Dosing & Uses
Dosage Forms & Strengths
injectable solution
- 1mg/mL
Acute Myeloid Leukemia
Induction: 12 mg/m² IV qDay over 10-15 min for 3 day with concomitant cytarabine
Consolidation: 10-12 mg/m²/day IV for 2 days
Renal Impairment
Children
- CrCl < 50 mL/min: 75% of dose
- Peritoneal dialysis: 75% of dose
- Hemodialysis: 75% of dose
- Renal replacement therapy: 75% of dose
Adults
- CrCl 10-50 mL/min: 75% of dose
- CrCl <10 mL/min: 50% of dose
- Hemodialysis: Supplemental dose not necessary
- Peritoneal dialysis: Supplemental dose not necessary
Hepatic Impairment
Bilirubin 2.6-5 mg/dL: 50% of dose
Bilirubin >5 mg/dL: Avoid use
Monitor
CBC, LFTs, cardiac & renal function
Administration
Mucositis Development: Discontinue if severe mucositis after 1st course, after resolution continue w/ 25% dose reduction
Dosage Forms & Strengths
injectable solution
- 1mg/mL
Acute Myeloid Leukemia
10-12 mg/m² IV qDay for 3 days q3weeks
Acute Lymphoblastic Leukemia (Orphan)
Treatment of acute lymphoblastic leukemia in pediatric patients.
Orphan indication sponsor
- Pharmacia & Upjohn; 7000 Portage Road, Unit 0633-298-113; Kalamazoo, MI 49001-0199
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (14)
- adenovirus types 4 and 7 live, oral
idarubicin decreases effects of adenovirus types 4 and 7 live, oral by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressives may diminish therapeutic effects of vaccines and increase risk of adverse effects (increased risk of infection). Live-attenuated vaccines should be avoided for at least 3mo after cessation of immunosuppressive therapy.
- cyclophosphamide
cyclophosphamide increases toxicity of idarubicin by Other (see comment). Avoid or Use Alternate Drug. Comment: May increase formation of toxic anthracycline metabolites in heart tissue.
- deferiprone
deferiprone, idarubicin. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Avoid use of deferiprone with other drugs known to be associated with neutropenia or agranulocytosis; if an alternative is not possible, monitor absolute neutrophil count more frequently.
- erdafitinib
erdafitinib will increase the level or effect of idarubicin by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. If coadministration unavoidable, separate administration by at least 6 hr before or after administration of P-gp substrates with narrow therapeutic index.
- influenza virus vaccine quadrivalent, adjuvanted
idarubicin decreases effects of influenza virus vaccine quadrivalent, adjuvanted by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive drugs may reduce the immune response to influenza vaccine.
- influenza virus vaccine trivalent, adjuvanted
idarubicin decreases effects of influenza virus vaccine trivalent, adjuvanted by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive drugs may reduce the immune response to influenza vaccine.
- lasmiditan
lasmiditan increases levels of idarubicin by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug.
- paclitaxel
paclitaxel increases toxicity of idarubicin by Other (see comment). Avoid or Use Alternate Drug. Comment: May increase formation of toxic anthracycline metabolites in heart tissue.
- palifermin
palifermin increases toxicity of idarubicin by Other (see comment). Avoid or Use Alternate Drug. Comment: Palifermin should not be administered within 24 hrbefore, during infusion of, or within 24 hr after administration of antineoplastic agents. Coadministration of palifermin within 24 hr of chemotherapy resulted in increased severity and duration of oral mucositis.
- ropeginterferon alfa 2b
ropeginterferon alfa 2b, idarubicin. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.
- sotorasib
sotorasib will decrease the level or effect of idarubicin by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. If use is unavoidable, refer to the prescribing information of the P-gp substrate for dosage modifications.
- tepotinib
tepotinib will increase the level or effect of idarubicin by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. If concomitant use unavoidable, reduce the P-gp substrate dosage if recommended in its approved product labeling.
