New Drugs of 2005 (notes to accompany videos)
19 new molecular entities : 8 new biological products licensed
Diabetes :
Byetta (exenatide)
New class – incretin mimeti
Glucagon-like synthetic peptide
Type 2 in combination with metformin,
a sulfonylurea, or both
Improves glycemic control
Dose: 5 mcg bid within 60 min of meals
SC Injection – 250 mcg/mL
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Levemir (insulin detemir)
Type 1 (pediatrics) or 2 (adults)
Long-acting insulin analog
Up to 24 hours duration of action
Patients who require basal insulin for control
of hyperglycemia
Administration:
QD: with evening meal or hs
BID: AM and 12 hours later or evening meal |
Symlin (pramlintide acetate)
Amylin (naturally occurring pancreatic hormone) analog
Slows the emptying of the stomach
Lowers blood-glucose after meals
Type 1 or 2 as an adjunct for mealtime insulin treatment
First non-insulin therapy available for Type 1
Subcutaneous injection
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Antivirals
Baraclude (entecavir)
Treatment of chronic hepatitis B
Dose:0.5 mg once daily
If lamivudine-resistance: 1 mg once daily
0.5 mg oral tablets
Oral solution: 0.05 mg/mL |
Aptivus (tipranavir)
New class – nonpeptidic PIs
Combination therapy with ritonavir for the treatment
of HIV in adult patients that have tried other therapies
or have strains resistant to other protease inhibitors
250 mg soft gelatin oral capsules |
Arthritis: Orencia (abatacept)
New class – selective co-stimulation modulators
Second-line treatment for adults with moderate to severe rheumatoid arthritis
30-minute IV infusion at day 0, 2 weeks, and every 4 weeks thereafter
Insomnia: Rozerem (ramelteon)
Insomnia due to prolonged sleep onset
First product approved for insomnia that is not a controlled-substance
New class – melatonin receptor agonist
8 mg HS within 30 minutes of retiring
8 mg tablet
Hyponatremia: Vaprisol (conivaptan hydrochloride)
Treatment of hyponatremia in patients whose total body water volume has increased without a
concomitant rise in total sodium
IV infusion
Chronic Iron Overload: Exjade (deferasirox)
Treatment of chronic iron overload due to blood transfusions (2 years and older)
First orally administered medication approved for indication
125, 250 and 500 mg tablets for oral suspension
Dissolve in water, orange or apple juice
Genetic Disorders: Naglazyme (galsulfase)
Treatment of the genetic disease mucopolysaccharidosis type VI
IV infusion
Anti-infective: Mycamine (micafungin sodium)
Injection
Esophageal candidiasis
Prophylaxis of Candida infections in patients undergoing hematopoietic stem-cell transplantation
Cancer
Revlimid (lenalidomide)
Treatment of transfusion-dependent myelodysplastic syndrome with deletion 5q chromosomal abnormalities
7,000 – 10,000 elderly patients are newly diagnosed each year
First medication for treatment
Reduces need for blood transfusion
5 or 10 mg oral capsules
Arranon (nelarabine)
Orphan drug
Third-line treatment
Treatment of T-cell acute lymphoblastic
leukemia and
T-cell lymphoblastic lymphoma
that persists or recurs
after two previous chemotherapy regimens
Intravenous injection |
Abraxane (paclitaxel)
Second-line treatment of
metastatic breast cancer
Protein-bound particles for
injectable suspension
Uses protein albumin rather
than chemical solvent
|
Nexavar (sorafenib)
Treatment of patients with advanced
renal cell carcinoma
400 mg orally bid without food,
at least one hour before or two hours after eating
Oral tablets |
|
Pain/Inflammation: Nevanac (nepafenac)
Treatment of ocular pain and inflammation associated with cataract surgery
Pro-drug
0.01% ophthalmic suspension 3 mL
Translucent, yellow color
Misc. Drugs: Tygacil (tigecycline)
Treatment of complicated skin and skin structure infections
Complicated intra-abdominal infections
Spectrum includes Escherichia coli,
Enterococcus faecalis, Staphylococcus aureus, and Klebsiella osytoca
100 mg IV, followed by 50 mg q 12 h over 30-60 minutes
Misc. Drugs: Hydase (hyaluronidase)| Hylenex (hyaluronidase)
Adjuvant to increase the absorption and dispersion of other injected drugs
Hypodermoclysis
Improving resorption of radiopaque agents
Hydase (bovine): 150 USP units/mL
Hylenex – Recombinant human
Misc. Drugs: Increlex (mecasermin): iPlex (mecasermin rinfabate)
Long-term treatment of growth failure in children that
is caused by severe primary insulin-like growth factor-1 deficiency
Biologics
ProQuad (attenuated live virus)
Measles
Mumps
Rubella
Varicella
Children 12 months to 12 years old |
Menactra (conjugate vaccine)
Meningococcal polysaccharide
(groups A, C, Y, and W-135)
Diphtheria toxoid
Active immunization for ages 11-55 of meningococcal
disease caused by Neisseria meningitidis serogroups
A, C, Y and W-135 |
Adacel (adsorbed)
Tetanus toxoid
Reduced diphtheria toxoid
Acellular pertussus
Booster for ages 11-64 years of age |
Boostrix (adsorbed):
Tetanus toxoid
Reduced diphtheria toxoid
Acellular pertussis vaccine
Booster for adolescents 10-18 years of age |
Vaccinia Immune Globulin
(vaccinia immune globulin, i.v., human)
Treatment of rare complications of smallpox vaccination
Eczema vaccinatum, progressive vaccinia, and other
vaccine-related complications
(including vaccinia infections of the mouth and eye)
Two different manufacturers approved |
Fluarix (influenza virus)
Inactivated
Fourth manufacturer (GSK) of seasonal flu vaccine
Active immunization of adults 18 and older against
influenza types A and B |
Gammagard (immune globulin, i.v., human)
Treatment of primary immune deficiency |
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