United States - English - NLM (National Library of Medicine)

pharmacia and upjohn company llc - pegvisomant (unii: n824aou5xv) (pegvisomant - unii:n824aou5xv) - pegvisomant 10 mg in 1 ml - 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. the goal of treatment is to normalize serum insulin-like growth factor-i (igf-i) levels. none. risk summary the limited data with somavert in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage. in animal reproduction studies, fetotoxicity was observed at a dose that was 6 times the maximum recommended human dose based on body surface area following subcutaneous administration of pegvisomant during organogenesis or during the preimplantation period (see data ). the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively. data animal data the effects of pegviso

Israel - English - Ministry of Health

pfizer pharmaceuticals israel ltd - pegvisomant - powder and solvent for solution for injection - pegvisomant 10 mg - pegvisomant - pegvisomant - treatment of adult patient with acromegaly who have had an inadequate response to surgery and/or radiation therapy and in whom an appropriate medical treatment with somatostatin analogues did not normalize igf-i concentrations or was not tolerated.

Israel - English - Ministry of Health

pfizer pharmaceuticals israel ltd - pegvisomant - powder and solvent for solution for injection - pegvisomant 15 mg - pegvisomant - pegvisomant - treatment of adult patient with acromegaly who have had an inadequate response to surgery and/or radiation therapy and in whom an appropriate medical treatment with somatostatin analogues did not narmalize igf-i concentrations or was not tolerated.

Israel - English - Ministry of Health

pfizer pharmaceuticals israel ltd - pegvisomant - powder and solvent for solution for injection - pegvisomant 20 mg - pegvisomant - pegvisomant - treatment of adult patient with acromegaly who have had an inadequate response to surgery and/or radiation therapy and in whom an appropriate medical treatment with somatostatin analogues did not narmalize igf-i concentrations or was not tolerated.

United States - English - NLM (National Library of Medicine)

pharmacia & upjohn company llc - pegvisomant (unii: n824aou5xv) (pegvisomant - unii:n824aou5xv) - pegvisomant 10 mg in 1 ml - 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. the goal of treatment is to normalize serum insulin-like growth factor-1 (igf-1) levels. none. risk summary postmarketing reports of somavert use in pregnant women are insufficient to establish a drug-associated risk for major birth defects, miscarriage or adverse maternal or fetal outcomes. acromegaly may improve during pregnancy (see clinical considerations) . in animal reproduction studies, fetotoxicity was observed at a dose that was 6 times the maximum recommended human dose based on body surface area following subcutaneous administration of pegvisomant during organogenesis or during the preimplantation period (see data) . the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively. clinical considerations disease-associated maternal and/or embryofetal risk published data from case reports, case series, and a small interventional study in pregnant women with acromegaly have demonstrated that acromegaly may improve or stabilize without treatment during pregnancy, particularly if acromegaly is treated before pregnancy. in rare cases, acromegaly may worsen during pregnancy. since igf-1 levels may change physiologically during pregnancy and interpreting igf-1 and growth hormone levels in pregnant women with acromegaly may be unreliable, clinical monitoring is recommended. data animal data 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. there was no evidence of teratogenic effects associated with pegvisomant administration during organogenesis. at the 10-mg/kg/day dose (6 times the maximum human therapeutic dose based on body surface area), a reproducible, slight increase in post-implantation loss was observed in both studies. risk summary limited information from a case report in published literature reported that the level of pegvisomant in human milk was below the level of detection. there is no information available on the effects of the drug on the breastfed infant or the effects of the drug on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for somavert and any potential adverse effects on the breastfed child from somavert or from the underlying maternal condition. discuss the potential for unintended pregnancy with premenopausal women as the therapeutic benefits of a reduction in growth hormone (gh) levels and normalization of insulin-like growth factor 1 (igf-1) concentration in acromegalic females treated with pegvisomant may lead to improved fertility. the safety and effectiveness of somavert in pediatric patients have not been established. clinical studies of somavert did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. somavert was not studied in patients with renal impairment and the safety and efficacy in these patients is not known. 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. there may be new information. this leaflet does not take the place of talking to your healthcare provider about your medical condition or your treatment. your healthcare provider should show you or a caregiver how to inject somavert the right way before you inject it for the first time. somavert is available in two types of packaging: important: step 1. things you need you will also need: step 2. getting ready before you start: step 3. choose injection area step 4. remove vial cap step 5. remove syringe cap step 6. attach safety needle step 7. remove needle cover step 8. insert needle step 9. add liquid step 10. swirl vial step 11. check medicine step 12. reposition needle step 13. draw off dose step 14. insert needle step 15. inject medicine step 16. make needle safe step 17. dispose step 18. after injection questions and answers what should i do if anything has accidentally touched the vial stopper? what should i do with the syringe if it has been dropped? how many times can i safely insert the needle into the vial stopper? is it okay to shake the vial if the powder is not dissolving? how can i tell if there is any foam in the vial? how can i prevent the medicine from foaming? i can see some air in the syringe. is this okay? why can i not get all of the medicine out of the vial? what should i do if i have any doubts about my medicine? safe syringe disposal information if you do not have a fda-cleared sharps disposal container, you may use a household container that is: when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles and syringes. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda's website at: http://www.fda.gov/safesharpdisposal this instructions for use has been approved by the u.s. food and drug administration. u.s. license no. 1216 lab-0784-3.0 revised: july 2023

Australia - English - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - pegvisomant, quantity: 20 mg - injection, solution - excipient ingredients: water for injections - the treatment of acromegaly in patients who have had inadequate response to surgery and/or radiation and/or other medical therapies or for whom these therapies are not appropriate. the treatment goal is to normalise igf-1 levels.

Australia - English - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - pegvisomant, quantity: 15 mg - injection, solution - excipient ingredients: water for injections - the treatment of acromegaly in patients who have had inadequate response to surgery and/or radiation and/or other medical therapies or for whom these therapies are not appropriate. the treatment goal is to normalise igf-1 levels.

Australia - English - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - pegvisomant, quantity: 10 mg - injection, solution - excipient ingredients: water for injections - the treatment of acromegaly in patients who have had inadequate response to surgery and/or radiation and/or other medical therapies or for whom these therapies are not appropriate. the treatment goal is to normalise igf-1 levels.

Australia - English - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - pegvisomant, quantity: 20 mg - injection, solution - excipient ingredients: water for injections - the treatment of acromegaly in patients who have had inadequate response to surgery and/or radiation and/or other medical therapies or for whom these therapies are not appropriate. the treatment goal is to normalise igf-1 levels.

Australia - English - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - pegvisomant, quantity: 15 mg - injection, solution - excipient ingredients: water for injections - the treatment of acromegaly in patients who have had inadequate response to surgery and/or radiation and/or other medical therapies or for whom these therapies are not appropriate. the treatment goal is to normalise igf-1 levels.