Octagam 5% 2.5gm/50ml Inj, 1 Vial

• Live virus vaccines (e.g., measles, mumps, rubella, varicella): IVIG may interfere with the immune response to live virus vaccines. Defer vaccination for at least 3 months after IVIG administration. For measles vaccine, defer for up to 11 months depending on IVIG dose.
• Loop diuretics: Increased risk of acute renal failure, especially in patients with pre-existing renal impairment or risk factors.

• ACE inhibitors: Potential for increased risk of angioedema, though evidence is limited.
• Nephrotoxic drugs: Concurrent use may increase the risk of acute renal dysfunction, especially in susceptible patients.

• Headache
• Fever
• Chills
• Nausea
• Vomiting
• Fatigue
• Rash
• Hives
• Dyspnea
• Chest tightness
• Back pain
• Muscle cramps
• Signs of allergic reaction (swelling of face/throat, difficulty breathing)
• Signs of thrombosis (pain, swelling, warmth, redness in an arm or leg; sudden shortness of breath; chest pain; vision changes; slurred speech)
• Signs of acute renal dysfunction (decreased urine output, swelling, fatigue)
• Signs of aseptic meningitis (severe headache, neck stiffness, photophobia, nausea, vomiting)

Category C. Animal reproduction studies have not been conducted. It is not known whether Octagam 5% can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Octagam 5% should be given to a pregnant woman only if clearly needed. IgG antibodies are known to cross the placenta, particularly in the third trimester.

L2 (Safer). Human IgG is excreted into breast milk and may contribute to the transfer of immunity to the infant. No adverse effects on the breastfed infant are expected. Consider the benefits of breastfeeding along with the mother's clinical need for Octagam 5% and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition.

Dosing is weight-based and indication-specific. Children, especially those with underlying conditions, may be at increased risk for adverse events such as acute renal dysfunction or thrombosis. Close monitoring of fluid status, renal function, and infusion rate is crucial.

Elderly patients (≥65 years) are at increased risk for acute renal dysfunction and thrombotic events. Use with caution, ensure adequate hydration, and administer at the minimum concentration and slowest infusion rate practicable. Monitor renal function and signs of thrombosis closely.

• Always ensure adequate hydration of the patient before, during, and after IVIG infusion to minimize the risk of renal adverse events.
• Start infusions at a slow rate and gradually increase if tolerated, especially for the first infusion or in patients at high 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.
• Patients with pre-existing renal impairment, diabetes mellitus, advanced age, volume depletion, sepsis, paraproteinemia, or concomitant nephrotoxic drugs are at higher risk for acute renal dysfunction.
• Patients with IgA deficiency who have antibodies to IgA are at increased risk of severe allergic reactions, including anaphylaxis. Octagam 5% contains trace amounts of IgA.
• Monitor for signs of aseptic meningitis syndrome (AMS) which can occur hours to 2 days post-infusion, characterized by severe headache, neck stiffness, photophobia, nausea, and vomiting. It is usually self-limiting.
• Thrombotic events can occur, even in the absence of known risk factors. Maintain a high index of suspicion for symptoms of thrombosis.

• Subcutaneous Immune Globulin (SCIG) for primary immunodeficiency (e.g., Hizentra, Cutaquig, Xembify)
• Corticosteroids (e.g., prednisone, dexamethasone) for ITP, CIDP, or other autoimmune conditions
• Other immunosuppressants (e.g., rituximab, azathioprine, mycophenolate mofetil) depending on the specific autoimmune indication
• Plasma exchange (plasmapheresis) for certain neurological or autoimmune conditions (e.g., CIDP, Guillain-Barré Syndrome)
• Splenectomy for refractory ITP