HIZENTRA Rx

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HIZENTRA

Primary immune deficiency
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Generic Name and Formulations:

Immune globulin (human) 0.2g/mL (20%); liq for slow SC infusion; contains L-proline, polysorbate-80; preservative-, and sucrose-free.

Company:

CSL Behring, LLC

Select therapeutic use:

Indications for HIZENTRA:

As replacement therapy for primary humoral immunodeficiency (eg, congenital or X-linked agammaglobulinemia, common variable immunodeficiency, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies).

Adults and Children:

See full labeling. Individualize. Before receiving treatment: ensure patients have received IGIV at regular intervals for at least 3 months; obtain serum IgG trough level to guide subsequent dose adjustments. Can be administered as a weekly or biweekly SC infusion using an infusion pump into abdomen, thigh, upper arm, or lateral hip areas. For weekly dosing: may use up to 4 sites simultaneously or up to 12 sites consecutively per infusion. Start treatment 1 week after last IGIV infusion. Initial dose: (1.53 x previous IVIG dose [in grams])/number of weeks between IGIV doses; max volume of 15mL/site for first dose; may increase to 20mL/site after the 4th infusion and then to 25mL/site as tolerated; max flow rate of 15mL/hour per site for first dose; may increase to 25mL/hour per site as tolerated for subsequent infusions. For biweekly dosing: increase the number of inj sites as needed. Start treatment 1 or 2 weeks after last IGIV infusion or 1 week after that last weekly Hizentra infusion. Biweekly dose: multiply the calculated weekly dose by 2. Adjust subsequent doses based on desired clinical response and serum IgG trough levels after 2–3 months (see full labeling for dosing chart). Risk of measles exposure: give a minimum weekly dose of 200mg/kg for 2 consecutive weeks; if biweekly dosing: give one infusion at minimum of 400mg/kg. Renal dysfunction or thrombosis risk: give at minimum dose and/or infusion rate practicable.

Contraindications:

IgA-deficiency with antibodies against IgA and history of hypersensitivity. Hyperprolinemia (type I or II). Previous severe reaction to human immune globulin.

Warnings/Precautions:

Advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity, cardiovascular disorders: increased risk of thrombosis. Monitor for signs/symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity. Diabetes mellitus, >65yrs, overweight, hypovolemia: increase risk of renal dysfunction. Correct volume depletion; assess renal function before and during therapy; discontinue if renal function deteriorates. Monitor for aseptic meningitis, hemolysis, delayed hemolytic anemia, transfusion-related acute lung injury (eg, pulmonary edema, dyspnea, hypoxemia). Antibody formation. Risk of transmission of blood-borne diseases. Pregnancy (Cat.C). Nursing mothers.

Interactions:

Concomitant nephrotoxic drugs: increased risk of renal toxicity. May affect response to live virus vaccinations. May interfere with serological test interpretation.

Pharmacological Class:

Immune globulin.

Adverse Reactions:

Local reactions (eg, swelling, redness, heat, pain, itching), headache, diarrhea, fatigue, back pain, nausea, pain in extremity, cough, rash, pruritus, vomiting, upper abdominal pain, migraine, pain.

How Supplied:

Single-use vial (5mL, 10mL, 20mL, 50mL)—1

HIZENTRA 20ml of 4g vials (Qty:12)

appx. price $8235.00