Acromegaly Support Group
Acromegaly (from Greek akros "high" and megas "large" - extremities enlargement) is a hormonal disorder that results when the pituitary gland produces excess growth hormone (hGH). Acromegaly most commonly affects middle-aged adults and can result in serious illness and premature death. Join the group to discuss symptoms, diagnosis, and treatments.
This may be a good opportunity for some of you to try this self injectable medication:
Dear Patient:
Tercica, Inc. (A Subsidiary of the Ipsen Group) has launched a study for patients with Acromegaly called "Somatuline Depot (lanreotide) Injection for Acromegaly (SODA)". Somatuline Depot is currently approved in the USA for the long-term treatment of acromegalic patients who have had an inadequate response to, or cannot be treated with, surgery and/or radiotherapy. In this multi-center, open-label observational study, patients with a clinical diagnosis of acromegaly who are prescribed Somatuline Depot will be followed for two years.
To determine if you are able to enroll in the study, please see the following criteria all of which patients must fulfill at enrollment:
The patient must have a clinical diagnosis of acromegaly
The patient must be treated with Somatuline Depot (including patients newly prescribed Somatuline Depot)
The patient or legally authorized representative must be able to understand the protocol and give signed informed consent. Assent from the patient should also be obtained, where appropriate. Signed informed consent and assent must be obtained before any study-related activities are conducted.
Patients with the following conditions at enrollment are not able to enroll in this study:
Symptomatic, untreated biliary lithiasis (gallbladder stones)
Known hypersensitivity to somatostatin analogs or related compounds (e.g., octreotide)
Somatuline Depot should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Number of Patients: Up to 500
Locations: United States
Enrollment: Open. Treating physician must be an Investigator for the study for patients to participate
For more information, please:
Contact: 1-866-TERCICA (837-2422), Option 3, Press 7, leave a message about your interest in this study: Provide information such as a phone number or email address so that someone can contact you in a confidential manner.
Email: mrios@tercica.com
Other Links:
www.clinicaltrials.gov, Search for "SODA"
www.somatulinedepot.com/diagnosed_with_acromegaly.html
www.somatulinedepot.com
IMPORTANT SAFETY INFORMATION
Somatuline Depot (lanreotide) Injection is a somatostatin analog indicated for the long-term treatment of patients with acromegaly who have had an inadequate response to or cannot be treated with surgery and/or radiotherapy.
Lanreotide may reduce gallbladder motility and lead to gallstone formation. Periodic monitoring may be needed. Patients treated with Somatuline Depot may experience hypoglycemia or hyperglycemia. Glucose levels monitoring is recommended and antidiabetic treatment adjusted accordingly. Lanreotide may lead to a decrease in heart rate. Use with caution in at-risk patients.
Patients with moderate and severe renal impairment or moderate and severe hepatic impairment should begin treatment with Somatuline Depot 60mg.
There are no adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human responses, Somatuline Depot should be used during pregnancy only if the potential benefit justifies risk to the fetus. A decision should be made whether to discontinue nursing or discontinue the drug taking into account the importance of the drug to the mother.
Somatuline Depot may decrease the bioavailability of cyclosporine. Cyclosporine dose may need to be adjusted to maintain levels.
Patients receiving beta-blockers, calcium channel blockers, or other drugs that affect heart rate may need dose adjustments. Somatuline Depot may reduce the intestinal absorption of co-administered drugs. Caution should be used.
The most common adverse reactions (incidence >5%) are diarrhea, cholelithiasis, abdominal pain, nausea, injection site reaction, flatulence, arthralgia, and loose stools.
Please see full Prescribing Information for additional important information.
SOMATULINE DEPOT IS MARKETED BY TERCICA, INC. AND MANUFACTURED BY IPSEN PHARMA BIOTECH (SIGNES, FRANCE).
THIS EMAIL IS INTENDED FOR US RESIDENTS ONLY. TERCICA, INC. ALL RIGHTS RESERVED.
Please do not reply directly to this e-mail.
