Nevirapine: profile and news
Tercica to Present at Ninth Annual Lehman Brothers' Global Health ... 07 Mar 2006
The company's first product, Increlex(TM) (mecasermin (rDNA origin) injection), or recombinant human insulin-like growth factor-1 (rhIGF-1), is approved by the ... - Genetic Engineering News,
Insmed Incorporated Announces Proposed Public Offering of Common ... 07 Mar 2006
For further information about Insmed and IPLEX(TM)(mecasermin rinfabate, rDNA origin, injection), our FDA-approved drugfor the treatment of growth failure in ... - Finanzen.net,
Apidra (insulin glulisine [rDNA origin] injection) Now Available ... Feb 28, 2006
BRIDGEWATER, NJ -- February 28, 2006 -- Sanofi-aventis US announced today that Apidra® (insulin glulisine [rDNA origin] injection), a new prandial or mealtime ... - DG News
God and the New Foodstuffs Mar 1, 2006
Over the past decade, agribusiness companies have been investing heavily in recombinant DNA, or rDNA, technology, which enables them to transplant genes from ... - Science & Spirit,
Apidra(R) - a New Rapid-Acting Insulin Analog - Is Now Available ... Feb 28, 2006
28 /PRNewswire-FirstCall/ -- Sanofi-aventis US announced today that Apidra(R) (insulin glulisine [rDNA origin] injection), a new prandial or mealtime insulin ... - PR Newswire (press release),
Apidra - a New Rapid-Acting Insulin Analog - Is Now Available in ... Feb 28, 2006
BRIDGEWATER, NJ, February 28, 2006 /PRNewswire-FirstCall/ -- Sanofi-aventis US announced today that Apidra(R) (insulin glulisine [rDNA origin] injection), a ... - PharmaLive.com (press release),
Apidra(R) - a New Rapid-Acting Insulin Analog - Is Now Available ... Feb 28, 2006
28 /PRNewswire-FirstCall/ -- Sanofi-aventis US announced today that Apidra® (insulin glulisine [rDNA origin] injection), a new prandial or mealtime insulin ... - Yahoo! News (press release)
Sanofi's Apidra hits the US market Mar 2, 2006
Sanofi says Apidra (insulin glulisine rDNA origin injection) is to be used in regimens that include a longer-acting insulin or basal insulin analog such as ... - Pharmaceutical Business Review
FDA Approves Inhalable Insulin Mar 3, 2006
Exubera, which is being manufactured by Pfizer Inc., is an inhaled powder form of recombinant human insulin (rDNA), which will be used to treat adult patients ... - City on a Hill Press,
First report of a defect of processing potatoes in Texas and ... Feb 27, 2006
Restriction fragment length polymorphism (RFLP) analysis of the PCR-amplified 16S rDNA using enzymes AluI, MseI, HhaI, BfaI, and Tsp509I indicated that 4 ... - FreshPlaza,
Lilly launches new diabetes product Feb 8, 2006
The new formula, which comprises 50% insulin lispro protamine suspension and 50% insulin lispro injection (rDNA origin), is now available in an easy-to-use pen ... - Pharmaceutical Business Review
Lilly Launches Humalog® Mix50/50™ Insulin In United States Feb 12, 2006
LLY) announces the launch of a new pre-mixed insulin, Humalog® Mix50/50™ (50% insulin lispro protamine suspension, 50% insulin lispro injection (rDNA origin ... - Medical News Today (press release),
FDA Approves First Ever Inhaled Insulin Combination Product for ... Feb 15, 2006
Exubera, an inhaled powder form of recombinant human insulin (rDNA) for the treatment of adult patients with type 1 and type 2 diabetes, is the first new ... - Pharmaceutical Processing,
Lilly Launches Humalog Mix50/50 Insulin in United States Feb 7, 2006
...announces the launch of a new pre-mixed insulin, Humalog(R) Mix50/50(TM) (50% insulin lispro protamine suspension, 50% insulin lispro injection (rDNA origin)). ... - PharmaLive.com (press release),
NPS Pharmaceuticals Reports Fourth Quarter and Year-End Operating ... Feb 16, 2006
...* Filing the PREOS(R) (parathyroid hormone [rDNA origin] for injection) new drug application (NDA) in the United States and the Preotact(TM) marketing ... - MSN Money
CHMP Recommends Authorization to Market Preotact (PREOS) in Europe Feb 23, 2006
...the European Medicines Agency has adopted a positive opinion recommending authorization for Nycomed to market Preotact® (parathyroid hormone [rDNA origin] for ... - DG News
Tercica Reports Fourth Quarter Financial Results; Conference Call ... Feb 15, 2006
Completion of the manufacturing, distribution and commercial operations requirements necessary to launch Increlex (mecasermin (rDNA origin) injection) in ... - Genetic Engineering News,
