Teduglutide - (Gattex- @- (Dec 2012)- Gastro-intestinal
Drug Name:Teduglutide - (Gattex- @- (Dec 2012)- Gastro-intestinal
List Of Brands:
Indication Type Description:
Drug Interaction
Indication
Adverse Reaction
Contra-Indications
Dosages/ Overdosage Etc
Patient Information
Pharmacology/ Pharmacokinetics
Pregnancy and lactation
Drug Interaction:
GATTEX has the potential to increase absorption of concomitant oral medications.
Careful monitoring and possible dose adjustment of oral medications that require titration
or have a narrow therapeutic index is recommended.
Indication:
GATTEX (teduglutide [rDNA origin]), for injection, for subcutaneous use
Initial U.S. Approval: 2012
Drug Name- Gattex
Active Ingredient - Teduglutide
To treat adults with short bowel syndrome (SBS) who need additional nuttrition
from intravenous feeding (parentral nutrion)
Indication-
To treat adults with short bowel syndrome(SBS)
Approved by FDA on 21-12--2012 (Ref- FDA approved List- 2012)
Adverse Reaction:
The most common adverse reactions (. 10%) across all studies with GATTEX are
abdominal pain, injection site reactions, nausea, headaches, abdominal distension,
upper respiratory tract infection. In addition, vomiting and fluid overload were
reported in the SBS studies (1 and 3) at rates 10%.
Contra-Indications:
CONTRAINDICATIONS
None
WARNINGS AND PRECAUTIONS.
Neoplastic growth. There is a risk for acceleration of neoplastic growth.
Colonoscopy of the entire colon with removal of polyps should be done before
initiating treatment with GATTEX and is recommended after 1 year.
Subsequent colonoscopies should be done as needed, but no less frequently
than every 5 years. In case of intestinal malignancy discontinue GATTEX.
The clinical decision to continue GATTEX in patients with non-gastrointestinal
malignancy should be made based on risk and benefit considerations.
.
Intestinal obstruction. In patients who develop obstruction, GATTEX should be
temporarily discontinued pending further clinical evaluation and management.
.
Biliary and pancreatic disease. Patients should undergo laboratory assessment
(bilirubin, alkaline phosphatase, lipase, amylase) before starting GATTEX.
Subsequent laboratory tests should be done every 6 months.
If clinically meaningful changes are seen, further evaluation is recommended
including imaging, and continued treatment with GATTEX should be reassessed.
.
Fluid overload.
There is a potential for fluid overload while on GATTEX.
If fluid overload occurs, especially in patients with cardiovascular disease,
parenteral support should be appropriately adjusted, and GATTEX treatment reassessed.
Dosages/ Overdosage Etc:
INDICATIONS AND USAGE
GATTEXR (teduglutide [rDNA origin]) for injection is a glucagon-like peptide-2 (GLP-2) analog indicated for the treatment of adult patients with Short Bowel Syndrome (SBS) who are dependent on parenteral support.
DOSAGE AND ADMINISTRATION-.
The recommended once daily dose of GATTEX is 0.05 mg/kg.
.
Administer by subcutaneous injection; alternate sites between 1 of the 4 quadrants of the
abdomen, or into alternating thighs or alternating arms.
.
For subcutaneous injection only.
.
For single-use only. Use within 3 hours after reconstitution, discard any unused portion
.
50% dosage reduction recommended in patients with moderate to severe renal impairment.
Patient Information:
PATIENT COUNSELING INFORMATION
.
General Counseling Information
1. Prior to treatment, patients should fully understand the risks and benefits
of GATTEX. Ensure that all patients receive the Medication Guide prior
to initiating GATTEX therapy.
2.Advise patients with active gastrointestinal malignancy (GI tract, hepatobiliary,
pancreatic), that GATTEX therapy should be discontinued.
3.In patients with active non-gastrointestinal malignancy, the clinical decision
to continue GATTEX should be discussed with patients and be made based on
risk-benefit considerations.
4.Colorectal polyps.
Advise patients that colonoscopy of the entire colon with removal of polyps
should be done within 6 months prior to starting treatment with GATTEX.
