New Drugs of 2008 for Pharmacy Technicians A Quick Overview
MSHP/ICHP Spring Meeting April 25, 2009
Anna Nowobilski-Vasilios PharmD MBA FASHP BCNSP Principal, Anovation Care Management Innovation, Chicago IL Adjunct Assistant Professor, Midwestern University, Downers Grove IL
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Disclosures • Speaker owns less than 100 shares of Amgen stock. • Branded product packaging is included for educational purposes to assist in the prevention of medication errors. Inclusion does not represent speaker endorsement. • All conflicts have been resolved through peer review. • Speaker has no other disclosures. 2/70
Learning Objectives • Name the disease state and therapeutic class for each new agent. • Discuss the dosage form and route of administration for each new agent. • Describe the most serious adverse effects for each class of agent discussed. • List special issues related to dosing, storage, and dispensing for each new agent.
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1 New Drug Approvals 2008 January (7): ciclesonide, rh-thrombin, July (1): gadoxetate etravirine, somatropin, amoxicillin, August (3): clevidipine, tetrabenazine, fosaprepitant romiplostim February (4): niacin-simvastatin, September (2): granisetron patch, rilonacept, desvenlafaxine, r- lobenguane sulfate I 123 antihemophilic factor October (6): silodosin, C1 inhibitor March (2): levoleucovorin, (human), benzoyl peroxide & bendamustine clindamycin topical, lacosamide, April (6): rotavirus vaccine, mesalamine, fesoterodine regadenoson, olopatadine, November (3): rufinamide, sumatriptan-naproxen, certolizumab eltrombopag, tapentadol pegol, methylnaltrexone bromide December (7): synthetic conjugated May (2): alvimopan, r-Factor VIIa estrogen, adapalene & benzoyl June (5): triamcinolone acetonide, DTP- peroxide, plerixafor, zolpidem Polio-H.influenzae vaccine, tartrate, gadofosveset trisodium, metformin-repaglinide, difluprednate, bimatroprost, degarelix DTP-Polio vaccine (47) New Approvals (6) New Biologicals (28%) (21) New Molecular Entities (14) New Parenterals (67%)
Pharmacist’s Letter, New Drugs Approved by the FDA in 2008 Drug Information Online. www.drugs.com 4/70
Review of Systems • Ophthalmology • Endocrinology • Pulmonology • Hematology • Cardiology • Oncology • Gastroenterology • Dermatology •Urology • Psychiatry • Obstetrics & • Infectious Disease Gynecology • Pediatrics • Neurology • Radiology • Immunology • Surgery
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Ophthalmology
• difluprednate (Durezol™)
• bimatroprost (Latisse™)
• triamcinolone (Trivaris™)
Pharmacist’s Letter, New Drugs Approved by the FDA in 2008 Drug Information Online. www.drugs.com 6/70
2 difluprednate (Durezol™) • Corticosteroid • Sterile topical ophthalmic emulsion • For pain and swelling after eye surgery • Start 24 hours after surgery, 4x/day for 2 weeks after surgery; then 2x/day for a week, then taper • Don’t use if eye infection • Store at room temperature • Rx; not CS Epocrates Drug Information. www.epocrates.com Durezol™ (difluprednate) [package insert]. Tampa FL: Sirion Therapeutics, Inc.; August 2008. 7/70
bimatroprost (Latisse™) • Prostaglandin-like drug for hypotrichosis • Approved in 2001 for glaucoma (Lumigan®) – Found to increase length, thickness and darkness of eye lashes • May lower intraocular pressure • Applied with applicator once nightly • To base of eyelashes on top lids only • May increase pigmentation • Store at room temperature • Rx; not CS • L/SA: brimonidine; latanoprost Epocrates Drug Information. www.epocrates.com Latisse™ (bimatroprost) [package insert]. Irvine CA: Allergan, Inc.; 2009. 8/70 L/SA = look/sound-alike drugs
triamcinolone acetonide (Trivaris™) • Initially approved in 1957 • New suspension formulation • For intravitreal injection • 8mg/0.1ml single-use glass syringe • Doesn’t come with a needle • Do NOT give IV • Store refrigerated • Rx; not CS • Others: Triescence™ & generics for intravitreal, intramuscular, and intra-articular injection
Epocrates Drug Information. www.epocrates.com Trivaris™ (triamcinolone acetonide) [package insert]. Irvine CA: Allergan, Inc.; 2008. 9/70
3 What do you know?
Bimatroprost is a prostaglandin-like drug that A. is available as an eye drop to decrease intraocular pressure. B. is applied to the lower eyelid to thicken eye lashes. C. is applied to the upper eyelid at the eyelash line to thicken eye lashes. D. A and C only.
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Pulmonology
• olopatadine (Patanase®)
• ciclesonide (Alvesco®)
Pharmacist’s Letter, New Drugs Approved by the FDA in 2008 Drug Information Online. www.drugs.com 11/70
olopatadine (Patanase®) • Seasonal allergic rhinitis > 12 yo • Antihistamine nasal spray • 2x/day 2 in each nostril • Prime (x5) initially & (x2) if not used x7d • ADR: bitter taste, HA, nosebleed, cough • Caution: can cause sleepiness – Alone, EtOH, CNS depressants • Contains 240 sprays (30 days) • Store at room temperature • Rx; not CS
Epocrates Drug Information. www.epocrates.com Patanase® (olopatadine) [package insert]. Fort Worth TX: Alcon, Inc.; March 2008. 12/70
4 ciclesonide (Alvesco®) • Inhaled synthetic corticosteroid • Asthma prevention – adults & peds > 12 yo • 2x/day inhalation; Prime (x3) • NOT for acute attack • Rinse mouth after use • ADR: bronchospasm • Store at room temp • Rx; not CS
Epocrates Drug Information. www.epocrates.com Alvesco® (ciclesonide) [package insert]. Fort Worth TX: Sepracor; Marlborough MA; May 2008. 13/70
What do you know? Which of the following is TRUE? A. Ciclesonide is an antihistamine. B. Olopatadine is a corticosteroid. C. Both ciclesonide and olopatadine devices must be primed prior to initial use. D. Both ciclesonide and olopatadine are administered once daily.
