RALOXIFENE HCL (raloxifene hcl)

There are 9 contraindications. Absolute contraindication.

Contraindication List
Deep venous thrombosis
History of deep vein thrombosis
History of pulmonary embolism
History of retinal vein thrombosis
History of venous thromboembolism
Pregnancy
Pulmonary thromboembolism
Retinal thrombosis
Venous thrombosis

There are 8 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Cerebrovascular accident
Coronary artery disease
Hypertension
Lupus anticoagulant disorder
Thrombophilia
Thrombophlebitis
Tobacco smoker
Transient cerebral ischemia

There are 8 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Atrial fibrillation
Chronic heart failure
Chronic kidney disease stage 3A (moderate) GFR 45-59 ml/min
Chronic kidney disease stage 3B (moderate) GFR 30-44 ml/min
Chronic kidney disease stage 4 (severe) GFR 15-29 ml/min
Disease of liver
Hypertriglyceridemia
Kidney disease with likely reduction in glomerular filtration rate (GFr)

There are 13 severe adverse reactions.

More Frequent	Less Frequent
Chest pain Infection Urinary tract infection	Biliary calculus Gastroenteritis Migraine Pneumonia

Rare/Very Rare
Cerebrovascular accident Deep venous thrombosis Pulmonary thromboembolism Retinal thrombosis Thromboembolic disorder Thrombotic disorder

There are 21 less severe adverse reactions.

More Frequent	Less Frequent
Cramps in legs Cystitis Drug-induced hot flash Fever Flu-like symptoms Peripheral edema Pharyngitis Sinusitis Skin rash Vaginitis	Arthralgia Arthritis Depression Gastrointestinal irritation Hyperhidrosis Insomnia Laryngitis Myalgia Vaginal discharge Weight gain

Rare/Very Rare
Phlebitis

Raloxifene may cause fetal toxicity when administered to pregnant women. Effects on reproductive function are expected because raloxifene is an estrogen agonist-antagonist. Since the risks clearly outweigh any possible benefits in women who are pregnant, raloxifene is contraindicated in such women; the drug also is not indicated for use in women of childbearing potential.

If raloxifene is inadvertently administered during pregnancy or if the patient becomes pregnant while receiving the drug, raloxifene should be discontinued and the patient informed of the potential hazard to the fetus. In reproductive studies in rabbits using raloxifene hydrochloride doses of 0.1 mg/kg or more (at least 0.04 times the recommended dose in humans on a mg/m2 basis), abortion and a low rate of fetal heart anomalies (i.e., ventricular septal defects) were observed, and in rabbits using raloxifene doses of 10 mg/kg or more (at least 4 times the recommended dose in humans on a mg/m2 basis), hydrocephaly was observed in the fetuses.

In reproductive studies in rats using raloxifene hydrochloride doses of 1 mg/kg or more (at least 0.2 times the recommended dose in humans on a mg/m2 basis), retardation of fetal development and developmental abnormalities (i.e., wavy ribs, kidney cavitation) were observed. In studies in rats using raloxifene hydrochloride doses of 0.1-10 mg/kg (0.02-1.6 times the recommended dose in humans on a mg/m2 basis) during gestation and lactation, delayed and disrupted parturition, decreased neonatal survival and altered physical development, sex- and age-specific reductions in growth and changes in pituitary hormone content, and decreased lymphoid compartment size in offspring were observed.

Disruption of parturition, which resulted in maternal and progeny morbidity and/or death, was observed in rats given raloxifene hydrochloride 10 mg/kg. While ovarian or vaginal pathology was not observed in adult offspring (4 months of age), uterine hypoplasia and reduced fertility were noted.

It is not known whether raloxifene distributes into human milk or if the drug affects milk production or the nursing infant; however, because raloxifene is an estrogen agonist-antagonist, estrogenic effects on mammary tissue during lactation may be affected.

No enhanced Geriatric Use information available for this drug.