Drug Interaction:
Antineuoplastic agents include-
Interferon ALFA 2a, Interferon ALFA -2b, Interferon ALFA -n3, Levamisole, Altretamine, Cladribine, Hydroxyurea, Aldesleukin, Paclitaxel, Docetaxel,Tretinion, Procarbazine,Dacarbazine, Gemcitabine, Mitotane, Asparaginase, Pegaspargase,Porfimer Sodium
Interacting drugs
Paciltaxel +-
Cisplatin- decrease in Placitaxel clearance
Ketaconazole- use caution while treating patients receiving concurrent Ketoconazole
Indication:
Approved by FDA in December 1992
U.S.FDA APPROVED DUGS FROM 01-01-08 TO 31-12-08
Drug name Indication Date of Approval
21. Paclitaxel nanoparticle Solution 22-01-08
for Injection
(Addl.indication)
Ovarian cancer,non-small cell lung cancer, and AIDS related
Kaposis Sarcoma
237. Paclitaxel inj. 30/100/300mg vial 08-11-08
(Addl.Indication)
For the treatment of advanced gastric carcinoma
U.S FDA APPROVED DRUGS DURING 2006
111. Paciltaxel nanoparticle inj (20mg/ml) 23-08-2006
For metastatic breast cancer
144. Paclitaxel (protein bound particle) 11-10-07
for injectable suspension
(paclitaxel (100mg) +
Albumin Human 900mg per 20ml
For breast cancer after failure of combination
chemotherapy for metastatic disease or relapse
within 6 months of adjuvant chemotherapy
ABRAXANE® for Injectable Suspension (paclitaxel protein-bound particles
for injectable suspension) (albumin-bound)
Initial U.S. Approval: 2005
WARNING: NEUTROPENIA
See full prescribing information for complete boxed warning.
Do not administer ABRAXANE therapy to patients with
baseline neutrophil counts of less than 1,500 cells/mm3. (4)
It is recommended that frequent peripheral blood cell counts be performed to monitor
the occurrence of bone marrow suppression. (4, 5.1, 6.1, 6.2, 6.3)
DO NOT SUBSTITUTE FOR OR WITH OTHER PACLITAXEL
FORMULATIONS.
RECENT MAJOR CHANGES
Indications and Usage (1.3) 09/2013
Dosage and Administration (2.3, 2.5) 09/2013
Warnings and Precautions, Hematologic Effects (5.1),
Nervous System (5.2), Sepsis (5.3), Pneumonitis (5.4) 09/2013
Paclitaxel Injection concentrate for Nanodispersion 100mg and 300mg ( Additional dosage)
Indication -
Treatment of Breast Cancer after failure of combination therapy
metastatic disease or relapse within six months of adjuvant chemotherapy .
Prior therapy should have included an anthracycline unless clinically contraindicated
Approved by FDA on 22-01-14 (Ref- FDA approved List- 2014)
Proprietary Name- ABRAXENE*
Established Name- Pacitaxel-Protein Bound Particles
Applicant- ABRAXIS BIO-SCIENCE LLC (CELGINE CORPN.)
Indication- In combination with Gemcitabine for the first-line treatment of
patients with metastatic adenocarcinoma of the pancreas
Approval Date- September 6,2013
Approved by U.S.FDA (Ref- FDA approved List- 2013)
Antineuoplastic agents include-
Interferon ALFA 2a, Interferon ALFA -2b, Interferon ALFA -n3, Levamisole, Altretamine, Cladribine, Hydroxyurea, Aldesleukin, Paclitaxel, Docetaxel,Tretinion, Procarbazine,Dacarbazine, Gemcitabine, Mitotane, Asparaginase, Pegaspargase,Porfimer Sodium
Metastatic carcinoma of ovary .
Approved by FDA in December 1992
New Drugs Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
1.Paclitaxel injection Anti-cancer August 1994
2.Paclitaxel Injection 24-02-2011
30mg/100mg/300mg
Addl.Indn.
