Drug Interaction:
Drug interactions - summary
+ Ixabepilone
Azole antifungals ( fluconazole , itraconazole, ketoconazole, voriconazole )
coadministration increased ixabepilone AUC . Consider dose reduction.
Monitor closely for toxicities
Carbamaxepine
Carbamazepine may decrease ixabepilone concentration, leading to subthrapeutic levels
Delavirdine
Delavirirdine may increase ixabepilone concnentration. Avoid co-administration
Dexamethasone
Dexamethasone may decrease ixabepilone concentration. leading to subtherapeutic levels
Macrolide antibiotics ( clarithromycin, erythromycin ) macrolides may increase ixabipilone concentration. Avoid co-administration
Nefazodone
Mefazodone may increase ixabepilone concentration. Avoid co-administration
Penobarbital
Phenibarbital may decrease ixabeilone concentration, leading to subtherapeutic levels
Phenytoin
Phenytoin may decrease ixabepilone conentration,leading to subtherapeutic levels
Rifamycins ( rifabutin, rifampin )
Rifamycin may decrease ixabepilone conentration,leading to subtherapeutic levels
Telithromycin
Telithromycin may increase ixabepilone concentration and should be avoided
Verapramil
Verapramil may increase ixabepilone plasma concentration. Use caution and monitor toxicites
Indication:
U.S.FDA APPROVED DRUGS FROM 01-01-08 TO 31-12-08
Drug name Indication Date of Approval
192. Ixabepilone lyophillised powder for Inj 13-09-08
15mg/45mg per vial
In combination with capecitabine for the treatment
of patients with metastatic or locally advanced
breast cancer resistent to treatment with an
anthracyline and a taxine, or whose cancer is
taxane resistent and for whom further antracycline
therapy is contraindicated
222. Ixabepilone lyophillized powder 09-10-08
(Addl.Indication)
As a montherapy for the treatment of metastic or
locally advanced breast cancer in patients whose
tumors are resistent to cytotoxic chemotherapy,
Previuos therapy should have included as anthracycline,
a taxane,and capecitabine
Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
1.Ixabepilone Lyophilized 09-10-2008
Powder (Addl.Indcn.)
As monotherapy treatment of metastatic or locally advanced breast cancer
in patients whose tumors are resistent or refractory to cytotoxic chemotherapy
Previous therapy should have included as anthracycline, a taxane and
capecitabine
2.Ixabepilone Lyophilized 15-09-2008
Powder Inj. 15mg/45mg per vial
In combination with Capacitabine for the treatment of patients with
metastatic or locally advanced breast cancer resistent to treatment
with Anthracycline and a Taxane , or whose cancer is taxane resistent
and for whom further anthracycline therapy is contraindicated
Breast cancer
Adverse Reaction:
Most common adverse reactions- ( 15% )
alpoecia, diarhea, fatigue/asthenia, musculoskeletal pain, nause and vomiting.
Cardiovascular-
dizziness 6% fatigue/asthenia 55% sensory neuropathy 60%
Dermatologic
Alopecia 25% nail disorder 20% Palmar -plantar syndrome 55% skin hyperpigmentation 9%
GI
Abdominal pain 20% anorexia 30% constipation 20% diarrhea 40%
Musculoskeletal
Muscular pain 20% myalgia 30%
Contra-Indications:
Hypersensitivity reactions to the components
Special Precautions/warnings
Peripheral neuropathy-
Monitor patients treated with ixbepilone for symptoms of neuropathy, burning sensation,
hyperesthesia, parathesia, discomfort or neuropathic pain.
Mylosuppression-
Myelosuppression is dose related and primarily manifested as neutropenia
Patients who experience severe neutropenia should have the dose reduced
Hypersensitivity reactions- do not treat treat patients with a history of hypersensitivity
reactions to agents containing ployoxyethylated castor oil with ixabepilone.
Premeditate all patients with H1 and H2 antagonist approximately 1 hour before ixabepilone
infusion and observe for hypersensitivity reactions
Pregnancy
If the patient becomes pregnant while taking this drug appraise the patient of the potential
hazard to the fetus.
Lactation-
Decide whether to discontinue the drug or the breast feeding taking into the importance
of the drug to the mother.
Children -
Safety and effectiveness of ixabepilone in children have not been established.
Elderly -
Few toxicity related deaths occurred in patients 65 years of age with normal baseline hepatic function or mild impairment
Monitoring-
Monitor patients treated with ixbepilone for symptoms of neuropathy, burning sensation,
hyperesthesia, parathesia, discomfort or neuropathic pain.
Dosages/ Overdosage Etc:
Indication-
Breast cancer
Dosage-
40mg/m2 administered intravenously IV over 3 hours every 3 weeks.
Doses for patients with body surface area greater than 2,2m2 should be calculated
based on 2.2m2
Patient Information:
1. Advice patients to report to their doctor about any numbness , tingling of the hands or feet.
2. Inform your Doctor if the fever of 100F or more or other evidence of potential infection,
such as chills, cough or burning on urination develops.
3. Inform your doctor if you experience urticaria, pruritus, rash, flushing, swelling , chest tightness, or hypersensitivity related reactions.
4. Inform your doctor if you have chest pain, difficulty in breathing ,palpitations, or unusual weight gain
Pregnancy and lactation:
Pregnancy
If the patient becomes pregnant while taking this drug appraise the patient of the potential
hazard to the fetus.
Lactation-
Decide whether to discontinue the drug or the breast feeding taking into the importance
of the drug to the mother.
Children -
Safety and effectiveness of ixabepilone in children have not been established.
Elderly -
Few toxicity related deaths have occurred in patients 65 years of age with normal baseline hepatic function or mild impairment
Manufacturer Details