Verenigde Staten - Engels - NLM (National Library of Medicine)

pfizer laboratories div pfizer inc - spironolactone (unii: 27o7w4t232) (spironolactone - unii:27o7w4t232) - spironolactone 25 mg - aldactone is indicated for treatment of nyha class iii–iv heart failure and reduced ejection fraction to increase survival, manage edema, and reduce the need for hospitalization for heart failure. aldactone is usually administered in conjunction with other heart failure therapies. aldactone is indicated as add-on therapy for the treatment of hypertension, to lower blood pressure in patients who are not adequately controlled on other agents. lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. these benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes. control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. many patients will require more than one drug to achieve blood pressure goals. for specific advice on goals and management, see published guidelines, such as those of the national high blood pressure education program's joint national committee on prevention, detection, evaluation, and treatment of high blood pressure (jnc). numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. the largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmhg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). these considerations may guide selection of therapy. aldactone is indicated for the management of edema in the following settings: because it increases serum potassium, aldactone may be useful for treating edema when administration of other diuretics has caused hypokalemia. aldactone is indicated in the following settings: aldactone is contraindicated in the patients with: risk summary based on mechanism of action and findings in animal studies, spironolactone may affect sex differentiation of the male during embryogenesis (see data) . rat embryofetal studies report feminization of male fetuses and endocrine dysfunction in females exposed to spironolactone in utero. limited available data from published case reports and case series did not demonstrate an association of major malformations or other adverse pregnancy outcomes with spironolactone. there are risks to the mother and fetus associated with heart failure, cirrhosis and poorly controlled hypertension during pregnancy (see error! hyperlink reference not valid. ) . because of the potential risk to the male fetus due to anti-androgenic properties of spironolactone and animal data, avoid spironolactone in pregnant women or advise a pregnant woman of the potential risk to a male fetus. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss or other adverse outcomes. 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 embryo/fetal risk pregnant women with congestive heart failure are at increased risk for preterm birth. stroke volume and heart rate increase during pregnancy, increasing cardiac output, especially during the first trimester. clinical classification of heart disease may worsen with pregnancy and lead to maternal death. closely monitor pregnant patients for destabilization of their heart failure. pregnant women with symptomatic cirrhosis generally have poor outcomes including hepatic failure, variceal hemorrhage, preterm delivery, fetal growth restriction and maternal death. outcomes are worse with coexisting esophageal varices. pregnant women with cirrhosis of the liver should be carefully monitored and managed accordingly. hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section, and post-partum hemorrhage). hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death. data animal data teratology studies with aldactone have been carried out in mice and rabbits at doses of up to 20 mg/kg/day. on a body surface area basis, this dose in the mouse is substantially below the maximum recommended human dose and, in the rabbit, approximates the maximum recommended human dose. no teratogenic or other embryotoxic effects were observed in mice, but the 20 mg/kg dose caused an increased rate of resorption and a lower number of live fetuses in rabbits. because of its antiandrogenic activity and the requirement of testosterone for male morphogenesis, aldactone may have the potential for adversely affecting sex differentiation of the male during embryogenesis. when administered to rats at 200 mg/kg/day between gestation days 13 and 21 (late embryogenesis and fetal development), feminization of male fetuses was observed. offspring exposed during late pregnancy to 50 and 100 mg/kg/day doses of aldactone exhibited changes in the reproductive tract including dose-dependent decreases in weights of the ventral prostate and seminal vesicle in males, ovaries and uteri that were enlarged in females, and other indications of endocrine dysfunction, that persisted into adulthood. aldactone has known endocrine effects in animals including progestational and antiandrogenic effects. risk summary spironolactone is not present in breastmilk; however, limited data from a lactating woman at 17 days postpartum reports the presence of the active metabolite, canrenone, in human breast milk in low amounts that are expected to be clinically inconsequential. in this case, there were no adverse effects reported for the breastfed infant after short term exposure to spironolactone; however, long term effects on a breastfed infant are unknown. there are no data on spironolactone effects on milk production. consider the developmental and health benefits of breastfeeding along with the mother's clinical need for spironolactone and any potential adverse effects on the breastfed child from spironolactone or from the underlying maternal condition. safety and effectiveness in pediatric patients have not been established. aldactone is substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, monitor renal function. aldactone is substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. patients with renal impairment are at increased risk of hyperkalemia. monitor potassium closely. aldactone can cause sudden alterations of fluid and electrolyte balance which may precipitate impaired neurological function, worsening hepatic encephalopathy and coma in patients with hepatic disease with cirrhosis and ascites. in these patients, initiate aldactone in the hospital [see dosage and administration (2.4) and clinical pharmacology (12.3)] . clearance of spironolactone and its metabolites is reduced in patients with cirrhosis. in patients with cirrhosis, start with lowest initial dose and titrate slowly [see dosage and administration (2.4) and clinical pharmacology (12.3)] .

