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These highlights do not include all the information needed to use stavudine safely and effectively. See full prescribing information for stavudine capsules, USP.Stavudine Capsules, USPInitial U.S. Approval: 1994 | Stavudine

05:42 EDT 27th August 2014 | BioPortfolio

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Table 1: Recommended Dosage Adjustment for Adult Patients with Renal Impairment
Creatinine Clearance
(mL/min)
Recommended Stavudine Capsules Dose
by Patient Weight
at least 60 kg less than 60 kg
* Administered after the completion of hemodialysis on dialysis days and at the same time of day on non-dialysis days.
greater than 50
40 mg every 12 hours
30 mg every 12 hours
26–50
20 mg every 12 hours
15 mg every 12 hours
10–25
20 mg every 24 hours*
15 mg every 24 hours
Hemodialysis
20 mg every 24 hours*
15 mg every 24 hours*

When stavudine is used in combination with other agents with similar toxicities, the incidence of adverse reactions may be higher than when stavudine is used alone.

Table 2: Selected Adverse Reactions in Study AI455-019a (Monotherapy)
Adverse Reaction Percent (%)
Stavudineb
(40 mg twice daily)
(n=412)
Zidovudine
(200 mg 3 times daily) (n=402)
a The incidences reported included all severity grades and all reactions regardless of causality.
b Median duration of stavudine therapy = 79 weeks; median duration of zidovudine therapy = 53 weeks.
   Headache
54
49
   Diarrhea
50
44
   Peripheral Neurologic Symptoms/Neuropathy
52
39
   Rash
40
35
   Nausea and Vomiting
39
44
Table 3: Selected Adverse Reactionsa in START 1 and START 2b Studies (Combination Therapy)
Adverse Reaction Percent (%)
START 1 START 2b
Stavudine + Lamivudine + Indinavir (n=100c) Zidovudine + Lamivudine + Indinavir
(n=102)
Stavudine + Didanosine + Indinavir (n=102c) Zidovudine + Lamivudine + Indinavir (n=103)
a The incidences reported included all severity grades and all reactions regardless of causality.
b START 2 compared two triple-combination regimens in 205 treatment-naive patients. Patients received either stavudine (40 mg twice daily) plus didanosine plus indinavir or zidovudine plus lamivudine plus indinavir.
c Duration of stavudine therapy = 48 weeks.
   Nausea
43
63
53
67
   Diarrhea
34
16
45
39
   Headache
25
26
46
37
   Rash
18
13
30
18
   Vomiting
18
33
30
35
   Peripheral Neurologic Symptoms/Neuropathy
8
7
21
10
Table 4: Selected Laboratory Abnormalities in Study AI455-019a,b
Parameter Percent (%)
Stavudine
(40 mg twice daily)
(n=412)
Zidovudine
(200 mg 3 times daily) (n=402)
a Data presented for patients for whom laboratory evaluations were performed.
b Median duration of stavudine therapy = 79 weeks; median duration of zidovudine therapy = 53 weeks.
ULN = upper limit of normal.
   AST (SGOT) (>5 x ULN)
11
10
   ALT (SGPT) (>5 x ULN)
13
11
   Amylase (≥1.4 x ULN)
14
13
Table 5: Selected Laboratory Abnormalities in START 1 and START 2 Studies (Grades 3 to 4)
Parameter Percent (%)
START 1 START 2
Stavudine + Lamivudine + Indinavir (n=100) Zidovudine + Lamivudine + Indinavir (n=102) Stavudine + Didanosine + Indinavir (n=102) Zidovudine + Lamivudine + Indinavir (n=103)
ULN = upper limit of normal.
   Bilirubin (>2.6 x ULN)
7
6
16
8
   AST (SGOT) (>5 x ULN)
5
2
7
7
   ALT (SGPT) (>5 x ULN)
6
2
8
5
   GGT (>5 x ULN)
2
2
5
2
   Lipase (>2 x ULN)
6
3
5
5
   Amylase (>2 x ULN)
4
<1
8
2
Table 6: Selected Laboratory Abnormalities in START 1 and START 2 Studies (All Grades)
Parameter Percent (%)
START 1 START 2
Stavudine + Lamivudine + Indinavir (n=100) Zidovudine + Lamivudine + Indinavir (n=102) Stavudine + Didanosine + Indinavir (n=102) Zidovudine + Lamivudine + Indinavir (n=103)
