Nolvadex


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Nolvadex

 [nol´vah-deks]
trademark for a preparation of tamoxifen, an antiestrogen used for breast cancer.

tamoxifen citrate

Apo-Tamox, Gen-Tamoxifen, Nolvadex, Nolvadex-D, Novo-Tamoxifen, PMS-Tamoxifen, Soltamox, TamofenBazetham, Contiflo XL, Flomax, Flomax CR, Flomaxtra, Novo-Tamsulosin, Omnic MR, Ran-TamsulosinW, Ratio-Tamsulosin, Sandoz Tamsulosin, Stronazon, Tabphyn

Pharmacologic class: Nonsteroidal antiestrogen

Therapeutic class: Antineoplastic

Pregnancy risk category D

Pharmacologic class: Alpha-adrenergic blocker

Therapeutic class: Anti-adrenergic

Pregnancy risk category B

FDA Box Warning

For women with ductal carcinoma in situ or high risk of breast cancer, serious and life-threatening events associated with drug use in riskreduction setting include stroke, pulmonary embolism, and uterine cancer. Some of these events were fatal. Discuss potential benefits versus potential risks of these events with these patients. In women already diagnosed with breast cancer, drug's benefits outweigh risks.

Action

Competes with estrogen receptors in tumor cells for binding to target tissues (such as breast); reduces DNA synthesis and estrogen response

Availability

Oral solution: 10 mg/5 ml

Tablets: 10 mg, 20 mg

Tablets (enteric-coated): 20 mg

Indications and dosages

Adjunctive treatment of breast cancer

Adults: 20 to 40 mg P.O. daily for 5 years. Daily dosages of 20 mg may be taken as a single dose; daily dosages above 20 mg should be divided and taken b.i.d. (morning and evening).

To reduce breast cancer incidence in high-risk women; treatment of ductal carcinoma in situ

Adults: 20 mg P.O. daily for 5 years

Off-label uses

• Mastalgia
• Ovulation stimulation

Contraindications

• Hypersensitivity to drug
• Concurrent warfarin use
• Women with a history of deep-vein thrombosis or pulmonary embolism
• Pregnancy or breastfeeding

Precautions

Use cautiously in:
• decreased bone marrow reserve, leukopenia, thrombocytopenia, cataracts, hyperlipidemia
• females of childbearing age.

Administration

• Don't break or crush enteric-coated tablets.
• Know that drug is indicated for reducing breast cancer risk only in high-risk women, defined as those older than age 35 who have at least a 1.67% chance of developing breast cancer over 5 years.

Adverse reactions

CNS: confusion, depression, headache, weakness, fatigue, light-headedness

CV: chest pain, deep-vein thrombosis

EENT: blurred vision, ocular lesion, retinopathy, corneal opacity

GI: nausea, vomiting, abdominal cramps, anorexia

GU: vaginal bleeding, discharge, or dryness; irregular menses; amenorrhea; oligomenorrhea; ovarian cyst; pruritus vulvae; endometrial or uterine cancer

Hematologic: leukopenia, thrombocytopenia

Metabolic: hypercalcemia, fluid retention

Musculoskeletal: bone pain

Respiratory: cough, pulmonary embolism

Skin: skin changes, hair thinning or partial hair loss

Other: altered taste, weight loss, tumor flare, tumor pain, hot flashes, edema

Interactions

Drug-drug. Aminoglutethimide, estrogens: decreased tamoxifen effects

Antineoplastics: increased risk of thromboembolic events

Bromocriptine: increased tamoxifen blood level

Warfarin: increased anticoagulant effect

Drug-diagnostic tests. Aspartate aminotransferase, bilirubin, calcium, creatinine, hepatic enzymes: increased levels

Platelets, white blood cells: decreased counts

Patient monitoring

• Monitor lipid panel, calcium level, mammography results, and gynecologic exam results.

Watch for signs and symptoms of thromboembolic events, including cerebrovascular accident and pulmonary embolism.
• Monitor menstrual cycle pattern for changes that may signal endometrial or uterine cancer.

Patient teaching

• Tell patient to swallow enteric-coated tablets whole without breaking or crushing.

Instruct patient to immediately report leg or calf pain, swelling, or tenderness; unexpected shortness of breath; sudden chest pain; coughing up blood; new breast lumps; vaginal bleeding; menstrual irregularities; changes in vaginal discharge; pelvic pain or pressure; and vision changes.
• Inform patient that increase in bone or tumor pain usually means drug will be effective. Advise her to discuss pain management with prescriber.
• Stress importance of undergoing regular blood tests, mammograms, and gynecologic exams to identify early signs of serious adverse reactions.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs and tests mentioned above.


tamsulosin hydrochloride

Bazetham, Contiflo XL, Flomax, Flomax CR, Flomaxtra, Novo-Tamsulosin, Omnic MR, Ran-TamsulosinW, Ratio-Tamsulosin, Sandoz Tamsulosin, Stronazon, Tabphyn


Pharmacologic class: Alpha-adrenergic blocker

Therapeutic class: Anti-adrenergic

Pregnancy risk category B

 

Action

Decreases smooth muscle contractions of prostate by binding to alpha1-adrenergic receptors. This action increases urine flow and reduces symptoms of benign prostatic hyperplasia (BPH).

