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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

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

Stavudine [Greenstone LLC]

(Patient Information Leaflet Included)

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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 [5 Associated PubMed Articles listed on BioPortfolio]

A Direct Comparison of the Effects of the Antiretroviral Drugs Stavudine, Tenofovir and the Combination Lopinavir/Ritonavir on Bone Metabolism in a Rat Model.

Antiretroviral (ARV) treatment may induce metabolic complications in HIV patients on long-term therapy that can affect bone health. In this study, the effects of the ARVs Stavudine (d4T), Tenofovir (T...

A retrospective case-cohort study comparing treatment outcomes in abacavir versus stavudine containing first line antiretroviral treatment regimens in children <3yrs old, at a paediatric programme based in Soweto, South Africa.

The current World Health Organization guideline for first line antiretroviral therapy (ART) in HIV-infected children recommends the use of abacavir and lamivudine as nucleoside backbones and no longer...

Drug resistance testing through remote genotyping and predicted treatment options in human immunodeficiency virus type 1 infected Tanzanian subjects failing first or second line antiretroviral therapy.

Antiretroviral therapy (ART) has been successfully introduced in low-middle income countries. However an increasing rate of ART failure with resistant virus is reported. We therefore described the pat...

HBV, HCV, and HBV/HCV co-infection among HIV-positive patients in Hunan province, China: regimen selection, hepatotoxicity, and antiretroviral therapy outcome.

Background Co-infection with hepatitis B (HBV) and C (HCV) is common among people living with HIV (PLHIV). This study investigates the impacts of hepatitis co-infection on antiretroviral therapy (ART)...

Comparison of antiretroviral drug resistance among treatment-naive and treated HIV-infected individuals in Shiraz, Iran.

The use of anti-retroviral therapy has been effective in controlling the spread of HIV-1, and has prolonged life expectancy, but this success can be affected by the emergence of drug resistance. The m...

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