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Plenaxis Drug Description

Plenaxis™
(abarelix) for Injectable Suspension


WARNING
Immediate-onset systemic allergic reactions, some resulting in hypotension and syncope, have occurred after administration of Plenaxis™. These immediate-onset reactions have been reported to occur following any administration of Plenaxis™, including after the initial dose. The cumulative risk of such a reaction increases with the duration of treatment (see WARNINGS). Following each injection of Plenaxis™, patients should be observed for at least 30 minutes in the office and in the event of an allergic reaction, managed appropriately.
Only physicians who have enrolled in the Plenaxis™ PLUS Program (Plenaxis™ User Safety Program), based on their attestation of qualifications and acceptance of prescribing responsibilities, may prescribe Plenaxis™ (See DOSAGE AND ADMINISTRATION and HOW SUPPLIED).
Plenaxis™ is indicated for the palliative treatment of men with advanced symptomatic prostate cancer, in whom LHRH agonist therapy is not appropriate and who refuse surgical castration, and have one or more of the following: (1) risk of neurological compromise due to metastases, (2) ureteral or bladder outlet obstruction due to local encroachment or metastatic disease, or (3) severe bone pain from skeletal metastases persisting on narcotic analgesia.
The effectiveness of Plenaxis™ in suppressing serum testosterone to castrate levels decreases with continued dosing in some patients (see CLINICAL PHARMACOLOGY, Pharmacodynamics). Effectiveness beyond 12 months has not been established. Treatment failure can be detected by measuring serum total testosterone concentrations just prior to administration on Day 29 and every 8 weeks thereafter (see WARNINGS).
DRUG DESCRIPTION



What are the possible side effects of abarelix (Plenaxis)?

In some cases, the use of abarelix has resulted in serious allergic reactions. An allergic reaction may occur after any injection of the medication, including, but not limited to the first dose. Patients should be observed in the doctor's office for at least 30 minutes following each dose so that immediate treatment of an allergic reaction can be obtained if needed.
Other, less serious side effects may be more likely to occur. Talk to your doctor if you experience

hot flashes;
sleep...
Read All Potential Side Effects for Plenaxis »




Abarelix for injectable suspension (Plenaxis™) is a synthetic decapeptide with potent antagonistic activity against naturally occurring gonadotropin releasing-hormone (GnRH). Plenaxis™ inhibits gonadotropin and related androgen production by directly and competitively blocking GnRH receptors in the pituitary. Abarelix is chemically described as acetyl-D-ß-naphthylalanyl- D-4-chlorophenylalanyl-D-3-pyridylalanyl-L-seryl-L- N-methyl-tyrosyl-D-asparagyl-L-leucyl-L-N(e )-isopropyl-lysyl-L-prolyl-D-alanyl-amide. It is initially manufactured as an acetate water complex and converted to a carboxymethylcellulose (CMC) water complex in manufacturing the drug product. The molecular weight for abarelix anhydrous free base is 1416.06. Abarelix for injectable suspension is supplied as a white to off-white sterile dry powder which, when mixed with the diluent, 0.9% Sodium Chloride Injection, USP, becomes a depot suspension intended for intramuscular (IM) injection. The single-dose vial contains 113 mg of anhydrous free base abarelix peptide (net) supplied in an abarelix CMC complex. This complex also contains 19.1 to 31 mg of CMC. After the vial is reconstituted with 2.2 mL of 0.9% sodium chloride injection, 2 mL is administered to deliver a dose of 100 mg of abarelix (net) as the abarelix CMC complex at a pH of 5±1. Last reviewed on RxList: 12/8/2004




