Pegvisomant package insert. Oct 16, 2025 · Drug Saf 1996;15:135—57.

Pegvisomant package insert. 51310 - Sandostatin LAR Depot (octreotide acetate) injection package insert. Revised: 7/2023 PATIENT INFORMATIONSOMAVERT (SOM-ah-vert) (pegvisomant)for injection, for subcutaneous use What is SOMAVERT? Jan 24, 2025 · Detailed Pegvisomant dosage information for adults. Be sure to tell your doctor if you use insulin or other medicines (oral hypoglycemic medicines) for Acromegalic patients with diabetes mellitus being treated with insulin and/or oral hypoglycemic agents may require dose reductions of these therapeutic agents after the initiation of therapy with SOMAVERT (pegvisomant for injection) (see 7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism, Glucose Metabolism and see 9 DRUG INTERACTIONS, Drug SOMAVERT® WITH PREFILLED DILUENT SYRINGE (pegvisomant with PREFILLED DILUENT SYRINGE) Medication Guide This Patient Information has been approved by the U. Package insert information contains recommendations if test results are abnormal. Mar 12, 2021 · Somavert (pegvisomant) is a brand-name prescription drug that's approved to treat acromegaly in adults. PEGVISOMANT KIT | PHARMACIA & UPJOHN COMPANY LLC 0009716601Medication Information 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2. The clinical picture includes typical somatic changes, multiple general and local Food and Drug Administration PHARMACY PRIOR AUTHORIZATION Clinical Guideline – GROWTH HORMONE ANTAGONISTS Somavert® (pegvisomant) 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. 3 Loading Dose Injection Procedure 2. The NDC Packaged Code 64052-001-01 is assigned to an UNFINISHED drug package of 1850 g in 1 bottle of Pegvisomant, a bulk ingredient labeled by Pfizer Ireland Pharmaceuticals Unlimited Company. A Consensus Statement on acromegaly therapeutic outcomes. Somavert (pegvisomant) is a growth hormone receptor antagonist 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. Oct 1, 2022 · Somavert [package insert]. Learn about dosage, side effects, cost, and more. Katznelson L, Laws ER, Melmed S, et al. Includes dosages for Acromegaly; plus renal, liver and dialysis adjustments. ° In the space provided on the carton, record the date when the carton was removed from the refrigerator and the discard date (30 days a) Before administering the dose, remove one package (1 vial of lyophilized powder of SOMAVERT containing 10 mg, 15 mg, 20 mg, 25 mg or 30 mg of pegvisomant and one 2. Attention is being drawn to the possibility of tumor enlargement via the information included in the “Important Precautions” section of the package insert for pegvisomant. 1 Hypoglycemia Associated Korlym® [package insert on the Internet Menlo Park (CA): Corcept Therapeutics Incorporated; 2019Nov. Pegvisomant is usually given after other medications, surgery, or radiation have been tried These highlights do not include all the information needed to use SOMAVERT safely and effectively. There may be new information. Here we provide package inserts, product approvals, and Package insert information contains recommendations if test results are abnormal. : 021106 Approval Date: 3/25/2003 Approvable Letter (PDF) Approval Letter 7 (PDF) Printed Labeling (PDF) Medical Review (s) Part 1 (PDF) Part 2 (PDF) Chemistry Review (s) (PDF) Pharmacology Review (s) Part 1 (PDF) Part 2 (PDF) Part 3 (PDF) Statistical Review (s) (PDF) Microbiology Review (s) (PDF Jan 17, 2025 · What is pegvisomant? Pegvisomant is a man-made protein that is similar to human growth hormone. Pegvisomant is used to treat acromegaly (a growth disorder caused by too much growth hormone). Apr 9, 2024 · SOMAVERT (pegvisomant) for injection is a white lyophilized powder supplied in the following strengths and package configurations: One Day Package Get label info, coverage requirements, PA forms & patient materials for Somavert (pegvisomant). Oct 16, 2025 · Drug Saf 1996;15:135—57. This can cause discomfort and increases risk of skin Jul 13, 2025 · Telisotuzumab Vedotin package insert / prescribing information for healthcare professionals. The predominant molecular weights of REFERENCES Somavert [package insert]. East Hanover (NJ): Novartis Pharmaceuticals Corporation; 2020Jun. Includes common brand names, drug descriptions, warnings, side effects and dosing information. The Journal of Clinical Endocrinology & Metabolism. SOMAVERT® WITH PREFILLED DILUENT SYRINGE (pegvisomant with PREFILLED DILUENT SYRINGE) Medication Guide This Patient Information has been approved by the U. Food and Drug Administration providing information on regulations, guidelines, or updates related to public health and safety. SOMAVERT 15 mg: One vial of powder contains 15 mg pegvisomant. The relative bioavailability of 1 × 30 mg pegvisomant was compared to 2 × 15 mg pegvisomant in a single-dose study. Package Type (abbreviated as DRLS_PKG_TYPE in the MIS … punctuation permissible. The primary efficacy endpoint was IGF-I percent change in IGF-I concentrations from baseline to week 12. Unlike dopamine or somatostatin analogs (which inhibit growth hormone secretion), this drug actually blocks the hepatic (GH-mediated) production of insulin like growth factor (IGF-1), which is the main mediator of growth hormone activity. ety Clinical Practice Guideline. Somavert contains the active substance pegvisomant. . The predominant molecular weights of Apr 9, 2024 · SOMAVERT (pegvisomant) for injection is a white lyophilized powder supplied in the following strengths and package configurations: One Day Package The One Day Package and intermediate cartons in the 30-Day Package containing the SOMAVERT vials, may be stored at room temperature up to 77°F (25°C) for a single period of up to 30 days. All three patients completely recovered after discontinuation of treatment. … Package Insert-VARIZIG The NDC Packaged Code 0009-7188-30 is assigned to a package of 30 kit in 1 carton / 1 kit in 1 kit * 1 ml in 1 vial, single-dose (0009-5179-02) * 1 ml in 1 syringe (0009-5936-01) of Somavert, a human prescription drug labeled by Pharmacia & Upjohn Company Llc. (registered or updated, whichever is most recent) Example: Byetta. Nature Reviews Endocrinology. 2 Assess Liver Tests Prior to Initiation of SOMAVERT 2. Pegvisomant binds to the same receptor in the body as growth hormone, and blocks the effects of growth hormone. This can cause discomfort and increases risk of skin SOMAVERT® WITH PREFILLED DILUENT SYRINGE (pegvisomant with PREFILLED DILUENT SYRINGE) How Supplied/Storage and Handling 16 HOW SUPPLIED/STORAGE AND HANDLING SOMAVERT (pegvisomant) for injection is a white lyophilized powder supplied in the following strengths and package configurations: One Day Package Configuration Strength NDC Description 10 mg per medication page for healthcare Feb 15, 2007 · However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. 6. Apr 1, 2021 · Somavert (pegvisomant) is a non-preferred product and will only be considered for coverage under the pharmacy benefit when the following criteria are met: Members must be clinically diagnosed with one of the following disease states and meet their individual criteria as stated. FDA Codes representing these package types shall consist of a maximum of eight letters. 2014; 99:3933-3951. 8. Since then, new evidence emerged on the biochemical and clinical effects of PEG and on its long-term efficacy and safety. The predominant molecular weights of Pegvisomant is a protein of recombinant DNA origin containing 191 amino acid residues to which several polyethylene glycol (PEG) polymers are covalently bound (predominantly 4 to 6 PEG/protein molecule). The product's dosage form is kit and is administered via form. The AUC inf and C max of pegvisomant when administered as one injection of 30 mg strength was approximately 6% and 4% greater, respectively, as compared to when administered as two injections of 15 mg strengths. a box of 10 single-dose vials of lyophilized vaccine (package A), NDC 0006-4827-00 a box of 10 vials of diluent (package B). There was no evidence of teratogenic effects associated with pegvisomant administration during organogenesis. Apr 20, 2000 · Pegvisomant is a genetically engineered analogue of human growth hormone that functions as a growth hormone–receptor antagonist. Indian J Endocrinol Metab. Sep 30, 2025 · Package Insert Medication Name. Aug 22, 2025 · Pegvisomant reference guide for safe and effective use from the American Society of Health-System Pharmacists (AHFS DI). In 2007, we published an opinion document to review the role of pegvisomant (PEG) in the treatment of acromegaly. Jan 8, 2025 · Somavert is used to treat acromegaly, a growth disorder caused by too much growth hormone. Our study was conducted in clinical practice in Poland where, for years, only the first-generation SRLs (octreotide and lanreotide) were reimbursed for treatment of acromegaly (32, 33). Medscape - Indication-specific dosing for Somavert (pegvisomant), frequency-based adverse effects, comprehensive interactions, contraindications, pregnancy & lactation schedules, and cost information. V. 51250 - Somavert (pegvisomant) package insert. The mean Feb 16, 2015 · Profile of pegvisomant (PEG) in the management of acromegaly: an evidence based review of its place in therapy Acromegaly is a rare and chronic disease, which in more than 95% of cases is caused by a benign growth hormone (GH)-producing pituitary adenoma, determining an increased production of IGF-I. Drug Review PackageSomavert (pegvisomant) injectable Company: Pharmacia and Upjohn Application No. Aug 7, 2023 · Somavert (Pegvisomant) may treat, side effects, dosage, drug interactions, warnings, patient labeling, reviews, and related medications including drug comparison and health resources. 