confusion
+ Weakness
+ Seizures
+ Changes in balance

Other Possible Side Effects

While many people may not experience any side effects or only minor side effects, it is essential to report any of the following symptoms to your doctor if they bother you or do not go away:

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

Reporting Side Effects

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 online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Severe headache
  • Fever or chills during or after infusion
  • Nausea or vomiting
  • Rash or hives
  • Difficulty breathing or wheezing
  • Swelling of the face, lips, tongue, or throat (signs of a severe allergic reaction)
  • Pain, swelling, warmth, or redness in an arm or leg (signs of a blood clot)
  • Sudden numbness or weakness, especially on one side of the body (signs of a stroke)
  • Dark urine, decreased urination, or unusual swelling (signs of kidney problems)
  • Unusual tiredness or weakness
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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, and 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, as some products contain sorbitol; discuss this with your doctor.

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.

This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions to ensure safe use. Always verify with your doctor before starting, stopping, or changing the dose of any medication.
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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 medication.

Regular blood tests and other laboratory evaluations should be performed as directed by your doctor. Additionally, inform all 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 that can cause disease. Discuss this risk 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 crucial 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 taking 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 it is necessary to weigh the 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)
  • Acute renal dysfunction

What to Do:

In case of suspected overdose, seek immediate medical attention. Management is supportive and may include slowing or stopping the infusion, monitoring vital signs, fluid balance, and renal function. In severe cases, plasmapheresis may be considered. Call 911 or your local emergency number. For poison control, call 1-800-222-1222.

Drug Interactions

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Contraindicated Interactions

  • Live virus vaccines (e.g., measles, mumps, rubella, varicella) - due to potential interference with vaccine efficacy. Delay vaccination for at least 3 months (up to 1 year for measles) after IVIG administration.
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Major Interactions

  • Live virus vaccines (e.g., measles, mumps, rubella, varicella)
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Moderate Interactions

  • Loop diuretics (e.g., furosemide) - increased risk of acute renal dysfunction, especially in predisposed patients.
  • Nephrotoxic drugs (e.g., aminoglycosides, NSAIDs) - increased risk of acute renal dysfunction when co-administered with IVIG, particularly in patients with risk factors.

Monitoring

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Baseline Monitoring

Renal function (BUN, serum creatinine)

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

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 infusion.

Serum IgA levels

Rationale: To screen for IgA deficiency, which increases the risk of anaphylactic reactions in patients with antibodies to IgA.

Timing: Prior to first infusion, or if not previously known.

Hydration status

Rationale: Adequate hydration is crucial to prevent renal dysfunction and thrombosis.

Timing: Prior to and during infusion.

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Routine Monitoring

Vital signs (blood pressure, heart rate, temperature)

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

Target: Within patient's normal limits; report significant changes.

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

Urine output

Frequency: Monitor during and after infusion, especially in at-risk patients.

Target: Adequate urine output.

Action Threshold: Decreased urine output or oliguria warrants immediate assessment of renal function and hydration.

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

Frequency: Continuously during and for several hours after infusion.

Target: Absence of symptoms.

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

Renal function (BUN, serum creatinine)

Frequency: Periodically during therapy, especially in patients with risk factors for renal dysfunction.

Target: Within normal limits or stable for patient's baseline.

Action Threshold: Significant increase warrants dose adjustment, hydration optimization, or discontinuation.

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Symptom Monitoring

  • Headache
  • Chills
  • Fever
  • Nausea
  • Vomiting
  • Rash
  • Hives
  • Chest pain
  • Shortness of breath (dyspnea)
  • Wheezing
  • Swelling of face, lips, tongue, or throat (signs of anaphylaxis)
  • Pain, swelling, warmth, or redness in an arm or leg (signs of thrombosis)
  • Sudden numbness or weakness on one side of the body (signs of stroke)
  • Sudden severe headache
  • Changes in vision
  • Dark urine
  • Decreased urine output
  • Unusual tiredness or weakness

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) where the benefits outweigh potential risks.

Trimester-Specific Risks:

First Trimester: Limited data, but generally considered low risk if clinically indicated. Antibodies are transferred across the placenta primarily in the third trimester.
Second Trimester: Limited data, but generally considered low risk if clinically indicated.
Third Trimester: Antibody transfer to the fetus is highest. No specific increased risks identified, but monitor for maternal adverse effects.
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Lactation

L3 (Moderately Safe). 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 and any potential adverse effects on the breastfed infant from Octagam or the underlying maternal condition.

Infant Risk: Low risk. IgG is a normal component of breast milk and is generally considered safe for the infant. Oral absorption of intact IgG by the infant is minimal.
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Pediatric Use

Dosing is weight-based and indication-specific. Safety and efficacy have been established for various pediatric indications (e.g., PI, ITP, Kawasaki disease). Infusion rates should be carefully monitored, especially in younger children and those with underlying cardiac or renal conditions, to minimize the risk of adverse reactions.

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Geriatric Use

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

Clinical Information

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Clinical Pearls

  • Always ensure adequate hydration before, during, and after infusion to minimize the risk of renal dysfunction and thrombosis.
  • Start infusion at a slow rate and gradually increase if tolerated, especially for the first infusion or in patients at risk for adverse reactions.
  • Pre-medication (e.g., antihistamines, acetaminophen) may be considered for patients with a history of infusion-related reactions.
  • Screen patients for IgA deficiency prior to the first infusion. Patients with severe IgA deficiency and antibodies to IgA are at increased risk of anaphylaxis.
  • Monitor vital signs closely throughout the infusion and for a period afterward.
  • Be vigilant for signs of thrombosis (e.g., localized pain, swelling, neurological deficits) and renal dysfunction (e.g., decreased urine output, elevated creatinine).
  • Educate patients about the importance of reporting any adverse symptoms promptly.
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Alternative Therapies

  • Other IVIG products (different brands/manufacturers)
  • Subcutaneous Immune Globulin (SCIG) for primary immunodeficiencies
  • Corticosteroids (e.g., prednisone) for autoimmune conditions like ITP, CIDP
  • Other immunosuppressants (e.g., rituximab, azathioprine, mycophenolate mofetil) for autoimmune conditions
  • Plasma exchange (plasmapheresis) for certain neurological conditions (e.g., GBS, CIDP)
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Cost & Coverage

Average Cost: Highly variable (depends on dose, concentration, and indication) per gram
Insurance Coverage: Specialty drug, typically covered under medical benefit (Part B in Medicare) or pharmacy benefit for home infusion. Requires prior authorization and often specific indication criteria.
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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 or take someone else's medication. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion.

Proper disposal of unused or expired medications is crucial. Do not dispose of them by flushing down the toilet or pouring down the drain unless specifically instructed to do so. If you are unsure about the best disposal method, consult your pharmacist for guidance. Many communities have drug take-back programs, which your pharmacist can help you locate.

Some medications may come with an additional patient information leaflet, so it is a good idea to check with your pharmacist. If you have any questions or concerns about your medication, do not hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider.

In the event of a suspected overdose, immediately contact your local poison control center or seek medical attention. Be prepared to provide information about the medication taken, the amount, and the time it was taken, as this will help healthcare professionals provide appropriate care.