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

arrotex pharmaceuticals pty ltd - varenicline tartrate, quantity: 1.71 mg (equivalent: varenicline, qty 1 mg) - tablet, film coated - excipient ingredients: calcium hydrogen phosphate; triacetin; hypromellose; hyprolose; titanium dioxide; indigo carmine aluminium lake; croscarmellose sodium; sodium stearylfumarate - varenicline tablets are indicated as an aid to smoking cessation in adults over the age of 18 years.

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

arrotex pharmaceuticals pty ltd - varenicline tartrate, quantity: 1.71 mg (equivalent: varenicline, qty 1 mg) - tablet, film coated - excipient ingredients: calcium hydrogen phosphate; triacetin; hypromellose; hyprolose; titanium dioxide; indigo carmine aluminium lake; croscarmellose sodium; sodium stearylfumarate - varenicline tablets are indicated as an aid to smoking cessation in adults over the age of 18 years.

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

arrotex pharmaceuticals pty ltd - varenicline tartrate, quantity: 1.71 mg (equivalent: varenicline, qty 1 mg) - tablet, film coated - excipient ingredients: calcium hydrogen phosphate; hyprolose; titanium dioxide; hypromellose; triacetin; indigo carmine aluminium lake; croscarmellose sodium; sodium stearylfumarate - varenicline tablets are indicated as an aid to smoking cessation in adults over the age of 18 years.

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

arrotex pharmaceuticals pty ltd - varenicline tartrate, quantity: 1.71 mg (equivalent: varenicline, qty 1 mg) - tablet, film coated - excipient ingredients: calcium hydrogen phosphate; hyprolose; titanium dioxide; hypromellose; triacetin; indigo carmine aluminium lake; croscarmellose sodium; sodium stearylfumarate - varenicline tablets are indicated as an aid to smoking cessation in adults over the age of 18 years.

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

carilion materials management - varenicline tartrate (unii: 82269asb48) (varenicline - unii:w6hs99o8zo) - chantix is indicated for use as an aid to smoking cessation treatment. chantix is contraindicated in patients with a known history of serious hypersensitivity reactions or skin reactions to chantix pregnancy category c. there are no adequate and well-controlled studies of chantix use in pregnant women. in animal studies, chantix caused decreased fetal weights, increased auditory startle response, and decreased fertility in offspring. chantix should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. in reproductive and developmental toxicity studies, pregnant rats and rabbits received varenicline succinate during organogenesis at oral doses up to 15 and 30 mg/kg/day, respectively. these exposures were 36 (rats) and 50 (rabbits) times the human exposure (based on auc) at the maximum recommended human dose (mrhd) of 1 mg twice daily. while no fetal structural abnormalities occurred in either species, reduced fetal weights occurred in rabbits at the highest dose (e

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

a-s medication solutions - varenicline tartrate (unii: 82269asb48) (varenicline - unii:w6hs99o8zo) - chantix is indicated for use as an aid to smoking cessation treatment. chantix is contraindicated in patients with a known history of serious hypersensitivity reactions or skin reactions to chantix. risk summary available data have not suggested an increased risk for major birth defects following exposure to varenicline in pregnancy, compared with women who smoke [see data]. smoking during pregnancy is associated with maternal, fetal, and neonatal risks (see clinical considerations) . in animal studies, varenicline did not result in major malformations but caused decreased fetal weights in rabbits when dosed during organogenesis at exposures equivalent to 50 times the exposure at the maximum recommended human dose (mrhd). additionally, administration of varenicline to pregnant rats during organogenesis through lactation produced developmental toxicity in offspring at maternal exposures equivalent to 36 times human exposure at the mrhd [see data] . the estimated background risk of oral clefts is increased by

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

a-s medication solutions - varenicline tartrate (unii: 82269asb48) (varenicline - unii:w6hs99o8zo) - chantix is indicated for use as an aid to smoking cessation treatment. chantix is contraindicated in patients with a known history of serious hypersensitivity reactions or skin reactions to chantix. risk summary available data have not suggested an increased risk for major birth defects following exposure to varenicline in pregnancy, compared with women who smoke [see data]. smoking during pregnancy is associated with maternal, fetal, and neonatal risks (see clinical considerations) . in animal studies, varenicline did not result in major malformations but caused decreased fetal weights in rabbits when dosed during organogenesis at exposures equivalent to 50 times the exposure at the maximum recommended human dose (mrhd). additionally, administration of varenicline to pregnant rats during organogenesis through lactation produced developmental toxicity in offspring at maternal exposures equivalent to 36 times human exposure at the mrhd [see data] . the estimated background risk of oral clefts is increased by

