APIDRYL- (Docetaxel Injection USP)- TAJ PHARMA

Docetaxel Injection USP

Docetaxel belongs to the group of cancer-fighting medications known as antineoplastics, and specifically to the group of antineoplastics known as taxanes. Docetaxel kills cancer cells by interfering with the genetic material DNA, which is necessary for their growth and reproduction.
Docetaxel is used alone or in combination with other antineoplastic medications to treat cancers of the ovary, breast, prostate, or lung. It may also be used to treat head and neck cancer after a previous chemotherapy treatment has failed.

 What the drug is used for:

  •     Approved in treatment of breast cancer, non-small cell lung cancer, advanced stomach cancer, head and neck cancer and metastatic prostate cancer.
  •     Also being investigated to treat small cell lung, ovarian, bladder, and pancreatic cancers, soft tissue sarcoma and melanoma.

How the drug is given?

  • Docetaxel is given through a vein (intravenously, IV).
  • There is no pill form of docetaxel.
  • Premedication with a corticosteroid pill starting a day prior to docetaxel infusion for 3 days    is given to reduce the severity of fluid retention and allergic reactions.  Your doctor will prescribe the exact regimen.
  • The amount of docetaxel that you will receive depends on many factors, including your height and weight, your general health or other health problems, and the type of cancer or condition being treated.  Your doctor will determine your dose and schedule.

Side effects:Important things to remember about the side effects of docetaxel:

  • Most people do not experience all of the side effects listed
  • Side effects are often predictable in terms of their onset and duration
  • Side effects are almost always reversible and will go away after treatment is complete
  • There are many options to help minimize or prevent side effects
  • There is no relationship between the presence or severity of side effects and the effectiveness of the medication.
  • The side effects of docetaxel and their severity depend on how much of the drug is given.  In other words, high doses may produce more severe side effects).

The following side effects are common (occurring in greater than 30%) for patients taking docetaxel.

  • Low white blood cell count.  (This can increase your risk for infection)
  • Low red blood cell count (anemia)
Nadir: Meaning low point, nadir is the point in time between chemotherapy cycles in which you experience low blood counts.
  • Onset: 4-7 days
  • Nadir: 5-9 days
  • Recovery: 21 days

Fluid retention with weight gain, swelling of the ankles or abdominal area.

These side effects are less common, meaning they occur in 10-29 percent of patients receiving docetaxel:

  • Vomiting
  • Muscle/bone/joint pain (myalgias and arthralgias).
  • Low platelet count (This can increase your risk of bleeding).
  • Increases in blood tests measuring liver function.  These return to normal once treatment is discontinued.
Infusion-related side effects (symptoms which may occur during the actual treatment) include:
  • Allergic reactions (rash, flushing, fever, lowered blood pressure).  Happens rarely, usually occurs in the first or second infusion.  Frequency is reduced by premedication with corticosteroid starting one day before infusion.  You will be monitored closely during the infusion for any signs of allergic reaction.
  • Infusion site reactions (uncommon and generally mild, consist of darkening of the vein, inflammation, redness or dryness of the skin, or swelling of the vein).These highlights do not include all the information needed to use Apidryl® safely and effectively. See full prescribing information for Apidryl®.Apidryl® (docetaxel) Injection Concentrate, Intravenous Infusion (IV).
  • WARNING: TOXIC DEATHS, HEPATOTOXICITY, NEUTROPENIA, HYPERSENSITIVITY REACTIONS, and FLUID RETENTION
    See full prescribing information for complete boxed warning
    – Treatment-related mortality increases with abnormal liver function, at higher doses, and in patients with NSCLC and prior platinum-based therapy receiving Apidryl® at 100 mg/m2.
    – Should not be given if bilirubin > ULN, or if AST and/or ALT > 1.5 × ULN concomitant with alkaline phosphatase > 2.5 × ULN. LFT elevations increase risk of severe or life-threatening complications.
    Obtain LFTs before each treatment cycle.
    – Should not be given if neutrophil counts are < 1500 cells/mm3. Obtain frequent blood counts to monitor for neutropenia.
    – Severe hypersensitivity, including very rare fatal anaphylaxis, has been reported in patients who received dexamethasone premedication. Severe reactions require immediate discontinuation of
    Apidryl® and administration of appropriate therapy.
    – Contraindicated if history of severe hypersensitivity reactions to Apidryl® or to drugs formulated with polysorbate 80.
    – Severe fluid retention may occur despite dexamethasone.INDICATIONS AND USAGEApidryl® is a microtubule inhibitor indicated for:
    – Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC.
    – Non-Small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC.
    – Hormone Refractory Prostate Cancer (HRPC): with prednisone in androgen independent (hormone refractory) metastatic prostate cancer.
    – Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction.
    – Squamous Cell Carcinoma of the Head and Neck Cancer (SCCHN): with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN.

