bazedoxifene
bazedoxifene/conjugated estrogens
(ba-ze-dox-i-feen / kon-joo-gay-ted es-troe-jenz ) bazedoxifeneconjugatedestrogens,Duavee
(trade name)Classification
Therapeutic: bone resorption inhibitorsPharmacologic: selective estrogen receptor modulators
Indications
Action
Therapeutic effects
Pharmacokinetics
Time/action profile (effect on vasomotor symptoms†)
| ROUTE | ONSET | PEAK | DURATION |
|---|---|---|---|
| PO | within 4 wk | 12 wk | duration of treatment |
Contraindications/Precautions
Adverse Reactions/Side Effects
Cardiovascular
- thromboembolism (life-threatening)
- ↑ blood pressure
- edema
Ear, Eye, Nose, Throat
- retinal vascular thrombosis
Gastrointestinal
- cholestatic jaundice
- diarrhea
- dyspepsia
- gall bladder disease
- nausea
- oropharyngeal pain
- upper abdominal pain
Dermatologic
- hot flash (most frequent)
Fluid and Electrolyte
- hypocalemia
Musculoskeletal
- muscle spasms
- neck pain
Interactions
BazedoxifeneDrug-Drug interaction
Concurrent use with UGT inducers including carbamazepine, phenobarbital, phenytoin and rifampin may ↓ levels and result in ↑ risk of endometrial hyperplasia (monitoring during long term concurrent use is recommended)Interactions
Conjugated estrogensDrug-Drug interaction
Concurrent use with CYP3A4 inhibitors including clarithromycin, erythromycin, itraconazole, , ketoconazole or ritonavir may ↑ levels of conjugated estrogens and the risk of endometrial hyperplasia (monitoring during long term concurrent use is recommended)Concurrent use with CYP3A4 inducers including carbamazepine, phenobarbital, and rifampin may ↓ effectiveness and alter uterine bleeding patterns. Concurrent use of progestins, other estrogens or estrogen agonist/antagonists may alter the effectiveness or treatment and/or ↑ risk of adverse reactions and should be avoided.Concurrent use with St. John's wort may ↓ effectiveness and alter uterine bleeding patterns.Concurrent use with grapefruit juice may ↑ levels of conjugated estrogens and the risk of endometrial hyperplasia.Route/Dosage
Availability
Nursing implications
Nursing assessment
- Assess for frequency and intensity of postmenopausal vasomotor symptoms (hot flashes).
- Assess BP before and periodically during therapy.
- Monitor intake and output ratios and weekly weight. Report significant discrepancies or steady weight gain.
- Lab Test Considerations: May cause hypocalcemia.
- May cause ↑ HDL and triglycerides, and ↓ serum LDL concentrations.
- May cause ↑ prothrombin time, partial thromboplastin time, and platelet aggregation time. May ↑ factors II, VII, VIII, IX, X, XII levels. May ↓ antithrombin III, ↑ levels of fibrinogen and fibrinogen activity and plasminogen antigen and activity.
- May cause ↑ thyroid-binding globulin causing increased circulating total thyroid hormone; may require higher doses of thyroid replacement therapy.
- May cause impaired glucose tolerance.
Potential Nursing Diagnoses
Sexual dysfunction (Indications)Implementation
- Supplemental calcium and/or vitamin D should be added if diet inadequate.
- Oral: Administer once daily without regard to meals. Swallow tablets whole; do not crush, break, or chew.
Patient/Family Teaching
- Instruct patient to take medication as directed. Take missed doses as soon as remembered unless almost time for next dose; do not double doses. Advise patient to keep Duavee in original container to protect from moisture; avoid placing in pill boxes or organizers. Open only one blister pouch and one tablet at a time; record date opened and discard after 60 days.
- Advise patient to avoid grapefruit juice during therapy.
- Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to avoid concurrent use of Rx, OTC, and herbal products, especially progestins, additional estrogens, or additional estrogen agonist/antagonists without consulting health care professional; may increase risk of uterine cancer.
- Advise patient to report signs and symptoms of fluid retention (swelling of ankles and feet, weight gain), thromboembolic disorders (pain, swelling, tenderness in extremities; headache; chest pain; blurred vision), new breast lumps, changes in vision or speech, sudden new severe headaches, severe pains in chest or legs with or without shortness or breath, weakness, and fatigue, or abnormal vaginal bleeding to health care professional.
- Caution patient that cigarette smoking during estrogen therapy may increase risk of serious side effects, especially for women over age 35.
- Advise patient treated for osteoporosis that exercise has been found to arrest and reverse bone loss. Discuss any exercise limitations with health care professional before beginning program.
- Emphasize the importance of routine follow-up physical exams, including BP; breast, abdomen, and pelvic examinations; Papanicolaou smears every 6–12 mo; and mammogram every 12 mo or as directed. Health care professional will evaluate possibility of discontinuing medication every 3–6 mo.
- Advise patient to notify health care professional if pregnancy is planned or suspected or if breastfeeding. May cause fetal harm.
Evaluation/Desired Outcomes
- Reduction in frequency and intensity of moderate to severe hot flashes.
- Decreased risk of development of osteoporosis.
- Therapy should be used for the shortest time possible and need for therapy evaluated regularly.