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Highlights: New Medications 2008

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Review selection of drugs approved in 2008 and 2009- most likely to be seen in ... 5 mg and 10 mg Oral spray ... Meda Pharmaceutical 2008. ... – PowerPoint PPT presentation

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Title: Highlights: New Medications 2008


1
Highlights New Medications 2008 2009
  • Joe Manganelli, PharmD, MPA, RPh
  • August 2009

2
Objectives
  • Review selection of drugs approved in 2008 and
    2009- most likely to be seen in pharmacy practice
  • Drugs grouped by body system
  • Indications, adverse effects, warnings
  • Similar drugs already on the market
  • Selection of drugs in the pharma pipeline

3
Central Nervous System
  • ZolpiMist (zolpidem)-
  • 5 mg and 10 mg Oral spray
  • Short-term treatment of insomnia characterized by
    difficulties with sleep initiation.
  • Bioequivalent with Ambien tablets
  • Adverse Effects sleep driving, sleep
    cooking, amnesia, drowsiness, dizziness

4
CNS
  • Fanapt (iloperidone)--
  • Tablets 1,2,4,6,8,10,12mg. Titrate dose.
  • Serotonin /dopamine antagonist (atypical
    antipsychotic)
  • Indicated for treatment of schizophrenia
  • Warning Use in elderly who have dementia
  • A/E- prolong QT interval, syncope, weight gain,
    hyperglycemia, dizziness, fatigue
  • Similar Invega

5
CNS
  • Savella (milnacipran)--
  • Tablets 12.5, 25, 50, 100mg- titrate dose
  • Selective serotonin and norepinephrine reuptake
    inhibitor -SNRI
  • Indicated for fibromyalgia- pain inhibition
  • A/E- increased suicide risk, nausea, vomiting,
    palpitations, hypertension
  • Similar Cymbalta

6
CNS
  • Pristiq (desvenlafaxine)-
  • Extended release tablets 50, 100mg
  • Treatment of Major Depressive Disorder
  • Potent serotonin norepinephrine reuptake
    inhibitor (SNRI), potentiates receptors
  • Warning Suicide risk
  • A/E Anxiety, constipation, dizziness, decreased
    appetite, nausea, headache
  • Similar Effexor

7
CNS
  • Saphris (asenapine)--
  • Tablets -sublingual
  • Treatment of schizophrenia and bipolar disorder
  • A/E insomnia, agitation, nausea

8
CNS
  • Vimpat (lacosamide)--
  • Tablets 50, 100, 150, 200mg and injection
  • Stabilizes hyperexcitable neuronal membranes
  • Anticonvulsant drug for the treatment of partial
    onset seizures
  • A/E- dizziness, nausea, vomiting, diarrhea- all
    dose dependent titrate dose
  • Similar Keppra

9
CNS
  • Banzel (rufinamide)-
  • 200 and 400mg tablets
  • Adjunctive treatment of seizures associated with
    Lennox-Gastaut syndrome
  • A/E- somnolence, headache, n,v,d
  • Warning suicide risk
  • Similar Lamictil

10
Ophthalmology
  • Besivance (besifloxacin)--
  • Ophthalmic suspension
  • Fluoroquinolone antibiotic
  • Treatment of bacterial conjunctivitis
  • A/E- Redness, eye irritation
  • Similar Vigamox, Ocuflox

11
Cardiovascular
  • Simcor 1000/20 mg-
  • Niaspan(ER)/
  • Simvastatin
  • tablets
  • Used along with diet to lower elevated total
    cholesterol, LDL, triglycerides, raise HDL.
  • A/E Flushing
  • Similar Advicor

12
Cardiovascular
  • TriLipix - (Fenofibrate)-
  • 45 mg, 135 mg Delayed Release Capsule
  • Hypertriglyceridemia
  • Hypercholesterolemia
  • Mixed Dyslipidemia
  • CI Severe renal, hepatic, gallbladder disease
  • Warning May prolong INR (monitor pts)
  • A/E- headache, backache, nausea
  • Similar Tricor, Lofibra

13
Cardiovascular
  • Multaq (dronedarone)--
  • 400mg tablets
  • Help maintain normal heart rhythms in patients
    with history of atrial fibrillation or atrial
    flutter.
  • Warning do not use in severe heart failure
  • A/E nausea, vomiting, diarrhea, fatigue
  • Considered a safer alternative to amiodarone

14
Pulmonary
  • Inhaled corticosteroid that inhibit multiple
    inflammatory cell types and chemicals involved in
    the asthmatic process.
  • A/E (gt3) headache, nasopharyngitis, sinusitis,
    pharyngolarynegeal pain, URI, arthralgia, nasal
    congestion, pain in the extremities and back pain.
  • Alvesco -Inhalation Aerosol
  • Ciclesonide
  • Maintenance treatment of asthma gt 12 y/o.
  • 160 mcg or 80 mcg inhaler
  • Once daily
  • NOT for relief of acute bronchospasm.

