Six hot drugs for today and beyond

This is not another “New drugs” article. Though these six drugs are relatively new, they are highlighted here because of their potential impact on patients’ lives and health care itself.
One is the first new insulin delivery option since the discovery of insulin 80 years ago. Another holds the promise of abruptly decreasing the incidence of cervical cancer. All six of the information capsules below focus on the essential facts you need to understand and administer these hot drugs.

Gardasil (quadrivalent human papillomavirus [types 6, 11, 16, 18] recombinant vaccine)
Why is it hot? The human papillomavirus (HPV) causes cervical cancer, pre-cancers, benign cervical lesions, and genital warts. Cervical cancer, one of the leading cancers among women, results in some 290,000 deaths worldwide each year. Gardasil should dramatically reduce the incidence of cervical cancer. In studies, it prevented 100% of high-grade cervical pre-cancers and noninvasive cervical cancers from HPV types 16 and 18.

Description. This vaccine targets HPV types 6 and 11, which account for 90% of genital warts, and types 16 and 18, which account for 70% of cervical cancers. These four types of virus may also cause benign cervical changes that produce abnormal Pap smear results. The Food and Drug Administration (FDA) approved Gardasil for females ages 9 to 26 in June 2006.

Dosage. The vaccine is available in 0.5-ml, single-dose vials and prefilled syringes. It’s given as three separate 0.5-ml intramuscular (I.M.) doses. The second dose is given 2 months after the first dose, and the third dose is given 6 months after the first dose.

Administration. Before administration, shake the vaccine; don’t dilute it. Administer it I.M. in the deltoid area of the upper arm or the high anterolateral area of the thigh. Don’t give Gardasil subcutaneously or intradermally. See the package insert for specific instructions on using the single-dose syringe.

Monitoring. If the patient has a reaction to the first dose, check for signs and symptoms of anaphylaxis and hypersensitivity. Don’t give subsequent doses.


Patient teaching. Explain that the patient may have pain, swell­ing, erythema, or pruritus at the injection site; some patients develop a fever. Advise the patient to contact the prescriber if these signs and symptoms become severe. Make sure the patient understands that she still needs routine cervical cancer screening and that the vaccine prevents, but doesn’t treat, cervical cancer and genital warts.

Eraxis (anidulafungin)
Why is it hot? Serious fungal infections are difficult to treat because side effects or severe drug toxicity often limits therapy. Unlike other antifungals, Eraxis doesn’t significantly alter electrolyte levels or require routine dosage adjustments to maintain renal function.

Description. Eraxis is a new type of antifungal called an echinocandin. It destroys the cell wall of the fungus by inhibiting glucan synthase. The FDA approved Eraxis in February 2006.

Dosage. The specific dosage depends on the type of infection. The loading dose is 100 to 200 mg I.V., followed by a daily maintenance dose of 50 to 100 mg I.V. for 14 to 21 days.

Administration. Using the supplied diluent, reconstitute the drug. Then, add the solution to normal saline solution or D5W; the concentration varies, based on the dose. Use the reconstituted solution within 24 hours of preparation. Don’t use an infusion rate greater than 1.1 mg/minute.

Monitoring. Monitor liver function and blood chemistry test results to evaluate the risks and benefits of therapy.

Patient teaching. Explain that Eraxis has mild side effects, such as headache, nausea, and rash, and serious side effects such as jaundice. Make sure the patient understands that the prescriber will order blood tests to check for serious side effects during therapy.

Chantix (varenicline)
Why is it hot? According to the Centers for Disease Control and Prevention, about 44.5 million American adults smoke cigarettes, and about 20% of them have at least one serious illness caused by smoking. Tobacco use, particularly cigarette smoking, is the leading cause of preventable death in the United States, and Chantix may help decrease mortality from smoking.

Description. Chantix acts at brain receptors by providing some nicotinic effects to ease withdrawal symptoms, while preventing nicotine binding, so the rewards of smoking are blocked. The FDA approved Chantix in May 2006.

Dosage. The drug is available in 0.5-mg and 1-mg tablets. Here’s the 12-week regimen: 0.5 mg P.O. daily on days 1 through 3; then, 0.5 mg P.O. twice daily on days 4 through 7; and then, 1 mg P.O. twice daily for 11 weeks. Patients who successfully quit smoking during treatment may continue with an additional 12 weeks of Chantix to increase the likelihood of long-term success.

Administration. The drug should be taken with a full glass of water after eating.
Monitoring. Patients receiving other drug therapy may need dosage adjustments when smoking stops.

Patient teaching. Explain that if intolerable nausea or insomnia develops, the patient should contact the healthcare provider. Smoking cessation programs are more successful when patients are motivated to stop and are provided with education materials and support. Advise your patient to set a firm date to stop smoking and to start taking Chantix 1 week before the quit date.

Exubera (insulin human [rDNA origin]) Inhalation Powder
Why is it hot? Exubera is the first new insulin delivery option since the discovery of insulin in the 1920s. This new inhaled powder form of recombinant human insulin (rDNA) treats type 1 and type 2 diabetes in adults. For the 5 million Americans who currently inject insulin, Exubera provides a significant alternative.

Description. Exubera works like injected insulin, except it’s inhaled. Considered a rapid insulin, Exubera lowers blood glucose levels by stimulating peripheral glucose uptake in skeletal muscle and fat. It also inhibits hepatic glucose production, lipolysis, and proteolysis and enhances protein synthesis. The FDA approved Exubera in January 2006.

