This group of high-impact drugs includes three that establish new drug classes, two that are important new formulations, and one with a novel mechanism of action. All six represent new approaches and advances in treating serious conditions.
Why is it hot? As the first dipeptidyl peptidase-4 (DPP-4) inhibitor approved in the United States, Januvia is an important addition to the arsenal of drugs for treating type 2 diabetes. That’s because using different combinations of drugs to treat diabetes can improve a patient’s response to therapy.
Description: This DPP-4 inhibitor increases and prolongs the action of the hormone incretin. This, in turn, increases insulin release and decreases glucagon levels, resulting in better glycemic control. It’s not effective for diabetic ketoacidosis. The Food and Drug Administration (FDA) approved Januvia in October 2006.
Dosage: Januvia comes in 25-, 50-, and 100-mg tablets. The usual dosage is 100 mg P.O. once daily either alone or with metformin or a thiazolidinedione. For patients with renal insufficiency, the dosage should be lowered to 25 or 50 mg P.O. once daily, depending on the degree of insufficiency.
Administration: A patient can take the drug with or without food and without regard to the timing of hemodialysis.
Monitoring: Before and periodically during therapy, monitor renal function by checking creatinine clearance. To monitor the effectiveness of therapy, periodically measure blood glucose and hemoglobin A1C levels.
Patient teaching: Tell the patient to contact the prescriber if upper respiratory tract infection, nasopharyngitis, or headache develops. Explain the importance of diet, exercise, and blood tests to manage glucose levels.
Why is it hot? Many magic mouthwashes have been used for mucositis, but none of them were ever proven to be effective. Kepivance is the first FDA-approved systemic drug for treating and preventing mucositis from chemotherapy or radiation therapy.
Description: Kepivance, a human keratinocyte growth factor, decreases the incidence and duration of severe oral mucositis in patients who have hematologic cancer and who receive myelotoxic therapy and need hematopoietic stem-cell support. The drug enhances the proliferation of epithelial cells, increasing the tissue thickness of the tongue, buccal mucosa, and GI tract. The FDA approved Kepivance in December 2004.
Dosage: The drug is available in 6.25-mg vials. The course of therapy has a total of six doses. Give 60 mcg/kg daily as an I.V. bolus for 3 consecutive days before myelotoxic therapy. The last of these doses should be given 24 to 48 hours before myelotoxic therapy begins. Then, give 60 mcg/kg daily as an I.V. bolus for 3 consecutive days after myelotoxic therapy. The first of these doses should be given on the last day of hematopoietic stem-cell infusion and at least 4 days after the most recent Kepivance dose.
Administration: Reconstitute the drug and use it immediately after preparation. Don’t filter the drug. Before administering the bolus, flush the I.V. line with saline solution. Don’t flush the line with heparin because it may bind to Kepivance.
Monitoring: Monitor the patient for mucocutaneous adverse effects, including rash, erythema, edema, pruritus, oral or perioral dysesthesia, tongue discoloration, tongue thickening, and changes in taste. Check, too, for fever and arthralgias.
Patient teaching: Tell the patient that if he doesn’t feel well, he should notify the physician because the cancer treatment may need to be delayed.
Boniva Injection (ibandronate sodium)
Why is it hot? Before Boniva Injection was approved, all bisphosphonates were taken orally either daily or weekly and posed a significant risk of GI adverse effects. With Boniva Injection, which is injected once every 3 months, this risk decreases.
Description: Boniva Injection is the first injectable form of a bisphosphonate used for osteoporosis. The drug inhibits osteoclastic activity and reduces bone resorption and turnover. In postmenopausal women, Boniva Injection reduces the rate of bone turnover, leading to a net gain in bone mass. The FDA approved Boniva Injection in January 2006.
Dosage: The drug is available as a prefilled, 3 mg/3-ml syringe. The dosage is 3 mg I.V. once every 3 months.
Administration: Give the I.V. injection over 15 to 30 seconds. Patients also must receive supplemental calcium and vitamin D. Those with severe renal impairment shouldn’t receive this drug.
Monitoring: Check the patient’s calcium level and correct hypocalcemia before giving Boniva Injection. Check renal function before each dose, as well.
Patient teaching: Explain that the patient should continue taking calcium supplements and vitamin D. Tell the patient that only a healthcare professional should administer Boniva Injection.
Symlin (pramlintide acetate)
Why is it hot? In patients with diabetes, amylin, like insulin, is absent or insufficient. Symlin, the first in a new class of drugs called amylin analogs, treats this deficiency in diabetic patients who can’t control glucose levels with insulin therapy alone.
Description: Symlin is a synthetic analog of human amylin—a naturally occurring hormone secreted to control glucose levels during the postprandial period. The FDA approved it in January 2006.
