avyxa pharma, llc - Medication Listings

Gemcitabine is a nucleoside metabolic inhibitor. The chemical name of gemcitabine hydrochloride, is 2'-deoxy-2',2´-difluorocytidine monohydrochloride (β-isomer). The structural formula is as follows: Gemcitabine hydrochloride, USP is a white to off-white solid with a molecular formula of C 9 H 11 F 2 N 3 O 4 • HCl and a molecular weight of 299.66 g/mol. It is soluble in water, slightly soluble in methanol, and practically insoluble in ethanol and polar organic solvents. AVGEMSI is a sterile solution in multiple-dose vials for intravenous use. Each vial contains 200 mg, 1 g, or 2 g of gemcitabine equivalent to 227.57 mg, 1.137 g, or 2.275 g of gemcitabine hydrochloride, USP. Each mL contains 38 mg of gemcitabine-free base in water for injection equivalent to 43.26 mg of gemcitabine hydrochloride, USP. Sodium hydroxide is used for pH adjustment. structure

Pemetrexed is a folate analog metabolic inhibitor. The drug substance is pemetrexed dipotassium heptahydrate, has the chemical name L-glutamic acid, N-[4-[2-(2-amino-4,7-dihydro-4-oxo-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]-, dipotassium salt, heptahydrate. It is a white to off-white powder having blue or green tinge with a molecular formula of C 20 H 19 K 2 N 5 O 6 .7 H 2 O and a molecular weight of 629.49. Pemetrexed dipotassium is freely soluble in water. The reported pKaS are 3.6 and 4.5. The structural formula of pemetrexed dipotassium heptahydrate is as follows: AXTLE is supplied as a sterile white to light-yellow or green-yellow lyophilized powder or cake for intravenous infusion available in single-dose vials. Each 100-mg or 500-mg vial of AXTLE contains 100 mg pemetrexed equivalent to 118.3 mg pemetrexed dipotassium and 106 mg mannitol or 500 mg pemetrexed equivalent to 591.5 mg pemetrexed dipotassium and 500 mg mannitol, respectively. Hydrochloric acid may have been added to adjust the pH. Image

Cyclophosphamide is an alkylating drug. It is a synthetic antineoplastic drug chemically related to the nitrogen mustards. The chemical name for cyclophosphamide is (±)-2-[Bis(2-chloroethyl)amino]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate, and has the following structural formula: Cyclophosphamide is a white crystalline powder with the molecular formula C 7 H 15 Cl 2 N 2 O 2 P•H 2 O and a molecular weight of 279.1. Cyclophosphamide is soluble in water, saline, or ethanol. The pK a of cyclophosphamide is 5.7. Cyclophosphamide Injection is a clear, colorless to slight yellow sterile solution available as 500 mg/mL, 1 g/2 mL, and 2 g/4 mL in single dose vials for dilution prior to intravenous administration. 500 mg/mL vial contains 534.5 mg cyclophosphamide monohydrate, equivalent to 500 mg cyclophosphamide and 500 mg dehydrated alcohol (equivalent to 63% v/v). 1 g/2 mL vial contains 1069.0 mg cyclophosphamide monohydrate equivalent to 1 g cyclophosphamide and 1000 mg dehydrated alcohol (equivalent to 63% v/v). 2 g/4 mL vial contains 2138.0 mg cyclophosphamide monohydrate, equivalent to 2 g cyclophosphamide and 2000 mg dehydrated alcohol (equivalent to 63% v/v). Image

Docetaxel is an antineoplastic agent belonging to the taxoid family. It is prepared by semisynthesis beginning with a precursor extracted from the renewable needle biomass of yew plants. The chemical name for docetaxel is (2R,3S)-N-carboxy-3-phenylisoserine, N- tert -butyl ester, 13-ester with 5β-20- epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4-acetate 2-benzoate, trihydrate. Docetaxel has the following structural formula: Docetaxel is a white to almost-white powder with an empirical formula of C 43 H 53 NO 14 ·3H 2 O, and a molecular weight of 861.9. It is highly lipophilic and practically insoluble in water. DOCIVYX (docetaxel) Injection is a sterile, non-pyrogenic, pale-yellow to brownish-yellow solution at 10 mg/mL concentration. Each mL contains 10 mg docetaxel (anhydrous), 0.38 grams of sulfoxybutyl ether cyclodextrin (SBECD), 0.16 grams of polyethylene glycol 300, 40 mg of polyvinylpyrrolidone k 12 , and 0.22 grams of dehydrated alcohol in water for injection, with citric acid for pH adjustment. DOCIVYX is available in single-dose vials containing 20 mg (2 mL), 80 mg (8 mL) or 160 mg (16 mL) docetaxel (anhydrous). DOCIVYX requires NO prior dilution with a diluent and is ready to add to the infusion solution. Docetaxel-Structure