CHMP Recommends Authorization to Market Preotact(R) (PREOS(R)) in ... Feb 23, 2006
EMEA, www.emea.eu.int) has adopted a positive opinion recommending authorization for Nycomed to market Preotact® (parathyroid hormone [rDNA origin] for ... - Yahoo! News (press release)
NPS Pharmaceuticals Reports Fourth Quarter and Year-End Operating ... Feb 16, 2006
The company's accomplishments in 2005 included: * Filing the PREOS(R) (parathyroid hormone [rDNA origin] for injection) new drug application (NDA) in the ... - CNW Telbec (Communiqués de presse),
Former Professor Sued For Patent Infringement Feb 9, 2006
The US Food and Drug Administration (FDA) has approved the inhalable formulation of recombinant human insulin [rDNA origin] powder for the treatment of adult ... - Patent Baristas,
NPS Pharmaceuticals Reports Fourth Quarter and Year-End Operating ... Feb 16, 2006
...compared with the same periods in the prior year are primarily due to decreases in the development costs of the PREOS(R) (parathyroid hormone [rDNA origin] for ... - PharmaLive.com (press release),
Former Professor Sued For Patent Infringement 09 Feb 2006
The US Food and Drug Administration (FDA) has approved the inhalable formulation of recombinant human insulin [rDNA origin] powder for the treatment of adult ... - Patent Baristas,
MultiVu Video Feed: FDA Approves Exubera(R) (insulin human [rDNA ... Jan 27, 2006
NEW YORK, Jan. 27 /PRNewswire/ -- Nearly 21 million Americans suffer from diabetes and the majority of those with type 2 diabetes ... - Yahoo! News (press release)
Lilly launches new diabetes product Feb 8, 2006
The new formula, which comprises 50% insulin lispro protamine suspension and 50% insulin lispro injection (rDNA origin), is now available in an easy-to-use pen ... - Pharmaceutical Business Review
Roger DuBuis SA, Helvetia dispute ending US distribution contract Jan 17, 2006
SA, based near Geneva, Switzerland, says it ended its contract with Helvetia Time Corp., doing business as Roger DuBuis North America (RDNA), in November for ... - JCK,
Reader's Digest Association Announces 2Q Fiscal 2006 Earnings ... Jan 26, 2006
RD North America (RDNA) declined 2 percent and Consumer Business Services (CBS) declined 9 percent. ... Reader's Digest North America (RDNA). ... - Yahoo! News (press release)
Reader's Digest Association Announces 2Q Fiscal 2006 Earnings ... Jan 26, 2006
...currency-neutral. RD North America (RDNA) declined 2 percent and Consumer Business Services (CBS) declined 9 percent. -- Profit: Adjusted ... - PR Newswire (press release),
FDA Approves First Ever Inhaled Insulin Combination Product for ... Jan 27, 2006
Exubera, an inhaled powder form of recombinant human insulin (rDNA) for the treatment of adult patients with type 1 and type 2 diabetes, is the first new ... - FDA.gov
Now it's true: Pfizer's Exubera approved Jan 27, 2006
Exubera, an inhaled powder form of recombinant human insulin (rDNA) for the treatment of adult patients with type 1 and type 2 diabetes, is the first new ... - United Press International
Exubera Inhaled Insulin Expected to be Available Soon for Diabetes ... Jan 28, 2006
Exubera, developed by Nektar Therapeutics, is a powder form of recombinant human insulin (rDNA) for treating adults with type 1 and type 2 diabetes. ... - Best Syndication,
Pfizer Receives FDA Approval for Exubera, the First Inhalable Form ... Jan 27, 2006
27 /PRNewswire-FirstCall/ -- Pfizer Inc said today that Exubera(R) (insulin human [rDNA origin]) Inhalation Powder has been approved by the US Food and Drug ... - PR Newswire (press release),
Inhaled Insulin Approved by FDA Jan 27, 2006
An inhaled powder form of recombinant human insulin (rDNA), the drug and delivery system is the first new insulin formulation introduced since the discovery of ... - Medscape (subscription)
FDA Approves Exubera, First Inhalable Form Of Insulin For ... Jan 29, 2006
Pfizer Inc said that Exubera® (insulin human [rDNA origin]) Inhalation Powder has been approved by the US Food and Drug Administration for the treatment of ... - Medical News Today (press release),
Pfizer Receives FDA Approval for Exubera, the First Inhalable Form ... Jan 27, 2006
NEW YORK, January 27, 2006 /PRNewswire-FirstCall/ -- Pfizer Inc said today that Exubera(R) (insulin human [rDNA origin]) Inhalation Powder has been approved by ... - PharmaLive.com (press release),
