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Drug overview for RETROVIR (zidovudine):
Generic name: ZIDOVUDINE (zye-DOE-vue-deen)
Drug class: Antiviral-HIV(Antiretroviral) Nucleoside/-tide RT Inhibitors
Therapeutic class: Anti-Infective Agents
Zidovudine, an antiretroviral agent, is a human immunodeficiency virus (HIV) nucleoside reverse transcriptase inhibitor (NRTI).
No enhanced Uses information available for this drug.
Generic name: ZIDOVUDINE (zye-DOE-vue-deen)
Drug class: Antiviral-HIV(Antiretroviral) Nucleoside/-tide RT Inhibitors
Therapeutic class: Anti-Infective Agents
Zidovudine, an antiretroviral agent, is a human immunodeficiency virus (HIV) nucleoside reverse transcriptase inhibitor (NRTI).
No enhanced Uses information available for this drug.
DRUG IMAGES
RETROVIR 10 MG/ML SYRUP
RETROVIR 200 MG/20 ML VIAL
RETROVIR 100 MG CAPSULE
The following indications for RETROVIR (zidovudine) have been approved by the FDA:
Indications:
HIV infection
Prevention of maternal-fetal transmission of HIV
Professional Synonyms:
Human immunodeficiency virus disease
Human immunodeficiency virus infection
Maternal-fetal HIV transmission prophylaxis
Indications:
HIV infection
Prevention of maternal-fetal transmission of HIV
Professional Synonyms:
Human immunodeficiency virus disease
Human immunodeficiency virus infection
Maternal-fetal HIV transmission prophylaxis
The following dosing information is available for RETROVIR (zidovudine):
Dosage of zidovudine in pediatric patients usually is based on body weight or, alternatively, body surface area. To avoid medication errors, use extra care in calculating the dose, transcribing the medication order, dispensing the prescription, and providing dosage instructions. Use a graduated oral syringe with 0.1
mL measurement increments to ensure accurate dosing of zidovudine oral solution in neonates. Zidovudine dosage in pediatric patients should not exceed adult dosage.
Dosage interruption of zidovudine may be required in patients that develop significant anemia (hemoglobin levels of less than 7.5 g/dL or a reduction of over 25% from baseline) and/or neutropenia (granulocyte count less than 750 cells/mm3or a reduction of over 50% from baseline) until bone marrow recovery is evident. In patients who develop significant anemia, dosage interruption does not necessarily eliminate the need for blood transfusions.
If marrow recovery occurs following dosage interruption, reinitiation of zidovudine therapy may be appropriate using adjunctive measures (e.g., epoetin alfa), depending on hematologic indices such as serum erythropoetin level and patient tolerance.
mL measurement increments to ensure accurate dosing of zidovudine oral solution in neonates. Zidovudine dosage in pediatric patients should not exceed adult dosage.
Dosage interruption of zidovudine may be required in patients that develop significant anemia (hemoglobin levels of less than 7.5 g/dL or a reduction of over 25% from baseline) and/or neutropenia (granulocyte count less than 750 cells/mm3or a reduction of over 50% from baseline) until bone marrow recovery is evident. In patients who develop significant anemia, dosage interruption does not necessarily eliminate the need for blood transfusions.
If marrow recovery occurs following dosage interruption, reinitiation of zidovudine therapy may be appropriate using adjunctive measures (e.g., epoetin alfa), depending on hematologic indices such as serum erythropoetin level and patient tolerance.
No enhanced Administration information available for this drug.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| RETROVIR 100 MG CAPSULE | Maintenance | Adults take 2 capsules (200 mg) by oral route every 8 hours |
| RETROVIR 10 MG/ML SYRUP | Maintenance | Adults take 20 milliliters (200 mg) by oral route every 8 hours |
| RETROVIR 200 MG/20 ML VIAL | Maintenance | Adults infuse 1 mg/kg over 1 hour(s) by intravenous route every 4 hours 5 times per day |
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| ZIDOVUDINE 100 MG CAPSULE | Maintenance | Adults take 2 capsules (200 mg) by oral route every 8 hours |
| ZIDOVUDINE 50 MG/5 ML SYRUP | Maintenance | Adults take 20 milliliters (200 mg) by oral route every 8 hours |
The following drug interaction information is available for RETROVIR (zidovudine):
There are 0 contraindications.