25 mL syringe containing the diluent) from the refrigerator about 10 minutes prior to the planned injection time. Jun 30, 2025 · CareSource considers Somavert (pegvisomant) not medically necessary for the treatment of conditions that are not listed in this document. SOMAVERT 20 Jun 13, 2005 · Pegvisomant is a highly selective growth hormone (GH) receptor antagonist. e. For convenience, the One Day Package and intermediate cartons in the 30-Day Package containing the SOMAVERT vial(s), may be stored at room temperature up to 25°C (77°F) for a single period of up to 30 days. Revised: 7/2023 PATIENT INFORMATIONSOMAVERT (SOM-ah-vert) (pegvisomant)for injection, for subcutaneous use What is SOMAVERT? SOMAVERT is a prescription medication page for patients to search for scientific a) Before administering the dose, remove one package (1 vial of lyophilized powder of SOMAVERT containing 10 mg, 15 mg, 20 mg, 25 mg or 30 mg of pegvisomant and 1 vial containing the diluent) from the refrigerator about 10 minutes prior to the planned injection time. The predominant molecular weights of Do not use SOMAVERT if you are allergic to SOMAVERT or any of its ingredients. NY, NY: Pharmacia and Upjohn Company LLC; 8/2021. Before administering the dose, remove one package (1 vial of lyophilized powder of SOMAVERT containing 10, 15 or 20 mg of pegvisomant and 1 vial containing the diluent) from the refrigerator about 10 minutes prior to the planned injection time. Learn about side effects, interactions and indications. Study Description: Data from a randomized, double-blind, multicenter, placebo-controlled, fixed daily pegvisomant dose (10 mg, 15 mg, and 20 mg), 12-week study in 112 patients with acromegaly who may have been previously treated with surgery, radiation therapy, and/or drug therapy. Strosberg JR. The One Day Package and intermediate cartons in the 30-Day Package containing the SOMAVERT vials, may be stored at room temperature up to 77°F (25°C) for a single period of up to 30 days. Corcept Therapeutics Incorporated Announces FDA Approval of KorlymTM(mifepristone) 300 mg Tablets: First and Only Approved Medication for Cushing’s Syndrome Patients [press release on the Internet]. Package insert. SOMAVERT® WITH PREFILLED DILUENT SYRINGE (pegvisomant with PREFILLED DILUENT SYRINGE) INSTRUCTIONS FOR USE INSTRUCTIONS FOR USE SOMAVERT® (SOM-ah-vert) (pegvisomant) for injection, for subcutaneous use Read these Instructions for Use before you start using SOMAVERT and each time you get a refill. Sep 15, 2021 · The National Library of Medicine (NLM)’s DailyMed searchable database provides the most recent labeling submitted to the Food and Drug Administration (FDA) by companies and currently in use (i. The recommended initiation of INVEGA SUSTENNA® is with a dose of 234 mg on treatment day 1 and 156 mg one week later, both administered in the deltoid muscle. 2018;14(9):552-5 The NDC Packaged Code 59267-5201-4 is assigned to an UNFINISHED drug package of 1 ml in 1 vial, single-dose of Pegvisomant, drug for further processing labeled by Pfizer Manufacturing Belgium Nv. • Revision Dates of the Prescribing Information, Patient Package Insert, and Instructions for Use were updated to reflect the date of approval of this supplement. 6 Somatuline ® Depot (lanreotide) is for deep subcutaneous injection only, initially administered every 4 weeks by a healthcare professional. New York (NY): Pharmacia and Upjohn; 2021Aug. See full list on drugs. 7 Sandostatin ® LAR Depot (octreotide acetate) and The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. For more information about using Somavert, see the package leaflet or contact your doctor or pharmacist. The molecular weight of the protein of pegvisomant is 21,998 Daltons. GH-receptor antagonist pegvisomant, which is particularly useful in patients with associated diabetes was not financed from public funds at the time the study Remove one package of Somavert from the refrigerator and allow it to warm up to room temperature for approximately 10 minutes while you get ready to prepare your injection. Following the second initiation dose, monthly maintenance doses can be administered in either the deltoid or gluteal muscle. The recommended dosing of INVEGA SUSTENNA® for each approved indication is displayed in Table 1. American Association of Clinical Endocrinologists Acromegaly Guidelines Task Force. Patient Product Information SOMAVERT Pre-filled Syringe U. Thanabalasingham G, Grossman AB. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. The safety and efficacy of pegvisomant in combination with other medicinal products, including somatostatin analogues, in the treatment of acromegaly have not been established and, therefore, the combination of somatostatin analogues with pegvisomant is not recommended. Acromegaly: an Endocrine Society clinical practice guideline. Feb 10, 2020 · Includes Pegvisomant indications, dosage/administration, pharmacology, mechanism/onset/duration of action, half-life, dosage forms, interactions, warnings, adverse Jan 31, 2014 · In a 2-year rat carcinogenicity study, pegvisomant injected subcutaneously on a daily basis at doses of 0, 2, 8, or 20 mg/kg/day produced malignant fibrous histiocytomas (MFHs) at the injection sit Aug 26, 2025 · Home / Official Guidance / FDA / FDA Package Inserts Package Inserts & EUAs FDA’s Center for Biologics Evaluation and Research regulates biological products, including vaccines, for human use. Manufacturer’s Name; Year. The predominant molecular weights of The one-day package of SOMAVERT and 3 intermediate cartons of the 30-day package can be stored at room temperature up to 77°F (25°C) for a maximum single period of up to 30 days The pharmacokinetics of pegvisomant are similar in normal healthy volunteers and acromegaly patients, although heavier individuals tend to have a higher total body clearance of pegvisomant than lighter individuals, and may thus require greater doses of pegvisomant. 7. Dublin, Ireland: Pfizer Ireland Pharmaceuticals; 2012 June. SOMAVERT® WITH PREFILLED DILUENT SYRINGE (pegvisomant with PREFILLED DILUENT SYRINGE) Instructions For Use INSTRUCTIONS FOR USE SOMAVERT® (SOM-ah-vert) (pegvisomant) for injection, for subcutaneous use Read these Instructions for Use before you start using SOMAVERT and each time you get a refill. This leaflet does not take the medication page for patients to Mar 13, 2025 · Find patient medical information for Somavert (pegvisomant) on WebMD including its uses, side effects and safety, interactions, pictures, warnings, and user ratings Before administering the loading dose, remove the first package (1 vial of lyophilized powder of SOMAVERT containing 20 mg of pegvisomant and 1 vial containing the diluent) from the refrigerator about 10 minutes prior to the planned injection time. Growth hormone promotes growth during childhood and adolescence. Acromegaly: Beyond surgery. Before administering the dose, remove one package (1 vial of lyophilized powder of SOMAVERT containing 10 mg, 15 mg, 20 mg, 25 mg or 30 mg of pegvisomant and 1 vial containing the diluent) from the refrigerator about 10 minutes prior to the planned injection time. Oct 1, 2022 · CareSource considers Somavert (pegvisomant) not medically necessary for the treatment of conditions that are not listed in this document. Patients with diabetes should be monitored for hypoglycemia. See full prescribing information for SOMAVERT® WITH PREFILLED DILUENT SYRINGE (pegvisomant with PREFILLED DILUENT SYRINGE) Full Patient Information medication page for patients to search for scientific information & prescribing information about Pfizer medications in the US. Somavert® [package insert on the Internet]. How does Somavert work? Acromegaly occurs when the pituitary gland at the base of the brain makes too much growth hormone, generally because of a benign (non-cancerous) tumour. Includes: indications, dosage, adverse reactions and pharmacology. for Consumers: SOMAVERT U. As part of their responsibility of ensuring that these products are safe and effective, they also approve product labeling, or package inserts. It is used to treat acromegaly. 16,17 We conducted a 12-week study of the efficacy and Medscape - Phenylketonuria (PKU) dosing for Palynziq (pegvaliase), frequency-based adverse effects, comprehensive interactions, contraindications, pregnancy & lactation schedules, and cost information. 1 Dosage Information 2. We here Apr 1, 2021 · Somavert (pegvisomant) is a non-preferred product and will only be considered for coverage under the pharmacy benefit when the following criteria are met: Members must be clinically diagnosed with one of the following disease states and meet their individual criteria as stated. Be sure to tell your doctor if you use narcotic painkillers (opioid medicines) because the dose of SOMAVERT may need to be changed. Baseline IGF-1 is >2x ULN for age OR IGF-1 remains elevated despite a 6 month trial of maximally tolerated dose of cabergoline (unless patient cannot tolerate cabergoline or has a contraindication) Somavert (pegvisomant) will only be considered for coverage under the pharmacy benefit when the following criteria are met: Members must be clinically diagnosed with one of the following disease states and meet their individual criteria as stated. 