Octagam 10gm/200ml Inj, 1 Vial

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

Overview

ā„¹ļø

What is this medicine?

Immune Globulin (IVIG) is a medicine made from human blood plasma that contains antibodies. Antibodies are proteins that your body uses to fight off infections and diseases. This medicine is given directly into your vein to help your immune system work better, either by providing missing antibodies or by calming down an overactive immune system.
šŸ“‹

How to Use This Medicine

Taking Your Medication

To use this medication correctly, follow your doctor's instructions and carefully read all the information provided to you. It is essential to follow all instructions closely. This medication is administered as an infusion into a vein over a specified period.

Storing and Disposing of Your Medication

If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the proper storage procedure.

Missing a Dose

If you miss a dose, contact your doctor immediately to receive guidance on what to do next.
šŸ’”

Lifestyle & Tips

  • Stay well-hydrated before, during, and after your infusion to help prevent side effects like kidney problems or 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 this medication, as it can make the vaccine less effective. Discuss your vaccination schedule with your doctor.

Dosing & Administration

šŸ‘Øā€āš•ļø

Adult Dosing

Standard Dose: Highly variable based on indication. Examples:

Condition-Specific Dosing:

Primary Humoral Immunodeficiency (PIDD): 300-600 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): 2 g/kg divided over 2-5 days as loading dose, then 1 g/kg every 3 weeks or 0.4-1 g/kg every 1-2 weeks as maintenance
Kawasaki Disease: 2 g/kg as a single infusion over 10-12 hours
šŸ‘¶

Pediatric Dosing

Neonatal: Dosing is highly individualized based on indication and weight (e.g., for sepsis, ITP, PIDD).
Infant: Dosing is highly individualized based on indication and weight (e.g., for PIDD, ITP, Kawasaki Disease).
Child: Dosing is highly individualized based on indication and weight (e.g., for PIDD, ITP, Kawasaki Disease, CIDP).
Adolescent: Dosing is highly individualized based on indication and weight, often similar to adult dosing for weight-based regimens.
āš•ļø

Dose Adjustments

Renal Impairment:

Mild: Use with caution. Consider lower concentration (e.g., 5%) and slower infusion rate. Monitor renal function closely.
Moderate: Use with caution. Consider lower concentration (e.g., 5%) and slower infusion rate. Monitor renal function closely. Avoid sucrose-containing formulations if possible.
Severe: Use with extreme caution. Consider lower concentration (e.g., 5%) and slower infusion rate. Monitor renal function closely. Avoid sucrose-containing formulations. Benefits must outweigh risks.
Dialysis: Not significantly removed by dialysis. Administer after dialysis. Use with caution, monitor renal function and fluid status.

Hepatic Impairment:

Mild: No specific dose adjustment generally required.
Moderate: No specific dose adjustment generally required.
Severe: No specific dose adjustment generally required.

Pharmacology

šŸ”¬

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, varying by indication. In immunodeficiency, it provides passive immunity by replacing deficient IgG antibodies. In autoimmune and inflammatory conditions, it is thought to modulate the immune system through several mechanisms, including: Fc receptor blockade on macrophages, modulation of cytokine production, inhibition of complement activation, neutralization of autoantibodies, suppression of pathogenic T-cell and B-cell activity, and upregulation of inhibitory Fcγ receptors.
šŸ“Š

Pharmacokinetics

Absorption:

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

Distribution:

Vd: Approximately 3-4 L (similar to plasma volume), with distribution into extravascular spaces over several days.
ProteinBinding: Not applicable (it is a protein)
CnssPenetration: Limited, but sufficient for therapeutic effect in some neurological conditions.

Elimination:

HalfLife: Highly variable, typically 21-35 days in patients with normal IgG catabolism; can be shorter in hypercatabolic states or certain disease states.
Clearance: Primarily through catabolism of IgG.
ExcretionRoute: Not renally excreted in significant amounts.
Unchanged: Not applicable
ā±ļø

Pharmacodynamics

OnsetOfAction: Immediate for passive immunity; days to weeks for immunomodulatory effects in chronic conditions.
PeakEffect: Varies by indication; typically within hours for acute effects (e.g., ITP), or weeks for steady-state levels in chronic conditions (e.g., PIDD).
DurationOfAction: Weeks to months, depending on half-life and indication.