Availability

Capsules: 0.4 mg

Indications and dosages

BPH

Adults: 0.4 mg/day P.O. after a meal. After 2 to 4 weeks, may increase to 0.8 mg/day.

Contraindications

• Hypersensitivity to drug or its components

Precautions

Use cautiously in:
• concurrent use of other alpha-adrenergic blockers or strong CYP3A4 inhibitors (avoid use)
• concurrent use of moderate CYP3A4 inhibitors, strong or moderate CYP2D6 inhibitors, other cytochrome P450 inhibitors, warfarin, and in patients who are poor CYP2D6 metabolizers
• patients at increased risk for prostate cancer.

Administration

• Give 30 minutes after same meal each day.

Adverse reactions

CNS: dizziness, headache, asthenia, insomnia, drowsiness, syncope, vertigo

CV: orthostatic hypotension, chest pain

EENT: rhinitis, amblyopia, pharyngitis, sinusitis

GU: retrograde or diminished ejaculation, decreased libido

Musculoskeletal: back pain

Respiratory: increased cough

Other: tooth disorder, infection

Interactions

Drug-drug. Cimetidine: increased tamsulosin blood level, greater risk of toxicity

Doxazosin, prazosin, terazosin: increased risk of hypotension

Ketoconazole (strong CYP3A4 inhibitor), paroxetine (strong CYP2D6 inhibitor): increased tamsulosin Cmax and area under the curve

Drug-behaviors. Alcohol use: increased risk of hypotension

Patient monitoring

• Monitor blood pressure. Stay alert for orthostatic hypotension.

Patient teaching

• Tell patient to take 30 minutes after same meal each day.
• Instruct patient not to chew or open capsule. Advise him to swallow it whole.
• Tell patient to move slowly when sitting up or standing, to avoid dizziness or light-headedness from sudden blood pressure decrease.
• Caution patient to avoid hazardous activities on first day of therapy.
• Inform patient that drug may cause abnormal ejaculation. Advise him to discuss this issue with prescriber.
• As appropriate, review all other significant adverse reactions and interactions, especially those related to the drugs and behaviors mentioned above.

Nolvadex

(nōl′və-dĕks′)
A trademark for the drug tamoxifen.

Nolvadex

a trademark for an antiestrogen (tamoxifen).
References in periodicals archive ?
AstraZeneca has seen its Zestril drug hit by generic competition since July while Prilosec was affected from early December and Nolvadex will be hit from February.
Zeneca's tamoxifen -- labeled as either Nolvadex or the generic sold by Barr -- is the only tamoxifen available.
Special Considerations: In the study that led to the approval, the side effects of Nolvadex in women with DCIS were similar to those in other trials of Nolvadex and included hot flashes and vaginal discharge.
Soon after the trial results were released, Zeneca applied to the FDA for approval to market Nolvadex for breast cancer prevention.
AstraZeneca has seen Zestril hit by generic competition since July while Prilosec was affected from December and Nolvadex will be hit from February.
The makers of tamoxifen, marketed under the brand name Nolvadex, acknowledge several side effects: increased fertility (but warn against using oral contraceptives because they can change the effects of the drug), blurred vision, confusion, pain or swelling in legs, shortness of breath, vaginal bleeding, insomnia, hot flashes, headaches, itching in genital area, nausea, vomitting, weight gain and skin rash.
Drug resistance: There remains a significant need to improve current therapies where drug resistance develops against cytotoxic and hormonal therapies; for example, between 25-35% of patients develop resistance to Nolvadex (tamoxifen).
He believed the expected cost savings could offset the shorfalls in profit over the years 2001-2002 as patents expire on Losec and on Zeneca's Zestril and Nolvadex.
9 Global Revenues ($m) of Aromatase Inhibitors and Nolvadex 2002-2007
Other tests in the program assist in either the safe dosing or efficacy of drugs such as Coumadin (warfarin), Plavix (clopidogrel), Nolvadex (tamoxifen), Ziagen (abacavir) and Selzentry (maraviroc), as well as Home Biometric Testing for diabetes.
An FDA advisory panel said tamoxifen, sold as Nolvadex by British-based Zeneca Group Plc, could reduce the risk of breast cancer in the short term in women who might be predisposed to get it.
For medications generally dispensed through PBM services, the target medications will include: Imuran, Nolvadex, Plavix, Tabloid, Tegretol, and Ziagen.