Egrifta tesamorelin for injection 301500851021 somatotropin agonists criteria for coverage egrifta tesamorelin for injection will be considered for coverage under the pharmacy benefit program when the following criteria are met. Cytarabine injection, an antineoplastic, is a sterile solution of cytarabine for intravenous and subcutaneous use which contains no preservative and is available in 20 mgml mg50 ml pharmacy bulk package. Torisel kit temsirolimus injection, for intravenous infusion only initial u. 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. Confidential page 1 of 53 highlights of prescribing information. Patient is 18 years of age or older and patient has been diagnosed with human immunodeficiency virus hiv. 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 with injection kit.
Highlights of prescribing information diabetic macular edema. Idamycin idarubicin hydrochloride for injection, usp is intended for administration under the supervision of a physician who is experienced in leukemia chemotherapy. Emcyt estramustine phosphate sodium capsules description. Highlights of prescribing information these highlights do not include all the information needed to use tasignasafely and effectively. Egrifta prior authorization form if this is an urgent request, please call upmc health plan pharmacy services. Egrifta is available in a package comprised of two boxes. Egrifta is not indicated for weight loss management weight neutral effect. Store the medication box of egrifta vials in the refrigerator between 2c to 8c 36f to 46f.
Panther fusion specimen lysis tubes specimen transport panther fusion specimen lysis tubes 3 aw16835 rev. Egrifta is approved when the following criteria are met. Isoniazid, usp is an antibacterial available as 100 mg and 300 mg tablets for oral administration. Nov 04, 2019 insert the needle into the rubber stopper of the egrifta sv 2 mg vial. Ivassociate d a significa essary beca adult patien ied in patie no publish y. Find patient medical information for egrifta subcutaneous on webmd including its uses, side effects and safety, interactions, pictures, warnings and user ratings. Egrifta tesamorelin is usually injected into the abdomen once a day. Two tesamorelin vials are necessary for a single dose. Assay definition file adf instructions to import adf into genexpert software flyer 1 per kit directions to locate the product insert and quick reference instructions on. Egrifta fda prescribing information, side effects and uses. The reconstituted vaccine should be an opalescent, colorless to pale brownish liquid. There are no data to support improved compliance with antiretroviral therapies in hiv positive patients taking egrifta. This page of the emedtv archives explains why and lists other important precautions and warnings with egrifta to be aware of before beginning treatment.
Keep trikafta and all medicines out of the reach of children. Cyanokit package insert highlights of prescribing information these highlights do not include all the information needed to use cyanokit safely and effectively. Egrifta is the only fdaapproved treatment for excess abdominal fat. Egrifta treatment may cause injection site reactions, including injection site erythema, pruritus, pain, irritation, and bruising. Egrifta is an injectable prescription medicine used to reduce the excess in. The recommended dose of egrifta is 2 mg injected subcutaneously once a day. People who have decreased liver or kidney function, as well as those with diabetes, may require extra monitoring when treating hivassociated lipodystrophy with egrifta. Egrifta sv ndc 6206424 is available in a package comprised of two boxes, containing 30 thirty 2 mg singledose vials of egrifta sv 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. There are no data to support improved compliance with antiretroviral therapies in hivpositive patients taking egrifta. 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. Since the longterm cardiovascular safety and potential longterm cardiovascular benefit of egrifta treatment have not been studied and are not known, careful consideration should be given whether to continue egrifta treatment in patients who do not show a clear efficacy response as.
Use di water to dilute 5% to 7% sodium hypochlorite solution. This package insert is intended for the eye care professional, but. Nada 141456, approved by fda dexmedetomidine oromucosal gel each ml of sileo contains 0. Longterm cardiovascular benefit and safety of egrifta have not been studied. Highlights of prescribing information these highlights do not include all the information needed to use votrient safely and effectively. While egrifta tesamorelin is fdaapproved for the reduction of excess. Assay definition file adf instructions to import adf into genexpert software flyer 1 per kit directions to locate the product insert on. Be sure to read the egrifta package insert about how to properly mix the powdered drug with the sterile water provided. 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. Emcyt capsules are white and opaque, each containing estramustine phosphate sodium as the disodium salt monohydrate equivalent to 140 mg estramustine phosphate, for oral administration. Instructions for use integra meshed bilayer wound matrix without negative pressure therapy application. See full prescribing information for complete boxed warning. Egrifta tesamorelin rationale for inclusion in pa program. This package insert is effective as of december 2018 and applicable to the lotrafilcon b contact lenses described below.