15
Pulmonary
  • Astepro (azelastine hydrochloride)- 137 mcg
    nasal spray
  • Approved for relief of symptoms of seasonal
    allergic rhinitis in patients gt 12 y/o.
  • Dose 1 to 2 sprays per nostril twice daily
  • Long Term (6 month) Safety Trial
  • Astepro vs. Astelin vs. placebo
  • Headache, bitter taste, epistaxis and
    nasopharyngitis
  • Similar between treatment groups

16
Pulmonary
  • Adcirca (tadalafil)--
  • Tablets- 20mg
  • Phosphodiesterase type 5 inhibitor
  • Indicated for treatment of pulmonary arterial
    hypertension (PAH)
  • Improves exercise tolerability
  • Warning contraindicated with nitrates
  • A/E- headache, dyspepsia

17
Pulmonary
  • Tyvaso (treprostinil) -
  • Inhalation solution
  • Improves exercise tolerability
  • Pulmonary Hypertension
  • A/E- cough, headache, nausea, dizziness
  • Similar Remodulin injection

18
Endocrine
  • Glumetza (Metformin HCl ER) 1000 mg improve
    glycemic control in Type II
  • Tablets- Once daily titrate to 2000 mg max dose
  • CI SCr 1.4 mg/dL (f) or 1.5 mg/dL (m)
  • Warning risk of lactic acidosis
  • A/E when combined with sulfonylurea
    hypoglycemia, diarrhea, and nausea.
  • Similar Glucophage XR

19
Endocrine
  • Onglyza (saxagliptin)--
  • Tablets once daily
  • Reduce blood sugars in Type II diabetes
  • DPP-4 inhibitor- stimulate pancreas
  • A/E- upper respiratory infection, rash, headache
  • Similar Januvia

20
Rheumatology
  • Uloric (febuxostat)--
  • Tablets 40 and 80mg
  • Xanthine oxidase inhibitor- decreases serum uric
    acid
  • Indicated for the chronic management of
    hyperuricemia in patients with gout.
  • A/E- nausea, rash, liver function abnormalities
  • Similar allopurinol

21
Rheumatology
  • Simponi (golimumab)--
  • Injection 50mg/0.5ml -monthly
  • Human anit-tumor necrosis factor (TNF)
  • Indicated as treatment of Rheumatoid Arthritis,
    Psoriatic Arthritis and Ankylosing Spondylitis
  • A/E- injections site reactions, increase LFTs
  • Warning more susceptible to infections, FDA
    advisory re fungal infections.

22
Oncology
  • Treanda (bendamustine hydrochloride)-
  • Injection 100mg
  • Alkylating agent- active against dividing cells
  • Indicated as treatment of CLL and NHL
  • A/E- infections, site reactions, n, v, d

23
Oncology
  • Afinitor (everolimus)--
  • Tablets- once daily, 5 and 10mg
  • Reduce cell proliferation
  • Indicated as treatment for patients with advanced
    kidney cancer
  • A/E- asthenia, cough, stomatitis, infections,
    fatigue
  • Similar Torisel injection

24
Oncology
  • Eoquin (apaziquone) fast track status --
  • Instillation directly into the bladder
  • Cytotoxic alkylating agent
  • Bladder cancer non-muscle invasive
  • A/E- phase III trials

25
Gastroenterology
  • Kapidex (dexlansoprazole)--
  • Capsules, once daily
  • Proton pump inhibitor delayed release
  • Indicated as treatment of GERD
  • A/E Most commonly reported adverse reactions
    include diarrhea, abdominal pain, nausea,
    vomiting, flatulence

26
Gastroenterology
  • Cimzia (certolizumab pegol)-
  • Injection 200mg, 2 weeks, then 4 weeks
  • TNF blocker
  • Indicated treatment of Crohns Disease, also used
    for RA
  • Warning gtrisk of infections, lymphoma
  • A/E- abdominal pain, diarrhea, skin reactions

27
Hematology
  • Promacta (eltrombopag)-
  • Tablets 25, 50mg special program
  • Thrombopoietin receptor agonist
  • Indicated for treatment of ITP
  • Warning hepatotoxicity monitor LFTs
  • A/E- nausea, vomiting

28
Hematology
  • Effient (prasugrel)--
  • Tablets 5 10mg, 60mg LD, take w/ ASA
  • Anti-platelet agent
  • Reduces the rate of MI and strokes in pts with
    acute coronary syndromes, stents
  • A/E increased risk of bleeding, headache
  • Similar Plavix

29
Hematology
  • Nplate (romiplostim)-
  • Injection 250, 500 mcg
  • Increases platelet production
  • Indicated for treatment of thrombocytopenia
  • A/E headache, dizziness, athralgia, myalgia,
    insomnia

30
Dermatology
  • Epiduo (adapalene benzoyl peroxide) --
  • External gel
  • Once daily topical acne treatment
  • Antimicrobial
  • A/E- may cause dry skin, peeling
  • Similar Tazorac, other combinations

31
Urology
  • Toviaz (festerodine fumerate) -
  • Extended release tablets, 4, 8mg
  • Competitive muscarinic receptor antagonist
  • Indicated for the treatment of urge urinary
    incontinence overactive bladder OAB
  • A/E- dry mouth, constipation
  • Similar Detrol LA

