Octagam 5% 10gm/200ml 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 kidney problems and other side effects.
- Report any unusual symptoms immediately to your healthcare provider during or after the infusion.
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 when 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
+ 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, seek medical attention immediately:
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, seek medical attention immediately:
Headache
Fever
Chills
Nausea or vomiting
Stiff neck
Rash
Sensitivity to light
Feeling sleepy or confused
Other Potential Side Effects
Some patients, especially those receiving immune globulin therapy for the first time or who have not had it within the past 8 weeks, may be at risk for certain side effects, including:
Fever
Chills
Nausea
Vomiting
This may also occur in people who switch brands of immune globulin. If you experience any of these side effects, inform your doctor right away.
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, seek medical attention immediately:
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 Side Effects
Most people do not experience severe side effects, but some may occur. If you experience any of the following side effects, inform your doctor:
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 experience any side effects, inform 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, stiff neck, sensitivity to light, nausea, vomiting (signs of aseptic meningitis)
- Sudden pain, swelling, warmth, or redness in an arm or leg (signs of a blood clot)
- Sudden shortness of breath, chest pain, coughing up blood (signs of a blood clot in the lung)
- Sudden numbness or weakness on one side of the body, sudden severe headache, vision changes, slurred speech (signs of a stroke)
- Decreased urination, swelling in legs or feet, unusual tiredness (signs of kidney problems)
- Hives, rash, itching, difficulty breathing, wheezing, dizziness, fainting (signs of an allergic reaction)
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 lacks a specific type of 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 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 discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. This will help ensure your safety while taking this medication. Never start, stop, or adjust the dose of any medication without first consulting your doctor.
Precautions & Cautions
Before receiving any vaccinations, consult with your doctor, as the use of certain vaccines with this medication may increase the risk of infection or reduce the vaccine's effectiveness.
Regular blood tests and other laboratory evaluations should be performed as directed by your doctor. Additionally, this medication may interfere with certain lab tests, so it is crucial to notify all your healthcare providers and laboratory personnel that you are taking this drug.
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.
For individuals with high blood sugar (diabetes), it is essential to discuss with your doctor which glucose tests are most suitable for you 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 necessary 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, visual disturbances, or stroke-like symptoms
- Fluid overload (e.g., shortness of breath, swelling)
- Acute renal dysfunction
What to Do:
In case of suspected overdose, discontinue the infusion immediately. Management is supportive, focusing on maintaining hydration, monitoring vital signs, renal function, and blood viscosity. 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 these vaccines. Vaccination should be deferred for at least 3 months after IVIG administration. For measles, deferral may be up to 11 months depending on the IVIG dose.
Moderate Interactions
- Loop diuretics: Increased risk of acute renal dysfunction, especially in patients with pre-existing renal impairment or risk factors.
- Nephrotoxic drugs: Concomitant use may increase the risk of acute renal failure.
Monitoring
Baseline Monitoring
Rationale: To assess baseline kidney function and identify patients at risk for acute renal failure.
Timing: Prior to initiation of therapy
Rationale: To ensure adequate hydration, which is crucial to minimize renal risk.
Timing: Prior to and during infusion
Rationale: To identify patients with selective IgA deficiency who are at increased risk of developing anti-IgA antibodies and severe anaphylactic reactions.
Timing: Prior to first infusion
Rationale: To assess baseline hematologic status, especially in conditions like ITP.
Timing: Prior to initiation of therapy
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
Action Threshold: Significant changes (e.g., hypotension, tachycardia, fever) warrant slowing or stopping infusion and assessment.
Frequency: Continuously during and immediately after infusion
Target: Absence of symptoms
Action Threshold: Presence of symptoms warrants slowing or stopping infusion and appropriate management.
Frequency: Periodically, especially in patients with risk factors for renal dysfunction (e.g., elderly, pre-existing renal impairment, diabetes, volume depletion)
Target: Within patient's normal limits or stable
Action Threshold: Significant increase in creatinine (>0.5 mg/dL or >50% from baseline) warrants immediate investigation and consideration of stopping IVIG.
Frequency: During and after infusion, especially in at-risk patients
Target: Adequate
Action Threshold: Oliguria or anuria
Symptom Monitoring
- Headache
- Fever
- Chills
- Nausea
- Vomiting
- Rash
- Hives
- Dyspnea
- Chest tightness
- Back pain
- Muscle cramps
- Dizziness
- Fatigue
- Signs of thrombosis (e.g., pain, swelling, discoloration of limb, shortness of breath, chest pain, neurological deficits)
- Signs of aseptic meningitis (e.g., severe headache, nuchal rigidity, photophobia, fever, nausea, vomiting)
- Signs of acute renal failure (e.g., decreased urine output, swelling, fatigue)
Special Patient Groups
Pregnancy
Category C. Octagam 5% should be given to a pregnant woman only if clearly needed. Human IgG is known to cross the placental barrier, particularly during the third trimester. Clinical experience with IVIG in pregnant women suggests no adverse effects on the course of pregnancy, fetus, or neonate.
Trimester-Specific Risks:
Lactation
L2 (Likely Compatible). Human IgG is excreted into breast milk. The effects of orally ingested immunoglobulin on the breast-fed infant have not been evaluated. However, immunoglobulins are proteins and are likely to be digested in the infant's gastrointestinal tract. Benefits of breastfeeding should be weighed against the potential risks.
Pediatric Use
Dosing is weight-based and indication-specific. Neonates and infants may be at increased risk for acute renal failure and should receive IVIG at the minimum concentration available and the slowest infusion rate practicable. Close monitoring of renal function and fluid status is essential.
Geriatric Use
Patients >65 years of age are at increased risk for acute renal failure and thrombotic events. Administer at the minimum dose and infusion rate practicable. Ensure adequate hydration. Monitor renal function and for signs/symptoms of thrombosis.
Clinical Information
Clinical Pearls
- Always ensure adequate hydration before, during, and after IVIG infusion to minimize the risk of acute renal failure.
- Start infusions at a slow rate and gradually increase if tolerated, especially in patients at high risk for adverse reactions (e.g., first-time users, those with IgA deficiency, renal impairment, or cardiovascular disease).
- Pre-medication (e.g., acetaminophen, antihistamines, corticosteroids) may be considered for patients with a history of infusion-related reactions, but is not routinely required for all patients.
- Monitor vital signs closely throughout the infusion. Headache, chills, and fever are common infusion-related reactions; slowing the infusion rate often helps manage these.
- Be vigilant for signs of serious adverse events such as thrombosis, acute renal failure, aseptic meningitis, and hemolytic anemia.
- Patients with selective IgA deficiency with known antibodies to IgA are at increased risk of severe hypersensitivity reactions, including anaphylaxis. Octagam 5% contains trace amounts of IgA.
Alternative Therapies
- Other IVIG products (e.g., Gammagard S/D, Gamunex-C, Privigen, Flebogamma DIF)
- Subcutaneous Immune Globulin (SCIG) products (e.g., Hizentra, Cuvitru, Xembify) for primary immunodeficiency
- Corticosteroids (e.g., prednisone) for autoimmune conditions like ITP or CIDP
- Other immunosuppressants or immunomodulators depending on the specific indication (e.g., rituximab, azathioprine, cyclophosphamide, plasma exchange)