Verenigde Staten - Engels - NLM (National Library of Medicine)

pfizer laboratories div pfizer inc - romidepsin (unii: cx3t89xqbk) (romidepsin - unii:cx3t89xqbk) - romidepsin 10 mg in 2 ml - romidepsin is indicated for the treatment of cutaneous t-cell lymphoma (ctcl) in adult patients who have received at least one prior systemic therapy. romidepsin is indicated for the treatment of peripheral t-cell lymphoma (ptcl) in adult patients who have received at least one prior therapy. this indication is approved under accelerated approval based on response rate [see clinical studies (14.2)]. continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. none. risk summary based on its mechanism of action and findings from animal studies, romidepsin can cause embryo-fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . there are no available data on romidepsin use in pregnant women to inform a drug associated risk of major birth defects and miscarriage. in an animal reproductive study, romidepsin was embryocidal and caused adverse developmental outcomes including embryo-fetal toxicity and malformati

Verenigde Staten - Engels - NLM (National Library of Medicine)

pfizer laboratories div pfizer inc - dacomitinib (unii: 5092u85g58) (dacomitinib anhydrous - unii:2xjx250c20) - vizimpro is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (nsclc) with epidermal growth factor receptor (egfr) exon 19 deletion or exon 21 l858r substitution mutations as detected by an fda-approved test [see dosage and administration (2.1)] . none. risk summary based on findings from animal studies and its mechanism of action, vizimpro can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . there are no available data on vizimpro use in pregnant women. in animal reproduction studies, oral administration of dacomitinib to pregnant rats during the period of organogenesis resulted in an increased incidence of post-implantation loss and reduced fetal body weight at doses resulting in exposures near the exposure at the 45 mg human dose (see data) . the absence of egfr signaling has been shown to result in embryolethality as well as post-natal death in animals (see data) . advise pregnant women of the potential risk to a fetus

Verenigde Staten - Engels - NLM (National Library of Medicine)

pfizer laboratories div pfizer inc - talazoparib tosylate (unii: 02wk9u5nzc) (talazoparib - unii:9qhx048frv) -       talzenna is indicated as a single agent for the treatment of adult patients with deleterious or suspected deleterious germline breast cancer susceptibility gene (brca )-mutated (gbrca m) human epidermal growth factor receptor 2 (her2)-negative locally advanced or metastatic breast cancer. select patients for therapy based on an fda-approved companion diagnostic for talzenna [see dosage and administration (2.1)] . talzenna is indicated in combination with enzalutamide for the treatment of adult patients with homologous recombination repair (hrr) gene-mutated metastatic castration-resistant prostate cancer (mcrpc) [see dosage and administration (2.3)] . none. risk summary based on findings from animal studies and its mechanism of action [see clinical pharmacology (12.1)] , talzenna can cause embryo-fetal harm when administered to a pregnant woman. there are no available data on talzenna use in pregnant women to inform a drug-associated risk. in an animal reproduction study, the administration of talazoparib to pregnant rats during the period of organogenesis caused fetal malformations and structural skeletal variations and embryo-fetal death at maternal exposures that were 0.24 times the auc in patients receiving the recommended dose of 1 mg daily (see data) . apprise pregnant women and females of reproductive potential of the potential risk to a fetus. the background risk of major birth defects and miscarriage for the indicated population is unknown. in the general u.s. population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2% to 4% and 15% to 20%, respectively. data animal data in an embryo-fetal development toxicity study, pregnant rats received oral doses of 0.015, 0.05, and 0.15 mg/kg/day talazoparib during the period of organogenesis. talazoparib caused embryo-fetal death at doses ≥0.015 mg/kg/day (approximately 0.24 times the auc in patients at the recommended dose of 1 mg daily). a dose of 0.015 mg/kg/day caused decreased fetal body weights and an increased incidence of fetal malformations (depressed eye bulge, small eye, split sternebra, and fused cervical vertebral arch) and structural variations including misshapen or incomplete ossification of the sternebra, skull, rib, and vertebra. risk summary there are no data on the presence of talazoparib in human milk, the effects of the drug on milk production, or the effects of the drug on the breastfed child. because of the potential for serious adverse reactions in a breastfed child from talazoparib, advise lactating women not to breastfeed during treatment with talzenna and for 1 month after the final dose. talzenna can cause fetal harm when administered to pregnant women [see use in specific populations (8.1)] . pregnancy testing verify pregnancy status in females of reproductive potential prior to initiating talzenna treatment. contraception females advise females of reproductive potential to use effective contraception during treatment and for 7 months following the last dose of talzenna. males based on genotoxicity and animal reproduction studies, advise male patients with female partners of reproductive potential and pregnant partners to use effective contraception during treatment with talzenna and for 4 months following the last dose [see use in specific populations (8.1), nonclinical toxicology (13.1)] . infertility males based on animal studies, talzenna may impair fertility in males of reproductive potential [see nonclinical toxicology (13.1)]. the safety and effectiveness of talzenna have not been established in pediatric patients. in clinical trials of talzenna enrolling 494 patients with advanced solid tumors who received talzenna 1 mg daily as a single agent, 85 (17%) patients were ≥65 years of age, and this included 19 (4%) patients who were ≥75 years old. there were 5 patients ≥85 years old. in the talapro-2 trial, of 197 patients who received talzenna, 77% were ≥65 years of age, while 30% were ≥75 years of age. no overall differences in safety or effectiveness of talzenna were observed between these patients and younger patients. no dosage modification is recommended for patients with hepatic impairment [see clinical pharmacology (12.3)] . reduce the recommended dosage of talzenna in patients with moderate (clcr 30 – 59 ml/min) and severe (clcr 15 – 29 ml/min) renal impairment [see dosage and administration (2.7)] . monitor patients with severe renal impairment for increased adverse reactions and modify the dosage as recommended for adverse reactions [see dosage and administration (2.5)] . no dose adjustment is recommended for patients with mild renal impairment (clcr 60 – 89 ml/min). talzenna has not been studied in patients requiring hemodialysis.

