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Feraheme® (ferumoxytol injection) Important Safety Information

WARNING: RISK FOR SERIOUS HYPERSENSITIVITY/ANAPHYLAXIS REACTIONS

Fatal and serious hypersensitivity reactions including anaphylaxis have occurred in patients receiving Feraheme. Initial symptoms may include hypotension, syncope, unresponsiveness, cardiac/cardiorespiratory arrest.

  • Only administer Feraheme as an intravenous infusion over at least 15 minutes and only when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions.
  • Observe for signs or symptoms of hypersensitivity reactions during and for at least 30 minutes following Feraheme infusion including monitoring of blood pressure and pulse during and after Feraheme administration.
  • Hypersensitivity reactions have occurred in patients in whom a previous Feraheme dose was tolerated.

FERAHEME® (ferumoxytol injection) Billing and Coding Information for Outpatient Services

Product, Administration, and Diagnosis Codes*

Codes Pertaining to IDA Underlying Conditions*

Product, Administration, and Diagnosis Codes*
HCPCS1 Injection, ferumoxytol, for treatment of IDA, 1 mg
Q0138 non-ESRD use OR Q0139 ESRD on dialysis
Drug administration CPT® codes2,†
96365 Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug); initial, up to 1 hour
National Drug Codes (NDC)3,‡
59338-0775-01 FERAHEME 510 mg/17 mL, 1 vial
59338-0775-10 FERAHEME 510 mg/17 mL, 10 vials
Diagnosis codes
(ICD-10)4
D50.0 Blood loss (chronic)
D50.1 Sideropenic dysphagia
D50.8 Poor iron absorption
D50.9 Iron deficiency
 
Confirm iron deficiency before using the following codes:
D63.0 Anemia in neoplastic disease
CODE NEOPLASM FIRST
D63.1 Anemia in chronic kidney disease
CODE CKD STAGE
D63.8 Anemia in other chronic diseases classified elsewhere
CODE UNDERLYING DISEASE FIRST
D64.81 Antineoplastic chemotherapy-induced anemia
CKD
N18.1 CKD, Stage 1
N18.2 CKD, Stage 2 (mild)
N18.3 CKD, Stage 3 (moderate)
N18.4 CKD, Stage 4 (severe)
N18.5 CKD, Stage 5
N18.6 End-stage renal disease (requiring dialysis)
N18.9 CKD, unspecified
*This table is provided for informational purposes only. Correct coding is the responsibility of the provider submitting the claim for the item or service. Please check with the payer to verify codes and specific billing requirements. AMAG Pharmaceuticals, Inc. does not make any representation or guarantees concerning reimbursement or coverage for any service or item.
CPT® is a registered trademark of the American Medical Association.
Payer requirements regarding 10-digit and 11-digit NDC may vary.
CKD: chronic kidney disease; CPT: Current Procedural Terminology; ESRD: end-stage renal disease; HCPCS: Healthcare Common Procedure Coding System; ICD: International Classification of Diseases.
References: 1. Centers for Medicare & Medicaid Services, US Department of Health and Human Services. HCPCS 2018 index. https://www.cms.gov/Medicare/Coding/HCPCSReleaseCodeSets/Downloads/2018-HCPCS-Index.pdf. Updated February 15, 2018. Accessed April 9, 2018. 2. American Medical Association. Current Procedural Terminology 2017: Professional Edition, Chicago. IL: American Medical Association; 2016. 3. Feraheme [prescribing information]. AMAG Pharmaceuticals, Inc; February 2018. 4. Centers for Medicare & Medicaid Services. 2018 code tables and index. https://www.cms.gov/Medicare/Coding/ICD10/Downloads/2018-ICD-10-Table-And-Index.zip. Accessed April 9, 2018.
Codes Pertaining to IDA Underlying Conditions*

