Octagam 10% 20g/200ml Inj, 1 Vial
Overview
What is this medicine?
How to Use This Medicine
If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the proper storage procedure.
In the event that you miss a dose, contact your doctor immediately to receive guidance on the appropriate course of action.
Lifestyle & Tips
- Stay well-hydrated before, during, and after the infusion to help prevent kidney problems and other side effects.
- Report any unusual symptoms immediately to your healthcare provider during or after the infusion.
- Avoid live virus vaccines for several months after receiving Octagam 10% as it may 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 when 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
+ 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
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
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
+ Fast 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, tiredness, or 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, stiff neck, sensitivity to light, fever, nausea, vomiting (signs of aseptic meningitis)
- Sudden swelling, pain, redness, or warmth in an arm or leg (signs of a blood clot)
- Sudden chest pain, shortness of breath, coughing up blood (signs of a blood clot in the lung)
- Sudden weakness or numbness on one side of the body, sudden severe headache, vision changes, slurred speech (signs of a stroke)
- Decreased urination, swelling in legs or feet, unusual tiredness (signs of kidney problems)
- Hives, rash, itching, difficulty breathing, wheezing, dizziness, swelling of face/lips/tongue/throat (signs of a severe allergic reaction)
- Dark urine, yellowing of skin or eyes (signs of hemolysis)
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 contain sorbitol, which may 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. 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, as it is crucial 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
- Acute renal failure
- Thrombotic events
What to Do:
Discontinue infusion immediately. Manage symptoms supportively. May require diuretics for fluid overload. Monitor renal function and coagulation parameters. 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): Antibodies in IVIG may interfere with the immune response to live virus vaccines. Vaccination should be deferred for at least 3 months after IVIG administration. For measles, deferral may be up to 11 months depending on the IVIG dose.
Moderate Interactions
- Loop diuretics: Increased risk of acute renal failure, especially in patients with pre-existing renal impairment or risk factors.
- Nephrotoxic drugs (e.g., aminoglycosides, NSAIDs): Concomitant use may increase the risk of acute renal failure.
- ACE inhibitors/ARBs: Potential for increased risk of renal dysfunction in susceptible patients.
Monitoring
Baseline Monitoring
Rationale: To assess baseline renal status and identify patients at risk for acute renal failure.
Timing: Prior to initiation of therapy
Rationale: To ensure adequate hydration and prevent fluid overload, especially in patients with cardiac or renal compromise.
Timing: Prior to and during infusion
Rationale: To screen for IgA deficiency, which increases the risk of anaphylactic reactions due to anti-IgA antibodies.
Timing: Prior to first infusion (if not previously known)
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 hourly for several hours 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 infusion and for several hours post-infusion.
Target: Absence of symptoms
Action Threshold: Presence of symptoms warrants slowing/stopping infusion and symptomatic treatment.
Frequency: Daily during infusion, then as clinically indicated, especially in at-risk patients.
Target: Within normal limits or patient's baseline
Action Threshold: Increase in creatinine by >0.5 mg/dL or significant percentage increase from baseline warrants investigation and potential discontinuation.
Frequency: Continuously during and after infusion.
Target: Absence of symptoms
Action Threshold: Any new or worsening symptoms warrant immediate medical evaluation.
Frequency: Daily, especially in at-risk patients.
Target: Adequate for hydration status
Action Threshold: Oliguria or anuria warrants immediate investigation.
Symptom Monitoring
- Headache
- Fever
- Chills
- Nausea
- Vomiting
- Flushing
- Rash
- Hives
- Dyspnea
- Chest tightness
- Back pain
- Muscle cramps
- Dizziness
- Signs of thrombosis (e.g., swelling, pain, redness in an extremity; sudden chest pain; shortness of breath; sudden vision changes)
- Signs of renal dysfunction (e.g., decreased urine output, swelling, fatigue)
- Signs of aseptic meningitis (e.g., severe headache, nuchal rigidity, photophobia, fever, nausea, vomiting)
Special Patient Groups
Pregnancy
Category C. Use only if clearly needed and the potential benefits outweigh the potential risks to the fetus. Human IgG is known to cross the placental barrier, particularly during the third trimester.
Trimester-Specific Risks:
Lactation
Human IgG is excreted into breast milk. However, antibodies in breast milk are generally considered beneficial to the infant. Oral absorption of intact IgG by the infant is unlikely. Use is generally considered compatible with breastfeeding, but caution is advised.
Pediatric Use
Dosing is weight-based and indication-specific. Pediatric patients, especially neonates and infants, may be at increased risk for acute renal failure and fluid overload. Use lower concentrations and slower infusion rates. Monitor closely for adverse reactions.
Geriatric Use
Elderly patients (âĨ65 years) are at increased risk for acute renal failure and thrombotic events. Administer at the minimum concentration available and at the slowest infusion rate practicable. Ensure adequate hydration. Monitor renal function and for signs/symptoms of thrombosis closely.
Clinical Information
Clinical Pearls
- Always ensure adequate hydration before, during, and after IVIG infusion to minimize the risk of renal dysfunction and thrombosis.
- Infusion rate should be started slowly and gradually increased if tolerated. Patients at high risk for adverse events (e.g., renal impairment, cardiovascular disease, elderly) should receive the slowest possible infusion rate and lowest concentration.
- Pre-medication with antihistamines, acetaminophen, or corticosteroids may be considered for patients with a history of infusion-related reactions.
- Screen for IgA deficiency before the first infusion. Patients with severe IgA deficiency and known antibodies to IgA are at increased risk of severe hypersensitivity reactions, including anaphylaxis.
- Monitor for signs of aseptic meningitis syndrome (AMS), which can occur hours to days after infusion and typically resolves spontaneously within several days.
- Be vigilant for signs and symptoms of thrombosis, especially in patients with risk factors. Consider prophylactic anticoagulation in high-risk patients if appropriate.
- IVIG can interfere with serological tests (e.g., Coombs test) due to passive transfer of antibodies.
Alternative Therapies
- Corticosteroids (e.g., prednisone, methylprednisolone) for autoimmune conditions like ITP, CIDP.
- Other immunomodulators (e.g., rituximab, azathioprine, mycophenolate mofetil, cyclophosphamide) depending on the specific autoimmune indication.
- Plasma exchange (plasmapheresis) for certain neurological or autoimmune conditions.
- Specific disease-modifying therapies for primary immunodeficiencies (e.g., subcutaneous immune globulin for maintenance therapy).