The doctor should check the response every four to six weeks and adjust the dose if needed. Always follow the detailed instructions that are given below instructions for use when you are preparing or injecting somavert. Somavert 10 mg powder and solvent for solution for injection. Pegvisomant somavert is a genetically engineered analogue, with attachment of polymers to prolong drug activity, of human growth hormone that functions as a hormone receptor antagonist. Sterile water for injection, usp, is a sterile, nonpyrogenic. For more information about using somavert, see the package leaflet or contact your doctor or pharmacist. Highlights of prescribing information reduction or. Somavert is a prescription medicine used to treat people who. Along with its needed effects, pegvisomant the active ingredient contained in somavert may cause some. This patient information summarizes the most important information about somavert. What should i discuss with my health care provider before using pegvisomant somavert.
These highlights do not include all the information needed to use somavert safely and effectively. For more information, ask your doctor or pharmacist. Somavert pegvisomant access and prescribing criteria. This document contains side effect information about pegvisomant. Highlights of prescribing information these highlights do not include all the information needed to use sodium iodide i 1 solution therapeutic safely and formation for sodium iodide i 1. Sodium iodide i 1 solution therapeutic is indicated for the treatment of hyperthyroidism and thyroid carcinomas that take up iodide. The most common side effects with somavert are pain, infection, reaction at the site of injection, flu symptoms, nausea, and diarrhea. Tell your doctor about all the medicines you take, including prescription and non. Somavert pegvisomant, rbe pfizer medical information. Sections or subsections omitted from the full prescribing information are not listed.
See full prescribing information for lupaneta pack. Somavert, innpegvisomant european medicines agency. Detailed information on this medicinal product is available on the website of. Pegvisomant interferes with commercially available growth hormone assays. Highlights of prescribing information these highlights do not include all the information needed to use somatuline depot safely and effectively. Somavert pegvisomant access and prescribing criteria somavert pegvisomant is recommended as a thirdline treatment of acromegaly in adults by nhs england, the all wales medicines strategy group. Somavert is available in singledose sterile vials containing 10 mg, 15 mg, 20 mg, 25 mg or 30 mg of pegvisomant protein.
This leaflet answers some common questions about somavert. Drug information on somavert pegvisomant includes side effects, uses, drug interactions, dosage, drug pictures, overdose symptoms, and what to avoid. Instructions for use your health care professional shoud teach you how to mix and inject somavert. Side effects of somavert pegvisomant, warnings, uses.
When conditions are met, we will authorize the coverage of somavert. Somavert official prescribing information for healthcare professionals. Fda approved indications somavert is indicated for the treatment of acromegaly in patients who have had an inadequate response to surgery or radiation therapy, or for whom these therapies are not appropriate. Highlights of prescribing information pregnancy or. Patients with diabetes should be monitored for hypoglycemia. This prior approval supplemental new drug application provides for alignment of the prescribing information pi for the vial presentation with the pi for the prefilled syringe presentation. Package insert information contains recommendations if test results are abnormal. It does not take the place of talking to your doctor or pharmacist. Nda 21106 somavert proposed package insert 032403 2 somavert is supplied in packages that include a plastic vial containing diluent. Somavert for injection is supplied as a sterile, white lyophilized powder intended for subcutaneous injection after reconstitution with 1 ml of sterile water for injection. Full prescribing information 1 indications and usage somavert is indicated for the treatment of acromegaly in patients who have had an inadequate response to surgery or radiation therapy, or for whom these therapies are not appropriate. Pdr drug summaries are concise pointofcare prescribing, dosing and administering information to help phsyicans more efficiently and accurately prescribe in their practice pdr s drug summaries are. In many of these cases, discontinuation of somavert therapy resulted in improvement or resolution of hepatic laboratory abnormalities.
You may contact paramount by phone at 14198872520 with questions regarding the prior authorization process. Sterile water for injection, usp, is a sterile, nonpyrogenic preparation of water for injection that contains no bacteriostat, antimicrobial agent, or added buffer, and is supplied in singledose. Dosing and administration pfizer for professionals. Somavert fda prescribing information, side effects and uses.
Full prescribing information 1 indications and usage somavert is indicated for the treatment of acromegaly. Nucala mepolizumab for injection nucala mepolizumab. Patient information somavert somahvert pegvisomant for injection read the patient information that comes with somavert before you start using it and each time you get a refill. Gh levels increase when pegvisomant somavert is administered, and the gh levels have no effect on pegvisomant somavert dosing. Somavert pegvisomant access and prescribing criteria somavert pegvisomant is recommended as a thirdline treatment of acromegaly in adults by nhs england, the all wales medicines strategy group awmsg and the scottish medicines consortium smc.
See full prescribing information for somatuline depot. What links here related changes upload file special pages permanent link page information wikidata item cite this page. Dosage, administration and monitoring prescribers guide. Somavert pegvisomant for injection product monograph page 25of 34 part iii. The therapeutic goal is normalization of ageadjusted serum insulinlike growth factori igfi levels. Some of the dosage forms listed on this page may not apply to the brand name somavert. Somavert is a prescription medicine used to treat people who have too much growth hormone acromegaly. Information to be completed by prescribing physician drug name somavert pegvisomant strength dose somavert pegvisomant will be eligible for reimbursement only if the patient satisfies the conditions listed. If a patient develops liver test elevations, or any other symptoms of. You can ask your pharmacist or healthcare provider for information about somavert that is written for health professionals. We would like to show you a description here but the site wont allow us.