    DOSAGE AND ADMINISTRATION
    Administer in a facility equipped to manage possible complications (e.g., anaphylaxis). Administer intravenously (IV) over 1 hr every 3 weeks. PVC equipment is not recommended.
    – BC locally advanced or metastatic: 60 mg/m2 to 100 mg/m2 single agent.
    – BC adjuvant: 75 mg/m2 administered 1 hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 every 3 weeks for 6 cycles.
    – NSCLC: after platinum therapy failure: 75 mg/m2 single agent.
    – NSCLC: chemotherapy-naive: 75 mg/m2 followed by cisplatin 75 mg/m2.
    – HRPC: 75 mg/m2 with 5 mg prednisone twice a day continuously.
    – GC: 75 mg/m2 followed by cisplatin 75 mg/m2 (both on day 1 only) followed by fluorouracil 750 mg/m2 per day as a 24-hr IV (days 1–5), starting at end of cisplatin infusion.
    – SCCHN: 75 mg/m2 followed by cisplatin 75 mg/m2 IV (day 1), followed by fluorouracil 750 mg/m2 per day as a 24-hr IV (days 1–5), starting at end of cisplatin infusion; for 4 cycles.

    – SCCHN: 75 mg/m2 followed by cisplatin 100 mg/m2 IV (day 1), followed by fluorouracil 1000 mg/m2 per day as a 24-hr IV (days 1–4); for 3 cycles.
    For all patients: Premedicate with oral corticosteroids.
    Adjust dose as needed.

    DOSAGE FORMS AND STRENGTHS
    Two vial Apidryl®:
    80 mg/2 mL and Diluent for Apidryl® 80 mg,
    20 mg/0.5 mL and Diluent for Apidryl® 20 mg.

    1. INDICATIONS AND USAGE

    1.1 Breast Cancer
    Apidryl® is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy. Apidryl® in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with operable node-positive breast cancer.
    1.2 Non-Small Cell Lung Cancer Apidryl® as a single agent is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior platinum-based chemotherapy. Apidryl® in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small cell lung cancer who have not previously received  chemotherapy for this condition.
    1.3 Prostate Cancer Apidryl® in combination with prednisone is indicated for the treatment of patients with androgen independent (hormone refractory) metastatic prostate cancer.
    1.4 Gastric Adenocarcinoma Apidryl® in combination with cisplatin and fluorouracil is indicated for the treatment of patients with advanced gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for advanced disease.
    1.5 Head and Neck Cancer
    Apidryl® in combination with cisplatin and fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN).

    2. DOSAGE AND ADMINISTRATION
    For all indications, toxicities may warrant dosage adjustments.
    Administer in a facility equipped to manage possible complications (e.g. anaphylaxis).

    Tell your doctor if you have any side effect that bothers you or does not go away.
    These are not all the possible side effects of Apidryl®. For more information ask your doctor or pharmacist. Call your doctor for medical advice about side effects.
    You may report side effects to FDA

    Apidryl® Injection Concentrate

    (generic name = docetaxel)(pronounced as API-D-DRYL)

    Apidryl® is a medication to treat breast cancer, non-small cell lung cancer and prostate cancer. It has severe side effects in some patients. This leaflet is designed to
    help you understand how to use Apidryl® and avoid its side effects to the fullest extent possible. The more you understand your treatment, the better you will be able to participate in your care. If you have questions or concerns, be sure to ask your doctor or nurse. They are always your best source of information about your condition and treatment.

