Brand names: Paclitaxel
Microtubule Inhibitor
Route: Intravenous
FDA Black Box Warning
WARNING: SEVERE MYELOSUPPRESSION Do not administer paclitaxel protein-bound particles for injectable suspension (albumin-bound) therapy to patients with baseline neutrophil counts of less than 1,500 cells/mm 3 [see Contraindications (4) ]. Monitor for neutropenia, which may be severe and result in infection or sepsis, it is recommended that frequent [see Warnings and Precautions (5.1 , 5.3) ]. Perform frequent complete blood cell counts on all patients receiving praclitaxel protein-bound particles for injectable suspension (albumin-bound) [see Contraindications (4) , Warnings and Precautions (5.1 , 5.3) ]. WARNING: SEVERE MYELOSUPPRESSION See full prescribing information for complete boxed warning . Do not administer paclitaxel protein-bound particles for injectable suspension (albumin-bound) therapy to patients with baseline neutrophil counts of less than 1,500 cells/mm 3 . ( 4 ) Monitor for neutropenia, which may be severe and result in infection or sepsis. ( 5.1 , 5.3 ) Perform frequent complete blood cell counts on all patients receiving paclitaxel protein-bound particles for injectable suspension (albumin-bound). ( 5.1 , 5.3 )
Contraindications
4 CONTRAINDICATIONS Paclitaxel protein-bound particles for injectable suspension (albumin-bound) is contraindicated in patients with: Baseline neutrophil counts of < 1,500 cells/mm 3 [see Warnings and Precautions (5.1) ] A history of severe hypersensitivity reactions to paclitaxel protein-bound particles for injectable suspension (albumin-bound) [see Warnings and Precautions (5.5) ] Neutrophil counts of < 1,500 cells/mm 3 . ( 4 ) Severe hypersensitivity reactions to paclitaxel protein-bound particles for injectable suspension (albumin-bound). ( 4 )
Pregnancy & Breastfeeding
8.1 Pregnancy Risk Summary Based on its mechanism of action and findings in animals, paclitaxel (albumin-bound) can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] . There are no available human data on paclitaxel (albumin-bound) use in pregnant women to inform the drug-associated risk. In animal reproduction studies, administration of paclitaxel formulated as albumin-bound particles to pregnant rats during the period of organogenesis resulted in embryo-fetal toxicity at doses approximately 2% of the daily maximum recommended human dose on a mg/m 2 basis ( see Data ). Advise females of reproductive potential of the potential risk to a fetus. The background rate of major birth defects and miscarriage is unknown for the indicated population. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data In embryo-fetal development studies, intravenous administration of paclitaxel formulated as albumin-bound particles to rats during pregnancy, on gestation days 7 to 17 at doses of 6 mg/m 2 (approximately 2% of the daily maximum recommended human dose on a mg/m 2 basis) caused embryo-fetal toxicities, as indicated by intrauterine mortality, increased resorptions (up to 5-fold), reduced numbers of litters and live fetuses, reduction in fetal body weight, and increase in fetal anomalies. Fetal anomalies included soft tissue and skeletal malformations, such as eye bulge, folded retina, microphthalmia, and dilation of brain ventricles.
1 interaction on record
Avoid coadministration of relacorilant plus nab-paclitaxel with strong CYP3A inducers. Both are CYP3A substrates; inducers decrease concentrations and may reduce effectiveness.
Source: NLP:relacorilant