ue-mek-li-din-ee-um
(Incruse Ellipta)
Do not confuse umeclidinium with aclidinium or clidinium.
Anoro Ellipta: umeclidinium/vilanterol (long-acting beta2-adrenergic agonist): 62.5 mcg/25 mcg.
PHARMACOTHERAPEUTIC: Anticholinergic. CLINICAL: Bronchodilator.
Long-term, once daily, maintenance treatment of airflow obstruction in pts with COPD including chronic bronchitis and/or emphysema.
Contraindications: Hypersensitivity to umeclidinium. Severe hypersensitivity to milk proteins or any drug components. Cautions: Bladder neck obstruction, myasthenia gravis, narrow-angle glaucoma, prostatic hypertrophy, urinary retention. Not recommended in pts with acutely deteriorating COPD requiring emergent relief of acute symptoms.
Inhibits muscarinic M3 receptor in lungs, resulting in relaxation of bronchial smooth muscle. Therapeutic Effect: Relieves bronchospasm, reduces airway resistance, improves bronchodilation.
Rapidly absorbed following inhalation. Primarily metabolized by enzyme cytochrome P4502D6. Protein binding: 89%. Peak concentration: 5–15 min. Steady state reached within 14 days. Half-life: 11 hrs.
Pregnancy/Lactation: Unknown if distributed in breast milk. Must either discontinue drug or discontinue breastfeeding. Children: Not indicated in this pt population. Elderly: No age-related precautions noted.
DRUG: Anticholinergics (e.g., atropine, dicyclomine, glycopyrrolate, scopolamine), medications with anticholingeric properties (e.g., diphenhydramine) may increase effects/risk of toxicity. HERBAL: None significant. FOOD: None known. LAB VALUES: None known.
Inhalation Powder: 62.5 mcg/capsule (in blister packs containing 7 or 30 doses).
Inhalation
Administration • Follow instructions for preparation according to manufacturer guidelines. • Fully exhale with inhaler away from mouth and place mouthpiece between lips. • Do not block air vent with fingers. • Take one long, steady, deep breath and continue inhalation for as long as possible. • Remove mouthpiece and hold breath for 3–4 sec. Do not inhale another dose if medication not tasted or felt (dose was delivered). • Close lid cover.
Storage • Store at room temperature up to 6 wks after opening tray. • Do not refrigerate or freeze. • Protect from sunlight and moisture. • Discard after counter reaches 0. • Do not reuse inhaler.
COPD
Inhalation: ADULTS, ELDERLY: One inhalation (62.5 mcg) once daily, at same time each day. Maximum: 1 inhalation/24 hrs.
Dose Modification
Deterioration of COPD: Discontinue treatment. Institute short-acting bronchodilators and supportive pulmonary therapy.
Dosage in Renal Impairment
No dose adjustment.
Dosage in Hepatic Impairment
Mild to moderate impairment: No dose adjustment. Severe impairment: Use caution.
Occasional (8%–5%): Nasopharyngitis, upper respiratory tract infection. Rare (3%–1%): Cough, arthralgia, viral respiratory tract infection, pharyngitis, myalgia, abdominal pain, toothache, tachycardia.
Life-threatening asthma-related events, bronchospasm, worsening of COPD-related symptoms have been reported. Hypersensitivity reactions may occur (esp. in pts with undiagnosed, severe milk protein allergy or allergy to products containing lactose). Worsening of narrow-angle glaucoma (eye pain, blurry vision, visual halos, colored images in association with red eyes from conjunctival congestion and corneal edema) may occur. May cause worsening of urinary retention, esp. in pts with prostatic hypertrophy or bladder neck obstruction.
BASELINE ASSESSMENT
Obtain baseline O2 saturation, vital signs; pulmonary function test, if applicable. Assess respiratory rate, depth, rhythm. Assess lung sounds for wheezing, rales. Screen for concomitant use of anticholinergic medications. Question history of asthma, BPH, bladder neck obstruction. Teach proper inhaler priming and administration techniques. Conduct ophthalmologic exam in pts with narrow-angle glaucoma.
INTERVENTION/EVALUATION
Routinely monitor O2 saturation, vital signs. Auscultate lung sounds and monitor for symptom improvement. Recommend discontinuation of short-acting beta2-agonists while on long-term therapy. Monitor for COPD deterioration, narrow-angle glaucoma, urinary retention/obstruction. Monitor for increased use of rescue inhaler; may indicate worsening of respiratory status.
