Usual Adult Dose for Idiopathic (Immune) Thrombocytopenic Purpura

Initial dose:

• First day of treatment: 11 mg bolus IV injection at least 15 minutes prior to plasma exchange followed by an 11 mg subcutaneous injection after completion of plasma exchange on Day 1

• Subsequent days of treatment during daily plasma exchange: 11 mg subcutaneous injection once a day following plasma exchange
• Treatment after plasma exchange period: 11 mg subcutaneous injection once a day continuing for 30 days following the last daily plasma exchange. If after initial treatment course sign(s) of persistent underlying disease such as suppressed ADAMTS13 activity levels remain present, treatment may be extended for a maximum of 28 days.

• Discontinue this drug if the patient experiences more than 2 recurrences of acquired thrombotic thrombocytopenic purpura (aTTP) during treatment with this drug.
• Withhold this drug 7 days prior to elective surgery, dental procedures, or other invasive interventions.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Mild to moderate liver dysfunction: Data not available
Severe liver dysfunction: Caution recommended; monitor closely for bleeding

Precautions

CONTRAINDICATIONS:

• Previous severe hypersensitivity reaction (e.g., urticaria) to the active component or any of the ingredients

Dialysis

Data not available

Other Comments

Administration advice:

• The first dose should be administered by a healthcare provider as a bolus IV injection. Administer subsequent doses subcutaneously in the abdomen. Avoid injections around the navel. Do not administer consecutive injections in the same abdominal quadrant.
• Patients or caregivers may inject this drug subcutaneously after proper training on the preparation and administration of this drug, including aseptic technique.
• If a dose is missed during the plasma exchange period, it should be given as soon as possible.
• If a dose is missed after the plasma exchange period, it can be administered within 12 hours of the scheduled time of administration. Beyond 12 hours, the missed dose should be skipped, and the next daily dose administered according to the usual dosing schedule.

• Store refrigerated at 2C to 8C (36F to 46F) in the original carton to protect from light.
• Do not freeze.
• Unopened vials may be stored in the original carton at room temperature up to 30C (86F) for a single period of up to 2 months.
• Do not return the drug to the refrigerator after it has been stored at room temperature.
• Use the reconstituted solution immediately, if possible. Otherwise, use within 4 hours after reconstitution when stored in the refrigerator at 2C to 8C (36F to 46F).

• Cardiovascular: Bleeding

• Advise patients that bruising and bleeding may occur more easily and that it may take longer than usual to stop bleeding.
• Advise patients to contact their healthcare provider immediately if excessive bruising or bleeding occurs.
• Advise patients to inform their healthcare provider before scheduling any elective surgery, dental procedure, or other invasive intervention.

• Cardiovascular: Bleeding

• Advise patients that bruising and bleeding may occur more easily and that it may take longer than usual to stop bleeding.
• Advise patients to contact their healthcare provider immediately if excessive bruising or bleeding occurs.
• Advise patients to inform their healthcare provider before scheduling any elective surgery, dental procedure, or other invasive intervention.