Octagam 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, as directed by your healthcare provider.
- Report any unusual symptoms immediately during or after the infusion, such as headache, fever, chills, rash, difficulty breathing, chest pain, or swelling/pain in your arms or legs.
- Avoid live virus vaccines (like MMR, chickenpox) for at least 3 months after receiving Octagam, as the antibodies can make the vaccine less effective. Discuss your vaccination schedule with your doctor.
- Follow all instructions regarding infusion rate and duration. Do not adjust the rate yourself.
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
While rare, some people may experience severe and potentially life-threatening side effects when 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 or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Trouble 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
+ Passing out or 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 given intravenously. If you experience any of the following symptoms, contact your doctor right away:
Dry skin, mouth, or eyes
Thirst
Fast heartbeat
Dizziness
Fast breathing
Confusion
Headache
Trouble focusing
Memory problems
Feeling confused
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 contact your doctor or seek medical attention if you experience 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 spasm
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 online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe headache, neck stiffness, sensitivity to light, nausea, vomiting (signs of aseptic meningitis)
- Sudden decrease in urine output, swelling in legs/feet, unusual fatigue (signs of kidney problems)
- Sudden chest pain, shortness of breath, pain/swelling/redness in an arm or leg, vision changes, weakness or numbness on one side of the body (signs of a blood clot)
- Hives, rash, itching, swelling of face/lips/tongue/throat, wheezing, difficulty breathing, dizziness, fainting (signs of a severe allergic reaction)
- Fever, chills, muscle aches, back pain (common infusion-related reactions, but report them)
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 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 inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins. This will help ensure your safety while taking this medication. Never start, stop, or adjust the dosage of any medication without first consulting your doctor to confirm that it is safe to do so.
Precautions & Cautions
Before receiving any vaccines, 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:
- Fluid overload (e.g., shortness of breath, swelling)
- Increased blood viscosity
- Acute renal failure (in susceptible patients)
What to Do:
Discontinue infusion immediately. Manage symptoms supportively. May require diuretics for fluid overload or dialysis for severe renal impairment. 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): Antibodies in IVIG may interfere with the immune response to live virus vaccines. Vaccination should be deferred for at least 3 months after IVIG administration. If vaccination is necessary, antibody titers should be checked after vaccination to ensure adequate immune response.
Moderate Interactions
- Loop diuretics: Concomitant use may increase the risk of acute renal failure, especially in patients with pre-existing renal impairment or risk factors. Monitor renal function closely.
- Nephrotoxic drugs: Increased risk of renal dysfunction when co-administered with other nephrotoxic agents. Monitor renal function.
Monitoring
Baseline Monitoring
Rationale: To identify pre-existing renal impairment and establish baseline for monitoring potential acute renal failure.
Timing: Prior to initiation of therapy
Rationale: To ensure adequate hydration before infusion, reducing risk of renal adverse events.
Timing: Prior to and during infusion
Rationale: To establish baseline and detect immediate infusion-related reactions.
Timing: Prior to infusion
Rationale: To screen for IgA deficiency, which increases risk of anaphylactic reactions in patients with anti-IgA antibodies.
Timing: Prior to first infusion (if not previously known)
Routine Monitoring
Frequency: Every 15-30 minutes during infusion, then hourly for 1 hour post-infusion
Target: Within patient's normal limits
Action Threshold: Significant changes (e.g., hypotension, tachycardia, fever) warrant slowing/stopping infusion and intervention.
Frequency: Continuously during and for several hours post-infusion
Target: Absence of symptoms
Action Threshold: Presence of symptoms warrants slowing/stopping infusion and symptomatic treatment.
Frequency: During and after infusion, especially in at-risk patients
Target: Adequate urine output
Action Threshold: Decreased urine output or signs of fluid overload warrant intervention.
Frequency: Within 24-48 hours post-infusion, especially in at-risk patients (e.g., pre-existing renal impairment, diabetes, elderly, volume depletion, concomitant nephrotoxic drugs)
Target: Within baseline limits
Action Threshold: Significant increase (e.g., >0.5 mg/dL or >50% from baseline) warrants investigation and potential discontinuation.
