Mar 21, FORTEO safely and effectively. See full prescribing information for FORTEO. FORTEO (teriparatide [rDNA origin] injection) for subcutaneous. FORTEO safely and effectively. See full prescribing information for. FORTEO. FORTEO (teriparatide [rDNA origin] injection) for subcutaneous use. Initial U.S. Mar 21, FORTEO (teriparatide [rDNA origin] injection) for subcutaneous use See full prescribing information for complete boxed warning. • In rats.
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FORTEO® is a prescription medication used for patients with osteoporosis at high risk for FORTEO information and injection training; Insurance investigation . risk of fracture in men. †Consistent with the FORTEO prescribing information, fracture data in patients with glucocorticoid-induced osteoporosis are not shown. updates to the Prescribing Information for FORTEO (teriparatide [rDNA origin] The label includes information regarding the new indication for the treatment of.
Serious allergic reactions have been reported. Before you take FORTEO, you should tell your healthcare provider if you have a bone disease other than osteoporosis, have cancer in your bones, have trouble injecting yourself and do not have someone who can help you, have or have had kidney stones, have or have had too much calcium in your blood, take medications that contain digoxin Digoxin, Lanoxicaps, Lanoxin , or have any other medical conditions. You should also tell your healthcare provider, before you take FORTEO, if you are pregnant or thinking about becoming pregnant.
You should not do both. FORTEO can cause serious side effects including a decrease in blood pressure when you change positions.
Some people feel dizzy, get a fast heartbeat, or feel faint right after the first few doses. For the first few doses, take your injections of FORTEO in a place where you can sit or lie down right away if you get these symptoms. Tell your healthcare provider if you have nausea, vomiting, constipation, low energy, or muscle weakness.
These may be signs there is too much calcium in your blood. Common side effects of FORTEO include nausea, joint aches, pain, leg cramps, and injection site reactions including injection site pain, swelling and bruising. You are encouraged to report negative side effects of Prescription drugs to the FDA.
Visit www. However, some issues remained outstanding, including a the reliance on an indirect comparison across placebo-controlled trials to infer the superiority claim for teriparatide over alendronate rather than a head-to-head randomised trial; b use of the results of the post hoc sub-group analysis in place of the overall ITT results for teriparatide in the clinical conclusions and the economic model; and c the continuing use of the same utilities and disutilities, as previously, in the model where the sensitivity analyses indicate the model is sensitive to the assumptions used to derive the incremental utility estimates from the trial-based outcome measures.
Overall, the PBAC was concerned that no further fracture outcome trials have been performed with teriparatide since the conclusion of the GHAC trial which might otherwise have helped address the important residual uncertainties.
The PBAC noted the submission had appropriately chosen alendronate as the comparator.
The Committee further noted that the submission had compared the results of the high risk group for teriparatide with the overall trial population for alendronate, in the absence of the available data for the high risk group for alendronate.
The PBAC noted that although the tests for interaction between baseline fracture severity and treatment effect for the GHAC trial groups indicate that there is a statistically significant difference in absolute risk between the high risk sub-group and the remainder of the trial population, however, as previously, there was no statistically significant difference for the relative risk which is used in the modelled economic evaluation across the two sub-groups.
The PBAC concluded, as previously, that the relative risk results of the overall trial population applied to the different baseline risk of the high-risk sub-group should form the basis of any clinical or economic evaluation.
The PBAC did not accept the statistical arguments presented by the submission to support a claim of a treatment effect modification, which would validate the use of the high-risk sub-group.
How do I travel with FORTEO?
Furthermore, no evidence was submitted to suggest any biologically plausible reason that teriparatide is more effective in the high risk sub-group than in the overall trial population. Although a biologically plausible argument could be mounted that alendronate may be less effective in the high risk sub-group because of a lower bone turnover associated with loss of bone architecture in this sub-group, as noted above, the submission did not rely on using the results of a sub-group analysis in place of the overall trial population results for alendronate in its modelled economic evaluation.
As noted previously, the submission again sought to base its biological plausibility arguments on the different mechanisms of action of the two alternative drugs. The PBAC concluded that although this might be relevant to the question of differential treatment effects across the drugs, it is irrelevant to the question here of the biological plausibility of the one drug teriparatide having an increasing relative treatment effect as baseline fracture severity worsens.
The PBAC therefore rejected the submission because of uncertain clinical benefit and the resulting uncertain and unacceptable cost-effectiveness. It considers submissions in this context.If you are going to have surgery, tell the surgeon or anaesthetist that you are using this medicine.
Consumer medicine information
Keep this consent form as you may need to show this to your doctor in the future. It may affect other medicines used during surgery.
The delivery device contains 28 daily doses of 20 mcg each. Some airlines may not allow you to bring unsealed needles onto a plane. All medicines have risks and benefits.
This medicine helps most people with osteoporosis, but it may have unwanted side effects in a few people. Talk to a healthcare provider about how to rotate injection sites.
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