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Cardiology
• niacin-simvastatin (Simcor®)
• clevidipine (Cleviprex™)
Pharmacist’s Letter, New Drugs Approved by the FDA in 2008 Drug Information Online. www.drugs.com 15/70
5 niacin-simvastatin (Simcor®) • Unscored oral combination tablets for high cholesterol • Niacin is extended-release A. 500mg/20mg A B. 750mg/20mg C. 1000mg/20mg • Take at bedtime with low-fat snack B • Do not cut, crush or chew • Pregnancy Category X
• Watch blood sugar, muscle pain C Epocrates Drug Information. www.epocrates.com Simcor® (niacin-simvastatin) [package insert]. North Chicago IL: Abbot Laboratories; August 2008. 16/70
clevidipine (Cleviprex™) • Calcium Channel Blocker • RTU emulsion for IV infusion • For hypertensive crisis when oral not poss. – i.e. ICU, OR, ED • ADRs: È BP, Ç HR (rebound) • Store refrigerator, photosensitive • RT ok x 2 months • Light okay during infusion
The Medical Letter 2008; 50(1295):73. Epocrates Drug Information. www.epocrates.com 17/70 Cleviprex™ (clevidipine) [package insert]. Parsippany NJ: The Medicines Company; August 2008.
What do you know? Which of the following is TRUE? A. Niacin/simvastatin is an ORAL drug for high blood pressure B. Niacin/simvastatin can be CRUSHED and dispersed in apple sauce. C. Clevidipine is a ready-to-use emulsion for IV infusion. D. Clevidipine must be protected from light during infusion.
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6 Gastroenterology
• certolizumab (Cimzia®) • methylnaltrexone (Relistor®) • alvimopan (Entereg®) • granisetron (Sancuso®) • mesalamine ER (Apriso™)
Pharmacist’s Letter, New Drugs Approved by the FDA in 2008 Drug Information Online. www.drugs.com 19/70
certolizumab pegol (Cimzia®) • Subcutaneous injection • Crohn’s disease in adults • Don’t give w/: adalimumab, infliximab; natalizumab • ADR: serious infection, muscle weakness, injection site reactions • Reconstitute w/ SWI • Vial = 200mg; Dose = 400mg (2 shots) • 2 injections q 4wks by healthcare provider • Rx; not CS The Medical Letter 2008; 60(1297):81-2. Epocrates Drug Information. www.epocrates.com 20/70 Cimzia® (certolizumab pegol) [package insert]. Smyrna GA: UCB, Inc. April 2008.
methylnaltrexone (Relistor®) • Subcutaneous injection • Opioid-induced constipation • Similar to naltrexone – doesn’t cross into CNS • ADR: flatulence, DC if severe NVD • Tell patient to be close to bathroom • Works within 30 min to 4 hours • Given NMT 1x/day PRN until BM • Store at room temp • RX, not CS The Medical Letter 2008;50(1292):63. Epocrates Drug Information. www.epocrates.com Resistor® (methylnaltrexone) [package insert]. Philadelphia PA and Tarrytown NY: Wyeth Pharmaceuticals and Progenics Pharmaceuticals; April 2008. 21/70
7 alvimopan (Entereg®) • Oral capsules • Peripheral opioid receptor blocker • Regain GI function after bowel resection • Restricted access – hospitals must register • May not be dispensed to discharge patients • Caution if recent opioid use • Store at room temperature • Rx; not CS Epocrates Drug Information. www.epocrates.com Pharmacist's Letter/Prescriber's Letter 2008;24(6):240608. 22/70 Entereg® (alvimopan) [package insert]. Research Triangle Park NC: GlaxoSmithKline; 2008.
granisetron (Sancuso®) • Transdermal patch • Chemo-induced NV • Apply to upper outer arm – 24 hrs before chemo • Protect patched skin from sunlight • Can be worn for up to 7days • Store at room temperature • Rx; not CS
Epocrates Drug Information. www.epocrates.com Sancuso® (granisetron) [package insert]. Bedminster NJ: ProStrakan, Inc.; August 2008. 23/70
mesalamine (Apriso™) • New extended release form • Locally acting aminosalicylate • Maintain ulcerative colitis remission • Once-daily (5 capsules) • Don’t Crush or chew or give with antacids ADR: HA, diarrhea, upper abdominal pain • Store at room temperature • Rx; not CS • L/SA: megestrol; memantine; metaxalone; sulfasalazine
Epocrates Drug Information. www.epocrates.com Apriso™ (mesalamine) [package insert]. Morris NC: Salix Pharmaceuticals, Inc.; 2008. 24/70 L/SA = look/sound-alike drugs
