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Octagam 10% 10gm/100ml Inj, 100ml

Manufacturer OCTAPHARMA USA Active Ingredient Immune Globulin (IV)(i MYUN GLOB yoo lin) Pronunciation ih-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
Immunomodulator, Immunizing Agent
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Pharmacologic Class
Immune Globulin
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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 10% is a medicine made from human blood plasma that contains antibodies (proteins that fight infections). It is given into a vein to help people whose bodies don't make enough of their own antibodies, 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 provided guidelines. This drug is administered via infusion into a vein over a specified period of time.

For proper storage and disposal, consult with your doctor, nurse, or pharmacist to determine the best approach if you need to store this medication at home.

If you miss a dose, contact your doctor immediately to receive guidance on the next steps to take.
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Lifestyle & Tips

  • Stay well-hydrated before, during, and after your infusion, as directed by your healthcare provider. This helps reduce the risk of kidney problems.
  • Report any unusual symptoms immediately to your nurse or doctor during or after the infusion.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

Standard Dose: Highly variable, depends on indication and patient response. Examples: Primary Immunodeficiency (PI): 0.2-0.8 g/kg every 3-4 weeks. Idiopathic Thrombocytopenic Purpura (ITP): 0.4 g/kg/day for 2-5 days or 1 g/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: 0.2 - 2 mg

Condition-Specific Dosing:

Primary Immunodeficiency: 0.2-0.8 g/kg every 3-4 weeks
Idiopathic Thrombocytopenic Purpura: 0.4 g/kg/day for 2-5 days or 1 g/kg/day for 1-2 days
Chronic Inflammatory Demyelinating Polyneuropathy: Loading dose 2 g/kg over 2-5 days, then 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 extreme caution due to renal risk.
Infant: Dosing is weight-based and indication-specific, similar to adult per kg dosing (e.g., PI, ITP).
Child: Dosing is weight-based and indication-specific, similar to adult per kg dosing (e.g., PI, ITP, CIDP).
Adolescent: Dosing is weight-based and indication-specific, similar to adult per kg dosing (e.g., PI, ITP, CIDP).
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Dose Adjustments

Renal Impairment:

Mild: Use with caution. Ensure adequate hydration. Consider slower infusion rate and lowest effective dose.
Moderate: Use with caution. Ensure adequate hydration. Consider slower infusion rate and lowest effective dose. Monitor renal function closely.
Severe: Contraindicated or use with extreme caution. Increased risk of acute renal failure. Consider alternative therapies or use lowest effective dose at slowest possible infusion rate with aggressive hydration and close renal monitoring.
Dialysis: Not specifically studied. Use with extreme caution due to increased risk of renal dysfunction and fluid overload. Monitor fluid status and renal function closely.

Hepatic Impairment:

Mild: No specific dose adjustment required.
Moderate: No specific dose adjustment required, but monitor for fluid overload and other complications.
Severe: No specific dose adjustment required, but monitor for fluid overload and other complications.

Pharmacology

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Mechanism of Action

Immune Globulin Intravenous (IGIV) contains a broad spectrum of IgG antibodies against various infectious agents and toxins. Its mechanism of action in various conditions is not fully elucidated but involves multiple immunomodulatory effects, including: Fc receptor blockade on macrophages, modulation of complement activation, suppression of autoantibody production, anti-idiotypic antibody activity, and modulation of cytokine production and immune 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 plasma and extravascular space)
ProteinBinding: Not applicable (is a protein)
CnssPenetration: Limited

Elimination:

HalfLife: Approximately 21-35 days (highly variable depending on patient's underlying condition and IgG catabolism rate)
Clearance: Variable, depends on individual IgG catabolism
ExcretionRoute: Primarily intracellular catabolism; minimal renal excretion of intact IgG.
Unchanged: Not applicable (catabolized)
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Pharmacodynamics

