Retrovir IV
- Generic Name: zidovudine injection
- Brand Name: Retrovir IV
Retrovir IV(Zidovudine Injection) side effects drug center
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- nausea
- vomiting
- constipation
- sleep problems (insomnia)
- weight loss
- muscle or joint pain
- headache
- tired feeling
- weakness
- skin rash
- pain or irritation at the injection site, or
- changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and trunk)
What Is Retrovir IV?
Retrovir (zidovudine) IV Infusion is an antiviral medication used to treat HIV, which causes the acquired immunodeficiency syndrome (AIDS). Retrovir IV is also given during pregnancy to prevent an HIV-infected woman from passing the virus to her baby. Retrovir IV is not a cure for HIV or AIDS. Retrovir IV is available in generic form.
What Are Side Effects of Retrovir IV?
Common side effects of Retrovir IV include:
Dosage for Retrovir IV
The recommended intravenous adult dose of Retrovir is 1 mg/kg infused over 1 hour. This dose should be administered 5 to 6 times daily (5 to 6 mg/kg daily).
What Drugs, Substances, or Supplements Interact with Retrovir IV?
Retrovir may interact with atovaquone, doxorubicin, fluconazole, interferon-alfa, methadone, phenytoin, probenecid, or other antiviral medications. Tell your doctor all medications and supplements you use.
Retrovir IV During Pregnancy and Breastfeeding
Retrovir may be harmful to a fetus. Tell your doctor if you are pregnant or plan to become pregnant during treatment. HIV can be passed to the baby if the mother is not properly treated during pregnancy. Use all of your HIV medicines as directed to control your infection while you are pregnant. You may need to register with an antiviral pregnancy registry when you start using this drug. Because breast milk can transmit HIV, do not breastfeed.
Additional Information
Our Retrovir (zidovudine) IV Infusion Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Retrovir IV (Zidovudine Injection)
Retrovir IV Professional Information
SIDE EFFECTS
The adverse events reported during intravenous administration of RETROVIR IV (zidovudine injection) Infusion are similar to those reported with oral administration; neutropenia and anemia were reported most frequently. Long-term intravenous administration beyond 2 to 4 weeks has not been studied in adults and may enhance hematologic adverse events. Local reaction, pain, and slight irritation during intravenous administration occur infrequently.
Adults
The frequency and severity of adverse events associated with the use of RETROVIR are greater in patients with more advanced infection at the time of initiation of therapy.
Table 5 summarizes events reported at a statistically significantly greater incidence for patients receiving RETROVIR orally in a monotherapy study:
Table 5. Percentage (%) of Patients with Adverse Events*
in Asymptomatic HIV Infection (ACTG 019)
| Adverse Event | RETROVIR 500 mg/day (n = 453) |
Placebo (n = 428) |
| Body as a whole | ||
| Asthenia | 8.6%† | 5.8% |
| Headache | 62.5% | 52.6% |
| Malaise | 53.2% | 44.9% |
| Gastrointestinal | ||
| Anorexia | 20.1% | 10.5% |
| Constipation | 6.4%† | 3.5% |
| Nausea | 51.4% | 29.9% |
| Vomiting | 17.2% | 9.8% |
| *Reported in ≥ 5% of study population. † Not statistically significant versus placebo. |
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In addition to the adverse events listed in Table 5, other adverse events observed in clinical studies were abdominal cramps, abdominal pain, arthralgia, chills, dyspepsia, fatigue, hyperbilirubinemia, insomnia, musculoskeletal pain, myalgia, and neuropathy.
Selected laboratory abnormalities observed during a clinical study of monotherapy with oral RETROVIR are shown in Table 6.
Table 6. Frequencies of Selected (Grade 3/4) Laboratory Abnormalities
in Patients with Asymptomatic HIV Infection (ACTG 019)
| Adverse Event | RETROVIR 500 mg/day (n = 453) |
Placebo (n = 428) |
| Anemia (Hgb < 8 g/dL) | 1.1% | 0.2% |
| Granulocytopenia ( < 750 cells/mm3) | 1.8% | 1.6% |
| Thrombocytopenia (platelets < 50,000/mm3) | 0% | 0.5% |
| ALT ( > 5 x ULN) | 3.1% | 2.6% |
| AST ( > 5 x ULN) | 0.9% | 1.6% |
| Alkaline phosphatase ( > 5 x ULN) | 0% | 0% |
| ULN = Upper limit of normal. | ||
Pediatrics
Study ACTG300: Selected clinical adverse events and physical findings with a ≥ 5% frequency during therapy with EPIVIR 4 mg/kg twice daily plus RETROVIR 160 mg/m2 orally 3 times daily compared with didanosine in therapy-naive ( ≤ 56 days of antiretroviral therapy) pediatric patients are listed in Table 7.
