Octagam 2.5gm/50ml Inj, 1 Vial
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.
Drug Class
Immunomodulator; Blood Product
Pharmacologic Class
Immune Globulin (Human), Intravenous
Pregnancy Category
Category C
FDA Approved
Jul 2004
DEA Schedule
Not Controlled
Overview
What is this medicine?
Octagam is a medicine made from human blood plasma that contains antibodies. Antibodies are proteins that help your body fight off infections and diseases. It's given directly into your vein (intravenously) to help people with certain immune system problems or autoimmune diseases where their own immune system is attacking their body.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. It is essential to follow the dosage instructions carefully. 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.
To use this medication correctly, follow your doctor's instructions and read all the information provided. It is essential to follow the dosage instructions carefully. 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.
Lifestyle & Tips
- Stay well-hydrated before, during, and after your infusion to help prevent side effects, especially kidney problems.
- Report any unusual symptoms immediately to your healthcare provider.
- 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.
Available Forms & Alternatives
Available Strengths:
- Octagam 1gm/20ml Inj, 1 Vial
- Octagam 2.5gm/50ml Inj, 1 Vial
- Octagam 5% Inj, 5gm/100ml
- Octagam 10gm/200ml Inj, 1 Vial
- Octagam 20grams Inj, 200ml
- Octagam 30mg/300ml Inj 300ml
- Octagam 5gm/50ml Inj, 50ml
- Octagam 10% 10gm/100ml Inj, 100ml
- Octagam 10% 2gm/20ml Inj, 20ml
- Octagam 5% 2.5gm/50ml Inj, 1 Vial
- Octagam 5% 5gm/100ml Inj, 1 Vial
- Octagam 5% 10gm/200ml Inj, 200ml
- Octagam 10% 20g/200ml Inj, 1 Vial
- Octagam 10% 30mg/300ml Inj, 300ml
Dosing & Administration
Adult Dosing
Standard Dose:
Highly variable based on indication. Examples: Primary Immunodeficiency (PI): 300-600 mg/kg every 3-4 weeks; Idiopathic Thrombocytopenic Purpura (ITP): 400 mg/kg/day for 2-5 days or 1000 mg/kg/day for 1-2 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):
300-600 mg/kg every 3-4 weeks
Idiopathic Thrombocytopenic Purpura (ITP):
400 mg/kg/day for 2-5 days or 1000 mg/kg/day for 1-2 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
Kawasaki Disease:
2 g/kg as a single infusion over 10-12 hours
Pediatric Dosing
Neonatal:
Not established for all indications, but used off-label for some conditions (e.g., neonatal sepsis, hemolytic disease of the newborn) with specific dosing.
Infant:
Dosing is weight-based and indication-specific, similar to older children (e.g., PI, ITP, Kawasaki Disease).
Child:
Dosing is weight-based and indication-specific (e.g., PI: 300-600 mg/kg every 3-4 weeks; ITP: 400 mg/kg/day for 2-5 days or 1000 mg/kg/day for 1-2 days; Kawasaki Disease: 2 g/kg as a single infusion).
Adolescent:
Dosing is weight-based and indication-specific, similar to adults.
Dose Adjustments
Renal Impairment:
Mild:
Caution advised; monitor renal function. Consider lower infusion rates.
Moderate:
Caution advised; monitor renal function closely. Consider lower infusion rates and doses.
Severe:
Use with extreme caution. Contraindicated in patients with pre-existing renal insufficiency unless the benefit outweighs the risk. Monitor renal function closely, ensure adequate hydration, and consider lower infusion rates and doses.
Dialysis:
Not removed by dialysis. Use with caution, monitor renal function, and ensure adequate hydration.
Hepatic Impairment:
Mild:
No specific dose adjustment generally required.
Moderate:
No specific dose adjustment generally required.
Severe:
No specific dose adjustment generally required.
Pharmacology
Mechanism of Action
Immune Globulin Intravenous (IVIG) contains a broad spectrum of opsonizing and neutralizing IgG antibodies derived from pooled human plasma. Its mechanism of action is complex and multifactorial, varying by indication. In primary immunodeficiency, it provides passive immunity by replacing deficient IgG antibodies. In autoimmune and inflammatory conditions (e.g., ITP, CIDP), it is thought to modulate the immune system through various mechanisms including: Fc receptor blockade, modulation of cytokine production, inhibition of autoantibody production, neutralization of pathogenic autoantibodies, and modulation of complement activation.