OnsetOfAction: Rapid (within hours for some effects like ITP platelet increase), but full immunomodulatory effects may take days to weeks.
PeakEffect: Variable, depending on indication (e.g., platelet count increase in ITP within 24-48 hours; sustained effects for PI over weeks).
DurationOfAction: Weeks to months, depending on half-life and indication (e.g., 3-4 weeks for PI replacement therapy).
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 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. 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 use of nephrotoxic drugs. Administer Octagam 10% at the minimum concentration available and the minimum infusion rate practicable.
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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

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 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

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 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, contact 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 have 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, stiff neck, sensitivity to light, nausea, or vomiting (signs of aseptic meningitis)
  • Sudden chest pain, shortness of breath, coughing up blood (signs of blood clot in lungs)
  • Pain, swelling, warmth, or redness in an arm or leg (signs of blood clot in a vein)
  • Sudden weakness or numbness on one side of the body, slurred speech, sudden vision changes (signs of stroke)
  • Decreased urine output, swelling in your legs or feet, unexplained weight gain, dark urine (signs of kidney problems)
  • Hives, rash, itching, difficulty breathing, wheezing, dizziness, or fainting (signs of a severe allergic reaction)
  • Fever, chills, or shaking during or after the infusion
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following conditions to ensure safe treatment:

Any allergies you have, including allergies to this medication, its components, or other substances. 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, consult with your doctor, as some products contain sorbitol.

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.

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. They will help you determine whether it is safe to take this medication with your existing treatments and health status. Never start, stop, or adjust the dosage of any medication without consulting your doctor.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you have a latex allergy, be sure to discuss this with your doctor.

Before receiving any vaccinations, consult with your doctor, as 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 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. It is also important to note that this medication is derived from human plasma and may potentially contain viruses that can cause disease. Although the product is thoroughly screened, tested, and treated to minimize the risk of infection, 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. Furthermore, if you have diabetes (high blood sugar), discuss with your doctor which glucose tests are most suitable for you 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 to discuss the potential benefits and risks to you and your baby.
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Overdose Information

Overdose Symptoms:

  • Fluid overload (e.g., shortness of breath, swelling, headache)
  • Increased blood viscosity (rare, but can exacerbate thrombosis risk)

What to Do:

In case of suspected overdose or severe adverse reaction, stop the infusion immediately. Provide supportive care, manage symptoms (e.g., diuretics for fluid overload), and contact emergency services. Call 1-800-222-1222 for poison control.

Drug Interactions

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Major Interactions

  • Live virus vaccines (e.g., measles, mumps, rubella, varicella): Antibodies in IGIV may interfere with the immune response to live attenuated virus vaccines. Vaccination should be deferred for at least 3 months after IGIV administration. For measles, the deferral period may be up to 11 months depending on the IGIV dose.
  • Loop diuretics: May increase the risk of acute renal dysfunction, especially in patients with pre-existing renal impairment or risk factors.
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Moderate Interactions

  • Nephrotoxic drugs: Concomitant use may increase the risk of acute renal dysfunction. Monitor renal function closely.
  • ACE inhibitors/ARBs: May increase risk of renal dysfunction 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 increased risk for acute renal failure.

Timing: Prior to initiation of therapy

Hydration status

Rationale: To ensure adequate hydration, which is critical to prevent renal complications.

Timing: Prior to and during infusion

Serum IgA levels

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

Timing: Prior to first infusion (if not previously known)

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; report significant changes.

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

Urine output

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

Target: Adequate for hydration status.

Action Threshold: Oliguria or anuria may indicate acute renal dysfunction.

Signs/symptoms of thrombosis

Frequency: During and for several days following infusion.

Target: Absence of symptoms.

Action Threshold: New onset of pain, swelling, discoloration of an extremity; chest pain, shortness of breath, neurological deficits.

Signs/symptoms of renal dysfunction

Frequency: During and for several days following infusion.

Target: Absence of symptoms.

Action Threshold: Decreased urine output, edema, unexplained weight gain, dark urine.

