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New Drug Update 2012. Nancy Letassy, PharmD, CDE Professor University of Oklahoma College of Pharmacy. 2012. New Molecular entities. Belviq ® (locaserin).

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new drug update 2012

New Drug Update 2012

Nancy Letassy, PharmD, CDE


University of Oklahoma

College of Pharmacy

belviq locaserin
Belviq® (locaserin)
  • Approved as an adjunct to a reduced caloric diet and increased activity for chronic weight management in adult with a BMI of >30 or >27 in presence of type 2 diabetes, hypertension, or dyslipidemia
  • Serotonin 2c agonist that activates receptor in the brain to decrease food consumption and promote satiety.
belviq locaserin1
Belviq® (locaserin)

Adverse reactions:

  • Headache, dizziness, euphoria, cognitive impairment, hallucinations
  • Fatigue, dry mouth, diarrhea, constipation
  • Hypoglycemia in patients on a glucose lowering agent
  • Bradycardia
  • Decreased white and red blood cells
qsymia phentermine and topiramate
Qsymia® (phentermine and topiramate)
  • Indicated for chronic weight management in obese or overweight adults with at least one weight-related comorbidity such as hypertension, type 2 diabetes or dyslipidemia
  • Combines low doses of phentermine and extended-release topiramate
  • Weight loss on average 20 pounds in one year
  • Previously called Qnexa®
qsymia adr
Qsymia® ADR
  • cognition, fatigue, dizziness, dysgeusia, insomnia, constipation, dry mouth, tachycardia, depression, anxiety, kidney stones, decreased sweating and increased body temperature, hypokalemia, metabolic acidosis, hypoglycemia, hypotension.
  • Ensure adequate fluid intake to decrease risk of renal stones
  • Advise patients to watch for decreased sweating and increased body temperature with increased physical activity in hot weather
qsymia adr1
  • Monitor for suicidal thoughts and behavior
  • Monthly pregnancy tests
  • Monitor blood pressure
  • Monitor blood glucose in those on glucose lowering agents
  • Check potassium, bicarbonate, creatinine, and other electrolytes
elelyso taliglucerase alfa
Elelyso® (taliglucerase alfa)
  • Hydrolytic, lysosomal, glucocerebroside-specific enzyme indicated for a long-term enzyme replacement therapy (ERT) for adults with a confirmed diagnosis of Type 1 Gaucher disease.
gaucher disease
Gaucher Disease
  • Most common form: Type 1 non-neurological
  • Cause: absence of glucocerebrosidase in lysosomes
  • Fatty material accumulates in spleen and liver
  • Symptoms can begin early in life or adulthood
  • Spleen, liver, lungs, brain and bone marrow affected
  • Increased bruising, fatigue, increased fractures, lung and kidney impairment, anemia
  • Autosomal recessive
treatment of gaucher disease
Treatment of Gaucher Disease
  • Current treatment
    • Enzyme replacement therapy (ERT)
      • Cerezyme®: mammalian cell –recombinant
        • 10-15% antibodies; allergic reactions
      • VPRIV®: human cell recombinant
      • Elelyso®: plant cell recombinant
  • Gene for human enzyme is inserted into carrot cells.
  • Decreases liver and spleen volume, anemia, increases platelets.
  • Dose: 60 units/kg IV over 1-2 hours every 2 weeks
  • Adverse Drug Reactions
    • Infusion reactions--Usually mild
      • Reduce risk by slow infusion rate, pretreat with antihistamines or corticosteroids
    • Common ADRs
      • URI, throat infections, UTI, extremity pain
erivedge vismodegib
Erivedge® (vismodegib)
  • First and only oral agent approved for treatment of adults with metastatic basal cell cancer (BCC) or locally advanced BCC recurrent post-surgery or those not candidates for surgery or radiation
erivedge moa
Erivedge® MOA
  • Designed to inhibit selectively the Hedgehog pathway
  • This pathway is active in the proper development of embryos.
  • In adults it is less active except for tissue repair and maintenance
  • . When it malfunctions it can result is diseases like BCC.
erivedge dosing
Erivedge® Dosing
  • Dose: 150 mg capsule every day until disease progression or until unacceptable adverse reaction.
  • Verify pregnancy 7 days before administration.
  • Embryo-fetal death or severe birth defects can occur
  • Continue birth control 7 months past last dose. Males using Erivedge encouraged to use a condom with spermicide even if post-vasectomy while on medication and two months thereafter.
  • Do not donate blood or blood products while taking this drug and for 7 months after last dose.
erivedge adrs
Erivedge® ADRs
  • GI: change in how things taste or loss of taste, nausea, diarrhea, decreased appetite, constipation and vomiting
  • Joint aches, Muscle spasms
  • Hair loss
  • Weight loss
  • Tiredness
inlyta axitinib
Inlyta® (axitinib)
  • Kinase inhibitor for the treatment of advanced renal cell carcinoma (RCC) after failure of one prior systemic therapy.
  • Inhibits vascular endothelial growth factor receptors (VEGFR)-1, VEGFR-2, and VEGFR-3
  • These receptors are implicated in pathologic angiogenesis, tumor growth, and cancer progression.
inlyta axitinib1
Inlyta® (axitinib)
  • 5 to 10 mg PO every 12 hours with a full glass of water.
  • Reduce dose if liver impairment present or is used with a strong CYP 3A4/5 inhibitor
  • Avoid grapefruit juice
  • Both partners need to use effective birth control methods.
  • Use during pregnancy can cause fetal harm.