Pharmacokinetics
Absorption:
Bioavailability:
100%
Tmax:
End of infusion
FoodEffect:
Not applicable (IV administration)
Distribution:
Vd:
Approximately 0.07-0.1 L/kg (primarily plasma and extravascular fluid)
ProteinBinding:
Not applicable (is a protein)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 20-40 days (highly variable among individuals and indications)
Clearance:
Variable, depends on individual IgG catabolism rate.
ExcretionRoute:
Primarily intracellular catabolism; minimal renal excretion of intact IgG.
Unchanged:
Not applicable (catabolized)
Pharmacodynamics
OnsetOfAction:
Immediate (antibody levels rise rapidly post-infusion); clinical effect may take hours to days depending on indication.
PeakEffect:
Variable; for antibody replacement, peak IgG levels are at the end of infusion. For immunomodulation, peak clinical effect may be delayed (days to weeks).
DurationOfAction:
Variable, typically 3 weeks to 3 months, depending on half-life and indication.
Safety & Warnings
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, 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 prior to administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek 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
+ Fainting or loss of consciousness
+ 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
Severe Lung Problems and Aseptic Meningitis
This medication can cause severe lung problems, which can be life-threatening. If you experience any of the following symptoms, contact your doctor right away:
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, contact your doctor immediately:
Headache
Fever
Chills
Severe nausea or vomiting
Stiff neck
Rash
Sensitivity to light
Drowsiness
Confusion
Immune Globulin Therapy and Dehydration
If you are receiving immune globulin therapy for the first time, have not had it in the past 8 weeks, or are switching brands, you may be at risk for certain side effects, including:
Fever
Chills
Nausea
Vomiting
Dehydration and low sodium levels can also occur when this medication is administered intravenously. If you experience any of the following symptoms, contact your doctor 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 be aware of the following possible side effects:
Irritation at the injection site
Dizziness
Fatigue
Weakness
Headache
Upset stomach or vomiting
Stomach pain or diarrhea
Back pain
Muscle spasm
Signs of a common cold
Flushing
* Cramps
If you experience any of these side effects or any other symptoms that concern you, contact your doctor or seek medical attention. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek 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
+ Fainting or loss of consciousness
+ 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
Severe Lung Problems and Aseptic Meningitis
This medication can cause severe lung problems, which can be life-threatening. If you experience any of the following symptoms, contact your doctor right away:
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, contact your doctor immediately:
Headache
Fever
Chills
Severe nausea or vomiting
Stiff neck
Rash
Sensitivity to light
Drowsiness
Confusion
Immune Globulin Therapy and Dehydration
If you are receiving immune globulin therapy for the first time, have not had it in the past 8 weeks, or are switching brands, you may be at risk for certain side effects, including:
Fever
Chills
Nausea
Vomiting
Dehydration and low sodium levels can also occur when this medication is administered intravenously. If you experience any of the following symptoms, contact your doctor 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 be aware of the following possible side effects:
Irritation at the injection site
Dizziness
Fatigue
Weakness
Headache
Upset stomach or vomiting
Stomach pain or diarrhea
Back pain
Muscle spasm
Signs of a common cold
Flushing
* Cramps
If you experience any of these side effects or any other symptoms that concern you, contact your doctor or seek medical attention. 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, neck stiffness, sensitivity to light, nausea, or vomiting (signs of aseptic meningitis)
- Sudden chest pain, shortness of breath, pain/swelling/redness in an arm or leg (signs of a blood clot)
- Decreased urination, swelling in your legs or feet, unusual tiredness (signs of kidney problems)
- Severe allergic reaction symptoms: rash, itching, hives, swelling of the face/lips/tongue/throat, difficulty breathing or swallowing, dizziness, fainting.
- Fever, chills, body aches, fatigue (common infusion-related reactions, but report if severe or persistent).
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 symptoms you experienced during an allergic reaction.
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 excessive 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.
Interactions with Other Medications and Health Conditions:
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.
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 symptoms you experienced during an allergic reaction.
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 excessive 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.
Interactions with Other Medications and Health Conditions:
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.
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 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. 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 medication is thoroughly screened, tested, and treated to minimize the risk of infection, discuss any concerns 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, plan to become pregnant, or are breastfeeding, inform your doctor to discuss the potential benefits and risks to both you and your baby.