Dosage: Symlin is available in 5-ml vials containing 0.6 mg/ml. Doses start at 15 to 60 mcg injected subcutaneously into the abdomen or upper thigh and may be adjusted upward to 60 to 120 mcg. The dosage depends on whether the patient has type 1 or type 2 diabetes, how concurrent insulin doses are adjusted, and how well the patient tolerates the drug. At the beginning of Symlin therapy, insulin doses are reduced to avoid hypoglycemia.
Administration: The patient injects Symlin before major meals—those containing 250 or more calories or 30 or more grams of carbohydrate. He should not mix Symlin and insulin in the same syringe.
Monitoring: The patient needs to monitor blood glucose levels closely.
Patient teaching: Tell the patient to contact his prescriber if hypoglycemia or nausea occurs. If the patient misses a dose of Symlin, advise him to wait until the next meal and take his usual dose.
Why is it hot? Life-threatening bacterial infections are increasingly difficult to treat because of increasingly resistant strains. This new type of antibiotic provides a new broad-spectrum option for serious infections resistant to other antibiotics.
Description: Tygacil, the first in a new class of antibiotics known as glycylcyclines, can be used empirically to treat serious infections. Unlike several other broad-spectrum antibiotics, Tygacil doesn’t require a dosage adjustment for patients with impaired renal function. The FDA approved Tygacil in June 2005.
Dosage: Tygacil is available in 50-mg vials. Therapy begins with a 100-mg I.V. loading dose and continues with 50 mg I.V. every 12 hours.
Administration: Give each dose over 30 to 60 minutes. You can use an I.V. line for sequential infusions of other drugs, as long as it’s flushed between infusions. Treatment should continue for 5 to 14 days.
Monitoring: Routine renal and hepatic monitoring isn’t required, but give the drug cautiously to a patient with Child-Pugh C hepatic impairment. If a patient is taking warfarin, monitor his International Normalized Ratio (INR).
Patient teaching: Before starting therapy in a female patient, ask if she is pregnant. If so, inform the prescriber. Explain to all patients that Tygacil doesn’t treat viral infections and the course of therapy will continue until it’s completed—even if the patient feels better after a few days.
Why is it hot? Postoperative nausea and vomiting are significant adverse effects of surgery. Many drugs, such as prochlorperazine, promethazine, and ondansetron, are used to treat these effects, but the results can be disappointing. Emend, with its novel mechanism of action, may provide a better option.
Description: Originally approved in 2003 to prevent chemotherapy-induced nausea and vomiting, Emend was approved by the FDA to prevent postoperative nausea and vomiting (PONV) in June 2006.
Dosage: For PONV, the drug is available in 40-mg capsules. Give 40 mg P.O. within 3 hours before the induction of anesthesia.
Administration: Emend may be given without regard to food, and dosage adjustments are needed for the elderly or those with renal or hepatic insufficiency.
Monitoring: Carefully review the patient’s current medications before therapy. Life-threatening drug interactions may occur, especially with prescription drugs, over-the-counter drugs, and supplements that are metabolized by the cytochrome P450 system. Patients using long-term warfarin therapy should have their INR checked for decreased warfarin efficacy after Emend therapy.
Patient teaching: Women who take oral contraceptives should use a backup method during Emend therapy and for 1 month after the last dose of Emend to avoid pregnancy.New approaches
These six information capsules, along with the six in the March issue, bring you up to date on significant advances in drug therapy. Each hot drug addresses a significant condition—such as diabetes or life-threatening infections—in a new way and with new hope.
Boniva Injection [package insert]. Nutley, N.J. Roche Therapeutics Inc. Available at: http://www.rocheusa.com/products/Boniva/Injection_PI.pdf.
Emend [package insert]. Whitehouse Station, N.J. Merck & Co., Inc. Available at: http://www.merck.com/product/usa/pi_circulars/e/emend/emend_pi.pdf.
Januvia [package insert]. Whitehouse Station, N.J. Merck & Co., Inc. Available at: www.merck.com/product/usa/pi_circulars/j/januvia/januvia_pi.pdf.
Kepivance [package insert]. Thousand Oaks, Calif. Amgen. Available at: www.ext.amgen.com/medpro/kepivance_pi.html.
Symlin [package insert]. San Diego, Calif. Amylin Pharmaceuticals, Inc. Available at: www.symlin.com/1100prescribingInfo.aspx.
Tygacil [package insert]. Philadelphia, Pa. Wyeth Pharmaceuticals Inc. Available at: www.wyeth.com/content/showlabeling.asp?id=474.
Lawrence P. Carey, PharmD, is an Assistant Professor at Philadelphia (Pennsylvania) University.