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Retrovir IV

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Retrovir IV

Retrovir IV Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Retrovir (zidovudine) IV Infusion is an antiviral medication used to treat HIV, which causes the acquired immunodeficiency syndrome (AIDS). It is also given during pregnancy to prevent an HIV-infected woman from passing the virus to her baby. Retrovir is not a cure for HIV or AIDS. This medication is available in generic form. Common side effects include nausea, vomiting, constipation, insomnia, muscle or joint pain, headache, tired feeling, 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).

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). 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 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.

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.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Retrovir IV in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

This medication may cause lactic acidosis (a build-up of lactic acid in the body, which can be fatal). Lactic acidosis can start slowly and get worse over time. Get emergency medical help if you have even mild symptoms of lactic acidosis, such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, fast or uneven heart rate, dizziness, or feeling very weak or tired.

Stop using zidovudine and call your doctor at once if you have any of these other serious side effects:

  • severe muscle pain;
  • signs of a new infection such as fever, chills, body aches, flu symptoms, sores in your mouth and throat;
  • pale skin, feeling light-headed, rapid heart rate, trouble concentrating;
  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
  • increased sweating, tremors in your hands, anxiety, feeling irritable, sleep problems (insomnia);
  • diarrhea, unexplained weight loss, menstrual changes, impotence, loss of interest in sex;
  • swelling in your neck or throat (goiter);
  • problems with walking, breathing, speech, swallowing, or eye movement;
  • weakness or prickly feeling in your fingers or toes;
  • severe lower back pain, loss of bladder or bowel control;
  • liver problems--upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • pancreatitis--severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate; or
  • severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Less serious side effects may include:

  • sleep problems (insomnia);
  • mild nausea, constipation;
  • joint pain;
  • headache; or
  • changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and trunk).

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 Retrovir IV (Zidovudine Injection) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Retrovir IV Overview - Patient Information: Side Effects

SIDE EFFECTS: Consult your pharmacist.

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)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Retrovir IV FDA Prescribing Information: Side Effects
(Adverse Reactions)

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.

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.

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) »

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