Plenaxis Drug Description

Plenaxis™
(abarelix) for Injectable Suspension


WARNING
Immediate-onset systemic allergic reactions, some resulting in hypotension and syncope, have occurred after administration of Plenaxis™. These immediate-onset reactions have been reported to occur following any administration of Plenaxis™, including after the initial dose. The cumulative risk of such a reaction increases with the duration of treatment (see WARNINGS). Following each injection of Plenaxis™, patients should be observed for at least 30 minutes in the office and in the event of an allergic reaction, managed appropriately.
Only physicians who have enrolled in the Plenaxis™ PLUS Program (Plenaxis™ User Safety Program), based on their attestation of qualifications and acceptance of prescribing responsibilities, may prescribe Plenaxis™ (See DOSAGE AND ADMINISTRATION and HOW SUPPLIED).
Plenaxis™ is indicated for the palliative treatment of men with advanced symptomatic prostate cancer, in whom LHRH agonist therapy is not appropriate and who refuse surgical castration, and have one or more of the following: (1) risk of neurological compromise due to metastases, (2) ureteral or bladder outlet obstruction due to local encroachment or metastatic disease, or (3) severe bone pain from skeletal metastases persisting on narcotic analgesia.
The effectiveness of Plenaxis™ in suppressing serum testosterone to castrate levels decreases with continued dosing in some patients (see CLINICAL PHARMACOLOGY, Pharmacodynamics). Effectiveness beyond 12 months has not been established. Treatment failure can be detected by measuring serum total testosterone concentrations just prior to administration on Day 29 and every 8 weeks thereafter (see WARNINGS).
DRUG DESCRIPTION



What are the possible side effects of abarelix (Plenaxis)?

In some cases, the use of abarelix has resulted in serious allergic reactions. An allergic reaction may occur after any injection of the medication, including, but not limited to the first dose. Patients should be observed in the doctor's office for at least 30 minutes following each dose so that immediate treatment of an allergic reaction can be obtained if needed.
Other, less serious side effects may be more likely to occur. Talk to your doctor if you experience

hot flashes;
sleep...
Read All Potential Side Effects for Plenaxis »




Abarelix for injectable suspension (Plenaxis™) is a synthetic decapeptide with potent antagonistic activity against naturally occurring gonadotropin releasing-hormone (GnRH). Plenaxis™ inhibits gonadotropin and related androgen production by directly and competitively blocking GnRH receptors in the pituitary. Abarelix is chemically described as acetyl-D-ß-naphthylalanyl- D-4-chlorophenylalanyl-D-3-pyridylalanyl-L-seryl-L- N-methyl-tyrosyl-D-asparagyl-L-leucyl-L-N(e )-isopropyl-lysyl-L-prolyl-D-alanyl-amide. It is initially manufactured as an acetate water complex and converted to a carboxymethylcellulose (CMC) water complex in manufacturing the drug product. The molecular weight for abarelix anhydrous free base is 1416.06. Abarelix for injectable suspension is supplied as a white to off-white sterile dry powder which, when mixed with the diluent, 0.9% Sodium Chloride Injection, USP, becomes a depot suspension intended for intramuscular (IM) injection. The single-dose vial contains 113 mg of anhydrous free base abarelix peptide (net) supplied in an abarelix CMC complex. This complex also contains 19.1 to 31 mg of CMC. After the vial is reconstituted with 2.2 mL of 0.9% sodium chloride injection, 2 mL is administered to deliver a dose of 100 mg of abarelix (net) as the abarelix CMC complex at a pH of 5±1. Last reviewed on RxList: 12/8/2004




Plenaxis Drug Description

Plenaxis™
(abarelix) for Injectable Suspension


WARNING
Immediate-onset systemic allergic reactions, some resulting in hypotension and syncope, have occurred after administration of Plenaxis™. These immediate-onset reactions have been reported to occur following any administration of Plenaxis™, including after the initial dose. The cumulative risk of such a reaction increases with the duration of treatment (see WARNINGS). Following each injection of Plenaxis™, patients should be observed for at least 30 minutes in the office and in the event of an allergic reaction, managed appropriately.
Only physicians who have enrolled in the Plenaxis™ PLUS Program (Plenaxis™ User Safety Program), based on their attestation of qualifications and acceptance of prescribing responsibilities, may prescribe Plenaxis™ (See DOSAGE AND ADMINISTRATION and HOW SUPPLIED).
Plenaxis™ is indicated for the palliative treatment of men with advanced symptomatic prostate cancer, in whom LHRH agonist therapy is not appropriate and who refuse surgical castration, and have one or more of the following: (1) risk of neurological compromise due to metastases, (2) ureteral or bladder outlet obstruction due to local encroachment or metastatic disease, or (3) severe bone pain from skeletal metastases persisting on narcotic analgesia.
The effectiveness of Plenaxis™ in suppressing serum testosterone to castrate levels decreases with continued dosing in some patients (see CLINICAL PHARMACOLOGY, Pharmacodynamics). Effectiveness beyond 12 months has not been established. Treatment failure can be detected by measuring serum total testosterone concentrations just prior to administration on Day 29 and every 8 weeks thereafter (see WARNINGS).
DRUG DESCRIPTION



What are the possible side effects of abarelix (Plenaxis)?

