Stavudine

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Side Effects & Adverse Reactions

1.Lactic Acidosis / Severe Hepatomegaly with Steatosis:

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination, including stavudine and other antiretrovirals. Although relative rates of lactic acidosis have not been assessed in prospective well-controlled trials, longitudinal cohort and retrospective studies suggest that this infrequent event may be more often associated with antiretroviral combinations containing stavudine. Female gender, obesity, and prolonged nucleoside exposure may be risk factors. Fatal lactic acidosis has been reported in pregnant women who received the combination of stavudine and didanosine with other antiretroviral agents. The combination of stavudine and didanosine should be used with caution during pregnancy and is recommended only if the potential benefit clearly outweighs the potential risk (see PRECAUTIONS: Pregnancy ).

Particular caution should be exercised when administering stavudine to any patient with known risk factors for liver disease; however, cases of lactic acidosis have also been reported in patients with no known risk factors. Generalized fatigue, digestive symptoms (nausea, vomiting, abdominal pain, and unexplained weight loss); respiratory symptoms (tachypnea and dyspnea); or neurologic symptoms (including motor weakness, see 3. Neurologic Symptoms) might be indicative of the development of symptomatic hyperlactatemia or lactic acidosis syndrome.

Treatment with stavudine should be suspended in any patient who develops clinical or laboratory findings suggestive of symptomatic hyperlactatemia, lactic acidosis, or pronounced hepatotoxicity (which may include hepatomegaly and steatosis even in the absence of marked transaminase elevations).

2.Hepatic Impairment and Toxicity:

The safety and efficacy of stavudine have not been established in HIV-infected patients with significant underlying liver disease. During combination antiretroviral therapy, patients with preexisting liver dysfunction, including chronic active hepatitis, have an increased frequency of liver function abnormalities, including severe and potentially fatal hepatic adverse events, and should be monitored according to standard practice. If there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment must be considered.

An increased risk of hepatotoxicity may occur in patients treated with stavudine in combination with didanosine and hydroxyurea compared to when stavudine is used alone. Deaths attributed to hepatotoxicity have occurred in patients receiving this combination. This combination should be avoided.

Use with Interferon and Ribavirin-Based Regimens

In vitro studies have shown ribavirin can reduce the phosphorylation of pyrimidine nucleoside analogues such as stavudine. Although no evidence of a pharmacokinetic or pharmacodynamic (eg, loss of HIV/HCV virologic suppression) interaction was seen when ribavirin was coadministered with stavudine in HIV/HCV co-infected patients (see CLINICAL PHARMACOLOGY: Drug Interactions), hepatic decompensation (some fatal) has occurred in HIV/HCV co-infected patients receiving combination antiretroviral therapy for HIV and interferon and ribavirin. Patients receiving interferon with or without ribavirin and stavudine should be closely monitored for treatment-associated toxicities, especially hepatic decompensation. Discontinuation of stavudine should be considered as medically appropriate. Dose reduction or discontinuation of interferon, ribavirin, or both should also be considered if worsening clinical toxicities are observed, including hepatic decompensation (eg, Child-Pugh >6) (see the complete prescribing information for interferon and ribavirin).

3. Neurologic Symptoms:

Motor weakness has been reported rarely in patients receiving combination antiretroviral therapy including stavudine. Most of these cases occurred in the setting of lactic acidosis. The evolution of motor weakness may mimic the clinical presentation of Guillain-Barré syndrome (including respiratory failure). Symptoms may continue or worsen following discontinuation of therapy.

Peripheral neuropathy, manifested by numbness, tingling, or pain in the hands or feet, has been reported in patients receiving stavudine therapy. Peripheral neuropathy has occurred more frequently in patients with advanced HIV disease, with a history of neuropathy, or in patients receiving other drugs that have been associated with neuropathy, including didanosine (see ADVERSE REACTIONS).

4. Pancreatitis

Fatal and nonfatal pancreatitis have occurred during therapy when stavudine was part of a combination regimen that included didanosine, in both treatment-naive and treatment-experienced patients, regardless of degree of immunosuppression. The combination of stavudine and didanosine and any other agents that are toxic to the pancreas should be suspended in patients with suspected pancreatitis. Reinstitution of stavudine after a confirmed diagnosis of pancreatitis should be undertaken with particular caution and close patient monitoring. The new regimen should not contain didanosine .

