Pharmaceutical compositions and methods for the treatment of prostate cancer

A kit comprising:

• at least one starting container comprising a lyophilisate of degarelix or pharmaceutically acceptable salt thereof and an excipient, wherein the lyophilisate of degarelix or pharmaceutically acceptable salt thereof is present in an amount ranging from 200 mg to 300 mg;
• at least one maintenance container comprising a lyophilisate of degarelix or pharmaceutically acceptable salt thereof and an excipient, wherein the lyophilisate of degarelix or pharmaceutically acceptable salt thereof is present in an amount ranging from 320 mg to 550 mg;
• and
• at least one container comprising a solvent.

A method of preparing a starting concentration and a maintenance concentration for treating prostate cancer in a patient in need thereof comprising:

• combining at least one starting container comprising a lyophilisate of degarelix or pharmaceutically acceptable salt thereof and an excipient with at least one container comprising a solvent, wherein the lyophilisate of degarelix or the pharmaceutically acceptable salt thereof and the excipient are dissolved in the solvent to achieve a concentration range from 20 mg to 80 mg of degarelix per mL of the solvent to form the starting concentration;
• combining, after an interval ranging from 14 to 56 days from the combination of the starting concentration, at least one maintenance container comprising a lyophilisate of degarelix or pharmaceutically acceptable salt thereof and an excipient with at least one container comprising a solvent, wherein the lyophilisate of degarelix or the pharmaceutically acceptable salt thereof and the excipient are dissolved in the solvent to achieve a concentration range from 50 mg to 80 mg of degarelix per mL of the solvent to form the maintenance concentration;
• and
• repeating, at least once, the combination of the at least one maintenance container with the at least one container comprising a solvent to form the maintenance concentration, after an interval ranging from 56 days to 112 days from the combination of the prior maintenance concentration.

A method of treating prostate cancer in a patient in need thereof comprising:

• administering to the patient a starting dose comprising degarelix or pharmaceutically acceptable salt thereof, an excipient, and a solvent, wherein the starting dose ranges from 200 mg to 300 mg of degarelix or pharmaceutically acceptable salt thereof at a concentration ranging from 20 mg to 80 mg of degarelix per mL of the solvent;
• administering to the patient, at an interval ranging from 14 to 56 days after the administration of the starting dose, a maintenance dose comprising degarelix or pharmaceutically acceptable salt thereof, an excipient, and a solvent, wherein the maintenance dose ranges from 320 mg to 550 mg of degarelix or pharmaceutically acceptable salt thereof at a concentration ranging from 50 mg to 80 mg of degarelix per mL solvent;
• and
• repeating, at least once, the administration of the maintenance dose to the patient, after an interval ranging from 56 days to 112 days from the administration of the prior maintenance dose.

A method of treating prostate cancer in a patient in need thereof comprising:

• administering to the patient a starting dose comprising degarelix or pharmaceutically acceptable salt thereof, an excipient, and a solvent, wherein the starting dose is 240 mg of degarelix or pharmaceutically acceptable salt thereof at a concentration of 40 mg of degarelix per mL of the solvent;
• administering to the patient, 28 days after the administration of the starting dose, a maintenance dose comprising degarelix or pharmaceutically acceptable salt thereof, an excipient, and a solvent, wherein the maintenance dose is 480 mg of degarelix or pharmaceutically acceptable salt thereof at a concentration of 60 mg of degarelix per mL solvent;
• and
• repeating, at least once, the administration of the maintenance dose to the patient 84 days after the administration of the prior maintenance dose.

A method of treating prostate cancer in a patient in need thereof comprising:

• administering to the patient a starting dose comprising degarelix or pharmaceutically acceptable salt thereof, an excipient, and a solvent, wherein the starting dose is 240 mg of degarelix or pharmaceutically acceptable salt thereof at a concentration of 40 mg of degarelix per mL of the solvent;
• administering to the patient, 28 days after the administration of the starting dose, a maintenance dose comprising degarelix or pharmaceutically acceptable salt thereof, an excipient, and a solvent, wherein the maintenance dose is 360 mg of degarelix or pharmaceutically acceptable salt thereof at a concentration of 60 mg of degarelix per mL solvent;
• and
• repeating, at least once, the administration of the maintenance dose to the patient 84 days after the administration of the prior maintenance dose.