Verenigde Staten - Engels - NLM (National Library of Medicine)

pfizer laboratories div pfizer inc - lorlatinib (unii: osp71s83eu) (lorlatinib - unii:osp71s83eu) - lorbrena® is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (nsclc) whose tumors are anaplastic lymphoma kinase (alk)-positive as detected by an fda-approved test. lorbrena is contraindicated in patients taking strong cyp3a inducers, due to the potential for serious hepatotoxicity [see warnings and precautions (5.1)] . risk summary based on findings from animal studies and its mechanism of action [see clinical pharmacology (12.1)] , lorbrena can cause embryo-fetal harm when administered to a pregnant woman. there are no available data on lorbrena use in pregnant women. administration of lorlatinib to pregnant rats and rabbits by oral gavage during the period of organogenesis resulted in malformations, increased post-implantation loss, and abortion at maternal exposures that were equal to or less than the human exposure at the recommended dose of 100 mg once daily based on auc (see data) . advise a pregnant woman of the potential risk to a fetus. in the u.s. general p

Verenigde Staten - Engels - NLM (National Library of Medicine)

pfizer laboratories div pfizer inc - filgrastim (unii: pvi5m0m1gw) (filgrastim - unii:pvi5m0m1gw) - nivestym is indicated to decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever [see clinical studies (14.1)] . nivestym is indicated for reducing the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (aml) [see clinical studies (14.2)] . nivestym is indicated to reduce the duration of neutropenia and neutropenia-related clinical sequelae‚ e.g.‚ febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation [see clinical studies (14.3)]. nivestym is indicated for the mobilization of autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis [see clinical studies (14.4)] . nivestym is indicated for chronic administration to reduce the incidence and duration of sequelae of neutropenia (e.g.‚ fever‚ infections‚ oropharyngeal ulcers) in symptomatic patients with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia [see clinical studies (14.5)] . nivestym is contraindicated in patients with a history of serious allergic reactions to human granulocyte colony-stimulating factors such as filgrastim products or pegfilgrastim products [see warnings and precautions (5.3)] . risk summary available data from published studies, including several observational studies of pregnancy outcomes in women exposed to filgrastim products and those who were unexposed, have not established an association with filgrastim products use during pregnancy and major birth defects, miscarriage, or adverse maternal or fetal outcomes (see data) . reports in the scientific literature have described transplacental passage of filgrastim in pregnant women when administered ≤ 30 hours prior to preterm delivery (≤ 30 weeks gestation). in animal reproduction studies, effects of filgrastim on prenatal development have been studied in rats and rabbits. no malformations were observed in either species. no maternal or fetal effects were observed in pregnant rats at doses up to 58 times the human doses. filgrastim has been shown to have adverse effects in pregnant rabbits at doses 2 to 10 times higher than the human doses (see data) . the estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively. data human data several observational studies based on the severe chronic neutropenia international registry (scnir) described pregnancy outcomes in women with severe chronic neutropenia (scn) who were exposed to filgrastim products during pregnancy and women with scn who were unexposed. no major differences were seen between treated and untreated women with respect to pregnancy outcome (including miscarriage and preterm labor), newborn complications (including birth weight) and infections. methodological limitations of these studies, include small sample size, and lack of generalizability due to the underlying maternal condition. animal data effects of filgrastim on prenatal development have been studied in rats and rabbits. no malformations were observed in either species. filgrastim has been shown to have adverse effects in pregnant rabbits at doses 2 to 10 times higher than the human doses. in pregnant rabbits showing signs of maternal toxicity, reduced embryo-fetal survival (at 20 and 80 mcg/kg/day) and increased abortions (at 80 mcg/kg/day) were observed. in pregnant rats, no maternal or fetal effects were observed at doses up to 575 mcg/kg/day, which is approximately 58 times higher than the human dose of 10 mcg/kg/day. offspring of rats administered filgrastim during the peri-natal and lactation periods exhibited a delay in external differentiation and growth retardation (≥ 20 mcg/kg/day) and slightly reduced survival rate (100 mcg/kg/day). risk summary there is published literature documenting transfer of filgrastim into human milk. there are a few case reports describing the use of filgrastim in breastfeeding mothers with no adverse effects noted in the infants. there are no data on the effects of filgrastim products on milk production. other filgrastim products are secreted poorly into breast milk, and filgrastim products are not absorbed orally by neonates. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for nivestym and any potential adverse effects on the breastfed child from nivestym or from the underlying maternal condition. nivestym prefilled syringe with bd ultrasafe plus™ passive needle guard may not accurately measure volumes less than 0.3 ml due to the needle spring mechanism design. therefore, the direct administration of a volume less than 0.3 ml using nivestym prefilled syringe is not recommended due to the potential for dosing errors. for direct administration of doses less than 0.3 ml (180 mcg) use nivestym single-dose vial. in patients with cancer receiving myelosuppressive chemotherapy‚ 15 pediatric patients median age 2.6 (range 1.2 to 9.4) years with neuroblastoma were treated with myelosuppressive chemotherapy (cyclophosphamide‚ cisplatin‚ doxorubicin‚ and etoposide) followed by subcutaneous filgrastim at doses of 5, 10, or 15 mcg/kg/day for 10 days (n = 5/dose) (study 8). the pharmacokinetics of filgrastim in pediatric patients after chemotherapy were similar to those in adults receiving the same weight-normalized doses, suggesting no age-related differences in the pharmacokinetics of filgrastim. in this population‚ filgrastim was well-tolerated. there was one report of palpable splenomegaly and one report of hepatosplenomegaly associated with filgrastim therapy; however‚ the only consistently reported adverse event was musculoskeletal pain‚ which is no different from the experience in the adult population. the safety and effectiveness of nivestym have been established in pediatric patients with scn [see clinical studies (14.5)] . use of nivestym for this indication is supported by nivestym’s approval as a biosimilar to filgrastim and evidence from a phase 3 study (study 7) to assess the safety and efficacy of filgrastim in the treatment of scn where 123 patients with a median age of 12 years (range 7 months to 76 years) were studied. of the 123 patients, 12 were infants (7 months to 2 years of age), 49 were children (2 to 12 years of age), and 9 were adolescents (12 to 16 years of age). additional information is available from a scn postmarketing surveillance study, which includes long-term follow-up of patients in the clinical studies and information from additional patients who entered directly into the postmarketing surveillance study. of the 731 patients in the surveillance study, 429 were pediatric patients < 18 years of age (range 0.9 to 17) [see indications and usage (1.5), dosage and administration (2.5), and clinical studies (14.5)] . long-term follow-up data from the postmarketing surveillance study suggest that height and weight are not adversely affected in patients who received up to 5 years of filgrastim treatment. limited data from patients who were followed in the phase 3 study for 1.5 years did not suggest alterations in sexual maturation or endocrine function. pediatric patients with congenital types of neutropenia (kostmann's syndrome, congenital agranulocytosis, or schwachman-diamond syndrome) have developed cytogenetic abnormalities and have undergone transformation to mds and aml while receiving chronic filgrastim treatment. the relationship of these events to filgrastim product administration is unknown [see warnings and precautions (5.8) and adverse reactions (6)] . among 855 subjects enrolled in 3 randomized, placebo-controlled trials of filgrastim-treated patients receiving myelosuppressive chemotherapy, there were 232 subjects age 65 or older, and 22 subjects age 75 or older. no overall differences in safety or effectiveness were observed between these subjects and younger subjects. clinical studies of filgrastim in other approved indications (i.e., bmt recipients, pbpc mobilization, and scn) did not include sufficient numbers of subjects aged 65 and older to determine whether elderly subjects respond differently from younger subjects. instructions for use nivestym (neye-ves-tim) (filgrastim-aafi) injection single-dose prefilled syringe important read the patient information for important information you need to know about nivestym before using this instructions for use. before you use a nivestym prefilled syringe, read this important information. storing your prefilled syringe using your prefilled syringe call your healthcare provider if you have any questions. about the nivestym prefilled syringe nivestym prefilled syringe parts (see figure a). nivestym 300 mcg/0.5 ml prefilled syringe is shown as an example.   figure a what you need for your injection included in the carton: not included in the carton (see figure b)   figure b preparing the nivestym prefilled syringe step 1: find a clean, well-lit flat work surface. step 2: take the carton containing the nivestym prefilled syringe out of the refrigerator and leave it unopened on your work surface for at least 30 minutes so that it reaches room temperature. put the original carton with any unused prefilled syringes back in the refrigerator. step 3: wash your hands with soap and water. step 4: remove the prefilled syringe from the carton by the needle guard only. do not remove the prefilled syringe by its plunger or needle cover. see figure c. check to make sure that the needle guard is covering the barrel of the prefilled syringe.   