8 What do you know?
Which of the following is TRUE? A. Certolizumab is a self-administered. B. Methylnaltrexone causes opioid withdrawal symptoms. C. Alvimopan can be obtained from community pharmacies. D. Granisetron transdermal patches can cause skin photosensitivity reactions for up to 10 days after removal. E. Meselamine extended release capsules can be
given with antacids. 25/70
Urology
• silodosin (Rapaflo™)
• fesoterodine (Toviaz™)
Pharmacist’s Letter, New Drugs Approved by the FDA in 2008 Drug Information Online. www.drugs.com 26/70
silodosin (Rapaflo™) • Oral capsule: 4mg & 8 mg • Alpha-blocker • Benign prostatic hyperplasia (BPH) • Once daily with meal • Caution: postural hypotension • NOT for high blood pressure! • Store at room temperature • Rx; not CS
Rapaflo™ (silodosin) [package insert]. Corona CA: Watson Pharmaceuticals, Inc.; 2008. 27/70
9 fesoterodine (Toviaz™) • Oral extended-release tablet – 4mg “FS” (A); 8mg “FT” (B) • For overactive bladder • Can be taken with/without food • ADR: dry mouth, constipation, urinary retention • Caution in heat • Store at room temperature • Protect from moisture A • Rx; not CS B Epocrates Drug Information. www.epocrates.com Toviaz™ (fesoterodine) [package insert]. New York NY: Pfizer Labs.; April 2008. 28/70
Obstetrics/Gynecology
• synthetic conjugated estrogen (SCE-A)
Pharmacist’s Letter, New Drugs Approved by the FDA in 2008 Drug Information Online. www.drugs.com 29/70
synthetic conjugated estrogen (SCE-A) • Plant-derived estrogen vaginal cream • Initially approved in 1999 • For severe vaginal dryness and painful intercourse due to menopausal changes • Reusable applicators – Remove plunger from barrel – Wash with mild soap and warm water • Store at room temperature • Rx; not CS
Synthetic Conjugated Estrogens [package insert]. San Antonio TX and Pomona NY: DPT Laboratories and Duramed Pharmaceuticals; November 2008. 30/70
10 What do you know? Which of the following is FALSE? A. Silodosin is used to treat hypertension and benign prostatic hyperplasia. B. Fesoterodine can not be crushed or chewed, but can be taken with or without meals. C. Alcohol can increase drowsiness with fesoterodine. D. Applicators provided with synthetic conjugated estrogen vaginal cream can be washed with mild soap and warm
water. 31/70
Neurology
• sumatriptan-naproxen (Treximet®) • lacosamide (Vimpat®) • rufinamide (Banzel™) • tapentadol
Pharmacist’s Letter, New Drugs Approved by the FDA in 2008 Drug Information Online. www.drugs.com 32/70
sumatriptan/naproxen (Treximet®) • Oral tablet: 500mg/85mg for acute migraine – Sumatriptan is a 5-HT1 agonist – Naproxen is a NSAID • NMT 2 tabs/24 hours, separated by 2 hrs • May increase risk of Heart Attack or GI Bleed • Pregnancy registry • Can be taken with/without food • Store at room temperature • Don’t repackage • Rx; not CS Drug Information On Line, www.drugs.com. Epocrates Drug Information. www.epocrates.com 33/70 Treximet® (sumatriptan/naproxen) [package insert]. Research Triangle Park NC: GlaxoSmithKline.; July 2008.
11 lacosamide (Vimpat®) • Oral tablets and IV injection • Adjunct in partial onset seizures > 17 yo • PO 2x/day film-coated tablets – 50 mg (pink), 100 mg (dark yellow) – 150 mg (salmon), 200 mg (blue) • IV when PO isn’t possible – IV daily dose equivalent to oral daily dose – Compatible w/ NSS, D5W & LR x24h in PVC or glass at room temperature • Caution: suicidal behavior • Pregnancy registry • Store at room temperature • Rx; not CS
® Vimpat (lacosamide) [package insert]. Smyrna GA: UCB, Inc..; October 2008. 34/70 NOTE: Image is of EU products. US does not have oral liquid form and orals are available in bottles and not boxes.
rufinamide (Banzel™) • Oral tablets: – 200mg (A) & 400mg (B) • Antiepileptic, not like any other • Adjunct for Lennox-Gastaut Syndrome (LGS) seizures •Adult and Pediatric use > 4 yo • Caution: suicidal ideation, seizures, decreased WBC, A sleepiness • Store at room temperature • Rx, not CS B Epocrates Drug Information. www.epocrates.com The Medical Letter 2009;51(1307):18. 35/70 Banzel™ (rufinamide) [package insert]. Woodcliff Lake NJ: Eisai Co, Ltd.; November 2008.
tapentadol • Oral opioid analgesic tablets • Moderate to severe acute pain > 18 yo • Caution: respiratory depression, CNS effects • 50, 75, 100mg q4-6hrs PRN pain • For short term use only • Physical dependence • Addictive potential • Rx, CS; in DEA review C? (tapentadol) [package insert]. Gurabo PR and Raritan NJ: Jansson Ortho LLC and PriCara, a division of Ortho- McNeil-Janssen Pharmaceuticals, Inc.; November 2008. 36/70 NOTE: tapentadol is the generic name.
12 What do you know?
Which of the following is TRUE? A. Sumatriptan/naproxen can be unit dosed in the hospital pharmacy. B. The IV and oral doses of lacosamide are equivalent. C. Rufinamide is a controlled substance. D. Tapentadol is available from wholesalers for stocking in the pharmacy.
