With the needle at a slight angle, slowly push the plunger of the syringe all the way down so that the sterile water goes down the inside wall of the egrifta sv 2 mg vial instead of directly onto the powder to avoid foaming. After reconstitution with the supplied diluent sterile water for injection, usp, a solution of egrifta is clear and colorless. Supplement submission and receipt date provides for. Egrifta is not indicated for weight loss management weight neutral effect. There are no data to support improved compliance with antiretroviral therapies in hivpositive patients taking egrifta. Peel back the paper cover from the vial adapter package revealing the adapter spike without removing. S012 december 21, 2018 change in the proprietary name from egrifta to egrifta sv on all labeling pieces for the 2.
The member is currently receiving antiretroviral therapy c. It is used to treat people infected with hiv who have developed a condition called lipodystrophy, which causes fat to accumulate in their abdomens. Find patient medical information for egrifta subcutaneous on webmd including its uses, side effects and safety, interactions, pictures, warnings and user ratings. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Be sure to read the egrifta package insert about how to properly mix the powdered drug with the sterile water provided. Carefirst bluecross blueshield is the shared business name of carefirst of maryland, inc. Egrifta is indicated for the reduction of excess abdominal fat in human immunodeficiency virus hivinfected patients with lipodystrophy. Egrifta is not a weightloss medication and should not be used to treat obesity. Budesonide, the active ingredient in ortikos, is a synthetic corticosteroid.
Insert the needle into the rubber stopper of the egrifta sv 2 mg vial. Longterm cardiovascular benefit and safety of egrifta have not been studied. Taxol paclitaxel injection is a clear, colorless to slightly yellow viscous solution. Updated references to include medispan and egrifta package insert. Egrifta is not indicated for weight loss management. Authorization of 6 months may be granted to members with lipodystrophy prescribed egrifta for continuation of. Treatment with antiretroviral therapy at the same time is necessary. Serostim somatropin for injection website for patients. This condition is also called lipodystrophy lyepoedistroefee. Documentation of waist circumference greater than or equal to 95 cm. This dosage and administration information only applies to egrifta 2 mgvial formulation.
Two formulations and strengths are available for egrifta. These prior approval supplemental new drug applications provides for. Consult the full prescribing information prior to use for potential drug interactions. Dec 01, 2018 egrifta ndc 6206404 is available in a package comprised of two boxes, containing 30 thirty 2 mg singledose vials of egrifta in the medication box and 30 singledose 10 ml bottles of sterile water for injection, usp diluent with a 30day supply of disposable syringes and needles in the injection box. Authorization of 6 months may be granted to members with lipodystrophy prescribed egrifta for continuation of therapy to reduce excess abdominal fat when all of the following criteria are met. Highlights of prescribing information diabetic macular edema. Egrifta sgm p2017 cvs caremark is an independent company that provides pharmacy benefit management services to carefirst bluecross blueshield and carefirst bluechoice, inc. Egrifta can harm an unborn baby or cause birth defects. The determination is based on medical information provided by the member, the members familycaretaker and the primary care practitioner, as well as any other providers, programs. The impact and safety of egrifta on cardiovascular health has not been studied. The recommended dose of egrifta is 2 mg injected subcutaneously once a day. Serostim is an injectable prescription medicine used for the treatment of hivpositive patients with wasting or cachexia to increase lean body mass and body weight, and improve physical endurance.
Dosing recommendations for children, elderly, or people with kidney or liver disease have not been established. Is the requested drug being used for the reduction of excess abdominal fat in an hivinfected patient who has lipodystrophy syndrome. Rationale for inclusion in pa program background egrifta is approved by the fda for hivassociated lipodystrophy which is defined as a condition in which excess fat develops in different areas of the body, especially around the liver, stomach and other abdominal organs commonly observed in hivinfected patients. Egrifta tesamorelin for injection prescribing information.
Egrifta would be considered investigational in the following circumstances. Egrifta dosage for hivassociated lipodystrophy the standard recommended dose for treating lipodystrophy in people infected with human immunodeficiency virus is 2 mg injected just under the skin subcutaneously once daily. Egrifta is being studied in patients who have abdominal obesity without hiv infection. Egrifta is used to reduce excess fat around the stomach that is caused by taking certain hiv medications. Physician and practice information patients personal information. Metabolic effects of a growth hormonereleasing factor in patients with hiv. Egrifta contains a growth hormonereleasing factor grf. Patients and caregivers who administer forteo should receive appropriate training and instruction on the proper use of the forteo delivery device from a qualified health professionalsee patient counseling information 17. Egrifta is an injectable prescription medicine to reduce the excess in abdominal fat in hivinfected patients with lipodystrophy. Sep 16, 2019 ortikos budesonide extendedrelease capsules. Nonformulary prior authorization guideline for egrifta. Eylea aflibercept injection, for intravitreal use initial u. Highlights of prescribing information known hypersensitivity. Egriftatm is a growth hormone releasing factor grf analog indicated for the reduction of excess abdominal fat in hivinfected patients with lipodystrophy.
Full prescribing information 1 indications and usage nuedexta is indicated for the treatment of pseudobulbar affect pba. Egrifta description egrifta tesamorelin background egrifta is approved by the fda for hivassociated lipodystrophywhich is defined as a condition in which excess fat develops in different areas of the body, especially around the liver, stomach and other abdominal organs commonly observed in hivinfected patients 1. Some patients may need every 4 week 52019 dosage and administration 2 82019 indications and usage eylea is a vascular endothelial growth factor vegf inhibitor indicated for. Abdominal obesity in patients without hiv infection. Egrifta tesamorelin rationale for inclusion in pa program. If you have cancer or a problem with your pituitary gland, you cannot use egrifta. Egrifta fda prescribing information, side effects and uses. Invanz ertapenemfor injection for intravenous iv or intramuscular im use initial u. Egrifta criteria version 1 last updated 11182011 approved 11182011 alaska medicaid egriftatm tesamorelin 1mg vial for subcutaneous injection indications. It is supplied as a nonaqueous solution intended for dilution with a suitable parenteral fluid prior to intravenous infusion.
Highlights of prescribing information these highlights do not include all the information needed to use torisel safely and effectively. Torisel kit temsirolimus injection, for intravenous infusion only initial u. This page of the emedtv archives explains why and lists other important precautions and warnings with egrifta to be aware of before beginning treatment. Member is at risk for medical complications due to excess abdominal fat c.
The long term safety of egrifta on the heart and blood vessels cardiovascular is not known. Jul 29, 2019 egrifta is a sterile, white to offwhite, preservativefree lyophilized powder for subcutaneous injection. Medication policies are developed to help ensure safe, effective and appropriate use of selected medications. Pba occurs secondary to a variety of otherwise unrelated neurologic conditions, and is characterized by. Tymlos is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy. Patient authorization to help hivinfected patients with excess abdominal fat obtain egrifta egrifta assist, you need to fax this completed form and the accompanying statement of medical necessity to. Highlights of prescribing information safely and effectively. Egrifta is the first and only fdaapproved treatment for the reduction of excess abdominal fat in hivinfected patients with lipodystrophy.
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