There are 10 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
| Drug Interaction | Drug Names |
|---|---|
| Zidovudine/Ganciclovir, Valganciclovir SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: The magnitude of the toxic effects of both drugs are increased. CLINICAL EFFECTS: Increased side effects, including hematologic and gastrointestinal toxicity. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: When possible, avoid this combination. Coadministration should be considered only if the potential benefits are judged to outweigh the risks. Dose reduction or interruption may be needed. Monitor with frequent complete blood counts with differential and platelet counts. DISCUSSION: Patients receiving zidovudine and ganciclovir concurrently developed hematologic toxicity, including neutropenia and anemia, and gastrointestinal toxicity. Both ganciclovir and zidovudine have box warnings regarding hematologic toxicity. Granulocytopenia (neutropenia), anemia, thrombocytopenia, and pancytopenia have been reported. In a study in 12 patients, an oral dose of ganciclovir (1000 mg every 8 hours) administered concurrently with zidovudine (100 mg every 4 hours) decreased the mean steady state area-under-the-curve (AUC) of ganciclovir 17% and increased the zidovudine AUC 19%. |
GANCICLOVIR SODIUM, VALCYTE, VALGANCICLOVIR HCL |
| Stavudine; Zidovudine/Ribavirin SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Ribavirin is believed to inhibit the phosphorylation of zidovudine to its active form, zidovudine triphosphate, by reducing the activity of thymidine kinase.(1) Ribavirin is also believed to inhibit the phosphorylation of stavudine to its active form.(2) CLINICAL EFFECTS: Concurrent use of ribavirin with stavudine may result in decreased efficacy of stavudine(2,3) or hepatic failure.(4) Concurrent use of ribavirin and zidovudine may result in decreased efficacy of zidovudine,(3,5,6) hepatic failure,(4) neutropenia,(4) or anemia.(4) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The manufacturer of zidovudine states that concurrent use with ribavirin should be avoided.(3,5) The manufacturer of Rebetol (ribavirin) states that the combination should be used with caution.(6) Patients receiving concurrent therapy with zidovudine and ribavirin should be closely monitored for hepatic failure, neutropenia, and anemia. The manufacturer of stavudine states that concurrent use with ribavirin should be approached with caution.(7) The manufacturer of Rebetrol (ribavirin) states that the combination should be used with caution.(6) Patients receiving concurrent therapy with stavudine and ribavirin should be closely monitored for hepatic failure. DISCUSSION: Zidovudine is converted to its active form by a series of phosphorylations. Ribavirin reduces the activity of thymidine kinase, resulting in higher levels of the natural nucleoside thymidine triphosphate and decreased levels of zidovudine triphosphate. Zidovudine triphosphate competes with thymidine triphosphate for insertion in the viral DNA chain. (3) Several in-vitro studies have shown that the concurrent administration of ribavirin results in decreased phosphorylation of zidovudine(1,8-10), increased sensitivity to zidovudine toxicity,(8) and decreased sensitivity to zidovudine.(9,10) However, no pharmacokinetic or pharmacodynamic changes were seen in a study of 6 subjects receiving concurrent ribavirin and zidovudine.(4) In study NR15961, patients receiving concurrent ribavirin, interferon, and zidovudine developed severe neutropenia (ANC less than 500, 15% versus 9%) and severe anemia (hemoglobin less than 8 g/dL, 5% versus 1%) more frequently than patients not receiving zidovudine.(4) Stavudine is also converted to its active form by a series of phosphorylations.(7) In vitro studies have shown that ribavirin inhibits this process.(2,4,7) However, no pharmacokinetic or pharmacodynamic changes were seen in a study of 10 subjects receiving concurrent ribavirin and stavudine.(4) In study NR15961, 14 (11%) of 129 HIV-positive chronic hepatitis C patients receiving HAART developed hepatic decompensation. All 14 patients were on NRTIs, including stavudine, didanosine, abacavir, zidovudine, and lamivudine.(4) |
RIBAVIRIN |