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Immunology
• rilonacept (Arcalyst™) • human C-1 inhibitor (Cinryze™)
Pharmacist’s Letter, New Drugs Approved by the FDA in 2008 Drug Information Online. www.drugs.com 38/70
rilonacept (Arcalyst™) • Cryopyrin-associated periodic syndromes (CAPS) • Extremely rare inherited inflammatory response – 300 pts in US; 50% due to gene mutation – Acute attack after exposure to cold • Adults & children > 12 yo • Injection site reactions • Subcutaneous injection • Lyophilized powder, use w/in 3 hrs •1st dose observed, then self-administered • Doesn’t come with supplies • Refrigerate, protect from light •Rx; not CS
E-Medicine. www.emedicine.medscape.com. Arcalyst™ (rilonacept) [package insert]. Tarrytown NY: Regeneron Pharmaceuticals, Inc. July 2008. 39/70
13 human C-1 inhibitor (Cinryze™) • From human plasma • Hereditary angioedema prophylaxis – Life-threatening inherited condition • Missing plasma protein; • 6,000 – 10,000 pts in US • IV 1 mL/min q3-4 days • Freeze-dried powder – Reconstitute w/ 5ml SWI (not provided) – Withdraw via filter needle – Use w/in 3 hours • Restricted access • Refrigerate. Protect from light. •Rx; not CS
Epocrates Drug Information. www.epocrates.com 40/70 Cinryze™ (C1 Inhibitor, human) [package insert]. New York NY: Lev Pharmaceuticals. October 2008.
Endocrinology
• somatropin (Accretropin™)
• metformin-repaglinide (Prandimet™)
Pharmacist’s Letter, New Drugs Approved by the FDA in 2008 Drug Information Online. www.drugs.com 41/70
somatropin (Accretropin™) • Yet another growth hormone product! • Pediatric growth hormone deficiency – Growth failure due to inadequate GH – Short stature due to Turner Syndrome • Multi-dose vial – Use up to 14 days after first use • Refrigerate • Do not freeze. Do not shake. •Rx Drug Information Online. www.drugs.com. Accretropin™ (somatropin) [prescribing information]. Winnipeg Canada: Cangene Corporation. March 2007. 42/70
14 repaglinide-metformin (PrandiMet™) • Combination for Type 2 diabetes • Oral tablets – 1mg/500mg (yellow) –2mg/500mg (pink) • 2-3x daily, 15-30 minutes before a meal • If meal is skipped, dose should not be taken. • ADR: low blood sugar (repaglinide); NVD (metformin) • Store at room temp. • Protect from moisture. • Rx; not CS PrandiMet™ (repaglinide-metformin) [prescribing information]. Princeton NJ: Novo-Nordisk, Inc.. 2008. 43/70
What do you know? Which of the following is TRUE? A. Rilonacept packaging does not include the syringes, needles, diluent, alcohol wipes and gauze the patient needs to administer the drug. B. Human C-1 inhibitor packaging does not include the sterile water needed for reconstitution. C. Repaglinide-metformin should be taken 15-30 minutes before a meal. D. All of the above are TRUE. 44/70
Hematology
• r-antihemophilic factor (Xyntha™) • romiplostim (Nplate™) • eltrombopag (Promacta®) • bendamustine (Treanda®) • plerixafor (Mozobil™)
Pharmacist’s Letter, New Drugs Approved by the FDA in 2008 Drug Information Online. www.drugs.com 45/70
15 r-antihemophilic factor (Xyntha™) • Hemophilia A (FVIII deficiency) – Bleeding control – Surgical prophylaxis • Additional treatment option • recombinant • Plasma and albumin free – Minimizing risk of infection • Pt reconstitutes & gives IV over a few minutes • Use within 3 hours of reconstitution • Kit includes all supplies • Store refrigerated • RT storage ok for up to 3 mo • Rx; not CS Epocrates Drug Information. www.epocrates.com Xyntha™ (recombinant antihemophilic factor) [package insert]. Philadelphia PA: Wyeth Pharmaceuticals, 2008. 46/70
romiplostim (Nplate™) • Weekly subcutaneous injection • Restricted distribution (REMS) • Thrombopoietin receptor activator • Idiopathic thrombocytopenic purpura (ITP) • Do NOT use to normalize platelet counts • Administered by healthcare provider • FDA-mandated medication guide • Lyophilized powder, refrigerate • Use syringes w/ 0.01ml graduations • Use w/in 24hrs of reconstitution • Rx; not CS Epocrates Drug Information. www.epocrates.com The Medical Letter 2009;51(1305):10. 47/70 Nplate™ (romiplostim) [package insert]. Thousand Oaks CA: Amgen, Inc. August 2008.
eltrombopag (Promacta®) • Oral once daily tablets – 25 mg (A); 50mg (B) – Give on empty stomach – Lower dose in East Asians & Liver Disease • Restricted distribution (REMS) • Thrombopoietin receptor agonist • Idiopathic thrombocytopenic purpura (ITP) – Stop if no response in 4 weeks • Do NOT use to normalize platelet counts A • CAUTION: liver toxicity • Pregnancy Registry • Rx; not CS B Epocrates Drug Information. www.epocrates.com The Medical Letter 2009;51(1305):10. 48/70 Promacta® (eltrombopag) [package insert]. Research Triangle Park NC: GlaxoSmithKline. 2008.
