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 Zambia HIV National Guidelines
 


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 Guide Editors
 Editor In Chief
    Joel E. Gallant, MD, MPH

Pharmacology Editor
    Paul Pham, PharmD, BCPS

Zambia Guideline Team
   Peter Mwaba MMed PhD FRCP
   Alywn Mwinga MMed
   Isaac Zulu MMed MPH
   Velepie Mtonga MMed
   Albert Mwango MBChB
   Jabbin Mulwanda MMed FCS
 

 

 

Drugs>Antiretrovirals>
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Nelfinavir

Paul A. Pham, Pharm.D. and John G. Bartlett, M.D.
11-01-2010

Zambia Specific Information

  • Available formulation in Zambia: Oral powder: 50 mg/g. Tablet: 250 mg (as mesilate).
  • Not first-line PI due to lower potency vs. EFV and LPV/r.
  • Since absorption dependent on fatty food intake, suboptimal serum concentrations may be more common in resource-limited countries.
  • Extensive experience in pregnancy.
Zambia Information Author: Paul A. Pham, Pharm. D.

INDICATIONS

FDA

  • Treatment of HIV infection in combination with other antiretrovirals.

FORMS

brand 
name
 
generic 
Mfg 
brand 
forms
 
cost* 
Viracept Nelfinavir (NFV)Pfizer (U.S. Canada) and Roche (outside the US and Canada) oral
tablet
250 mg; 625 mg
$2.81 per 250 mg tablet; $7.03 per 625 mg tablet.
      oral
powder
50 mg/g (144 gm container)
$74.15

*Prices represent cost per unit specified and are representative of "Average Wholesale Price" (AWP). AWP Prices were obtained and gathered by Lakshmi Vasist Pharm D using the Red Book, manufacturer's information, and the McKesson database.

^Dosage is indicated in mg unless otherwise noted.

USUAL ADULT DOSING

NFV 1250 mg twice-daily with fatty meal. Pill burden:4 tabs/d (625 mg tab)

  • With EFV or NVP: standard doses
  • With IDV: NFV 1250 mg twice-daily + IDV 1200 mg twice-daily (limited data, not recommended).
  • With RTV: limited data, high rate of GI intolerance with marginal PK benefit, not recommended.
  • With SQV: limited data; limited PK benefit; not recommended.
  • With LPV/r: limited  data; generally not recommended)
  • ATV, FPV, TPV, and DRV: no data, avoid co-administration.
  • With MVC: no data; consider MVC 150 mg twice-daily.
  • With RAL: no data; standard doses likely.
  • With ETR: no data, consider standard doses.

RENAL DOSING

DOSING FOR GLOMERULAR FILTRATION OF 50-80

Usual dose.

DOSING FOR GLOMERULAR FILTRATION OF 10-50

Usual dose likely.

DOSING FOR GLOMERULAR FILTRATION OF <10 ML/MIN

Usual dose likely (PK unchanged in renal failure).

DOSING IN HEMODIALYSIS

Usual dose. Removed with HD, must be given post-HD on days of dialysis.

DOSING IN PERITONEAL DIALYSIS

No data: Usual dose likely.

DOSING IN HEMOFILTRATION

No data.

ADVERSE DRUG REACTIONS

COMMON

  • Self-limited secretory diarrhea in 10-30%. Typically responds to regular use of fiber supplements, calcium supplements, or loperamide.
OCCASIONAL

RARE

  • Urticaria (rare)
  • Severe hepatitis

DRUG INTERACTIONS

Substrate of 2C19 (major) and CYP3A4 (minor), inducer and inhibitor at CYP 3A4, and inducer of glucuronosyl transferase. NFV active M8 metabolite is a substrate of CYP3A4 (major). Drugs that are inhibitors of CYP3A4 may increase levels of main NFV metabolite (N8). Drugs that are inducers of CYP2C19 may decrease NFV serum levels.

