Prescribing Information
Patient | Healthcare Professional

Welcome to ADZYNMA Patient Support

If your eligible patient has been prescribed ADZYNMA, support is here to help them gain access to their medication.

How to access ADZYNMA

As a buy-and-bill product, ADZYNMA is available through one of the following options:

Hematology Support Center: Get access to patient support, including reimbursement, procurement, and financial assistance.

1-888-229-8379

Orsini (Specialty Pharmacy): For outpatient or homecare setting administration.

1-800-240-9572
Fax: 1-847-427-7976

Cardinal (Specialty Distributor)

1-855-855-0708
Fax: 1-614-553-6301

Hemophilia Alliance: Participating Hemophilia Treatment Centers may purchase ADZYNMA directly through the Hemophilia Alliance GPO. To access ADZYNMA, simply follow the normal product acquisition process.

Enrollment in the Patient Support Program is not required for these options.

Dosing Guide1

ADZYNMA should be administered under the supervision of a healthcare professional.

Each vial of ADZYNMA is labeled with the actual rADAMTS13 activity, measured in terms of its potency in International Units (IU).

Calculate administration dose and volume based on the patient’s body weight using the actual potency (and not the nominal potency) as printed on ADZYNMA vial.

Prophylactic Therapy (example calculation below)

  • Administer 40 IU/kg body weight once every other week intravenously at a rate of 2 to 4 mL per minute.
  • The prophylaxis dosing frequency may be adjusted to 40 IU/kg body weight once weekly based on prior prophylactic dosing regimen or clinical response.

On-Demand Therapy

Administer intravenously at a rate of 2 to 4 mL per minute:

  • 40 IU/kg body weight on day 1.
  • 20 IU/kg body weight on day 2.
  • 15 IU/kg body weight on day 3 and beyond until two days after the acute event is resolved.

Example calculation for prophylactic dosing

1

Example calculation:
Patient’s weight = 21 kg

Obtain patient’s weight
2

Example calculation:
21 kg x 40 IU/kg of ADZYNMA = 840 IU

Recommended prophylactic dose of ADZYNMA is 40 IU/kg patient body weight administered once every other week as an IV infusion. Calculate the dosage of ADZYNMA required: Patient weight (kg) x 40 IU/kg
3

Example calculation:
840/500 = 1.68 vials needed (2 vials are needed to extract 840 units of ADZYNMA)

ADZYNMA is supplied in 500 IU or 1500 IU single-dose vials Calculate the number of vials needed: Dosage of ADZYNMA required/500 or 1500

Each vial of ADZYNMA is labeled with the actual rADAMTS13 activity, measured in terms of its potency in International Units (IU). Calculate administration dose and volume based on the patient’s body weight using the actual potency (and not the nominal potency) as printed on ADZYNMA vial.

ADZYNMA Healthcare Professional (HCP) Important Safety Information (ISI)

INDICATION

ADZYNMA (ADAMTS13, recombinant-krhn) is a human recombinant “A disintegrin and metalloproteinase with thrombospondin motifs 13” ADAMTS13 (rADAMTS13) indicated for prophylactic or on-demand enzyme replacement therapy (ERT) in adult and pediatric patients with congenital thrombotic thrombocytopenic purpura (cTTP).

IMPORTANT SAFETY INFORMATION

ADZYNMA is contraindicated in patients who have experienced life-threatening hypersensitivity reactions to ADZYNMA or its components.

Hypersensitivity Reactions: Allergic-type hypersensitivity, including anaphylactic reactions, may occur with ADZYNMA. Patients should be educated about early signs of hypersensitivity such as tachycardia, chest tightness, wheezing and/or acute respiratory distress, hypotension, generalized urticaria, pruritus, rhinoconjunctivitis, angioedema, lethargy, nausea, vomiting, paresthesia, and restlessness. If signs and symptoms of severe allergic reactions occur, immediately discontinue administration of ADZYNMA and provide appropriate supportive care.

Immunogenicity: There is a potential for immunogenicity with ADZYNMA. Patients may develop neutralizing antibodies to ADAMTS13, which could potentially result in a decreased or lack of response to ADAMTS13. Patients may develop antibodies to host cell proteins which could potentially result in adverse reactions. There are no data on immunogenicity with ADZYNMA or to host cell proteins in previously untreated patients (subjects naïve to plasma-based products).

Adverse Reactions: The most commonly observed adverse reactions (>5% of subjects) associated with ADZYNMA are headache, diarrhea, migraine, abdominal pain, nausea, upper respiratory tract infection, dizziness and vomiting.

Use in Specific Populations: The safety of ADZYNMA for use during pregnancy has not been established in controlled clinical trials. Limited data are insufficient to inform a drug associated risk of adverse developmental outcomes. There is no information regarding the presence of ADZYNMA in human milk, its effects on milk production, or the breastfed infant.

To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals U.S.A, Inc. at 1-877-TAKEDA-7 (1-877-825-3327) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information, including information for patients.

Coding and Reimbursement Information*†

The information contained here is provided for informational purposes only. It is the responsibility of the provider to select proper codes and ensure the accuracy of all claims used in seeking reimbursement.