In some cases, the use of abarelix has resulted in serious allergic reactions. An allergic reaction may occur after any injection of the medication, including, but not limited to the first dose. Patients should be observed in the doctor's office for at least 30 minutes following each dose so that immediate treatment of an allergic reaction can be obtained if needed.
Other, less serious side effects may be more likely to occur. Talk to your doctor if you experience

hot flashes;
sleep...
Read All Potential Side Effects for Plenaxis »




Abarelix for injectable suspension (Plenaxis™) is a synthetic decapeptide with potent antagonistic activity against naturally occurring gonadotropin releasing-hormone (GnRH). Plenaxis™ inhibits gonadotropin and related androgen production by directly and competitively blocking GnRH receptors in the pituitary. Abarelix is chemically described as acetyl-D-ß-naphthylalanyl- D-4-chlorophenylalanyl-D-3-pyridylalanyl-L-seryl-L- N-methyl-tyrosyl-D-asparagyl-L-leucyl-L-N(e )-isopropyl-lysyl-L-prolyl-D-alanyl-amide. It is initially manufactured as an acetate water complex and converted to a carboxymethylcellulose (CMC) water complex in manufacturing the drug product. The molecular weight for abarelix anhydrous free base is 1416.06. Abarelix for injectable suspension is supplied as a white to off-white sterile dry powder which, when mixed with the diluent, 0.9% Sodium Chloride Injection, USP, becomes a depot suspension intended for intramuscular (IM) injection. The single-dose vial contains 113 mg of anhydrous free base abarelix peptide (net) supplied in an abarelix CMC complex. This complex also contains 19.1 to 31 mg of CMC. After the vial is reconstituted with 2.2 mL of 0.9% sodium chloride injection, 2 mL is administered to deliver a dose of 100 mg of abarelix (net) as the abarelix CMC complex at a pH of 5±1. Last reviewed on RxList: 12/8/2004




Plenaxis Drug Description

Plenaxis™
(abarelix) for Injectable Suspension


WARNING
Immediate-onset systemic allergic reactions, some resulting in hypotension and syncope, have occurred after administration of Plenaxis™. These immediate-onset reactions have been reported to occur following any administration of Plenaxis™, including after the initial dose. The cumulative risk of such a reaction increases with the duration of treatment (see WARNINGS). Following each injection of Plenaxis™, patients should be observed for at least 30 minutes in the office and in the event of an allergic reaction, managed appropriately.
Only physicians who have enrolled in the Plenaxis™ PLUS Program (Plenaxis™ User Safety Program), based on their attestation of qualifications and acceptance of prescribing responsibilities, may prescribe Plenaxis™ (See DOSAGE AND ADMINISTRATION and HOW SUPPLIED).
Plenaxis™ is indicated for the palliative treatment of men with advanced symptomatic prostate cancer, in whom LHRH agonist therapy is not appropriate and who refuse surgical castration, and have one or more of the following: (1) risk of neurological compromise due to metastases, (2) ureteral or bladder outlet obstruction due to local encroachment or metastatic disease, or (3) severe bone pain from skeletal metastases persisting on narcotic analgesia.
The effectiveness of Plenaxis™ in suppressing serum testosterone to castrate levels decreases with continued dosing in some patients (see CLINICAL PHARMACOLOGY, Pharmacodynamics). Effectiveness beyond 12 months has not been established. Treatment failure can be detected by measuring serum total testosterone concentrations just prior to administration on Day 29 and every 8 weeks thereafter (see WARNINGS).
DRUG DESCRIPTION



What are the possible side effects of abarelix (Plenaxis)?