Drug-to-Drug Interactions

Drug-to-Drug Interaction

DrugEffect of InteractionRecommendations/Comments
Azithromycin NFV not significantly affected. Azithromcycin AUC increased by 100%.Monitor for azithromcyin adverse drug reaction (reversible ototoxicity and elevated LFTs).
EFV NFV AUC increased by 20%. EFV levels unchanged.No significant drug interaction. Use standard doses of both drugs.
Fluconazole NFV AUC increased by 30%.Use standard dose.
IDV IDV AUC increased by 51%; NFV AUC increased by 83%.Limited data for dosing IDV 1200 mg twice-daily + NFV 1250 mg twice-daily.
LPV/r LPV AUC decreased by 27%; NFV Cmin increased by 113%.Avoid co-administration or Consider increasing LPV/r dose to 3 tabs twice-daily with NFV co-administration (no data).
NVP No significant drug interactionUse standard dose of both drugs.
Rifampin NFV AUC decreased by 82%.Co-administration not recommended.
RTV NFV AUC increased by 150%, Cmax by 95%. Limited data: RTV 400 mg twice-daily and NFV 500 mg or 750 mg twice-daily. Generally not combined since boosting with RTV will yield only minimal PK enhancement of NFV serum concentrations at the expense of GI intolerance.
SQV SQVsgc AUC increased by 3-5 fold; NFV AUC increased by 18% and Cmax not alteredDose NFV 1250 mg twice-daily + SQV 1200 mg twice-daily or NFV 750 mg three times a day + SQV 800 mg three times a day.
FPV APV increased 1.5-fold. Insufficient data for dose recommendation.
MVC May increase maraviroc's serum concentrations. No data, but dose reduction of MVC to 150 mg twice-daily should be considered.
Etravirine NFV serum concentrations may be increased.Consider usual dose, but no PK data.
AlfuzosinMay increase alfuzosin serum concentrations. Contraindicated. Consider doxazosin and terazosin for BPH (with close monitoring).
Alprazolam May increase serum levels of alprazolamApplies to all PIs: Consider alternative benzodiazepine (i.e lorazepam, oxazepam, or temazepam).
AmiodaroneMay significantly increase amiodarone serum levelsApplies to all PIs: Data limited to case report of increased amiodarone levels with IDV co-administration. RTV, APV, and ATV manufacturers recommend against use of amiodarone, but all PIs have the same potential of significantly increasing amiodarone serum levels. If co-administration can not be avoided, monitor for amiodarone ADR (PFTs and TSH). Consider monitoring serum levels of amiodarone, but its long half-life may make titration difficult.
AmlodipineMay increase serum levels of amlodipineApplies to all PIs: Data limited to an interaction study conducted with ATV and diltiazem which resulted in doubling of diltiazem serum levels (this led to PR interval prolongation). All PIs have the potential of prolonging PR interval with Ca channel blocker co-administration. Ca channel blockers should be started with 50% of the dose and slowly titrated with close monitoring of BP and pulse.
APV APV clearance was decreased by 41%. NFV AUC increased by 15%.Data based on PK modeling with many confounding variables (i.e EFV in background regimen). Consider NFV 1250 mg twice-daily + APV 1200 mg twice-daily or APV 800 mg three times a day + NFV 750 mg three times a day with TDM.
Artemether (artemisinin)May increase serum levels of artemetherApplies to all PIs: Close monitoring for artemether toxicity (bone marrow suppression, bradycardia, and seizure).
AstemizoleMay significantly increase astemizole serum levelsContraindicated due to the potential for cardiac arrhythmias. Recommended alternative antihistamine: loratadine, fexofenadine, desloratidine, or cetirizine.
Atorvastatin Atorvastatin AUC increased by 74%Use with caution. Monitor for adverse effects (LFTs and CPK). Consider alternative agents: pravastatin, fluvastatin, or rosuvastatin.
AzathioprineInteraction unlikelyApplies to all PIs and NNRTI: Use standard dose.
BepridilMay significantly increase bepridil serum levelsApplies to all PIs: No data. The manufacturer of ATV, RTV, and FPV does not recommend bepridil co-administration. This contraindication should extend to all PIs since a significant increase in bepridil serum level can result in pro-arrhythmic events such as VT, PVC, and VFib.
Bosentan May significantly increase bosentan serum concentrations. Significant bosentan dose reduction needed.