Most common ADRs (>20%)

  • GI: diarrhea, decrease in appetite or ability to taste things, weight loss, nausea, vomiting, constipation, stomach pain, heart burn
  • redness, pain, swelling, numbness, tingling, or itching or peeling of the skin on your hands and feet
  • Hypertension, dysphonia
inlyta warning and precautions
Inlyta®Warning and Precautions
  • The following adverse events have occurred:
    • Hypertension and hypertensive crises
    • Arterial and venous thrombotic events fatal and nonfatal
    • Cerebral and GI bleeding, fatal and nonfatal
    • Hypothyroidism, proteinuria, increased liver enzymes
    • Fetal harm
kyprolis carflizomib
Kyprolis® (carflizomib)
  • A proteasome inhibitor for advanced multiple myeloma who have not responded to at least two other drugs.
  • Multiple myeloma is a malignant increase in plasma cells
  • Multiple myeloma associated with an increase in proteasome levels
  • Proteasomes present in all cells to degrade unneeded or damaged proteins
kyprolis dosing
Kyprolis® Dosing
  • Administered IV on two consecutive days every week for 3 weeks followed by a 12 day rest.
  • Dose: 20-27 mg/m2/day
  • Common side effects (>30%): nausea, diarrhea, pyrexia, anemia, thrombocytopenia, dyspnea and fatigue
kyprolis warnings and precautions
Kyprolis®Warnings and Precautions
  • Heart failure and ischemia
  • Pulmonary complications and hypertension
  • Liver toxicity and failure
  • Tumor lysis syndrome
  • Infusion reactions
  • Fetal harm
perjeta pertuzumab
Perjeta® (pertuzumab)
  • Approved for use in combination with Herceptin® and docetaxal for HER2 positive metastatic breast cancer who have not received prior anti-HER2 or chemotherapy for metastatic disease.
  • HER2 overexpression correlates with aggressive form of breast cancer—25% of all breast tumor
  • Dysregulation of HER-mediated signaling pathways results in growth and spread of cancer cells
  • Inappropriate signaling may lead to uncontrolled cell proliferation, decreased cell death, angiogenesis and increased cancer cell motility.
perjeta pertuzumab1
Perjeta® (pertuzumab)
  • Dose: initial 840 mg IV followed by 420 mg IV every 3 weeks.
  • Clinical effect: increases progression free survival by 6.1 months
perjeta serious adr
Perjeta® Serious ADR
  • Fetal death and Birth Defects: birth control during treatment and for 6 months after a patient's last dose of Perjeta. Heart problems: reduced heart function and CHF
  • Infusion-related reactions: fatigue, loss of taste, allergic reactions, muscle pain, and vomiting
  • Severe allergic reactions: may be severe, may happen quickly, and may affect many areas of the body
xtandi enzalutamide
Xtandi ® (enzalutamide)
  • An androgen receptor inhibitor for treatment of metastatic castration-resistant prostate cancer previously treated with docetaxel
  • Dose : 160 mg daily
drug interactions
Drug Interactions