Cyclophosphamide is an alkylating drug. It is an antineoplastic drug chemically related to the nitrogen mustards. The chemical name for cyclophosphamide is (±)-2-[Bis(2-chloroethyl)amino]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate, and has the following structural formula: Cyclophosphamide is a white crystalline powder with the molecular formula C 7 H 15 Cl 2 N 2 O 2 P•H 2 O and a molecular weight of 279.1. Cyclophosphamide is soluble in water, saline, or ethanol. The pK a of cyclophosphamide is 5.7. FRINDOVYX is a clear, colorless to slight yellow sterile solution available as 500 mg/mL, 1 g/2 mL, and 2 g/4 mL in multiple dose vial for dilution prior to intravenous administration. 500 mg/mL vial contains 534.5 mg cyclophosphamide monohydrate, equivalent to 500 mg cyclophosphamide and 500 mg dehydrated alcohol (equivalent to 63% v/v). 1 g/2 mL vial contains 1069.0 mg cyclophosphamide monohydrate equivalent to 1 g cyclophosphamide and 1000 mg dehydrated alcohol (equivalent to 63% v/v). 2 g/4 mL vial contains 2138.0 mg cyclophosphamide monohydrate, equivalent to 2 g cyclophosphamide and 2000 mg dehydrated alcohol (equivalent to 63% v/v). Image

KYXATA is a platinum-based drug. The chemical name for carboplatin is platinum, diammine [1,1- cyclobutane-dicarboxylato(2-)-0,0']-,(SP-4-2) and carboplatin has the following structural formula: Carboplatin is a white crystalline powder with the molecular formula of C 6 H 12 N 2 O 4 Pt and a molecular weight of 371.26 g/mol. It is sparingly soluble in water and very slightly soluble in acetone and in alcohol. The pH of a 1% carboplatin solution in water is 5 to 7. KYXATA (carboplatin) injection is supplied as a sterile, clear to pale yellow solution as 20 mg/2 mL, 80 mg/8mL, 500 mg/50 mL in multiple-dose vials for administration by intravenous infusion. Each mL contains 10 mg carboplatin. Image

Leuprolide acetate is a synthetic nonapeptide analog of naturally occurring gonadotropin-releasing hormone (GnRH). The analog possesses greater potency than the natural hormone. The chemical name is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate (salt) with the following structural formula: Where: n=1 or 2 Leuprolide acetate has a molecular weight of 1209.41 as "free base”. Leuprolide is freely soluble in water. LUTRATE DEPOT 22.5 mg for 3-month administration is available in a vial containing white to off white sterile lyophilized microspheres together with the corresponding sterile reconstitution diluent in a pre-filled syringe. When LUTRATE DEPOT and the diluent are mixed together they become a suspension intended as an intramuscular injection to be given ONCE EVERY 12 WEEKS as a single dose. Each vial of LUTRATE DEPOT 22.5 mg for 3-month administration delivers leuprolide acetate (22.5 mg), polylactic acid (188.4 mg), triethylcitrate (10.4 mg), polysorbate 80 (3.8 mg), mannitol (88.4 mg) and carmellose sodium (25 mg). The prefilled syringe containing the clear reconstitution diluent (2 mL) contains mannitol (16 mg), water for injection, and sodium hydroxide and hydrochloric acid to control pH. LUTRATE DEPOT is an extended release sterile, single dose injection in suspension form for intramuscular administration. Structure

Pemetrexed is a folate analog metabolic inhibitor. The drug substance is pemetrexed dipotassium heptahydrate, has the chemical name L-glutamic acid, N-[4-[2-(2-amino-4,7-dihydro-4-oxo-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]-, dipotassium salt, heptahydrate. It is a white to off-white powder having blue or green tinge with a molecular formula of C 20 H 19 K 2 N 5 O 6 .7 H 2 O and a molecular weight of 629.49. Pemetrexed dipotassium is freely soluble in water. The reported pKaS are 3.6 and 4.5. The structural formula of pemetrexed dipotassium heptahydrate is as follows: Pemetrexed for Injection is supplied as a sterile white to light-yellow or green-yellow lyophilized powder or cake for intravenous infusion available in single-dose vials. Each 100-mg or 500-mg vial of Pemetrexed for Injection contains 100 mg pemetrexed equivalent to 118.3 mg pemetrexed dipotassium and 106 mg mannitol or 500 mg pemetrexed equivalent to 591.5 mg pemetrexed dipotassium and 500 mg mannitol, respectively. Hydrochloric acid may have been added to adjust the pH. Image

POSFREA Injection contains palonosetron as palonosetron HCl, an antiemetic and antinauseant agent. It is a serotonin-3 (5-HT 3 ) receptor antagonist with a strong binding affinity for this receptor. Chemically, palonosetron HCl is: (3a S )-2-[ (S)- 1-Azabicyclo [2.2.2]oct 3-yl]-2,3,3a,4,5,6-hexahydro-1-oxo-1 H benz[ de ]isoquinoline hydrochloride. The empirical formula is C 19 H 24 N 2 O . HCl, with a molecular weight of 332.87. Palonosetron HCl exists as a single isomer and has the following structural formula: Palonosetron HCl is a white to off-white crystalline powder. It is freely soluble in water, soluble in propylene glycol, and slightly soluble in ethanol and 2-propanol. POSFREA Injection is a sterile, clear, colorless, non-pyrogenic, isotonic, buffered solution for intravenous administration. POSFREA Injection is available as a 5 mL or 1.5 mL single-dose vial. Each mL of aqueous solution contains 0.05 mg palonosetron (equivalent to 0.056 mg palonosetron hydrochloride). Each mL also contains 41.5 mg mannitol, 3.0 mg sodium acetate trihydrate, and water for injection (q.s. to 1.0 mL). The pH of the solution in the 5 mL and 1.5 mL vials is 4.5 to 5.5. Hydrochloric acid or sodium hydroxide may have been added to adjust pH. Image