Frequency: During and for several days/weeks post-infusion
Target: Absence of symptoms
Action Threshold: Presence of symptoms warrants immediate medical evaluation.
Symptom Monitoring
- Headache
- Chills
- Fever
- Nausea
- Vomiting
- Fatigue
- Dizziness
- Rash
- Hives
- Dyspnea
- Chest tightness
- Back pain
- Muscle cramps
- Signs of allergic reaction (wheezing, swelling of face/throat)
- Signs of aseptic meningitis (severe headache, nuchal rigidity, photophobia, fever, nausea, vomiting)
- Signs of renal dysfunction (decreased urine output, swelling, fatigue)
- Signs of thrombosis (pain, swelling, warmth, redness in limb; sudden shortness of breath, chest pain, vision changes, weakness/numbness on one side of body)
Special Patient Groups
Pregnancy
Octagam is classified as 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 course of pregnancy, fetus, or neonate. Use only if clearly needed and potential benefits outweigh potential risks.
Trimester-Specific Risks:
Lactation
Immune globulins are naturally present in human milk. While there are no specific studies on Octagam in lactating women, the transfer of intact antibodies into breast milk is minimal, and absorption by the infant is unlikely. Therefore, breastfeeding is generally considered safe and beneficial for the infant. The developmental and health benefits of breastfeeding should be considered along with the motherβs clinical need for Octagam and any potential adverse effects on the breastfed child from Octagam or from the underlying maternal condition.
Pediatric Use
Dosing is weight-based and indication-specific. Octagam has been studied and approved for use in pediatric patients for various indications (e.g., PI, ITP, CIDP, Kawasaki Disease). Caution should be exercised in neonates and infants due to potential for fluid overload and immature renal function. Monitor vital signs and renal function closely.
Geriatric Use
Use with caution in elderly patients, especially those with pre-existing renal impairment, diabetes mellitus, or cardiovascular disease, due to increased risk of acute renal failure and thrombotic events. Administer at the minimum concentration and infusion rate practicable. Ensure adequate hydration.
Clinical Information
Clinical Pearls
- Always ensure adequate hydration before, during, and after IVIG infusion to minimize the risk of renal adverse events.
- Infuse slowly initially 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., antihistamines, acetaminophen, corticosteroids) may be considered for patients with a history of infusion-related reactions, but is not routinely required for all patients.
- Octagam is sucrose-free, which may be advantageous for patients at risk for sucrose-induced osmotic nephropathy, but renal monitoring is still crucial.
- Patients with IgA deficiency and known anti-IgA antibodies are at increased risk of severe allergic reactions, including anaphylaxis. Octagam contains trace amounts of IgA. These patients should be monitored closely, and alternative treatments considered if severe reactions occur.
- Educate patients about the signs and symptoms of thrombosis and renal dysfunction, and advise them to seek immediate medical attention if these occur.
Alternative Therapies
- Other IVIG products (e.g., Gammagard S/D, Gamunex-C, Privigen, Flebogamma DIF)
- Subcutaneous Immune Globulin (SCIG) products (e.g., Hizentra, Gammaked, Cuvitru, Xembify) for primary immunodeficiency
- Corticosteroids (e.g., prednisone, dexamethasone) for autoimmune conditions like ITP or CIDP
- Immunosuppressants (e.g., azathioprine, mycophenolate mofetil, rituximab) for various autoimmune disorders
- Plasma exchange (plasmapheresis) for certain neurological or autoimmune conditions
Cost & Coverage
General Drug Facts
All medications should be stored in a secure location, out of the reach of children and pets, to prevent accidental ingestion. When disposing of unused or expired medications, do not flush them down the toilet or pour them down the drain unless specifically instructed to do so by a healthcare professional or pharmacist. Instead, consult with your pharmacist to determine the best method for disposal, as some communities have drug take-back programs in place.
Additionally, some medications may come with a separate patient information leaflet; if you have questions, consult with your pharmacist. If you have any concerns or questions about your medication, it is crucial 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 information about the medication taken, the amount, and the time it was taken, as this will aid healthcare professionals in providing appropriate treatment.