Bupropion May increase bupropion serum levels slightlyNot likely to be clinically significant. Start with the lowest possible dose of bupropion. In a small case series no seizures reported with co-administration.
CarbamazepineMay significantly decrease serum levels of NFVConsider alternative anticonvulsants (i.e valproic acid, lamotrigine, levetiracetam, or topiramate). Monitor carbamazepine levels and consider TDM of NFV.
CaspofunginCaspofungin serum levels were not affected. NFV not measured.Use standard dose.
Chlordiazepoxide May increase serum levels of chlordiazepoxideApplies to all PIs: Consider alternative benzodiazepine (lorazepam, oxazepam, or temazepam).
CisaprideMay significantly increase cisapride serum levelsContraindicated due to potential for cardiac arrhythmias. Recommended alternative: metoclopramide.
Clorazepate May increase serum levels of clorazepateApplies to all PIs: Consider an alternative benzodiazepine (lorazepam, oxazepam, or temazepam).
CyclophosphamideMay increase serum levels of cyclophosphamideApplies to all PIs: Data limited to an interaction study conducted with IDV resulting in a 50% increase in cyclophosphamide serum levels. Since all PIs have the potential of increasing cyclophosphamide levels, close monitoring of cyclophosphamide induced toxicity is recommended.
CyclosporineMay significantly increase serum levels of cyclosporineApplies to all PIs: Monitor serum levels of cyclosporine closely with co-administration. Cyclosporine dose may need to be decreased.
Depo-medroxyprogesterone acetate (DMPA) NFV and M8 metabolite were not affected.DMPA levels were not reported.No evidence of ovulation occurring based on progesterone levels through week 12. Use standard dose with co-administration.
Diazepam May increase diazepam serum concentrations. Diazepam dose reduction may be needed. Consider lorazepam, temazepam, or oxazepam.
DiltiazemMay increase serum levels of diltiazemApplies to all PIs: Data limited to an interaction study conducted with ATV which resulted in doubling of diltiazem serum levels (this led to PR interval prolongation). All PIs have the potential of prolonging the PR interval with diltiazem co-administration. Diltiazem should be started with 50% of the dose and slowly titrated with close monitoring of BP and pulse.
DisopyramideMay increase disopyramide serum levelsApplies to all PIs: No data. Monitor disopyramide serum levels (target: 2 to 7.5 mcg/mL).
DocetaxelMay increase serum levels of docetaxelApplies to all PIs: No data. Close monitoring of chemotherapy-induced toxicity recommended.
DofetilideMay significantly increase serum levels of dofetilideNo data. Applies to all PIs: No data. Use with caution. Monitor QTc closely and adjust dofetilide dosing based on QTc prolongation and renal function. Consider an alternative class III antiarrhythmic such as bretylium or ibutilide.
Dronabinol No significant interaction.Use standard dose.
Echinacea May decrease NFV serum levels. Echinacea decreased CYP3A4 substrate (midazolam) by 23%Clinical significance unknown but should be avoided with all PIs and NNRTIs until its safety is further evaluated.
Ergot AlkaloidMay significantly increase serum levels of ergotamine resulting in acute ergot toxicityContraindicated. Consider alternative agent for migraine such as sumatriptan (but not eletriptan since it is a CYP3A4 substrate and significant drug-drug interaction occurred with CYP3A4 inhibitor).
Estazolam May increase serum levels of estazolamApplies to all PIs: Consider alternative benzodiazepines (lorazepam, oxazepam, or temazepam).
Ethinyl estradiol and northindroneEthinyl estradiol AUC decreased by 47%, Northindrone decreased by 18%.Advise pts to use additional or alternative method of contraception.
EthosuximideMay increase serum levels of ethosuximideApplies to all PIs: Consider switching to valproic acid for the treatment of absence seizure.
EtoposideMay increase serum levels of etoposideApplies to all PIs: No data. Close monitoring of chemotherapy-induced toxicity recommended.
