Octagam 10gm/200ml Inj, 1 Vial
Overview
What is this medicine?
How to Use This Medicine
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.
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.
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
Condition-Specific Dosing:
Pediatric Dosing
Dose Adjustments
Renal Impairment:
Hepatic Impairment:
Pharmacology
Mechanism of Action
Pharmacokinetics
Absorption:
Distribution:
Elimination:
Pharmacodynamics
Safety & Warnings
BLACK BOX WARNING
Side Effects
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)
Before Using This Medicine
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.
Precautions & Cautions
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.
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
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
Baseline Monitoring
Rationale: To assess baseline renal status and identify patients at risk for acute renal dysfunction.
Timing: Prior to initiation of therapy.
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.
Rationale: To ensure adequate hydration, which is crucial to prevent renal complications and reduce risk of thrombosis.
Timing: Prior to and during infusion.
Rationale: To establish baseline and monitor for immediate infusion-related reactions.
Timing: Prior to infusion.
Routine Monitoring
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.
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.
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.
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).
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:
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.
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.
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
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.
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)
Cost & Coverage
General Drug Facts
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.