Treanda | Pharmacology Mentor

Generic Name

Treanda (10 % Intravenous Immunoglobulin [IVIG] – IgG)

Mechanism

Fcγ Receptor (FcγR) blockade – saturated binding to FcγRs on macrophages and neutrophils dampens antibody‑mediated phagocytosis.
Neutralization of auto‑antibodies and idiotype–anti‑idiotype interactions – decoys for pathogenic antibodies reduce immune complex deposition.
Complement inhibition – soluble C1‑suppressing fragments impair classical pathway activation.
Regulatory T‑cell (Treg) induction – increased IL‑10 production promotes immune tolerance.
Modulation of B‑cell activity – suppression of B‑cell receptor (BCR) signaling leads to decreased auto‑antibody secretion.

Pharmacokinetics

Parameter	Typical value
Absorption	Rapid IV distribution; bioavailability > 95 %
Volume of distribution	3–5 L/kg (largely extracellular fluid)
Half‑life	18–21 days (shorter in patients with high catabolic states)
Metabolism	Catabolized by mononuclear phagocyte system; degraded to peptides and amino acids
Excretion	Primarily renal; milde micro‑proteinuria common
Special populations	Renal impairment: minimal effect on clearance; hepatic disease: no dose adjustment required

Indications

Kawasaki Disease (children): first‑line IVIG rescue therapy.
Immune Thrombocytopenic Purpura (ITP) – acute, severe thrombocytopenia.
Idiopathic Thrombocytopenic Purpura (low‑grade ITP) – short‑term treatment.
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) – long‑term maintenance (off‑label in some regions).
Certain cases of immune‑mediated aplastic anemia – adjunctive therapy.
Autoimmune blistering diseases – off‑label, case reports indicate benefit.
Other autoimmune and inflammatory disorders – supportive evidence in sarcoidosis, vasculitis, and refractory lupus.

> *Note: Indication coverage may vary by region; consult local labeling.*

Contraindications

Absolute contraindication: documented IgA deficiency with anti‑IgA antibodies (risk of anaphylaxis).
Relative contraindication: active infection, uncontrolled sepsis, or severe bleeding disorders.
Warnings
Aseptic meningitis – rare, often in adults; monitor neurologic status.
Nephropathy – pre‑existing renal disease, especially with hyper‐tonic formulations.
Thromboembolic events – increased risk with high‑dose IVIG; avoid in patients with hypercoagulable states unless essential.
Hemolysis – monitor bilirubin and haptoglobin, particularly in patients with recent transfusion.
Serum sickness – delayed reaction; prophylactic steroids may be considered.

Dosing

Indication	Dose	Schedule	Patient‑specific notes
Kawasaki Disease	2 g/kg IV over ≤ 24 h (max 120 mg/kg/day)	Single infusion; repeat if fever persists > 36 h	Children < 8 mo: 2.5 g/kg (max 120 mg/kg).
Acute ITP	1–2 g/kg (1 g/kg on day 1; optional repeat on day 2)	Usually 2‑day course	Pre‑med with antihistamine/H₂ blocker to reduce infusion reactions.
Maintenance ITP/CIDP	1 g/kg every 2–4 weeks	Taper based on response	Monitor CBC and renal function after each cycle.
Low‑grade ITP	2 g/kg IV once	One‑time dose	Evaluate for relapse after 4–6 weeks.

• Infusion rate: start at 1 mg/kg/min; increase every 30 min to a maximum of 4 mg/kg/min, with or without pre‑infusion medications.
• Premedication: acetaminophen 650 mg, diphenhydramine 25 mg IV, or H₂ antagonist (ranitidine 50 mg) ≤ 30 min prior.
• IV fluid: maintain hydration (1–2 L/m²/day) to lower viscosity and prevent renal injury.

Adverse Effects

Adverse Effect	Incidence	Management
Infusion reactions (fever, chills, headache, back pain)	10–25 %	Slow infusion; pre‑med; discontinue if severe.
Mild headache	8–12 %	NSAIDs or acetaminophen.
Gastro‑intestinal upset (nausea, vomiting)	5–8 %	Antiemetics; post‑infusion monitoring.
Serious: Aseptic meningitis	< 1 %	Immediate cessation; supportive care.
Hemolysis	< 1 %	Check bilirubin, LDH; consider blood transfusion.
Renal dysfunction / nephropathy	1–5 %	Hydration, monitor creatinine; discontinue if acute kidney injury.
Thromboembolic events	1–4 %	Aspirin prophylaxis in high‑risk patients; monitor for DVT/PE.
Serum sickness	0.5–2 %	Steroid therapy; switch to alternative immunoglobulin if needed.

Monitoring

Baseline & Weekly
CBC with differential
Serum creatinine & eGFR
ALT/AST, total bilirubin
Electrolytes (Na⁺, K⁺, Ca²⁺)
During Infusion
Vital signs every 15 min initially; blood pressure, heart rate, temperature.
Monitor for signs of anaphylaxis (urticaria, bronchospasm).
Post‑Infusion
Continue CBC at 1 week, then monthly for maintenance therapy.
Special
For patients with IgA deficiency: screen for anti‑IgA antibodies pre‑treatment.
In patients on anticoagulants: monitor coagulation profile and platelet counts.

Clinical Pearls

1. Pre‑infusion antihistamine reduces the rate of infusion reactions by 35 %; consider diphenhydramine 25–50 mg IV.

2. Rapid re‑infusion within 72 h is reserved for refractory Kawasaki; otherwise repeat after 7–10 days to avoid immune exhaustion.

3. Hydration is critical—a deficit of > 10 % body weight during infusion predisposes to renal complications.

4. Use a two‑hour “fast‑track” infusion only if the patient is hemodynamically stable and has no prior reactions; otherwise, spread the dose over 24 h.

5. Anti‑IgA screening should be performed in all patients with a history of IgA deficiency or anaphylaxis to blood products to prevent fatal IgA‑mediated reactions.

6. Monitor for cold agglutinin hemolysis in patients receiving high‑dose IVIG—check haptoglobin and indirect bilirubin.

7. In chronic ITP, titrate to the lowest effective dose; many patients respond to 0.5 g/kg every 2–3 months, reducing exposure and cost.

8. For patients on warfarin or DOACs, consider the extra-HPA of IVIG; check INR/PT/PA early to adjust dosing.

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