Imetelstat
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Dosing in kidney impairment
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Preparation and administration
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2. DOSAGE AND ADMINISTRATION The recommended dosage of RYTELO is 7.1 mg/kg administered as an intravenous infusion over 2 hours every 4 weeks. Premedicate prior to dosing with RYTELO for potential infusion-related reactions. See full prescribing information for preparation and administration instructions. 2.1. Recommended Dosage The recommended dosage of RYTELO is 7.1 mg/kg administered as an intravenous infusion over 2 hours every 4 weeks.
Discontinue RYTELO if a patient does not experience a decrease in red blood cell (RBC) transfusion burden after 24 weeks of treatment (administration of 6 doses) or if unacceptable toxicity occurs at any time [see Dosage and Administration ] . 2.2. Recommended Premedications Administer the following pre-treatment medications at least 30 minutes prior to dosing to prevent or reduce potential infusion-related reactions: diphenhydramine (or equivalent) 25 mg to 50 mg, intravenously or orally hydrocortisone (or equivalent) 100 mg to 200 mg, intravenously or orally Monitor patients for adverse reactions for at least one hour after the infusion has been completed [see Warnings and Precautions and Adverse Reactions ] . 2.3.
Second and Third Delay RYTELO until recovery of ANC to 1 × 10 9 /L; restart at one dose level lower. Fourth Discontinue RYTELO. Grade 4 First and Second Delay RYTELO until recovery of ANC to 1 × 10 9 /L; restart at one dose level lower. Third Discontinue RYTELO. Dosage Modifications for Non-hematologic Adverse Reactions Dosage modifications for infusion-related reactions and other adverse drug reactions, including elevated liver function tests (LFTs), are described in Table 3.
Monitor liver function tests prior to administration of RYTELO, weekly for the first cycle, prior to each cycle thereafter, and as clinically indicated. [See table below.] 2.4. Preparation and Administration RYTELO is provided as a lyophilized powder in a single-dose vial for intravenous infusion only and must be reconstituted and diluted prior to administration.
Use aseptic technique to prepare RYTELO. RYTELO does not contain a preservative. Reconstitution: Calculate the dose of RYTELO needed based on the patient's body weight (kg). Determine the number of RYTELO vials needed to achieve the required dose (total mg) per Table 4. More than one vial may be needed to achieve a full dose.
Remove the RYTELO vials from the refrigerator and allow the vials to sit for 10 minutes to 15 minutes (not to exceed 30 minutes) to adjust to room temperature 20°C to 25°C (68°F to 77°F) before use. Reconstitute each vial of RYTELO with the volume of 0.9% Sodium Chloride Injection provided in Table 4 directly onto the lyophilized powder to obtain a concentration of 31.4 mg/mL of imetelstat. [See table below.] Swirl each vial gently to avoid foaming until the powder is fully reconstituted (not to exceed 15 minutes).
Do not shake. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The reconstituted solution in each vial should appear as a clear to slightly hazy solution, essentially free of visible contaminants, particles and/or particulates.
Do not use if discoloration or particulate matter is present. Use the reconstituted solution immediately to prepare the RYTELO diluted solution in the infusion bag. Dilution: Calculate the required volume of the reconstituted RYTELO solution needed to obtain the appropriate dose according to the patient's body weight. Withdraw a volume equal to the required reconstituted RYTELO solution from a 500 mL infusion bag of 0.9% Sodium Chloride Injection and discard it.
Add the required volume of reconstituted RYTELO solution into the infusion bag so that the total final volume of RYTELO solution in the bag is approximately 500 mL. Discard any unused portion of the reconstituted solution remaining in each vial. Gently invert the infusion bag at least 5 times to ensure that the reconstituted RYTELO is well-mixed.
Do not shake the infusion bag prior to administration. Diluted RYTELO Solution Storage: If not used immediately, ensure that diluted solution for infusion is used within the total timeframes specified below, according to storage temperature: When stored at room temperature 20°C to 25°C (68°F to 77°F) : The total time from the reconstitution of RYTELO to completion of the intravenous infusion should not exceed 18 hours from the time of reconstitution.
When stored refrigerated 2°C to 8°C (36°F to 46°F) : The total time from the reconstitution of RYTELO to completion of the intravenous infusion should not exceed 48 hours from the time of reconstitution. Administration : Administer the diluted RYTELO solution by intravenous infusion only over a period of 2 hours.
| Adverse Reaction | Severity GradeSeverity based on National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03. | Occurrence | Treatment Modification |
|---|---|---|---|
| Abbreviation: LFT = liver function test | |||
| Infusion-Related Reactions [see Warnings and Precautions (5.3)] | Grade 2 or 3 | First and Second | Interrupt the RYTELO infusion until resolution of the adverse reaction or until the intensity of the reaction decreases to Grade 1; restart infusion at 50% of the infusion rate administered prior to the adverse reaction. |
| Third | For Grade 2, stop infusion. May restart at next cycle. For Grade 3, permanently discontinue RYTELO. | ||
| Grade 4 | First | Stop infusion, administer supportive care as appropriate and permanently discontinue RYTELO. | |
| Other adverse reactions including elevated LFTs [see Adverse Reactions (6.1)] | Grade 3 or 4 | First and Second | Delay RYTELO until recovery of adverse reactions to Grade 1 or baseline; restart at one dose level lower. |
| Third | Permanently discontinue RYTELO. | ||
| StrengthRecommended to use the appropriate combination of vial strengths to most closely match the intended dose based on the patient's weight. | Volume of 0.9% Sodium Chloride Injection for Reconstitution per Vial | Final Concentration of Reconstituted Solution per Vial | Deliverable Volume per Vial |
|---|---|---|---|
| 47 mg | 1.8 mL | 31.4 mg/mLEach vial contains an overfill to account for loss of liquid during preparation and extraction of the reconstituted solution, resulting in the final concentration. | 1.5 mL |
| 188 mg | 6.3 mL | 31.4 mg/mL | 6 mL |
Contraindications
4. CONTRAINDICATIONS None. None. ( 4 )
Pregnancy and lactation
Pregnancy
8.1. Pregnancy Risk Summary Based on findings in animal studies, RYTELO can cause embryo-fetal harm when administered to a pregnant woman. There are no available data on RYTELO use in pregnant women to evaluate for drug-associated risk. In embryo-fetal developmental toxicity studies, administration of imetelstat to pregnant mice and rabbits during the period of organogenesis resulted in embryo-fetal mortality, which in mice occurred at maternal exposures approximately 2.5 times the human exposure at the recommended clinical dose. Advise pregnant women of the potential risk to a fetus [see Data ] . In the U.S.
general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data In embryo-fetal developmental toxicity studies, imetelstat was administered by IV bolus injection at doses of 4.7, 9.4, 14.1 or 28.2 mg/kg/day on gestation days 6, 9, and 12 in mice, or by 2-hour intravenous infusion at doses of 4.7, 14.1, or 28.2 mg/kg on gestation days 6 and 13 in rabbits. In rabbits, the dose of 28.2 mg/kg was maternally toxic.
Increased post-implantation loss due to an increase in early resorptions, resulting in a decrease in viable fetuses and litter was noted in mice at 28.2 mg/kg and in rabbits starting at 14.1 mg/kg; corresponding to exposures (based on AUC) that are approximately 2.5-times (mice) or 9.3-times (rabbits) the human exposure at the recommended clinical dose.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
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