Avoid co-administration with:

  • strong CYP2C8 inhibitors (gemfibrozil) and moderate to strong CYP 2C8 inducers (rifampin)
  • 3A4 inducers (carbamazepine, phenytoin, phenobarbital) or inhibitors (itraconazole), and
  • Xtandi® is a moderate to strong inducer of 3A4 (cyclosporine), 2C9 (warfarin), 2C19 (omeprazole). This interaction can decrease the effectiveness of these agents.
zaltrap ziv aflibercept
Zaltrap® (ziv-aflibercept)
  • Indicated for use in a multiple drug combination in the treatment of metastatic colorectal cancer resistant to or has progressed following an oxaliplatin-containing regimen
zaltrap mao
  • An angiogenesis inhibitor that results in decreased neovascularization and decreased vascular permeability
zaltrap dosing and adrs
Zaltrap® Dosing and ADRs
  • Dose: 4 mg IV over one hour every two weeks.
  • Administration continues until disease progression or unacceptable toxicity
  • Serious adverse reactions:
    • Hemorrhage
    • GI perforation
    • Compromised wound healing
    • Fistula formation
    • Hypertension
    • Arterial thromboembolic events
    • Proteinuria
    • Neutropenia
stivarga regorafenib
Stivarga® (regorafenib)
  • Recently approved for the treatment of metastatic colorectal cancer.
  • Oral novel multikinase inhibitor that blocks multiple enzymes that promote cancer growth
  • 29% increase in survival versus placebo
  • Black box warning—severe and fatal liver toxicity occurred during treatment
bosulif bosutinib
Bosulif® (bosutinib)
  • A kinase inhibitor for treatment of chronic myelogenous leukemia (CML) in adults with chronic, accelerated, or blast phase with resistance or intolerance to prior therapy.
  • CML due to chromosomal abnormality resulting in the formation of Philadelphia chromosome
  • Abnormal fusion of Brc-Abl tyrosine kinase implicated in pathogenesis of CML
  • One source of treatment resistance is activation of Src-family kinases.
bosulif bosutinib1
Bosulif® (bosutinib)
  • Dose: 500 – 600 mg daily
  • Avoid use with strong CYP3A inducers or inhibitors
  • Avoid use with proton pump inhibitors – decrease drug levels
  • Common ADR (>20%)
    • Diarrhea, nausea, thrombocytopenia,
  • Serious ADR
    • GI toxicity, Hepatic toxicity, fetal toxicity
    • Fluid retention
    • Myelosuppression
flumist quadrivalent influenza vaccine live
FluMist Quadrivalent ® (influenza vaccine live)
  • Intranasal influenza vaccine containing four strains of the influenza virus.
  • Indicated for active immunization for the prevention of disease caused by influenza A subtype and B viruses
  • Approved for use in person 2 through 49 years of age
  • Administered intranasally—one-half the dose in each nostril
flumist quadrivalent
FluMist® Quadrivalent
  • Do not administer to persons who have had a server allergic reaction to any component: egg protein, gentamicin, gelatin and arginine
  • Do not administer to children and adolescents through 17 who are on aspirin containing therapy because of risk of Reye’s syndrome

Package insert 2012

  • A vaccine for prevention of Neisseria meningitidis (C and Y) and Haemophilus influenzae type b infections in children.
  • Four doses IM at 2, 4, 6, and 12-15 months.
kalydeco ivacaftor
Kalydeco® (ivacaftor)
  • Approved for treatment of cystic fibrosis (CF) in patients ≥6 years who have a G551D mutation in the CFTR gene.
  • Transmembrane conductance regulator (CFTR) potentiator for cystic fibrosis patients with certain gene mutation
  • Treats the underlying mutation not just the symptoms
  • CFTR functions as an anion channel.
  • Found in epithelial cells of the lungs, liver, pancreas, GIT, skin, reproductive tract.
  • In CF, CFTR defects results in reduced transport of NaCl resulting in build up of sticky mucus
kalydeco ivacaftor1
Kalydeco® (ivacaftor)
  • 150 mg tablet every 12 hours with a high fat meal
  • Promotes weight gain and improved lung function
  • Costs $294,000/year. Available for only through specialty pharmacies