16 bendamustine (Treanda®) • Chemotherapy agent (alkylating) • Leukemia and lymphoma – Chronic lymphocytic leukemia (CLL) – Non-Hodgkin lymphoma (NHL) • CAUTION: ÈWBC, Èplatelets, NV, skin reactions, fever, fatigue • Lyophilized powder – store at room temp • Reconstitute w/ SWI and dilute with NSS w/in 30 minutes of reconstitution – Stable 3 hrs @ RT; 24 hrs refrigerated • Use chemo precautions • Pregnancy Category D • Rx; not CS The Medical Letter 2008;50(1299):91. Epocrates Drug Information. www.epocrates.com Treanda® (bendamustine) [package insert]. Frazer PA: Cephalon, Inc. 2008. 49/70
plerixafor (Mozobil™) • Mobilizes stem cells • Regimen includes filgrastim • Subcutaneous dose 11 hrs prior to each stem cell harvesting session • ADRs: NVD, fatigue, injection site reaction, HA, achiness, dizziness • Pregnancy Category D • Store at room temperature • Rx; not CS Drug Information Online. www.drugs.com. Epocrates Drug Information. www.epocrates.com 50/70 Mozobil™ (plerixafor) [package insert]. Cambridge MA: Genzyme Corporation. 2008.
What do you know?
Which of the following is FALSE? A. Recombinant antihemophilic factor is both human plasma and albumin free. B. Both romiplostim and eltrombopag are used in ITP. Neither should be used routinely to normalize platelet counts. C. When preparing bendamustine, chemo precautions should be used. D. Plerixafor is used alone to stimulate stem cells before transplantation. 51/70
17 Oncology
• fosaprepitant (Emend® Injection)
• levoleucovorin (Fusilev™)
• degarelix
Pharmacist’s Letter, New Drugs Approved by the FDA in 2008 Drug Information Online. www.drugs.com 52/70
fosaprepitant (Emend® Injection) • IV formulation • Chemo nausea & vomiting prevention • Given with corticosteroid and 5-HT3 antagonist • Rapidly converts to aprepitant when given IV • Given IV on first day only, continued with oral aprepitant • Not recommended for chronic use. • Refrigerate • Rx; not CS Epocrates Drug Information. www.epocrates.com 53/70 Emend® (fosaprepitant) [prescribing information]. Whitehouse Station NJ: Merck & Co. January 2008.
levoleucovorin (Fusilev™) •IV infusion • Folic Acid analogue for methotrexate rescue – After high-dose methotrexate – After accidental methotrexate overdose • Active enantiomer of leucovorin – ½ usual dose of racemic form • 50mg freeze-dried powder – Reconstitute w/ NSS – Given slowly because of Ca content • Store at room temperature • Rx; not CS Drug Information Online. www.drugs.com Epocrates Drug Information. www.epocrates.com Fusilev™ (levoleucovorin) [package insert]. Irvine CA: Spectrum Pharmaceuticals. 2008. 54/70
18 degarelix • Subcutaneous injection (deep) • Advanced prostate cancer • Slows growth & progression of prostate cancer by suppressing testosterone • ADR: injection site reactions, hot flashes • Pregnancy Category X • Use chemo precautions – Reconstitute 80 & 120 mg vials w/ SWI – Keep vial vertical & swirl gently (15 min) – Do not turn vial upside down to withdraw – Do not shake; Use w/in 1 hr • Store at room temperature •Rx; not CS Degarelix [package insert]. Parsippany NJ: Ferring Pharmaceuticals. 2008. 55/70 NOTE: degarelix is the generic name.
What do you know?
Which of the following is FALSE? A. Fosaprepitant is a prodrug of aprepitant that is use for chemotherapy-induced nausea and vomiting. B. The dosing of levoleucovorin is the same as leucovorin. C. Degarelix works on prostate cancer by decreasing testosterone levels. D. All of the above are TRUE.
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Dermatology
• benzoyl peroxide & clindamycin (Acanya™)
• adapalene & benzoyl peroxide (Epiduo™)
Pharmacist’s Letter, New Drugs Approved by the FDA in 2008 Drug Information Online. www.drugs.com 57/70
19 benzoyl peroxide & clindamycin (Acanya™) • Topical combination gel • Severe acne in > 12 yo • Wash face, apply small dab daily • Avoid sunlight & sunlamps • Use beyond 12 wks not studied • Supplied in a kit with spatula – Prepare prior to dispensing • Stable at RT for 2 months. • Keep jar tightly closed • Rx; not CS Epocrates Drug Information. www.epocrates.com Acanya™ (benzoyl peroxide & clindamycin) [prescribing information]. Redwood City CA: Arcutis Pharmaceuticals. 58/70 October 2008.
adapalene & benzoyl peroxide (Epiduo™) • Topical combination gel • Adapalene has retinoid-like properties • Severe acne in > 12 yo • Wash face & apply dab to forehead, chin, and each cheek, spread thinly • Avoid sunlight & sunlamps • 45 gram tube, keep tightly closed • Store at room temperature • Rx; not CS Epocrates Drug Information. www.epocrates.com Epiduo™ (adapalene & benzoyl peroxide) [prescribing information]. Fort Worth TX: Galderma Laboratories. 2008. 59/70
Psychiatry
• desvenlafaxine (Pristiq™)
• zolpidem (Zolpimist™)
Pharmacist’s Letter, New Drugs Approved by the FDA in 2008 Drug Information Online. www.drugs.com 60/70
20 desvenlafaxine (Pristiq™) • Oral Extended Release Tablet – 50mg (pink) or 100mg (orange) once daily • SNRI for major depression > 25 yo • Exposure 3rd trimester – Neonatal complications • Increased suicide in children, adolescents and young adults • Do not stop abruptly – taper gradually • Store at room temperature • Rx; not CS. Drug Information On Line, www.drugs.com. Epocrates Drug Information. www.epocrates.com 61/70 Pristiq™ (desvenlafaxine) [prescribing information]. Philadelphia PA: Wyeth Pharmaceuticals, Inc.. February 2009.
zolpidem (Zolpimist™) • New dosage form • Oral spray for insomnia • Cherry flavored solution • Zolpidem available since 1992 • 1-2 sprays, immediately before bedtime • Spray in mouth over the tongue • Prime container (5x) • Short term treatment • Store at room temperature • Rx, C-IV
Epocrates Drug Information. www.epocrates.com 62/70 Zolpimist™ (zolpidem) [prescribing information]. Fleming NJ: NovaDel Pharma, Inc.. December 2008.