FelodipineMay increase serum levels of felodipineApplies to all PIs: Data limited to study conducted with ATV and diltiazem which resulted in doubling of diltiazem serum levels (this led to PR interval prolongation). All PIs have the potential of prolonging the PR interval with Ca channel blocker co-administration. Ca channel blockers should be started with 50% of the dose and slowly titrated with close monitoring of BP and pulse.
Fentanyl May increase fentanyl serum levelsUse with caution. Consider morphine.
FlecainideMay increase antiarrhythmic serum levelsApplies to all PIs: Avoid co-administration; if necessary, monitor flecainide trough levels with co-administration. Target: 200-1000 ng/mL. Toxicity is frequent with trough serum levels above 1000 ng/mL.
Flurazepam May increase serum levels of flurazepamApplies to all PIs: Consider alternative benzodiazepines (lorazepam, oxazepam, or temazepam).
Fluticasone Fluticasone may be significantly increased. Avoid long term co-administration. Consider beclomethasone.
Food NFV AUC increased by 2-fold with 125 kcal with 20% fat meal. NFV AUC increased 5-fold 1000 kcal with 50% fatty meal.NFV must be taken with a fatty meal (a minimum of 500 kcal with 20% fat).
Garlic supplement 49% and 51% reduction of SQV Cmin and AUC, respectively.Studies only done with SQV. Effect of garlic on the PK parameters of NFV is not known. Avoid co-administration with PIs and NNRTIs until it can be further studied.
GranisetronMay increase serum levels of granisetronApplies to all PIs: Due to the large therapeutic index of granisetron, potential interaction is unlikely to be clinically significant.
Heroin (Diamorphine)Drug interactions unlikely.Applies to PIs and NNRTIs: interaction unlikely but illicit drug use should be avoided for obvious reasons.
IfosphamideMay increase serum levels of ifosphamideApplies to all PIs: No data. Close monitoring of chemotherapy-induced toxicity recommended.
IrinoteacanMay increase irinoteacan serum levelsApplies to all PIs: Co-administration of ATV is contraindicated by manufacturer. All PIs also have the potential for significant interaction with irinotecan, therefore the co-administration should be done with extreme caution.
 ItraconazoleCYP3A4 inhibitor and substrate -bidirectional inhibition with the potential to increase levels of itraconazole and co-administered PI. No data with NFV. Standard dose NFV likely. Consider monitoring itraconazole with co-administration.
Ketoconazole NFV AUC increased by 35%.Use standard dose.
LidocaineMay increase antiarrhythmic serum levelsApplies to all PIs: No data. Use with caution, monitor lidocaine serum levels (target: 1.5 to 6 mcg/mL) with co-administration.
Lovastatin May significantly increase lovastatin levelsContraindicated. Recommended alternatives include pravastatin, rosuvastatin, and fluvastatin (and possibly atorvastatin - start with 10 mg/d and monitor for myopathy).
Mefloquine May increase serum levels of mefloquineApplies to all PIs: Consider monitoring mefloquine levels and mefloquine-induced toxicity (i.e dizziness, LFTs, and periodic ophthalmic examination).
Methadone Decreased serum levels of inactive methadone (S)-isomer. No change in active methadone R-isomer.Use standard dose. No withdrawal symptoms observed.
MexiletineMay increase antiarrhythmic serum levelsApplies to all PIs: No data. Use with caution. Monitor EKG and serum levels. Serum levels exceeding 1.5 to 2 mcg/mL have been associated with an increased risk of toxicity.
Midazolam May significantly increase midazolam levelsDo not co-administer. Consider alternative benzodiazepines (temazepam, oxazepam,or lorazepam).
Milk thistle Data limited to interaction study with milk thistle and IDV. IDV AUC: unchanged; IDV Cmin: decreased by 25%. Clinical significance unknown. Unknown effect on the metabolism of other PIs or NNRTIs. Avoid co-administration with PIs and NNRTIs until it can be further evaluated.
MirtazapineMay increase serum levels of mirtazapineApplies to all PIs: Use with caution. Consider an alternative antidepressant (i.e SSRI: escitalopram, citalopram, sertraline, or fluoxetine).
Mycophenolate (MMF)NFV AUC decreased by 32%; NFV-M8 metabolite decreased by 32%.Clinical significance unknown. Proper dosing has not been established. Consider an alternative boosted PI.
