Selzentry

Add Info

Selzentry Recall

Get an alert when a recall is issued.

Ask a Question

Questions & Answers

Add Info

Side Effects & Adverse Reactions

There is currently no warning information available for this product. We apologize for any inconvenience.

Add Info

Legal Issues

There is currently no legal information available for this drug.

Add Info

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Add Info

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

Add Info

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Add Info

Uses

SELZENTRY, in combination with other antiretroviral agents, is indicated for adult patients infected with only CCR5-tropic HIV-1.

This indication is based on analyses of plasma HIV-1 RNA levels in two controlled studies of SELZENTRY in treatment-experienced subjects and one study in treatment-naïve subjects. Both studies in treatment-experienced subjects were conducted in clinically advanced, 3-class antiretroviral-experienced (NRTI, NNRTI, PI, or enfuvirtide) adults with evidence of HIV-1 replication despite ongoing antiretroviral therapy.

The following points should be considered when initiating therapy with SELZENTRY:

Adult patients infected with only CCR5-tropic HIV-1 should use SELZENTRY.
Tropism testing must be conducted with a highly sensitive tropism assay that has demonstrated the ability to identify patients appropriate for SELZENTRY use. Outgrowth of pre-existing low-level CXCR4- or dual/mixed-tropic HIV-1 not detected by tropism testing at screening has been associated with virologic failure on SELZENTRY. [see Microbiology (12.4) Clinical Studies (14.3)] .
Use of SELZENTRY is not recommended in subjects with dual/mixed or CXCR4-tropic HIV-1 as efficacy was not demonstrated in a phase 2 study of this patient group.
The safety and efficacy of SELZENTRY have not been established in pediatric patients.
In treatment-naïve subjects, more subjects treated with SELZENTRY experienced virologic failure and developed lamivudine resistance compared to efavirenz. [see Microbiology (12.4) Clinical Studies (14.3)]

Add Info

History

There is currently no drug history available for this drug.

Add Info

Other Information

SELZENTRY (maraviroc) is a selective, slowly reversible, small molecule antagonist of the interaction between human CCR5 and HIV-1 gp120. Blocking this interaction prevents CCR5-tropic HIV-1 entry into cells.

SELZENTRY is available as film-coated tablets for oral administration containing either 150 or 300 mg of maraviroc and the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate (anhydrous), sodium starch glycolate, and magnesium stearate. The film coat [Opadry® II Blue (85G20583)] contains FD&C blue #2 aluminum lake, soya lecithin, polyethylene glycol (macrogol 3350), polyvinyl alcohol, talc and titanium dioxide.

Maraviroc is chemically described as 4,4-difluoro-N-{(1S)-3-[exo-3-(3-isopropyl-5-methyl-4H-1,2,4-triazol-4-yl)-8-azabicyclo[3.2.1]oct-8-yl]-1-phenylpropyl}cyclohexanecarboxamide.

The molecular formula is C29H41F2N5O and the structural formula is:

Maraviroc is a white to pale colored powder with a molecular weight of 513.67. It is highly soluble across the physiological pH range (pH 1.0 to 7.5).

Sources

Selzentry Manufacturers

Pfizer Laboratories Div Pfizer Inc

Selzentry | Pfizer Laboratories Div Pfizer Inc

2.1 Dose Recommendations for Patients with Normal Renal Function
The recommended dose of SELZENTRY differs based on concomitant medications due to drug interactions (see Table 1). SELZENTRY can be taken with or without food. SELZENTRY must be given in combination with other antiretroviral medications.

Table 1 gives the recommended dose adjustments [see Drug Interactions (7.1)].
Table 1 Recommended Dosing Regimen Concomitant Medications SELZENTRY Dose
Potent CYP3A inhibitors (with or without a potent CYP3A inducer) including: protease inhibitors (except tipranavir/ritonavir) delavirdine ketoconazole, itraconazole, clarithromycin other potent CYP3A inhibitors (e.g., nefazodone, telithromycin) 150 mg twice daily Other concomitant medications, including tipranavir/ritonavir, nevirapine, raltegravir all NRTIs and enfuvirtide 300 mg twice daily Potent CYP3A inducers (without a potent CYP3A inhibitor) including: efavirenz rifampin etravirine carbamazepine, phenobarbital, and phenytoin 600 mg twice daily 2.2 Dose Recommendations for Patients with Renal Impairment
Table 2 provides dosing recommendations for patients based on renal function and concomitant medications.
Table 2 Recommended Dosing Regimens Based on Renal Function Concomitant Medications* SELZENTRY Dose Based on Renal Function Normal Mild Moderate Severe End Stage Renal Disease (ESRD) CrCl >80 mL/min CrCl >50 and ≤80 mL/min CrCl ≥30 and ≤50 mL/min CrCl <30 mL/min On Regular Hemodialysis NR = not recommended * See Table 1 for the list of concomitant medications. † The SELZENTRY dose should be reduced to 150 mg twice daily if there are any symptoms of postural hypotension [see Warnings and Precautions (5.2)]. Potent CYP3A inhibitors (with or without a CYP3A inducer)* 150 mg twice daily 150 mg twice daily 150 mg twice daily NR NR Other concomitant medications* 300 mg twice daily 300 mg twice daily 300 mg twice daily 300 mg twice daily† 300 mg twice daily† Potent CYP3A inducers (without a potent CYP3A inhibitor)* 600 mg twice daily 600 mg twice daily 600 mg twice daily NR NR