Highlights of prescribing information these highlights do not include all the information needed to use torisel safely and effectively. The long term safety of egrifta on the heart and blood vessels cardiovascular is not known. Using aseptic technique, peel open the outer pouch and gently drop the inner foil pouch onto a sterile field or surface. Egrifta tesamorelin for injection is indicated for the reduction of excess abdominal fat in hiv. Is the requested drug being used for the reduction of excess abdominal fat in an hivinfected patient who has lipodystrophy syndrome. Egrifta, please consult the prescribing information, patient information, and. Because this product is made from human blood, it may carry a risk of transmitting infectious agents, e.
General information about the safe and effective use of trikafta. Carefirst bluecross blueshield is the shared business name of carefirst of maryland, inc. If you have cancer or a problem with your pituitary gland, you cannot use egrifta. One box contains 30 vials of egrifta and a second box contains 30 singleuse 10 ml bottles of reconstitution diluent sterile water for injection, usp, disposable syringes, and needles sufficient for a 30 day supply. Severe acute exacerbations of hepatitis b have been reported in patients coinfected with hiv1 and hbv who have discontinued emtriva or viread, two of the components of stribild.
Integra meshed bilayer wound matrix package insert. Documentation of waist circumference greater than or equal to 95 cm. Egrifta ha ing availab d drug es, local m for the red ith lipodys enous grf gh, which ariety of tar gh and in in patients w n to decre ients with d ry tumor or r mannitol. Eylea aflibercept injection, for intravitreal use initial u. Egrifta can harm an unborn baby or cause birth defects. This condition is also called lipodystrophy lyepoedistroefee. Warnings and precautions also apply to women who are pregnant or breastfeeding, people who have problems with the pituitary gland. Integra meshed bilayer wound matrix package insert instructions for use integra meshed bilayer wound matrix without negative pressure therapy application 1. Hepatotoxicity see full prescribing information for complete boxed warning. Nonformulary prior authorization guideline for egrifta. Dosing recommendations for children, elderly, or people with kidney or liver disease have not been established. Cyanokit hydroxocobalamin for injection 5 g for intravenous infusion initial u. It is used to treat people infected with hiv who have developed a condition called lipodystrophy, which causes fat to accumulate in their abdomens. 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.
Egrifta tesamorelin egrifta fep clinical rationale rationale for inclusion in pa program background egrifta is approved by the fda for hivassociated lipodystrophy which is defined as a condition. Dec 01, 2018 egrifta is an injectable prescription medicine to reduce the excess in belly fat in hivinfected adult patients. Federal usa law restricts this drug to use by or on the order of a licensed veterinarian. Egrifta sv is a growth hormonereleasing factor ghrf analog indicated for the reduction of excess abdominal fat in hivinfected adult patients with. Remove the protective cap and insert the needle into. Idamycin idarubicin hydrochloride for injection, usp. Egrifta is not a weightloss medication and should not be used to treat obesity. Jul 29, 2019 egrifta is available in a package comprised of two boxes. These highlights do not include all the information needed to use advate safely and effectively. Member is at risk for medical complications due to excess abdominal fat c. Medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet.
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. Highlights of prescribing information these highlights do not include all the information needed to use tecentriq safely and effectively. Insert the needle into the rubber stopper of the egrifta sv 2 mg vial. Please read carefully and keep this information for future use.
These highlights do not include all the information needed to use cuvitru safely and effectively. Egrifta is used to reduce excess fat around the stomach that is caused by taking certain hiv medications. Use only the supplied adjuvant suspension component liquid for reconstitution. In the prescribing information, contraindications to tesamorelin. The compound is heat stable, has a high melting point, and is freely soluble in organic solvents. Egrifta is the first and only fdaapproved treatment for the reduction of excess abdominal fat in hivinfected patients with lipodystrophy.
Patient information is perforated for dispensing to the. Samples that have been assayed should be stored upright in the rack under one of the following conditions. Tesamorelin is a synthetic analog of human growth hormonereleasing factor. There is also the possibility that unknown infectious agents may be present in such products. Feb 24, 2020 egrifta is used to reduce excess fat around the stomach that is caused by taking certain hiv medications. The impact and safety of egrifta on cardiovascular health has not been studied. Egrifta is an injectable prescription medicine to reduce the excess in belly fat in hivinfected adult patients. Prior authorization approval criteria fallon health. Egrifta sgm p2017 cvs caremark is an independent company that provides pharmacy benefit management services to carefirst bluecross blueshield and carefirst bluechoice, inc. Highlights of prescribing information these highlights do not include all the information needed to use aromasin safely and effectively.