figure c do not push the needle guard over the needle cover before the injection. this may activate or lock the needle guard. see figure d that shows a needle guard that has not yet been activated. this is how the prefilled syringe looks before use.   figure d if the needle guard is covering the needle that means it has been activated. see figure e that shows a needle guard that has been activated. this is how the prefilled syringe looks after use. do not use the nivestym prefilled syringe. get another prefilled syringe that has not been activated and is ready to use.   figure e step 5: check the expiration date on the nivestym prefilled syringe. do not use the nivestym prefilled syringe if the expiration date has passed. step 6: inspect the medicine and prefilled syringe. turn the prefilled syringe so you can see the medicine and markings in the window. make sure that you look at the medicine only through the viewing window on the prefilled syringe (see figure f). do not inspect the medicine through the plastic of the needle guard. make sure the medicine in the prefilled syringe is clear and colorless.   figure f step 7: choose the injection site figure g step 8: clean your injection site with an alcohol wipe. see figure h.   figure h step 9: hold the prefilled syringe by the needle guard with the needle cover pointing up. carefully pull the needle cover straight off and away from your body. throw away the needle cover. do not recap the needle. see figure i.   figure i your healthcare provider has prescribed either a "full" syringe dose or a "partial" syringe dose. partial dosing step 10: point the needle up and tap gently until the air rises to the top. see figure j.   figure j step 11: holding the prefilled syringe as shown, slowly push up on the plunger rod to push out the extra air and medicine until the end of the conical base (edge) of the plunger stopper lines up with the syringe marking for your prescribed dose. see figure k for an example of a dose of 0.3 ml. your dose may be different than the example shown. be careful not to activate the needle guard before use. do not use a nivestym prefilled syringe that has been activated. see figure e above. check again to make sure the correct dose of nivestym is in the prefilled syringe.   figure k giving the nivestym prefilled syringe injection step 12: with one hand, gently pinch a fold of skin at the injection site. hold the pinch. see figure l.   figure l step 13: with your other hand, hold the prefilled syringe like you would hold a pencil. use a quick "dart-like" motion to insert the needle at a 45 to 90 degree angle into the skin as shown. see figure m.   figure m step 14: using slow and constant pressure, press down on the plunger rod until it reaches the bottom. see figure n.   figure n step 15: keep the plunger rod fully pressed down while you carefully pull the needle straight out from the injection site. see figure o.   figure o step 16: as you let go of the plunger rod, the needle guard will automatically slide over the needle until the needle is completely covered and the needle guard locks into place. do not recap the needle. see figure p.   figure p step 17: there may be a small amount of blood at the injection site. you can press a cotton ball or gauze over the injection site and hold it for 10 seconds. do not rub the injection site. you may cover the injection site with a small adhesive bandage, if needed. see figure q.   figure q step 18: throw away (dispose of) the syringe as instructed by your healthcare provider or by following the instructions below. see figure r.   figure r disposing of (throw away) used nivestym prefilled syringes this instructions for use has been approved by the u.s. food and drug administration. manufactured by: hospira, inc., a pfizer company lake forest, il 60045 usa us license no. 1974 distributed by pfizer labs, division of pfizer inc., new york, ny 10001 usa lab-0938-6.0 for more information go to www.pfizer.com or call 1-800-438-1985. revised: february 2024 instructions for use nivestym (neye-ves-tim) (filgrastim-aafi) injection single-dose vial important read the patient information for important information you need to know about nivestym before using these instructions for use. before you use a nivestym vial, read this important information: storing your nivestym vial keep nivestym and all medicines out of the reach of children. using your vial call your healthcare provider if you have any questions. step 1: prepare step 2: get ready pull back on the plunger and draw air into the syringe that is the same amount (ml) as the dose of nivestym that your healthcare provider prescribed. important: throw away the needle cap into the sharps disposal container. do not recap the needle. step 3: select and prepare the injection site you can use: step 4: subcutaneous (under the skin) injection step 5: finish this instructions for use has been approved by the u.s. food and drug administration. manufactured by: hospira, inc., a pfizer company lake forest, il 60045 usa us license no. 1974 distributed by pfizer labs, division of pfizer inc., new york, ny 10001 usa lab-0937-5.0 for more information go to www.pfizer.com or call 1-800-438-1985. revised: august 2023

