Ordering ALPHANATE ALPHANATE ordering, coding, and billing
Order ALPHANATE from these authorized distributors
ASD Healthcare
800-746-6273
www.asdhealthcare.com
BDI Pharma, Inc.
800-948-9834
www.bdipharma.com
BioCARE
800-304-3064
www.biocare-us.org
Cardinal Health Specialty Pharmaceutical Distribution
866-476-1340
www.cardinalhealth.com/spd
FFF Enterprises
800-843-7477
www.fffenterprises.com
McKesson Plasma and Biologics, LLC
877-625-2566
www.mckesson.com
National Hospital Specialties
800-344-6087
www.nhsusa.com
Prodigy Health Supplier
877-693-4376
www.prodigyhealth.com
For more information, call Grifols Customer Service at 888-GRIFOLS (888-474-3657).
Coding and billing
ALPHANATE® (antihemophilic factor/von Willebrand factor complex [human]) coding and billing chart.
| Coding System | Code | Description |
|---|---|---|
| Product CPT® and/or HCPCS | J7186 | Injection antihemophilic factor VIII/von Willebrand factor complex (human), per factor VIII IU |
| Administration CPT | 96365 | Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug); initial, up to 1 hour |
| Administration CPT | 96366 | Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug); each additional hour |
| ICD-9-CM | 286.0 | Congenital factor VIII disorder |
| ICD-9-CM | 286.4 | von Willebrand's disease |
| ICD-10-CM | D66.0 | Hereditary factor VIII deficiency |
| ICD-10-CM | D68.0 | von Willebrand's disease |
| Product NDC | 68516-4601-1 or 68516-4611-1 | 250 IU (5 mL diluent) |
| Product NDC | 68516-4602-1 or 68516-4612-1 | 500 IU (5 mL diluent) |
| Product NDC | 68516-4603-2 or 68516-4613-2 | 1000 IU (10 mL diluent) |
| Product NDC | 68516-4604-2 or 68516-4614-2 | 1500 IU (10 mL diluent) |
| Product NDC | 68516-4609-2 or 68516-4615-2 | 2000 IU (10 mL diluent) |
Indications
ALPHANATE® (antihemophilic factor/von Willebrand factor complex [human]) is indicated for:
- Control and prevention of bleeding episodes and perioperative management in adult and pediatric patients with factor VIII (FVIII) deficiency due to hemophilia A
- Surgical and/or invasive procedures in adult and pediatric patients with von Willebrand disease (VWD) in whom desmopressin (DDAVP) is either ineffective or contraindicated. It is not indicated for patients with severe VWD (type 3) undergoing major surgery
Important Safety Information
ALPHANATE is contraindicated in patients who have manifested life-threatening immediate hypersensitivity reactions, including anaphylaxis, to the product or its components.
Anaphylaxis and severe hypersensitivity reactions are possible with ALPHANATE. Discontinue use of ALPHANATE if hypersensitivity symptoms occur, and initiate appropriate treatment.
Development of procoagulant activity-neutralizing antibodies (inhibitors) has been detected in patients receiving FVIII-containing products. Carefully monitor patients treated with AHF products for the development of FVIII inhibitors by appropriate clinical observations and laboratory tests.
Thromboembolic events have been reported with AHF/VWF complex (human) in VWD patients, especially in the setting of known risk factors.
Intravascular hemolysis may occur with infusion of large doses of AHF/VWF complex (human).
Rapid administration of a FVIII concentrate may result in vasomotor reactions.
Because ALPHANATE is made from human plasma, it may carry a risk of transmitting infectious agents, eg, viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, despite steps designed to reduce this risk.
Monitor for development of FVIII and VWF inhibitors. Perform appropriate assays to determine if FVIII and/or VWF inhibitor(s) are present if bleeding is not controlled with expected dose of ALPHANATE.
The most frequent adverse drug reactions reported with ALPHANATE in >1% of infusions were pruritus, headache, back pain, paresthesia, respiratory distress, facial edema, pain, rash, and chills.
Please see full Prescribing Information for ALPHANATE.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1.800.FDA.1088.