Dosage. The drug comes in 1-mg and 3-mg blister packs. A 1-mg blister equals about 3 units of injected regular insulin; a 3-mg blister equals about 8 units of injected regular insulin. The dosage is based on this formula: weight (kg) x 0.05 mg/kg = pre-meal dosage in mg rounded down to nearest whole mg Adjust dosages based on patient-specific factors, such as weight, exercise level, and meals.

Administration. Patients with pulmonary diseases, such as asthma, bronchitis, or emphysema, shouldn’t use Exubera, nor should patients who smoke or those who stopped smoking in the last 6 months. Administer Exubera within 10 minutes of a meal because it acts rapidly.

Monitoring. Perform spirometry to assess pulmonary function before the start of therapy, 6 months after the start, and yearly thereafter, even if no symptoms exist. If forced expiratory volume in 1 second declines by more than 20% on two occasions, stop Exubera. Monitor blood glucose levels regularly to detect hypoglycemia.

Patient teaching. Teach the patient to use the inhaler as described in the package insert. Explain that inhaling the drug may cause cough, shortness of breath, sore throat, and dry mouth.

Caduet (amlodipine besylate and atorvastatin calcium)
Why is it hot? A leading drug used for hypertension and angina (amlodipine) has been combined with a leading drug used for hyperlipidemia (atorvastatin). Because compliance is such a big issue for today’s busy patients, this combination eliminates the need to remember several doses of separate drugs every day.

Description. Amlodipine inhibits calcium, acts as a peripheral vasodilator, and decreases afterload, while atorvastatin lowers cholesterol synthesis in the liver and lowers low-density lipoprotein levels. The FDA approved Caduet in January 2004.

Dosage. Caduet comes in several combinations containing between 2.5 and 10 mg of amlodipine and between 10 and 80 mg of atorva­-statin. Patients usually start with 5 mg of amlodipine and 20 mg of atorvastatin once daily. Doses should be adjusted based on patient tolerance and effectiveness.

Administration. Women of childbearing age shouldn’t take Caduet, unless they are highly unlikely to become pregnant and have been informed of the risks.

Monitoring. The patient needs blood-pressure measurements regularly and a lipid panel and liver function tests every 6 months. These tests should be performed more frequently at the start of therapy and after any dosage increase.

Patient teaching. Tell the patient to promptly report unexplained muscle pain, tenderness, and weakness, particularly if accompanied by malaise and fever.

Atripla (efavirenz, emtricitabine, and tenofovir disoproxil fumarate)
Why is it hot? This combination drug delivers three drugs in a single daily dose, thus increasing chances of compliance.

Description. Atripla is used with or without other drugs to treat human immunodeficiency virus (HIV). The agent consists of three distinct pharmacologic classes: a non-nucleoside reverse transcriptase inhibitor, a nucleoside analog, and a nucleotide analog. Such a combination is more effective in treating HIV than a single drug class. The FDA approved Atripla in July 2006.

Dosage. Atripla is available as a single tablet containing 600 mg of efavirenz, 200 mg of emtricitabine, and 300 mg of tenofovir disoproxil fumarate. The drug is taken once daily.

Administration. Atripla interacts with many other drugs. Before deciding on Atripla, a prescriber must carefully review other prescription drugs, over-the-counter drugs, and supplements that the patient is taking. Women who are pregnant or wish to become pregnant shouldn’t take this drug. The drug should be taken on an empty stomach, preferably in the evening because dizziness may develop.

Monitoring. Nucleoside analogs can cause lactic acidosis, hepato­megaly, and steatosis, so periodic liver function tests are needed, especially for those with hepatitis B infection, women, obese patients, and patients who have taken nucleoside analogs in the past. Also, monitor the patient for jaundice, unusual or unexplained fatigue, abdominal pain (especially with nausea and vomiting), fatigue, dizziness, rash, and changes in heartbeat.

Patient teaching. Atripla has significant side effects and drug interactions. Tell the patient to report any side effects while taking this drug. Also, explain that the patient shouldn’t drive or operate machinery, until the effects of the drug are known. Make sure the patient understands that Atripla doesn’t cure HIV or acquired immunodeficiency syndrome.

Up-to-date on hot drugs
There you go. You’re now up-to-date on six of the hottest drugs in health care today. And you have important nursing facts you need to administer them safely. For complete prescribing and administering information, see the package inserts.

Selected references
Atripla [package insert]. Foster City, Calif: Gilead Sciences. Available at: http://www.gilead.com/pdf/atripla_pi.pdf.
Caduet [package insert]. New York, NY: Pfizer, Inc. Available at: http://www.pfizer.com/pfizer/download/uspi_caduet.pdf.
Chantix [package insert]. New York, NY: Pfizer, Inc. Available at: http://www.pfizer.com/pfizer/download/uspi_chantix.pdf.
Eraxis [package insert]. New York, NY: Pfizer, Inc. Available at: http://www.pfizer.com/products/product-detail/eraxis.
Exubera [package insert]. New York, NY: Pfizer, Inc. Available at: http://www.pfizer.com/pfizer/download/uspi_exubera.pdf.
Gardasil [package insert]. Whitehouse Station, NJ: Merck & Co., Inc. Available at: http://www.merck.com/product/usa/pi_circulars/g/gardasil/gardasil_pi.pdf.

Lawrence P. Carey, PharmD, is an Assistant Professor at Philadelphia (Pennsylvania) University.

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