Drug Interaction:
Drug interactions - summary-
CYP450 isoenzymes -
Nilutamide has shown to inhibit the activity of liver cytochrome isoenzymes and reduce metabolism
Vitamin K antagonists/phenytoin/ theophylline -
Vitamin K and antagonists /phenytoin/ theophylline - could have a delayed elimination
and increases serumhalf life leading toxic levels
Dosages may need to be modified
Indication:
Metastatic Prostrate Cancer
Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
Nilutamide Anti-cancer October 1991
Patent Expiry Date of drugs (Ref - IDMA Publication)
Chemical Category Manufacturer/ US Patent
Ingredient- Marketer Expiration Date
Nilutamide Cancer/Oncology Hoechst-AG 19-09-2001
Adverse Reaction:
Frequently occuring adverse reactions-
hot flushes, impotence and decreased libido are associated with low serum androgen levels and known to occur with medical or surgical castration
Cardiovascular - angina 1% herat failure 3% syncope 1%
CNS - dry mouth 1% nervousness 1% paresthesia 2%
Dermatologic - pruritus 1%
GI - diarrhea 1% GI disorder 1% GI haemorrhage 1% melena 1%
Lab test abnormalites - increased haemoglobulin 1% leukopenia 2%
increased alkaline phosphatase 2% increased blood urea nitrogen BUN 1%
increased creatine 1% hyperglycemia 3%
Metabolic /Nutrional - alcohol intolerance 4% edema 1% weight loss 1%
Musculoskeletal - arthiritis 1%
Respiratory - increaed cough 1% interstinal lung disease 1% lung disorder 3%
rhinitis 1%
Special senses - cataract 1% photophobia 1%
Miscellaneous - malaise 1%
Contra-Indications:
Severe hepatic impairment - should be evaluated prior to treatment
severe respiratory insufficiency , hypersenstivity to nilutamide or any component
Special precautions/Warnings-
Intertitial pneumonitis - has been reported in few patients exposed to nilutamide
A routine chest X-ray should be peformed prior to strating treatment
Use in women - nilutamide not no indication for women and should not be used in this category, particularly in non-serious or non- threatening conditions.
Hepatic function impairment -
Hepatitis - rare cases of death or hospitalization due to severe liver injury has been reported. Hepatoxiciy has generally occured within the first 3 to 4 months of treatment
Serum transaminase levels should be measured prior to starting treatment with niltamide.
Liver function tests should also be obtained at the first sign of symptom suggesting of liver
dysfunction eg, nausea, vomiting, abdominal pain, fatigue, anorexia
Pregnancy - nilutamide should be given to a pregnant women only if needed.
Children- safety and efficacy in pediatric patients have not been established
Dosages/ Overdosage Etc:
Indication-
Metastatic Prostrate Cancer
Dosage-
recommended dose is 300mg once a day for 30 days, followed by 150mg once a day .
Can be taken with or without meals
Store - at 25C ( 77F)
Patient Information:
1. Patients should be informed that nilutamide should be started on thre day or on the day
after surgical castration.
2. Inform patients that they should not interrupt ot stop taking the medication without
consutling their physician
3. Patients should be told to report immediately any dyspepsia or aggrevation of prexising
dyspnea
4. Patients should inform their doctor shoulf nausea, vommiting , abdominal pain or jaundice occur.
5. Patients should avoid consuming alcoholic beverages, because of the possiblity of
getting reactions eg. facial flushes , malaise, hypotension
6. Patients receiving nilutamide have reported a delay in adaptation to dark, when
passing from lighted area to a dark area. This effect somtimes does not abate
as drug treatment is continued. Patients should be cautioned about driving at night.
Pregnancy and lactation:
Pregnancy -
Nilutamide should be given to a pregnant women only if needed.
Children-
Safety and efficacy in pediatric patients have not been established
Manufacturer Details