Bivigam 10% Inj, 50ml
Overview
What is this medicine?
How to Use This Medicine
To use this medication correctly, follow your doctor's instructions and read all the information provided. It is essential to follow the dosage instructions carefully. This medication is administered as an infusion into a vein over a specified period.
Storing and Disposing of Your Medication
If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the proper storage procedure.
Missing a Dose
If you miss a dose, contact your doctor immediately to receive guidance on what to do next.
Lifestyle & Tips
- Stay well-hydrated before, during, and after your infusion, as directed by your healthcare provider. This helps reduce the risk of kidney problems.
- Report any new or worsening symptoms immediately to your healthcare provider, especially headache, fever, chills, rash, shortness of breath, chest pain, or swelling/pain in your arms or legs.
- Avoid live virus vaccines (like MMR, chickenpox) for several months after receiving Bivigam, as it can make the vaccine less effective. Discuss your vaccination schedule with your doctor.
- Inform all healthcare providers that you are receiving Bivigam, especially before any surgeries or procedures.
Available Forms & Alternatives
Available Strengths:
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 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
If you are receiving this medication intravenously, you may be at risk for dehydration and low sodium levels. If you experience any of the following symptoms, seek medical attention right away:
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 Possible Side Effects
While many people do not experience side effects or only experience mild side effects, some people may experience:
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
If you experience any of these side effects or any other side effects that bother you or do not go away, 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, neck stiffness, sensitivity to light, fever, nausea, vomiting (signs of aseptic meningitis)
- Sudden chest pain, shortness of breath, pain/swelling/redness in an arm or leg (signs of a blood clot)
- Decreased urination, swelling in legs or feet, sudden weight gain (signs of kidney problems)
- Severe allergic reaction (hives, difficulty breathing, swelling of face/lips/tongue/throat)
- Dark urine, yellowing of skin or eyes (signs of red blood cell breakdown)
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 contain sorbitol, which may 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 Precautions:
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 dosage of any medication without first 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, discuss this with your doctor. It is also important to note that this medication is derived from human plasma and may potentially contain viruses that can cause disease. Although the medication is thoroughly screened, tested, and treated to minimize the risk of infection, you should still 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. Furthermore, if you have diabetes (high blood sugar), discuss with your doctor which glucose tests are 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, 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 dysfunction
- Thrombotic events
What to Do:
In case of suspected overdose, discontinue the infusion immediately. Management is supportive and symptomatic. Monitor vital signs, renal function, and fluid balance closely. Call 911 or your local emergency number. For specific guidance, contact a poison control center (e.g., 1-800-222-1222 in the US).
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, and up to 1 year depending on the IVIG dose and vaccine type.
Moderate Interactions
- Loop diuretics: Increased risk of renal dysfunction when co-administered with IVIG, especially in patients with pre-existing renal impairment or risk factors.
- Nephrotoxic drugs: Increased risk of renal dysfunction when co-administered with IVIG, especially in patients with pre-existing renal impairment or risk factors.
Monitoring
Baseline Monitoring
Rationale: To assess baseline kidney function and identify patients at increased risk for acute renal dysfunction.
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: For patients with Primary Immunodeficiency, to ensure adequate therapeutic levels are maintained.
Timing: Prior to subsequent infusions (trough levels).
Rationale: To establish baseline and monitor for immediate infusion-related reactions.
Timing: Prior to infusion.
Routine Monitoring
Frequency: Every 15-30 minutes during infusion, then periodically post-infusion.
Target: Within patient's normal range.
Action Threshold: Significant changes (e.g., hypotension, tachycardia, fever) warrant slowing/stopping infusion and intervention.
Frequency: Continuously during and for several hours after infusion.
Target: Absence of symptoms.
Action Threshold: Presence of symptoms warrants slowing/stopping infusion and intervention.
Frequency: Monitor during and after infusion, especially in at-risk patients.
Target: Adequate urine output.
Action Threshold: Decreased urine output or signs of renal impairment.
Frequency: As clinically indicated, especially in patients with risk factors for renal dysfunction (e.g., every 1-2 days for several days post-infusion).
Target: Within patient's normal range or stable.
Action Threshold: Significant increase in BUN/creatinine.
Symptom Monitoring
- Headache
- Fever
- Chills
- Nausea
- Vomiting
- Rash
- Hives
- Dizziness
- Fatigue
- Muscle cramps
- Back pain
- Shortness of breath
- Chest pain
- Swelling or pain in a limb (signs of thrombosis)
- Decreased urine output
- Sudden weight gain
- Swelling (signs of fluid retention/renal dysfunction)
- Signs of aseptic meningitis (severe headache, neck stiffness, photophobia, fever, nausea, vomiting)
Special Patient Groups
Pregnancy
Category C. Bivigam 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. While generally considered safe when indicated, potential risks and benefits should be carefully weighed.
Trimester-Specific Risks:
Lactation
L2 - Likely compatible. Human IgG is naturally secreted into breast milk and can provide passive immunity to the infant. No adverse effects on breastfed infants have been reported with IVIG use. Consider the clinical need of the mother and potential benefits to the infant.
Pediatric Use
Dosing is weight-based and varies by indication. Infusion rates should be carefully monitored, especially in infants and young children, to minimize the risk of adverse reactions. Ensure adequate hydration. Safety and efficacy in pediatric patients are established for approved indications (e.g., PID, ITP).
Geriatric Use
Use with caution. Elderly patients are at increased risk for thrombotic events and acute renal dysfunction due to higher prevalence of underlying risk factors (e.g., cardiovascular disease, diabetes, renal impairment, volume depletion). Administer at the minimum dose and infusion rate practicable. Ensure adequate hydration and monitor renal function closely.
Clinical Information
Clinical Pearls
- Always ensure adequate hydration before, during, and after infusion to minimize the risk of renal dysfunction and thrombosis.
- Start infusions at the lowest recommended rate and gradually increase if tolerated, especially for first-time infusions or in patients with risk factors.
- Pre-medication (e.g., acetaminophen, antihistamines) may be considered for patients with a history of infusion-related reactions, but is not routinely required.
- Monitor vital signs closely throughout the infusion and for a period afterward.
- Patients should be advised to report any adverse symptoms immediately.
- Bivigam is sucrose-free, which may reduce the risk of acute renal failure compared to sucrose-stabilized IVIG products, but renal monitoring is still crucial, especially in at-risk patients.
- Do not mix Bivigam with other medicinal products. Administer separately.
Alternative Therapies
- Other Immune Globulin Intravenous (IVIG) products (e.g., Gammagard S/D, Gamunex-C, Privigen, Octagam)
- Immune Globulin Subcutaneous (SCIG) products (e.g., Hizentra, Gammaked, Cuvitru, Xembify) for PID
- For ITP: Corticosteroids, anti-D immunoglobulin, thrombopoietin receptor agonists (e.g., eltrombopag, romiplostim), rituximab, splenectomy.
Cost & Coverage
General Drug Facts
To ensure safe and effective use of your medication, follow these guidelines:
- Do not share your prescription drugs with others, and never take medication that has been prescribed for someone else.
- Store all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion or exposure.
- Properly dispose of any unused or expired medications. Unless specifically instructed to do so by a healthcare professional or pharmacist, avoid flushing medications down the toilet or pouring them down the drain.
- For guidance on the safe disposal of medications, consult with your pharmacist, who can also inform you about potential drug take-back programs in your area.
- Some medications may come with an additional patient information leaflet; check with your pharmacist for more information.
- If you have any questions or concerns about your medication, consult 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 detailed information about the overdose, including the name of the medication, the amount taken, and the time it was ingested.