RETACRIT™ Drug Abuse and Dependence

(epoetin alfa-epbx)

9 DRUG ABUSE AND DEPENDENCE

     

9.1 Controlled Substance

RETACRIT contains epoetin alfa-epbx, which is not a controlled substance.

9.2 Abuse

Abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. Abuse of RETACRIT may be seen in athletes for the effects on erythropoiesis. Abuse of drugs that increase erythropoiesis, such as RETACRIT, by healthy persons may lead to life-threatening cardiovascular complications (e.g., stroke, myocardial infarction, and thromboembolism) [see Warnings and Precautions (5.1)].

In animal studies, epoetin alfa did not distribute to the CNS nor produce behavioral effects that are consistent with CNS activity.

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Drug Abuse and Dependence

9 DRUG ABUSE AND DEPENDENCE

     

9.1 Controlled Substance

RETACRIT contains epoetin alfa-epbx, which is not a controlled substance.

9.2 Abuse

Abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. Abuse of RETACRIT may be seen in athletes for the effects on erythropoiesis. Abuse of drugs that increase erythropoiesis, such as RETACRIT, by healthy persons may lead to life-threatening cardiovascular complications (e.g., stroke, myocardial infarction, and thromboembolism) [see Warnings and Precautions (5.1)].

In animal studies, epoetin alfa did not distribute to the CNS nor produce behavioral effects that are consistent with CNS activity.

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