Infectious Disease
• etravirine (Intelence™) • amoxicillin (Moxatag™) • rotavirus vaccine (Rotarix®) • DTP-Polio-H.flu vaccine (Pentacel®) • DTP-Polio vaccine (Kinrix™)
Pharmacist’s Letter, New Drugs Approved by the FDA in 2008 Drug Information Online. www.drugs.com 63/70
21 etravirine (Intelence™) • Oral tablet, 100mg • NNRTI for HIV infection • Used in combination with other select antiretrovirals • Two tabs twice daily after a meal • If unable to swallow tablet, can disperse in glass of water, stir & drink • Multiple drug interactions • Store at room temperature • Store in original container with desiccants. • Rx; not CS
Epocrates Drug Information. www.epocrates.com 64/70 Intelence™ (etravirine) [prescribing information]. Raritan NJ: Tibotec Therapeutics.. January 2008.
amoxicillin (Moxatag™) • New once daily formulation • For strep tonsillitis or pharyngitis > 12 yo • Take once daily x 10 days with meal • Do NOT cut, crush or chew • Store at room temperature • Contact MD if diarrhea after discontinuation* • Rx; not CS • L/SA: amoxapine, Amoxil®, ampicillin, Atarax®, Augmentin®
Epocrates Drug Information. www.epocrates.com Moxatag™ (amoxicillin) [prescribing information]. Germantown MD: Middlebrook Pharmaceuticals, Inc. 2008. 65/70 L/SA = look/sound alike
New Vaccines • Rotavirus Vaccine (Rotarix®) – Oral vaccine with diluent – Prevent severe gastroenteritis in infants & children – Requires one less dose than other vaccine, but includes only one serotype. – Syringes and vials. • DTP-Polio (Kinrix™) – Vaccine against diphtheria, tetanus, pertussis, and poliomyelitis – Similar protection to separate DTaP and IPV – Protection against four diseases with one less shot • DTP-Polio-H.influenzae (Pentacel®) – Vaccine against diphtheria, tetanus, pertussis, poliomyelitis, and Haemophilus influenza – Given as a four-dose series, reducing number of shots by seven • Rx; not CS The Medical Letter 2008;50(1293):66. Epocrates Drug Information. www.epocrates.com Kinrix™ (DTP-Polio vaccine) [prescribing information]. Research Triangle Park NC: GlaxoSmithKline. 2008. Pentacel® (DTP-Polio-H.flu vaccine) [prescribing information]. Swiftwater PA; Sanofi Pasteur, Inc. June 2008. 66/70 Rotarix® (rotavirus vaccine) [prescribing information]. Research Triangle Park NC. GlaxosSmithKline. 2008.
22 What do you know? If patients are unable to swallow, etravirine can be dispersed in water and amoxicillin once-daily can be crushed. A. True B. False
All three vaccines discussed in this presentation must be stored under refrigeration. A. True B. False 67/70
New Testing Products • regadenoson (Lexiscan™) – IV stress agent for cardiac testing in patients unable to do the exercise stress test – Store at room temperature • gadoxetate (Eovist®) – IV contrast agent – Store at room temperature • gadofosveset (Vasovist™) – gadolinium-based contrast agent • lobenguane I-123 (AndreView™) – Diagnostic radiopharmaceutical – Store at room temperature – Follow Nuclear Regulatory Commission – Safety & efficacy established in children > 1 month old Pharmacist’s Letter, New Drugs Approved by the FDA in 2008. Drug Information Online. www.drugs.com Lexiscan™ (regadenoson) [prescribing information]. Deerfield IL: Astellas US, Inc. April 2008. Eovist® (gadoxetate) [prescribing information]. Wayne NJ: Bayer Healthcare, Inc. January 2009. AndreView™ (lobenguane I-123) [prescribing information]. Arlington Heights IL: GE Healthcare, MediPhysics, Inc. 2008. 68/70 Vasovist™ (gadofosveset) [prescribing information]. Wayne NJ: Bayer Healthcare, Inc. January 2008.
