New Drugs-first one is new rx for HTN

IN THIS ARTICLE, you'll learn about 10 new drugs, including:

* nebivolol HCl, the newest beta-adrenergic blocking agent for hypertension
* methylnaltrexone bromide, a subcutaneous injection for opioid-induced constipation
* alvimopan, a selective mu-opioid receptor antagonist to combat postoperative ileus.
Unless otherwise specified, the information in the following summaries applies to adults, not children. Consult the product insert for information about each drug's safety during pregnancy and breast-feeding. Also consult a pharmacist, the product insert, or a comprehensive drug reference for more details on precautions, drug interactions, and adverse reactions* for all these drugs.

SELECTED REFERENCES

Drug Facts and Comparisons. St. Louis, MO: Facts and Comparisons, Inc.; 2009.

Nursing2009 Drug Handbook. Ambler, PA: Lippincott Williams & Wilkins; 2009. [Context Link]

Physicians' Desk Reference. 63rd ed. Montvale, NJ: Medical Economics; 2009.

The author has disclosed that he has no significant relationship with or financial interest in any commercial companies that pertain to this educational activity.

*Common adverse reactions are italicized throughout this article.

ANTIHYPERTENSIVE AGENT
Nebivolol HCl
Third-generation beta-blocker
Nebivolol HCl (Bystolic, Forest) joins a large group of beta-adrenergic blocking agents that have been marketed to treat hypertension. Designated by some as a newer- generation or third-generation beta-blocker, the new drug has a combination of actions that distinguishes it from previous agents in this class.Nebivolol is a preferentially beta1-selective beta-blocker when used in doses of 10 mg or less in patients who are extensive metabolizers of the drug, as most people are. However, it inhibits both beta1 and beta2 receptors at higher doses and in patients who are poor metabolizers. It doesn't inhibit alpha1-adrenergic receptors. Because of its selective properties, the new drug may be safer to use than other beta-blockers in patients with bronchospastic diseases.

Although beta-blockers have been associated with increased vascular resistance, reduced exercise capacity, cold extremities, Raynaud's disease, and other adverse reactions, nebivolol and carvedilol appear to reduce vascular resistance, although by different mechanisms. Nebivolol increases nitric oxide–mediated vasodilation, which may reduce the risk of vascular symptoms. However, there isn't enough research to conclude that the new drug is safer to use in patients with peripheral vascular disease. Beta-blockers may mask signs of hyperthyroidism and place patients at risk for symptom exacerbation if treatment is abruptly discontinued.

Nebivolol may be used alone or in combination with other antihypertensive agents. Its effectiveness was established in placebo-controlled studies, and additional antihypertensive effects were demonstrated in patients who were also treated with up to two other antihypertensive agents but who had inadequate BP control. However, no data indicate that nebivolol is more effective than previously approved agents in reducing BP.

Nebivolol's only labeled indication is for hypertension, although some other beta-blockers also are indicated for heart failure, left ventricular dysfunction following myocardial infarction, angina, and migraine prophylaxis.

Precautions: (1) Contraindicated in patients with sick sinus syndrome or severe bradycardia and heart block greater than first degree (unless the patient has a pacemaker), cardiogenic shock, decompensated heart failure, or severe hepatic impairment. (2) The initial dosage should be reduced in patients with moderate hepatic impairment. (3) Concurrent use with digoxin may increase the possibility of bradycardia. Patients treated with both a beta-blocker and diltiazem or verapamil may experience negative inotropic and chronotropic effects, so closely monitor concomitant use. (4) Use cautiously if the patient also is taking antiarrhythmic agents (such as disopyramide) that decrease atrioventricular conduction. (5) Patients also taking catecholamine-depleting drugs such as reserpine or guanethidine may experience excessive reduction of sympathetic activity and become hypotensive. (6) Concurrent use with fluoxetine or other CYP2D6 inhibitors may increase the concentration of nebivolol and should be closely monitored. (7) Concurrent use with sildenafil has a synergistic effect on reducing BP, so warn the patient about the risk of hypotension. (8) If the patient has a history of severe anaphylactic reactions, taking nebivolol (or any beta-blocker) may make him more reactive to the allergen and less responsive to the usual doses of epinephrine used to treat allergic reactions. (9) The risks of general anesthesia and surgical procedures are increased in patients who are on beta-blockers during surgery or whose beta-blocker therapy is withdrawn before surgery.

Adverse reactions: headache, dizziness, nausea, diarrhea, fatigue

Supplied as: 2.5-, 5-, and 10-mg tablets

Dosage: 5 mg once a day, increased at 2-week intervals, as needed, up to 40 mg once a day. Patients with severe renal impairment or moderate hepatic impairment should start with a lower dosage (2.5 mg once a day).

