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UVADEX® (methoxsalen) Sterile Solution is indicated for extracorporeal administration with the THERAKOS® CELLEX® Photopheresis System in the palliative treatment of the skin manifestations of Cutaneous T-Cell Lymphoma (CTCL) that is unresponsive to other forms of treatment.

Terms of Sale

Therakos Ecp Immunomodulation

1. Terms of Sale. These terms of sale are subject to any related agreement between the seller and the buyer. Absent any such agreement, this document constitutes an offer by the seller to sell the products covered by this invoice at the price, and subject to all terms, stated in this invoice. The buyer may not modify any terms of this offer, and the seller hereby objects in advance to any additional or different terms proposed by or on behalf of the buyer in any document requesting or confirming this invoice. Acceptance by the buyer of the products covered by this invoice will constitute an express waiver by the buyer of any additional or different term that it had previously proposed. Except as specifically stated herein there are no audit rights under there terms of sale.

2. Returns. The buyer may only return products covered by this invoice for credit if the seller has previously authorized that return.

3. Adjustments. If the buyer believes that an invoice contains any errors, it must notify the seller’s customer service department no later than fifteen (15) days after the date of the invoice to have seller review such asserted errors. If the buyer wishes to make a claim for lost or damaged products covered by an invoice as a result of shipment, it must include a copy of the delivery receipt.

4. Security Interests. The buyer hereby grants the seller a security interest in all products covered by an invoice as security for payment of all accounts due under said invoice. The buyer shall assist the seller in perfecting that security interest by signing at the seller’s request appropriate documents (including without limitation Form UCC-1 financing statements) and cooperating with the seller (at the seller’s expense) in taking any further actions reasonably necessary to perfect that security interest. The buyer’s nonpayment of any amounts due under an invoice will entitle the seller to all remedies of secured creditor under the Uniform Commercial Code.

5. Option to Accelerate. The seller may by written notice to the buyer demand that the buyer immediately pay all amounts due under an invoice if the seller believes in good faith that the prospect of the buyer paying those amounts has been impaired. By accepting the products covered by an invoice, the buyer is representing that it is not then insolvent within the meaning of Title 11, United States Code, or any similar federal or state law.

6. Taxes. In addition to the invoiced price the buyer shall pay any tax, duty or other fee imposed on this transaction by any federal, state, or local government authority. If the seller is required to prepay any such tax, duty or other fee, the buyer will reimburse the seller the amount of that tax, duty, or other fee.

7. Cost Reporting. The buyer acknowledges that it is required by law to disclose cost reports or claims for reimbursement submitted to Medicare, Medicaid, or certain other health care programs, the cost (including, but not limited to, any discounts, rebates, or any other price reductions) of any product covered by an invoice and on request, provide to the U.S. Department of Health and Human Services and any state agencies any invoices, coupons, statements, and other documentation reflecting such costs. The buyer may receive subsequent documentation under some programs reflecting adjustments or allocations to the price available hereunder. In preparing any cost reports, the buyer may be required to evaluate as a discount the value of any product listed as $0.00 on any invoice. The buyer should not include as a discount for cost-reporting purposes the value of any item that is designated as a sample or that the buyer knows constitutes a sample, and it should not seek reimbursement for any such items. The seller recommends that the buyer retain a copy of an invoice and any other documentation provided by the seller regarding any price concessions under an invoice. The buyer may request additional information form the seller to meet the buyer’s reporting or disclosure obligations by writing to the address on the reverse side.

8. No Resale. The products covered by an invoice are intended for the buyer’s own use in the United States and Canada are not for resale unless the buyer is the seller’s authorized distributor.

9. Product Shortages. The seller is not liable for delays in delivery due to product shortages, acts of nature, war, terrorism, regulatory or carrier issues, or any circumstances beyond its reasonable control.

10. Order Discrepancies. The buyer must notify seller of any defect, shortage in quantity, damage, loss or seller’s failure to comply with the purchase order within ten (10) days of receipt of the products.

