Drug interactions-

Additive effect of dagarelix with other drugs that prolong QT intervals cannot be excluded

The following drugs may prolong QT intervals-

antiarrhythmic agents - ( eg.amiodarone, bretylin , disopyramide, dofetilide, procainamide,
quinidine, sotalol)

 arsenic trioxide, chlopromazine, cisapride, dolasteron, droperidol,

mefloquine, mesoridazine, moxifloxacin, pentamidine, pimozide,

tracolimus, thioridazine,ziprasidone,

Advanced prostrate cancer

Adverse reactions-

CNS-     chills 4%   fatigue  5% 

Cardiovascular-   hot flash   25%     hypertension  6%

Musculoskeletal -     arthalgia  4%       back pain  5%

Miscellaneous-   constipation   3%    increases in ransaminase annd GGT   10%
                             injection site adverse reactions    43%   urinary tract infection  2%
                             weight increase  10%

Known hypersensitivity to degarelix or any of the components

Special precautions-

QT/QTc interval effects-  long term androgen-deprivation therapy prolongs QT intervals.
Consider whether the benefits of androgen deprivation therapy outweighs the potential risk
to patients with congenital long QT sundrome, electrolyte anbornmalites or congestive heart
failure and in patients taking Class IA eg procainamide, quinidine or class III eg amiodarone,
solatol antiarrhythmic medcations

Renal function impairment- use with caution in patients with CrCl less than 50ml/min

Hepatic funtion impairment-  it is recommended that in patients with hepatic impairment
 testosterone concentration are monitored on a monthly basis until medical castration is
acheived

Patients with severe hepatic function impairment have not been studied

Pregnancy- advice patients wo are oe may become pregnant to not take degarelix

Lactation - decide whether to discontinue breast feeding or the drug depending upon the
importance of the drug to the mother.

Children- safety and effectiveness in children have not been established

Elderly- no overal differences in safety and efficacy were observed between these subjects
and younger subjects

Indication-
Advanced prostrate cancer

Dosage-
Initial dosage- 240mg subcutaneously ( given as 2 injections of 120mg at a concentration of 40mg/ml

Maintenance dose- 80mg subcutaneous injection ( at a concentration of 20mg/ml ) every 28 days
The first mainetenance dose must be given 28 days after the starting dose

1. Inform patients of the possible adverse reactions of androgen-deprivation therapy including
    hot flushes, flushing of the skin, increasecweight, decreased sex drive, and difficulties,
   with erectile function.

2. Possible adverse reaction related to degarelix include, redness, swelling and itching at the
   injection site. These are mild self-limiting and decrease within 3 days.

Pregnancy-
Advice patients wo are oe may become pregnant to not take degarelix

Lactation -
Decide whether to discontinue breast feeding or the drug depending upon the
importance of the drug to the mother.

Children-
Safety and effectiveness in children have not been established

Elderly-                                                                                                                                                     No overal differences in safety and efficacy were observed between these subjects
and younger subjects