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 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. 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 medication is thoroughly screened, tested, and treated to minimize the risk of infection, discuss any concerns 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, plan to become pregnant, or are breastfeeding, inform your doctor to discuss the potential benefits and risks to both you and your baby.
Overdose Information
Overdose Symptoms:
- Fluid overload (e.g., shortness of breath, swelling)
- Increased blood viscosity (leading to potential thrombotic events)
- Acute renal failure (especially in at-risk patients)
- Severe headache, nausea, vomiting (aseptic meningitis symptoms)
What to Do:
Treatment is supportive. Discontinue infusion immediately. Manage symptoms such as fluid overload (e.g., diuretics), monitor renal function, and address any thrombotic events. Call 1-800-222-1222 (Poison Control) or seek immediate medical attention.
Drug Interactions
Major Interactions
- Live virus vaccines (e.g., measles, mumps, rubella, varicella): IVIG may impair the immune response to live attenuated virus vaccines. Vaccination should be deferred for at least 3 months (up to 11 months for measles) after IVIG administration. If vaccination is necessary, antibody titers should be checked post-vaccination.
Moderate Interactions
- Loop diuretics: Increased risk of acute renal failure, especially in patients with pre-existing renal impairment or risk factors.
- Nephrotoxic drugs: Increased risk of acute renal failure when co-administered with other nephrotoxic agents.
Monitoring
Baseline Monitoring
Renal function (BUN, serum creatinine)
Rationale: To assess baseline renal status and identify patients at risk for acute renal failure.
Timing: Prior to initiation of therapy.
Serum IgA levels
Rationale: To screen for IgA deficiency, as patients with severe IgA deficiency may develop anti-IgA antibodies and be at increased risk of anaphylactic reactions.
Timing: Prior to first infusion.
Vital signs (blood pressure, heart rate, temperature)
Rationale: To establish baseline and monitor for immediate infusion-related reactions.
Timing: Prior to infusion.
Hydration status
Rationale: Adequate hydration is crucial to minimize the risk of renal adverse events.
Timing: Prior to infusion.
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.
Signs and symptoms of adverse reactions (e.g., headache, chills, fever, nausea, rash, dyspnea, chest pain, back pain)
Frequency: Continuously during and for several hours after infusion.
Target: Absence of symptoms.
Action Threshold: Any new or worsening symptom warrants immediate assessment and potential intervention (e.g., slowing infusion, administering symptomatic treatment).
Renal function (BUN, serum creatinine)
Frequency: Periodically during therapy, especially in patients with risk factors for renal dysfunction (e.g., pre-existing renal impairment, diabetes, age >65, volume depletion, concomitant nephrotoxic drugs).
Target: Within normal limits or stable baseline.
Action Threshold: Significant increase in BUN/creatinine warrants immediate investigation, hydration, and potential discontinuation or dose adjustment.
Urine output
Frequency: Monitor during and after infusion, especially in at-risk patients.
Target: Adequate urine output.
Action Threshold: Oliguria or anuria warrants immediate investigation.
Signs of thrombosis (e.g., pain, swelling, discoloration of limb, shortness of breath, chest pain)
Frequency: Continuously during and for several days to weeks after infusion.
Target: Absence of symptoms.
Action Threshold: Any suspicious symptom warrants immediate medical evaluation.
Symptom Monitoring
- Headache
- Chills
- Fever
- Nausea
- Vomiting
- Fatigue
- Dizziness
- Rash
- Hives
- Itching
- Dyspnea
- Wheezing
- Chest tightness
- Back pain
- Muscle cramps
- Joint pain
- Signs of allergic reaction (swelling of face/throat, difficulty breathing)
- Signs of thrombosis (pain, swelling, warmth, redness in limb; sudden shortness of breath, chest pain, vision changes, weakness/numbness on one side of body)
- Signs of renal dysfunction (decreased urine output, swelling, fatigue)
- Signs of aseptic meningitis (severe headache, neck stiffness, photophobia, nausea, vomiting, fever)
Special Patient Groups
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. Passive transfer of antibodies from mother to fetus is expected.
Trimester-Specific Risks:
First Trimester:
Limited data, theoretical risk of immune modulation.
Second Trimester:
Limited data, generally considered if benefits outweigh risks.
Third Trimester:
Limited data, generally considered if benefits outweigh risks. Passive transfer of antibodies to the fetus is expected, which may interfere with live virus vaccines given to the infant post-birth.
