ANTARES RECEIVES FDA APPROVAL OF XYOSTED[emoji769] (TESTOSTERONE ENANTHATE) INJECTION FOR TESTOSTERONE REPLACEMENT THERAPY IN ADULT MALES
https://www.antarespharma.com/...XYO...oval_Final.pdf
A Novel Subcutaneous Auto Injector Product Approved For Once-Weekly At-Home Therapy
Antares Pharma, Inc. (NASDAQ: ATRS) today announced the approval of XYOSTED[emoji769] (testosterone enanthate) injection by the U.S. Food and Drug Administration (FDA). XYOSTED[emoji769] is the first FDA approved subcutaneous testosterone enanthate product for once-weekly, at-home self-administration with an easy-to-use, single dose, disposable QuickShot[emoji2400] auto injector. XYOSTED[emoji769] has been approved in three dosage strengths, 50 mg, 75 mg and 100 mg and is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone (see Indications and Usage below).
BOXED WARNING: BLOOD PRESSURE INCREASES
· XYOSTED[emoji769] can cause blood pressure increases that can increase the risk for major adverse cardiovascular events (MACE), including non-fatal myocardial infarction, non-fatal stroke and cardiovascular death, with greater risk for MACE in patients with cardiovascular risk factors or established cardiovascular disease.
· Before initiating XYOSTED[emoji769], consider the patient’s baseline cardiovascular risk and ensure blood pressure is adequately controlled.
· Starting approximately 6 weeks after initiating therapy, periodically monitor for and treat new-onset hypertension or exacerbations of pre-existing hypertension in patients on XYOSTED[emoji769].
· Re-evaluate whether the benefits of XYOSTED[emoji769] outweigh its risks in patients who develop cardiovascular risk factors or cardiovascular disease while on treatment.
· Due to this risk, use XYOSTED[emoji769] only for the treatment of men with hypogonadal conditions associated with structural or genetic etiologies.
https://www.antarespharma.com/...XYO...oval_Final.pdf
A Novel Subcutaneous Auto Injector Product Approved For Once-Weekly At-Home Therapy
Antares Pharma, Inc. (NASDAQ: ATRS) today announced the approval of XYOSTED[emoji769] (testosterone enanthate) injection by the U.S. Food and Drug Administration (FDA). XYOSTED[emoji769] is the first FDA approved subcutaneous testosterone enanthate product for once-weekly, at-home self-administration with an easy-to-use, single dose, disposable QuickShot[emoji2400] auto injector. XYOSTED[emoji769] has been approved in three dosage strengths, 50 mg, 75 mg and 100 mg and is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone (see Indications and Usage below).
BOXED WARNING: BLOOD PRESSURE INCREASES
· XYOSTED[emoji769] can cause blood pressure increases that can increase the risk for major adverse cardiovascular events (MACE), including non-fatal myocardial infarction, non-fatal stroke and cardiovascular death, with greater risk for MACE in patients with cardiovascular risk factors or established cardiovascular disease.
· Before initiating XYOSTED[emoji769], consider the patient’s baseline cardiovascular risk and ensure blood pressure is adequately controlled.
· Starting approximately 6 weeks after initiating therapy, periodically monitor for and treat new-onset hypertension or exacerbations of pre-existing hypertension in patients on XYOSTED[emoji769].
· Re-evaluate whether the benefits of XYOSTED[emoji769] outweigh its risks in patients who develop cardiovascular risk factors or cardiovascular disease while on treatment.
· Due to this risk, use XYOSTED[emoji769] only for the treatment of men with hypogonadal conditions associated with structural or genetic etiologies.
No comments:
Post a Comment