Bivigam 10% 10gm Inj, 100ml

Immune Globulin Intravenous (Human) (IVIG) contains a broad spectrum of IgG antibodies against various infectious agents and toxins. The precise mechanism of action in many of its therapeutic uses is not fully understood but is thought to involve several immunomodulatory effects, including: Fc receptor blockade (saturating Fc receptors on macrophages), modulation of cytokine production, inhibition of complement activation, neutralization of autoantibodies, and suppression of pathogenic B-cell and T-cell activity. It provides passive immunity by increasing circulating IgG levels.

Urgent Side Effects: Seek Medical Help Right Away

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, contact your doctor or seek medical help 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 Brain Inflammation

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
Severe nausea or vomiting
Stiff neck
Rash
Sensitivity to light
Feeling sleepy or confused

Other Important 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, contact your doctor right away.

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, contact your doctor 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

Common Side Effects

Not everyone will experience side effects, but some people may have mild or moderate side effects. If you experience any of the following symptoms, contact your doctor or seek medical help if they bother you or do not go away:
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 have questions about side effects or experience any symptoms that concern you, 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.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following conditions to ensure safe treatment:

Any allergies you have, including allergies to this medication, its components, or other substances. Describe the symptoms you experienced with the allergy.
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, consult with your doctor, as some products contain sorbitol.

Special Considerations for Children:

* If your child is an infant or baby, and it is unknown whether they can break down sucrose or fructose, do not administer this medication.

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist. Verify that it is safe to take this medication with your existing treatments and health conditions. Never start, stop, or adjust the dosage of any medication without consulting your doctor.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you have a latex allergy, be sure to discuss this with your doctor.

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 drug.

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. 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 product is thoroughly screened, tested, and treated to minimize the risk of infection, 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.

Older adults (65 years and older) should exercise caution when taking this medication, as they may be more susceptible to side effects. If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor to discuss the potential benefits and risks to you and your baby.

• Live virus vaccines (e.g., measles, mumps, rubella, varicella): IVIG may interfere with the immune response to live attenuated virus vaccines. Vaccination should be deferred for at least 3 months after IVIG administration. If given concurrently, vaccine efficacy may be reduced.
• Loop diuretics (e.g., furosemide): Increased risk of acute renal failure, especially in patients with pre-existing renal impairment or risk factors for renal dysfunction.

• ACE inhibitors: Potential for increased risk of hypotension, especially with rapid infusion.
• Nephrotoxic drugs: Increased risk of renal dysfunction when co-administered with other nephrotoxic agents.

• Headache (mild to severe)
• Flushing
• Chills/rigors
• Fever
• Nausea/vomiting
• Fatigue
• Dizziness
• Muscle cramps
• Back pain
• Chest tightness/dyspnea
• Rash/urticaria
• Signs of thrombosis (e.g., pain, swelling, discoloration of limb, shortness of breath, chest pain)
• Signs of acute renal failure (e.g., decreased urine output, edema, fatigue)
• Signs of aseptic meningitis (e.g., severe headache, nuchal rigidity, photophobia, fever, vomiting, altered mental status)

Category C. Animal reproduction studies have not been conducted. It is not known whether Bivigam can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Bivigam should be given to a pregnant woman only if clearly needed. However, IVIG has been used in pregnant women for various autoimmune conditions (e.g., ITP, recurrent pregnancy loss) and is generally considered compatible when clinically indicated.

L2 (Safer). Human IgG is excreted into breast milk. However, antibodies in breast milk are generally considered beneficial for the infant's immune system. Oral absorption of intact IgG by the infant is minimal. Therefore, Bivigam is generally considered compatible with breastfeeding. Monitor the infant for any unusual symptoms.

Dosing is weight-based and similar to adults for many indications. Safety and efficacy have been established for various indications (e.g., PI, ITP, Kawasaki disease). Infusion rates may need to be adjusted, especially in very young children or those with underlying cardiac/renal conditions. Close monitoring for adverse reactions is crucial.

Use with caution, especially in patients with pre-existing renal impairment, diabetes, cardiovascular disease, or risk factors for thrombosis. Administer at the minimum dose and infusion rate practicable. Ensure adequate hydration. Monitor renal function and signs of thrombosis closely. The risk of acute renal failure and thrombotic events may be higher in this population.

• Always ensure adequate hydration before, during, and after IVIG infusion to minimize the risk of renal dysfunction.
• Start infusions slowly and gradually increase the rate if tolerated, especially for first-time infusions or in patients at risk for adverse reactions.
• Pre-medication (e.g., acetaminophen, antihistamines) may be considered for patients with a history of infusion-related reactions, but is not routinely required for all patients.
• Monitor vital signs frequently, particularly during the initial phase of infusion, and be prepared to slow or stop the infusion if adverse reactions occur.
• Patients with IgA deficiency are at higher risk for anaphylactic reactions due to anti-IgA antibodies; consider IgA-deficient IVIG products if available and necessary.
• Educate patients about the signs and symptoms of serious adverse events (e.g., thrombosis, renal dysfunction, aseptic meningitis) and when to seek immediate medical attention.
• Document lot number and expiration date of the product for traceability.

• Other IVIG products (e.g., Gammagard S/D, Gamunex-C, Octagam, Privigen, Flebogamma DIF, Asceniv, Panzyga)
• Subcutaneous Immune Globulin (SCIG) products (e.g., Hizentra, Gammaked, Cuvitru, Xembify) for primary immunodeficiency.
• For specific indications, alternative treatments may include corticosteroids, rituximab, plasma exchange, or other immunosuppressants/immunomodulators.

If your symptoms or health problems persist or worsen, it is essential to contact your doctor for further guidance. To ensure safe use, never share your medication with others, and do not take medication prescribed for someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Properly dispose of unused or expired medications by checking with your pharmacist for the recommended method, as some medications may require specific disposal procedures. Additionally, many communities have drug take-back programs; your pharmacist can provide more information. Some medications may come with a separate patient information leaflet, so be sure to check with your pharmacist. 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 call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it occurred.