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

a-s medication solutions - varenicline tartrate (unii: 82269asb48) (varenicline - unii:w6hs99o8zo) - chantix is indicated for use as an aid to smoking cessation treatment. chantix is contraindicated in patients with a known history of serious hypersensitivity reactions or skin reactions to chantix. risk summary available data have not suggested an increased risk for major birth defects following exposure to varenicline in pregnancy, compared with women who smoke [see data]. smoking during pregnancy is associated with maternal, fetal, and neonatal risks (see clinical considerations) . in animal studies, varenicline did not result in major malformations but caused decreased fetal weights in rabbits when dosed during organogenesis at exposures equivalent to 50 times the exposure at the maximum recommended human dose (mrhd). additionally, administration of varenicline to pregnant rats during organogenesis through lactation produced developmental toxicity in offspring at maternal exposures equivalent to 36 times human exposure at the mrhd [see data] . the estimated background risk of oral clefts is increased by

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

proficient rx lp - varenicline tartrate (unii: 82269asb48) (varenicline - unii:w6hs99o8zo) - chantix is indicated for use as an aid to smoking cessation treatment. chantix is contraindicated in patients with a known history of serious hypersensitivity reactions or skin reactions to chantix. risk summary available data have not suggested an increased risk for major birth defects following exposure to varenicline in pregnancy, compared with women who smoke [see data]. smoking during pregnancy is associated with maternal, fetal, and neonatal risks (see clinical considerations) . in animal studies, varenicline did not result in major malformations but caused decreased fetal weights in rabbits when dosed during organogenesis at exposures equivalent to 50 times the exposure at the maximum recommended human dose (mrhd). additionally, administration of varenicline to pregnant rats during organogenesis through lactation produced developmental toxicity in offspring at maternal exposures equivalent to 36 times human exposure at the mrhd [see data] . the estimated background risk of oral clefts is increased by

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

oyster point pharma - varenicline tartrate (unii: 82269asb48) (varenicline - unii:w6hs99o8zo) - tyrvaya (varenicline solution) nasal spray is indicated for the treatment of the signs and symptoms of dry eye disease. none risk summary there are no available data on tyrvaya use in pregnant women to inform any drug associated risks. in animal reproduction studies, varenicline did not produce malformations at clinically relevant doses. all pregnancies have a risk of birth defect, loss, or other adverse outcomes. in the us general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. data animal data pregnant rats and rabbits received varenicline succinate during organogenesis at oral doses up to 15 and 30 mg/kg/day, respectively. while no fetal structural abnormalities occurred in either species, maternal toxicity, characterized by reduced body weight gain, and reduced fetal weights occurred in rabbits at the highest dose (4864 times the mrhd on a mg/m2 basis). in a pre- and postnatal development study, pregnant rats received up to 15 mg/kg/day of oral varenicline succinate from organogenesis through lactation. maternal toxicity, characterized by a decrease in body weight gain, was observed at 15 mg/kg/day (1216 times the mrhd on a mg/m2 basis). decreased fertility and increased auditory startle response occurred in offspring at the highest maternal dose of 15 mg/kg/day. risk summary there are no data on the presence of varenicline in human milk, the effects on the breastfed infant, or the effects on milk production. in animal studies varenicline was present in milk of lactating rats. however, due to species-specific differences in lactation physiology, animal data may not reliably predict drug levels in human milk. the lack of clinical data during lactation precludes a clear determination of the risk of tyrvaya to an infant during lactation; however, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for tyrvaya and any potential adverse effects on the breastfed child from tyrvaya. safety and efficacy of tyrvaya in pediatric patients have not been established.  no overall differences in safety or effectiveness have been observed between elderly and younger adult patients. instructions for use   tyrvaya ®   (teer-vye-ah) (varenicline solution ) n asal s pray , for intranasal use read this instructions for use before you start using tyrvaya and each time you get a refill. there may be new information. this information does not take the place of talking to your healthcare provider about your medical condition or your treatment. - tyrvaya is for use in the nose. - do not shake the bottles. - the tyrvaya carton contains enough medicine for 30 days.  each carton has 2 glass nasal spray bottles. each nasal spray bottle has enough medicine for 15 days of treatment.   do not open the second nasal spray bottle until you have used the entire first bottle.  - each carton has 2 glass nasal spray bottles. - each nasal spray bottle has enough medicine for 15 days of treatment.   - do not open the second nasal spray bottle until you have used the entire first bottle.  - reprime : if you do not use tyrvaya for more than 5 days , you will need to reprime the nasal spray bottle with 1 spray before you start using it. to reprime, hold the nasal spray bottle upright and away from your face and fully  press and release the nasal spray applicator 1   time . - avoid priming the nasal spray bottle more than needed : priming the nasal spray bottle more than needed will reduce the amount of medicine in the nasal spray bottle. this instructions for use has been approved by the u.s. food and drug administration. tyrvaya® is a registered trademark of oyster point pharma, inc., a viatris company. tyrvaya® and/or the use of tyrvaya® in a method may be covered by one or more patents or patent applications, available at www.oysterpointrx.com/patent-notices. manufactured for: oyster point pharma, inc., 202 carnegie center, suite 106, princeton, nj 08540 ©2023 oyster point pharma, inc.                                     revised: 2/2024