Methoxy polyethylene glycol-epoetin beta

CKD patients on dialysis: 0.6 mcg/kg body weight administered once every two weeks. CKD patients not on dialysis: 1.2 mcg/kg body weight administered once every month as a single subcutaneous injection. Alternatively, a starting dose of 0.6 mcg/kg body weight may be administered once every two weeks as a single intravenous or subcutaneous injection.

Administer Mircera either intravenously or subcutaneously. When administered subcutaneously, Mircera should be injected in the abdomen, arm or thigh. For Adult Patients with CKD on dialysis : The recommended starting dose of Mircera for the treatment of anemia in adult CKD patients who are not currently treated with an ESA is 0.6 mcg/kg body weight administered once every two weeks as a single intravenous or subcutaneous injection.

The intravenous route is recommended for patients receiving hemodialysis because the intravenous route may be less immunogenic [see Adverse Reactions] . Once the hemoglobin has been stabilized, Mircera may be administered once monthly using a dose that is twice that of the every-two-week dose and subsequently titrated as necessary.

For Adult Patients with CKD not on dialysis :

For Adult Patients with CKD Prefilled syringes are not designed for administration of partial doses. Round doses to the closest dose achievable with the prefilled syringes. When initiating or adjusting therapy, monitor hemoglobin levels at least weekly 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. Decreases in dose can occur more frequently. Avoid frequent dose adjustments.

If the hemoglobin rises rapidly (e.g., more than 1 g/dL in any 2-week period), reduce the dose of Mircera by approximately 25% to the closest dose achievable with the prefilled syringes to reduce rapid responses.

If the hemoglobin continues to rise following a dose reduction, discontinue Mircera until the hemoglobin level begins to decrease, at which point therapy should be restarted with a dose that is 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 approximately 25% to the closest dose achievable with the prefilled syringes.

For patients who do not respond adequately over a 12-week escalation period, increasing the Mircera 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 Mircera if responsiveness does not improve.

Administer Mircera either intravenously or subcutaneously. When administered subcutaneously, Mircera should be injected in the abdomen, arm or thigh. For Adult Patients with CKD on dialysis :

Initiate Mircera treatment when the hemoglobin level is less than 10 g/dL.

If the hemoglobin level approaches or exceeds 11 g/dL, reduce or interrupt the dose of Mircera.

The recommended starting dose of Mircera for the treatment of anemia in adult CKD patients who are not currently treated with an ESA is 0.6 mcg/kg body weight administered once every two weeks as a single intravenous or subcutaneous injection. The intravenous route is recommended for patients receiving hemodialysis because the intravenous route may be less immunogenic [see Adverse Reactions] .

Once the hemoglobin has been stabilized, Mircera may be administered once monthly using a dose that is twice that of the every-two-week dose and subsequently titrated as necessary. For Adult Patients with CKD not on dialysis :

Consider initiating Mircera treatment only when the hemoglobin level is less than 10 g/dL and the following considerations apply: o The rate of hemoglobin decline indicates the likelihood of requiring a RBC transfusion and , o Reducing the risk of alloimmunization and/or other RBC transfusion-related risks is a goal.

If the hemoglobin level exceeds 10 g/dL, reduce or interrupt the dose of Mircera, and use the lowest dose of Mircera sufficient to reduce the need for RBC transfusions.

The recommended starting dose of Mircera for the treatment of anemia in adult CKD patients who are not currently treated with an ESA is 1.2 mcg/kg body weight administered once every month as a single subcutaneous injection. Alternatively, a starting dose of 0.6 mcg/kg body weight may be administered once every two weeks as a single intravenous or subcutaneous injection.

Once the hemoglobin has been stabilized, Mircera may be administered once monthly using a dose that is twice that of the every-two-week dose and subsequently titrated as necessary. Refer patients who self-administer Mircera to the Instructions for Use [see Patient Counseling Information] . Conversion from Epoetin alfa or Darbepoetin alfa to Mircera in Adult Patients with CKD Mircera can be administered once every two weeks or once monthly to patients whose hemoglobin has been stabilized by treatment with an ESA (see Table 1 ).

The dose of Mircera, given as a single intravenous or subcutaneous injection, should be based on the total weekly ESA dose at the time of conversion. Table1: Mircera Starting Doses for Adult Patients Currently Receiving an ESA [See table below.]

Preparation and Administration of Mircera Mircera is packaged as single-dose prefilled syringes. Mircera contains no preservatives. Discard any unused portion. Do not pool unused portions from the prefilled syringes. Do not use the prefilled syringe more than once. Always store Mircera prefilled syringes in their original cartons.

Vigorous shaking or prolonged exposure to light should be avoided. Do not mix Mircera with any parenteral solution. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Do not use any prefilled syringes exhibiting particulate matter or a coloration other than colorless to slightly yellowish.

For administration using the prefilled syringe, the plunger must be fully depressed during injection in order for the needle guard to activate. Following administration, remove the needle from the injection site and then release the plunger to allow the needle guard to move up until the entire needle is covered. Children and adolescents less than 17 years of age should not self-inject Mircera.

Intravenous and subcutaneous administration should be performed by a healthcare professional or adult caregiver. See “Instructions for Use” for complete instructions on the preparation and administration of Mircera. Examine each prefilled syringe for the expiration date. Do not use Mircera after the expiration date.