Nursing considerations: (1) Tell the patient to assess how he responds to the medication before driving or engaging in other activities that require alertness. (2) Tell him he may take nebivolol without regard to meals. (3) If he misses a dose, tell him to take the next dose at the scheduled time, not to double the dose. (4) Warn him not to abruptly stop therapy. If the healthcare provider discontinues treatment, the drug should be tapered over 1 to 2 weeks if possible and the patient advised to minimize physical activity. (5) Warn your patient that beta-blockers may mask signs and symptoms of hypoglycemia (such as tachycardia) and may precipitate or aggravate symptoms in patients with peripheral vascular disease.

DRUG FOR OPIOID-INDUCED CONSTIPATION
Methylnaltrexone bromide
Subcutaneous solution for a discomforting problem
Each year, an estimated 1.5 million Americans take an opioid continuously to relieve pain associated with incurable cancer and other advanced illnesses. Opioids produce analgesia by acting on receptors in the central nervous system. But because they also act at opioid receptors in peripheral tissues such as the gastrointestinal (GI) tract, almost all patients who receive continuous opioid therapy experience constipation. Patients usually are told to follow a bowel regimen, typically a laxative and stool softener, but this may not prevent opioid-induced constipation.

Methylnaltrexone bromide (Relistor; Progenics, Wyeth) is an opioid antagonist related to naltrexone, which has been used for opioid and alcohol dependence. The new drug, which doesn't cross the blood-brain barrier, functions as a selective peripherally acting mu-opioid receptor antagonist in the GI tract and other tissues. As a result, it decreases the constipating action of opioids without reducing their analgesic effects.

Administered subcutaneously, methylnaltrexone is indicated for the treatment of opioid-induced constipation in palliative-care patients with advanced illness who haven't responded sufficiently to laxative therapy. Its effectiveness was demonstrated in placebo-controlled studies. In two studies testing the drug at several dosage intervals, about one-third of patients reported a laxative action within 30 minutes following administration of the drug. In a single-dose study, about 60% of patients treated with the new drug experienced a laxative action within 4 hours, compared with 16% of those taking placebo.

An orally administered formulation of methylnaltrexone is being evaluated, as is an I.V. formulation for treating postoperative ileus.

The use of methylnaltrexone for longer than 4 months hasn't been studied.

Precautions: Contraindicated in patients with known or suspected mechanical GI obstruction

Adverse reactions: abdominal pain, flatulence, nausea, dizziness, diarrhea

Supplied as: single-use vials containing 12 mg of the drug in 0.6 mL of solution

Dosage: 8 mg for patients weighing 84 to 135 pounds (38 to 61 kg), 12 mg for patients weighing 136 to 251 pounds (62 to 114 kg), administered subcutaneously in the upper arm, abdomen, or thigh once every other day, as needed. For patients weighing less than 84 pounds (38 kg) or more than 251 pounds (114 kg), administer 0.15 mg/kg.

Nursing considerations: (1) Don't give more than one dose in a 24-hour period. (2) Report severe or persistent diarrhea to the healthcare provider, who will probably discontinue the drug. (3) Expect to reduce the dosage by one-half in patients with severe renal impairment (creatinine clearance less than 30 mL/minute). Dosage adjustment isn't needed in patients with mild or moderate renal or hepatic impairment. The drug hasn't been evaluated in patients with severe hepatic impairment. (4) The drug may be stored at room temperature, protected from light. (5) If you don't give the drug immediately after drawing it into the syringe, store it at room temperature and administer within 24 hours. The syringe doesn't need to be kept away from light during this 24-hour period. (6) Discard the vial after one use, even if some drug remains; don't use the vial more than once. (7) Discontinue methylnaltrexone therapy as ordered if the patient stops taking an opioid.

DRUG FOR POSTOPERATIVE ILEUS
Alvimopan
Speeding GI recovery
Following major abdominal surgery and certain nonabdominal surgeries, some patients experience postoperative ileus as a result of impaired GI motility. Postoperative ileus is characterized by abdominal distension and bloating, nausea, vomiting, pain, accumulation of gas and fluids in the bowel, and constipation. Lasting 5 to 6 days or longer, the condition may delay recovery from surgery and hospital discharge.

Opioid analgesics are used to relieve postsurgical pain after most major abdominal surgeries, but these drugs inhibit GI motility and may prolong postoperative ileus.

Alvimopan (Entereg; Adolor, GlaxoSmithKline) is a selective antagonist of mu-opioid receptors in peripheral tissues. By binding to mu-opioid receptors in the GI tract, it antagonizes the peripheral effects of opioids on GI motility and secretion. Because it acts selectively at opioid receptors in peripheral tissues, it doesn't reverse the analgesic action of the opioids.