Safety & Warnings

āš ļø

BLACK BOX WARNING

Thrombosis may occur with immune globulin products, including Octagam. Risk factors include advanced age, prolonged immobilization, hypercoagulable conditions, history of thrombosis or cardiovascular risk factors, estrogen use, indwelling central vascular catheters, and hyperviscosity. For patients at risk of thrombosis, administer Octagam at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients prior to administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity. Acute renal dysfunction/failure: Acute renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur with immune globulin products, including Octagam. 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. For patients at risk of renal dysfunction or failure, administer Octagam at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients prior to administration. Monitor renal function, including blood urea nitrogen (BUN) and serum creatinine, and urine output.
āš ļø

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 notice 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 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 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

If you are receiving this medication intravenously, you may be at risk for dehydration and low sodium levels. If you experience any of the following symptoms, seek medical attention right away:

Signs of dehydration, such as:
+ Dry skin, mouth, or eyes
+ Thirst
+ Rapid heartbeat
+ Dizziness
+ Rapid breathing
+ Confusion
Signs of low sodium levels, such as:
+ Headache
+ Difficulty focusing
+ Memory problems
+ Confusion
+ Weakness
+ Seizures
+ Changes in balance

Other Possible Side Effects

While many people may not experience any side effects or only minor ones, 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.
🚨

Seek Immediate Medical Attention If You Experience:

  • Severe headache, especially with neck stiffness or sensitivity to light (could be aseptic meningitis)
  • Signs of a blood clot: sudden pain, swelling, warmth, or redness in an arm or leg; sudden chest pain, shortness of breath, coughing up blood; sudden numbness or weakness on one side of the body, slurred speech, sudden vision changes (could be DVT, PE, stroke)
  • Signs of kidney problems: decreased urination, swelling in your legs or feet, unusual tiredness (could be acute renal dysfunction)
  • Signs of an allergic reaction: rash, hives, itching, difficulty breathing, wheezing, dizziness, swelling of face/lips/tongue/throat
  • Fever, chills, nausea, vomiting, or back pain during or shortly after the infusion (common infusion-related reactions)
šŸ“‹

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, such as foods or drugs. Describe the allergic reactions you have experienced.
If you have IgA deficiency, a condition where your body lacks a specific 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 fructose intolerance.

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 Precautions:

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. Verify that 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.
āš ļø

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. 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 crucial to discuss with your doctor which glucose tests are suitable for use with this medication.

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 weigh the benefits and risks of this medication to both you and your baby.
šŸ†˜

Overdose Information

Overdose Symptoms:

  • Fluid overload (e.g., shortness of breath, swelling)
  • Increased blood viscosity (leading to potential thrombotic events)
  • 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, renal function, and fluid balance, and treating symptoms. Call 1-800-222-1222 (Poison Control).

Drug Interactions

šŸ”“

Major Interactions

  • Live virus vaccines (e.g., measles, mumps, rubella, varicella): IVIG can interfere with the immune response to live attenuated virus vaccines. Vaccination should be deferred for at least 3 months, and up to 1 year, after IVIG administration depending on the vaccine and IVIG dose.
  • Loop diuretics (e.g., furosemide): Increased risk of acute renal dysfunction, especially in patients with pre-existing renal impairment or risk factors.

Monitoring

šŸ”¬

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.

Serum IgA levels

Rationale: To screen for IgA deficiency, as patients with severe IgA deficiency may develop antibodies to IgA and experience anaphylactic reactions.

Timing: Prior to first infusion.

Hydration status

Rationale: To ensure adequate hydration, which is crucial to prevent renal complications and reduce risk of thrombosis.

Timing: Prior to and during infusion.

Vital signs (blood pressure, heart rate, temperature)

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

Timing: Prior to infusion.

šŸ“Š

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 range.

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

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

Frequency: Continuously during and for several hours after infusion.

Target: Absence of symptoms.

Action Threshold: Any new or worsening symptom warrants immediate assessment and intervention.

Renal function (BUN, serum creatinine)

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

Target: Within patient's normal range or stable.

Action Threshold: Increase in creatinine >0.5 mg/dL or significant percentage increase from baseline.

Fluid balance

Frequency: During and after infusion, especially in patients at risk for fluid overload.

Target: Euvolemic.

Action Threshold: Signs of fluid overload (e.g., dyspnea, edema).

šŸ‘ļø

Symptom Monitoring

  • Headache
  • Fever
  • Chills
  • Nausea
  • Vomiting
  • Rash
  • Hives
  • Dyspnea
  • Wheezing
  • Chest tightness
  • Back pain
  • Muscle cramps
  • Dizziness
  • Fatigue
  • Signs of thrombosis (e.g., pain, swelling, warmth, discoloration of an extremity; sudden chest pain, shortness of breath, slurred speech, weakness on one side of the body)
  • Signs of renal dysfunction (e.g., decreased urine output, swelling in legs/feet, fatigue)
  • Signs of aseptic meningitis (e.g., severe headache, neck stiffness, photophobia, fever, nausea, vomiting)

Special Patient Groups

🤰

Pregnancy

Immune globulins cross the placenta, particularly in the third trimester. While animal reproduction studies have not been conducted, clinical experience with IVIG in pregnant women has not shown evidence of adverse effects on the fetus. It is often used in pregnant women for specific indications (e.g., ITP, recurrent pregnancy loss). Use only if clearly needed.