No Recall
Viiv Healthcare Company

Selzentry | Viiv Healthcare Company

2.1 Dose Recommendations for Patients With Normal Renal Function
The recommended dose of SELZENTRY differs based on concomitant medications due to drug interactions (see Table 1). SELZENTRY can be taken with or without food. SELZENTRY must be given in combination with other antiretroviral medications.

Table 1 gives the recommended dose adjustments [see Drug Interactions (7.1)].
Table 1. Recommended Dosing Regimen Concomitant Medications Dose of SELZENTRY
Potent CYP3A inhibitors (with or without a potent CYP3A inducer) including:
protease inhibitors (except tipranavir/ritonavir) delavirdine ketoconazole, itraconazole, clarithromycin other potent CYP3A inhibitors (e.g., nefazodone, telithromycin) 150 mg twice daily Other concomitant medications, including tipranavir/ritonavir, nevirapine, raltegravir, all NRTIs, and enfuvirtide 300 mg twice daily
Potent CYP3A inducers (without a potent CYP3A inhibitor) including:
efavirenz rifampin etravirine carbamazepine, phenobarbital, and phenytoin 600 mg twice daily 2.2 Dose Recommendations for Patients With Renal Impairment
Table 2 provides dosing recommendations for patients based on renal function and concomitant medications.
Table 2. Recommended Dosing Regimens Based on Renal Function Concomitant Medicationsa Dose of SELZENTRY Based on Renal Function
Normal
(CrCl>80 mL/min)
Mild
(CrCl >50 and ≤80 mL/min)
Moderate
(CrCl ≥30 and ≤50 mL/min)
Severe
(CrCl <30 mL/min)
End-Stage Renal Disease (ESRD)
On Regular Hemodialysis Potent CYP3A inhibitors (with or without a CYP3A inducer)a 150 mg twice daily 150 mg twice daily 150 mg twice daily NR NR Other concomitant medicationsa 300 mg twice daily 300 mg twice daily 300 mg twice daily 300 mg twice dailyb 300 mg twice dailyb Potent CYP3A Inducers (without a potent CYP3A inhibitor)a 600 mg twice daily 600 mg twice daily 600 mg twice daily NR NR
NR = Not recommended.

a See Table 1 for the list of concomitant medications.

b The dose of SELZENTRY should be reduced to 150 mg twice daily if there are any symptoms of postural hypotension [see Warnings and Precautions (5.2)].

No Recall
Physicians Total Care, Inc.

Selzentry | Physicians Total Care, Inc.

2.1 Dose Recommendations for Patients with Normal Renal Function
The recommended dose of SELZENTRY differs based on concomitant medications due to drug interactions (see Table 1). SELZENTRY can be taken with or without food. SELZENTRY must be given in combination with other antiretroviral medications.

Table 1 gives the recommended dose adjustments [see Drug Interactions (7.1)].
Table 1 Recommended Dosing Regimen Concomitant Medications SELZENTRY Dose
Potent CYP3A inhibitors (with or without a potent CYP3A inducer) including: protease inhibitors (except tipranavir/ritonavir) delavirdine ketoconazole, itraconazole, clarithromycin other potent CYP3A inhibitors (e.g., nefazodone, telithromycin) 150 mg twice daily Other concomitant medications, including tipranavir/ritonavir, nevirapine, raltegravir all NRTIs and enfuvirtide 300 mg twice daily Potent CYP3A inducers (without a potent CYP3A inhibitor) including: efavirenz rifampin etravirine carbamazepine, phenobarbital, and phenytoin 600 mg twice daily 2.2 Dose Recommendations for Patients with Renal Impairment
Table 2 provides dosing recommendations for patients based on renal function and concomitant medications.
Table 2 Recommended Dosing Regimens Based on Renal Function Concomitant Medications* SELZENTRY Dose Based on Renal Function Normal Mild Moderate Severe End Stage Renal Disease (ESRD) CrCl >80 mL/min CrCl >50 and ≤80 mL/min CrCl ≥30 and ≤50 mL/min CrCl <30 mL/min On Regular Hemodialysis NR = not recommended * See Table 1 for the list of concomitant medications. † The SELZENTRY dose should be reduced to 150 mg twice daily if there are any symptoms of postural hypotension [see Warnings and Precautions (5.2)]. Potent CYP3A inhibitors (with or without a CYP3A inducer)* 150 mg twice daily 150 mg twice daily 150 mg twice daily NR NR Other concomitant medications* 300 mg twice daily 300 mg twice daily 300 mg twice daily 300 mg twice daily† 300 mg twice daily† Potent CYP3A inducers (without a potent CYP3A inhibitor)* 600 mg twice daily 600 mg twice daily 600 mg twice daily NR NR

No Recall
Remedyrepack Inc.