Verenigde Staten - Engels - NLM (National Library of Medicine)

pfizer laboratories div pfizer inc - palbociclib (unii: g9zf61le7g) (palbociclib - unii:g9zf61le7g) - ibrance is indicated for the treatment of adult patients with hormone receptor (hr)-positive, human epidermal growth factor receptor 2 (her2)-negative advanced or metastatic breast cancer in combination with: none. risk summary based on findings from animal studies and its mechanism of action, ibrance can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . there are no available data in pregnant women to inform the drug-associated risk. in animal reproduction studies, administration of palbociclib to pregnant rats and rabbits during organogenesis resulted in embryo-fetal toxicity at maternal exposures that were ≥4 times the human clinical exposure based on auc (see data) . advise pregnant women of the potential risk to a fetus. 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 in a fertility and early embryonic development study in female rats, palbociclib was administered orally for 15 days before mating through to day 7 of pregnancy, which did not cause embryo toxicity at doses up to 300 mg/kg/day with maternal systemic exposures approximately 4 times the human exposure (auc) at the recommended dose. in embryo-fetal development studies in rats and rabbits, pregnant animals received oral doses of palbociclib up to 300 mg/kg/day and 20 mg/kg/day, respectively, during the period of organogenesis. the maternally toxic dose of 300 mg/kg/day was fetotoxic in rats, resulting in reduced fetal body weights. at doses ≥100 mg/kg/day in rats, there was an increased incidence of a skeletal variation (increased incidence of a rib present at the seventh cervical vertebra). at the maternally toxic dose of 20 mg/kg/day in rabbits, there was an increased incidence of skeletal variations, including small phalanges in the forelimb. at 300 mg/kg/day in rats and 20 mg/kg/day in rabbits, the maternal systemic exposures were approximately 4 and 9 times the human exposure (auc) at the recommended dose, respectively. cdk4/6 double knockout mice have been reported to die in late stages of fetal development (gestation day 14.5 until birth) due to severe anemia. however, knockout mouse data may not be predictive of effects in humans due to differences in degree of target inhibition. risk summary there is no information regarding the presence of palbociclib in human milk, its effects on milk production, or the breastfed infant. because of the potential for serious adverse reactions in breastfed infants from ibrance, advise a lactating woman not to breastfeed during treatment with ibrance and for 3 weeks after the last dose. pregnancy testing based on animal studies, ibrance can cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)]. females of reproductive potential should have a pregnancy test prior to starting treatment with ibrance. contraception females ibrance can cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . advise females of reproductive potential to use effective contraception during treatment with ibrance and for at least 3 weeks after the last dose. males because of the potential for genotoxicity, advise male patients with female partners of reproductive potential to use effective contraception during treatment with ibrance and for 3 months after the last dose [see nonclinical toxicology (13.1)] . infertility males based on animal studies, ibrance may impair fertility in males of reproductive potential [see nonclinical toxicology (13.1)] . the safety and efficacy of ibrance in pediatric patients have not been studied. altered glucose metabolism (glycosuria, hyperglycemia, decreased insulin) associated with changes in the pancreas (islet cell vacuolation), eye (cataracts, lens degeneration), kidney (tubule vacuolation, chronic progressive nephropathy) and adipose tissue (atrophy) were identified in a 27 week repeat-dose toxicology study in rats that were immature at the beginning of the studies and were most prevalent in males at oral palbociclib doses ≥30 mg/kg/day (approximately 11 times the adult human exposure [auc] at the recommended dose). some of these findings (glycosuria/hyperglycemia, pancreatic islet cell vacuolation, and kidney tubule vacuolation) were present with lower incidence and severity in a 15 week repeat-dose toxicology study in immature rats. altered glucose metabolism or associated changes in the pancreas, eye, kidney and adipose tissue were not identified in a 27-week repeat-dose toxicology study in rats that were mature at the beginning of the study and in dogs in repeat-dose toxicology studies up to 39 weeks duration. toxicities in teeth independent of altered glucose metabolism were observed in rats. administration of 100 mg/kg palbociclib for 27 weeks (approximately 15 times the adult human exposure [auc] at the recommended dose) resulted in abnormalities in growing incisor teeth (discolored, ameloblast degeneration/necrosis, mononuclear cell infiltrate). other toxicities of potential concern to pediatric patients have not been evaluated in juvenile animals. of 444 patients who received ibrance in paloma-2, 181 patients (41%) were ≥65 years of age and 48 patients (11%) were ≥75 years of age. of 347 patients who received ibrance in paloma-3, 86 patients (25%) were ≥65 years of age and 27 patients (8%) were ≥75 years of age. no overall differences in safety or effectiveness of ibrance were observed between these patients and younger patients. no dose adjustment is required in patients with mild or moderate hepatic impairment (child-pugh classes a and b). for patients with severe hepatic impairment (child-pugh class c), the recommended dose of ibrance is 75 mg once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete cycle of 28 days [see dosage and administration (2.2)] . based on a pharmacokinetic trial in subjects with varying degrees of hepatic function, the palbociclib unbound exposure (unbound aucinf ) decreased by 17% in subjects with mild hepatic impairment (child-pugh class a), and increased by 34% and 77% in subjects with moderate (child-pugh class b) and severe (child-pugh class c) hepatic impairment, respectively, relative to subjects with normal hepatic function. peak palbociclib unbound exposure (unbound cmax ) increased by 7%, 38% and 72% for mild, moderate and severe hepatic impairment, respectively, relative to subjects with normal hepatic function [see clinical pharmacology (12.3)] . review the full prescribing information for the aromatase inhibitor or fulvestrant for dose modifications related to hepatic impairment. no dose adjustment is required in patients with mild, moderate, or severe renal impairment (crcl >15 ml/min). based on a pharmacokinetic trial in subjects with varying degrees of renal function, the total palbociclib exposure (aucinf ) increased by 39%, 42%, and 31% with mild (60 ml/min ≤ crcl <90 ml/min), moderate (30 ml/min ≤ crcl <60 ml/min), and severe (crcl <30 ml/min) renal impairment, respectively, relative to subjects with normal renal function. peak palbociclib exposure (cmax ) increased by 17%, 12%, and 15% for mild, moderate, and severe renal impairment, respectively, relative to subjects with normal renal function. the pharmacokinetics of palbociclib have not been studied in patients requiring hemodialysis [see clinical pharmacology (12.3)] .