Alkermes and Lilly Announce Agreement for the Development and ... Jan 10, 2006
Lilly's recombinant PTH, Forteo® (teriparatide (rDNA origin) injection), was approved in 2002 by the Food and Drug Administration (FDA) for the treatment of ... - Chemie.de (press release),
Pfizer Receives FDA Approval for Exubera, the First Inhaleable ... Jan 27, 2006
Nektar Therapeutics (Nasdaq:NKTR) today reported that Pfizer Incsaid that Exubera(R) (insulin human (rDNA origin)) Inhalation Powderhas been approved by the US ... - Finanzen.net,
Innovative Hand-Held Insulin Device Effectively Controls Diabetes ... Jan 27, 2006
January 28, 2006 Pfizer’s Exubera (insulin human [rDNA origin]) Inhalation Powder has been approved by the US Food and Drug Administration for the treatment ... - Gizmag,
Inhaled Human Insulin Approved for Diabetes Treatment Jan 27, 2006
By Pfizer, Pfizer Inc said today that Exubera® (insulin human [rDNA origin]) Inhalation Powder has been approved by the US Food and Drug Administration for ... - RxPG NEWS,
Senior Diabetics Say Goodbye to Injections as FDA Welcomes Exubera Jan 28, 2006
Pfizer also said Exubera (insulin human [rDNA origin]) Inhalation Powder has been approved for the treatment of adults with type 1 and type 2 diabetes. ... - SeniorJournal.com,
Pfizer Receives FDA Approval for Exubera, the First Inhaleable ... Jan 28, 2006
Nektar Therapeutics (Nasdaq:NKTR) today reported that Pfizer Inc (Nachrichten/Aktienkurs) said that Exubera(R) (insulin human (rDNA origin)) Inhalation Powder ... - FinanzNachrichten.de,
Pfizer Receives FDA Approval for Exubera, The First Inhalable Form Jan 31, 2006
New York, NY--(HISPANIC PR WIRE)--January 31, 2005--Pfizer Inc said today that Exubera(R) (insulin human [rDNA origin]) Inhalation Powder has been approved by ... - HispanicBusiness.com,
Tercica to Hold 2005 Fourth Quarter and Year End Financial Results ... Feb 1, 2006
The company's first product, Increlex(TM) (mecasermin (rDNA origin) injection), or recombinant human insulin-like growth factor-1 (rhIGF-1), is approved by the ... - Genetic Engineering News,
Pfizer Receives FDA Approval for Exubera, the First Inhaleable ... Jan 27, 2006
Nektar Therapeutics (Nasdaq:NKTR) today reported that Pfizer Inc said that Exubera(R) (insulin human (rDNA origin)) Inhalation Powder has been approved by the ... - Business Wire (press release),
Pfizer Receives FDA Approval for Exubera and CytoDyn Annual ... Jan 30, 2006
...industry news provided by Financial News USA (OTC: FNWU) Pfizer Inc (NYSE:PFE) said recently that Exubera® (insulin human [rDNA origin]) Inhalation Powder has ... - Financial News USA (press release),
Novo Nordisk Introduces New Storage Flexibility For Norditropin® ... Jan 29, 2006
Novo Nordisk today announced that Norditropin NordiFlex® (somatropin [rDNA origin] injection) 5 mg and 10 mg, the only prefilled, multi-dose, disposable ... - Medical News Today (press release),
FDA APPROVES Exubera(R) Jan 31, 2006
...(insulin human [rDNA origin]) Inhalation Powder THE FIRST INHALED INSULIN FOR THE TREATMENT OF ADULTS WITH TYPE 1 AND TYPE 2 DIABETES ADDITIONAL RESOURCES ... - PR Newswire (press release),
Alkermes and Lilly Announce Agreement for the Development and ... Jan 9, 2006
Lilly's recombinant PTH, Forteo(R) (teriparatide (rDNA origin) injection), was approved in 2002 by the Food and Drug Administration (FDA) for the treatment of ... - Genetic Engineering News,
Novo Nordisk Introduces New Storage Flexibility for Norditropin(R) Jan 11, 2006
11 /PRNewswire-FirstCall/ -- Novo Nordisk today announced that Norditropin NordiFlex® (somatropin [rDNA origin] injection) 5 mg and 10 mg, the only prefilled ... - Yahoo! News (press release)
Novo Nordisk Introduces New Storage Flexibility for Norditropin Jan 11, 2006
PRINCETON, NJ, January 11, 2006 /PRNewswire-FirstCall/ -- Novo Nordisk today announced that Norditropin NordiFlex(R) (somatropin [rDNA origin] injection) 5 mg ... - PharmaLive.com (press release),
Novo Nordisk Introduces New Storage Flexibility for Norditropin Jan 11, 2006
PRINCETON, NJ -- January 11, 2006 -- Novo Nordisk today announced that Norditropin NordiFlex(R) (somatropin [rDNA origin] injection) 5 mg and 10 mg, the only ... - DG News
Other information
Indication
For use in combination with other antiretroviral drugs in the ongoing treatment of HIV-1 infection.