Table 7. Selected Clinical Adverse Events and Physical Findings
( ≥ 5% Frequency) in Pediatric Patients in Study ACTG300
| Adverse Event | EPIVIR plus RETROVIR (n = 236) |
Didanosine (n = 235) |
| Body as a Whole | ||
| Fever | 25% | 32% |
| Digestive | ||
| Hepatomegaly | 11% | 11% |
| Nausea & vomiting | 8% | 7% |
| Diarrhea | 8% | 6% |
| Stomatitis | 6% | 12% |
| Splenomegaly | 5% | 8% |
| Respiratory | ||
| Cough | 15% | 18% |
| Abnormal breath sounds/wheezing | 7% | 9% |
| Ear, Nose, and Throat | ||
| Signs or symptoms of ears* | 7% | 6% |
| Nasal discharge or congestion | 8% | 11% |
| Other | ||
| Skin rashes | 12% | 14% |
| Lymphadenopathy | 9% | 11% |
| *Includes pain, discharge, erythema, or swelling of an ear. | ||
Selected laboratory abnormalities experienced by therapy-naive ( ≤ 56 days of antiretroviral therapy) pediatric patients are listed in Table 8.
Table 8. Frequencies of Selected (Grade 3/4) Laboratory Abnormalities
in Pediatric Patients in Study ACTG300
| Test (Abnormal Level) | EPIVIR plus RETROVIR | Didanosine |
| Neutropenia (ANC < 400 cells/mm3) | 8% | 3% |
| Anemia (Hgb < 7.0 g/dL) | 4% | 2% |
| Thrombocytopenia (platelets < 50,000/mm3) | 1% | 3% |
| ALT ( > 10 x ULN) | 1% | 3% |
| AST ( > 10 x ULN) | 2% | 4% |
| Lipase ( > 2.5 x ULN) | 3% | 3% |
| Total amylase ( > 2.5 x ULN) | 3% | 3% |
| ULN = Upper limit of normal. ANC = Absolute neutrophil count. |
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Additional adverse events reported in open-label studies in pediatric patients receiving RETROVIR 180 mg/m2 every 6 hours were congestive heart failure, decreased reflexes, ECG abnormality, edema, hematuria, left ventricular dilation, macrocytosis, nervousness/irritability, and weight loss.
The clinical adverse events reported among adult recipients of RETROVIR may also occur in pediatric patients.
Use for the Prevention of Maternal-Fetal Transmission of HIV
In a randomized, double-blind, placebo-controlled trial in HIV-infected women and their neonates conducted to determine the utility of RETROVIR for the prevention of maternal-fetal HIV transmission, RETROVIR Syrup at 2 mg/kg was administered every 6 hours for 6 weeks to neonates beginning within 12 hours following birth. The most commonly reported adverse experiences were anemia (hemoglobin < 9.0 g/dL) and neutropenia ( < 1,000 cells/mm3). Anemia occurred in 22% of the neonates who received RETROVIR and in 12% of the neonates who received placebo. The mean difference in hemoglobin values was less than 1.0 g/dL for neonates receiving RETROVIR compared to neonates receiving placebo. No neonates with anemia required transfusion and all hemoglobin values spontaneously returned to normal within 6 weeks after completion of therapy with RETROVIR. Neutropenia was reported with similar frequency in the group that received RETROVIR (21%) and in the group that received placebo (27%). The long-term consequences of in utero and infant exposure to RETROVIR are unknown.
Observed During Clinical Practice
In addition to adverse events reported from clinical trials, the following events have been identified during use of RETROVIR in clinical practice. 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 either their seriousness, frequency of reporting, potential causal connection to RETROVIR, or a combination of these factors.
Body as a Whole: Back pain, chest pain, flu-like syndrome, generalized pain.
Cardiovascular: Cardiomyopathy, syncope.
Endocrine: Gynecomastia.
Eye: Macular edema.
Gastrointestinal: Constipation, dysphagia, flatulence, oral mucosal pigmentation, mouth ulcer.
General: Sensitization reactions including anaphylaxis and angioedema, vasculitis.
Hemic and Lymphatic: Aplastic anemia, hemolytic anemia, leukopenia, lymphadenopathy, pancytopenia with marrow hypoplasia, pure red cell aplasia.
Hepatobiliary Tract and Pancreas: Hepatitis, hepatomegaly with steatosis, jaundice, lactic acidosis, pancreatitis.
Musculoskeletal: Increased CPK, increased LDH, muscle spasm, myopathy and myositis with pathological changes (similar to that produced by HIV disease), rhabdomyolysis, tremor.
Nervous: Anxiety, confusion, depression, dizziness, loss of mental acuity, mania, paresthesia, seizures, somnolence, vertigo.
Respiratory: Cough, dyspnea, rhinitis, sinusitis.
Skin: Changes in skin and nail pigmentation, pruritus, rash, Stevens-Johnson syndrome, toxic epidermal necrolysis, sweat, urticaria.
Special Senses: Amblyopia, hearing loss, photophobia, taste perversion.
Urogenital:Urinary frequency, urinary hesitancy.
Read the entire FDA prescribing information for Retrovir IV (Zidovudine Injection)
&Copy; Retrovir IV Patient Information is supplied by Cerner Multum, Inc. and Retrovir IV Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.