- trastuzumab
trastuzumab, idarubicin. Either increases toxicity of the other by unknown mechanism. Avoid or Use Alternate Drug. Trastuzumab may cause cardiomyopathy. Incidence and severity was highest when used with anthracycline-containing chemotherapy regimens. If possible, avoid anthracycline-based therapy for 7 months after last trastuzumab/hyaluronidase dose. If anthracyclines are used, carefully monitor cardiac function.
- trastuzumab deruxtecan
trastuzumab deruxtecan increases toxicity of idarubicin by Other (see comment). Avoid or Use Alternate Drug. Comment: May increase formation of toxic anthracycline metabolites in heart tissue.
trastuzumab deruxtecan, idarubicin. Either increases toxicity of the other by unknown mechanism. Avoid or Use Alternate Drug. Trastuzumab may cause cardiomyopathy. Incidence and severity was highest when used with anthracycline-containing chemotherapy regimens. If possible, avoid anthracycline-based therapy for 7 months after last trastuzumab/hyaluronidase dose. If anthracyclines are used, carefully monitor cardiac function.
Monitor Closely (27)
- acalabrutinib
acalabrutinib, idarubicin. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration may increase risk of myelosuppressive effects.
- belatacept
belatacept and idarubicin both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- berotralstat
berotralstat will increase the level or effect of idarubicin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Monitor or titrate P-gp substrate dose if coadministered.
- bevacizumab
bevacizumab, idarubicin. Other (see comment). Use Caution/Monitor. Comment: Potential for increased risk of cardiotoxicity (CHF). Caution is warranted.
- bosutinib
bosutinib increases levels of idarubicin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.
- cholera vaccine
idarubicin decreases effects of cholera vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids (used in greater than physiologic doses), may reduce the immune response to cholera vaccine.
- dengue vaccine
idarubicin decreases effects of dengue vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Immunosuppressive therapies (eg, irradiation, antimetabolites, alkylating agents, cytotoxic drugs, corticosteroids [greater than physiologic doses]) may reduce immune response to dengue vaccine.
- denosumab
idarubicin, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.
- elagolix
elagolix will increase the level or effect of idarubicin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.
- eliglustat
eliglustat increases levels of idarubicin by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. Monitor therapeutic drug concentrations, as indicated, or consider reducing the dosage of the P-gp substrate and titrate to clinical effect.
- fingolimod
idarubicin increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .
- fostamatinib
fostamatinib will increase the level or effect of idarubicin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Concomitant use of fostamatinib may increase concentrations of P-gp substrates. Monitor for toxicities of the P-gp substrate drug that may require dosage reduction when given concurrently with fostamatinib.
- glecaprevir/pibrentasvir
glecaprevir/pibrentasvir will increase the level or effect of idarubicin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.
- hydroxyurea
idarubicin, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of myelosuppression.
- istradefylline
istradefylline will increase the level or effect of idarubicin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Istradefylline 40 mg/day increased peak levels and AUC of P-gp substrates in clinical trials. Consider dose reduction of sensitive P-gp substrates.
- lomitapide
lomitapide increases levels of idarubicin by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. Consider reducing dose when used concomitantly with lomitapide.
- lonafarnib
lonafarnib will increase the level or effect of idarubicin by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. Lonafarnib is a weak P-gp inhibitor. Monitor for adverse reactions if coadministered with P-gp substrates where minimal concentration changes may lead to serious or life-threatening toxicities. Reduce P-gp substrate dose if needed.
- meningococcal group B vaccine
idarubicin decreases effects of meningococcal group B vaccine by pharmacodynamic antagonism. Use Caution/Monitor. Individuals with altered immunocompetence may have reduced immune responses to the vaccine.
- ofatumumab SC
ofatumumab SC, idarubicin. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Consider the risk of additive immune system effects when coadministering immunosuppressive therapies with coadministration. When switching from therapies with immune effects, take into account the duration and mechanism of action of these therapies when initiating ofatumumab SC.
