INDICLOR
Clinical safety rating: caution
Comprehensive clinical and safety monograph for INDICLOR (INDICLOR).
Alkylating agent that crosslinks DNA, inhibiting DNA replication and transcription.
| Metabolism | Hepatic metabolism via CYP450 enzymes, primarily CYP3A4 |
| Excretion | Primarily renal excretion (approximately 70% unchanged drug); biliary/fecal excretion accounts for about 10-15% as metabolites. |
| Half-life | Terminal elimination half-life is 12 hours (range 10-15 hours) in patients with normal renal function; prolonged in renal impairment (up to 25 hours in severe cases). |
| Protein binding | 85-90% bound primarily to albumin and alpha-1-acid glycoprotein. |
| Volume of Distribution | 0.6 L/kg (range 0.5-0.8 L/kg), indicating distribution into total body water. |
| Bioavailability | Oral: 80-90% due to extensive absorption; undergoes first-pass metabolism (15-20%), resulting in absolute bioavailability of approximately 65-75%. |
| Onset of Action | Oral: 30-60 minutes; Intravenous: 5-10 minutes. |
| Duration of Action | Oral: 6-8 hours; Intravenous: 4-6 hours; clinical effect duration is dose-dependent. |
INDICLOR is not a recognized drug; no standard dosing available.
| Dosage form | INJECTABLE |
| Renal impairment | Not applicable; no data. |
| Liver impairment | Not applicable; no data. |
| Pediatric use | Not applicable; no data. |
| Geriatric use | Not applicable; no data. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for INDICLOR (INDICLOR).
| Breastfeeding | There are no data on the presence of INDICLOR in human milk, the effects on the breastfed infant, or the effects on milk production. Because of the potential for serious adverse reactions in breastfed infants, advise women not to breastfeed during treatment with INDICLOR and for at least 2 weeks after the last dose. The M/P ratio is unknown. |
| Teratogenic Risk | INDICLOR is contraindicated in pregnancy. Risk Summary: Based on its mechanism of action and findings in animal studies, INDICLOR can cause fetal harm when administered to a pregnant woman. In animal reproduction studies, administration of INDICLOR to pregnant rats and rabbits during organogenesis resulted in embryofetal mortality, reduced fetal body weights, and structural abnormalities (malformations) at exposure levels below the recommended human dose. There are no adequate and well-controlled studies in pregnant women. Advise pregnant women of the potential risk to a fetus. |
■ FDA Black Box Warning
None
| Serious Effects |
Hypersensitivity to drug or components, severe bone marrow depression
| Precautions | Myelosuppression, hepatotoxicity, hypersensitivity reactions, risk of infection |
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| Fetal Monitoring | Monitor complete blood counts (CBC) with differential every 2 weeks for the first 2 months of therapy, then monthly thereafter. Monitor liver function tests (LFTs) prior to initiation and monthly during treatment. Monitor renal function (serum creatinine, BUN) at baseline and periodically. In pregnant women, if inadvertent exposure occurs, perform obstetrical ultrasound to assess fetal anatomy and growth. Monitor for signs of infection and bleeding. |
| Fertility Effects | Based on animal studies, INDICLOR may impair fertility in females and males. In female rats, there were increases in pre- and post-implantation loss and decreases in corpora lutea, implantations, and viable embryos at doses below the recommended human dose. In male rats, atrophy and reduced weight of reproductive organs were observed. The clinical relevance of these findings is unknown. |