| Stavudine; Zidovudine/Doxorubicin SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Doxorubicin may inhibit the phosphorylation of stavudine(1,2) and zidovudine(3) to their active forms. Prolonged use of zidovudine may result in the resistance of tumor cells to doxorubicin.(4) CLINICAL EFFECTS: The concurrent use of doxorubicin may result in decreased levels and effectiveness of stavudine(1) and zidovudine.(3) Prolonged use of zidovudine may result in decreased effectiveness of doxorubicin.(4) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The US manufacturer of stavudine states that concurrent use of doxorubicin should be approached with caution.(2) The US manufacturer of zidovudine states that the concomitant use of zidovudine and doxorubicin should be avoided.(5) DISCUSSION: An in vitro study showed that doxorubicin inhibits the intracellular phosphorylation of stavudine to its active form at clinically relevant concentrations.(1) An in vitro study showed that doxorubicin inhibits the intracellular phosphorylation of zidovudine to its active form.(3) Another in vitro study found that long-term exposure to zidovudine decreased cell sensitivity to doxorubicin.(4) |
ADRIAMYCIN, CAELYX, DOXIL, DOXORUBICIN HCL, DOXORUBICIN HCL LIPOSOME |
| Deferiprone/Selected Myelosuppressive Agents SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Concurrent use of deferiprone with other drugs known to be associated with neutropenia or agranulocytosis may increase the frequency or risk for severe toxicity.(1) CLINICAL EFFECTS: Concurrent use of deferiprone and myelosuppressive agents may result in severe neutropenia or agranulocytosis, which may be fatal. PREDISPOSING FACTORS: Agranulocytosis may be less common in patients receiving deferiprone for thalassemia, and more common in patients treated for other systemic iron overload conditions (e.g. myelodysplastic syndromes, sickle cell disease).(2,3) Inadequate monitoring appears to increase the risk for severe outcomes. Manufacturer post market surveillance found that in all fatal cases of agranulocytosis reported between 1999 and 2005, data on weekly white blood count (WBC) monitoring was missing. In three fatal cases, deferiprone was continued for two to seven days after the detection of neutropenia or agranulocytosis.(2) PATIENT MANAGEMENT: If possible, discontinue one of the drugs associated with risk for neutropenia or agranulocytosis. If alternative therapy is not available, documentation and adherence to the deferiprone monitoring protocol is essential. Baseline absolute neutrophil count (ANC) must be at least 1,500/uL prior to starting deferiprone. Monitor ANC weekly during therapy. If infection develops, interrupt deferiprone therapy and monitor ANC more frequently. If ANC is less than 1,500/uL but greater than 500/uL, discontinue deferiprone and any other drugs possibly associated with neutropenia. Initiate ANC and platelet counts daily until recovery (i.e. ANC at least 1,500/uL). If ANC is less than 500/uL, discontinue deferiprone, evaluate patient and hospitalize if appropriate. Do not resume deferiprone unless potential benefits outweigh potential risks.(1) DISCUSSION: Drugs linked to this monograph have an FDA Boxed Warning for risk of neutropenia, agranulocytosis, or pancytopenia, or have > 5% risk for neutropenia and/or warnings describing risk for myelosuppression in manufacturer prescribing information.(1-25) In pooled clinical studies submitted to the FDA, 6.1% of deferiprone patients met criteria for neutropenia and 1.7% of patients developed agranulocytosis.(1) The time to onset of agranulocytosis was highly variable with a range of 65 days to 9.2 years (median, 161 days).(3) |
DEFERIPRONE, DEFERIPRONE (3 TIMES A DAY), FERRIPROX, FERRIPROX (2 TIMES A DAY), FERRIPROX (3 TIMES A DAY) |