Alvimopan is similar in action to methylnaltrexone, which is indicated to prevent opioid-induced constipation, but its indications are different. Given orally, alvimopan is indicated for short-term use in hospitalized patients to accelerate the time to upper and lower GI recovery following partial large or small bowel resection with primary anastomosis. Many patients undergoing bowel resections have colorectal cancer and other serious conditions; alvimopan is the first drug to be approved to accelerate GI recovery following these procedures. Alvimopan isn't indicated to treat opioid-induced constipation because a long-term study raised questions about its cardiovascular safety.

In placebo-controlled studies, bowel recovery times ranged from 10 to 26 hours less for alvimopan- treated patients compared with placebo-treated patients. Patients who took the new drug (most of whom had taken opioid analgesics) were discharged home 13 to 21 hours sooner than patients receiving placebo.

Because of cardiovascular risks, the drug is supplied only to hospitals that have registered in and met requirements for the Entereg Access Support and Education program, which sets standards for distribution of the drug. Alvimopan may not be dispensed to patients after hospital discharge. For more information on the program, call 1-866-423-6567.

Although some patients in the clinical studies had total abdominal hysterectomies, alvimopan's effectiveness following this type of surgery hasn't been established. The drug is being studied in patients undergoing radical cystectomy.

Precautions: (1) Because of cardiovascular risks, the drug carries a black-box warning that establishes restrictions regarding its distribution and dosage. (2) Contraindicated in patients who've taken therapeutic doses of an opioid for more than 7 consecutive days immediately before taking alvimopan. (3) Not recommended for patients with end-stage renal disease or severe hepatic impairment. (4) Because of a greater possibility of GI adverse reactions (such as abdominal pain, nausea, and diarrhea), use with caution in patients receiving more than three doses of an opioid within the week before surgery.

Adverse reactions: hypokalemia, dyspepsia, anemia, constipation, flatulence, back pain, urinary retention

Supplied as: 12-mg capsules

Dosage: 12 mg administered 30 minutes to 5 hours before surgery, followed by 12 mg twice daily beginning the day after surgery for a maximum of 7 days or until discharge

Nursing considerations: (1) Dosage adjustments aren't needed in patients with renal impairment or mild to moderate hepatic impairment, but monitor these patients closely. (2) Administer no more than 15 doses of alvimopan to any hospitalized patient. (3) The drug may be taken without regard to meals. (4) Monitor the patient's response to the drug (specifically, return of bowel function). (5) Teach the patient to report adverse reactions.

ANTIVIRAL DRUG
Etravirine
Latest weapon against HIV
Etravirine (Intelence, Tibotec) is the 25th antiretroviral agent to be marketed to treat HIV infection and the 4th antiretroviral to be classified as a nonnucleoside reverse transcriptase inhibitor (NNRTI). However, etravirine is effective in some patients with HIV strains that are resistant to other NNRTIs.

Combined with other antiretroviral agents, etravirine is indicated for the treatment of HIV infection in antiretroviral-treatment-experienced adults who have evidence of viral replication and HIV strains resistant to an NNRTI and other antiretroviral agents. The drug isn't indicated for initial treatment in treatment-naive patients. The use of etravirine should be guided by the treatment history and, when possible, resistance testing. In patients who've experienced virologic failure on an NNRTI- containing regimen, etravirine shouldn't be used in combination with only nucleoside/nucleotide reverse transcriptase inhibitors.

As part of a combination regimen, the new drug has been effective in placebo-controlled trials, reducing viral load in 60% of patients, compared with 40% of those who received a placebo in addition to the background regimen.

Precautions: (1) Etravirine may interact with other antiretroviral agents. Concurrent use with another NNRTI isn't recommended because the concentration and activity of etravirine may be altered. (2) Etravirine shouldn't be given with tipranavir/ ritonavir, fosamprenavir/ritonavir, atazanavir/ritonavir, ritonavir (600 mg twice a day), or other protease inhibitors without the coadministration of low-dose ritonavir. (3) Use cautiously in patients also taking lopinavir/ritonavir, as the activity of etravirine may be significantly increased. (4) Etravirine is an inducer of CYP3A4 and an inhibitor of CYP2C9 and CYP2C19 metabolic pathways. The new drug's action may be reduced by the concurrent use of carbamazepine, phenobarbital, phenytoin, rifampin, rifabutin, dexamethasone, and St. John's wort. The drug's activity may be increased by the concurrent use of azole antifungal agents or clarithromycin. (5) Etravirine may decrease the activity of certain statins, immunosuppressants, antiarrhythmic agents, and sildenafil. (6) Warfarin concentrations may be increased when the drug is used concurrently with etravirine. See the product insert for more details about potential drug interactions.

