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Zerit

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Zerit

SIDE EFFECTS

The following adverse reactions are discussed in greater detail in other sections of the labeling:

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

Clinical Trial Experience in Adults

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Selected adverse reactions that occurred in adult patients receiving ZERIT in a controlled monotherapy study (Study AI455-019) are provided in Table 2.

Table 2: Selected Adverse Reactions in Study AI455-019a (Monotherapy)

Adverse Reaction Percent (%)
ZERITb (40 mg twice daily)
(n=412)
zidovudine (200 mg 3 times daily)
(n=402)
Headache 54 49
Diarrhea 50 44
Peripheral Neurologic Symptoms/Neuropathy 52 39
Rash 40 35
Nausea and Vomiting 39 44
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.

Pancreatitis was observed in 3 of the 412 adult patients who received ZERIT in study AI455-019.

Selected adverse reactions that occurred in antiretroviral-naive adult patients receiving ZERIT from two controlled combination studies are provided in Table 3.

Table 3: Selected Adverse Reactionsa in START 1 and START 2b Studies (Combination Therapy)

Adverse Reaction Percent (%)
START 1 START2b
ZERIT + lamivudine + indinavir
(n=100c)
zidovudine+ lamivudine+ indinavir
(n=102)
ZERIT+ didanosine+ indinavir
(n=102c)
zidovudine + lamivudine + indinavir
(n=103)
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
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 ZERIT (40 mg twice daily) plus didanosine plus indinavir or zidovudine plus lamivudine plus indinavir.
c Duration of stavudine therapy = 48 weeks.

Selected laboratory abnormalities reported in a controlled monotherapy study (Study AI455-019) are provided in Table 4.

Table 4: Selected Laboratory Abnormalities in Study AI455-019a,b

Parameter Percent (%)
ZERIT (40 mg twice daily)
(n=412)
zidovudine (200 mg 3 times daily)
(n=402)
AST (SGOT) ( > 5.0 x ULN) 11 10
ALT (SGPT) ( > 5.0 x ULN) 13 11
Amylase ( ≥ 1.4 x ULN) 14 13
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.

Selected laboratory abnormalities reported in two controlled combination studies are provided in Tables 5 and 6.

Table 5: Selected Laboratory Abnormalities in START 1 and START 2 Studies (Grades 3–4)

Parameter Percent(%)
START 1 START 2
ZERIT + lamivudine + indinavir
(n=100)
zidovudine + lamivudine + indinavir
(n=102)
ZERIT + didanosine + indinavir
(n=102)
zidovudine + lamivudine + indinavir
(n=103)
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
ULN = upper limit of normal.

Table 6: Selected Laboratory Abnormalities in START 1 and START 2 Studies (All Grades)

Parameter Percent (%)
START1 START2
ZERIT + lamivudine +indinavir
(n=100)
zidovudine + lamivudine + indinavir
(n=102)
ZERIT + 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

Clinical Trial Experience in Pediatric Patients

Adverse reactions and serious laboratory abnormalities reported in pediatric patients from birth through adolescence during clinical trials were similar in type and frequency to those seen in adult patients. [See Use in Specific Populations.]

Postmarketing Experience

The following adverse reactions have been identified during postmarketing use of ZERIT. Because these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These reactions have been chosen for inclusion due to their seriousness, frequency of reporting, causal connection to ZERIT, or a combination of these factors.

Body as a Whole: abdominal pain, allergic reaction, chills/fever, and redistribution/accumulation of body fat [see WARNINGS AND PRECAUTIONS].

Digestive Disorders: anorexia.

Exocrine Gland Disorders: pancreatitis, including fatal cases [see WARNINGS AND PRECAUTIONS].

Hematologic Disorders: anemia, leukopenia, thrombocytopenia, neutropenia, and macrocytosis.

Liver: symptomatic hyperlactatemia/lactic acidosis and hepatic steatosis [see WARNINGS AND PRECAUTIONS], hepatitis and liver failure.

Metabolic Disorders: lipoatrophy, lipodystrophy [see WARNINGS AND PRECAUTIONS], diabetes mellitus and hyperglycemia.

Musculoskeletal: myalgia.

Nervous System: insomnia, severe motor weakness (most often reported in the setting of lactic acidosis) [see WARNINGS AND PRECAUTIONS].

Use with Didanosine- and Hydroxyurea-Based Regimens

When stavudine is used in combination with other agents with similar toxicities, the incidence of these toxicities may be higher than when stavudine is used alone. Thus, patients treated with ZERIT in combination with didanosine, with or without hydroxyurea, may be at increased risk for pancreatitis and hepatotoxicity, which may be fatal, and severe peripheral neuropathy [see WARNINGS AND PRECAUTIONS]. The combination of ZERIT and hydroxyurea, with or without didanosine, should be avoided.

Read the Zerit (stavudine) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

ZERIT is unlikely to interact with drugs metabolized by cytochrome P450 isoenzymes.

Zidovudine: Zidovudine competitively inhibits the intracellular phosphorylation of stavudine. Therefore, use of zidovudine in combination with ZERIT (stavudine) should be avoided.

Doxorubicin: In vitro data indicate that the phosphorylation of stavudine is inhibited at relevant concentrations by doxorubicin. The clinical significance of this interaction is unknown; therefore, concomitant use of stavudine with doxorubicin should be undertaken with caution.

Ribavirin: In vitro data indicate ribavirin reduces phosphorylation of lamivudine, stavudine, and zidovudine. The clinical significance of the interaction with stavudine is unknown; therefore, concomitant use of stavudine with ribavirin should be undertaken with caution. No pharmacokinetic (eg, plasma concentrations or intracellular triphosphorylated active metabolite concentrations) or pharmacodynamic (eg, loss of HIV-1/HCV virologic suppression) interaction was observed when ribavirin and lamivudine (n=18), stavudine (n=10), or zidovudine (n=6) were coadministered as part of a multi-drug regimen to HIV-1/HCV co-infected patients [see WARNINGS AND PRECAUTIONS].

Read the Zerit Drug Interactions Center for a complete guide to possible interactions

Last reviewed on RxList: 12/6/2011
This monograph has been modified to include the generic and brand name in many instances.

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