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From: Gate Pharmaceuticals 8/04 Introduces Purinethol 60-count Bottles Dear Pharmacist: GATE Pharmaceuticals, a division of TEVA Pharmaceuticals USA, is pleased to introduce a new 60-count bottle size for Purinethol (mercaptopurine) Tablets. This new size provides the following advantages for you and our patients: -Dispensing Convenience: PURINETHOL will be supplied in a 60-count plastic bottle, sized to accommodate a prescription label, and now featuring a child-resistant closure. -Improved Shelf-Life: With the switch from glass to plastic, we have been able to significantly extend the shelf-life of PURINETHOL Tablets from a 12-month to a 24-month shelf-life. The 60-count bottle is being introduced at the same per-tablet price as the 25-count bottle. The 25-count bottles will be phased out by GATE later in 2004; however product will remain available for a limited time from your wholesaler. Pharmacy inventory of 25 count bottles can be dispensed through the product expiration date. Once your wholesaler's supply of 25-count bottles is depleted, it will be necessary to replenish PURINETHOL Tablets in the 60-count bottles only. Additional product information is as follows: PURINETHOL NDC # SWP SWP Tablets, 50 mg 57844- per bottle per Tablet Bottles of 60 522-06 $........... $......... Now Available Bottles of 25 522-07 $.......... $......... To be phased out when existing supplies are depleted We appreciate your support of PURINETHOL during this transition period. For additional details please refer to the enclosed prescribing information. If you have questions regarding this information, please feel free to contact GATE Customer Service at 1-800-292-GATE. Sincerely, Joseph W. Grotzinger, R.Ph. Director of Marketing |
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June 01, 2004 The First and Only lgG1 Monoclonal Antibody That Binds Specifically to the EGF Receptor (HER1 or c-ErbB-1) on Both Normal and Tumor Cells ImClone Systems Incorporated and Bristol-Myers Squibb Compan are pleased to announce the approval of ERBITUX (Cetuximab), the first and only Monoclonal Antibody That Binds Specifically to the epidermal growth factor receptor (EGFR, HER1 or c-ErbB-1) on both normal and tumor cells. ERBITUX, used in combination with irinotecan, is indicated for the treatment of EGFR-expressing, metastatic colorectal carcinoma in patients who are refractory to irinotecan-based chemotherapy. ERBITUX administered as a single agent is indicated for the treatment of EGFR-expressing, metastatic colorectal carcinoma in patients who are intolerant to irinotecan-based chemotherapy. The effectiveness of ERBITUX is based on objective response rates. Currently, no data available that demonstrate an improvement in disease-related symptoms or increased survival with ERBITUX. The recommended dose of ERBITUX, in combination with irinotecan or as a single agent is 400 mg/m as an initial loading dose (first infusion) administered as a 120-minute IV infusion (maximum infusion rate 5 mL/min). The recommended weekly maintenance dose (all other infusions) is 250 mg/m infused over 60 minutes (maximum infusion rate 5 mL/min). Premedication with H antagonist (eg 50 mg of diphenhydramine IV) is recommended. In clinical trials, grade 3/4 infusion reactions, rarely with fatal outcome ( < 1 in 1,000), occured in approximately 3% (17/633) of patients receiving ERBITUX. Reactions were characterized by rapid onset of airway obstruction (bronchospasm, stridor, hoarseness), urticaria, and hypotension. Caution must be exercsed with every ERBITUX infusion, as there were patients who experienced their first severe infusion reaction during later infusions. Following the ERBITUX infusion, a 1-hour observation period is recommended. Most reactions (90%) were associated with the first infusion of ERBITUX despite the use of prophylactic antihistamines. Severe infusion reactions require immediate and permanent discontinuation of ERBITUX therapy. Premedication with an H, antagonist (eg, 50 mg diphenhydramine IV) is recommended. Appropriate medical therapy including epinephrine, corticosteroids, intravenous antihistamines, bronchodilators, and oxygen should be available for use in the treatment of such reactions. Patients should be carefully observed until the complete resolution of all signs and