   Total Bilirubin
65
60
68
55
   AST (SGOT)
42
20
53
20
   ALT (SGPT)
40
20
50
18
   GGT
15
8
28
12
   Lipase
27
12
26
19
   Amylase
21
19
31
17
IMAGE stavudine-str.jpg
Table 7: Steady-State Pharmacokinetic Parameters of Stavudine in HIV-1-Infected Adults
Parameter Stavudine 40 mg BID
Mean ± SD (n=8)
AUC0-24 = Area under the curve over 24 hours.
Cmax = Maximum plasma concentration.
Cmin = Trough or minimum plasma concentration.
   AUC0-24 (ng•h/mL)
2568 ± 454
   Cmax (ng/mL)
536 ± 146
   Cmin (ng/mL)
8 ± 9
Table 8: Pharmacokinetic Parameters of Stavudine in HIV-1-Infected Adults: Bioavailability, Distribution, and Clearance
Parameter Mean ± SD n
a Following 1-hour IV infusion.
b Following single oral dose.
c Assuming a body weight of 70 kg.
d Over 12 to 24 hours.
   Oral bioavailability (%)
86.4 ± 18.2
25
   Volume of distribution (L)a
46 ± 21
44
   Total body clearance (mL/min)a
594 ± 164
44
   Apparent oral clearance (mL/min)b
560 ± 182c
113
   Renal clearance (mL/min)a
237 ± 98
39
   Elimination half-life, IV dose (h)a
1.15 ± 0.35
44
   Elimination half-life, oral dose (h)b
1.6 ± 0.23
8
   Urinary recovery of stavudine (% of dose)a,d
42 ± 14
39
Table 9: Pharmacokinetic Parameters (Mean ± SD) of Stavudine in HIV-1-Exposed or -Infected Pediatric Patients
Parameter Ages 5 Weeks to 15 Years       n       Ages 14 to 28 Days       n       Day of Birth       n      
a Following 1-hour IV infusion.
b At median time of 2.5 hours (range 2 to 3 hours) following multiple oral doses.
c Following single oral dose.
d Over 8 hours.
ND = Not determined.
   Oral bioavailability (%)
76.9 ± 31.7
20
ND
ND
   Volume of distribution (L/kg)a
0.73 ± 0.32
21
ND
ND
   Ratio of CSF: plasma concentrations (as %)b
59 ± 35
8
ND
ND
   Total body clearance (mL/min/kg)a
9.75 ± 3.76
21
ND
ND
   Apparent oral clearance (mL/min/kg)c
13.75 ± 4.29
20
11.52 ± 5.93
30
5.08 ± 2.8
17
   Elimination half-life, IV dose (h)a
1.11 ± 0.28
21
ND
ND
   Elimination half-life, oral dose (h)c
0.96 ± 0.26
20
1.59 ± 0.29
30
5.27 ± 2.01
17
   Urinary recovery of stavudine
   (% of dose)c,d
34 ± 16
19
ND
ND
Table 10: Mean ± SD Pharmacokinetic Parameter Values of Stavudinea in Adults with Varying Degrees of Renal Function
a Single 40 mg oral dose.
b Determined while patients were off dialysis.
T½ = Terminal elimination half-life.
NA = Not applicable.
Creatinine Clearance
Hemodialysis
Patientsb (n=11)
>50 mL/min
(n=10)
26 to
50 mL/min
(n=5)
9 to 25 mL/min
(n=5)
   Creatinine clearance (mL/min)
104 ± 28
41 ± 5
17 ± 3
NA
   Apparent oral clearance (mL/min)
335 ± 57
191 ± 39
116 ± 25
105 ± 17
   Renal clearance (mL/min)
167 ± 65
73 ± 18
17 ± 3
NA
   T½ (h)
1.7 ± 0.4
3.5 ± 2.5
4.6 ± 0.9
5.4 ± 1.4
Table 11: Results of Drug Interaction Studies with Stavudine: Effects of Coadministered Drug on Stavudine Plasma AUC and Cmax Values
Drug Stavudine Dosage       na       AUC of Stavudine (95% CI) Cmax of Stavudine
(95% CI)
↑ indicates increase.
↔ Indicates no change, or mean increase or decrease of <10%.
a HIV-1-infected patients.
   Didanosine, 100 mg q 12 h for 4 days
40 mg q 12 h for 4 days
10

↑ 17%
   Lamivudine, 150 mg single dose
40 mg single dose
18

(92.7–100.6%)
↑ 12%
(100.3–126.1%)
   Nelfinavir, 750 mg q 8 h for 56 days
30 to 40 mg q 12 h
for 56 days
8


Table 12: Results of Drug Interaction Studies with Stavudine: Effects of Stavudine on Coadministered Drug Plasma AUC and Cmax Values
Drug Stavudine Dosage       na       AUC of Coadministered Drug
(95% CI)
Cmax of Coadministered Drug
(95% CI)
↔ Indicates no change, or mean increase or decrease of <10%.
a HIV-1-infected patients.
   Didanosine, 100 mg q 12 h for 4 days
40 mg q 12 h for 4 days
10


