Apadamtase Alfa, Recombinant Dosage

Medically reviewed by Drugs.com. Last updated on Jan 16, 2024.

Applies to the following strengths: krhn 500 intl units; krhn 1500 intl units

Usual Adult Dose for Thrombotic Thrombocytopenic Purpura

Prophylactic Therapy: 40 IU/kg IV at 2 to 4 mL per minute once every other week

May be adjusted to 40 IU/kg IV at 2 to 4 mL per minute once every week based on prior prophylactic dosing regimen or clinical response.

On-Demand Therapy for Acute Event:

Treatment Day 1: 40 IU/kg IV at 2 to 4 mL per minute
Treatment Day 2: 20 IU/kg IV at 2 to 4 mL per minute
Treatment Day 3 and beyond: 15 IU/kg IV at 2 to 4 mL per minute once a day until 2 days after the acute event is resolved

Comments:

Calculate administration dose and volume based on the patient's body weight using the actual potency (not the nominal potency) as indicated on the medication vial.

Use: For the prophylactic or on-demand enzyme replacement therapy (ERT) in patients with congenital thrombotic thrombocytopenic purpura (cTTP)

2 years and older:
Prophylactic Therapy: 40 IU/kg IV at 2 to 4 mL per minute once every other week

May be adjusted to 40 IU/kg IV at 2 to 4 mL per minute once every week based on prior prophylactic dosing regimen or clinical response.

On-Demand Therapy for Acute Event:

Treatment Day 1: 40 IU/kg IV at 2 to 4 mL per minute
Treatment Day 2: 20 IU/kg IV at 2 to 4 mL per minute
Treatment Day 3 and beyond: 15 IU/kg IV at 2 to 4 mL per minute once a day until 2 days after the acute event is resolved

Comments:

Calculate administration dose and volume based on the patient's body weight using the actual potency (not the nominal potency) as indicated on the medication vial.

Use: For the prophylactic or on-demand enzyme replacement therapy (ERT) in patients with congenital thrombotic thrombocytopenic purpura (cTTP)

Baseline estimated glomerular filtration rate: No adjustment recommended

Baseline bilirubin: No adjustment recommended

CONTRAINDICATIONS:

Patients who have manifested life-threatening hypersensitivity reactions to this drug or its components

Safety and efficacy have not been established in patients younger than 2 years.

Consult WARNINGS section for additional precautions.

Data not available

Administration advice:

For IV use after reconstitution only.
Aseptic technique should be used throughout the procedure.
Advise patients to discontinue therapy and seek immediate medical care if symptoms of hypersensitivity reactions occur.

Storage requirements:

Use within 3 hours after reconstitution; discard any unused reconstituted product after 3 hours.
Store reconstituted product at room temperature at no more than 30C (86F).
Store unopened vials at refrigerated temperatures 2C to 8C (36F to 46F) for up to 36 months from the date of manufacture until the expiration date on the drug label. Within this period, this drug may be stored at room temperature at no more than 30C (86F); do not return to the refrigerator.
Do not freeze.
Store in the original box and protect from extreme exposure to light.

Reconstitution/preparation techniques:

General:

To report suspected adverse reactions, contact Takeda Pharmaceuticals at 1-877-825-3327 or the FDA at www.fda.gov/medwatch.

Patient advice:

Read the US FDA-approved patient labeling (Patient Information).
Inform your health care provider of any travel plans and carry an adequate supply of this drug based on your current regimen during your trip.
Discontinue treatment immediately and seek emergency care if you experience signs of hypersensitivity reactions such as tightness of the chest, wheezing and/or acute respiratory distress, nausea, and vomiting.
Women of reproductive potential should contact their healthcare provider if they become pregnant or suspect a pregnancy.