Australië - Engels - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - daptomycin, quantity: 350 mg - inhalation, powder for - excipient ingredients: sodium hydroxide; citric acid - daptomycin is active against gram positive bacteria only. in mixed infections where gram negative and/or certain types of anaerobic bacteria are suspected, daptomycin should be co-administered with appropriate antibacterial agent(s).,consideration should be given to official guidance on the appropriate use of antibacterial agents.,daptomycin is not indicated for the treatment of pneumonia.,adult patients (?18 years of age):,complicated skin and skin structure infections,pfizer daptomycin is indicated for the treatment of adults (? 18 years of age) with complicated skin and skin structure infections (csssi) who require parenteral therapy and who have intolerance to alternative agents (especially penicillin allergy) or who have failed on other therapy, and when caused by organisms known to be susceptible to daptomycin.,staphylococcus aureus bloodstream infections (bacteraemia),pfizer daptomycin is indicated in adults (?18 years of age) for staphylococcus aureus bloodstream infections (bacteraemia), including right-sided native valve infective endocarditis (rie), caused by methicillin-susceptible and methicillin-resistant isolates.,the efficacy of daptomycin in patients with prosthetic heart valves or in left-sided endocarditis due to staphylococcus aureus has not been demonstrated. in the setting of staphylococcus aureus bacteraemia (sab), if a focus of infection is diagnosed as left-sided endocarditis after daptomycin therapy has been initiated, then consideration should be given to instituting alternative antibacterial therapy.,paediatric patients (1 to 17 years of age):,daptomycin is not indicated for treatment of patients less than 1 year of age.,daptomycin has not been studied in treatment of infective endocarditis in children.,complicated skin and skin structure infections,pfizer daptomycin is indicated for the treatment of patients aged 1 to 17 years with complicated skin and skin structure infections (csssi) who require parenteral therapy and who have intolerance to alternative agents (especially penicillin allergy) or who have failed on other therapy, and when caused by organisms known to be susceptible to daptomycin.,staphylococcus aureus bloodstream infections (bacteraemia),pfizer daptomycin is indicated in paediatric patients (1 to 17 years of age) with staphylococcus aureus bacteraemia not due to pneumonia, caused by daptomycin-susceptible isolates. empiric treatment should be reviewed based on the results of susceptibility testing. prescribing should be in accordance with nationally or locally-endorsed guidelines for the treatment of staphylococcus aureus bacteraemia.