2009 Tercica, Inc.
Legal Notices | Privacy Statement
Tercica, Inc. | 2000 Sierra Point Parkway, Suite 400 | Brisbane, CA 94005
If you would prefer not to receive future messages from this sender, unsubscribe now.
Dear Patient:
Tercica, Inc. (A Subsidiary of the Ipsen Group) has launched a study for patients with Acromegaly called "Somatuline Depot (lanreotide) Injection for Acromegaly (SODA)". Somatuline Depot is currently approved in the USA for the long-term treatment of acromegalic patients who have had an inadequate response to, or cannot be treated with, surgery and/or radiotherapy. In this multi-center, open-label observational study, patients with a clinical diagnosis of acromegaly who are prescribed Somatuline Depot will be followed for two years.
To determine if you are able to enroll in the study, please see the following criteria all of which patients must fulfill at enrollment:
The patient must have a clinical diagnosis of acromegaly
The patient must be treated with Somatuline Depot (including patients newly prescribed Somatuline Depot)
The patient or legally authorized representative must be able to understand the protocol and give signed informed consent. Assent from the patient should also be obtained, where appropriate. Signed informed consent and assent must be obtained before any study-related activities are conducted.
Patients with the following conditions at enrollment are not able to enroll in this study:
Symptomatic, untreated biliary lithiasis (gallbladder stones)
Known hypersensitivity to somatostatin analogs or related compounds (e.g., octreotide)
Somatuline Depot should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Number of Patients: Up to 500
Locations: United States
Enrollment: Open. Treating physician must be an Investigator for the study for patients to participate
For more information, please:
Contact: 1-866-TERCICA (837-2422), Option 3, Press 7, leave a message about your interest in this study: Provide information such as a phone number or email address so that someone can contact you in a confidential manner.
Email: mrios@tercica.com
Other Links:
www.clinicaltrials.gov, Search for "SODA"
www.somatulinedepot.com/diagnosed_with_acromegaly.html
www.somatulinedepot.com
IMPORTANT SAFETY INFORMATION
Somatuline Depot (lanreotide) Injection is a somatostatin analog indicated for the long-term treatment of patients with acromegaly who have had an inadequate response to or cannot be treated with surgery and/or radiotherapy.
Lanreotide may reduce gallbladder motility and lead to gallstone formation. Periodic monitoring may be needed. Patients treated with Somatuline Depot may experience hypoglycemia or hyperglycemia. Glucose levels monitoring is recommended and antidiabetic treatment adjusted accordingly. Lanreotide may lead to a decrease in heart rate. Use with caution in at-risk patients.
Patients with moderate and severe renal impairment or moderate and severe hepatic impairment should begin treatment with Somatuline Depot 60mg.
There are no adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human responses, Somatuline Depot should be used during pregnancy only if the potential benefit justifies risk to the fetus. A decision should be made whether to discontinue nursing or discontinue the drug taking into account the importance of the drug to the mother.
Somatuline Depot may decrease the bioavailability of cyclosporine. Cyclosporine dose may need to be adjusted to maintain levels.
Patients receiving beta-blockers, calcium channel blockers, or other drugs that affect heart rate may need dose adjustments. Somatuline Depot may reduce the intestinal absorption of co-administered drugs. Caution should be used.
The most common adverse reactions (incidence >5%) are diarrhea, cholelithiasis, abdominal pain, nausea, injection site reaction, flatulence, arthralgia, and loose stools.
Please see full Prescribing Information for additional important information.
SOMATULINE DEPOT IS MARKETED BY TERCICA, INC. AND MANUFACTURED BY IPSEN PHARMA BIOTECH (SIGNES, FRANCE).
THIS EMAIL IS INTENDED FOR US RESIDENTS ONLY. TERCICA, INC. ALL RIGHTS RESERVED.
Please do not reply directly to this e-mail.
2009 Tercica, Inc.
Legal Notices | Privacy Statement
Tercica, Inc. | 2000 Sierra Point Parkway, Suite 400 | Brisbane, CA 94005
If you would prefer not to receive future messages from this sender, unsubscribe now.
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