Medical Editor: John P. Cunha, DO, FACOEP
Zerit (stavudine) is an antiviral medication that prevents human immunodeficiency virus (HIV) from multiplying in the body used to treat HIV, which causes the acquired immunodeficiency syndrome (AIDS). Zerit is not a cure for HIV or AIDS. Zerit is available in generic form. Common side effects of Zerit include headache, diarrhea, nausea, skin rash, or changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and trunk). Seek emergency medical attention if you experience severe side effects of Zerit such as muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, dizziness, lightheadedness, tiredness, weakness, stomach pain, vomiting, or fast or uneven heart rate.
The recommended adult dosage of Zerit 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. Consult your doctor for pediatric dosing. Zerit may interact with didanosine, doxorubicin, hydroxyurea, interferon-alfa, ribavirin, or zidovudine. Tell your doctor all medications and supplements you use. During pregnancy, Zerit should be used only when prescribed. It is normal to prescribe HIV medicines for pregnant women with HIV. This has been shown to decrease the risk of giving HIV to the baby. This drug may be part of that treatment. Consult your doctor. It is unknown if this medication passes into breast milk. Because breast milk can transmit HIV, do not breastfeed.
Our Zerit (stavudine) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
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Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Mild symptoms of lactic acidosis may worsen over time, and this condition can be fatal. Get emergency medical help if you have: unusual muscle pain, trouble breathing, stomach pain, vomiting, irregular heart rate, dizziness, feeling cold, or feeling very weak or tired.
Call your doctor at once if you have:
- numbness, tingling, or pain in your hands or feet;
- weakness in your legs, feet, arms, or hands;
- liver problems--swelling around your midsection, right-sided upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
- pancreatitis--fever, severe pain in your upper stomach spreading to your back, nausea and vomiting.
Stavudine affects your immune system, which may cause certain side effects (even weeks or months after you've taken this medicine). Tell your doctor if you have:
- signs of a new infection--fever, night sweats, swollen glands, cold sores, cough, wheezing, diarrhea, weight loss;
- trouble speaking or swallowing, problems with balance or eye movement, weakness or prickly feeling; or
- swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence.
Common side effects may include:
- weakness, numbness, tingling, or burning pain in your hands or feet;
- nausea, vomiting, diarrhea;
- rash; or
- headache.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Zerit (Stavudine)
SLIDESHOW
A Timeline of the HIV/AIDS Pandemic See SlideshowSIDE EFFECTS
The following adverse reactions are discussed in greater detail in other sections of the labeling:
- lactic acidosis and severe hepatomegaly with steatosis [see WARNINGS AND PRECAUTIONS]
- hepatic toxicity [see WARNINGS AND PRECAUTIONS]
- neurologic symptoms and motor weakness [see WARNINGS AND PRECAUTIONS]
- pancreatitis [see WARNINGS AND PRECAUTIONS]
- lipoatrophy [see WARNINGS AND PRECAUTIONS]
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 Trials Experience
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.
Clinical Trials Experience In Adults
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 | START 2b | |||
| 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 (%) | |||
| START 1 | START 2 | |||
| 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 Trials 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.
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 [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].
Read the entire FDA prescribing information for Zerit (Stavudine)
© Zerit Patient Information is supplied by Cerner Multum, Inc. and Zerit Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.