| Clozapine/Selected Myelosuppressive Agents SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Clozapine and other myelosuppressive agents may be associated with neutropenia or agranulocytosis.(2) CLINICAL EFFECTS: Moderate neutropenia, even if due to combination therapy, may require abrupt discontinuation of clozapine resulting in decompensation of the patient's psychiatric disorder (e.g. schizophrenia). The disease treated by the myelosuppressive agent may be compromised if myelosuppression requires dose reduction, delay, or discontinuation of the myelosuppressive agent. Undetected severe neutropenia or agranulocytosis may be fatal. PREDISPOSING FACTORS: Low white blood counts prior to initiation of the myelosuppressive agent may increase risk for clinically significant neutropenia. PATIENT MANAGEMENT: If a patient stabilized on clozapine therapy requires treatment with a myelosuppressive agent, the clozapine prescriber should consult with prescriber of the myelosuppressive agent (e.g. oncologist) to discuss treatment and monitoring options.(2) More frequent ANC monitoring or treatment alternatives secondary to neutropenic episodes may need to be considered. Clozapine is only available through a restricted distribution system which requires documentation of the absolute neutrophil count (ANC) prior to dispensing.(1-2) For most clozapine patients, clozapine treatment must be interrupted for a suspected clozapine-induced ANC < 1000 cells/microliter. For patients with benign ethnic neutropenia (BEN), treatment must be interrupted for suspected clozapine-induced neutropenia < 500 cells/microliter.(2) DISCUSSION: Clozapine is only available through a restricted distribution system which requires documentation of the ANC prior to dispensing.(1) Agents linked to this interaction generally have > 5% risk for neutropenia and/or warnings describing risk for myelosuppression in manufacturer prescribing information.(3-26) |
CLOZAPINE, CLOZAPINE ODT, CLOZARIL, VERSACLOZ |
| Sodium Iodide I 131/Myelosuppressives; Immunomodulators SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Sodium iodide I 131 can cause depression of the hematopoetic system. Myelosuppressives and immunomodulators also suppress the immune system.(1) CLINICAL EFFECTS: Concurrent use of sodium iodide I 131 with agents that cause bone marrow depression, including myelosuppressives or immunomodulators, may result in an enhanced risk of hematologic disorders, including anemia, blood dyscrasias, bone marrow depression, leukopenia, and thrombocytopenia. Bone marrow depression may increase the risk of serious infections and bleeding.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The US manufacturer of sodium iodide I 131 states that concurrent use with bone marrow depressants may enhance the depression of the hematopoetic system caused by large doses of sodium iodide I 131.(1) Sodium iodide I 131 causes a dose-dependent bone marrow suppression, including neutropenia or thrombocytopenia, in the 3 to 5 weeks following administration. Patients may be at increased risk of infections or bleeding during this time. Monitor complete blood counts within one month of therapy. If results indicate leukopenia or thrombocytopenia, dosimetry should be used to determine a safe sodium iodide I 131 activity.(1) DISCUSSION: Hematologic disorders including death have been reported with sodium iodide I 131. The most common hematologic disorders reported include anemia, blood dyscrasias, bone marrow depression, leukopenia, and thrombocytopenia.(1) |
HICON, SODIUM IODIDE I-131 |
| Betibeglogene Autotemcel/Anti-Retrovirals; Hydroxyurea SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Betibeglogene autotemcel is prepared from apheresed cells that are transduced with a replication defective, self-inactivating lentiviral vector. Antiretrovirals may interfere with the manufacturing of apheresed cells. Hydroxyurea may interfere with hematopoietic stem cell (HSC) mobilization of CD34+ cells.(1) CLINICAL EFFECTS: Use of hydroxyurea before mobilization may result in unsuccessful stem cell mobilization. Use of antiretrovirals before mobilization and apheresis may interfere with the production of betibeglogene autotemcel. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Discontinue antiretrovirals and hydroxyurea for at least one month prior to mobilization and until all cycles of apheresis are completed. If a patient requires antiretrovirals for HIV prophylaxis, then confirm a negative HIV test before beginning mobilization and apheresis of CD34+ cells. DISCUSSION: Antiretroviral medications and hydroxyurea may interfere with the manufacturing of betibeglogene autotemcel therapy.(1) |
ZYNTEGLO |