NefazodoneMay increase serum levels of nefazodoneApplies to all PIs: Use with caution. Consider an alternative antidepressant (i.e SSRI: escitalopram, citalopram, sertraline, or fluoxetine).
NifedipineMay increase serum levels of nifedipineApplies to all PIs: Data limited to an interaction study conducted with ATV and diltiazem which resulted in doubling of diltiazem serum levels (this led to PR interval prolongation). All PIs have the potential of prolonging PR interval with Ca channel blocker co-administration. Ca channel blockers should be started with 50% of the dose and slowly titrated with close monitoring of BP and pulse.
NisoldipineMay increase serum levels of nisoldipineApplies to all PIs: Data limited to an interaction study conducted with ATV and diltiazem which resulted in doubling of diltiazem serum levels (this led to PR interval prolongation). All PIs have the potential of prolonging PR interval with Ca channel blocker co-administration. Ca channel blockers should be started with 50% of the dose and slowly titrated with close monitoring of BP and pulse.
Paclitaxel May increase paclitaxel serum levelsApplies to all PIs: Since all PIs have the potential of significantly increasing paclitaxel serum levels, close monitoring of paclitaxel-induced toxicity is recommended.
PCPMay significantly increase serum levels of PCPApplies to all PIs. Illicit drug use should be avoided for obvious reasons.
PhenobarbitalMay significantly decrease serum levels of NFVConsider alternative anticonvulsants (i.e valproic acid, lamotrigine, levetiracetam, or topiramate). Monitor phenobarbital levels and consider TDM of NFV.
PhenytoinPhenytoin AUC decreased by 20-40%; No change in NFV AUC.Monitor phenytoin levels, may need to increase phenytoin dose. Consider valproic acid or levetiracetem.
PimozideMay significantly increase pimozide serum levels resulting in QTc prolongationContraindicated. Consider alternative: Olanzapine.
Pravastatin Pravastatin AUC decreased with co-administration.Clinical significance unknown. May need to increase dose of pravastatin.
PropafenoneMay increase antiarrhythmic serum levelsApplies to all PIs: No data. Co-administration should be avoided. Serum levels are not routinely recommended due to the poor correlation with efficacy and toxicity.
Proton Pump Inhibitors Nelfinavir and M8 metabolite AUC decreased by 36% and 92%, respectively. Contraindicated.
Quinidine May increase antiarrhythmic serum levelsApplies to all PIs: No data. Contraindicated with RTV. With all Ps and NNRTI co-administration, monitor EKG (QTc) and serum levels: Target: 2 to 5 mcg/mL.
Raltegravir NFV may induce raltegravir's metabolism. RAL 400 mg twice daily currently recommended, but no PK data.
Ranolazine May significantly increase ranolazine serum concentrations. Contraindicated. May increase risk of QTc prolongation.
Rifabutin NFV AUC decreased by 32%; Rifabutin levels increased by 207%.If co-administration required, dose NFV to 1000 mg PO three times a day with rifabutin to 150 mg PO once-daily or 300 mg 3x/wk.
Rifapentine NFV serum levels may be significantly decreased.Avoid co-administration. Consider using rifabutin.
RosiglitazoneNFV AUC increased by 14% and Cmin increased by 18% (NS) (n="3).No significant interaction. Use standard dose.
Rosuvastatin Other CYP3A4 inhibitor (i.e erythromycin) did not affect rosuvastatin serum level.Applies to PIs and NNRTI. In one study, rosuvastatin AUC and Cmax increased when co-administered with LPV. Clinical significance unknown and no data available with other PIs and NNRTIs. Close monitoring recommended due to limited clinical data.
SildenafilMay increase sildenafil levels. No change in NFV serum levels.Use with caution. Do not exceed 25 mg of sildenafil in 48hrs.
Simvastatin Simvastatin AUC increased by 506%.Contraindicated. Alternatives include pravastatin, fluvastatin, and atorvastatin (start with 10 mg/day). Monitor for ADRs due to limited clinical data.
SirolimusCase report of sirolimus Cmin increased by 5-fold with NFV co-administrationDose sirolimus based on serum levels. A significantly reduction of sirolimus dose with NFV co-administration is recommended.