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Legal Issues

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FDA Safety Alerts

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Manufacturer Warnings

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FDA Labeling Changes

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Uses

Stavudine capsules , in combination with other antiretroviral agents, is indicated for the treatment of HIV-1 infection (see Clinical Studies).

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History

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Other Information

Stavudine (d4T), a synthetic thymidine nucleoside analogue, active against the human immunodeficiency virus (HIV).

Stavudine Capsules are supplied for oral administration in strengths of 15, 20, 30, and 40 mg of stavudine. Each capsule also contains inactive ingredients microcrystalline cellulose, sodium starch glycolate, lactose anhydrous, and magnesium stearate. The hard gelatin shell consists of gelatin, sodium lauryl sulfate, titanium dioxide, and iron oxides.The capsules are printed with Black ink containing black iron oxide E172 dye.

The chemical name for stavudine is 2',3'-didehydro-3'-deoxythymidine. Stavudine has the following structural formula:

Stavudine is a white to off-white crystalline solid with the molecular formula C10 H12 N2 O4 and a molecular weight of 224.2. The solubility of stavudine at 23° C is approximately 83 mg/mL in water and 30 mg/mL in propylene glycol. The n-octanol/water partition coefficient of stavudine at 23° C is 0.144.

Sources

Stavudine Manufacturers

Kaiser Foundation Hospitals

Stavudine | Kaiser Foundation Hospitals

The interval between doses of stavudine should be 12 hours. Stavudine may be taken with or without food.

Adults:The recommended dose based on body weight is as follows:

40 mg twice daily for patients ≥ 60 kg.

30 mg twice daily for patients < 60 kg.

Pediatrics: The recommended dose for newborns from birth to 13 days old is 0.5 mg/kg/dose given every 12 hours (see CLINICAL PHARMACOLOGY). The recommended dose for pediatric patients at least 14 days old and weighing less than 30 kg is 1 mg/kg/dose, given every 12 hours. Pediatric patients weighing 30 kg or greater should receive the recommended adult dosage.
Dosage Adjustment
Patients should be monitored for the development of peripheral neuropathy, which is usually manifested by numbness, tingling, or pain in the feet or hands. These symptoms may be difficult to detect in young children (see WARNINGS). If these symptoms develop during treatment, stavudine therapy should be interrupted. Symptoms may resolve if therapy is withdrawn promptly. In some cases, symptoms may worsen temporarily following discontinuation of therapy. If symptoms resolve completely, patients may tolerate resumption of treatment at one-half the recommended dose:

20 mg twice daily for patients ≥ 60 kg.

15 mg twice daily for patients < 60 kg.

If peripheral neuropathy recurs after resumption of stavudine, permanent discontinuation should be considered.
Renal Impairment
Stavudine may be administered to adult patients with impaired renal function with adjustment in dose as shown in Table 12.
Table 12: Recommended Dosage Adjustment for Renal Impairment Creatinine Clearance
Recommended Stavudine Dose by Patient Weight (mL/min) ≥60 kg <60 kg >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
Since urinary excretion is also a major route of elimination of stavudine in pediatric patients, the clearance of stavudine may be altered in children with renal impairment. Although there are insufficient data to recommend a specific dose adjustment of stavudine in this patient population, a reduction in the dose and/or an increase in the interval between doses should be considered.
Hemodialysis Patients
The recommended dose is 20 mg every 24 hours (>60 kg) or 15 mg every 24 hours (<60 kg), administered after the completion of hemodialysis and at the same time of day on non-dialysis days.

No Recall
State Of Florida Doh Central Pharmacy

Stavudine | State Of Florida Doh Central Pharmacy

The interval between doses of stavudine should be 12 hours. Stavudine may be taken with or without food.

Adults:The recommended dose based on body weight is as follows:

40 mg twice daily for patients ≥ 60 kg.

30 mg twice daily for patients < 60 kg.

