Dosing & Uses
Dosage Forms & Strengths
powder for injection
Metastatic or locally advanced
After failure to anthracyclines
Monitor: CBC, LFTs
Give H1-blocker and H2-blocker 1 hour prior to infusion
If patient had hypersensitivity to drug in prior infusion, also premedicate with corticosteroid
Increase dose 1 week after inhibitor discontinuation
AST/ALT <2.5 times upper limit of normal and Bilirubin < 1 time upper limit of normal: 40 mg/m²
AST/ALT <10 times upper limit of normal and Bilirubin < 1.5 times upper limit of normal: 32 mg/m²
AST/ALT <10 times upper limit of normal and Bilirubin 1.5-3 times upper limit of normal: 20-30 mg/m²
Do NOT use with capecitabine if AST/ALT >2.5 times upper limit of normal or bilirubin >1 time upper limit of normal
Monotherapy not recommended if AST/ALT >10 times upper limit of normal or bili >3 times upper limit of normal
Safety and efficacy not established
Serious - Use Alternative
Significant - Monitor Closely
Inflammatory disease of mucous membrane (19%)
Abdominal pain (13%)
Nail changes (9%)
Hand-foot syndrome (8%)
Gastroesophageal reflux disease
Frequency Not Defined
Left ventricular cardiac dysfunction
Hypersensitivity reaction (severe)
Black Box Warnings
This drug in combination with capecitabine is contraindicated in patients with AST or ALT > 2.5 times the upper limit of normal (ULN) or bilirubin >1 times ULN due to increased risk of toxicity and neutropenia-related death
History of hypersensitivity to Cremophor EL or its derivatives
ANC <1.5 K/m³ or Platelets <100 K/m³
Ixabepilone/capecitabine combo contraindicated if AST/ALT >2.5 times ULN or bilirubin >1 time ULN
Risk of usual chemotherapy ADRs (esp peripheral neuropathy and myelosuppression)
Avoid grapefruit juice
Strong CYP3A4 inducers (eg, rifampin) decrease ixabepilone AUC by 43% compared to ixabepilone treatment alone
History of cardiac disease
May cause neuropathy, primarily sensory; neuropathy is cumulative, generally reversible, and should be managed by dose adjustment and delays
Pregnancy & Lactation
Pregnancy Category: D
Lactation: not known if excreted in breast milk, do not nurse
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.
Mechanism of Action
Microtubule inhibitor of epothilone group; promotes tubulin polymerization and stabilizes microtubular function, causing cell cycle (G2/M) arrest and subsequently apoptosis
Half-life elimination: 52 hr
Peak plasma time: 3 hr
Protein bound: 67-77%
Vd: >1000 L
Metabolism: Liver CYP3A4
Excretion: Feces (65%); urine (21%)
If kit refrigerated, warm kit at room temp for 30 min (dissolves precipitate in diluent if any and produces clear diluent)
Reconstitute vials with supplied diluent: 15 mg with the 8 mL diluent; 45 mg with the 23.5 mL diluent (final conc 2 mg/mL)
Aseptically withdraw diluent and add to drug vial; swirl and invert to completely dissolve
Reconstituted solution stable for 1 hr at room temp and light
Dilute further in LR ~250 mL in DEHP-free bag
Stable for up to 6 hr at room temp and light (including 3 hr infusion time, ie upto 3 hr idle storage+3 hr infusion)
Use 0.2-1.2 micron inline filter
Use DEHP-free infusion apparatus
Infuse over 3 hr
Store original kit refrigerated and unopened
To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.
Adding plans allows you to:
- View the formulary and any restrictions for each plan.
- Manage and view all your plans together – even plans in different states.
- Compare formulary status to other drugs in the same class.
- Access your plan list on any device – mobile or desktop.
The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.
|1||This drug is available at the lowest co-pay. Most commonly, these are generic drugs.|
|2||This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.|
|3||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.|
|4||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.|
|5||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.|
|6||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.|
|NC||NOT COVERED – Drugs that are not covered by the plan.|
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
Select a box to add or remove a plan.
Select a class to view formulary status for similar drugs