New Surgery Product • rh-thrombin (Recothrom™) – Recombinant human thrombin – For TOPICAL use in surgery – Stops blood oozing – Sterile lyophilized powder for solution: 5,000 A (A) & 20,000 (B) unit kits – Apply saturated on gel sponge or with spray applicator kit (C) B – Store at 2-25oC (36-77oF) – Once reconstituted, use within 24 hours at these same temperatures. C –Rx; not CS. Pharmacist’s Letter, New Drugs Approved by the FDA in 2008 Drug Information Online. www.drugs.com Recothrom™ (rh-thrombin) [prescribing information]. Seattle WA: ZymoGenetics, Inc. May 2008. 69/70
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24 NEW DRUGS AND BIOLOGICALS 2008 RESOURCE LIST
Specialty Generic Name Brand Name Manufacturer Rte Class & Indication Approved Cardiology clevidipine Cleviprex™ Medicines Co. IV Injectable calcium channel blocker emulsion for HTN when 8/1/2008 oral therapy is not feasible Cardiology niacin-simvastatin Simcor® Abbott PO Niacin-statin combination product 2/15/2008 Cardiology regadenoson Lexiscan™ CV IV Stress agent for radionuclide myocardial perfusion imaging 4/10/2008 Therapeutics & in patients unable to undergo exercise stress testing. Astellas Dermatology adapalene & benzoyl Epiduo® Galderma TOP New topical combination product for acne 12/8/2008 peroxide Dermatology Benzoyl peroxide & Acanya™ Dow TOP Topical antibacterial/antibiotic for acne 10/21/2008 Clindamycin Endocrinology metformin- PrandiMet™ Novo Nordisk PO New combination for type 2 diabetes 6/23/2008 repaglinidine Endocrinology somatropin Accretropin™ Cangene SQ Recombinant HGH for pediatric GHD and Turner’s 1/23/2008 syndrome Gastroenterology alvimopan Entereg® Adolor PO Mu opioid receptor antagonist to help patients regain GI 5/20/2008 function earlier following bowel resection surgery Gastroenterology certolizumab pegol Cimzia® UCB SQ Pegylated anti-TNF for moderate to severe Crohn’s disease 4/22/2008 in adults Gastroenterology granisetron Sancuso® ProStraken TOP Transdermal patch for prevention of chemo-induced N/V 9/12/2008 Gastroenterology mesalamine Apriso™ Salix PO Once-daily extended-release for maintenance of ulcerative 10/31/2008 colitis remission Gastroenterology methylnaltrexone Relistor® Progenics- SQ Mu opioid receptor antagonist for opioid-induced 4/24/2008 bromide Wyeth constipation in palliative care patients Hematology bendamustine Treanda® Cephalon IV Purine alkylating chemotherapeutic for chronic lymphocytic 3/20/2008 leukemia and non-Hodgkin's lymphoma Hematology eltrombopag Promacta® GSK PO Thrombopoietin receptor agonist for thrombocytopenia in 11/20/2008 patients with chronic idiopathic thrombocytopenic purpura
Hematology Factor VIIa NovoSeven® RT Novo Nordisk IV New room temperature formulation 5/9/2008 Hematology prelixafor Mozobil™ Genzyme INJ CXCR4 chemokine receptor antgonist for use in 12/15/2008 combination with G-CSF to mobilize stem cells for collection and autologous transplantation in patients with non- Hodgkin's lymphma and multiple myeloma. Hematology r-antihemophilic factor Xyntha™ Wyeth IV Plasma and albumin free antihemophilic factor for 2/21/2008 VIII hemophilia A
NOTE: This chart is provided for reference purposes only. Product specific prescribing information (see Brand Name links) should be consulted prior to application in the clinical setting. 1 of 3 NEW DRUGS AND BIOLOGICALS 2008 RESOURCE LIST
Specialty Generic Name Brand Name Manufacturer Rte Class & Indication Approved Hematology romiplostim Nplate™ Amgen SQ Thrombopoietin agonist to increase platelet production in 8/22/2008 patients with idiopathic thrombocytopenic purpura (ITP)
Immunology C1 inhibitor (human) Cinryze™ Lev Pharm IV C1-esterase inhibitor for prevention of hereditary 10/10/2008 angioedema attacks Immunology rilonacept Arcalyst™ Regeneron SQ IL-1 blocker for cryopyrin-associated periodic syndromes 2/27/2008
Infectious Disease amoxicillin Moxatag™ Middlebrook PO Once-daily extended-release amoxicillin for tonsillitis or 1/23/2008 pharyngitis caused by Streptococcus pyogenes Infectious Disease etravirine Intelence™ Tibotec PO HIV infection refractory to other antiretrovirals. 1/18/2008
Neurology lacosamide Vimpat® UCB PO & Anticonvulsant for partial onset seizures in adults 10/28/2008 IV Neurology rufinamide Banzel™ Eisai PO Tiazole antiepileptic drug for adjunctive treatment of 11/14/2008 seizures associated with Lennox-Gestaut syndrome Neurology sumatriptan-naproxen Treximet® GSK PO Combination triptan-NSAID for acute migraine 4/15/2008 Neurology tetrabenazine Xenazine® Prestwick PO Monoamine depletor for involuntary movement of 8/15/2008 Pharma Huntington's Chorea OB-GYN synthetic conjugated SCE-A Duramed TOP Plant-derived estrogen vaginal cream for moderate to 12/1/2008 estrogen severe vaginal dryness and pain with intercourse Oncology degarelix TBA Ferring SQ Gonadotropin releasing hormone (GnRH) receptor inhibitor 12/29/2008 for prostate cancer. Oncology fosaprepitant Emend® Merck IV IV prodrug of aprepitant for chemotherapy-induced NV 1/25/2008 (same brand name for both) Oncology levoleucovorin Fusilev™ Spectrum IV Enantiomer of leucovorin for use in high-dose methotrexate 3/7/2008 therapy. Ophthalmology bimatroprost Latisse™ Allergan OPH hypotrichosis (reduced amount of hair) of the eyelashes 12/29/2008 Ophthalmology difluprednate Durezol™ Sirion OPH Ophthalmic corticosteroid for inflammation/pain post ocular 6/23/2008 Therapeutics surgery Ophthalmology triamcinolone Trivaris™ Allergan IO Injectable corticosteroid suspension for intravitreal 6/16/2008 acetonide administration. Pain Management tapentadol TBA Pricara PO Analgesic for moderate to severe acute pain 11/20/2008
