Octagam 5gm/50ml Inj, 50ml

Immune Globulin Intravenous (Human) provides a broad spectrum of IgG antibodies against various infectious agents and toxins. Its mechanism of action in immunomodulatory conditions (e.g., ITP, CIDP) is complex and not fully elucidated, involving: Fc-receptor blockade on macrophages, modulation of cytokine production, anti-idiotypic antibodies, complement modulation, and regulation of B and T cell activity.

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while 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
+ 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, 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

Other Side Effects

Most people do not experience significant side effects, but some may occur. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact 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 have questions about side effects or want to report any 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.

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. Be sure to 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, consult with your doctor, as some products contain sorbitol.

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.

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. Verify that it is safe to take this medication with your existing treatments and health issues. 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 most suitable for you to use.

When taking this medication, individuals 65 years or older should exercise caution, as they may be more susceptible to side effects.

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor, as it is crucial to discuss the potential benefits and risks of this medication to both you and your baby.

• Live virus vaccines (e.g., measles, mumps, rubella, varicella): May interfere with the immune response to these vaccines. Defer vaccination for at least 3 months after IVIG administration. For measles, defer for up to 1 year depending on IVIG dose.
• Loop diuretics (e.g., furosemide): Increased risk of acute renal failure 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 other nephrotoxic agents (e.g., aminoglycosides, NSAIDs, contrast media).
• Anticoagulants/Antiplatelets: Theoretical increased risk of thrombosis, though not a direct interaction, but rather a shared risk factor for thrombotic events.

• Headache
• Fever
• Chills
• Nausea
• Vomiting
• Rash
• Hives
• Dyspnea
• Chest tightness
• Back pain
• Flushing
• Signs of allergic reaction (e.g., anaphylaxis)
• Signs of thrombosis (e.g., pain/swelling in limb, shortness of breath, chest pain, neurological changes)
• Signs of acute renal dysfunction (e.g., decreased urine output, swelling)
• Signs of aseptic meningitis (e.g., severe headache, nuchal rigidity, photophobia, fever, nausea, vomiting)

Category C. Animal reproduction studies have not been conducted. However, immune globulins are known to cross the placental barrier, particularly in the third trimester. Octagam should be given to a pregnant woman only if clearly needed. Clinical experience with IVIG in pregnant women suggests no adverse effects on the course of pregnancy, fetus, or neonate.

L2 (Safer). Immune globulins are naturally present in human milk and are transferred to the infant. Oral absorption of intact IgG by infants is minimal. No adverse effects on the breastfed infant are expected. Octagam can be used during lactation if clinically indicated.

Safety and efficacy have been established in pediatric patients for certain indications (e.g., PI, ITP). Dosing is weight-based. Caution is advised in neonates and infants due to potential for fluid overload and renal immaturity. Infusion rates may need to be slower.

Use with caution in elderly patients, especially those with pre-existing renal impairment, diabetes, or cardiovascular disease, due to increased risk of acute renal dysfunction and thrombotic events. Ensure adequate hydration and use the minimum dose and infusion rate practicable.

• Always ensure adequate hydration before, during, and after IVIG infusion to minimize the risk of renal complications.
• Infuse slowly initially, especially for first-time infusions or in patients at high risk for adverse reactions. The infusion rate can be gradually increased if tolerated.
• Pre-medication (e.g., acetaminophen, antihistamines, corticosteroids) may be considered for patients with a history of infusion-related reactions.
• Monitor for signs of aseptic meningitis (severe headache, neck stiffness, photophobia) which can occur hours to days after infusion.
• Be vigilant for signs of thrombosis, particularly in patients with risk factors. Consider assessing blood viscosity in high-risk patients.
• Octagam is sucrose-free, which is an advantage for renal safety compared to some other IVIG products, but renal monitoring is still crucial.

• Other Immune Globulin Intravenous (IVIG) products (e.g., Gammagard S/D, Gamunex-C, Privigen, Flebogamma DIF)
• Subcutaneous Immune Globulin (SCIG) products (e.g., Hizentra, Cuvitru, Xembify, Gamunex-C/Gammagard S/D for subcutaneous use) for primary immunodeficiency.
• For ITP: Corticosteroids, anti-D immunoglobulin, thrombopoietin receptor agonists (e.g., eltrombopag, romiplostim), splenectomy.
• For CIDP: Corticosteroids, plasma exchange (PLEX).

If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure safe use, never share your prescription medications with others, and do not take medications prescribed to 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 guidance on the best disposal method. Unless instructed to do so, avoid flushing medications down the toilet or pouring them down the drain, as this can harm the environment. Many communities have drug take-back programs that provide a safe and responsible way to dispose of medications. Some medications may have additional patient information leaflets available; consult with your pharmacist if you have questions. If you have concerns or questions about your medication, discuss them 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. Be prepared to provide information about the medication taken, the amount, and the time it was taken to ensure prompt and effective treatment.