symptoms, Mild-to-moderate (grade 1/2) infusion reactions are managed by permanently slowing the infusion rate by 50% and by continued use of antihistamine medications (eg diphenhydramine) in subsequent doses. Severe cases of interstitial lung disease (ILD), which was fatal in one case, occured in < 0.5% of patients (3/633) with advanced colorectal cancer receiving ERBITUX. In the event of acute onset or worsening pulmonary symptoms, ERBITUX therapy should be interrupted and a prompt investigation of these symptoms should occur. If ILD is confirmed, ERBITUX should be discontinued and the patients should be treated appropriately. In clinical studies of ERBITUX (Cetuximab), dernatologic toxicities, including acneform rash, skin drying and fisuring, and inflammatory and infectious sequelae (eg, blephartis, cheilitis, cellulitis, cyst), were reported. Acneform rash mostly commonly occured on the face, upper chest, and back; however, it may extend to the extremities. The onset of acneform rash generally occurs within the first 2 weeks of therapy. An acneform shin rash of any grade occured during treatment in 88% and 90% of patients receiving ERBITUX in combination with irinotecan and ERBITUX as a single agent, respectively (14% and 10% grade 3 respectively). Subsequent to the development of severe dermatologic toxicities, complications including S aureus sepsis and abscesses requiring incision and drainage were reported. Patients developing dermatologic toxicities while receiving ERBITUX should be monitored for the development of inflammatory or infectious sequalae, and appropriate treatment of these symptoms initiated. The most serious adverse reactions (n = 633) associated with ERBITUX were infusion reaction (3%), dermatologic toxicity (1%), interstitial lung disease (<0.5%), sepsis (3%), fever (5%), kidney failure (2%), pulmonary embolus (1%), dehydration (5% in patients receiving ERBITUX in combination with irinotecan, 2% in patients receiving ERBITUX as a single agent), and diarrhea (6% in patients receiving ERBITUX in combination with irinotecan, 0% in patients receving ERBITUX as a single agent). The most common adverse events in patients receiving ERBITUX in combination with irinotecan (n = 354) were acneform rash (88%), asthenia/malaise (73%), diarrhea (72%), nausea (55%), abdominal pain (45%), and vomiting (41%). The most common adverse events in patients receiving ERBITUX as a single agent (n = 279) were acneform rash (90%), asthenia/malaise (49%) fever (33%), nausea (29%), consitpation (28%), and diarrhea (28%). If a patient experiences severe acneform rash, ERBITUX dosage adjustments should be made as follows: ERRBITUX Dose Modification Guidelines
In patients with mild and moderate skin toxicity, treatment should continue without dose modification. Treatment with topical and/or oral antibiotics should be considered; topical corticosteroids are not recommended. Sunlight can exacerbate any skin reactions, therefore, it is recommended that patients wear sunscreen and hats, and limit sun exposure. Nail disorder was observed in 14% of patients, any grade (0.3% to grade 3), and was characterized as a paronychial inflammation with associated swelling of the lateral nail folds of the toes and fingers, with the great toes and thumbns as the most commonly affected digits. ERBITUX must be administered with the use of a low protein binding 0.22-micrometter in-line filter. ERBITUX is supplied as a 5--mL, single-use vial containing 100 mg of Cetuximab at a concentration of 2 mg /mL in phosphate-buffered saline. The solution should be clear and colorless and may contain a small amount of easily visible, white, amorphois Cetuximab particulates. DO NOT SHAKE OR DILUTE. DO NOT ADMINISTER ERBITUX AS AN IV PUSH OR BOLUS. ERBITUX can be administered bia an infusion pump or a syringe pump and should be piggybacked to the patient's infusion line. For more information on these two infusion alternatives, please see the enclosed full presribing information. We at ImClone Systems Incorporated and Bristol-Myers Squibb Company are proud to offer ERBITUX (Cetuximab) as a new treatment option in the fight against EGFR-expressing metastatic colorectal cancer. For more information on ERBITUX, please visit our website at www.ERBITUX.com or call 1-888-ERBITUX (372-4889).
Source: Imclone Systems Incorporated Bristol-Myers Squibb Company |
