Fulvestrant - @ -Antiestrogens - Hormones - (Aug 2006)
Drug Name:
Fulvestrant - @ -Antiestrogens - Hormones - (Aug 2006)
List Of Brands:
Indication Type Description:
Indication:
LIST OF DRUGS DURING 2006
Sr.No- 125
Name of the Drug- Fulvestrant Inj 250mg/5ml prefilled syringe Pharmacological Classification- Anti Cancer
Date of Approval- 30-08-2006
Approved by U.S.FDA on 30-12-2006 (Ref- FDA approved List)
Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
Fulversant Inj 250mg/5ml Anti-cancer 30-08-2006
Prefilled syringe
Breast Cancer
Adverse Reaction:
Adverse reactions -
Cardiovascular - 25%
Vasodilation 25%
CNS - 30%
Dizziness 5% insomnia 5% paresthesia 5% depression 4% anxiety 3%
Dermatologic - 20%
Rash 6% sweating 4%
GI - 50%
Nausea 23% vomiting 10% constipation 10% diarrhea 10% anorexia 8%
GU - 16%
Urinary tract infection 5%
Hemic/lymphatic - 11%
Anemia 4%
Metabolic/nutrional - 16%
Peripheral edema 8%
Musculoskeletal - 22%
Bone pain 13% arthiritis 2%
Respiratory - 35%
Pharyngitis 15% dyspnea 13% increased cough 8%
Miscellaneous - 65%
Asthenia 20% pain 16% headache 14% back pain 13% abdominal pain 10%
injection site pain 9% pelvic pain 8% chest pain 6% flu syndrome 6% fever 5%
accidental injury 3%
Contra-Indications:
Pregnany women . hypersensitivity to the drug
Special precautions/Warnings-
Child bearing women- exclude pregnancy before stating treatment with fulvestrant
Pregnancy - women of child bearing age should be adviced not to become pregnant while
receiving fulvestarant. Fulvestarant can cause harm when adsminstrated to a pregnant woman.
Lactation- Decide whether to discontinue nursing or discontinue the drug depending on the
importance of the drug to the mother
Children- safety and efficacy have not been established
Dosages/ Overdosage Etc:
Indication-
Breast Cancer
Dosage-
Adults - 250mg administerd intramuscularly into the buttock at intervals of 1 month as either
a single 5ml injection or concurrent 2.5ml injections . The injection should be administered slowly.
Storage - Refrigerate 2 to 8C ( 36 to 46F ) . Store in the original package.
Patient Information:
1. Advice women of child bearing age not to become pregnant while receiving fulvestarant.
Fulvestarant can cause harm when adminstrated to a pregnant woman.
2. Your doctor may decide whether to you should discontinue nursing or the drug depending on the importance of the drug to the mother
3. Safety and efficacy have not been established
Pregnancy and lactation:
Pregnancy -
Women of child bearing age should be adviced not to become pregnant while
receiving fulvestrant. Fulvestrant can cause harm when adsminstrated to a pregnant woman.
Lactation-
Decide whether to discontinue nursing or discontinue the drug depending on the
importance of the drug to the mother
Children-
Safety and efficacy have not been established