| Elivaldogene Autotemcel/Anti-Retrovirals SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Elivaldogene autotemcel is prepared from apheresed cells that are transduced with a replication defective, self-inactivating lentiviral vector. Antiretrovirals may interfere with the manufacturing of apheresed cells. CLINICAL EFFECTS: Use of antiretrovirals before mobilization and apheresis may interfere with the production of elivaldogene autotemcel. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Discontinue antiretrovirals for at least one month prior to mobilization and until all cycles of apheresis are completed. If a patient requires antiretrovirals for HIV prophylaxis, then confirm a negative HIV test before beginning mobilization and apheresis of CD34+ cells. DISCUSSION: Antiretroviral medications may interfere with the manufacturing of elivaldogene autotemcel therapy.(1) |
SKYSONA |
| Lovotibeglogene Autotemcel/Anti-Retrovirals SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Lovotibeglogene autotemcel is prepared from apheresed cells that are transduced with a replication defective, self-inactivating lentiviral vector. Antiretrovirals may interfere with the manufacturing of apheresed cells. CLINICAL EFFECTS: Use of antiretrovirals before mobilization and apheresis may interfere with the production of lovotibeglogene autotemcel.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Discontinue antiretrovirals for at least one month prior to mobilization and until all cycles of apheresis are completed.(1) There are some long-acting antiretroviral medications that may require a longer duration of discontinuation for elimination of the medication. If a patient is taking anti-retrovirals for HIV prophylaxis, confirm a negative test for HIV before beginning mobilization and apheresis of CD34+ cells.(1) DISCUSSION: Antiretroviral medications may interfere with the manufacturing of lovotibeglogene autotemcel therapy.(1) |
LYFGENIA |
| Atidarsagene Autotemcel/Anti-Retrovirals SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Atidarsagene autotemcel is prepared from apheresed cells that are transduced with a replication defective, self-inactivating lentiviral vector. Antiretrovirals may interfere with the manufacturing of apheresed cells. CLINICAL EFFECTS: Use of antiretrovirals before mobilization and apheresis may interfere with the production of atidarsagene autotemcel. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Discontinue antiretrovirals for at least one month prior to mobilization (or the expected duration of time needed for elimination of the medication) until all cycles of apheresis are completed. If a patient requires antiretrovirals for HIV prophylaxis, then confirm a negative HIV test before beginning mobilization and apheresis of CD34+ cells. DISCUSSION: Antiretroviral medications may interfere with the manufacturing of atidarsagene autotemcel therapy.(1) |
LENMELDY |
There are 1 moderate interactions.
The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.
| Drug Interaction | Drug Names |
|---|---|
| Zidovudine/Probenecid SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Inhibition of zidovudine metabolism by probenecid. CLINICAL EFFECTS: Increased serum zidovudine levels and cutaneous reactions with systemic symptoms (eg, fever, malaise, myalgia,) have been reported. PREDISPOSING FACTORS: There may be an increased tendency of patients with disorders of the immune system to develop adverse reaction to these drugs. PATIENT MANAGEMENT: Observe patient for unexpected cutaneous reactions. It may be necessary to reduce the dosing frequency of zidovudine if probenecid is administered concurrently. DISCUSSION: Concomitant administration of zidovudine and probenecid may be therapeutically beneficial in reducing the daily dose of zidovudine. However, because of the narrow therapeutic index of zidovudine, the frequent need to treat patients with immune system disorders with various additional drugs, and the known ability of probenecid to inhibit metabolism or renal excretion of many drugs, would make combined zidovudine/probenecid treatment difficult to manage in many of these type of patients. Cutaneous reactions have been reported in many patients receiving zidovudine and probenecid concurrently. |
PROBENECID, PROBENECID-COLCHICINE |
The following contraindication information is available for RETROVIR (zidovudine):
Drug contraindication overview.