Somavert pegvisomant dose, indications, adverse effects. You may contact paramount by phone at 14198872520 with questions regarding the prior. Before using somavert, tell your doctor if you have diabetes, liver disease, a latex allergy, or a tumor that secretes growth. Highlights of prescribing information these highlights do not include all the information needed to use somavert safely and effectively. Common side effects of somavert include lumps under the skin if the same injection site is used often. Somavert is used to treat people who are not able to be treated or have not already been helped by surgery or radiation.
Somavert 10 mg powder and solvent for solution for injection one vial contains 10 mg of pegvisomant. Pegvisomant trade name somavert is a growth hormone receptor antagonist used in the. A loading dose of 40 mg of somavert should be administered subcutaneously under physician supervision. Nucala mepolizumab for injection, for subcutaneous use nucala mepolizumab injection, for subcutaneous use. Somavert is indicated for the treatment of acromegaly in patients who have had an inadequate response to surgery or radiation therapy, or for whom these therapies are not appropriate. Cosmetic act fdca for somavert pegvisomant for injection.
These are not all of the possible side effects of somavert. Somavert is usually given after other medications, surgery, or radiation have been tried without successful treatment of symptoms. Highlights of prescribing information these highlights do not include all the information needed to use lupaneta pack safely and effectively. Somavert pegvisomant description pfizer medical information. Somavert 15 mg powder and solvent for solution for injection. Somavert pegvisomant for injection, for subcutaneous use. Somaverts prescribing information regarding initiation of therapy based on liver function test results combination therapy with a somatostatin analog octreotide, lanreotide will only be covered if somavert pegvisomant alone is unsuccessful in controlling igf1 levels. The patient or caregiver can inject somavert after being trained by a doctor or a nurse. Somavert pegvisomant is a growth hormone receptor antagonist indicated for the treatment.
Nucala mepolizumab for injection nucala mepolizumab injection. Highlights of prescribing information these highlights do not include all the information needed to use nucala safely and effectively. Somavert pegvisomant for injection, for subcutaneous use initial u. Talking to your doctor about acromegaly somavert pegvisomant for injection is a prescription medicine for.
Dosage, administration and monitoring prescribers guide to. If a patient develops liver test elevations, or any other symptoms of liver dysfunction while receiving somavert, please see liver tests section of the full prescribing information. You should not use somavert if you are allergic to pegvisomant. Read the patient information that comes with somavert before you start. Somavert pegvisomant is a manufactured protein similar to human growth hormone hgh used for the treatment of acromegaly a growth disorder caused by too much growth hormone.
Consumer information prsomavert pegvisomant for injection somavert singledose vial with prefilled syringe diluent this leaflet is part iii of a threepart product monograph published when somavert pegvisomant for injection was approved for sale in canada and is. After reconstitution, 1 ml of solution contains 10 mg of pegvisomant. Fda approved indications somavert is indicated for the treatment of acromegaly in patients who have. Somavert is used for the treatment of acromegaly, a hormonal disorder resulting from the increased secretion of growth hormone gh and igfi insulinlike. Pegvisomant somavert is a growth hormone receptor antagonist. It is for patients whose disease has not been controlled by surgery or radiation, or patients for whom these options are not appropriate. Sep 01, 2019 patient information somavert somahvert pegvisomant for injection, for subcutaneous use. Somavert stock ordered and dispensed by their nominated pharmacy octreotide, lanreotide or pasireotide. Somavert pegvisomant highlights pfizer medical information. Information to be completed by prescribing physician drug name somavert pegvisomant strength dose somavert pegvisomant will be eligible for reimbursement only if the patient satisfies the. Somaverts prescribing information regarding initiation of therapy based on liver function test results.
Somavert will be approved based on the following criteria. Policycriteria provider must submit documentation such as office chart notes, lab results or other clinical information. This prior approval supplemental new drug application provides for alignment of the prescribing information pi for the vial presentation. Patient information somavert somahvert pegvisomant for injection, for subcutaneous use. For the different dosage regimens the following strengths are available. If you would like more information, talk with your healthcare provider. Talking to your doctor about acromegaly somavert pegvisomant for injection is a prescription medicine for acromegaly. Mar 05, 2019 this patient information summarizes the most important information about somavert. Somavert medication page for healthcare professionals to search for scientific information on pfizer medications. Somavert pegvisomant dosing, indications, interactions. The goal of treatment with somavert is to have a normal igfi level in the blood. Please fax signed forms to paramount at 18442562025.
What should i avoid while taking pegvisomant somavert. Documentation of positive clinical response to somavert therapy authorization will be issued for 12 months. Patient is currently on somavert therapy for acromegaly authorization will be issued for 12 months. Somavert pegvisomant for injection, for subcutaneous. Also find the package insert, announcements, resources, and ways to connect with pfizer. Excipient with known effect the 10 mg strength of the medicinal product contains 0. American association of clinical endocrinologists medical guidelines for clinical practice for the diagnosis and treatment of acromegaly2011 update. Somavert is a prescription medicine used to treat people who have too much. Medicinal product subject to restricted medical prescription see annex i. Feb 06, 2020 what is the most important information i should know about pegvisomant somavert. Find patient medical information for somavert subcutaneous on webmd including its uses, side effects and safety, interactions, pictures, warnings and user ratings. Mar 05, 2019 somavert pegvisomant is a manufactured protein similar to human growth hormone hgh used for the treatment of acromegaly a growth disorder caused by too much growth hormone.