11. Prescription Products. Any product on an invoice labeled “Caution: Federal law prohibits dispensing without a prescription” is sold for such use only.

12. Single-Use Products. The buyer shall ensure that units of any patented Single-Use Product that it purchases are used once and only once in delivering patient care and the seller conveys no right in such patented Single-Use Product other than the right to use those units once and only once. A “Single-Use Product”, means any product that is labeled “For Single Use” or “Single Use Only” or “Do Not Reuse” or otherwise labeled to indicate that the product is to be used once and only once in delivering patient care. The seller does not grant the buyer or any other person or entity any license to reprocess, remanufacture, or reconstruct any patented Single-Use Product. In addition to other available remedies, the sale or use of any reprocessed, remanufactured or reconstructed patented Single-Use Product will be subject to available remedies for patent infringement.

13. Deductions or Short Payment of Invoices. Deductions or short payments of invoices must be previously authorized by seller and require receipt of appropriate supporting documentation. Seller will not accept unauthorized deductions form payment of invoices.

14. Warranties. Any warranties provided by the seller for any product covered by this invoice are as described in the package inserts accompanying units of that product on purchase. OTHER THAN AS SET FORTH IN THE PREVIOUS SENTENCE, THERE IS NO IMPLIED OR EXPRESS WARRANTY ON THE PRODUCTS COVERED BY THIS INVOICE, INCLUDING THOSE OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.

INDICATIONS AND USAGE

UVADEX® (methoxsalen) Sterile Solution is indicated for extracorporeal administration with the THERAKOS® CELLEX® Photopheresis System in the palliative treatment of the skin manifestations of Cutaneous T-Cell Lymphoma (CTCL) that is unresponsive to other forms of treatment.

IMPORTANT SAFETY INFORMATION

CAUTION: READ THE THERAKOS® CELLEX® PHOTOPHERESIS SYSTEM’S OPERATOR’S MANUAL PRIOR TO PRESCRIBING OR DISPENSING THIS MEDICATION.

UVADEX (methoxsalen) Sterile Solution should be used only by physicians who have special competence in the diagnosis and treatment of cutaneous T-cell lymphoma and who have special training and experience in the THERAKOS CELLEX Photopheresis System. Please consult the CELLEX Operator's Manual before using this product.

CONTRAINDICATIONS

UVADEX is contraindicated in:

  • Patients exhibiting idiosyncratic or hypersensitivity reactions to methoxsalen, other psoralen compounds, or any of the excipients
  • Patients possessing a specific history of a light-sensitive disease state, including lupus erythematosus, porphyria cutanea tarda, erythropoietic protoporphyria, variegate porphyria, xeroderma pigmentosum, and albinism
  • Patients with aphakia because of significantly increased risk of retinal damage
  • Patients that have contraindications to the photopheresis procedure

WARNINGS AND PRECAUTIONS

  • Patients who are receiving concomitant therapy (either topically or systemically) with known photosensitizing agents such as anthralin, coal tar or coal tar derivatives, griseofulvin, phenothiazines, nalidixic acid, halogenated salicylanilides (bacteriostatic soaps), sulfonamides, tetracyclines, thiazides, and certain organic staining dyes such as methylene blue, toluidine blue, rose bengal, and methyl orange may be at greater risk for photosensitivity reactions with UVADEX
  • Oral administration of methoxsalen followed by cutaneous UVA exposure (PUVA therapy) is carcinogenic. Methoxsalen also causes DNA damage, interstrand cross-links and errors in DNA repair
  • Methoxsalen may cause fetal harm when given to a pregnant woman. Women of childbearing potential should be advised to avoid becoming pregnant.  If UVADEX is used during pregnancy, or if the patient becomes pregnant while receiving UVADEX, the patient should be apprised of the potential hazard to the fetus 
  • Severe photosensitivity can occur in patients treated with UVADEX. Advise patients to wear UVA absorbing, wrap-around sunglasses and cover exposed skin or use a sunblock (SPF 15 or higher), and avoid all exposure to sunlight for twenty-four (24) hours following photopheresis treatment
  • After methoxsalen administration, exposure to sunlight and/or ultraviolet radiation may result in "premature aging" of the skin
  • Since oral psoralens may increase the risk of skin cancers, monitor closely those patients who exhibit multiple basal cell carcinomas or who have a history of basal cell carcinomas
  • Serious burns from either UVA or sunlight (even through window glass) can result if the recommended dosage of methoxsalen is exceeded or precautions are not followed
  • Exposure to large doses of UVA light causes cataracts in animals. Oral methoxsalen exacerbates this toxicity
  • Safety in children has not been established
  • Thromboembolic events, such as pulmonary embolism and deep vein thrombosis, have been reported with UVADEX administration through photopheresis systems for treatment of patients with graft-versus-host disease, a disease for which UVADEX is not approved

