Apadamtase alfa, recombinant

Generic name: apadamtase alfa, recombinant
Brand name: Adzynma
Dosage form: intravenous kit (krhn 1500 intl units; krhn 500 intl units)
Drug class: Lysosomal enzymes

Medically reviewed by Drugs.com on Jan 16, 2024. Written by Cerner Multum.

What is apadamtase alfa, recombinant?

Apadamtase alfa, recombinant is used to prevent or treat blood clots in adults and children with congenital thrombotic thrombocytopenic purpura (cTTP).

Apadamtase alfa, recombinant may also be used for purposes not listed in this medication guide.

Apadamtase alfa, recombinant side effects

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

Some side effects may occur during the injection. Tell your medical caregiver if you feel dizzy, nauseated, light-headed, itchy, sweaty, or have a headache, chest tightness, back pain, trouble breathing, or swelling in your face.

Common side effects of apadamtase alfa, recombinant may include:

• headache, migraines;

• diarrhea, stomach pain;

• dizziness, nausea, vomiting; or

• cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Warnings

Tell your doctor if you use other medicines or have other medical conditions or allergies.

Before taking this medicine

You should not use apadamtase alfa, recombinant if you are allergic to it.

Tell your doctor if you have ever had:

• any allergies, especially to hamsters.

It is not known if apadamtase alfa, recombinant will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Ask a doctor if it is safe to breastfeed while using apadamtase alfa, recombinant.

How should I take apadamtase alfa, recombinant?

Follow all directions on your prescription label and read all medication guides or instruction sheets.

Apadamtase alfa, recombinant is injected into a vein with an infusion pump. A healthcare provider will give you this injection.

Doses are based on weight. Your doctor will confirm your weight before starting treatment with apadamtase alfa, recombinant.

Your doctor will determine the right treatment schedule for you.

Tell your doctor if you have a trip planned.

Your doctor will need to perform blood tests to make sure apadamtase alfa, recombinant does not stop working for you.

Apadamtase alfa, recombinant dosing information

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)

Usual Pediatric Dose for Thrombotic Thrombocytopenic Purpura:

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)

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your apadamtase alfa, recombinant injection.

What happens if I overdose?

In a medical setting an overdose would be treated quickly.

What should I avoid after receiving apadamtase alfa, recombinant?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What other drugs will affect apadamtase alfa, recombinant?

Other drugs may affect apadamtase alfa, recombinant, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

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