*History of potentially life-threatening hypersensitivity reaction (e.g., anaphylaxis, Stevens-Johnson syndrome) to the drug or any ingredient in the formulation. *
*History of potentially life-threatening hypersensitivity reaction (e.g., anaphylaxis, Stevens-Johnson syndrome) to the drug or any ingredient in the formulation. *
There are 2 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Lactation |
| Lactic acidosis |
There are 7 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Anemia |
| Chronic kidney disease stage 5 (failure) GFr<15 ml/min |
| Hepatomegaly |
| Myopathy |
| Myositis |
| Neutropenic disorder |
| Severe hepatic disease |
There are 2 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Disease of liver |
| Toxic amblyopia |
The following adverse reaction information is available for RETROVIR (zidovudine):
Adverse reaction overview.
Adverse reactions occurring in 15% or more of adult patients receiving zidovudine for HIV-1 in clinical trials include headache, malaise, nausea, vomiting, and anorexia. In pediatric patients receiving zidovudine for HIV-1 in clinical trials, fever and cough were the most commonly reported adverse reactions, occurring in 15% or more of patients. In neonates who received zidovudine for the prevention of maternal-fetal transmission of HIV-1, the most common adverse reaction was anemia (incidence of 15% or greater).
Adverse systemic effects reported with IV zidovudine are similar to those reported with oral zidovudine. However, long-term IV zidovudine therapy (i.e., longer than 2-4 weeks) has not been evaluated in adults and may enhance adverse hematologic effects.
Adverse reactions occurring in 15% or more of adult patients receiving zidovudine for HIV-1 in clinical trials include headache, malaise, nausea, vomiting, and anorexia. In pediatric patients receiving zidovudine for HIV-1 in clinical trials, fever and cough were the most commonly reported adverse reactions, occurring in 15% or more of patients. In neonates who received zidovudine for the prevention of maternal-fetal transmission of HIV-1, the most common adverse reaction was anemia (incidence of 15% or greater).
Adverse systemic effects reported with IV zidovudine are similar to those reported with oral zidovudine. However, long-term IV zidovudine therapy (i.e., longer than 2-4 weeks) has not been evaluated in adults and may enhance adverse hematologic effects.
There are 26 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Anemia Leukopenia Neutropenic disorder |
None. |
| Rare/Very Rare |
|---|
|
Anaphylaxis Angioedema Aplastic anemia Cardiomyopathy CNS toxicity Hemolytic anemia Hepatitis Jaundice Lactic acidosis Macular retinal edema Manic disorder Myopathy Myositis Pancreatitis Pancytopenia Pure red cell aplasia Rhabdomyolysis Seizure disorder Steatosis of liver Stevens-johnson syndrome Thrombocytopenic disorder Toxic epidermal necrolysis Vasculitis |
There are 52 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Anorexia Cough Fever Headache disorder Malaise Myalgia Nausea Vomiting |
Abdominal pain with cramps Arthralgia Chills Constipation Dyspepsia Fatigue General weakness Insomnia Macrocytosis Musculoskeletal pain Nail discoloration Peripheral sensory neuropathy |
| Rare/Very Rare |
|---|
|
Acute cognitive impairment Back pain Chest pain Depression Dizziness Drowsy Dyschromia Dysgeusia Dysphagia Dyspnea Flatulence Flu-like symptoms Gynecomastia Hearing loss Hyperbilirubinemia Hyperhidrosis Hyperpigmentation of oral mucosa Increased urinary frequency Lipodystrophy Lymphadenopathy Paresthesia Photophobia Pruritus of skin Rhinitis Sinusitis Symptoms of anxiety Syncope Toxic amblyopia Tremor Urinary hesitancy Urticaria Vertigo |
The following precautions are available for RETROVIR (zidovudine):
Pharmacokinetics of zidovudine in pediatric patients older than 3 months of age are similar to those reported in adults. Zidovudine pharmacokinetics in neonates 2 weeks of age and younger are substantially different from neonates over 2 weeks of age
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Zidovudine crosses the human placenta and concentrations in neonatal plasma at birth were equivalent to maternal plasma concentrations. In neonates and infants exposed to zidovudine in utero, cases of mild and transient serum lactate elevations, possibly due to mitochondrial dysfunction, have been reported; the clinical significance of these elevations is unknown. There have also been few reports of seizures, developmental delays, and other neurological disorders; however, a causal relationship of zidovudine exposure in utero or during the peri-partum phase with these events has not been established.