Psychiatry desvenlafaxine Pristiq™ Wyeth PO SNRI for depression 2/29/2008 Psychiatry zolpidem tartrate ZolpimistTM NovaDel PO Oral spray for short-term treament of insomnia. 12/22/2008 Pulmonology ciclesonide Alvesco® Nycomed INH Inhaled corticosteroid for asthma 1/10/2008
NOTE: This chart is provided for reference purposes only. Product specific prescribing information (see Brand Name links) should be consulted prior to application in the clinical setting. 2 of 3 NEW DRUGS AND BIOLOGICALS 2008 RESOURCE LIST
Specialty Generic Name Brand Name Manufacturer Rte Class & Indication Approved Pulmonology olopatadine Patanase® Novalar NAS New nasal spray formulationfor seasonal allergic rhinitis 4/15/2008 Radiology gadofosveset trisodium Vasovist™ EPIX IV A blood pool magnetic resonance angiography agent, for 12/24/2008 use in adults whose pelvic arteries may have become narrowed or blocked Radiology gadoxetate Eovist® Bayer IV Gadolinium-based contrast agent for MRI of the liver 7/3/2008 Radiology lobenguane suftate I AndreViewTM GE Healthcare IV Diagnostic radiopharmaceutical for detection of rare 9/19/2008 123 neuroendocrine tumors in children (neuroblastoma) and adults (pheochromocytoma). Surgery rh-thrombin Recothrom™ ZymoGenetics TOP Recombinant human thrombin for hemostatis during surgery 1/17/2008
Urology fesoterodine Toviaz™ Pfizer PO Antimuscarinic for overactive bladder 10/31/2008 Urology silodosin Rapaflo™ Watson PO Alpha-blocker of treatment of benign prostatic hyperplasia. 10/8/2008
Vaccine DTP-Polio Kinrix™ GSK IM Active immunization against diphtheria, tetatuns, pertussis, 6/24/2008 and poliomyelitis in children Vaccine DTP-Polio- Pentacel® Sanofi-Pasteur IM Active immunization against diphtheria, tetanus, pertussis, 6/20/2008 H.influenzae poliomyelitis and Haemophilus influenzae in infants and children. Vaccine rotavirus Rotarix® GSK PO Oral live two-dose vaccine to prevent rotavirus 4/3/2008 gastroenteritis in infants and children Sources: Pharmacist’s Letter; FDA.gov; drugs.com; manufacturer websites
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NOTE: This chart is provided for reference purposes only. Product specific prescribing information (see Brand Name links) should be consulted prior to application in the clinical setting. 3 of 3 New Drugs of 2008 for Pharmacy Technicians MSHP/ICHP Spring Meeting
Self-Assessment Questions
1. Bimatroprost is a prostaglandin-like drug that A. is available as an eye drop to decrease intraocular pressure. B. is applied to the lower eyelid to thicken eye lashes. C. is applied to the upper eyelid at the eyelash line to thicken eye lashes. D. A and C only.
2. Which of the following is TRUE? A. Ciclesonide is an antihistamine. B. Olopatadine is a corticosteroid. C. Both ciclesonide and olopatadine devices must be primed prior to initial use. D. Both ciclesonide and olopatadine are administered once daily.
3. Which of the following is TRUE? A. Niacin/simvastatin is an ORAL drug for high blood pressure B. Niacin/simvastatin can be CRUSHED and dispersed in apple sauce. C. Clevidipine is a ready-to-use emulsion for IV infusion. D. Clevidipine must be protected from light during infusion.
4. Which of the following is TRUE? A. Certolizumab is a self-administered. B. Methylnaltrexone causes opioid withdrawal symptoms. C. Alvimopan can be obtained from community pharmacies. D. Granisetron transdermal patches can cause skin photosensitivity reactions for up to 10 days after removal. E. Meselamine extended release capsules can be given with antacids.
5. Which of the following is FALSE? A. Silodosin is used to treat hypertension and benign prostatic hyperplasia. B. Fesoterodine can not be crushed or chewed, but can be taken with or without meals. C. Alcohol can increase drowsiness with fesoterodine. D. Applicators provided with synthetic conjugated estrogen vaginal cream can be washed with mild soap and warm water.
6. Which of the following is TRUE? A. Sumatriptan/naproxen can be unit dosed in the hospital pharmacy. B. The IV and oral doses of lacosamide are equivalent. C. Rufinamide is a controlled substance. D. Tapentadol is available from wholesalers for stocking in the pharmacy.
7. Which of the following is TRUE? A. Rilonacept packaging does not include the syringes, needles, diluent, alcohol wipes and gauze the patient needs to administer the drug. B. Human C-1 inhibitor packaging does not include the sterile water needed for reconstitution. C. Repaglinide-metformin should be taken 15-30 minutes before a meal. D. All of the above are TRUE.
8. Which of the following is FALSE? A. Recombinant antihemophilic factor is both human plasma and albumin free. B. Both romiplostim and eltrombopag are used in ITP. Neither should be used routinely to normalize platelet counts. C. When preparing bendamustine, chemo precautions should be used. D. Plerixafor is used alone to stimulate stem cells before transplantation.
9. Which of the following is FALSE? A. Fosaprepitant is a prodrug of aprepitant that is use for chemotherapy-induced nausea and vomiting. B. The dosing of levoleucovorin is the same as leucovorin. C. Degarelix works on prostate cancer by decreasing testosterone levels. D. All of the above are TRUE.
10. If patients are unable to swallow, etravirine can be dispersed in water and amoxicillin once- daily can be crushed. A. True B. False
11. All three vaccines discussed in this presentation must be stored under refrigeration. A. True B. False