Pediatrics: The recommended dose for newborns from birth to 13 days old is 0.5 mg/kg/dose given every 12 hours (see CLINICAL PHARMACOLOGY). The recommended dose for pediatric patients at least 14 days old and weighing less than 30 kg is 1 mg/kg/dose, given every 12 hours. Pediatric patients weighing 30 kg or greater should receive the recommended adult dosage.
Dosage Adjustment
Patients should be monitored for the development of peripheral neuropathy, which is usually manifested by numbness, tingling, or pain in the feet or hands. These symptoms may be difficult to detect in young children (see WARNINGS). If these symptoms develop during treatment, stavudine therapy should be interrupted. Symptoms may resolve if therapy is withdrawn promptly. In some cases, symptoms may worsen temporarily following discontinuation of therapy. If symptoms resolve completely, patients may tolerate resumption of treatment at one-half the recommended dose:

20 mg twice daily for patients ≥ 60 kg.

15 mg twice daily for patients < 60 kg.

If peripheral neuropathy recurs after resumption of stavudine, permanent discontinuation should be considered.
Renal Impairment
Stavudine may be administered to adult patients with impaired renal function with adjustment in dose as shown in Table 12.
Table 12: Recommended Dosage Adjustment for Renal Impairment Creatinine Clearance
Recommended Stavudine Dose by Patient Weight (mL/min) ≥60 kg <60 kg >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
Since urinary excretion is also a major route of elimination of stavudine in pediatric patients, the clearance of stavudine may be altered in children with renal impairment. Although there are insufficient data to recommend a specific dose adjustment of stavudine in this patient population, a reduction in the dose and/or an increase in the interval between doses should be considered.
Hemodialysis Patients
The recommended dose is 20 mg every 24 hours (>60 kg) or 15 mg every 24 hours (<60 kg), administered after the completion of hemodialysis and at the same time of day on non-dialysis days.

No Recall
State Of Florida Doh Central Pharmacy

Stavudine | State Of Florida Doh Central Pharmacy

The interval between doses of stavudine should be 12 hours. Stavudine may be taken with or without food.

Adults:The recommended dose based on body weight is as follows:

40 mg twice daily for patients ≥ 60 kg.

30 mg twice daily for patients < 60 kg.

Pediatrics: The recommended dose for newborns from birth to 13 days old is 0.5 mg/kg/dose given every 12 hours (see CLINICAL PHARMACOLOGY). The recommended dose for pediatric patients at least 14 days old and weighing less than 30 kg is 1 mg/kg/dose, given every 12 hours. Pediatric patients weighing 30 kg or greater should receive the recommended adult dosage.
Dosage Adjustment
Patients should be monitored for the development of peripheral neuropathy, which is usually manifested by numbness, tingling, or pain in the feet or hands. These symptoms may be difficult to detect in young children (see WARNINGS). If these symptoms develop during treatment, stavudine therapy should be interrupted. Symptoms may resolve if therapy is withdrawn promptly. In some cases, symptoms may worsen temporarily following discontinuation of therapy. If symptoms resolve completely, patients may tolerate resumption of treatment at one-half the recommended dose:

20 mg twice daily for patients ≥ 60 kg.

15 mg twice daily for patients < 60 kg.

If peripheral neuropathy recurs after resumption of stavudine, permanent discontinuation should be considered.
Renal Impairment
Stavudine may be administered to adult patients with impaired renal function with adjustment in dose as shown in Table 12.
Table 12: Recommended Dosage Adjustment for Renal Impairment Creatinine Clearance
Recommended Stavudine Dose by Patient Weight (mL/min) ≥60 kg <60 kg >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
Since urinary excretion is also a major route of elimination of stavudine in pediatric patients, the clearance of stavudine may be altered in children with renal impairment. Although there are insufficient data to recommend a specific dose adjustment of stavudine in this patient population, a reduction in the dose and/or an increase in the interval between doses should be considered.
Hemodialysis Patients
The recommended dose is 20 mg every 24 hours (>60 kg) or 15 mg every 24 hours (<60 kg), administered after the completion of hemodialysis and at the same time of day on non-dialysis days.

No Recall
Remedyrepack Inc.

Stavudine | Remedyrepack Inc.

The interval between doses of stavudine capsules should be 12 hours. Stavudine capsules may be taken with or without food.

Adults

The recommended dose based on body weight is as follows:

40 mg twice daily for patients less then 60 kg.
30 mg twice daily for patients greater then 60 kg.

No Recall
Mylan Pharmaceuticals Inc.

Stavudine | Mylan Pharmaceuticals Inc.

