AGROTECH AUSTRALIA PTY LTD - search results

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

zevalin- ibritumomab tiuxetan kit

acrotech biopharma inc - ibritumomab tiuxetan (unii: 4q52c550xk) (ibritumomab tiuxetan - unii:4q52c550xk) - zevalin is indicated for the treatment of adult patients with relapsed or refractory, low-grade or follicular b-cell non-hodgkin's lymphoma (nhl). zevalin is indicated for the treatment of previously untreated follicular nhl in adult patients who achieve a partial or complete response to first-line chemotherapy. none. risk summary based on its radioactivity, y-90 zevalin may cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . immunoglobulins are known to cross the placenta. there are no available data on zevalin use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. advise women of childbearing potential to use adequate contraception for a minimum of twelve months. inform women who become pregnant while receiving zevalin of the potential fetal risks. the estimated background risk of major birth defects and miscarriage for the indicated populations are unknown. all pregnancies have a background risk of birth defect, loss, or other

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

marqibo- vincristine sulfate kit

acrotech biopharma llc - vincristine sulfate (unii: t5iro3534a) (vincristine - unii:5j49q6b70f) - marqibo® is indicated for the treatment of adult patients with philadelphia chromosome negative (ph-) acute lymphoblastic leukemia (all) in second or greater relapse or whose disease has progressed following two or more anti leukemia therapies. this indication is approved under accelerated approval based on overall response rate [see clinical studies (14)]. continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). marqibo is contraindicated in patients with demyelinating conditions, including charcot-marie-tooth syndrome. marqibo is contraindicated in patients with hypersensitivity to vincristine sulfate or any of the other components of marqibo (vincristine sulfate liposome injection). marqibo is contraindicated for intrathecal administration risk summary based on findings from nonclinical studies and its mechanism of action, marqibo can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1 ),

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

evomela- melphalan injection, powder, lyophilized, for solution

acrotech biopharma inc - melphalan hydrochloride (unii: 1vxp4v453t) (melphalan - unii:q41or9510p) - evomela is indicated for use as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma. history of serious allergic reaction to melphalan. risk summary based on its mechanism of action, evomela can cause fetal harm when administered to a pregnant woman, including teratogenicity and/or embryo-fetal lethality [see clinical pharmacology (12.1)] . melphalan is a genotoxic drug and can cause chromatid or chromosome damage in humans [see nonclinical toxicology (13.1)] . in animal studies, melphalan was embryolethal and teratogenic in rats at doses below the recommended clinical doses [see data] . advise a pregnant woman of the potential risk to a fetus.. the background risk of major birth defects and miscarriage for the indicated populations are unknown. however, the background risk in the u.s. general population of major birth defects is 2-4% and of miscarriage is 15-20% of clinically recognized pregnancies. data animal data adequate ani

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

folotyn- pralatrexate injection

acrotech biopharma inc - pralatrexate (unii: a8q8i19q20) (pralatrexate - unii:a8q8i19q20) - folotyn is indicated for the treatment of patients with relapsed or refractory peripheral t-cell lymphoma (ptcl). this indication is approved under accelerated approval based on overall response rate [see clinical studies (14)] . continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). none risk summary based on findings from animal studies and its mechanism of action [see clinical pharmacology (12.1)] , folotyn can cause fetal harm when administered to a pregnant woman. there are insufficient data on folotyn use in pregnant women to evaluate for a drug- associated risk. folotyn was embryotoxic and fetotoxic in rats and rabbits when administered during organogenesis at doses about 1.2% (0.012 times) of the clinical dose on a mg/m2 basis. advise pregnant women of the potential risk to a fetus. the estimated background risk of major birth defects and miscarriage for the indicated population(s) is unknown. all pregnancies have

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

hemady- dexamethasone tablet

acrotech biopharma llc - dexamethasone (unii: 7s5i7g3jql) (dexamethasone - unii:7s5i7g3jql) - hemady is indicated in combination with other anti-myeloma products for the treatment of adults with multiple myeloma (mm). hemady is contraindicated in patients with: - hypersensitivity to dexamethasone, or any of the excipients. rare instances of anaphylactic reactions have been reported [see adverse reactions (6), description (11) ]. - systemic fungal infections. corticosteroids may exacerbate systemic fungal infections [see warnings and precautions (5.2)]. risk summary corticosteroids, including hemady, readily cross the placenta. adverse developmental outcomes including orofacial clefts (cleft lip with or without cleft palate), intrauterine growth restriction, and decreased birth weight have been reported with maternal use of corticosteroids, including hemady, during pregnancy. in animal developmental and reproductive toxicology studies administration of corticosteroids to pregnant animals during organogenesis resulted in structural abnormalities, embryo-fetal mortality, functional impairment, and altera