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Symptom Monitoring

  • Headache (common, often infusion-related)
  • Fever, chills, rigors (infusion reactions)
  • Nausea, vomiting
  • Rash, urticaria, pruritus (allergic reactions)
  • Chest pain, shortness of breath, wheezing (cardiopulmonary reactions, anaphylaxis)
  • Back pain, muscle aches
  • Signs of thrombosis (e.g., pain, swelling, warmth, redness in an extremity; sudden chest pain, shortness of breath; sudden vision changes, slurred speech, weakness on one side)
  • Signs of renal dysfunction (e.g., decreased urine output, swelling in legs/feet, fatigue, dark urine)
  • Signs of aseptic meningitis (e.g., severe headache, nuchal rigidity, fever, photophobia, nausea, vomiting)

Special Patient Groups

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Pregnancy

Pregnancy Category C. Animal reproduction studies have not been conducted. Octagam 10% should be given to a pregnant woman only if clearly needed. IgG antibodies are known to cross the placenta, particularly during the third trimester.

Trimester-Specific Risks:

First Trimester: Limited data, but generally considered low risk for congenital malformations.
Second Trimester: Limited data, but generally considered low risk.
Third Trimester: Significant placental transfer of IgG occurs, potentially affecting neonatal immune response or screening tests. No known direct teratogenic effects.
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Lactation

L1 - Safest. Immune globulins are naturally present in breast milk and are not expected to cause harm to a breastfed infant. Breastfeeding is generally considered compatible with Octagam 10% use.

Infant Risk: Low risk. IgG is transferred into breast milk, potentially providing passive immunity to 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. Pediatric patients, especially neonates and infants, may be at increased risk for acute renal dysfunction and thrombosis, similar to adults with risk factors. Ensure adequate hydration and use the slowest practicable infusion rate.

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Geriatric Use

Geriatric patients (age >65 years) are at increased risk for acute renal dysfunction and thrombotic events. Use with caution, ensure adequate hydration, and administer at the minimum concentration and slowest infusion rate practicable. Monitor renal function and signs of thrombosis closely.

Clinical Information

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Clinical Pearls

  • Always ensure adequate hydration of the patient prior to and during Octagam 10% infusion to minimize the risk of renal dysfunction.
  • Start the infusion at the slowest recommended rate and gradually increase if tolerated, especially for the first infusion or in high-risk patients.
  • Pre-medication with antihistamines or acetaminophen may be considered for patients with a history of infusion-related reactions.
  • Monitor vital signs closely throughout the infusion and for a period afterward.
  • Be vigilant for signs and symptoms of thrombosis (e.g., chest pain, shortness of breath, limb pain/swelling) and acute renal dysfunction (e.g., decreased urine output, elevated creatinine).
  • Patients with IgA deficiency who have anti-IgA antibodies are at increased risk of severe allergic reactions, including anaphylaxis. Octagam 10% contains trace amounts of IgA.
  • 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

  • Other Intravenous Immune Globulin (IVIG) products (e.g., Gammagard, Privigen, Flebogamma, Gamunex-C)
  • Subcutaneous Immune Globulin (SCIG) products (e.g., Hizentra, Cuvitru, Xembify, Gamunex-C SC)
  • For specific indications: Immunosuppressants (e.g., corticosteroids, rituximab, azathioprine, mycophenolate mofetil for autoimmune conditions), plasma exchange, splenectomy (for ITP).
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Cost & Coverage

Average Cost: Highly variable, depends on dose, indication, and purchasing agreements. Can range from hundreds to thousands of dollars per infusion. per gram or per vial
Insurance Coverage: Specialty Tier or Medical Benefit (often requires prior authorization and is covered under medical benefit for in-office/hospital administration)
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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. Properly dispose of unused or expired medications by checking with your pharmacist for guidance, as some communities have drug take-back programs. Unless instructed to do so, avoid flushing medications down the toilet or pouring them down the drain. If you have questions about disposing of medications, consult your pharmacist, who may also have additional patient information leaflets available for certain drugs. For any concerns or questions about your medication, consult your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time of ingestion.