Usual Adult Dose for Castleman's Disease

11 mg/kg IV over 1 hour every 3 weeks until treatment failure

Treatment Criteria:

• Requirements before the first dose is given: The absolute neutrophil count (ANC) must be 1 x 10(9) or greater AND the platelet count must be 75 x 10(9) or greater AND hemoglobin must be less than 17 g/dL.
• Retreatment criteria: The absolute neutrophil count (ANC) must be 1 x 10(9) or greater AND the platelet count must be 50 x 10(9) or greater AND hemoglobin must be less than 17 g/dL.

Comments:

• This drug was not studied in patients with MCD who are HIV positive or HHV-8 positive because it did not bind to virally produced IL-6 in a nonclinical study.
• Perform hematology laboratory tests prior to each dose for the first 12 months and every 3 dosing cycles thereafter.
• Do not initiate therapy in patients with severe infections until the infection resolves.
• Discontinue therapy in patients with severe infusion related reactions, anaphylaxis, severe allergic reactions, or cytokine release syndromes. Do not reinstitute treatment.

Use: For the treatment of patients with multicentric Castleman's disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative.

Renal Dose Adjustments

Mild to severe renal impairment (CrCl 15 mL/min to under 90 mL/min): No adjustment recommended.
End stage renal disease (CrCl less than 15 mL/min): Data not available

Liver Dose Adjustments

Mild or moderate liver dysfunction (Child-Pugh A or B): No adjustment recommended.
Severe liver dysfunction (Child-Pugh C): Data not available

Precautions

CONTRAINDICATIONS:

• Hypersensitivity to the active component or any of the ingredients

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration Advice:

• If treatment criteria are not met a delay in treatment may be necessary; dose should not be reduced.
• Do not administer to patients with severe infections until the infection resolves.
• Perform hematology lab tests prior to each dose for the first 12 months and every 3 dosing cycles thereafter.
• Absolute Neutrophil Count should be 1 x 10(9)/L or higher before administration.
• Platelet count should be 75 × 10(9)/L or higher before first dose and 50 × 10(9)/L or higher before subsequent doses.
• Hemoglobin should be less than 17 g/dL before administration.
• Administer in a setting that provides resuscitation equipment, medication, and personnel trained to provide resuscitation.
• Stop infusion if patient develops signs of anaphylaxis. Discontinue further therapy.
• Stop infusion if patient develops mild to moderate infusion reactions. If reaction resolves, infusion may be restarted at a lower infusion rate. Consider medication with antihistamines, acetaminophen, and corticosteroids. Discontinue if patient does not tolerate infusion following these interventions.

Storage requirements:

• Refrigerate; protect from light.

Reconstitution/preparation techniques: The manufacturer product information should be consulted.

IV compatibility:

• Do not infuse concomitantly in the same intravenous line with other agents.

Patient advice:

• May lower resistance to infections. Contact your doctor immediately when symptoms suggesting infection appear to assure rapid evaluation and appropriate treatment.
• Discuss recommended vaccinations prior to treatment.
• Seek immediate medical attention for any symptoms of serious allergic reactions during the infusion. Signs include: difficulty breathing, chest tightness, wheezing, severe dizziness or light-headedness, swelling of the lips or skin rash.
• Patients of childbearing potential should avoid pregnancy which may include use of contraception during treatment and for 3 months after therapy.