Octagam 5% 5gm/100ml 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.
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 kidney problems and other side effects.
- Report any unusual symptoms immediately during or after the infusion.
- Avoid live virus vaccines for several months after receiving Octagam 5% as it may 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 immediate medical attention:
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 immediately:
Trouble breathing
Shortness of breath
New or worsening cough
Additionally, this medication may increase the risk of aseptic meningitis, a severe brain problem. Seek medical help right away if you experience:
Headache
Fever
Chills
Severe 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. Contact your doctor immediately if you experience:
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
+ Confusion
+ Weakness
+ Seizures
+ Changes in balance
Other Side Effects
While many people do not experience side effects or only have minor ones, it is essential to report any concerns to your doctor. Other possible side effects include:
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 side effects that bother you or do not go away, contact your doctor for medical advice. 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 (signs of aseptic meningitis syndrome)
- Sudden chest pain, shortness of breath, pain/swelling/redness in an arm or leg (signs of blood clot)
- Decreased urine output, swelling in legs/ankles (signs of kidney problems)
- Severe allergic reaction (e.g., difficulty breathing, hives, swelling of face/lips/tongue, dizziness)
- Fever, chills, nausea, vomiting, muscle aches (common infusion-related reactions, usually mild but report if severe)
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, such as foods or medications. Be sure to describe the symptoms you experienced.
If you have IgA deficiency, a condition where your body does not produce enough immunoglobulin A (IgA), an antibody that plays a key role in your immune system.
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 may contain sorbitol, which can be problematic for individuals with 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 Important Information:
This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. Your healthcare team will assess potential interactions between this medication and your other medications or health conditions to ensure safe treatment. Never start, stop, or modify 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.
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.
If you have diabetes (high blood sugar), consult with your doctor to determine the most suitable glucose tests 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, 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)
- Hyperviscosity (e.g., headache, dizziness, visual disturbances, stroke-like symptoms)
- Acute renal dysfunction
What to Do:
Discontinue infusion immediately. Manage symptoms supportively. May require diuretics for fluid overload. 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): May interfere with the immune response to live attenuated virus vaccines. Defer vaccination for at least 3 months after IVIG administration. For measles vaccine, defer for up to 11 months depending on IVIG dose.
Moderate Interactions
- Loop diuretics: Increased risk of acute renal failure, especially in patients with pre-existing renal impairment or risk factors for renal dysfunction. Monitor renal function closely.
- Nephrotoxic drugs: Concurrent use may increase the risk of acute renal failure. Monitor renal function closely.
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 assess risk of fluid overload, especially in patients with cardiac or renal impairment.
Timing: Prior to and during 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 for indications like ITP.
Timing: Prior to initiation of therapy.
Rationale: To establish baseline and monitor for infusion-related reactions.
Timing: Prior to and during infusion.
Routine Monitoring
Frequency: Every 15-30 minutes during infusion, then periodically post-infusion.
Target: Within patient's normal limits; stable.
Action Threshold: Significant changes (e.g., hypotension, tachycardia, fever) warrant temporary cessation or slowing of infusion and assessment.
Frequency: Continuously during and for several hours post-infusion.
Target: Absence of symptoms.
Action Threshold: Presence of symptoms warrants slowing or stopping infusion, and appropriate management (e.g., pre-medication, symptomatic treatment).
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: Stable or within acceptable limits.
Action Threshold: Significant increase in creatinine warrants investigation, potential dose adjustment, or discontinuation.
Frequency: Continuously during and for several days to weeks post-infusion.
Target: Absence of symptoms.
Action Threshold: Suspicion of thrombosis warrants immediate medical evaluation.
Symptom Monitoring
- Headache
- Fever
- Chills
- Nausea
- Vomiting
- Rash
- Hives
- Dyspnea
- Chest tightness
- Back pain
- Flushing
- Dizziness
- Signs of thrombosis (e.g., swelling, pain, redness in limb; sudden shortness of breath, chest pain, vision changes)
- Signs of acute renal dysfunction (e.g., decreased urine output, swelling)
Special Patient Groups
Pregnancy
Category C. Animal reproduction studies have not been conducted. However, immune globulins are known to cross the placental barrier, particularly in the third trimester. Clinical experience with IVIG in pregnant women suggests no adverse effects on the fetus. Use only if clearly needed and potential benefits outweigh risks.
Trimester-Specific Risks:
Lactation
L1 - Safest. Immune globulins are naturally present in breast milk and are considered compatible with breastfeeding. No adverse effects on the breastfed infant are expected.
Pediatric Use
Dosing is weight-based and indication-specific. Infusion rates should be carefully monitored, especially in infants and young children, due to potential for fluid overload and renal considerations. Safety and efficacy in pediatric patients are established for approved indications.
Geriatric Use
Use with caution in patients >65 years of age due to increased risk of acute renal dysfunction and thrombotic events. Ensure adequate hydration and monitor renal function closely. Consider slower infusion rates.
Clinical Information
Clinical Pearls
- Always ensure adequate hydration before, during, and after infusion to minimize the risk of renal dysfunction and thrombosis.
- Start infusion slowly and gradually increase rate if tolerated, especially for the first infusion or in patients at risk for adverse reactions.
- Pre-medication (e.g., acetaminophen, antihistamines, corticosteroids) may be considered for patients with a history of infusion-related reactions.
- Test for IgA deficiency prior to first infusion. Patients with selective IgA deficiency and known anti-IgA antibodies are at increased risk of severe allergic reactions, including anaphylaxis.
- Monitor vital signs closely throughout the infusion and for a period afterward.
- Be vigilant for signs and symptoms of thrombosis (e.g., DVT, PE, stroke, MI) and acute renal dysfunction, especially in at-risk patients.
- Octagam 5% has a lower osmolarity compared to 10% solutions, which may be advantageous for patients at risk of renal impairment or fluid overload, but vigilance is still required.
Alternative Therapies
- Other intravenous immune globulin (IVIG) products (e.g., Gammagard S/D, Gamunex-C, Privigen, Flebogamma DIF, Bivigam, Asceniv, Panzyga)
- Subcutaneous immune globulin (SCIG) products (e.g., Hizentra, Cuvitru, Xembify, Gamunex-C/Gammagard S/D for subcutaneous use) for primary immunodeficiency.
- For specific indications, other immunosuppressants or immunomodulators may be alternatives (e.g., corticosteroids, rituximab, thrombopoietin receptor agonists for ITP).