Selzentry | Remedyrepack Inc.

The recommended dose of SELZENTRY differs based on concomitant medications due to drug interactions (see Table 1). SELZENTRY can be taken with or without food. SELZENTRY must be given in combination with other antiretroviral medications.

Table 1 gives the recommended dose adjustments [see Drug Interactions (7.1)].
Table 1. Recommended Dosing Regimen
Concomitant Medications

Dose of SELZENTRY

Potent CYP3A inhibitors (with or without a potent CYP3A inducer) including:
protease inhibitors (except tipranavir/ritonavir) delavirdine ketoconazole, itraconazole, clarithromycin other potent CYP3A inhibitors (e.g., nefazodone, telithromycin)
150 mg twice daily

Other concomitant medications, including tipranavir/ritonavir, nevirapine, raltegravir, all NRTIs, and enfuvirtide

300 mg twice daily

Potent CYP3A inducers (without a potent CYP3A inhibitor) including:
efavirenz rifampin etravirine carbamazepine, phenobarbital, and phenytoin
600 mg twice daily

Table 2 provides dosing recommendations for patients based on renal function and concomitant medications.
Table 2. Recommended Dosing Regimens Based on Renal Function
Concomitant Medicationsa

Dose of SELZENTRY Based on Renal Function

Normal

(CrCl>80 mL/min)

Mild

(CrCl >50 and ≤80 mL/min)

Moderate

(CrCl ≥30 and ≤50 mL/min)

Severe

(CrCl <30 mL/min)

End-Stage Renal Disease

On Regular Hemodialysis

Potent CYP3A inhibitors (with or without a CYP3A inducer)a

150 mg twice daily

150 mg twice daily

150 mg twice daily

NR

NR

Other concomitant medicationsa

300 mg twice daily

300 mg twice daily

300 mg twice daily

300 mg twice dailyb

300 mg twice dailyb

Potent CYP3A Inducers (without a potent CYP3A inhibitor)a

600 mg twice daily

600 mg twice daily

600 mg twice daily

NR

NR

NR = Not recommended.

aSee Table 1 for the list of concomitant medications.

bThe dose of SELZENTRY should be reduced to 150 mg twice daily if there are any symptoms of postural hypotension [see Warnings and Precautions (5.3)].

No Recall
Viiv Healthcare Company

Selzentry | Viiv Healthcare Company

2.1 Dose Recommendations for Patients with Normal Renal Function
The recommended dose of SELZENTRY differs based on concomitant medications due to drug interactions (see Table 1). SELZENTRY can be taken with or without food. SELZENTRY must be given in combination with other antiretroviral medications.

Table 1 gives the recommended dose adjustments [see Drug Interactions (7.1)].
Table 1. Recommended Dosing Regimen
Concomitant Medications

Dose of SELZENTRY

Potent CYP3A inhibitors (with or without a potent CYP3A inducer) including:
• protease inhibitors (except tipranavir/ritonavir) • delavirdine • elvitegravir/ritonavir • ketoconazole, itraconazole, clarithromycin • other potent CYP3A inhibitors (e.g., nefazodone, telithromycin) • boceprevir
150 mg twice daily

Other concomitant medications, including tipranavir/ritonavir, nevirapine, raltegravir, all NRTIs, and enfuvirtide

300 mg twice daily

Potent CYP3A inducers (without a potent CYP3A inhibitor) including:
• efavirenz • rifampin • etravirine • carbamazepine, phenobarbital, and phenytoin
600 mg twice daily
2.2 Dose Recommendations for Patients with Renal Impairment
Table 2 provides dosing recommendations for patients based on renal function and concomitant medications.
Table 2. Recommended Dosing Regimens Based on Renal Function
Concomitant Medications

Dose of SELZENTRY Based on Renal Function

Normal

(CrCl >80 mL/min)

Mild

(CrCl >50 and ≤80 mL/min)

Moderate

(CrCl ≥30 and ≤50 mL/min)

Severe

(CrCl <30 mL/min)

End-stage Renal Disease

on Regular Hemodialysis

Potent CYP3A inhibitors (with or without a CYP3A inducer)a

150 mg twice daily

150 mg twice daily

150 mg twice daily

NR

NR

Other concomitant medicationsa

300 mg twice daily

300 mg twice daily

300 mg twice daily

300 mg twice dailyb

300 mg twice dailyb

Potent CYP3A Inducers (without a potent CYP3A inhibitor)a

600 mg twice daily

600 mg twice daily

600 mg twice daily

NR

NR

NR = Not recommended.

aSee Table 1 for the list of concomitant medications.

bThe dose of SELZENTRY should be reduced to 150 mg twice daily if there are any symptoms of postural hypotension [see Contraindications (4), Warnings and Precautions (5.3)].

No Recall