In some cases, the use of abarelix has resulted in serious allergic reactions. An allergic reaction may occur after any injection of the medication, including, but not limited to the first dose. Patients should be observed in the doctor's office for at least 30 minutes following each dose so that immediate treatment of an allergic reaction can be obtained if needed.
Other, less serious side effects may be more likely to occur. Talk to your doctor if you experience

hot flashes;
sleep...
Read All Potential Side Effects for Plenaxis »




Abarelix for injectable suspension (Plenaxis™) is a synthetic decapeptide with potent antagonistic activity against naturally occurring gonadotropin releasing-hormone (GnRH). Plenaxis™ inhibits gonadotropin and related androgen production by directly and competitively blocking GnRH receptors in the pituitary. Abarelix is chemically described as acetyl-D-ß-naphthylalanyl- D-4-chlorophenylalanyl-D-3-pyridylalanyl-L-seryl-L- N-methyl-tyrosyl-D-asparagyl-L-leucyl-L-N(e )-isopropyl-lysyl-L-prolyl-D-alanyl-amide. It is initially manufactured as an acetate water complex and converted to a carboxymethylcellulose (CMC) water complex in manufacturing the drug product. The molecular weight for abarelix anhydrous free base is 1416.06. Abarelix for injectable suspension is supplied as a white to off-white sterile dry powder which, when mixed with the diluent, 0.9% Sodium Chloride Injection, USP, becomes a depot suspension intended for intramuscular (IM) injection. The single-dose vial contains 113 mg of anhydrous free base abarelix peptide (net) supplied in an abarelix CMC complex. This complex also contains 19.1 to 31 mg of CMC. After the vial is reconstituted with 2.2 mL of 0.9% sodium chloride injection, 2 mL is administered to deliver a dose of 100 mg of abarelix (net) as the abarelix CMC complex at a pH of 5±1. Last reviewed on RxList: 12/8/2004




Plenaxis Drug Description

Plenaxis™
(abarelix) for Injectable Suspension


WARNING
Immediate-onset systemic allergic reactions, some resulting in hypotension and syncope, have occurred after administration of Plenaxis™. These immediate-onset reactions have been reported to occur following any administration of Plenaxis™, including after the initial dose. The cumulative risk of such a reaction increases with the duration of treatment (see WARNINGS). Following each injection of Plenaxis™, patients should be observed for at least 30 minutes in the office and in the event of an allergic reaction, managed appropriately.
Only physicians who have enrolled in the Plenaxis™ PLUS Program (Plenaxis™ User Safety Program), based on their attestation of qualifications and acceptance of prescribing responsibilities, may prescribe Plenaxis™ (See DOSAGE AND ADMINISTRATION and HOW SUPPLIED).
Plenaxis™ is indicated for the palliative treatment of men with advanced symptomatic prostate cancer, in whom LHRH agonist therapy is not appropriate and who refuse surgical castration, and have one or more of the following: (1) risk of neurological compromise due to metastases, (2) ureteral or bladder outlet obstruction due to local encroachment or metastatic disease, or (3) severe bone pain from skeletal metastases persisting on narcotic analgesia.
The effectiveness of Plenaxis™ in suppressing serum testosterone to castrate levels decreases with continued dosing in some patients (see CLINICAL PHARMACOLOGY, Pharmacodynamics). Effectiveness beyond 12 months has not been established. Treatment failure can be detected by measuring serum total testosterone concentrations just prior to administration on Day 29 and every 8 weeks thereafter (see WARNINGS).
DRUG DESCRIPTION



What are the possible side effects of abarelix (Plenaxis)?

In some cases, the use of abarelix has resulted in serious allergic reactions. An allergic reaction may occur after any injection of the medication, including, but not limited to the first dose. Patients should be observed in the doctor's office for at least 30 minutes following each dose so that immediate treatment of an allergic reaction can be obtained if needed.
Other, less serious side effects may be more likely to occur. Talk to your doctor if you experience

hot flashes;
sleep...
Read All Potential Side Effects for Plenaxis »