Diagnosis codes (ICD-10)1

  • E83.10 Iron metabolism
  • E83.19 Other disorders of iron metabolism, specified NEC
  • K50.00, K50.90, K50.919 Crohn’s disease (regional enteritis)
  • K51.00, K51.90, K51.919 Pancolitis, ulcerative colitis, complication
  • K90.0 Celiac disease
  • K90.49 Malabsorption due to intolerance
  • K90.89 Intestinal malabsorption, specified NEC
  • K90.9 Intestinal malabsorption
  • N18.1 CKD, stage 1
  • N18.2 CKD, stage 2
  • N18.3 CKD, stage 3
  • N18.4 CKD, stage 4
  • N18.5 CKD, stage 5
  • N18.6 CKD, end-stage (failure)
  • N18.9 CKD
  • N92.0, N92.6 Excessive, frequent, and irregular menstruation
  • N95.0 Postmenopausal bleeding
  • T45.4X5 [A,S,D] Adverse effect of iron and its compounds
  • T50.905 [A,S,D] Adverse effect of unspecified drugs, medicaments, and biological substances

*This table is provided for informational purposes only. Correct coding is the responsibility of the provider submitting the claim for the item or service. Please check with the payer to verify codes and specific billing requirements. AMAG Pharmaceuticals, Inc. does not make any representation or guarantees concerning reimbursement or coverage for any service or item.
CKD: chronic kidney disease; ICD: International Classification of Diseases; NEC: not elsewhere classified.
Reference: 1. Centers for Medicare & Medicaid Services. 2018 code tables and index. https://www.cms.gov/Medicare/Coding/ICD10/Downloads/2018-ICD-10-Table-And-Index.zip. Accessed April 9, 2018.
 
Feraheme® (ferumoxytol injection) Important Safety Information

WARNING: RISK FOR SERIOUS HYPERSENSITIVITY/ANAPHYLAXIS REACTIONS

Fatal and serious hypersensitivity reactions including anaphylaxis have occurred in patients receiving Feraheme. Initial symptoms may include hypotension, syncope, unresponsiveness, cardiac/cardiorespiratory arrest.

  • Only administer Feraheme as an intravenous infusion over at least 15 minutes and only when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions.
  • Observe for signs or symptoms of hypersensitivity reactions during and for at least 30 minutes following Feraheme infusion including monitoring of blood pressure and pulse during and after Feraheme administration.
  • Hypersensitivity reactions have occurred in patients in whom a previous Feraheme dose was tolerated.
Indication and Dosing

Feraheme is indicated for the treatment of iron deficiency anemia (IDA) in adult patients:

  • who have intolerance to oral iron or have had unsatisfactory response to oral iron or
  • who have chronic kidney disease (CKD)

The recommended dose of FERAHEME is an initial 510 mg dose followed by a second 510 mg dose as early as 3 days and up to 8 days later, each dose infused over at least 15 minutes while the patient is in a reclined or semi-reclined position.

Contraindications

Feraheme is contraindicated in patients with known hypersensitivity to Feraheme or any of its components or a history of allergic reaction to any intravenous iron product.

Warnings and Precautions

Hypersensitivity: In addition to the fatal and serious adverse reactions in the Boxed Warning, other adverse reactions associated with hypersensitivity have occurred (pruritus, rash, urticaria, and wheezing). Allergic reactions have occurred following the first dose or subsequent doses in patients in whom a previous dose was tolerated. Patients with a history of multiple drug allergies may have a greater risk of anaphylaxis with parenteral iron products. Carefully consider the potential risks and benefits before administering Feraheme to these patients. Elderly patients with multiple or serious co-morbidities who experience hypersensitivity reactions and/or hypotension following administration of Feraheme may have more severe outcomes.

Hypotension: Feraheme may cause clinically significant hypotension. Monitor patients for signs and symptoms of hypotension following each Feraheme administration.

Iron Overload: Excessive therapy with parenteral iron can lead to excess storage of iron with the possibility of iatrogenic hemosiderosis. Regularly monitor the hematologic response during parenteral iron therapy. Do not administer Feraheme to patients with iron overload.

Magnetic Resonance (MR) Imaging Test Interference: Administration of Feraheme may transiently affect the diagnostic ability of MR imaging. Alteration of MR imaging studies may persist for up to 3 months following the last Feraheme dose. Maximum alteration of vascular MR imaging is anticipated to be evident for 1 – 2 days following Feraheme administration.

Adverse Reactions

The most common adverse reactions (≥ 2%) are diarrhea, headache, nausea, dizziness, hypotension, constipation, and peripheral edema.

You may report an adverse event related to AMAG Pharmaceuticals’ products by calling 1-877-411-2510 or emailing amag@druginfo.com. If you prefer, you may contact the U.S. Food and Drug Administration (FDA) directly at fda.gov/medwatch or call 1-800-FDA-1088.