5.A follow-up colonoscopy (or alternate imaging) is recommended at the
end of 1 year of GATTEX.
Subsequent colonoscopies should be done every 5 years or more often
as needed.
6.If a polyp is found, adherence to current polyp follow-up guidelines
is recommended.
7.In case of diagnosis of colorectal cancer, GATTEX therapy should
be discontinued.
8.Small Bowel Neoplasia.
Advise patients that they should be monitored clinically for small bowel neoplasia
If a benign neoplasm is found, it should be removed. In case of small bowel
cancer, GATTEX therapy should be discontinued.
9. Intestinal Obstruction
Advise patients to tell their physician if they experience any signs or symptoms
suggestive of intestinal obstruction. If obstruction is present, the physician should
temporarily discontinue GATTEX.
10. Gallbladder and Bile Duct Disease
Advise patients that laboratory assessments should be done before and then
every 6 months while on GATTEX to monitor gallbladder and biliary function.
11. If clinically significant change occurs, further evaluation (i.e., imaging studies
or other) may be necessary.
12.Advise patients to report to their physician all signs and symptoms suggestive
of cholecystitis, cholangitis, or cholelithiasis while on GATTEX.
13. Pancreatic Disease Advise patients that laboratory assessments should be done before and then every 6 months while on GATTEX.
If clinically significant change occurs, further evaluation (i.e., imaging studies
or other) may be necessary.
14.Advise patients to report to their physician all signs and symptoms suggestive
of pancreatic disease while on GATTEX.
15. Cardiovascular Disease
Advise patients with cardiovascular disease to report to their physician any
signs of fluid overload or cardiac decompensation while on GATTEX.
16. Risks Resulting from Increased Absorption of Concomitant Oral Medication-
Instruct patients to report to all of their physicians any concomitant oral medications
that they are taking in order to assess any potential for increased absorption
during GATTEX treatment of those oral medications requiring titration or with
a narrow therapeutic index.
17. Instructions Inform patients that GATTEX should not be administered
intravenously or intramuscularly
The drug should be used for subcutaneous injection within 3 hours after
reconstitution. Advise patients that subcutaneous administration has
been associated with injection site reactions, but if they experience
a severe reaction including severe rash, they should contact
their physician.
18.Advise patients that while they may experience abdominal pain and swelling
of their stoma especially when starting therapy with GATTEX, if they experience
symptoms of intestinal obstruction, they should contact their physician.
19.Instruct patients to read the Medication Guide as they are starting GATTEX
therapy and to re-read it each time their prescription is renewed.
Pharmacology/ Pharmacokinetics:
1. Mechanism of Action
Teduglutide is an analog of naturally occurring human
glucagon-like peptide-2 (GLP-2), a peptide secreted by L-cells of the distal
intestine. GLP-2 is known to increase intestinal and portal blood flow, and inhibit
gastric acid secretion.
2.Pharmacokinetics
Absorption:
In healthy subjects, GATTEX administered subcutaneously had an absolute
bioavailability of 88% and reached maximum plasma teduglutide
concentrations at 3-5 hours after administration.
No accumulation of teduglutide was observed following repeated subcutaneous
administrations
Pregnancy and lactation:
USE IN SPPECIFIC POPULATIONS
1. Pregnancy Category B
Risk Summary
Adequate and well controlled studies with GATTEX have not been conducted in pregnant
women.
Because animal reproductive studies are not always predictive of human response,
GATTEX should be used during pregnancy only if clearly needed.
2. Nursing Mothers
It is not known whether GATTEX is present in human milk.
Because many drugs are excreted in human milk, because of the potential
for serious adverse reactions to nursing infants from GATTEX , a decision
should be made whether to discontinue nursing or to discontinue the drug,
taking into account the importance of the drug to the mother.
3.Pediatric Use
Safety and efficacy in pediatric patients have not been established.
4. Geriatric Use
No dose adjustment is necessary in patients above the age
of 65 years.
In the SBS studies, no overall differences in safety or efficacy were observed
between these subjects and younger subjects, and other reported clinical
experience has not identified differences in responses between the elderly
and younger patients, but greater sensitivity of some older individuals
cannot be ruled out.
