Octagam 5% Inj, 5gm/100ml
Overview
What is this medicine?
How to Use This Medicine
To ensure safe and effective use, take this medication exactly as directed by your doctor. Carefully review all accompanying information and follow the instructions provided. This medication is administered as an intravenous infusion, which means it is given through a vein over a specified period of time.
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 promptly to receive guidance on the appropriate course of action.
Lifestyle & Tips
- Stay well-hydrated before, during, and after the infusion to help prevent side effects, especially kidney problems and blood clots.
- Report any unusual symptoms immediately during or after the infusion.
- Avoid live virus vaccines for several months after receiving Octagam, as the antibodies can interfere with the vaccine's effectiveness. Discuss vaccination schedules 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 experience any of the following symptoms, 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 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 or 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 immediately:
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
This medication can cause dehydration and low sodium levels when given intravenously. If you experience any of the following symptoms, seek medical attention immediately:
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 Side Effects
Most people do not experience significant side effects, but some may occur. If you experience any of the following side effects, contact your doctor:
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 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 (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, or coughing up blood (signs of a blood clot in the lung)
- Sudden weakness or numbness on one side of the body, slurred speech, or sudden vision changes (signs of a stroke)
- Decreased urination, swelling in legs or feet, or unusual fatigue (signs of kidney problems)
- Severe allergic reaction symptoms like difficulty breathing, hives, swelling of face/lips/tongue/throat, dizziness.
Before Using This Medicine
It is essential to inform your doctor about the following conditions before starting this medication:
Any allergies you have, including allergies to this drug, its components, or other substances. Be sure to describe the symptoms you experienced.
If you have IgA deficiency or hyperprolinemia (elevated proline levels 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, as some products contain sorbitol. Discuss this with your doctor.
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.
This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues. Verify that it is safe to take this medication with your existing medications 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 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 screened, tested, and treated to minimize the risk of infection, it may still pose a risk 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 most 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, plan to become pregnant, or are breastfeeding, inform your doctor, as it is necessary 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
- Acute renal dysfunction (rare)
What to Do:
Overdose is rare due to the nature of the product. Management is supportive, focusing on managing fluid overload (e.g., diuretics) and monitoring for adverse effects. In severe cases, plasmapheresis may be considered. Call 1-800-222-1222 (Poison Control) for advice.
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. Defer vaccination for at least 3 months after IVIG administration. For measles, defer for up to 11 months.
Moderate Interactions
- Loop diuretics: Increased risk of renal dysfunction, especially in patients with pre-existing renal impairment or risk factors.
- Nephrotoxic drugs: Increased risk of renal dysfunction when co-administered with other nephrotoxic agents.
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 ensure adequate hydration before infusion, which helps prevent renal complications and thrombosis.
Timing: Prior to and during infusion
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 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 limits; report significant changes.
Action Threshold: Significant changes (e.g., hypotension, tachycardia, fever) warrant slowing or stopping infusion and intervention.
Frequency: Continuously during infusion and for several hours post-infusion.
Target: Absence of symptoms.
Action Threshold: Any new or worsening symptom warrants immediate assessment and intervention.
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 patient's normal limits.
Action Threshold: Significant increase in BUN/creatinine warrants investigation and potential discontinuation or dose adjustment.
Frequency: Monitor during and after infusion, especially in at-risk patients.
Target: Adequate urine output.
Action Threshold: Oliguria or anuria.
Symptom Monitoring
- Headache
- Fever
- Chills
- Nausea
- Vomiting
- Fatigue
- Rash
- Hives
- Dyspnea
- Chest tightness
- Back pain
- Flank pain
- Signs of thrombosis (e.g., swelling, pain, redness in limb; sudden chest pain, shortness of breath, slurred speech, weakness on one side of body)
- Signs of acute renal failure (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. Animal reproduction studies have not been conducted. However, immune globulins are known to cross the placental barrier, particularly during the third trimester. Clinical experience with IVIG in pregnant women suggests no harmful effects on the course of pregnancy, the fetus, or the neonate. Use only if clearly needed and the potential benefits outweigh the potential risks.
Trimester-Specific Risks:
Lactation
L3 (Moderately Safe). IgG is naturally present in human milk and is transferred to the infant. Oral absorption of intact IgG is minimal. No adverse effects on the breastfed infant are expected. IVIG is generally considered compatible with breastfeeding.
Pediatric Use
Dosing for pediatric patients is typically weight-based and similar to adults for approved indications (e.g., ITP, PHI, Kawasaki disease). Safety and efficacy have been established in pediatric patients for these indications. Close monitoring for adverse reactions is important, especially for infusion rate and hydration.
Geriatric Use
Use with caution in patients aged 65 years and older, especially those with pre-existing renal impairment, diabetes mellitus, volume depletion, or cardiovascular disease, due to increased risk of acute renal dysfunction and thrombotic events. Ensure adequate hydration and use the minimum dose and infusion rate practicable.
Clinical Information
Clinical Pearls
- Always ensure adequate hydration before, during, and after IVIG infusion to minimize the risk of renal dysfunction and thrombosis.
- Start infusions at a slow rate and gradually increase if tolerated, especially for the first infusion or in patients at risk for adverse reactions.
- 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.
- Screen patients for IgA deficiency before the first infusion. Patients with severe IgA deficiency may be at higher risk of anaphylactic reactions due to anti-IgA antibodies.
- Monitor for signs of aseptic meningitis (severe headache, neck stiffness, photophobia) which can occur hours to days after infusion.
- Be vigilant for signs and symptoms of thrombosis (e.g., DVT, PE, stroke, MI), particularly in at-risk patients. Octagam is sucrose-free, which may reduce renal risk compared to some other IVIG products, but renal monitoring is still crucial.
- IVIG can interfere with serological tests (e.g., Coombs test, blood typing) due to passive transfer of antibodies.
Alternative Therapies
- Other IVIG brands (e.g., Gammagard, Privigen, Flebogamma, Gamunex)
- Subcutaneous Immune Globulin (SCIG) for primary immunodeficiencies (e.g., Hizentra, Cuvitru, Xembify)
- Corticosteroids (e.g., prednisone) for autoimmune conditions like ITP, CIDP
- Other immunosuppressants (e.g., rituximab, azathioprine, mycophenolate mofetil) depending on the specific autoimmune indication
- Splenectomy for refractory ITP