The interval between doses of stavudine capsules should be 12 hours. Stavudine capsules may be taken with or without food.
2.1 Recommended Adult Dosage
The recommended adult dosage is based on body weight as follows:
• For patients weighing less than 60 kg: 30 mg every 12 hours. • For patients weighing at least 60 kg: 40 mg every 12 hours. 2.2 Recommended Pediatric Dosage • For newborns from birth to 13 days old: 0.5 mg/kg given every 12 hours. • For pediatric patients at least 14 days old and weighing less than 30 kg: 1 mg/kg given every 12 hours. • For pediatric patients weighing at least 30 kg: use the recommended adult dosage. 2.3 Dosage Adjustment Renal Impairment Adult Patients
Stavudine capsules may be administered to adult patients with impaired renal function with an adjustment in dosage as shown in Table 1.
Table 1: Recommended Dosage Adjustment for Adult Patients with Renal Impairment * Administered after the completion of hemodialysis on dialysis days and at the same time of day on non-dialysis days.
Creatinine
Clearance

(mL/min)

Recommended Stavudine Dose
by Patient Weight

at least 60 kg

less than 60 kg

greater than 50

40 mg every 12 hours

30 mg every 12 hours

26 to 50

20 mg every 12 hours

15 mg every 12 hours

10 to 25

20 mg every 24 hours

15 mg every 24 hours

Hemodialysis

20 mg every 24 hours*

15 mg every 24 hours*

Pediatric Patients
Since urinary excretion is also a major route of elimination of stavudine in pediatric patients, the clearance of stavudine may be altered in children with renal impairment. There are insufficient data to recommend a specific dose adjustment of stavudine capsules in this patient population.

No Recall
Edenbridge Pharmaceuticals, Llc

Stavudine | Edenbridge Pharmaceuticals, Llc

The interval between doses of stavudine should be 12 hours. Stavudine may be taken with or without food.
2.1 Recommended Adult Dosage
The recommended adult dosage is based on body weight as follows:
For patients weighing less than 60 kg: 30 mg every 12 hours. For patients weighing at least 60 kg: 40 mg every 12 hours. 2.2 Recommended Pediatric Dosage For newborns from birth to 13 days old: 0.5 mg/kg given every 12 hours. For pediatric patients at least 14 days old and weighing less than 30 kg: 1 mg/kg given every 12 hours. For pediatric patients weighing at least 30 kg: use the recommended adult dosage. 2.3 Dosage Adjustment
Renal Impairment

Adult Patients: Stavudine may be administered to adult patients with impaired renal function with an adjustment in dosage as shown in Table 1.
Table 1: Recommended Dosage Adjustment for Adult Patients with Renal Impairment Creatinine Clearance Recommended Stavudine Dose by Patient Weight (mL/min) 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*
Pediatric Patients: Since urinary excretion is also a major route of elimination of stavudine in pediatric patients, the clearance of stavudine may be altered in children with renal impairment. There are insufficient data to recommend a specific dose adjustment of stavudine in this patient population.
2.4 Method of Preparation for Oral Solution
Prior to dispensing, the pharmacist must constitute the dry powder with purified water to a concentration of 1 mg stavudine per mL of solution, as follows:
Add 200 mL of purified water to the container. Shake container vigorously until the powder dissolves completely. Constitution in this way produces 200 mL (deliverable volume) of 1 mg/mL stavudine solution. The solution may appear slightly hazy. Dispense solution in original container with measuring cup provided. Instruct patient to shake the container vigorously prior to measuring each dose and to store the tightly closed container in a refrigerator, 2°C to 8°C (36°F to 46°F). Discard any unused portion after 30 days.

No Recall
Aurobindo Pharma Limited

Stavudine | Aurobindo Pharma Limited

The interval between doses of stavudine capsules should be 12 hours. Stavudine capsules may be taken with or without food.
2.1 Recommended Adult Dosage
The recommended adult dosage is based on body weight as follows:
For patients weighing less than 60 kg: 30 mg every 12 hours. For patients weighing at least 60 kg: 40 mg every 12 hours. 2.2 Recommended Pediatric Dosage For newborns from birth to 13 days old: 0.5 mg/kg given every 12 hours. For pediatric patients at least 14 days old and weighing less than 30 kg: 1 mg/kg given every 12 hours. For pediatric patients weighing at least 30 kg: use the recommended adult dosage. 2.3 Dosage Adjustment
Renal Impairment

Adult Patients: Stavudine capsules may be administered to adult patients with impaired renal function with an adjustment in dosage as shown in Table 1.

