Octagam 10% 30mg/300ml Inj, 300ml
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, especially kidney problems.
- Report any unusual symptoms immediately to your healthcare provider during or after the infusion.
- Discuss any planned vaccinations with your doctor, as this medication can affect the effectiveness of live virus vaccines.
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 immediately or seek emergency medical attention:
Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness or 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 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, 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
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 administered intravenously. If you experience any of the following symptoms, contact your doctor 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
While many people may not experience any side effects or only minor ones, it is essential to contact your doctor if you notice any of the following:
Irritation at the injection site
Dizziness, tiredness, or weakness
Headache
Upset stomach or vomiting
Stomach pain or diarrhea
Back pain
Muscle spasms
Signs of a common cold
Flushing
Cramps
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 https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe headache, stiff neck, sensitivity to light, nausea, vomiting (signs of aseptic meningitis)
- Sudden chest pain, shortness of breath, pain or swelling in an arm or leg, numbness or weakness on one side of the body (signs of blood clot)
- Decreased urination, swelling in legs or feet, unusual tiredness (signs of kidney problems)
- Hives, rash, itching, swelling of the face/lips/tongue, difficulty breathing, dizziness, fainting (signs of allergic reaction)
- Fever, chills, body aches, fatigue (common infusion-related reactions, but report if severe or persistent)
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, a type of sugar. Some products containing this medication may have sorbitol, which can be problematic for individuals with this condition.
For Parents or Caregivers of Infants and Babies:
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 Considerations:
This medication may interact with other drugs or health conditions. Therefore, it is crucial to provide your doctor and pharmacist with a comprehensive list of:
+ All prescription and over-the-counter medications you are taking.
+ Any natural products, vitamins, or supplements you are using.
+ Your existing health problems.
* Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to ensure your safety.
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 taken with this drug.
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 taking 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
- Acute renal dysfunction
- Increased risk of thrombosis
What to Do:
In case of suspected overdose, stop the infusion immediately. Management is supportive, focusing on maintaining hydration, monitoring vital signs, renal function, and managing any adverse reactions. 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): IVIG may impair the immune response to these vaccines. Vaccination should be deferred for at least 3 months (up to 11 months for some vaccines) after IVIG administration.
Moderate Interactions
- Loop diuretics: Increased risk of acute renal failure when co-administered with IVIG, especially in patients with pre-existing renal impairment.
- Nephrotoxic drugs: Increased risk of renal dysfunction when co-administered with IVIG, particularly in susceptible patients.
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 ensure adequate hydration before, during, and after infusion to minimize risk of renal adverse events.
Timing: Prior to and throughout infusion.
Rationale: To identify patients with selective IgA deficiency who 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 in patients with ITP or other hematologic conditions.
Timing: Prior to initiation of therapy.
Routine Monitoring
Frequency: Before, during (every 15-30 minutes for the first hour, then periodically), and after 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 assessing for adverse reaction.
Frequency: Continuously during and for several hours after infusion.
Target: Absence of symptoms.
Action Threshold: Any new or worsening symptom warrants slowing or stopping infusion and appropriate management.
Frequency: During and for several days after infusion, especially in at-risk patients.
Target: Normal urine output.
Action Threshold: Decreased urine output or signs of fluid overload/renal impairment.
Frequency: During and for several days after infusion, especially in at-risk patients.
Target: Absence of symptoms.
Action Threshold: Any new or worsening symptom suggestive of thrombosis.
Symptom Monitoring
- Headache
- Chills
- Fever
- Nausea
- Vomiting
- Fatigue
- Dizziness
- Rash
- Hives
- Dyspnea
- Chest pain
- Back pain
- Muscle cramps
- Joint pain
- Signs of allergic reaction (e.g., swelling of face/throat, difficulty breathing)
- Signs of acute renal failure (e.g., decreased urine output, swelling)
- Signs of thrombosis (e.g., pain, swelling, warmth in limb; sudden chest pain, shortness of breath; sudden neurological changes)
- 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. IVIG is known to cross the placental barrier, particularly in the third trimester. It is generally considered safe for use in pregnancy when clinically indicated, as IgG is a natural component of human plasma and provides passive immunity to the fetus. Use only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
Lactation
L3 (Moderately safe). IgG is naturally present in breast milk and provides passive immunity to the infant. Oral absorption of intact IgG by the infant is minimal. No adverse effects on breastfed infants have been reported. Considered compatible with breastfeeding.
Pediatric Use
Dosing is weight-based and indication-specific. Infusion rates should be carefully controlled, especially in neonates and infants, due to potential for fluid overload and renal immaturity. Close monitoring for adverse reactions is crucial.
Geriatric Use
Use with caution. Elderly patients are at increased risk for acute renal failure, thrombosis, and fluid overload due to age-related decline in renal function, pre-existing cardiovascular disease, and other comorbidities. Administer at the minimum dose and infusion rate practicable, ensuring adequate hydration and close monitoring of renal function and fluid status.
Clinical Information
Clinical Pearls
- Always ensure adequate hydration before, during, and after IVIG infusion to minimize the risk of renal adverse events and thrombosis.
- Start infusions slowly and gradually increase the rate if tolerated, especially for the first infusion or in patients at high risk for adverse reactions.
- Pre-medication (e.g., acetaminophen, antihistamines, corticosteroids) may be considered for patients with a history of infusion-related reactions.
- Monitor vital signs frequently, particularly during the initial phase of infusion.
- Patients with selective IgA deficiency are at higher risk for anaphylactic reactions due to anti-IgA antibodies; consider IgA-depleted products if available and necessary.
- Be vigilant for signs of thrombosis (e.g., headache, neurological symptoms, chest pain, limb pain/swelling) and acute renal failure (e.g., decreased urine output) for several days post-infusion.
- Inform patients about the potential interference with live virus vaccines and advise them to discuss vaccination schedules with their healthcare provider.
Alternative Therapies
- Subcutaneous Immune Globulin (SCIG) for primary immunodeficiency (e.g., Hizentra, Gammaked, Cuvitru, Xembify)
- Corticosteroids (e.g., prednisone) for autoimmune conditions like ITP or CIDP
- Other immunosuppressants (e.g., azathioprine, mycophenolate mofetil, rituximab) depending on the specific autoimmune indication
- Plasma exchange (plasmapheresis) for certain acute neurological or autoimmune conditions