Trimester-Specific Risks:

First Trimester: No known specific risks identified.
Second Trimester: No known specific risks identified.
Third Trimester: Significant placental transfer of IgG occurs, potentially affecting infant's response to live virus vaccines post-delivery. No direct fetal toxicity known.
🤱

Lactation

Immune globulins are naturally present in human milk. Exogenous immune globulin is unlikely to be absorbed systemically by the infant. Considered compatible with breastfeeding.

Infant Risk: L1 (Safest - compatible with breastfeeding).
šŸ‘¶

Pediatric Use

Dosing is weight-based and indication-specific. Safety and efficacy have been established for various pediatric indications. Close monitoring for infusion-related reactions and renal function is important, especially in neonates and infants.

šŸ‘“

Geriatric Use

Elderly patients (age >65) are at increased risk for acute renal dysfunction and thrombotic events. Use with caution, ensure adequate hydration, consider lower infusion rates, and monitor renal function and signs of thrombosis closely. Pre-existing conditions (e.g., diabetes, cardiovascular disease) increase risk.

Clinical Information

šŸ’Ž

Clinical Pearls

  • Always ensure adequate hydration before, during, and after IVIG infusion to minimize the risk of renal dysfunction and thrombosis.
  • Infuse at the slowest practicable rate, especially for the first infusion, and for patients at high risk of adverse reactions (e.g., elderly, renal impairment, cardiovascular disease). The rate can be gradually increased if tolerated.
  • Pre-medication (e.g., acetaminophen, antihistamines, corticosteroids) may be used to mitigate infusion-related reactions, especially in patients with a history of such reactions or those receiving their first infusion.
  • Patients with IgA deficiency who have antibodies to IgA are at increased risk of severe allergic or anaphylactic reactions. Octagam contains trace amounts of IgA. Screen for IgA deficiency prior to first infusion.
  • Monitor for signs of aseptic meningitis syndrome (AMS), which can occur hours to days after IVIG infusion. Symptoms include severe headache, neck stiffness, photophobia, nausea, and vomiting. It is usually self-limiting.
  • Thrombotic events, including stroke, myocardial infarction, DVT, and PE, can occur. Be vigilant for symptoms, especially in high-risk patients.
  • Acute renal dysfunction is a serious potential adverse effect. Monitor renal function and urine output, especially in at-risk populations. Avoid sucrose-containing IVIG formulations in patients at risk for renal failure.
šŸ”„

Alternative Therapies

  • Other Immune Globulin Intravenous (IVIG) brands (e.g., Gammagard, Privigen, Flebogamma, Gamunex-C, Asceniv, Panzyga)
  • Subcutaneous Immune Globulin (SCIG) for chronic immunodeficiency (e.g., Hizentra, Cuvitru, Xembify, HyQvia)
  • Corticosteroids (for autoimmune conditions like ITP, CIDP)
  • Immunosuppressants (e.g., azathioprine, mycophenolate mofetil, cyclophosphamide, rituximab for autoimmune conditions)
  • Plasma exchange (for acute severe autoimmune conditions)
šŸ’°

Cost & Coverage

Average Cost: Highly variable, typically several hundred to several thousand USD per vial depending on dose and concentration. per 10gm/200ml vial
Insurance Coverage: Specialty Tier (requires prior authorization, often covered under medical benefit for approved indications).
šŸ“š

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 evaluation and guidance. To ensure your safety and the safety of others, never share your prescription medications with anyone, and do not take medications that have been prescribed to someone else.

All medications should be stored in a secure location, out of the reach of children and pets, to prevent accidental ingestion. When disposing of unused or expired medications, do not flush them down the toilet or pour them down the drain unless specifically instructed to do so by a healthcare professional or the medication's packaging. Instead, consult with your pharmacist to determine the best disposal method, as some communities have drug take-back programs in place.

Additionally, some medications may have a separate patient information leaflet; check with your pharmacist to see if this applies to your prescription. If you have any questions or concerns about your medication, it is crucial to discuss them with your doctor, nurse, pharmacist, or other healthcare provider.

In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. Be prepared to provide critical information, including the name of the medication taken, the amount, and the time it was taken, to ensure prompt and effective treatment.