Australië - Engels - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - daptomycin, quantity: 500 mg - injection, powder for - excipient ingredients: citric acid; sodium hydroxide - daptomycin is active against gram positive bacteria only. in mixed infections where gram negative and/or certain types of anaerobic bacteria are suspected, daptomycin should be co-administered with appropriate antibacterial agent(s).,consideration should be given to official guidance on the appropriate use of antibacterial agents.,daptomycin is not indicated for the treatment of pneumonia.,adult patients (?18 years of age):,complicated skin and skin structure infections,pfizer daptomycin is indicated for the treatment of adults (? 18 years of age) with complicated skin and skin structure infections (csssi) who require parenteral therapy and who have intolerance to alternative agents (especially penicillin allergy) or who have failed on other therapy, and when caused by organisms known to be susceptible to daptomycin.,staphylococcus aureus bloodstream infections (bacteraemia),pfizer daptomycin is indicated in adults (?18 years of age) for staphylococcus aureus bloodstream infections (bacteraemia), including right-sided native valve infective endocarditis (rie), caused by methicillin-susceptible and methicillin-resistant isolates.,the efficacy of daptomycin in patients with prosthetic heart valves or in left-sided endocarditis due to staphylococcus aureus has not been demonstrated. in the setting of staphylococcus aureus bacteraemia (sab), if a focus of infection is diagnosed as left-sided endocarditis after daptomycin therapy has been initiated, then consideration should be given to instituting alternative antibacterial therapy.,paediatric patients (1 to 17 years of age):,daptomycin is not indicated for treatment of patients less than 1 year of age.,daptomycin has not been studied in treatment of infective endocarditis in children.,complicated skin and skin structure infections,pfizer daptomycin is indicated for the treatment of patients aged 1 to 17 years with complicated skin and skin structure infections (csssi) who require parenteral therapy and who have intolerance to alternative agents (especially penicillin allergy) or who have failed on other therapy, and when caused by organisms known to be susceptible to daptomycin.,staphylococcus aureus bloodstream infections (bacteraemia),pfizer daptomycin is indicated in paediatric patients (1 to 17 years of age) with staphylococcus aureus bacteraemia not due to pneumonia, caused by daptomycin-susceptible isolates. empiric treatment should be reviewed based on the results of susceptibility testing. prescribing should be in accordance with nationally or locally-endorsed guidelines for the treatment of staphylococcus aureus bacteraemia.

Verenigde Staten - Engels - NLM (National Library of Medicine)

pfizer manufacturing belgium nv - tozinameran (unii: 5085zfp6sj) (tozinameran - unii:5085zfp6sj), famtozinameran (unii: jsv288q5cv) (famtozinameran - unii:jsv288q5cv) - pfizer-biontech covid-19 vaccine, bivalent (original and omicron ba.4/ba.5) is authorized for use under an emergency use authorization (eua) for active immunization to prevent coronavirus disease 2019 (covid-19) caused by severe acute respiratory syndrome coronavirus 2 (sars-cov-2) in individuals 5 years of age and older. this eua prescribing information pertains only to pfizer-biontech covid-19 vaccine, bivalent (original and omicron ba.4/ba.5), hereafter referred to as pfizer-biontech covid-19 vaccine, bivalent, supplied in a multiple dose vial with an orange cap and a label with an orange border, which is authorized for use in individuals 5 through 11 years of age. the vial labels state: age 5y to <12y. the carton labels state: for age 5 years to <12 years. do not administer pfizer-biontech covid-19 vaccine, bivalent to individuals with known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the pfizer-biontech covid-19 vaccine or the pfizer-biontech covid-19 vaccine, bivalent [