raloxifene hydrochloride

raloxifene hydrochloride

(rah lox' i feen)

Evista

Pregnancy Category X

Drug class

Selective estrogen receptor modulator

Therapeutic actions

Increases bone mineral density without stimulating endometrium in women; modulates effects of endogenous estrogen at specific receptor sites.

Indications

·        Prevention and treatment of osteoporosis in postmenopausal women

·        Unlabeled use: Prevention of breast cancer

Contraindications and cautions

·        Contraindicated with allergy to raloxifene, pregnancy, lactation, active or history of DVT, pulmonary embolism, or retinal vein thrombosis.

·        Use cautiously with history of smoking, venous thrombosis.

Available forms

Tablets—60 mg

Dosages

ADULTS

60 mg PO daily.

Pharmacokinetics

Route	Onset	Peak
Oral	Varies	4–7 hr

Metabolism: Hepatic; T_1/2: 27.7 hr

Distribution: Crosses placenta; enters breast milk

Excretion: Feces

Adverse effects

·        CNS: Depression, insomnia, vertigo, neuralgia, hypoesthesia

·        CV: Venous thromboembolism

·        Dermatologic: Hot flashes, skin rash

·        GI: Nausea, vomiting, food distaste

·        GU: Vaginal bleeding, vaginal discharge

·        Other: Peripheral edema

Interactions

Drug-drug

·        Increased risk of bleeding with oral anticoagulants; monitor PT or INR closely

·        Decreased raloxifene absorption if taken with cholestyramine; avoid this combination

Nursing considerations

Assessment

·        History: Allergy to raloxifene, pregnancy, lactation, smoking, history of venous thrombosis

·        Physical: Skin lesions, color, turgor; pelvic examination; orientation, affect, reflexes; peripheral pulses, edema; LFTs, CBC and differential, bone density

Interventions

·        Administer daily without regard to food.

·        Arrange for periodic blood counts during therapy.

·        WARNING: Monitor patient for possible long-term effects, including cancers, thromboses associated with other drugs in this class.

·        WARNING: Counsel patient about the need to use contraceptive measures to avoid pregnancy while taking this drug; inform patient that serious fetal harm could occur.

·        Provide comfort measures to help patient deal with drug effects: Hot flashes (control environmental temperature); headache, depression (monitor light and noise); vaginal bleeding (use good hygiene).

Teaching points

·        Take this drug as prescribed.

·        This drug can cause serious fetal harm and must not be taken during pregnancy. Contraceptive measures should be used while you are taking this drug. If you become pregnant or would like to become pregnant, consult your health care provider immediately.

·        You may experience these side effects: Bone pain; hot flashes (staying in cool places may help); nausea, vomiting (eat frequent small meals); weight gain; dizziness, headache, light-headedness (use caution if driving or performing tasks that require alertness).

·        Report marked weakness, sleepiness, mental confusion, pain or swelling of the legs, shortness of breath, blurred vision.

Adverse effects in Italic are most common; those in Bold are life-threatening.