Octagam 1gm/20ml 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.
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 like kidney problems and blood clots.
- Report any unusual symptoms immediately to your healthcare provider during or after the infusion.
- Avoid live virus vaccines (like MMR or chickenpox) for several months after receiving Octagam, as it can make the vaccine less effective. Discuss your vaccination schedule 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
Acute renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur with immune globulin intravenous (IGIV) products in predisposed patients. Patients at risk include those with any degree of pre-existing renal insufficiency, diabetes mellitus, age >65, volume depletion, sepsis, paraproteinemia, or concomitant nephrotoxic drugs. Administer Octagam at the minimum concentration available and the minimum infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor renal function, including blood urea nitrogen (BUN) and serum creatinine, and urine output in patients at risk.
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 right away:
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 right away:
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 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
+ Confusion
+ Weakness
+ Seizures
+ Changes in balance
Other Possible Side Effects
While many people may not experience any side effects or only minor side effects, it is essential to report any of the following symptoms to your doctor if they bother you or do not go away:
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 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 online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe headache
- Fever or chills during or after infusion
- Nausea or vomiting
- Rash or hives
- Difficulty breathing or wheezing
- Swelling of the face, lips, tongue, or throat (signs of a severe allergic reaction)
- Pain, swelling, warmth, or redness in an arm or leg (signs of a blood clot)
- Sudden numbness or weakness, especially on one side of the body (signs of a stroke)
- Dark urine, decreased urination, or unusual swelling (signs of kidney problems)
- Unusual tiredness or weakness
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, and 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 without consulting your doctor.
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 conditions to ensure safe use. Always verify with your doctor before starting, stopping, or changing the dose of any medication.
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 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 thoroughly screened, tested, and treated to minimize the risk of infection, there is still a possibility of transmitting viruses that can cause disease. Discuss this risk 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 you 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, plan to become pregnant, or are breastfeeding, inform your doctor, as it is necessary to weigh the 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)
- Acute renal dysfunction
What to Do:
In case of suspected overdose, seek immediate medical attention. Management is supportive and may include slowing or stopping the infusion, monitoring vital signs, fluid balance, and renal function. In severe cases, plasmapheresis may be considered. Call 911 or your local emergency number. For poison control, call 1-800-222-1222.
Drug Interactions
Contraindicated Interactions
- Live virus vaccines (e.g., measles, mumps, rubella, varicella) - due to potential interference with vaccine efficacy. Delay vaccination for at least 3 months (up to 1 year for measles) after IVIG administration.
Major Interactions
- Live virus vaccines (e.g., measles, mumps, rubella, varicella)
Moderate Interactions
- Loop diuretics (e.g., furosemide) - increased risk of acute renal dysfunction, especially in predisposed patients.
- Nephrotoxic drugs (e.g., aminoglycosides, NSAIDs) - increased risk of acute renal dysfunction when co-administered with IVIG, particularly in patients with risk factors.
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 establish baseline and monitor for infusion-related reactions.
Timing: Prior to infusion.
Rationale: To screen for IgA deficiency, which increases the risk of anaphylactic reactions in patients with antibodies to IgA.
Timing: Prior to first infusion, or if not previously known.
Rationale: Adequate hydration is crucial to prevent renal dysfunction and thrombosis.
Timing: Prior to and during infusion.
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; report significant changes.
Action Threshold: Significant changes (e.g., hypotension, tachycardia, fever) warrant temporary cessation or slowing of infusion and assessment.
Frequency: Monitor during and after infusion, especially in at-risk patients.
Target: Adequate urine output.
Action Threshold: Decreased urine output or oliguria warrants immediate assessment of renal function and hydration.
Frequency: Continuously during and for several hours after infusion.
Target: Absence of symptoms.
Action Threshold: Presence of symptoms warrants slowing or stopping infusion and appropriate medical intervention.
Frequency: Periodically during therapy, especially in patients with risk factors for renal dysfunction.
Target: Within normal limits or stable for patient's baseline.
Action Threshold: Significant increase warrants dose adjustment, hydration optimization, or discontinuation.
Symptom Monitoring
- Headache
- Chills
- Fever
- Nausea
- Vomiting
- Rash
- Hives
- Chest pain
- Shortness of breath (dyspnea)
- Wheezing
- Swelling of face, lips, tongue, or throat (signs of anaphylaxis)
- Pain, swelling, warmth, or redness in an arm or leg (signs of thrombosis)
- Sudden numbness or weakness on one side of the body (signs of stroke)
- Sudden severe headache
- Changes in vision
- Dark urine
- Decreased urine output
- Unusual tiredness or weakness
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) where the benefits outweigh potential risks.
Trimester-Specific Risks:
Lactation
L3 (Moderately Safe). 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 and any potential adverse effects on the breastfed infant from Octagam or the underlying maternal condition.
Pediatric Use
Dosing is weight-based and indication-specific. Safety and efficacy have been established for various pediatric indications (e.g., PI, ITP, Kawasaki disease). Infusion rates should be carefully monitored, especially in younger children and those with underlying cardiac or renal conditions, to minimize the risk of adverse reactions.
Geriatric Use
Patients >65 years of age are at increased risk for acute renal dysfunction and thrombotic events. Administer at the minimum dose and infusion rate practicable. Ensure adequate hydration. Monitor renal function and for signs/symptoms of thrombosis closely.
Clinical Information
Clinical Pearls
- Always ensure adequate hydration before, during, and after infusion to minimize the risk of renal dysfunction and thrombosis.
- Start infusion 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., antihistamines, acetaminophen) may be considered for patients with a history of infusion-related reactions.
- Screen patients for IgA deficiency prior to the first infusion. Patients with severe IgA deficiency and antibodies to IgA are at increased risk of anaphylaxis.
- Monitor vital signs closely throughout the infusion and for a period afterward.
- Be vigilant for signs of thrombosis (e.g., localized pain, swelling, neurological deficits) and renal dysfunction (e.g., decreased urine output, elevated creatinine).
- Educate patients about the importance of reporting any adverse symptoms promptly.
Alternative Therapies
- Other IVIG products (different brands/manufacturers)
- Subcutaneous Immune Globulin (SCIG) for primary immunodeficiencies
- Corticosteroids (e.g., prednisone) for autoimmune conditions like ITP, CIDP
- Other immunosuppressants (e.g., rituximab, azathioprine, mycophenolate mofetil) for autoimmune conditions
- Plasma exchange (plasmapheresis) for certain neurological conditions (e.g., GBS, CIDP)
Cost & Coverage
General Drug Facts
Proper disposal of unused or expired medications is crucial. Do not dispose of them by flushing down the toilet or pouring down the drain unless specifically instructed to do so. If you are unsure about the best disposal method, consult your pharmacist for guidance. Many communities have drug take-back programs, which your pharmacist can help you locate.
Some medications may come with an additional patient information leaflet, so it is a good idea to check with your pharmacist. 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 medical attention. Be prepared to provide information about the medication taken, the amount, and the time it was taken, as this will help healthcare professionals provide appropriate care.