Abarelix for injectable suspension (Plenaxis™) is a synthetic decapeptide with potent antagonistic activity against naturally occurring gonadotropin releasing-hormone (GnRH). Plenaxis™ inhibits gonadotropin and related androgen production by directly and competitively blocking GnRH receptors in the pituitary. Abarelix is chemically described as acetyl-D-ß-naphthylalanyl- D-4-chlorophenylalanyl-D-3-pyridylalanyl-L-seryl-L- N-methyl-tyrosyl-D-asparagyl-L-leucyl-L-N(e )-isopropyl-lysyl-L-prolyl-D-alanyl-amide. It is initially manufactured as an acetate water complex and converted to a carboxymethylcellulose (CMC) water complex in manufacturing the drug product. The molecular weight for abarelix anhydrous free base is 1416.06. Abarelix for injectable suspension is supplied as a white to off-white sterile dry powder which, when mixed with the diluent, 0.9% Sodium Chloride Injection, USP, becomes a depot suspension intended for intramuscular (IM) injection. The single-dose vial contains 113 mg of anhydrous free base abarelix peptide (net) supplied in an abarelix CMC complex. This complex also contains 19.1 to 31 mg of CMC. After the vial is reconstituted with 2.2 mL of 0.9% sodium chloride injection, 2 mL is administered to deliver a dose of 100 mg of abarelix (net) as the abarelix CMC complex at a pH of 5±1. Last reviewed on RxList: 12/8/2004





Other reviews about Plenaxis on wordpress

Abarelix-Plenaxis
  by hijadoo
U.S. BRAND NAMES — Plenaxisâ„¢ [DSC]PHARMACOLOGIC CATEGORY Gonadotropin Releasing Hormone AntagonistDOSING: ADULTS — Male prostate cancer: I.M.: 100 mg administered on days 1, 15, 29 (week 4), then […]


Management of advanced prostate cancer: can we improve on androgen deprivation therapy?
  by Sitemaster
An article with this title, just published in the British Journal of Urology, addresses the potential of the development-stage agent degarelix as a superior form of hormonal therapy […]


Degarelix: in prostate cancer
  by Sitemaster
Degarelix is a gonadatropin releasing hormone (GnRH) or luteinizing hormone releasing hormone (LHRH) antagonist currently in development for the management of progressive prostate cancer as a potential alternative […]


Abarelix
  by kanlayanee
Abarelix (Plenaxis)is an injectable gonadotropin-releasing hormone antagonist (GnRH antagonist). It is primarily used in oncology to reduce the amount of testosterone made in patients with advanced symptomatic prostate […]


Understanding the potential of degarelix (and the risks)
  by Sitemaster
A review article and three different sets of editorial comments have just been published in Oncology. They lay out the opinions of several specialists on the potential uses […]


Dictionary of Cancer....(from: NCI)
  by fanymutiacahyani
A type of monoclonal antibody used in cancer detection or therapy. Monoclonal antibodies are laboratory-produced substances that can locate and bind to cancer cells. AAP An enzyme that […]



Other reviews about Plenaxis on web:

© Speciality European Pharma Limited, 16 John Street, London, WC1N 2DL, UK www.plenaxis.com


Learn about the prescription medication Plenaxis (Abarelix), drug uses, dosage, side effects, drug interactions, warnings, reviews and patient labeling. Plenaxis (Abarelix) Drug Information: Uses, Side Effects, Drug ...


Plenaxis (abarelix) is used in the treatment of advanced prostate cancer. Includes Plenaxis side effects, interactions and indications. Plenaxis Information from Drugs.com


Plenaxis (abarelix) patient information. Detailed drug information for the consumer, includes dosage, Plenaxis side effects and more. Plenaxis consumer information from Drugs.com


It belongs to the family of drugs called Gonadotropin-releasing hormone antagonists. It is marketed by Speciality European Pharma as Plenaxis. Plenaxis has received marketing ... Abarelix - Wikipedia, the free encyclopedia


Drug information and side-effects for Plenaxis (abarelix for injectable suspension) Plenaxis (abarelix for injectable suspension) - Drug information ...


What class of treatment is Plenaxis (Abarelix)? This treatment is no longer available. Category: Antineoplastics / Hormones/Antineoplastics. Type: Prescription Plenaxis - Drugs & Treatments - Revolution Health


Plenaxis, a trademark for abarelix. Plenaxis - definition of Plenaxis in the Medical dictionary - by ...


Find patient medical information for Plenaxis IM on WebMD including its uses, side effects and safety, interactions, pictures, warnings and user ratings. Plenaxis IM : Uses, Side Effects, Interactions, Pictures, Warnings ...


Speciality European Pharma (SEP) announced the launch of Plenaxis(R) in Germany. Plenaxis(R) is used to treat advanced and metastatic hormone responsive prostate cancer and it ... Plenaxis(R) Is The First GnRH Antagonist, A New Class Of Hormone ...





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