National drug codes:

500 IU: 64764-140-05
1500 IU: 64764-145-05

11-digit NDC codes:

500 IU: 64764-0140-05
1500 IU: 64764-0145-05

ICD-10-CM:

M31.19 (Other thrombotic microangiopathy, thrombotic thrombocytopenic purpura)

HCPCS:

J3590 (Unclassified biologics) /
C9399 (Unclassified drugs or biologicals)

CPT code:

96374 – Intravenous push, single or initial substance/drug

Revenue code:

Hospitals may use the following drugs and biologicals revenue code on Form UB-04 requiring an HCPCS code – 0636

*Based on the specific patient situation or procedure, other diagnosis codes may be applicable.

†The information contained here is provided for informational purposes only and is current as of Nov 2023. It is the responsibility of the provider to select proper codes and ensure the accuracy of all claims used in seeking reimbursement.

Takeda Patient Support Co-Pay Assistance Program

At Takeda Patient Support, our support specialists will review your patient’s coverage and help them understand what financial assistance options may be available.

Takeda's HSC offers co-pay assistance to eligible patients with commercial insurance

If your patient is commercially insured and eligible, the Co-Pay Assistance Program may cover 100% of eligible out-of-pocket costs related to your patient's Takeda hematology treatment for which there is a co-pay.* Co-pay costs may include expenses such as deductibles and coinsurances, up to the program maximum.

Takeda will let your patient know if they qualify.

To find out if your patient is eligible, a benefits verification is needed.

The maximum co-pay assistance available per calendar year is $20,000. If your patient reaches the Program maximum before the end of the year, Takeda will help them identify programs and resources that may provide them with additional assistance with access to their prescribed Takeda therapy.

If your patient is uninsured or experiencing a gap in therapy, Takeda can direct your patients to programs that may help. Call 1-888-229-8379 Monday through Friday, 8:30 AM to 8:00 PM ET.

Access the enrollment form to help your patients get started

For government-insured or uninsured patients

We can help answer questions about your patient's coverage and may be able to connect them to programs that may help.

*Important Notice

*IMPORTANT NOTICE: Takeda’s Co-pay Assistance Program ("the Program") provides financial support for commercially insured patients who qualify for the Program. Participation in the Program and provision of financial support is subject to all Program terms and conditions, including but not limited to eligibility requirements, the Program maximum benefit per claim and the annual calendar year Program maximum (“Annual Program Maximum”). The Annual Program Maximum for your prescribed Takeda product can be found by visiting: https://www.hematologysupport.com/

By enrolling in the Program, you agree that the Program is intended solely for the benefit of you—not health plans and/or their partners. Further, you agree to comply with all applicable requirements of your health plan. The Program cannot be used if the patient is a beneficiary of, or any part of the prescription is covered by: 1) any federal, state, or government-funded healthcare program (Medicare, Medicare Advantage, Medicaid, TRICARE, etc.), including a state pharmaceutical assistance program (the Federal Employees Health Benefit (FEHB) Program is not a government-funded healthcare program for the purpose of this offer), 2) the Medicare Prescription Drug Program (Part D), or if the patient is currently in the coverage gap, or 3) insurance that is paying the entire cost of the prescription. No claim for reimbursement of the out-of-pocket expense amount covered by the Program shall be submitted to any third-party payer, whether public or private.

Some health plans have established programs referred to as ‘co-pay maximizer’ programs. A co-pay maximizer program is one in which the amount of a patient’s out-of-pocket costs is adjusted to reflect the availability of support offered by a manufacturer’s co-pay assistance program. If you are enrolled in a co-pay maximizer program, your Annual Program Maximum may vary over time to ensure the program funds are used for your benefit (for the benefit of the patient). Takeda also reserves the right to reduce or eliminate the co-pay assistance available to patients enrolled in an insurance plan that utilizes a co-pay maximizer program.

If you learn your health plan has implemented a co-pay maximizer program, you agree to notify the Program immediately by calling 1-888-229-8379. It may be possible that you are unaware whether you are subject to a co-pay maximizer program when you enroll or re-enroll in the Program. Takeda will monitor program utilization data and reserves the right to discontinue assistance under the Program at any time if Takeda determines that you are subject to a co-pay maximizer, or similar program.

The Program only applies in the United States, including Puerto Rico and other U.S. territories, and does not apply where prohibited by law, taxed, or restricted. This does not constitute health insurance. Void where use is prohibited by your insurance provider. If your insurance situation changes you must notify the Program immediately at 1-888-229-8379. Coverage of certain administration charges will not apply for patients residing in states where it is prohibited by law.

This Program offer is not transferable and is limited to one offer per person and may not be combined with any other coupon, discount, prescription savings card, rebate, free trial, patient assistance, co-pay maximizer, alternative funding program, co-pay accumulator, or other offer, including those from third parties and companies that help insurers or health plan manage costs. Not valid if reproduced.

By utilizing the Program, you hereby accept and agree to abide by these terms and conditions. Any individual or entity who enrolls or assists in the enrollment of a patient in the Program represents that the patient meets the eligibility criteria and other requirements described herein. You must meet the Program eligibility requirements every time you use the Program. Takeda reserves the right to rescind, revoke, or amend the Program at any time without notice, and other terms and conditions may apply.

Questions?

The Hematology Support Center is available at
1-888-229-8379 to help answer any questions you may have.

References:

1. ADZYNMA Prescribing Information. Takeda Pharmaceuticals; 2023. 2. Centers for Medicare & Medicaid Services. (2020, Apr 23). Billing and coding: Hospital outpatient drugs and biologicals under the Outpatient Prospective Payment System (OPPS). (A55913). https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleId=55913