Pharmacology
Nevirapine is a non-nucleoside reverse transcriptase inhibitor (nNRTI) with activity against Human Immunodeficiency Virus Type 1 (HIV-1). HIV-2 RT and eukaryotic DNA polymerases (such as human DNA polymerases alpha, beta, or sigma) are not inhibited by nevirapine. Nevirapine is, in general, only prescribed after the immune system has declined and infections have become evident. It is always taken with at least one other HIV medication such as Retrovir or Videx. The virus can develop resistance to nevirapine if the drug is taken alone, although even if used properly, nevirapine is effective for only a limited time.
Mechanism Of Action
Nevirapine binds directly to reverse transcriptase (RT) and blocks the RNA-dependent and DNA-dependent DNA polymerase activities by causing a disruption of the enzyme's catalytic site. The activity of nevirapine does not compete with template or nucleoside triphosphates.
Drug Category
Anti-HIV Agents; Nonnucleoside Reverse Transcriptase Inhibitors; ATC:J05AG01
Brand Names/Synonyms
BIRG 0587; DRG-0116; HSDB 7164; NEV; NVP; Nevirapine; Nevirapine [Usan:Inn]; Viramune
Dosage Forms
Tablets, Oral suspension
Absorption
90% (absolute bioavailability 93 ± 9%)
Interactions
-->Interactions for Nevirapine:
Nevirapine is principally metabolized by the liver via the cytochrome P450 isoenzymes, 3A4 and 2B6. Nevirapine is
known to be an inducer of these enzymes. As a result, drugs that are metabolized by these enzyme systems may have
lower than expected plasma levels when coadministered with nevirapine.
The specific pharmacokinetic changes that occur with co-administration of nevirapine and other drugs are listed in
CLINICAL PHARMACOLOGY, Table 1. Clinical comments about possible dosage modifications
based on these pharmacokinetic changes are listed in Table 3. The data inTables 1 and 3 are based on the results of
drug interaction studies conducted in HIV-1 seropositive subjects unless otherwise indicated.
In addition to established drug interactions, there may be potential pharmacokinetic interactions between
nevirapine and other drug classes that are metabolized by the cytochrome P450 system. These potential drug
interactions are listed in Table 4. Although specific drug interaction studies in HIV-1 seropositive subjects have
not been conducted for the classes of drugs listed in Table 4, additional clinical monitoring may be warranted when
co-administering these drugs.
The in vitro interaction between nevirapine and the antithrombotic agent warfarin is complex. As a result,
when giving these drugs concomitantly, plasma warfarin levels may change with the potential for increases in
coagulation time. When warfarin is co-administered with nevirapine, anticoagulation levels should be monitored
frequently.
|
Table 3 Established Drug Interactions: Alteration in Dose or Regimen May Be Recommended Based on Drug
Interaction Studies
|
|
Drug Name
|
Effect on Concentration of Nevirapine or Concomitant Drug
|
Clinical Comment
|
|
Clarithromycin
|
¯ Clarithromycin 14OH- clarithromycin
|
Clarithromycin exposure was significantly decreased by nevirapine; however, 14-OH metabolite concentrations
were increased.Because clarithromycin active metabolite has reduced activity against
Mycobacteriumavium-intracellulare complex, overallactivity against this pathogen may bealtered. Alternatives
to clarithromycin,such as azithromycin, should be considered.
|
|
Efavirenz
|
¯ Efavirenz
|
Appropriate doses for this combination are not established.