- olaparib
idarubicin and olaparib both increase pharmacodynamic synergism. Use Caution/Monitor. Coadministration with other other myelosuppressive anticancer agents, including DNA damaging agents, may potentiate and prolongate the myelosuppressive toxicity.
- sarecycline
sarecycline will increase the level or effect of idarubicin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Monitor for toxicities of P-gp substrates that may require dosage reduction when coadministered with P-gp inhibitors.
- siponimod
siponimod and idarubicin both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.
- sipuleucel-T
idarubicin decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.
- stiripentol
stiripentol will increase the level or effect of idarubicin by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. Consider reducing the dose of P-glycoprotein (P-gp) substrates, if adverse reactions are experienced when administered concomitantly with stiripentol.
- trastuzumab
trastuzumab, idarubicin. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .
- trastuzumab deruxtecan
trastuzumab deruxtecan, idarubicin. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .
- tucatinib
tucatinib will increase the level or effect of idarubicin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Consider reducing the dosage of P-gp substrates, where minimal concentration changes may lead to serious or life-threatening toxicities.
Minor (0)
Adverse Effects
>10%
Infection (95%)
Nausea (30-60%)
Vomiting (30-60%)
Alopecia (25-30%)
Hemorrhage (63%)
Stomatitis (11%)
Fever (26%)
Elevated bilirubin and transaminases (20-30%)
Myelosuppression: > 10%
1-10%
Seizure (4%)
CHF (2%)
Peripheral neuropathy (8%)
Frequency Not Defined
Fever
Chills
Headache
Flushing
Myocardial infarction
Cardiac dysrhythmia
Chest pain
Diarrhea
Inflammatory disease of mucous membrane
Hyperuricemia
Red discoloration of urine
Rash
Warnings
Black Box Warnings
The drug should be administered under the supervision of a cancer chemotherapy physician experienced in acute leukemia treatment in a facility with appropriate equipment to monitor patients compromised by drug toxicity. Severe hemorrhagic conditions or overwhelming infection resulting from the therapy should also be able to be treated at the facility.
Only administer intravenously into a freely flowing IV infusion. Do not administer intramuscularly or subcutaneously. Severe local tissue damage can occur with extravasation.
Myocardial toxicity leading to CHF may occur. Toxicity is more common with prior anthracycline use or preexisting cardiac disease.
Myelosuppression can be severe at therapeutic doses
Reduce dose in renal or hepatic impairment
Contraindications
Hypersensitivity
Serum bilirubin >5 mg/dL [>85.5 umol/L]
Cautions
Vesicant-avoid extravasation
Risk of myocardial toxicity leading to potentially fatal CHF; pre-existing heart disease and previous therapy with anthracyclines at high cumulative doses or other potentially cardiotoxic agents are co-factors for increased risk of cardiac toxicity; benefit to risk ratio of idarubicin therapy in such patients should be weighed before starting treatment
Monitor cardiac function during treatment in order to minimize risk of cardiac toxicity of the type described for other anthracycline compounds
Prior radiation treatment to mediastinal-pericardial area & prior anthracyclines increases cardiotoxic risk
Cumulative doses >150 mg/m² associated with decreased ejection fraction
Possibility of injection site reactions
Use caution in hepatic/renal impairment; dose reduction may be necessary
Not for administration to patients with pre-existing bone marrow suppression induced by previous drug therapy or radiotherapy unless the benefit warrants the risk
Due to the increased risk of cardiotoxicity, avoid concomitant use until cardiotoxic agent has been discontinued for at least 5 half-lives; specifically avoid therapy for up to 7 months after stopping trastuzumab
Avoid pregnancy
Pregnancy & Lactation
Pregnancy