To monitor maternal-fetal outcomes of pregnant women exposed to antiretroviral agents, including zidovudine, the Antiretroviral Pregnancy Registry was established. Clinicians are encouraged to contact the registry at 800-258-4263 or https://www.APRegistry.com
to enroll such women. Data from the Antiretroviral Pregnancy Registry show no difference in the overall risk of birth defects for zidovudine compared with the background rate for birth defects in the US reference population of the Metropolitan Atlanta Congenital Defects Program (MACDP). Registry data include over 13,000 prospective reports of zidovudine exposures during pregnancy resulting in live births, including over 4000 first trimester exposures to the drug.
To monitor maternal-fetal outcomes of pregnant women exposed to antiretroviral agents, including zidovudine, the Antiretroviral Pregnancy Registry was established. Clinicians are encouraged to contact the registry at 800-258-4263 or https://www.APRegistry.com
to enroll such women. Data from the Antiretroviral Pregnancy Registry show no difference in the overall risk of birth defects for zidovudine compared with the background rate for birth defects in the US reference population of the Metropolitan Atlanta Congenital Defects Program (MACDP). Registry data include over 13,000 prospective reports of zidovudine exposures during pregnancy resulting in live births, including over 4000 first trimester exposures to the drug.
Zidovudine is distributed into human milk. The effects of zidovudine on milk production, or on the breast-fed infant are not known. The HHS perinatal HIV transmission guideline provides updated recommendations on infant feeding.
The guideline states that patients with HIV should receive evidence-based, patient-centered counseling to support shared decision making about infant feeding. During counseling, patients should be informed that feeding with appropriate formula or pasteurized donor human milk from a milk bank eliminates the risk of postnatal HIV transmission to the infant. Additionally, achieving and maintaining viral suppression with antiretroviral therapy during pregnancy and postpartum reduces the risk of breastfeeding HIV transmission to <1%, but does not completely eliminate the risk. Replacement feeding with formula or banked pasteurized donor milk is recommended when patients with HIV are not on antiretroviral therapy and/or do not have a suppressed viral load during pregnancy (at a minimum throughout the third trimester), as well as at delivery.
The guideline states that patients with HIV should receive evidence-based, patient-centered counseling to support shared decision making about infant feeding. During counseling, patients should be informed that feeding with appropriate formula or pasteurized donor human milk from a milk bank eliminates the risk of postnatal HIV transmission to the infant. Additionally, achieving and maintaining viral suppression with antiretroviral therapy during pregnancy and postpartum reduces the risk of breastfeeding HIV transmission to <1%, but does not completely eliminate the risk. Replacement feeding with formula or banked pasteurized donor milk is recommended when patients with HIV are not on antiretroviral therapy and/or do not have a suppressed viral load during pregnancy (at a minimum throughout the third trimester), as well as at delivery.