ADVERSE REACTIONS

  • Side effects of photopheresis (UVADEX used with the THERAKOS Photopheresis Systems) were primarily related to hypotension secondary to changes in extracorporeal volume (>1%)

For the THERAKOS® CELLEX® Photopheresis Procedure:
INDICATIONS
The THERAKOS CELLEX Photopheresis System is indicated for use in the ultraviolet-A (UVA) irradiation, in the presence of the photoactive drug 8-methoxypsoralen (8-MOP), of extracorporeally circulating leukocyte-enriched blood, in the palliative treatment of the skin manifestations of cutaneous T-cell lymphoma (CTCL), in persons who have not been responsive to other forms of treatment.

IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
The THERAKOS CELLEX Photopheresis System is not designated, sold, or intended for use except as indicated.

Certain underlying medical conditions contraindicate THERAKOS Photopheresis, including patients:

  • who cannot tolerate extracorporeal volume loss during the leukocyte-enrichment phase
  • exhibiting idiosyncratic or hypersensitivity reactions to 8-methoxypsoralen/psoralen compounds
  • with coagulation disorders
  • who have had previous splenectomy

WARNINGS AND PRECAUTIONS

  • THERAKOS Photopheresis treatments should always be performed in locations where standard medical emergency equipment is available. Volume replacement fluids and/or volume expanders should be readily available throughout the procedure
  • Patients who may not be able to tolerate the fluid changes associated with extracorporeal photopheresis should be monitored carefully
  • Procedures, such as renal dialysis, which might cause significant fluid changes (and expose the patient to additional anticoagulation) should not be performed on the same day as extracorporeal photopheresis
  • Individual patients may require a heparin dosage that varies from the recommended dose to prevent post-treatment bleeding or clotting during a treatment

ADVERSE REACTIONS

  • Hypotension may occur during any treatment involving extracorporeal circulation. Closely monitor the patient during the entire treatment for hypotension
  • Transient pyretic reactions, 37.7-38.9°C (100-102°F), have been observed in some patients within six to eight hours of reinfusion of the photoactivated leukocyte-enriched blood. A temporary increase in erythroderma may accompany the pyretic reaction
  • Treatment frequency exceeding labeling recommendations may result in anemia
  • Venous access carries a small risk of infection and pain

Please see accompanying Full Prescribing Information, including the BOXED WARNING for UVADEX, and see the THERAKOS Photopheresis System Operator’s Manual.

 

IMPORTANT SAFETY INFORMATION
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CAUTION: READ THE THERAKOS® CELLEX® PHOTOPHERESIS SYSTEM’S OPERATOR’S MANUAL PRIOR TO PRESCRIBING OR DISPENSING THIS MEDICATION.

UVADEX (methoxsalen) Sterile Solution should be used only by physicians who have special competence in the diagnosis and treatment of cutaneous T-cell lymphoma and who have special training and experience in the THERAKOS CELLEX Photopheresis System. Please consult the CELLEX Operator's Manual before using this product.