Adverse reactions: rash, nausea

Supplied as: 100-mg tablets

Dosage: 200 mg twice a day following a meal

Nursing considerations: (1) Teach the patient to take etravirine after a meal, as directed. (2) If he can't swallow tablets, he can crush the tablet and disperse its contents in a glass of water, stir well, and drink immediately. (The contents won't dissolve completely.) Tell him to then fill the glass with water several times and swallow the water to make sure he got the full dose. (3) If he misses a dose, teach him to take a tablet after a meal if it's within 6 hours of the scheduled time, then take the next dose at the regularly scheduled time. If the dose is more than 6 hours overdue, he should skip that dose and take his next dose at the regularly scheduled time. Warn him not to take double doses to make up for a missed dose. (4) Advise him that a rash may occur, most often in the second week of therapy, but it usually resolves within 1 to 2 weeks. Tell him to report a severe rash to his healthcare provider, who may discontinue treatment. (5) As the immune system responds to the treatment, patients may develop an inflammatory response to indolent or residual opportunistic infections, which may require further evaluation and treatment. Tell the patient to contact his healthcare provider if he develops signs or symptoms of inflammation. Antiretroviral regimens are also associated with redistribution or accumulation of body fat, including central obesity, buffalo hump, peripheral wasting, breast enlargement, and “cushingoid appearance.” (6) Closely monitor a patient on methadone maintenance therapy for withdrawal symptoms. The healthcare provider may need to adjust the methadone dosage. (7) Etravirine is classified in Pregnancy Category B and should be used during pregnancy only if the anticipated benefit justifies the risk to the fetus. If the drug is used during pregnancy, prescribers are encouraged to register patients in the Antiretroviral Pregnancy Registry by calling 1-800-258-4263.

ANTIDEPRESSANT
Desvenlafaxine succinate
New once-daily dosing for major depressive disorder
Desvenlafaxine succinate (Pristiq, Wyeth) is the major active metabolite of venlafaxine (Effexor). Like venlafaxine, desvenlafaxine is a serotonin-norepinephrine reuptake inhibitor (SNRI). It hasn't been directly compared with venlafaxine, and there's no reason to consider it more effective.

Unlike venlafaxine and other SNRIs, which have been approved for various other indications including panic disorder and social anxiety, desvenlafaxine is approved only for major depressive disorder. It's being studied for the treatment of vasomotor symptoms of menopause, neuropathic pain, and fibromyalgia, and its labeled indications will probably expand as research continues.

Precautions: (1) The labeling for all SNRIs includes a black-box warning about the increased risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (ages 18 to 24). Closely monitor all patients being treated with one of these drugs for worsening depression, suicidality, and behavior changes, particularly during the first several months of therapy and after dosage adjustments. (2) Contraindicated in patients with a history of hypersensitivity to desvenlafaxine or venlafaxine, in patients treated with a monoamine oxidase inhibitor (MAOI), and in those who discontinued an MAOI within the past 14 days. (3) Don't administer desvenlafaxine concurrently with venlafaxine. (4) Use with caution in patients with cardiovascular or cerebrovascular disease. (6) Concurrent use of anticoagulants, aspirin, and nonsteroidal anti-inflammatory drugs raises the risk of bleeding events such as ecchymosis, epistaxis, and hematoma. (7) Monitor patients with elevated intraocular pressure and those at risk for acute narrow-angle glaucoma for mydriasis. (8) Use caution when administering desvenlafaxine concurrently with other CNS-active drugs or other drugs that may affect serotonergic neurotransmitter systems (such as SSRIs and triptans). (9) Concurrent use of desvenlafaxine with serotonin precursors (such as tryptophan supplements) isn't recommended. (10) Concurrent use of a potent CYP3A4 inhibitor such as ketoconazole or clarithromycin may increase the bioavailability of desvenlafaxine.

Adverse reactions: nausea, dizziness, dry mouth, hyperhidrosis, constipation, insomnia, fatigue, decreased appetite, somnolence, hypertension, and sexual function disorders such as decreased libido

Supplied as: 50- and 100-mg extended- release tablets

Dosage: 50 mg once a day. The dosage may be increased in some patients. (See the product insert for details.)