While clinical experience to date has not revealed age-related differences in response to zidovudine, clinical studies evaluating zidovudine have not included sufficient numbers of adults 65 years of age or older to determine whether geriatric patients respond differently than younger adults. Zidovudine should be used with caution in geriatric patients because these individuals frequently have decreased hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.
The following prioritized warning is available for RETROVIR (zidovudine):
WARNING: Zidovudine can decrease bone marrow function, which may lead to low numbers of red and white blood cells. A low number of red blood cells can lead to anemia. A low number of white blood cells can decrease your body's ability to fight serious, life-threatening infections.
These serious side effects occur more often in people with advanced HIV disease (AIDS). Tell your doctor right away if you develop any signs of anemia (such as unusual tiredness, fast breathing, pale skin, fast heartbeat) or signs of infection (such as sore throat that doesn't go away, fever, chills). Your doctor will check your blood cell counts while you are taking this medication to decrease the risk of these side effects.
This medication may also cause muscle problems (myopathy). Tell your doctor right away if you develop symptoms of myopathy (such as wasting or decrease in muscle size, muscle weakness/pain/tenderness, weight loss). Rarely, zidovudine has caused severe (sometimes fatal) liver problems and a certain metabolic problem (lactic acidosis).
Get medical help right away if you develop symptoms of liver problems (such as nausea that doesn't go away, stomach/abdominal pain, dark urine, yellowing eyes/skin) or lactic acidosis (such as rapid breathing, drowsiness, muscle aches). These serious side effects may occur more often in women and obese patients.
WARNING: Zidovudine can decrease bone marrow function, which may lead to low numbers of red and white blood cells. A low number of red blood cells can lead to anemia. A low number of white blood cells can decrease your body's ability to fight serious, life-threatening infections.
These serious side effects occur more often in people with advanced HIV disease (AIDS). Tell your doctor right away if you develop any signs of anemia (such as unusual tiredness, fast breathing, pale skin, fast heartbeat) or signs of infection (such as sore throat that doesn't go away, fever, chills). Your doctor will check your blood cell counts while you are taking this medication to decrease the risk of these side effects.
This medication may also cause muscle problems (myopathy). Tell your doctor right away if you develop symptoms of myopathy (such as wasting or decrease in muscle size, muscle weakness/pain/tenderness, weight loss). Rarely, zidovudine has caused severe (sometimes fatal) liver problems and a certain metabolic problem (lactic acidosis).
Get medical help right away if you develop symptoms of liver problems (such as nausea that doesn't go away, stomach/abdominal pain, dark urine, yellowing eyes/skin) or lactic acidosis (such as rapid breathing, drowsiness, muscle aches). These serious side effects may occur more often in women and obese patients.
The following icd codes are available for RETROVIR (zidovudine)'s list of indications:
| HIV infection | |
| B20 | Human immunodeficiency virus [HIv] disease |
| B97.35 | Human immunodeficiency virus, type 2 [HIV 2] as the cause of diseases classified elsewhere |
| O98.7 | Human immunodeficiency virus [HIv] disease complicating pregnancy, childbirth and the puerperium |
| O98.71 | Human immunodeficiency virus [HIv] disease complicating pregnancy |
| O98.711 | Human immunodeficiency virus [HIv] disease complicating pregnancy, first trimester |
| O98.712 | Human immunodeficiency virus [HIv] disease complicating pregnancy, second trimester |
| O98.713 | Human immunodeficiency virus [HIv] disease complicating pregnancy, third trimester |
| O98.719 | Human immunodeficiency virus [HIv] disease complicating pregnancy, unspecified trimester |
| O98.72 | Human immunodeficiency virus [HIv] disease complicating childbirth |
| O98.73 | Human immunodeficiency virus [HIv] disease complicating the puerperium |
| Z21 | Asymptomatic human immunodeficiency virus [HIv] infection status |
| Prevention of maternal-fetal transmission of HIV | |
| O98.72 | Human immunodeficiency virus [HIv] disease complicating childbirth |
Formulary Reference Tool