Zerit Side Effects

Generic Name: stavudine

Please note - some side effects for Zerit may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Zerit - for the Consumer

Zerit

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Zerit:

Changes in body fat; constipation; diarrhea; headache; loss of appetite; nausea; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chills; dark urine; fever; lactic acid imbalance (general body discomfort, cold feeling, dizziness, lightheadedness, slow or irregular heartbeat); muscle aches or weakness; numbness, tingling, or pain in hands or feet; rapid breathing; severe or persistent nausea and vomiting; shortness of breath; sore throat; stomach pain; sudden weight loss; symptoms of high blood sugar (eg, increased thirst or urination, confusion, unusual drowsiness); unusual tiredness or weakness; weakness in the arms or legs; yellowing of the skin or eyes.

Zerit Solution

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Zerit Solution:

Changes in body fat; constipation; diarrhea; headache; loss of appetite; nausea; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chills; dark urine; fever; lactic acid imbalance (general body discomfort, cold feeling, dizziness, lightheadedness, slow or irregular heartbeat); muscle aches or weakness; numbness, tingling, or pain in hands or feet; rapid breathing; shortness of breath; severe or persistent nausea and vomiting; sore throat; stomach pain; sudden weight loss; symptoms of high blood sugar (eg, increased thirst or urination, confusion, unusual drowsiness); unusual tiredness or weakness; weakness in the arms or legs; yellowing of the skin or eyes.

Zerit Side Effects - for the Professional

Zerit

Adults

Fatal lactic acidosis has occurred in patients treated with Zerit in combination with other antiretroviral agents. Patients with suspected lactic acidosis should immediately suspend therapy with Zerit. Permanent discontinuation of Zerit should be considered for patients with confirmed lactic acidosis.

Zerit therapy has rarely been associated with motor weakness, occurring predominantly in the setting of lactic acidosis. If motor weakness develops, Zerit should be discontinued.

Zerit therapy has also been associated with peripheral sensory neuropathy, which can be severe, is dose related, and occurs more frequently in patients being treated with other drugs that have been associated with neuropathy (including didanosine), in patients with advanced HIV infection, or in patients who have previously experienced peripheral neuropathy.

Patients should be monitored for the development of neuropathy, which is usually manifested by numbness, tingling, or pain in the feet or hands. Stavudine-related peripheral neuropathy 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 dose. If neuropathy recurs after resumption, permanent discontinuation of Zerit should be considered.

Selected clinical adverse events that occurred in adult patients receiving Zerit (stavudine) in a controlled monotherapy study (Study AI455-019) are provided in Table 7.

Pancreatitis was observed in 3 of the 412 adult patients who received Zerit in a controlled monotherapy study.

Selected clinical adverse events that occurred in antiretroviral-naive adult patients receiving Zerit from two controlled combination studies are provided in Table 8.

Pancreatitis resulting in death was observed in patients treated with Zerit plus didanosine in controlled clinical studies and in postmarketing reports.

Selected laboratory abnormalities reported in a controlled monotherapy study (Study AI455‑019) are provided in Table 9.

Selected laboratory abnormalities reported in two controlled combination studies are provided in Tables 10 and 11.

Observed During Clinical Practice

The following events have been identified during post-approval use of Zerit (stavudine). Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events 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.

Digestive Disorders—anorexia.

Exocrine Gland Disorders—pancreatitis [including fatal cases].

Hematologic Disorders—anemia, leukopenia, thrombocytopenia, and macrocytosis.

Liver—symptomatic hyperlactatemia/lactic acidosis and hepatic steatosis, hepatitis and liver failure.

Metabolic Disorders—diabetes mellitus and hyperglycemia.

Musculoskeletal—myalgia.

Nervous System—insomnia, severe motor weakness (most often reported in the setting of lactic acidosis, see WARNINGS).

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. The combination of Zerit and hydroxyurea, with or without didanosine, should be avoided.

Pediatric Patients

Adverse reactions and serious laboratory abnormalities in pediatric patients from birth through adolescence were similar in type and frequency to those seen in adult patients.

Side Effects by Body System

General

Many of the side effects associated with nucleoside reverse transcriptase inhibitor therapy (neuropathy, pancreatitis, liver failure, lactic acidosis, etc.) are attributable to their direct toxic effect on mitochondria which causes decreased mitochondrial energy-generating capacity.

Nervous system

Nervous system toxicity is the major dose-limiting adverse effect of stavudine. Peripheral neuropathy was reported in 8% to 21% of patients taking up to 40 mg twice daily in clinical studies. Headache, dizziness, abnormal dreams, somnolence, insomnia, abnormal thinking, depression, ototoxicity, and severe motor weakness (usually with lactic acidosis) have also been reported.

Peripheral neuropathy (PN) seen with the administration of stavudine is both dosage- and treatment duration-dependent. It is also more common in patients who are being treated with other neurotoxic drugs, who have previously experienced PN, or who have been diagnosed with AIDS at the time of starting treatment. PN is generally characterized by numbness, tingling, or pain in the feet or hands. Stavudine should be discontinued if peripheral neuropathy develops. Once symptoms resolve, stavudine may be reinstituted with a 50% dosage reduction.

Hepatic

Hepatic side effects associated with the use of stavudine alone or in combination with other nucleoside analogs have included hyperlactatemia, lactic acidosis, hepatic steatosis, hepatitis, and liver failure. Elevations in ALT, AST, lipase, and bilirubin have also been reported.

Caution should be exercised when administering stavudine to any patient with known risk factors for liver disease. However, cases of hepatic toxicity have also been reported in patients with no known risk factors. Treatment with stavudine should be suspended in any patient who develops clinical or laboratory findings suggestive of lactic acidosis (fatigue, nausea, vomiting, abdominal pain, unexplained weight loss, tachypnea, dyspnea, motor weakness) or pronounced hepatotoxicity.

Fatal lactic acidosis has been reported in pregnant women who received the combination of stavudine and didanosine with other antiretroviral agents.

Gastrointestinal

Gastrointestinal side effects have included diarrhea (30% to 50%), nausea (40%), and vomiting (20%) and were observed in both stavudine monotherapy studies and in combination therapy studies. Dyspepsia and anorexia have also been reported. Pancreatitis has been reported in approximately 1% of patients and has been associated with several deaths.

When stavudine is used in combination with other drugs that have pancreatic toxic effects (other nucleoside analogs or drugs to treat/prevent Pneumocystis pneumonia) the incidence of pancreatitis may increase.

Hematologic

Hematologic side effects have included anemia (3%), leukopenia (1%), neutropenia (12%), and thrombocytopenia (4%). In a trial comparing stavudine and zidovudine, neutropenia was less common in the stavudine group (3% vs. 8%).

Other

Although progressive subcutaneous fat wasting has been attributed to the use of protease inhibitors, nucleoside reverse transcriptase inhibitors may have an independent contribution. This syndrome has been observed in patients naive to protease inhibitors, however, not to the same degree as in patients on a combination regimen that includes a protease inhibitor.

Dermatologic

Dermatologic side effects have included rash and pruritus.

Musculoskeletal

Musculoskeletal side effects have included myalgia, muscle weakness, and decreased bone mineral density.

Other

Other side effects have included abdominal pain, allergic reactions, and chills/fever.

Metabolic

Metabolic side effects have included new-onset diabetes mellitus, hyperglycemia, lipodystrophy, and hyperlipidemia.

Cardiovascular

Cardiovascular side effects have included edema. Edema has been reported with use of stavudine although no causal relationship has been established.

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