antares pharma, inc. - Medication Listings

Hyaluronidase is an endoglycosidase used to increase the dispersion and absorption of co-administered drugs when administered subcutaneously. It is a glycosylated single-chain protein produced by genetically engineered Chinese Hamster Ovary (CHO) cells containing a DNA plasmid encoding for a soluble fragment of human hyaluronidase (PH20). Hyaluronidase has an approximate molecular weight of 61 kDa. HYLENEX recombinant (hyaluronidase) injection is supplied as a sterile, clear and colorless, nonpreserved, ready-for-use 1 mL solution in a single-dose vial for infiltration use, for interstitial use, for intramuscular use, for intraocular use, for peribulbar use, for retrobulbar use, for soft tissue use, or for subcutaneous use. Each mL contains 150 USP units of hyaluronidase with albumin human (1 mg), dibasic sodium phosphate (1.4 mg), methionine (1.5 mg), polysorbate 80 (0.2 mg), and sodium chloride (8.5 mg). Hydrochloric acid and sodium hydroxide may be added during manufacture to adjust the pH. HYLENEX has an approximate pH of 7.0.

Otrexup contains methotrexate, a folate analog metabolic inhibitor. Chemically, methotrexate is [N-[4-[[(2,4-diamino-6-pteridinyl)methyl]methylamino]benzoyl]-Lglutamic acid. The structural formula is: C 20 H 22 N 8 O 5 M.W.= 454.45 Otrexup contains methotrexate in a sterile, preservative-free, unbuffered solution with a 27 gauge ½ inch needle for a single subcutaneous injection. Otrexup solution is yellow in color. Inactive ingredients include sodium chloride and water for injection, USP. The amounts of sodium chloride vary with the amount of methotrexate. Amount of methotrexate (mg) per 0.4 mL 10 12.5 15 17.5 20 22.5 25 Amount of sodium chloride (mg) per 0.4 mL 1.96 2.04 1.60 1.48 1.28 0.92 0.56 Hydrochloric acid and additional sodium hydroxide may have been added, if necessary, to adjust the pH to 8.0. Structure

TLANDO (testosterone undecanoate) capsules contain 112.5 mg testosterone undecanoate, an ester of testosterone, for oral administration. Testosterone, an androgen, is formed by cleavage of the ester side chain of testosterone undecanoate. The chemical name of testosterone undecanoate is 17β-undecanoyloxy-4-androsten-3-one. It has an empirical formula of C 30 H 48 O 3 and a molecular weight of 456.7. The structural formula is: Testosterone undecanoate is a white to off-white crystalline substance. The inactive ingredients in TLANDO capsules are ascorbyl palmitate, glyceryl monolinoleate, polyethylene glycol 8000, and polyoxyl 40 hydrogenated castor oil. The capsule shell contains black iron oxide, gelatin, and titanium dioxide. The capsule is imprinted with black ink that contains ammonium hydroxide, black iron oxide, propylene glycol, and shellac. Structure

XYOSTED (testosterone enanthate) injection contains testosterone enanthate, an ester derivative of an endogenous androgen, testosterone. Testosterone enanthate is a white to creamy white crystalline powder described by the chemical name (17β)-17-[(1-Oxoheptyl) oxy]-androst-4-en-3-one. Testosterone enanthate has the molecular formula C 26 H 40 O 3 , the molecular weight 400.59, and the molecular structure with the chemical formula: XYOSTED (testosterone enanthate) injection is a sterile, preservative-free, and nonpyrogenic colorless to pale yellow solution supplied in a single-dose syringe assembled in a pressure-assisted autoinjector for subcutaneous administration. Each XYOSTED autoinjector contains 50 mg, 75 mg, or 100 mg of testosterone in sesame oil to form 0.5 mL solution providing three product strengths of 50 mg/0.5 mL, 75 mg/0.5 mL, and 100 mg/0.5 mL. Testosterone enanthate structure