Lactation
Immune globulins are naturally present in human milk. While there is no specific data for Octagam, the benefits of breastfeeding are generally considered to outweigh any potential risks. IVIG is a large protein and is unlikely to be absorbed systemically by the infant. Consult with a healthcare provider.
Infant Risk:
Low risk. Antibodies are transferred to the infant via breast milk, which may provide some passive immunity. No adverse effects on the breastfed infant are expected.
Pediatric Use
Octagam is approved for use in pediatric patients for various indications (e.g., PI, ITP, Kawasaki Disease). Dosing is weight-based. Pediatric patients, especially those with underlying conditions, should be monitored closely for adverse reactions, including renal dysfunction and thrombosis.
Geriatric Use
Use with caution in patients aged 65 years or older due to an increased risk of acute renal failure and thrombotic events. Ensure adequate hydration and administer at the minimum dose and infusion rate practicable. Monitor renal function closely.
Clinical Information
Clinical Pearls
- Always ensure adequate hydration before, during, and after IVIG infusion to minimize the risk of renal adverse events and thrombosis.
- Infusion rate should be started slowly and gradually increased if tolerated. Patients with risk factors for adverse events (e.g., renal impairment, cardiovascular disease, advanced age) should receive the slowest practicable infusion rate.
- Pre-medication (e.g., antihistamines, acetaminophen, corticosteroids) may be considered for patients with a history of infusion-related reactions, but is not routinely required for all patients.
- Patients with IgA deficiency who have antibodies to IgA are at increased risk of severe hypersensitivity reactions, including anaphylaxis. Octagam contains trace amounts of IgA. Screen for IgA deficiency if suspected.
- Monitor for signs and symptoms of thrombosis for several days to weeks post-infusion, especially in at-risk patients. Educate patients on these symptoms.
- Aseptic meningitis syndrome is a known, though uncommon, side effect. Symptoms typically begin within hours to 2 days post-infusion and resolve spontaneously within several days after discontinuation.
Alternative Therapies
- Other Intravenous Immune Globulin (IVIG) products (e.g., Gammagard S/D, Gamunex-C, Privigen, Flebogamma DIF, Asceniv, Panzyga)
- Subcutaneous Immune Globulin (SCIG) products (e.g., Hizentra, Cuvitru, Xembify, Gamunex-C/Gammagard S/D for SC use) for primary immunodeficiency.
- For specific indications, alternative treatments may include corticosteroids, rituximab, thrombopoietin receptor agonists (for ITP), plasma exchange, or other immunomodulatory agents.
Cost & Coverage
Average Cost:
Highly variable, typically several hundred to several thousand USD per vial depending on strength and quantity. per 50ml vial (2.5gm)
Insurance Coverage:
Specialty Tier; typically covered by medical benefit for approved indications, often requires prior authorization.
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 safe use, do not share your medication with others, and never 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 flush medications down the toilet or pour them down the drain unless specifically instructed to do so by a healthcare professional or pharmacist. If you are unsure about the best method for disposing of medications, consult with your pharmacist, who can provide guidance on safe disposal practices. Additionally, you may want to inquire about potential drug take-back programs in your area, which can offer a safe and environmentally responsible way to dispose of unwanted medications.
Some medications may come with an additional patient information leaflet, so it is a good idea to check with your pharmacist to see if this applies to your prescription. If you have any questions or concerns about your medication, do not hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider for clarification and support.
In the event of a suspected overdose, it is critical to seek immediate medical attention. Call your local poison control center or visit the emergency room right away. Be prepared to provide detailed information about the overdose, including the name of the medication, the amount taken, and the time it was ingested, as this will help healthcare professionals provide the most effective treatment.
To ensure safe use, do not share your medication with others, and never 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 flush medications down the toilet or pour them down the drain unless specifically instructed to do so by a healthcare professional or pharmacist. If you are unsure about the best method for disposing of medications, consult with your pharmacist, who can provide guidance on safe disposal practices. Additionally, you may want to inquire about potential drug take-back programs in your area, which can offer a safe and environmentally responsible way to dispose of unwanted medications.
Some medications may come with an additional patient information leaflet, so it is a good idea to check with your pharmacist to see if this applies to your prescription. If you have any questions or concerns about your medication, do not hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider for clarification and support.
In the event of a suspected overdose, it is critical to seek immediate medical attention. Call your local poison control center or visit the emergency room right away. Be prepared to provide detailed information about the overdose, including the name of the medication, the amount taken, and the time it was ingested, as this will help healthcare professionals provide the most effective treatment.