Adverse Drug Effects

  • Headache, URI, nasal congestion, nasopharyngitis
  • Nausea, diarrhea
  • Rash, dizziness, abdominal pain
kalydeco drug interactions
Kalydeco® Drug Interactions
  • Strong 3A4 inhibitors like ketoconazole increases levels 8.5-fold; fluconazole 3-fold
  • Other drugs like rifampin and St. John’s Wort should be avoided
  • Kalydeco® has potential to inhibit 3A4, P-glycoprotein, and 2C9.
  • Check levels of cyclosporine, tacrolimusand digoxin and monitor INR (warfarin)
myrbetriq mirabegron
Myrbetriq® (mirabegron)
  • Beta-3 adrenergic agonist for overactive bladder
  • Simulation promotes relaxation of detrusor muscle in the bladder adding in urination
myrbetriq mirabegron1
  • Dosing: 25 to 50 mg QD
  • Reduce dose in moderate renal impairment
  • Warnings and Precautions
    • Hypertension
    • Bladder outlet obstruction
    • Concomitant medications metabolized by CYP2D6. Myrbetriq® is an inhibitor of this pathway. (digoxin)
omontys peginesatide
Omontys® (peginesatide)
  • Erythropoiesis-stimulating agent (ESA) for anemia in dialysis patients
  • Not indicated for patients:
    • with CKD not on dialysis
    • as a substitute for transfusions in acute situations,
    • On chemotherapy and have anemia not due to CKD
    • Without demonstrated benefit
  • Initial dosing: 0.04 mg/kg/month (injectable)
  • Dose conversion from another ESA based on total weekly dose at that time.
omontys peginesatide1
Omontys® (peginesatide)
  • Contraindicated in uncontrolled hypertension
  • Most common ADRs (>10%): dyspnea, diarrhea, cough, nausea, A-V fistula site complications
  • Warning: Increased risk of MI, stroke and thromboembolism when Hgb increased to >11 gm/dl

Package insert

picato gel ingenol mebutate
Picato® Gel (ingenol mebutate)
  • Inducer of cell death indicated in the topical treatment of actinic keratosis
  • Two strengths: 0.015% and 0.05% gel
  • Lower strength applied to AK on face and scalp daily for 3 consecutive days
  • Higher strength applied to AK on trunk and extremities daily for 2 consecutive days
picato gel ingenol mebutate1
Picato® Gel (ingenol mebutate)

Warnings and ADRs

  • Eye disorders: severe eye pain, ptosis, and edema.
  • Local skin reactions
  • : vesiculation, pustulation, pruritis, erosions, ulcerations, infection
  • Headache, nasopharyngitis
stendra avanafil
Stendra® (avanafil)
  • PDE5 inhibitor for erectile dysfunction
  • Dose 50 to 200 mg 30 minutes prior to sexual activity PRN (no more than one dose in 24 hours)
  • Do not use with strong CYP3A4 inhibitors
  • Decrease dose to 50 mg in 24 hours when using a moderate CYP3A4 inhibitor
  • Lower dose to 50 mg/day in patients on stable alpha-blocker therapy
stendra avanafil1
Stendra® (avanafil)

Strong CYP 3A4 inhibitors

Moderate CYP 3A4 inhibitors





Grapefruit juice


  • Protease inhibitors—ritinovir
  • Macrolide antibiotics—clarithromycin
  • Nefazodone
  • Azole antifungals --ketoconazole
alpha blockers
Alpha blockers
  • Selective α1-adrenergic blockers include:
  • alfuzoxin (Uroxatral)
  • prazosin (Minipres)
  • doxazosin (Cardura)
  • tamsulosin (Flomax)
  • terazosin (Hytrin)
  • silodosin (Rapaflo)
stendra avanafil warnings and adrs
Stendra® (avanafil)Warnings and ADRs
  • Increased hypotension: concomitant use of alcohol, nitrates, alpha blockers, and other antihypertensives
  • Seek immediate attention if patient experience loss of vision or hearing, or an erection lasting >4 hours
  • Most common ADRs: headache, flushing, nasal congestion, back pain, and nasopharyngitis