Advanced squmous cell carcinoma of Head and Neck Scchn
i. Diagnosed but Unrectable Locally Advanced Scchn
ii. Recurrent Scchn, if surgery or radiation is not feasible
iii.Palliative treatment metastatic Scchn
3.Pacitaxel (Protein Bound) Particle 11-10-2007
for Injectable suspension
Paclitaxel 100mg
+ Albumin Human 900mg per 20mg
For breast cancer after failure of combination Chemotherapy for
Metastatic disease or relapse within 6 months of Adjuvant
Chemotherapy
4.Paclitaxel Injection 08-11-2008
30/100/300mg vial
Addl.Indcn.
For the treatment of advanced Gastric Carcinoma
5.Paclitaxel Nanoparticle Inj 23-08-2006
20mg/ml
For Metastatic Breast Cancer
6.Paclitaxel Injection Concentrate 22-01-2014
for Nanodispersion 100mg and 300mg
Addl.Dosage Form
For the treatment of Breast Cancer after Failure of combination
therapy. Metastatic disease or relapse within 6 months of
Adjuvant chemotherapy. Prior Therapy should have included
an Anthracycline unless clinically contraindicated
7.Paclitaxel nanoparticle Solution 22-01-2008
For Injection 20mg/ml
Addl.Indn
Ovarian cancer, Non-small cell Lung Cancer and AIDS
related Kaposis Sarcoma
Patent Expiry Date of drugs (Ref - IDMA Publication)
Chemical Category Manufacturer/ US Patent
Ingredient- Marketer Expiration Date
Paclitaxel Cancer/Oncology Bristol-Meyer Squibb 03-08-2012
Paclitaxel Cancer/Oncology Bristol-Meyer Squibb 04-08-2004
Patient Information:
Ref - USP PDI Vol II 17th Edition (1997)
PACLITAXEL - Systemic
1.Allergies-
Tell your doctor if you have ever had any unusual or allergic reaction to
paclitaxel.
2.Pregnancy-
Tell your doctor if you are pregnant or intend to become pregnant. Studies
in rats and rabbits have shown that paclitaxel cause miscarriage and
death of the fetus, as well as problems in the mother.
3. Breast-feeding-
It is known whether placlitaxel passes into breast milk. However because
this medicine may cause serious side effects breast-feeding is generally
not recommended while you are receiving it.
4.Children-
There is no specific information comparing use of placlitaxel in children
with use in other age groups.
5.Older adults-
This medicine has been tested in a limited number of patients and has
not shown to cause different side effects or problems in older people,
than it does in younger adults.
6. Other medicines-
Tell your doctor if you are using any of the following -
Amphotericin B or
Azathioprine or
Chloramphenicol or
Colchicine or
Flucytosine or
Gangiciclovir or
Pilcamycin or
Zidovudine or
If you have ever been treated with x-rays in cancer medicines -
Paclitaxel may increase the effect of these medicines
7. Other medical problems-
Make sure you tell your doctor if you have any other medical problems
especially-
Chickenpox or
Herpes zoster - risk of severe disease affecting other parts of the body
Heart rhythm problems- may be made worse by paclitaxel
Infection- Paclitaxel may decrease your bodys ability to fight
infection
Pharmacology/ Pharmacokinetics:
Drug Facts And Comparisons(2010)
Pharmacology:
Paclitaxel is a natural product with antitumor activity. It is a novel antimicrotubule agent that
promotes the assembly of microtubules from tubulin dimers and stabilises microtubules by preventing depolymerization.
Pharmacokinetics:
Following IV admin the drug exhibits a biphase decline in plasma concentrations. The initial rapid decline represents distribution to the pripheral compartment and significant eliminatin of the drug.
Summary of Paclitaxel Pharmacokinetics Parameters(Mean Values)
Dose Infusion Patients Cmax AUC t 1/2 CL
(mg/m2) duration (n) (ng/ (ng*h/mL) (h) (L/h/m2)
(h)
135 24 2 195 6300 52.7 21.7
175 24 7 365 7993 15.7 23.8
135 3 7 2170 7952 13.1 17.7
175 3 5 3650 15007 20.2 12.2
Manufacturer Details