OMONTYS- peginesatide solution
Takeda Pharmaceuticals America, Inc.
WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE
Chronic Kidney Disease:
- In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered erythropoiesis-stimulating agents (ESAs) to target a hemoglobin level of greater than 11 g/dL.
- No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks [see Warnings and Precautions (5.1) ].
- Use the lowest OMONTYS dose sufficient to reduce the need for red blood cell (RBC) transfusions [see Warnings and Precautions (5.1) ].
OMONTYS® is indicated for the treatment of anemia due to chronic kidney disease (CKD) in adult patients on dialysis.
OMONTYS is not indicated and is not recommended for use:
- In patients with CKD not on dialysis because of safety concerns in this population [see Warnings and Precautions (5.1) ].
- In patients receiving treatment for cancer and whose anemia is not due to CKD, because ESAs have shown harm in some settings and the benefit-risk factors for OMONTYS in this setting have not been evaluated [see Warnings and Precautions (5.2) ].
- As a substitute for RBC transfusions in patients who require immediate correction of anemia.
- OMONTYS has not been shown to improve symptoms, physical functioning or health-related quality of life.
Evaluate the iron status in all patients before and during treatment and maintain iron repletion. Correct or exclude other causes of anemia (e.g., vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc.) before initiating OMONTYS [see Warnings and Precautions (5.7) ].
Individualize dosing and use the lowest dose of OMONTYS sufficient to reduce the need for RBC transfusions [see Warnings and Precautions (5.1) ]. In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered erythropoiesis-stimulating agents (ESAs) to target a hemoglobin level of greater than 11 g/dL. No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks. Physicians and patients should weigh the possible benefits of decreasing transfusions against the increased risks of death and other serious cardiovascular adverse events [see Boxed Warning and Clinical Studies (14) ].
Initiate OMONTYS treatment when the hemoglobin level is less than 10 g/dL.
The recommended starting dose for the treatment of anemia in patients who are not currently treated with an ESA is 0.04 mg/kg body weight administered as a single intravenous or subcutaneous injection once monthly.
OMONTYS is administered once monthly, either subcutaneously or intravenously.
In patients previously receiving epoetin alfa or darbepoetin alfa, estimate the starting monthly dose of OMONTYS for patients on the basis of the weekly dose of epoetin alfa or darbepoetin alfa at the time of substitution (see Table 1). Maintain the route of administration (intravenous or subcutaneous injection).
- For patients previously receiving epoetin alfa, the first dose of OMONTYS should be administered one week after the last epoetin alfa dose was administered.
- For patients previously receiving darbepoetin alfa, the first dose of OMONTYS should be administered at the next scheduled dose in place of darbepoetin alfa.
|Previous Total Weekly Epoetin Alfa Dose (U/week)||Previous Weekly Darbepoetin Alfa Dose (mcg/week)||OMONTYS Dose Once Monthly (mg/month)|
|Less than 2,500||Less than 12||2|
|2,500 to less than 4,300||12 to less than 18||3|
|4,300 to less than 6,500||18 to less than 25||4|
|6,500 to less than 8,900||25 to less than 35||5|
|8,900 to less than 13,000||35 to less than 45||6|
|13,000 to less than 19,000||45 to less than 60||8|
|19,000 to less than 33,000||60 to less than 95||10|
|33,000 to less than 68,000||95 to less than 175||15|
|greater than or equal to 68,000||greater than or equal to 175||20|
Monitor hemoglobin levels at least every 2 weeks until stable, then monitor at least monthly. When adjusting therapy, consider hemoglobin rate of rise, rate of decline, ESA responsiveness and hemoglobin variability. A single hemoglobin excursion may not require a dosing change.
- Do not increase the dose more frequently than once every 4 weeks.
- If the hemoglobin rises rapidly (e.g., more than 1 g/dL in the 2 weeks prior to the dose or more than 2 g/dL in 4 weeks), reduce the dose of OMONTYS by 25% or more as needed to reduce rapid responses.
- If the hemoglobin level approaches or exceeds 11 g/dL, reduce or interrupt the dose of OMONTYS. After a dose has been withheld and once the hemoglobin begins to decrease, OMONTYS may be restarted at a dose approximately 25% below the previously administered dose.
- For patients who do not respond adequately, if the hemoglobin has not increased by more than 1 g/dL after 4 weeks of therapy, increase the dose by 25%.
- For patients who do not respond adequately over a 12-week escalation period, increasing the OMONTYS dose further is unlikely to improve response and may increase risks. Use the lowest dose that will maintain a hemoglobin level sufficient to reduce the need for RBC transfusions. Evaluate other causes of anemia. Discontinue OMONTYS if responsiveness does not improve [see Warnings and Precautions (5.5) ].
- If a dose of OMONTYS is missed, administer the missed dose as soon as possible and restart OMONTYS at the prescribed once monthly dosing frequency.
Refer patients who self-administer OMONTYS to the Instructions for Use [see Patient Counseling Information (17) ].
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