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*

Pediatric Patients: Since urinary excretion is also a major route of elimination of stavudine in pediatric patients, the clearance of stavudine may be altered in children with renal impairment. There are insufficient data to recommend a specific dose adjustment of stavudine capsules in this patient population.

No Recall
State Of Florida Doh Central Pharmacy

Stavudine | State Of Florida Doh Central Pharmacy

The interval between doses of stavudine capsules should be 12 hours. Stavudine capsules may be taken with or without food.
2.1 Recommended Adult Dosage
The recommended adult dosage is based on body weight as follows:
For patients weighing less than 60 kg: 30 mg every 12 hours. For patients weighing at least 60 kg: 40 mg every 12 hours. 2.2 Recommended Pediatric Dosage For newborns from birth to 13 days old: 0.5 mg/kg given every 12 hours. For pediatric patients at least 14 days old and weighing less than 30 kg: 1 mg/kg given every 12 hours. For pediatric patients weighing at least 30 kg: use the recommended adult dosage. 2.3 Dosage Adjustment Renal Impairment Adult Patients
Stavudine capsules may be administered to adult patients with impaired renal function with an adjustment in dosage as shown in Table 1.
Table 1: Recommended Dosage Adjustment for Adult Patients with Renal Impairment * Administered after the completion of hemodialysis on dialysis days and at the same time of day on non-dialysis days.
Creatinine
Clearance
(mL/min) Recommended Stavudine Dose
by Patient Weight at least 60 kg less than 60 kg greater than 50 40 mg every 12 hours 30 mg every 12 hours 26 to 50 20 mg every 12 hours 15 mg every 12 hours 10 to 25 20 mg every 24 hours 15 mg every 24 hours Hemodialysis 20 mg every 24 hours* 15 mg every 24 hours*

Pediatric Patients
Since urinary excretion is also a major route of elimination of stavudine in pediatric patients, the clearance of stavudine may be altered in children with renal impairment. There are insufficient data to recommend a specific dose adjustment of stavudine capsules in this patient population.

No Recall
Aurobindo Pharma Limited

Stavudine | Aurobindo Pharma Limited

The interval between doses of stavudine for oral solution should be 12 hours. Stavudine for oral solution may be taken with or without food.
2.1 Recommended Adult Dosage
The recommended adult dosage is based on body weight as follows:
For patients weighing less than 60 kg: 30 mg every 12 hours. For patients weighing at least 60 kg: 40 mg every 12 hours. 2.2 Recommended Pediatric Dosage For newborns from birth to 13 days old: 0.5 mg/kg given every 12 hours. For pediatric patients at least 14 days old and weighing less than 30 kg: 1 mg/kg given every 12 hours. For pediatric patients weighing at least 30 kg: use the recommended adult dosage. 2.3 Dosage Adjustment
Renal Impairment

Adult Patients: Stavudine for oral solution may be administered to adult patients with impaired renal function with an adjustment in dosage as shown in Table 1.

Table 1: Recommended Dosage Adjustment for Adult Patients with Renal Impairment Creatinine Clearance
(mL/min) Recommended Stavudine for Oral Solution 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*

Pediatric Patients: Since urinary excretion is also a major route of elimination of stavudine in pediatric patients, the clearance of stavudine may be altered in children with renal impairment. There are insufficient data to recommend a specific dose adjustment of stavudine for oral solution in this patient population.
2.4 Method of Preparation for Oral Solution
Prior to dispensing, the pharmacist must constitute the dry powder with purified water to a concentration of 1 mg stavudine per mL of solution, as follows:
Add 193 mL of purified water to the container. Shake container vigorously until the powder dissolves completely. Constitution in this way produces 200 mL (deliverable volume) of 1 mg/mL stavudine solution. The solution may appear slightly hazy. Dispense solution in original container with measuring cup provided. Instruct patient to shake the container vigorously prior to measuring each dose and to store the tightly closed container in a refrigerator, 2° to 8°C (36° to 46°F). Discard any unused portion after 30 days.

No Recall