2014;99(11):39 Bronstein MD, Chanson P, et al. For any other indication, please refer to the Off-Label policy. Apr 9, 2024 · Somavert (pegvisomant) is a brand-name drug prescribed in certain adults to treat acromegaly, a growth hormone disorder. Pegvisomant is a protein of recombinant DNA origin containing 191 amino acid residues to which several polyethylene glycol (PEG) polymers are covalently bound (predominantly 4 to 6 PEG/protein molecule). SOMAVERT® WITH PREFILLED DILUENT SYRINGE (pegvisomant with PREFILLED DILUENT SYRINGE) How many times can I safely insert the needle into the vial stopper? How many times can I safely insert the needle into the vial stopper? • Only 1 time. Following this, the usual daily dose of pegvisomant is 10 mg, which is given by subcutaneous injection (just under the skin). J Clin Endocrinol Metab. Current, verified resources, all in one place. Oct 8, 2025 · Tepezza package insert / prescribing information for healthcare professionals. New York, NY: Pharmacia & Upjohn Co; April 2016. The active ingredient is pegvisomant, which includes polyethylene glycol. CONTENT OF LABELING As soon as possible, but no later than 14 days from the date of this letter, submit the content of labeling [21 CFR 314. S. 4 Maintenance Dose Injection Procedure 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5. gov. New York, NY: Pharmacia & Upjohn Company LLC; July 2023. Patient Product Information SOMAVERT WITH PREFILLED DILUENT SYRINGE - U. com Do not use SOMAVERT ® (pegvisomant for injection) if you are allergic to SOMAVERT or anything that is in it. DailyMed contains labeling for prescription and nonprescription drugs for human and animal use, and for additional products such as medical gases, devices, cosmetics, dietary A starting dose of 80 mg of pegvisomant will be given subcutaneously (just under the skin) by your doctor. Withdrawing and reinserting greatly increases the risk of needle damage, and will blunt the needle. The effects of pegvisomant on early embryonic development and embryo-fetal development were evaluated in two separate studies, which were conducted in pregnant rabbits with pegvisomant at subcutaneous doses of 1, 3, and 10 mg/kg/day. , "in use" labeling). Amylin Pharmaceuticals Inc; 2007. It’s given as an injection under the skin once per day. Blood sugar levels may go down when taking SOMAVERT. After reconstitution with ml of solvent, 1 ml of the solution contains 15 mg pegvisomant. 50(l)] in structured product labeling (SPL) format using the FDA automated drug registration and listing system (eLIST), as described at FDA. Medical Information Page - patient information, ways to contact Pfizer Medical & other resources for Healthcare professionals SOMAVERT® WITH PREFILLED DILUENT SYRINGE (pegvisomant with PREFILLED DILUENT SYRINGE) Instructions For Use INSTRUCTIONS FOR USE SOMAVERT® (SOM-ah-vert) (pegvisomant) for injection, for subcutaneous use Read these Instructions for Use before you start using SOMAVERT and each time you get a refill. Feb 18, 2025 · Detailed drug Information for Pegvisomant. Somavert ® (pegvisomant for injection) is a subcutaneous injection, self-administered once daily after a physician-supervised initial loading dose. REFERENCES Somavert [package insert]. SOMAVERT (pegvisomant) for injection is a sterile, white lyophilized powder intended for subcutaneous injection after reconstitution. Signifor®LAR [package insert on the internet]. 2018;14(9):552-5 Official document from the U. SOMAVERT is supplied in packages that include a single-dose prefilled syringe containing 1 mL of Sterile Water for Injection, USP, that is a sterile, nonpyrogenic preparation of water for injection that contains no bacteriostat, antimicrobial agent, or added Somavert (pegvisomant) will only be considered for coverage under the pharmacy benefit when the following criteria are met: Members must be clinically diagnosed with one of the following disease states and meet their individual criteria as stated. The molecular weight of the PEG portion of pegvisomant is approximately 5000 Daltons. 2013 Jul;17(4):563-7. Food and Drug Administration. The inactive ingredients are glycine, mannitol, sodium phosphate dibasic anhydrous, and sodium phosphate monobasic monohydrate. Adjustments of hypoglycemic agents may be necessary. 1 Content of labeling must be identical to the enclosed labeling (text for the PI, Patient Package Insert, and SOMAVERT® (pegvisomant) This product information is intended only for residents of the United States. Feb 27, 2025 · Somavert is used in patients who did not respond well to surgery and/or radiation therapy, and to treatment with somatostatin analogues (another type of medicine used in acromegaly). uh mna3 aj c4 nd6 w9f kipo oni gked4 8b