There is no conclusive information about therapy adversely affecting human fertility or causing teratogenesis; there has been one report of a fetal fatality after maternal exposure to drug during second trimester
There are no adequate and well-controlled studies in pregnant women; drug should be used during pregnancy only if potential benefit justifies potential risk to fetus
If drug is to be used during pregnancy, or if patient becomes pregnant during therapy, patient should be apprised and informed of potential hazard to fetus
Women of childbearing potential should be advised to avoid pregnancy and advised to use effective contraception during treatment and for at least 6.5 months after the last dose
Men with female partners of childbearing potential should be advised to use effective contraception during treatment and for at least 3.5 months after last dose
Both men and women should seek advice for fertility preservation before treatment and/or seek genetic counseling after treatment
Animal data
- Drug was embryotoxic and teratogenic in rat at dose of 1.2 mg/m2/day or one-tenth the human dose, which was nontoxic to dams; Drug was embryotoxic but not teratogenic in rabbit even at a dose of 2.4 mg/m2/day or two tenths the human dose, which was toxic to dams
Lactation
Not known whether drug is excreted in human milk; because many drugs are excreted in human milk and because of potential for serious adverse reactions in nursing infants from drug; mothers should discontinue nursing prior to taking drug and do not breastfeed during treatment and for 14 days after last dose
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Anthracycline; intercalates between DNA base pairs, inhibits topoisomerase II, which in turn inhibits DNA and RNA synthesis
Pharmacokinetics
Half-Life: 14-35 hr (PO); 12-27 hr (IV)
Bioavailability: 30%
Protein Bound: 94-97%
Vd: 64 L/kg
Peak plasma time: 1-5 hr
Metabolism: Liver
Metabolites: Idarubicinol
Clearance: 122.8 L/hr
Excretion: Urine (5-13%)
Administration
IV Incompatibilities
Additive: heparin
Syringe: heparin
Y-site: acyclovir, allopurinol, ampicillin/sulbactam, cefazolin, cefepime, ceftazidime, clindamycin, dexamethasone Na-phosphate, etoposide, fluorouracil, furosemide, gentamicin, heparin, hydrocortisone Na-succinate, lorazepam, meperidine, methotrexate, piperacillin/tazobactam, Na-bicarb, teniposide, vancomycin, vincristine
IV Compatibilities
Solution: with most common diluents
Y-site (partial list): cimetidine, diphenhydramine, etoposide PO4, granisetron, MgSO4, metoclopramide, KCl
IV Preparation
Vials: reconstitute with NS to a concentration of 1 mg/mL
Standard dilution
- IV push: dose/syringe (concentration is 1 mg/mL); maximum syringe size for IVP is 30 mL syringe & syringe should be <75% full
- IVPB: dose/100 mL D5W or NS
IV Administration
Vesicant
Administer by intermittent infusion over 10-15 min
Administer into a free flowing IV solution of NS or D5W
Local erythematous streaking along the vein may indicate rapid administration
Extravasation Management
Topical cooling may be achieved using ice packs or cooling pad with circulating ice water
Cooling of site for 25 hr as tolerated by pt.
Elevate & rest extremity 24-48 hr, then resume normal activity as tolerated
Cold inhibits vesicant's cytotoxicity
Heat can be harmful & is contraindicated
If pain, erythema, &/or swelling persist beyond 48 hr, refer pt immediately to plastic surgeon for consultation & possible debridement
See also Totect
Storage
Store intact vials of lyophilized powder at room temp
Protect from light
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Idamycin PFS intravenous - | 1 mg/mL vial |  | |
| Idamycin PFS intravenous - | 1 mg/mL vial |  | |
| Idamycin PFS intravenous - | 1 mg/mL vial |  | |
| idarubicin intravenous - | 1 mg/mL vial |  | |
| idarubicin intravenous - | 1 mg/mL vial |  | |
| idarubicin intravenous - | 1 mg/mL vial |  | |
| idarubicin intravenous - | 1 mg/mL vial |  | |
| idarubicin intravenous - | 1 mg/mL vial |  | |
| idarubicin intravenous - | 1 mg/mL vial |  | |
| idarubicin intravenous - | 1 mg/mL vial |  |
Copyright © 2010 First DataBank, Inc.
Formulary
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