Octagam 10% 2gm/20ml Inj, 20ml
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 your infusion to help prevent side effects like headache and kidney problems.
- Report any unusual symptoms immediately to your healthcare provider during or after the infusion.
- Avoid live vaccines for several months after receiving Octagam 10%. 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, 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
Serious Lung Problems
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
Aseptic Meningitis
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
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
Contact your doctor right away if you experience any of these symptoms.
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, contact your doctor immediately:
Signs of dehydration:
+ Dry skin, mouth, or eyes
+ Thirst
+ Fast heartbeat
+ Dizziness
+ Fast breathing
+ Confusion
Signs of low sodium levels:
+ 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 symptoms, contact your doctor or seek medical attention if they bother you or do not go away:
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 about side effects or want to report any, contact your doctor or the FDA at 1-800-332-1088 or https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe headache, especially with neck stiffness or sensitivity to light (signs of aseptic meningitis)
- Sudden chest pain, shortness of breath, or 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, or vision changes (signs of stroke)
- Decreased urination, swelling in legs or feet, or unusual fatigue (signs of kidney problems)
- Severe allergic reaction symptoms: difficulty breathing, wheezing, hives, swelling of face/lips/tongue, dizziness, fainting.
- Fever, chills, or shaking during or after infusion.
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 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 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 conditions. 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, it may still pose a risk of transmitting viruses.
If you are following a low-sodium or sodium-free diet, discuss this with your doctor, as some formulations of this medication may contain sodium.
For individuals with high blood sugar (diabetes), consult with your doctor to determine the most suitable glucose tests to use.
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 crucial to discuss the potential 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 headache, dizziness, signs of thrombosis)
- Acute renal failure
What to Do:
Discontinue infusion immediately. Manage symptoms supportively. May require diuretics for fluid overload or other interventions for severe adverse events. Call 1-800-222-1222 (Poison Control) or seek emergency medical attention.
Drug Interactions
Major Interactions
- Live virus vaccines (e.g., measles, mumps, rubella, varicella): IVIG may interfere with the immune response to live attenuated virus vaccines. Vaccination should be deferred for at least 3 months after IVIG administration. For measles vaccine, deferral may be up to 11 months depending on the IVIG dose.
- Loop diuretics (e.g., furosemide): Increased risk of renal dysfunction, especially in patients with pre-existing renal impairment or risk factors for acute renal failure. Monitor renal function closely.
Moderate Interactions
- ACE inhibitors: Potential for increased risk of angioedema, though evidence is limited.
- Nephrotoxic drugs: Concurrent use may increase the risk of acute renal failure, especially in susceptible patients. Monitor renal function closely.
Monitoring
Baseline Monitoring
Rationale: To identify pre-existing renal impairment and assess risk for acute renal failure.
Timing: Prior to initiation of therapy.
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.
Rationale: To assess baseline hematologic status, especially for indications like ITP.
Timing: Prior to initiation of therapy.
Rationale: To establish baseline and identify immediate reactions.
Timing: Prior to infusion.
Routine Monitoring
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; stable.
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 during therapy, especially in patients at risk for renal dysfunction (e.g., elderly, pre-existing renal impairment, diabetes, volume depletion, concomitant nephrotoxic drugs).
Target: Within patient's normal limits.
Action Threshold: Significant increase in BUN/creatinine warrants investigation and potential dose/rate adjustment or discontinuation.
Frequency: During and after infusion, especially in patients at risk for renal dysfunction or fluid overload.
Target: Adequate urine output, no signs of fluid overload.
Action Threshold: Oliguria, anuria, or signs of fluid overload (e.g., edema, dyspnea) require intervention.
Symptom Monitoring
- Headache
- Chills
- Fever
- Nausea
- Vomiting
- Fatigue
- Dizziness
- Rash
- Hives
- Flushing
- Chest pain or tightness
- Shortness of breath or difficulty breathing
- Swelling (especially face, lips, tongue, throat)
- Signs of thrombosis (e.g., pain, swelling, warmth, redness in a limb; sudden chest pain, shortness of breath, vision changes, slurred speech)
- Signs of renal dysfunction (e.g., decreased urine output, swelling, fatigue)
- Signs of aseptic meningitis (e.g., severe headache, neck stiffness, photophobia, nausea, vomiting)
Special Patient Groups
Pregnancy
Category C. Animal reproduction studies have not been conducted. It is not known whether Octagam 10% can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Octagam 10% should be given to a pregnant woman only if clearly needed. IgG antibodies are known to cross the placenta, particularly in the third trimester.
Trimester-Specific Risks:
Lactation
Human IgG is excreted into breast milk and may contribute to the transfer of protective antibodies to the neonate. No adverse effects on the breastfed infant are expected. Use is generally considered compatible with breastfeeding.
Pediatric Use
Dosing is weight-based and varies by indication. Infusion rates should be initiated slowly, especially in infants and young children, and carefully titrated. Monitor for adverse reactions, particularly renal function and fluid balance, as pediatric patients may be more susceptible to certain side effects.
Geriatric Use
Use with caution in elderly patients (âĨ65 years) due to 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 and signs of thrombosis closely.
Clinical Information
Clinical Pearls
- Always ensure adequate hydration before, during, and after infusion to minimize the risk of renal dysfunction and other adverse events.
- Infusion rate should be started slowly and gradually increased if tolerated. Patients who have not received IVIG before, or who are switching brands, or who have underlying risk factors (e.g., renal impairment, cardiovascular disease) should receive a slower initial infusion rate.
- Pre-medication (e.g., acetaminophen, antihistamines) 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 10% contains trace amounts of IgA. Screen for IgA deficiency prior to first infusion.
- Monitor for signs and symptoms of thrombosis (e.g., DVT, PE, stroke, MI) and acute renal failure, especially in high-risk patients. These are serious but rare complications.
- Aseptic meningitis syndrome (AMS) is a known but rare side effect, typically occurring within hours to 2 days post-infusion. Symptoms include severe headache, neck stiffness, photophobia, nausea, and vomiting. It is usually reversible upon discontinuation.
- Octagam 10% is sucrose-free, which may be advantageous for patients at risk of renal dysfunction compared to sucrose-stabilized IVIG products.
Alternative Therapies
- Other IVIG products (e.g., Gammagard, Gamunex-C, Privigen, Flebogamma DIF)
- Subcutaneous Immune Globulin (SCIG) products (e.g., Hizentra, Gammaked, Cuvitru, Xembify) for primary immunodeficiency
- For ITP: Corticosteroids, anti-D immunoglobulin, thrombopoietin receptor agonists (e.g., romiplostim, eltrombopag), splenectomy, rituximab.
- For CIDP: Corticosteroids, plasma exchange (PLEX).
- For PIDD: Prophylactic antibiotics, hematopoietic stem cell transplantation (for severe cases).