2012 Package insert

surfaxin lucinactant
Surfaxin ® (lucinactant)
  • Synthetic surfactant for prevention of respiratory distress syndrome (RDS) in premature infants
  • For intratracheal use only
  • Not indicated for adult RDS
  • Dose: 5.8 mL/kg
  • Up to four doses in first 48 hours of life
  • Most common ADR: endotracheal tube reflux or obstruction, pallor
tudorza pressair aclidinium
Tudorza Pressair® (aclidinium)
  • An anticholinergic oral inhaler for COPD
  • Approved for long-term maintenance treatment of bronchospasm
  • Not for treatment of acute bronchospasm
  • Not a rescue inhaler
  • Dose: one inhalation twice daily
  • Dry powder inhaler delivering 400 mcg per inhalation
tudorza pressair aclidinium1
Tudorza Pressair® (aclidinium)
  • ADRs and Warnings
  • Most common ADRs: cough, headache, nasopharyngitis
  • May worsen narrow angle glaucoma, urinary retention, paradoxical bronchospasm, immediate hypersensitivity reactions—use with caution in people with milk protein allergies
vascepa icosapent ethyl
Vascepa® (icosapent ethyl)
  • An omega 3 fatty acid for treatment of severe hypertriglyceridemia (>500 mg/dl) in adults.
  • Dose: 2 gm BID
  • Monitor liver function periodically
  • Use with caution in patients with history of allergies to fish or shellfish
  • Most common ADR: arthralgias
  • May prolong bleeding time
voraxaze glucarpidase
Voraxaze® (glucarpidase)
  • Injectable carboxypeptidase enzyme for treatment of toxic methotrexate blood levels due to kidney failure
  • A recombinant bacterial enzyme that hydrolyzes and inactivates MTX
  • Adults & Children Dosing:
  • <1 month: not recommended. ≥1 month: Give as bolus IV injection over 5 minutes. 50Units/kg as a single injection. Continue leucovorin therapy until the MTX concentration is below the leucovorin treatment threshold for at least 3 days.
voraxaze glucarpidase1
Voraxaze® (glucarpidase)
  • Warnings/Precautions:
  • Not indicated for use in patients who exhibit the expected clearance of MTX (plasma MTX concentrations within 2 standard deviations of the mean MTX ­excretion curve specific for the dose of MTX administered) or those with normal or mildly impaired renal function.
zioptan tafluprost
  • Ophthalmic prostaglandin analog to reduce elevated IOP in open angle glaucoma.
  • Also approved in ocular hypertension
  • Dose: one drop in affected eye daily in the evening
  • Use may cause a:
    • permanent darkening of an iris
    • Reversible darkening of the eyelid
    • Eyelash growth
  • Most common ADR is conjunctival hyperemia
aubagio teriflunomide
Aubagio® (teriflunomide)
  • An oral pyrimidine synthesis inhibitor for relapsing forms of multiple sclerosis
  • Immunomodulator with anti-inflammatory properties
  • Dose: 7 to 14 mg daily
  • Reduces relapses
  • Slows progression of physical disability
  • Reduces number of brain lesions as detected by MRI
aubagio teriflunomide adrs and warnings
Aubagio® (teriflunomide)ADRs and Warnings

