ইঙ্গিত ও ব্যবহার
Trisela এর জন্য নির্দেশিত:
ডোজ নির্দেশিকা
শুধুমাত্র নির্দেশিকা তথ্য
প্রদর্শিত ডোজগুলি সরকারি উৎসের সাধারণ নির্দেশিকা। ব্যক্তিগতকৃত ডোজের জন্য সর্বদা আপনার ডাক্তার বা ফার্মাসিস্টের পরামর্শ নিন।
প্রাপ্তবয়স্ক:
Dosage Recommended Dosage The recommended dose of Trilaciclib is 240 mg/m 2 per dose. Administer as a 30-minute intravenous infusion completed within 4 hours prior to the start of chemotherapy on each day chemotherapy is administered. The interval between doses of Trilaciclib on sequential days should not be greater than 28 hours.Missed Treatment Session(s): If the Trilaciclib dose is missed, discontinue chemotherapy on the day the Trilaciclib dose was missed. Consider resuming both Trilaciclib and chemotherapy on the next scheduled day for chemotherapy.Discontinuation of Treatment: If Trilaciclib is discontinued, wait 96 hours from the last dose of Trilaciclib before resumption of chemotherapy only.Preparation & Administration: Reconstitute and further dilute Trilaciclib prior to intravenous infusion as outlined below. Use aseptic technique for reconstitution and dilution. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
পার্শ্বপ্রতিক্রিয়া
Injection-Site Reactions, including phlebitis and thrombophlebitis Acute Drug Hypersensitivity Reactions ILD/Pneumonitis
সতর্কতা ও নিষেধাজ্ঞা
সতর্কতা ও সাবধানতা
Injection-Site Reactions, Including Phlebitis and Thrombophlebitis: Trisela administration can cause injection-site reactions including phlebitis and thrombophlebitis. Injection-site reactions including phlebitis and thrombophlebitis occurred in 56 (21%) of 272 patients receiving Trisela in clinical trials, including Grade 2 (10%) and Grade 3 (0.4%) adverse reactions (ARs). The median time to onset from start of Trisela was 15 days (range 1 to 542) and from the preceding dose of Trisela was 1 day (1 to 15).The median duration was 1 day (range 1 to 151 for the resolved cases). Injection-site reactions including phlebitis and thrombophlebitis resolved in 49 (88%) of the 56 patients and led to discontinuation of treatment in 3 (1%) of the 272 patients. Monitor patients for signs and symptoms of injection-site reactions, phlebitis, and thrombophlebitis, including infusion-site pain and erythema during infusion. For mild (Grade 1) to moderate (Grade 2) injection-site reactions, flush line/cannula with at least 20 mL of sterile 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP after end of infusion. For severe (Grade 3) or life-threatening (Grade 4) injection-site reactions, stop infusion and permanently discontinue Trisela.Acute Drug Hypersensitivity Reactions: Trisela administration can cause acute drug hypersensitivity reactions, including facial edema and urticaria. Acute drug hypersensitivity reactions occurred in 16 (6%) of 272 patients receiving Trisela in clinical trials, including Grade 2 reactions (2%). One patient experienced a Grade 2 anaphylactic reaction 4 days after receiving Trisela, which resolved with epinephrine, and treatment with Trisela was continued. The median time to onset from start of Trisela was 77 days (range 2 to 256) and from the preceding dose of Trisela was 1 day (range 1 to 28). The median duration was 6 days (range 1 to 69 for the resolved cases). Acute drug hypersensitivity reactions resolved in 12 (75%) of the 16 patients. Monitor patients for signs and symptoms of acute drug hypersensitivity reactions including facial, eye, and tongue edema, urticaria, pruritus, and anaphylactic reactions. For moderate (Grade 2) acute drug hypersensitivity reactions, stop infusion and hold Trisela until the adverse reaction recovers to Grade ≤1. For severe (Grade 3) or life-threatening (Grade 4) acute drug hypersensitivity reactions, stop infusion and permanently discontinue Trisela.Interstitial Lung Disease/Pneumonitis: Severe, life-threatening, or fatal interstitial lung disease (ILD) and/or pneumonitis can occur in patients treated with cyclin-dependent kinases (CDK)4/6 inhibitors, the same drug class as Trisela. ILD/pneumonitis occurred in 1 (0.4%) of 272 patients receiving Trisela in clinical trials. The adverse reaction was Grade 3 and reported 2 months after discontinuing Trisela, in a patient receiving a confounding medication. The adverse reaction did not resolve. Monitor patients for pulmonary symptoms indicative of ILD/pneumonitis such as cough, dyspnea, and hypoxia. For recurrent moderate (Grade 2) ILD/pneumonitis, permanently discontinue Trisela. For severe (Grade 3) or life-threatening (Grade 4) ILD/pneumonitis, permanently discontinue TriselaEmbryo-Fetal Toxicity: Based on its mechanism of action, Trisela can cause fetal harm when administered to a pregnant woman. Females of reproductive potential should use an effective method of contraception during treatment with Trisela and for at least 3 weeks after the final dose.
নিষেধাজ্ঞা
Trilaciclib is contraindicated in patients with a history of serious hypersensitivity reactions to Trilaciclib. Reactions have included anaphylaxis.