Nursing considerations: (1) Because desvenlafaxine may increase BP, monitor the patient's BP regularly during treatment. Make sure preexisting hypertension is under control before the patient starts treatment with desvenlafaxine. (2) Tell the patient to swallow the tablet whole with fluid. Warn him not to divide, crush, chew, or dissolve the tablet. (3) Tell him he can take desvenlafaxine without regard to food. (4) Advise him not to be concerned if he sees the inert matrix tablet in the stool. (5) Closely monitor him for signs and symptoms of serotonin syndrome, activation of mania/hypomania, seizures, hyponatremia, and interstitial lung disease and eosinophilic pneumonia. Tell him to watch for and report these signs and symptoms. (6) Tell him to avoid alcoholic beverages while being treated with desvenlafaxine. (7) Warn him not to stop therapy abruptly. To reduce the risk of new symptoms (such as irritability, anxiety, and abnormal dreams), his healthcare provider will taper the dosage if the drug is to be discontinued.

DRUG FOR CROHN'S DISEASE
Certolizumab pegol
Less-frequent dosing for this TNF blocker
Crohn's disease is a chronic, progressive inflammatory bowel disease typically characterized by inflammation at the end of the small intestine (ileum) and the beginning of the large intestine (colon). About half a million Americans have Crohn's disease and experience an ongoing cycle of flare-ups and remissions throughout their lives. Signs and symptoms include diarrhea, fever, abdominal pain and cramping, rectal bleeding, narrowing of the GI tract, GI obstruction, and fistulas. Corticosteroids, immunosuppressants, and other drugs, including tumor necrosis factor (TNF) inhibitors, are used to treat the disease.

Certolizumab pegol (Cimzia, UCB) is the third TNF blocker to be approved to treat Crohn's disease, joining infliximab and adalimumab. All of the TNF blockers are administered parenterally. Certolizumab is administered less frequently (every 4 weeks for maintenance doses) than adalimumab, but each dose is administered as two injections; adalimumab is administered as a single injection. Also, certolizumab and infliximab should be prepared and administered by a healthcare professional; adalimumab may be self-administered by patients.

Administered subcutaneously, certolizumab is indicated to reduce signs and symptoms of Crohn's disease and maintain clinical response in adults with moderately to severely active disease who've had an inadequate response to conventional therapy. Infliximab and adalimumab also are indicated for other conditions, such as rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, and ankylosing spondylitis, but these aren't labeled indications for certolizumab.

Precautions: (1) Potentially fatal infections (such as tuberculosis [TB] and invasive fungal infections) are the subject of a black-box warning in the new drug's labeling. (2) Certolizumab and anakinra (an interleukin-1 antagonist) shouldn't be used concurrently because this increases the risk of serious infections. (3) Certolizumab shouldn't be used in patients with active infections including chronic or localized infections. (4) Assess patients for TB risk factors and test for latent TB infection before therapy begins. (5) Certolizumab may reactivate hepatitis B virus in patients who are chronic carriers of this virus. (6) The TNF blockers are associated with a risk of malignancies such as lymphomas in children and young adults. (7) Certolizumab may cause hypersensitivity reactions, exacerbation or new onset of central nervous system demyelinating disorders such as multiple sclerosis, exacerbation or new onset of heart failure, hematologic reactions such as pancytopenia, and lupuslike syndrome.

Adverse reactions: upper respiratory tract infection, urinary tract infection, arthralgia, opportunistic or fungal infections

Supplied as: a lyophilized powder in single-use vials containing 200 mg of the drug

Dosage: 400 mg given as two subcutaneous injections of 200 mg initially and at weeks 2 and 4. If the patient responds well, follow with 400 mg subcutaneously every 4 weeks.

Nursing considerations: (1) Prepare two 200-mg vials for each dose. Reconstitute each vial with sterile water as directed in the product insert. Gently swirl the contents of the vial without shaking to thoroughly mix the lyophilized powder with the sterile water. (2) After reconstituting both vials, leave them undisturbed to permit complete reconstitution, which may take as long as 30 minutes. The doses should warm to room temperature before you administer them. (3) Following guidelines in the product insert, administer the doses subcutaneously at two separate sites in the abdomen or thigh. Monitor the sites for injection-site reactions. (4) Store drug vials in the refrigerator. If you can't administer reconstituted solution within 2 hours after preparation, you can refrigerate it for up to 24 hours before administering it. Let the drug rewarm to room temperature before administering it. (5) Teach the patient to notify his healthcare provider immediately if he experiences any signs and symptoms of infection. Give him a copy of the medication guide for certolizumab prepared by the manufacturer. (6) Don't administer live or attenuated vaccines to a patient being treated with certolizumab. (7) Certolizumab may cause erroneously elevated activated partial thromboplastin times in patients who don't have coagulation abnormalities.

