Octagam 20grams Inj, 200ml
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.
If 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 side effects like headache and kidney problems.
- Report any unusual symptoms immediately during or after the infusion.
- Avoid live virus vaccines for several months after receiving Octagam, as the antibodies can make the vaccine less effective. 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 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
Feeling sleepy or confused
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
+ Fast breathing
+ Confusion
Signs of low sodium levels, such as:
+ Headache
+ Trouble focusing
+ Memory problems
+ Feeling confused
+ 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, especially with neck stiffness or sensitivity to light (signs of aseptic meningitis)
- Sudden chest pain, shortness of breath, or pain/swelling in an arm or leg (signs of a blood clot)
- Decreased urination, swelling in legs or feet, unusual fatigue (signs of kidney problems)
- Severe allergic reaction symptoms: difficulty breathing, hives, swelling of face/lips/tongue/throat
- Fever, chills, nausea, vomiting, dizziness, or severe back pain during or shortly 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 with the allergy.
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 products containing this medication may have sorbitol, which can be problematic if you have this condition.
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 the use of certain vaccines in combination with this medication may increase the risk of infection or reduce the vaccine's effectiveness.
Regularly undergo blood tests and other laboratory examinations as directed by your doctor. This medication may interfere with the results of certain lab tests, so it is crucial to notify all your healthcare providers and laboratory personnel that you are taking this medication.
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. 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.
If you have diabetes (high blood sugar), 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, plan to become pregnant, or are breastfeeding, inform your doctor, as you will need to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Hyperviscosity (thickening of blood) leading to symptoms like headache, dizziness, confusion, visual disturbances, or stroke-like symptoms
- Fluid overload (e.g., shortness of breath, swelling)
- Acute renal failure
What to Do:
In case of suspected overdose, seek immediate medical attention. Call 911 or your local emergency number. Management is supportive, focusing on maintaining hydration, monitoring vital signs, and addressing specific symptoms. In severe cases of hyperviscosity, plasmapheresis may be considered. Call 1-800-222-1222 for Poison Control.
Drug Interactions
Major Interactions
- Live virus vaccines (e.g., measles, mumps, rubella, varicella): IVIG can interfere with the immune response to these vaccines. Vaccination should be delayed for at least 3 months, and up to 1 year for measles, after IVIG administration.
Moderate Interactions
- Loop diuretics: Increased risk of acute renal failure, especially with sucrose-containing IVIG products (Octagam is sucrose-free, but caution still advised in susceptible patients).
- 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 higher risk for acute renal failure.
Timing: Prior to initiation of therapy.
Rationale: To screen for IgA deficient patients who may develop anti-IgA antibodies and be at risk for severe anaphylactic reactions.
Timing: Prior to first infusion.
Rationale: To assess baseline hematologic status, especially in ITP patients.
Timing: Prior to initiation of therapy.
Rationale: To establish baseline and identify potential contraindications or risks.
Timing: Immediately prior to infusion.
Routine Monitoring
Frequency: Every 15-30 minutes during infusion, then hourly for 1 hour post-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: Presence of symptoms warrants slowing/stopping infusion and appropriate management.
Frequency: During and after infusion, especially in patients at risk for renal dysfunction or fluid overload.
Target: Adequate urine output, no signs of fluid retention.
Action Threshold: Decreased urine output or signs of fluid overload (e.g., dyspnea, edema) require immediate assessment.
Frequency: Periodically, especially in patients at risk for renal dysfunction (e.g., elderly, pre-existing renal impairment, diabetes, volume depletion, concomitant nephrotoxic drugs).
Target: Within baseline limits.
Action Threshold: Significant increase warrants investigation and potential discontinuation.
Symptom Monitoring
- Headache
- Fever
- Chills
- Nausea
- Vomiting
- Rash
- Flushing
- Dizziness
- Fatigue
- Muscle cramps
- Back pain
- Chest pain
- Dyspnea
- Signs of thrombosis (e.g., pain, swelling, discoloration of limb, sudden shortness of breath, chest pain, neurological deficits)
- Signs of acute renal failure (e.g., decreased urine output, edema, 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. 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. However, IVIG is often used in pregnancy for certain autoimmune conditions (e.g., ITP, recurrent pregnancy loss) and is generally considered relatively safe.
Trimester-Specific Risks:
Lactation
L2 (Safer). 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. Consider the benefits of breastfeeding along with the mother's clinical need for Octagam.
Pediatric Use
Dosing for PI, ITP, and CIDP is weight-based and similar to adults. Use with caution in neonates and infants due to potential for renal dysfunction and thrombosis, especially with higher concentrations or rapid infusion rates. Ensure adequate hydration.
Geriatric Use
Use with caution due to increased risk of thrombosis and acute renal failure. Ensure adequate hydration. Administer at the minimum dose and infusion rate practicable. Monitor renal function closely. Patients over 65 years of age are at higher risk for thrombotic events.
Clinical Information
Clinical Pearls
- Always ensure adequate hydration before, during, and after IVIG infusion to minimize the risk of renal dysfunction and headache.
- Infuse slowly initially, especially for the first infusion or in patients at high risk for adverse reactions, and gradually increase the rate if tolerated.
- Pre-medication (e.g., acetaminophen, antihistamines, corticosteroids) may be considered for patients with a history of infusion-related reactions.
- Monitor vital signs frequently during the infusion, particularly during the first hour.
- Be vigilant for signs of thrombosis (e.g., stroke, MI, DVT, PE) and acute renal failure, especially in high-risk patients.
- Octagam is sucrose-free, which may reduce the risk of osmotic nephrosis compared to sucrose-containing IVIG products, but renal dysfunction can still occur.
- Patients with selective IgA deficiency with known antibodies to IgA are at increased risk of severe hypersensitivity reactions, including anaphylaxis. Octagam contains trace amounts of IgA.
Alternative Therapies
- Other Immune Globulin Intravenous (IVIG) brands (e.g., Gammagard, Privigen, Flebogamma, Gamunex-C, Panzyga, Asceniv)
- Subcutaneous Immune Globulin (SCIG) for PI (e.g., Hizentra, Cuvitru, Xembify, HyQvia)
- Immunosuppressants (e.g., corticosteroids, rituximab, azathioprine, mycophenolate mofetil) for autoimmune conditions where IVIG is used.
- Splenectomy (for refractory ITP)
Cost & Coverage
General Drug Facts
Store all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion. Proper disposal of unused or expired medications is crucial. Unless instructed otherwise by a healthcare professional or pharmacist, do not dispose of medications by flushing them down the toilet or pouring them down the drain. Instead, consult with your pharmacist to determine the best disposal method, as some communities may have designated drug take-back programs.
Some medications may come with an additional patient information leaflet, so it is a good idea to check with your pharmacist for more information. If you have any questions or concerns about your medication, do not hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediately contact 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.