|
|
Ethinyl estradiol and Norethindrone
|
¯ Ethinyl estradiol ¯Norethindrone
|
Oral contraceptives and other hormonalmethods of birth control should not be usedas the sole method of
contraception inwomen taking nevirapine, since nevirapinemay lower the plasma levels of thesemedications. An
alternative or additional method of contraception is recommended.
|
|
Fluconazole
|
Nevirapine
|
Because of the risk of increased exposure tonevirapine, caution should be used inconcomitant administration,
and patients should be monitored closely for nevirapine-associated adverse events.
|
|
Indinavir
|
¯ Indinavir
|
Appropriate doses for this combination arenot established, but an increase in thedosage of indinavir may be
required.
|
|
Ketoconazole
|
¯ Ketoconazole
|
Nevirapine and ketoconazole should not beadministered concomitantly becausedecreases in ketoconazole
plasmaconcentrations may reduce the efficacy of the drug.
|
|
Lopinavir/Ritonavir
|
¯ Lopinavir
|
A dose increase of lopinavir/ritonavir to 533/133 mg twice daily with food isrecommended in combination with
nevirapine.
|
|
Methadone
|
¯ Methadonea
|
Methadone levels may be decreased;increased dosages may be required toprevent symptoms of opiate
withdrawal.Methadone maintained patients beginningnevirapine therapy should be monitored forevidence of
withdrawal and methadone dose should be adjusted accordingly.
|
|
Nelfinavir
|
¯ Nelfinavir M8 Metabolite ¯NelfinavirCmin
|
The appropriate dose for nelfinavir incombination with nevirapine, with respectto safety and efficacy, has
not been established.
|
|
Rifabutin
|
Rifabutin
|
Rifabutin and its metabolite concentrationswere moderately increased. Due to highintersubject variability,
however, somepatients may experience large increases inrifabutin exposure and may be at higher riskfor
rifabutin toxicity. Therefore, caution should be used in concomitant administration.
|
|
Rifampin
|
¯ Nevirapine
|
Nevirapine and rifampin should not beadministered concomitantly becausedecreases in nevirapine
plasmaconcentrations may reduce the efficacy ofthe drug. Physicians needing to treatpatients co-infected with
tuberculosis andusing a nevirapine containing regimen mayuse rifabutin instead.
|
|
Saquinavir
|
¯Saquinavir
|
Appropriate doses for this combination arenot established, but an increase in thedosage of saquinavir may be
required.
|
aBased on reports of narcotic withdrawal syndrome in patients treated with nevirapine and methadone
concurrently, and evidence of decreased plasma concentrations of methadone.
| Table 4 Potential Drug Interactions:Use With
Caution, Dose Adjustment of Co-administered Drug May Be Needed due to Possible Decrease in
Clinical Effect |
| Examples of Drugs in Which Plasma Concentrations May Be Decreased By
Co-administration With Nevirapine |
| Drug Class |
Examples of Drugs |
|
Antiarrhythmics
|
Amiodarone, disopyramide, lidocaine
|
|
Anticonvulsants
|
Carbamazepine, clonazepam, ethosuximide
|
|
Antifungals
|
Itraconazole
|
|
Calcium channel blockers
|
Diltiazem, nifedipine, verapamil
|
|
Cancer chemotherapy
|
Cyclophosphamide
|
|
Ergot alkaloids
|
Ergotamine
|
|
Immunosuppressants
|
Cyclosporin, tacrolimus, sirolimus
|
|
Motility agents
|
Cisapride
|
|
Opiate agonists
|
Fentanyl
|
|
Examples of Drugs in Which Plasma Concentrations May Be Increased By Co-administration With
Nevirapine
|
|
Antithrombotics
|
Warfarin
Potential effect on anticoagulation. Monitoring of
anticoagulation levels is recommended.
|
Fat redistribution: Redistribution/accumulation of body fat including central obesity, dorsocervical
fat enlargement (buffalo hump), peripheral wasting, facial wasting, breast enlargement, and "cushingoid appearance"
have been observed in patients receiving antiretroviral therapy. The mechanism and long-term consequences of these
events are currently unknown. A causal relationship has not been established.
Chemical IUPAC Name
1-cyclopropyl-5,11-dihydro-4-methyl-6H-dipyrido [3,2-b:2',3'-e][1,4] diazepin-6-one
Chemical Formula
C15H14N4O
Half Life
45 hours
Drug Type
Approved Drug
# Accession No
APRD00705
CAS Registry Number
129618-40-2