Most common: nausea, diarrhea, alopecia, paresthesias, influenza, increased ALT

  • Risk of hepatotoxicity and fatal liver failure
  • Risk of teratogenicity
  • Peripheral neuropathy
  • Hypertension
  • Severe skin reaction
linzess linaclotide
Linzess® (linaclotide)
  • Aguanylate cyclase-C agonist for IBS with constipation and chronic idiopathic constipation.
  • Acts locally in intestines with minimal systemic exposure. Relieves constipation by increasing frequency of bowel movements
  • Dose: 145-290 mg daily
  • ADRs: diarrhea, abdominal pain, abdominal distension
new acne products
New Acne Products
  • Ximino®(minocycline)
    • Extended release capsule formulation (45, 90, 135 mg capsules) for inflammatory moderate to severe acne
  • Fabior®(tazarotene)
    • retinoid topical foam formulation 0.1% for the treatment of acne vulgaris in patients >12 years and older
  • Absorica®(isotretinoin)
    • capsule formulation for severe recalcitrant nodular acne
    • oral Lidose® technology—drug is dissolved in a lipid melt matrix. The mixture is filled into a hard gelatin capsule and then cooled. When it is ingested the capsule melts at body temperature
    • More uniform absorption regardless of dietary intake
new diabetes products t2dm
New Diabetes Products T2DM
  • Janumet XR ®(sitagliptin/metformin) sitagliptin 50 to 100 mg in combination with metformin 1,000 mg extended release.
  • Jentadueto® (linagliptin/metformin)linagliptin 2.5 mg (DPP-4) plus increasing doses of 500, 850 and 1000 mg of metformin.
  • Take one tablet twice daily with meals.
  • Bydureon®(exenatide) extended release, weekly injectable suspension
new asthma allergic rhinitis products
New Asthma/allergic Rhinitis Products
  • Asthmanefrin®(reacepiniphrine)
    • An OTC non-CFC inhaler for mild asthma
    • Indicated for temporary relief of asthma symptoms in children and adults >4 years of age
  • Dymista®(aselastine/fluticasone)
    • Works better for nasal allergy symptoms than nasal fluticasone alone
    • Azelastine may cause a bitter taste in mouth
  • Zetonna®(ciclesonide)
    • Dry aerosol version of the aqueous nasal spray of Omnaris ®
    • One spray per nostril
  • Qnasl ®(beclomethasone)
    • dry powder nasal spray for allergic rhinitis in people >12 years of age
binosto alendronate
Binosto® (alendronate)
  • New effervescent tablet formulation for osteoporosis
  • Strawberry flavored tablet containing 70 mg alendronate
  • Rapid dissolution in 4 oz of water

Pharmacist’s Letter Oct 2011

cosopt pf dorzolamide timolol
Cosopt PF®(dorzolamide/timolol)
  • Combination of a carbonic anhydrase inhibitor and beta adrenergic blocker
  • Indicated for treatment of elevated IOP
  • Dose one drop in affected eye twice daily

Package insert

giazo balsalazide
Giazo® (balsalazide)
  • Indicated for the treatment of mildly to moderately active ulcerative colitis in male patients 18 years of age and older
  • Converted to mesalamine
  • Dose: three 1.1 g tablets to be taken BID for up to 8 weeks
korlym mifepristone
Korlym® (mifepristone)
  • To control hyperglycemia secondary to hypercortisolism in adults with endogenous Cushing’s syndrome who have type 2 diabetes or glucose intolerance and have failed surgery or are not candidates for surgery
  • Dose: 300 to 1200 mg/daily
  • Reduce dose when using strong CYP3A inhibitors
rayos prednisone
Rayos ® (prednisone)
  • Delayed release tablet (1, 2 and 5 mg) formulation of low dose prednisone
  • Indicated for inflammatory conditions like RA, asthma, COPD, psoriatic arthritis, polymyalgia rheumatica
  • Creates a four-hour lag time compared to immediate-release
sklice ivermectin
Sklice® (ivermectin)
  • Topical treatment of head lice infestation in patients >6 months
  • Lotion applied to dry hair in an amount sufficient to thoroughly coat the hair and scalp.
  • After 10 minutes, rinse off with water.
  • For single use. Discard any unused portion.
subsys fentanyl
Subsys® (fentanyl)
  • Sublingual spray indicated for treatment of breakthrough cancer pain in opioid-tolerant adults taking other opioid pain meds around the clock
  • One time use
  • Dose: limited to 4/day
  • Can cause fatal respiratory depression; avoid concomitant use with CYP3A4 inhibitors
suprenza phentermine
Suprenza® (phentermine)
  • Sympathomimetic indicated for the short-term adjunct to a weight loss program (exercise, caloric restriction, behavioral modification) in management of obesity for patients with a BMI >30 or >27 in presence of other risk factors
  • One daily, dissolve tablet on tongue for people >16 years of age.
new p ancrelipase products
New Pancrelipase Products

All contain porcine derived lipases, proteases and amylases for the treatment of exocrine pancreatic insufficiency

Products are not interchangeable.

  • Pertzye®(pancrelipase)
    • Indicated for children >12 months and adults
  • Ultresa®(pancrelipase)
    • delayed-release capsule for children and adults
    • Dosed according to weight and age
  • Viokace®(pancrelipase)
    • Indicated for adults
    • To be taken with a proton pump inhibitor