ANTINEOPLASTIC DRUG
Bendamustine HCl
New weapon against chronic lymphocytic leukemia
The most common form of leukemia in adults, chronic lymphocytic leukemia (CLL), is a slowly progressing blood and bone marrow disease. In the United States, about 15,000 new cases are diagnosed each year. For many years, alkylating agents such as chlorambucil and cyclophosphamide were the primary treatment, but these seldom provided a complete response. The purine nucleoside analogue fludarabine has been demonstrated to be more effective than the alkylating agents, but concurrent use of the two types of agents hasn't been shown to improve response rate or overall survival.

Bendamustine HCl (Treanda, Cephalon), described as a bifunctional mechlorethamine derivative, has a unique structure that includes a component that acts as an alkylating agent as well as a purinelike benzimidazole component. Although its exact mechanism of action isn't known, the new drug appears to damage DNA in cancer cells to cause apoptosis (programmed cell death) and also acts through a nonapoptotic pathway. A designated orphan drug, bendamustine is administered I.V.

When bendamustine was compared with oral chlorambucil in clinical trials, the overall and complete response rates with the new drug were 59% and 8%, respectively, compared with 26% and less than 1% with chlorambucil. The median progression-free survival was 18 months with bendamustine and 6 months with chlorambucil. Bendamustine hasn't been directly compared with other agents used to treat CLL.

Bendamustine is being studied for the treatment of other types of cancer, and recently was also approved for treating indolent non-Hodgkin's lymphoma.

Precautions: (1) Not recommended for patients with moderate or severe hepatic impairment or severe renal impairment (creatinine clearance less than 40 mL/minute). (2) Use with caution in patients with mild hepatic impairment or mild or moderate renal impairment. (3) Closely monitor patients who are concurrently using the new drug with a CYP1A2 inhibitor such as ciprofloxacin or a CYP1A2 inducer such as omeprazole or smoking. (4) Consult the product insert for additional precautions and interactions.

Adverse reactions: neutropenia, pyrexia, thrombocytopenia, nausea, anemia, leukopenia, vomiting, asthenia, fatigue, malaise, weakness, dry mouth, somnolence, cough, constipation, headache, mucosal inflammation, stomatitis, skin rash

Supplied as: single-use vials containing 100 mg of the drug as lyophilized powder

Dosage: 100 mg/m 2 given as an I.V. infusion over 30 minutes on days 1 and 2 of a 28-day cycle, for up to six cycles

Nursing considerations: (1) Most patients treated with bendamustine experience myelosuppression and may need a dosage reduction or a delay in continuing treatment. See the product insert for details. (2) Because patients with myelosuppression are more susceptible to infection, administer antimicrobial drugs as ordered if the patient has signs and symptoms of infection. (3) Monitor the patient for an anaphylactic or anaphylactoid reaction, a rare but serious complication that's most likely to occur in the second and subsequent cycles of therapy. Treatment may be discontinued in patients with a grade 3 or 4 infusion reaction. Pretreat patients who've experienced a grade 1 or 2 infusion reaction with an antihistamine, antipyretic, or corticosteroid before subsequent treatment cycles, as ordered. (4) To reduce the risk of tumor lysis syndrome, maintain adequate volume status, closely monitor the patient's blood chemistry, and administer allopurinol during the first 1 to 2 weeks of therapy in high-risk patients. (5) Discontinue or suspend therapy if the patient develops severe or progressive skin reactions, such as rash or toxic skin reactions. (6) Tell women to avoid becoming pregnant throughout treatment and for 3 months after treatment is discontinued. Men treated with bendamustine should use reliable contraception for the same period. (7) Consult the product insert for recommendations about delaying treatment and adjusting dosages in patients who experience hematologic or nonhematologic toxicity. (8) Reconstitute the drug with 20 mL of sterile water for injection, providing a drug concentration of 5 mg/mL. See the product insert for details. Administer the drug as soon as possible following preparation. (9) The final admixture is stable for 24 hours when refrigerated or for 3 hours at room temperature. Complete administration of the drug within 24 hours (if it was refrigerated) or 3 hours (if it was kept at room temperature).

DRUG FOR ALLERGIC RHINITIS
Ciclesonide
Seventh intranasal spray for sneezes and sniffles
Ciclesonide (Omnaris; Nycomed, Sepracor) is the seventh corticosteroid to be marketed as an intranasal spray for treating allergic rhinitis. Its effectiveness has been demonstrated in placebo-controlled studies, but it hasn't been directly compared with other intranasal corticosteroids. Although it was approved by the FDA in October 2006, it wasn't marketed until 2008.

Ciclesonide is indicated to treat nasal symptoms of seasonal rhinitis in adults and children age 6 and older and nasal symptoms of perennial allergic rhinitis in adults and adolescents age 12 and older. These labeled indications are more limited than those for other corticosteroid nasal sprays.