    WARNING
    Apidryl® (docetaxel) Injection Concentrate
    should be administered under the supervision of a qualified physician experienced in the use of antineoplastic agents. Appropriate managementof complications is possible only when adequate diagnostic and treatment facilities are readily available. The incidence of treatment-related mortality associated with Apidryl® therapy is increased in patients with abnormal liver function, in patients receiving higher doses, and in patients with non-small cell lung carcinoma and a history of prior treatment with platinum-based chemotherapy who receive Apidryl® as a single agent at a dose of 100 mg/m2(see WARNINGS).
    Apidryl® should generally not be given to patients with bilirubin > upper limit of normal(ULN), or to patients with SGOT and/or SGPT >1.5 x ULN concomitant with alkaline phosphatase > 2.5 x ULN. Patients with elevations of bilirubin or abnormalities of transaminase concurrent with alkaline phosphatase are at increased risk for the development of grade 4 neutropenia, febrile neutropenia, infections, severe thrombocytopenia, severe stomatitis, severe skin toxicity, and toxic death. Patients with isolated elevations of transaminase > 1.5 x ULN also had a higher rate of febrile neutropenia grade 4 but did not have
    an increased incidence of toxic death. Bilirubin, SGOT or SGPT,and alkaline phosphatase values should be obtained prior to each cycle of Apidryl® therapy and reviewed by the treating physician.
    Apidryl® therapy should not be given to patients with neutrophil counts of < 1500 cells/mm3.
    In order to monitor the occurrence of neutropenia, which may besevere and result in infection,frequent blood cell counts should be performed on all patients receiving Apidryl®.
    Severe hypersensitivityreactions characterized by hypotension and/or bronchospasm,orgeneralizedrash/erythema occurred in 2.2% (2/92) of patients who received the recommended 3-day dexamethasone premedication.
    Hypersensitivity reactions requiring discontinuation of the Apidryl® infusion were reported in five patients who did not receive premedication. These reactions resolved after discontinuation of the infusion and the
    administration of appropriatetherapy. Apidryl® must not be given to patientswho have a history of severe hypersensitivity reactions to Apidryl® or to other drugs formulated with polysorbate 80 (see WARNINGS ).
    Severe fluid retention occurred in 6.5% (6/92) of patients despite use of a 3-day dexamethasone premedication regimen.

    It was characterized by one or more of the following events: poorly tolerated peripheral
    edema, generalized edema,pleural effusion requiring urgent drainage,
    dyspnea at rest, cardiac tamponade, or pronounced abdominal distention (due to ascites) (seePRECAUTIONS).

    Apidryl® Docetaxel Injection
    Category: Anticancer
    Each vial contains:- Docetaxel….. 20mg, 80 mg and 120mg
    Quality Specification:
    Chromatographic Purity: NLT 99.5%

    Composition : 20mg/0.5 ml, 80mg/2ml, & 120mg/3ml

    Indication : Cancer : Breast, non-small cell lung cancer, prostate, bladder, stomach, Esophagus, overy,head and neck.
    Dosage :-Administered parenterally. The dose should be individualized depending on the size of the patient and whether or not other medicines are also being taken. Adults: 60 to 100 mg /1.73 ml intravenously.
    Contra Indications :-Hypersensitivity , alcohol abuse or history of, chickenpox, herps zoster, fluid in lungs, infection , liver disease.
    Special Precautions :-    Immunization specifically persons living in the patient’s household should not take oral polio vaccine.
    Paediatrics :Only limited studies are done.
    Pregnancy :-Contraindicated.
    Lactation :-Generally not recommended.
    Elderly :-Use with caution.

    General information about Apidryl®

    Apidryl ® that is written for healthcare professionals.
    Dosage :-1.2-2.4 mg/kg body wt or 60-75 mg/sq metre of body surface given as a single dose every 3 week by slow i.v. inj. Contra Indications :-    Cardiac disease. Hepatic dysfunction.
    Special Precautions :- ECG changes, arrhythmias, hypotension, or be delayed congestive heart failure. Paediatrics :Reduced dose necessary. Pregnancy :-Not usually prescribed.
    Lactation :-    Not prescribed. Elderly :-    Reduced dose may be necessary. Side Effects :-Cardiotoxicity, alopecia, Bone marrow depression, alopecia, cardiomyopathy, stomatitis, vomiting and local tissue damage.
    Drug Interactions :-Cyclosporin, cardiotoxic agents potentiates the cardiotoxicity.

    Purity : Not less than 99%.

    Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. This Patient Information leaflet summarizes the most important information about Apidryl ®.
    If you would like more information, talk with your doctor.

    You can ask your pharmacist or doctor for information about. *** Please consult local Prescribing Information for any product before use. This website is an international information resource for healthcare professionals with an interest in disease management. This website is not intended to replace the advice of a qualified healthcare professional. Above brand is a trademark of the Taj group of companies (Taj Pharmaceuticals Limited).
    Copyright © 2004-2014 Taj Pharmaceuticals Limited. All rights reserved. Legal Notice
    The products discussed herein may have different product labeling in different countries. The product information
    provided in this site is intended only for the residents of India.