PATIENT/FAMILY TEACHING
• Report fever, productive cough, body aches, paradoxical bronchospasm, difficulty breathing; may indicate lung infection, worsening of COPD. • Therapy not intended for acute COPD symptom relief, and extra doses are not advised. • Report symptoms of acute narrow-angle glaucoma, urinary retention, bladder distention. • Refill prescription when counter on left of inhaler reaches red area of scale. • Follow manufacturer guidelines for proper use of inhaler. • Drink plenty of fluids (decreases lung secretion viscosity). • Rinse mouth with water after inhalation to decrease mouth/throat irritation.
yoo-ste-kin-ue-mab
(Stelara)
Do not confuse Stelara with Aldara, or ustekinumab with infliximab or rituximab.
PHARMACOTHERAPEUTIC: Monoclonal antibody. CLINICAL: Antipsoriasis agent.
Treatment of adults 18 yrs or older with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Treatment of adults with active psoriatic arthritis alone or in combination with methotrexate. Treatment of adults with moderate to severe active Crohn’s disease.
Contraindications: Hypersensitivity to ustekinumab. Cautions: History of chronic infection, recurrent infection, active tuberculosis, prior malignancy, renal/hepatic impairment. Avoid use of live vaccines.
Strongly binds with cellular components involved in responses to inflammation and immune system, thereby decreasing likelihood of aggravating psoriatic eruptions. Therapeutic Effect: Significantly slows growth, migration of circulating total lymphocytes (predominant in psoriatic lesions).
Following subcutaneous injections, clearance is affected by body weight, is not affected by gender or race. Degraded into small peptides and amino acids via catabolic pathways. Serum concentration reaches steady state at 28 wks. Half-life: 10–126 days.
Pregnancy/Lactation: Unknown if distributed in breast milk. Children: Not indicated for use in this pt population. Elderly: Age-related increased incidence of infection requires cautious use.
DRUG: Immunosuppressive agents (e.g., abatacept, cyclosporine, fingolimod, methotrexate, sirolimus) increase risk of infection. Abciximab, trastuzumab may increase concentration/effects. May decrease therapeutic effects of vaccines; increase risk of adverse effects of live vaccines. HERBAL: Echinacea may decrease concentration/effects. FOOD: None known. LAB VALUES: May increase lymphocyte count.
Injection Solution (Prefilled Syringes): 45 mg/0.5 ml, 90 mg/ml.
SQ
• Do not inject into areas where skin is tender, bruised, erythematous, indurated. • Administer into thigh, abdomen, buttocks, upper arm. • Refrigerate unopened vial. • Solution appears colorless to light yellow. Discard if solution contains more than a few small translucent or white particles or is cloudy.
Plaque Psoriasis
SQ: ADULTS, ELDERLY WEIGHING 100 KG OR LESS: Initially, 45 mg, then 45 mg 4 wks later, followed by 45 mg every 12 wks. WEIGHING MORE THAN 100 KG: Initially, 90 mg, then 90 mg 4 wks later, followed by 90 mg every 12 wks. Note: 45 mg also efficacious; however, 90 mg is recommended due to greater efficacy.
Psoriatic Arthritis
SQ: ADULTS, ELDERLY: Initially, 45 mg repeated in 4 wks followed by 45 mg q12wks. PTS WITH COEXISTENT MODERATE TO SEVERE PLAQUE PSORIASIS WEIGHING MORE THAN 100 KG: Initially, 90 mg repeated in 4 wks, then 90 mg q12wks.
Crohn’s Disease
IV INFUSION: ADULTS, ELDERLY: Initially, 520 mg (greater than 85 kg); 390 mg (56–85 kg); 260 mg (up to 54 kg), then a subcutaneous 90-mg dose 8 wks after initial IV dose, then q8wks thereafter.
Dosage in Renal/Hepatic Impairment
No dose adjustment.
Occasional (8%–4%): Nasopharyngitis, upper respiratory tract infection, headache. Rare (3%–1%): Fatigue, diarrhea, back pain, dizziness, pruritus, injection site erythema, myalgia, depression.
Worsening of psoriasis, thrombocytopenia, malignancies, serious infections (cellulitis, diverticulitis, gastroenteritis, pneumonia, osteomyelitis, UTI, postoperative wound infection) have been noted. Reversible posterior leukoencephalopathy syndrome (headache, seizures, confusion, visual disturbances) occurs rarely.
BASELINE ASSESSMENT
Pts should not receive live vaccines during treatment, 1 yr prior to initiating treatment, or 1 yr following discontinuation of treatment. Inform pt of duration of treatment and required monitoring procedures. Assess skin prior to therapy; document extent and location of psoriasis lesions. Test pt for tuberculosis infection prior to initiating treatment.
INTERVENTION/EVALUATION
Closely monitor for signs/symptoms of active tuberculosis during and after treatment. Assess skin throughout therapy for evidence of improvement of psoriasis lesions. Monitor for worsening of lesions.
PATIENT/FAMILY TEACHING
• If appropriate, pt may self-inject after proper training in preparation and injection technique. • Report any signs of infection. • If new diagnosis of malignancy occurs, inform physician of current treatment with ustekinumab.