Covaryx HS and Infliximab, Infliximab-dyyb

• Generic Name: esterified estrogens / methyltestosterone
• Dosage Forms: n.a.
• Other Brand Names: Covaryx, Covaryx HS, EEMT, EEMT DS, EEMT HS, Essian, Essian HS, Estratest, Estratest HS, Menogen HS, Menogen, Syntest HS, Syntest DS

Esterified estrogens are female sex hormones produced by the ovaries.

Methyltestosterone is a sex hormone that is produced in a man's testicles. Small amounts of testosterone are also produced in a woman's ovaries and adrenal system.

Covaryx HS is a combination medicine used to treat symptoms of menopause such as hot flashes or night sweats. Covaryx HS is usually given only short-term (such as 3 to 6 months).

Covaryx HS may also be used for purposes not listed in this medication guide.

• Generic Name: infliximab
• Dosage Forms: n.a.
• Other Brand Names: Inflectra, Remicade, Renflexis

Used to reduce signs and symptoms of Crohn’s disease and to induce and maintain clinical remission in adults and pediatric patients with moderate to severe active disease who have had an inadequate response to conventional therapies (e.g., corticosteroids, mesalamine or sulfasalazine, azathioprine or mercaptopurine). (See Pediatric Use under Cautions.)

Used to reduce the number of draining enterocutaneous and rectovaginal fistulas and to maintain fistula closure in adults with fistulizing Crohn’s disease (designated an orphan drug by FDA for this use). Consider use when fistulas have not responded to appropriate anti-infective regimens (e.g., ciprofloxacin and/or metronidazole) and/or immunosuppressive therapy (e.g., azathioprine or mercaptopurine).

Used in conjunction with methotrexate to manage the signs and symptoms of rheumatoid arthritis, to improve physical function, and to inhibit progression of structural damage associated with the disease in adults with moderate to severe active rheumatoid arthritis.

Management of the signs and symptoms of active ankylosing spondylitis.

Used to manage the signs and symptoms of active arthritis, inhibit progression of structural damage associated with the disease, and improve physical function in adults with psoriatic arthritis.

Management of chronic, severe (i.e., extensive and/or disabling) plaque psoriasis in adults who are candidates for systemic therapy and in whom other systemic therapies are medically less appropriate. Use only in patients who will be closely monitored and who will have regular follow-up visits with a clinician.

Used to manage the signs and symptoms, to induce and maintain clinical remission and mucosal healing, and to eliminate corticosteroid use in adults with moderate to severe active ulcerative colitis who have had an inadequate response to conventional therapies.

Infliximab used to manage the signs and symptoms and to induce and maintain clinical remission in pediatric patients with moderate to severe active ulcerative colitis who have had an inadequate response to conventional therapies (designated an orphan drug by FDA for treatment of ulcerative colitis in pediatric patients ). Although safety and efficacy of infliximab-dyyb for such use also established, labeled indication for infliximab in pediatric patients with ulcerative colitis was still protected by exclusivity provisions of orphan drug designation when FDA approved infliximab-dyyb biosimilar. (See Pediatric Use under Cautions.)

Has been used in a limited number of pediatric patients with juvenile arthritis; further study needed.

Has been used in a limited number of patients with Behcet’s syndrome.