32
Urology
  • Rapaflo (silodosin)-
  • Treatment of signs and symptoms of Benign
    Prostatic Hyperplasia (BPH)
  • 8 mg once daily capsule
  • 4 mg daily dose gt men with moderate kidney
    (renal) impairment.
  • Not recommended for men with severe kidney
    (renal) or liver (hepatic) impairment
  • Selective alpha -1 antagonist
  • A/E Dizziness, light-headedness, diarrhea,
    orthostatic hypotension, headache, nasal
    congestion. Sexual dysfunction.
  • Similar Flomax

33
Womens Health
  • LoSeasonique (ethinyl estradiol and
    levonorgestrel)-
  • Tablets 28 day cycle
  • Indicated for contraception
  • Warning about smoking on OCs
  • A/E- same as other OCs

34
Wound Care
  • Microcyn (hydrogel)--
  • Super-oxidized solution
  • Wound dressing diabetic foot ulcers
  • Prescription and over the counter formulations

35
Infectious Disease
  • Coartem (artemether/ lumefantrine)--
  • Tablets- 20mg/120mg
  • Anti-malarial- uncomplicated
  • Take with food to enhance absorption
  • A/E- asthenia, dizziness, headache, sleep
    disorder, n, v, abdominal pain.

36
Drugs in the Pipeline
  • Diabetes
  • Other DP-4 drugs alogliptin and vildagliptin
    these drugs block the enzyme that degrades the
    hormone that stimulates insulin release.
  • Drugs with other mechanisms of action
  • Oncology
  • Arezerra (ofatumumab) for CLL

37
Drugs in the Pipeline
  • Infectious diseases
  • Seasonal influenza new formulation
  • H1N1
  • Pregnant women
  • Contacts of children aged younger than 6 months
  • Health care workers and emergency personnel
  • Children and young adults aged 6m -24y
  • Non-elderly adults with underlying risk
    conditions or medical conditions that increase
    their risk of complications from influenza

38
Drugs in the Pipeline
  • Cardiovascular
  • Livalo (pitavastatin)- has been used in Japan
  • Lipid agents with new mechanisms of action
  • Hematology
  • Xarelto (rivaroxaban)- anticoagulant
  • Respiratory
  • COPD treatments ultra -long acting beta
    agonist, other treatments

39
Drugs in the Pipeline
  • CNS-
  • Stedesa (eslicarbazepine acetate) treatment for
    epilepsy. New chemical entity- sodium channel
    blocker.
  • Acetavance (acetaminophen injection)-
  • Contrave (bupropion and naltrexone)
  • Acurox (oxycodone and niacin)
  • Silenor- insomnia treatment
  • Several treatments for dementia

40
References
  • 1. FDA news. FDA approves Rapaflo for the
    treatment of symptoms due to an enlarged prostate
    gland. online 24 Feb 2009 Available from
    http//www.fda.gov/bbs/topics/NEWS/2008/NEW01902.h
    tml
  • 2. Welchol (colesevelam HCl) Receives FDA
    Approval to Reduce Blood Glucose in Adults with
    Type 2 Diabetes Online 1 March 2009 Available
    fromhttp//www.drugs.com/newdrugs/welchol-colesev
    elam-hcl-receives-fda-approval-reduce-blood-glucos
    e-adults-type-2-diabetes-810.html
  • 3. Simcor. Online 1 March 2009 Available from
    http//www.drugs.com/newdrugs/abbott-receives-fda-
    approval-simcor-niaspan-simvastatin-novel-combinat
    ion-medicine-comprehensive-846.html
  • 4. Trilipix. PI. 2008 Abbot Lab. online 1 March
    2009 Available from http//www.rxabbott.com/pdf/
    Trilipix_pi.pdf
  • 5. Depomed Receives FDA Approval for 1000 mg
    Strength Tablets of Glumetza Online 1 March
    2009 Available from http//www.drugs.com/newdrug
    s/depomed-receives-fda-approval-1000-mg-glumetza-7
    69.html
  • 6. ZolpiMist. Online 1 March 2009 Available
    from http//www.drugs.com/nda/zolpimist_080123.ht
    ml
  • 7. Astepro. Prescribing information. Meda
    Pharmaceutical 2008.
  • 8. Alvesco Gains FDA Approval for the U.S. Market
    Online 1 March 2009 Available from
    http//www.drugs.com/newdrugs/alvesco-gains-fda-ap
    proval-u-s-market-803.html
  • 9. FDA Approves Advair 250/50 for Reduction of
    Exacerbations in Patients With COPD. Online 1
    March 2009 Available from http//www.drugs.com/n
    ewdrugs/fda-approves-advair-250-50-reduction-exace
    rbations-patients-copd-965.html

41
References
  • www.factsandcomparisons.com
  • www.fda.gov
  • www.centerwatch.com
  • www.pharmasentry.com
  • www.drugs.com/newdrugs
  • www.formularyjournal.modernmedicine.com

42
Thank you!
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