St. John's wortMay significantly decrease NFV serum levelsContraindicated. Studies done with IDV and NVP but St John's wort may affect the metabolism of other PIs and NNRTIs. Use an alternative (more effective) antidepressant.
TacrolimusCase report of increased tacrolimus serum levels with NFV co-administration.Dose tacrolimus based on serum levels. A significantly reduction of tacrolimus dose with NFV co-administration is recommended.
TadalafilMay increase serum levels of tadalafilApplies to all PIs: Start with 5 mg. Do not exceed 10 mg in 72 hrs. Consider sildenafil due to more clinical data and shorter half-life allowing for easier titration.
TamoxifenMay increase serum levels of tamoxifenApplies to all PIs: No data. Close monitoring of tamoxifen-induced toxicity recommended.
TeniposideMay increase serum levels of teniposideApplies to all PIs: No data. Close monitoring of teniposide-induced toxicity recommended.
TerfenadineMay significantly increase terfenadine serum levelsContraindicated due to the potential for cardiac arrhythmias. Recommended alternative antihistamine: loratadine, fexofenadine, desloratidine, or cetirizine.
THCNo interactions.No drug interactions but illicit drug use should be avoided for obvious reasons.
Trazodone May increase serum levels of trazodoneApplies to all PIs: Use with caution. Consider an alternative antidepressant (i.e. SSRI:escitalopram, citalopram, sertraline, or fluoxetine).
Triazolam May significantly increase triazolam serum levelsContraindicated. Consider alternative benzodiazepines (temazepam, oxazepam, or lorazepam).
VardenafilMay significantly increase serum levels of vardenafilApplies to all PIs: Do not exceed vardenafil 2.5 mg in 72hrs (with RTV) or 2.5 mg in 24 hrs (with other PIs). Consider sildenafil due to more clinical data and less pronounced interaction. Avoid co-administration with IDV.
VerapamilMay increase serum levels of verapamilApplies to all PIs: Data limited to an interaction study conducted with ATV and diltiazem which resulted in doubling of diltiazem serum levels (this led to PR interval prolongation). All PIs have the potential of prolonging the PR interval with Ca channel blockers co-administration. Ca channel blockers should be started with 50% of the dose and slowly titrated with close monitoring of BP and pulse.
VinblastineMay increase serum levels of vinblastineApplies to all PIs: No data. Close monitoring of vinblastine-induced toxicity recommended.
VincristineMay increase serum levels of vincristineApplies to all PIs: No data. Close monitoring of vincristine-induced toxicity recommended.
Vitamin C Data limited to interaction study with IDV and vitamin C (1 g/d): IDV AUC decreased by 14% and Cmin by 32%. Clinical significance unknown. Data not available for other PIs or NNRTIs.
Voriconazole May decrease voriconazole AUC. Voriconazole may increase NFV levels.Significant interaction with EFV and RTV (400 mg twice-daily) but not IDV, data with other PIs and NNRTIs are not available and should be used with caution. In severe cases of invasive aspergillosis where voriconazole is clearly the first line agent, the authors recommend voriconazole TDM (+/- addition of another antifungal for aspergillosis i.e ambisome or caspofungin). Target voriconazole Cmin > 2 mcg/mL.
Warfarin Case report of increased INR when
co-administered with IDV.
Other PIs and NNRTIs may affect warfarin requirements. Monitor INR closely.

RESISTANCE

  • D30N: most common primary mutation selected by NFV, resulting in intermediate resistance to NFV, but no cross-resistance to other PIs.
  • L90M: can also be selected by NFV, resulting in intermediate resistance to NFV and SQV, and low-level cross-resistance to other PIs.
  • Other PI mutations (10F/I, L36I, 46I/L, 71V/T, 77I, 82A/F/T/S, 84V, 88D/S): multiple mutations will result in high-level resistance.

PHARMACOLOGY

Pharmacology

COMMENTS

  • Pros: Extensive experience in pregnancy  
  • Cons: The only unboostable PI; less potent than NNRTIs and boosted PIs; high variability in absorption with dependence on fatty foods; more diarrhea compared to other PIs; failure with L90M can occur (compared to little or no resistance with boosted PIs), leading to greater PI cross-resistance; twice-daily dosing.

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