   Lamivudine, 150 mg single dose
40 mg single dose
18

(90.5-107.6%)

(87.1-110.6%)
   Nelfinavir, 750 mg q 8 h for 56 days
30 to 40 mg q 12 h
for 56 days
8


1.   Build up of acid in your blood (lactic acidosis). Lactic acidosis can cause death and must be treated in the hospital. The risk of lactic acidosis may be higher if you: 

It is important to call your healthcare provider right away if you: 

What should I avoid while taking stavudine capsules?  

Stavudine capsules can cause serious side effects including:

IMAGE stavudine-fig1.jpgIMAGE stavudine-fig2.jpgIMAGE stavudine-fig3.jpgIMAGE stavudine-fig4.jpg

Manufacturer

Aurobindo Pharma Limited

Active Ingredients

Source

Drugs and Medications [26 Associated Drugs and Medications listed on BioPortfolio]

Stavudine [Greenstone LLC]

(Patient Information Leaflet Included)

Stavudine [Aurobindo Pharma Limited]

These highlights do not include all the information needed to use stavudine safely and effectively. See full prescribing information for stavudine for oral solution, USP.Stavudine for Oral Solution, U...

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Stavudine [State of Florida DOH Central Pharmacy]

Clinical Trials [106 Associated Clinical Trials listed on BioPortfolio]

Evaluation of Viral Efficacy and Safety of a Reduced Dose of Stavudine (d4T): THE PHOENIX STUDY

Lipodystrophie, peripheral neuropathy and mitochondrial toxicity has been associated to stavudine at standard doses The aim of this study is to evaluate the efficacy of reduced doses of st...

A Study of Stavudine in HIV-Infected Patients Who Have Not Had Success With Other Anti-HIV Drugs

To make stavudine (d4T) available to patients with advanced HIV disease for whom no alternative antiretroviral is satisfactory. To study the safety and efficacy of two dose levels in a twi...

Study Comparing Reducing the Dose of Stavudine Versus Switching to Tenofovir in HIV-Infected Patients Receiving Antiretroviral Therapy

Background: Stavudine-containing regimens are associated with a potential for lipoatrophy and dyslipidemia. We assessed the safety and efficacy of reducing the dose of stavudine compared t...

Dose Optimisation of Stavudine for the Treatment of HIV Infection

The purpose of this study is to demonstrate whether low dose stavudine (d4T) is non-inferior (in terms of both viral suppression and toxicity) to tenofovir (TDF) after 2 years of HIV treat...

A Comparison of Two Dose Levels of Didanosine Used in Combination With Stavudine in HIV-Infected Patients

The purpose of this study is to compare the effectiveness of taking didanosine (ddI) once a day plus stavudine (d4T) twice a day with taking ddI twice a day plus d4T twice a day. This stud...

PubMed Articles [6 Associated PubMed Articles listed on BioPortfolio]

Substituting Abacavir for Stavudine in Children Who Are Virally Suppressed Without Lipodystrophy: Randomized Clinical Trial in Johannesburg, South Africa.

Abacavir has replaced stavudine in antiretroviral therapy (ART) regimens because it has largely been phased out as a result of toxicity concerns; this loss has reduced further the already-limited drug...

Lipoatrophy/lipohypertrophy outcomes after antiretroviral therapy switch in children in the UK/Ireland.

Following widespread use of stavudine, a thymidine analogue, in antiretroviral therapy (ART) over the past three decades, up to a third of children developed lipoatrophy (LA) and/or lipohypertrophy (L...

Removal of antiretroviral drugs stavudine and zidovudine in water under UV254 and UV254/H2O2 processes: Quantum yields, kinetics and ecotoxicology assessment.

The concentration of antiretroviral drugs in wastewater treatment plants (WWTP) effluents and surface waters of many countries has increased significantly due to their widespread use for HIV treatment...

Regimen durability in HIV-infected children and adolescents initiating first-line ART in a large public sector HIV cohort in South Africa.

In April 2010 tenofovir and abacavir replaced stavudine in public-sector first-line antiretroviral therapy (ART) for children under 20 years old in South Africa. The association of both abacavir and t...

Exposure to previous cART is associated with significant liver fibrosis and cirrhosis in human immunodeficiency virus-infected patients.

Combined antiretroviral therapy (cART) has improved survival in HIV-patients. While the first antiretrovirals, which became available in particular D-drugs (especially didanosine and stavudine) and un...

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