In clinical trials, ciclesonide's onset of effect occurred within 24 to 48 hours, with further symptomatic improvement over 1 to 2 weeks in patients with seasonal allergic rhinitis and over 5 weeks in patients with perennial allergic rhinitis.

In early 2008, a formulation of ciclesonide for oral inhalation (Alvesco) was approved as an asthma maintenance medication; the drug was marketed in late 2008.

Precautions: (1) Concurrent use with a potent CYP3A4 inhibitor, such as clarithromycin, may increase levels of des-ciclesonide, raising the possibility of nasal irritation and headache. (2) Use of ciclesonide or another intranasal corticosteroid may delay wound healing in patients who've had recent nasal surgery or nasal septal ulcers. Treatment shouldn't be initiated until healing has occurred. (3) Immune system suppression from corticosteroid use increases the patient's susceptibility to infection. (4) Intranasal corticosteroids may delay or impair growth in children.

Adverse reactions: headache, epistaxis, nasopharyngitis, ear pain

Supplied as: a metered-dose pump spray that contains 120 metered doses of 50 mcg each

Dosage: 200 mcg/day administered as two sprays (50 mcg/spray) in each nostril once a day

Nursing considerations: (1) Warn the patient not to exceed the recommended dosage and to contact his healthcare provider if symptoms persist or worsen. (2) Teach him to recognize and report signs and symptoms of localized fungal infection of the nose and pharynx. If he's using ciclesonide over several months or longer, tell him to see his healthcare provider periodically to be checked for evidence of Candida infection. (2) Closely monitor the patient for adrenal insufficiency if he was switched from prolonged systemic corticosteroid therapy to ciclesonide therapy. (3) Tell him to gently shake the bottle and prime the pump before the first use by pressing on the applicator eight times. If, after priming, he doesn't use the product for 4 or more consecutive days, he should gently shake the bottle and reprime the pump with one spray or until a fine mist appears. (4) Tell him to discard the bottle after 120 sprays following initial priming or after 4 months, whichever occurs first.

DRUG FOR GENITAL WARTS
Sinecatechins ointment
Green tea treatment for a common infection
Most genital warts are caused by human papillomavirus (HPV) types 6 and 11. Highly contagious, this virus is one of the most common sexually transmitted diseases, accounting for an estimated 6.2 million new infections every year in the United States. Typically, genital warts have been treated with cryotherapy, topical application of tissue-destructive agents such as podophyllin or trichloroacetic acid, or intralesional use of interferon alfa-2b and interferon alfa-n3. Although these treatments usually destroy wart tissue, they don't eradicate the virus, which recurs in about 25% of patients who initially respond to treatment.

Sinecatechins (Veregen, Bradley) is a botanical product that has been approved for the topical treatment of external genital and perianal warts in immunocompetent patients age 18 years and older. It's a partially purified fraction of an extract of green tea leaves. How sinecatechins treats genital and perianal warts isn't clear, although antioxidant activity is one possibility. In two studies, the sinecatechins ointment completely cleared warts in 54% of patients, compared with 35% of those treated with a placebo. Both groups had similar rates of wart recurrence at 12 weeks following completion of treatment. The new product hasn't been directly compared in clinical studies with other treatments for genital warts, nor has it been evaluated for the treatment of urethral, intravaginal, cervical, rectal, or intra-anal HPV disease or in immunosuppressed patients.

Precautions: Use during pregnancy only if the anticipated benefit outweighs the risk to the fetus.

Adverse reactions: erythema, pruritus, burning, pain/discomfort, erosion/ ulceration, edema, induration, vesicular rash

Supplied as: a water-free ointment including the drug in a 15% concentration

Dosage: a strand of ointment (about 0.5 cm) applied three times a day to all external genital and perianal warts

Nursing considerations: (1) The product should be stored in a refrigerator until it's dispensed; after that, it may be stored refrigerated or at room temperature up to 77° F (25° C). (2) Tell the patient to wash her hands before and after ointment application. (3) Tell her she needn't wash the ointment off the treated area before the next application. The treated areas shouldn't be covered or wrapped with an occlusive dressing. (4) Tell her to continue treatment until the warts are gone, but for no longer than 16 weeks. (5) Warn her that the ointment may weaken condoms and vaginal diaphragms, so unless she's trying to become pregnant, she should avoid relying on these birth control devices and engaging in sexual contact while the ointment is on the skin. (6) Tell her that the ointment may stain clothing and bedding.

DRUG FOR CRYOPYRIN-ASSOCIATED PERIODIC SYNDROMES
Rilonacept
First drug for these chronic inflammatory diseases
Cryopyrin-associated periodic syndromes (CAPS) are a group of rare, inherited chronic inflammatory diseases characterized by recurrent rash, fever and chills, joint pain, fatigue, and eye pain or redness. About 1 in 1 million Americans are affected with one of the three autoinflammatory diseases categorized as CAPS:

Familial cold autoinflammatory syndrome (FCAS), which begins during early childhood or adolescence. Symptoms are triggered by exposure to cooling temperatures.

Muckle-Wells syndrome (MWS), which often is associated with hearing loss or amyloidosis (an accumulation of amyloid protein in organs such as the kidney). Symptoms are triggered by random, unknown factors and possibly exercise, stress, or cold.

Neonatal-onset multisystem inflammatory disease (NOMID), which is the most severe form of CAPS. Characterized by significant central nervous system complications, it usually causes signs and symptoms shortly after birth.

In most but not all cases, CAPS are caused by mutations in the gene that encodes cryopyrin, a protein that regulates inflammation. The mutation causes increased activity of cryopyrin and overproduction of interleukin-1 beta, resulting in an inflammatory response and the symptoms of CAPS.

Rilonacept (Arcalyst, Regeneron), the first drug to be approved to treat CAPS, is an interleukin-1 blocker that's administered subcutaneously to treat FCAS and MWS in adults and children age 12 and older. It hasn't been evaluated in patients with NOMID.

In a study of patients with FCAS or MWS, the new drug improved symptoms within several days after the start of therapy.

Precautions: (1) Don't use in patients with active or chronic infections because rilonacept may interfere with the immune response to infections. (2) Concurrent use with a TNF inhibitor or the interleukin-1 blocker anakinra isn't recommended because of the increased risk of infection. (3) Because rilonacept causes immunosuppression, it may also increase the risk of malignancies.

Adverse reactions: injection-site reactions, upper respiratory tract infections

Supplied as: single-use vials containing 220 mg of the drug as a lyophilized powder

Dosage: Adults—a loading dose of 320 mg given as two 2-mL subcutaneous injections of 160 mg each on the same day at two different sites, followed by single injections of 160 mg once a week.

Children and adolescents ages 12 to 17—a loading dose of 4.4 mg/kg (up to a maximum of 320 mg), given as one or two subcutaneous injections with a maximum single-injection volume of 2 mL, followed by single injections of 2.2 mg/kg (up to a maximum of 160 mg) once a week.

Nursing considerations: (1) Don't administer live vaccines to a patient being treated with rilonacept. He should receive all recommended vaccinations before starting therapy. (2) Reconstitute the vial with 2.3 mL of preservative-free sterile water for injection. Shake the vial for about 1 minute and then let it sit for 1 minute. The resulting solution is viscous and contains the drug in a concentration of 80 mg/mL. (3) Withdraw the volume of solution needed to provide the recommended dose from the vial using a new 27-gauge, half-inch needle attached to a new 3-mL syringe for subcutaneous injection. (4) Protect the reconstituted solution from light and use it within 3 hours of reconstitution. Reconstituted solution may be kept at room temperature. (5) Administer the drug as directed, no more often than once a week. (6) Store vials in a refrigerator and in their original carton to protect them from light. (7) Monitor the patient's lipid profiles; increases in blood lipid concentrations have been reported during rilonacept treatment. Teach him about lipid-lowering therapy if indicated. (8) Teach the patient to rotate injection sites in the left and right sides of the abdomen or left and right thighs. If someone other than the patient is administering the drug, she may also use sites on the upper arms. (9) Teach the patient to immediately report signs and symptoms of infection to his healthcare provider, who will discontinue therapy if the infection is serious.

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Care of Patients with Temporary Pacers

http://www.nursingcenter.com/library/JournalArticle.asp?Article_ID=841496
Good article

Nursing Documentation

http://www.brainshark.com/brainshark/vu/view.asp?pi=871020673

Good information-Webcast format

February...it's "our" Month

Have a cuppa and read on...

February for our units means time:

To get TB tests from Infection control
Head down there on Monday, Tuesdays or Wednesdays to get yours planted and most importantly get it read 48-72 hours later and send back to Infection Control.

To get your glucose competency done.
So catch up with me to get your glucometer competency completed before you expire at the end of the month. You have all been seeing the countdown to when you are about to expire if you are using it, if you have done it with me then I have sent your papers down to Emily Cyr (the new coordinator for point of care tests) and she has to process them before we are all renewed.

For Change:
We are all still in a holding pattern for the move to Med/Surg. I have heard that the maintenance has commenced to get wiring set up and we are still on a day by day basis but bear with us, I know it's challenging but we will get there when the time is right, we need to do this safely for our patients no matter how frustrating it gets for us in the throes of the change.


still sipping on your cuppa good-have a good day/night!