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aubagio 14mg tablets

genzyme therapeutics ltd - teriflunomide - tablet - 14mg

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

cablivi- caplacizumab kit

genzyme corporation - caplacizumab (unii: 2r27ab6766) (caplacizumab - unii:2r27ab6766) - cablivi is indicated for the treatment of adult patients with acquired thrombotic thrombocytopenic purpura (attp), in combination with plasma exchange and immunosuppressive therapy. cablivi is contraindicated in patients with a previous severe hypersensitivity reaction to caplacizumab-yhdp or to any of the excipients. hypersensitivity reactions have included urticaria [see adverse reactions (6.1)] . risk summary there are no available data on cablivi use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. however, there are potential risks of hemorrhage in the mother and fetus associated with use of cablivi (see clinical considerations) . in animal reproduction studies, there was no evidence of adverse developmental outcomes with intramuscular administration of caplacizumab-yhdp during organogenesis in guinea pigs at exposures approximately 30 times the auc in humans at the recommended subcutaneous injection dose of 11 mg (see data) . all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. the background rate of major birth defects and miscarriage in the indicated population is unknown. in the u.s. general population, the estimated background rate of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. clinical considerations fetal/neonatal adverse reactions cablivi may increase the risk of bleeding in the fetus and neonate. monitor neonates for bleeding [see warnings and precautions (5.1)] . maternal adverse reactions all patients receiving cablivi, including pregnant women, are at risk for bleeding. pregnant women receiving cablivi should be carefully monitored for evidence of excessive bleeding [see warnings and precautions (5.1)] . data animal data two separate reproduction studies were conducted in pregnant guinea pigs with administration of caplacizumab-yhdp during the organogenesis period. in an embryo-fetal development study, caplacizumab-yhdp was administered intramuscularly at doses up to 20 mg/kg/day from gestational day (gd) 6 to gd 41 in guinea pigs. no maternal toxicity or adverse developmental outcomes were observed. in a toxicokinetic study assessing the exposure of caplacizumab-yhdp in the dams and fetuses, caplacizumab-yhdp was administered once daily to female guinea pigs at doses up to 40 mg/kg/day (corresponding to a drug exposure of approximately 30 times the auc in humans at the recommended dose of 11 mg) by intramuscular injection from gd 6 to gd 41 or gd 61. exposure to caplacizumab-yhdp was observed in the dams and fetuses, with no effects on embryo-fetal development. risk summary there is no information regarding the presence of caplacizumab-yhdp in human milk, the effects on the breastfed child or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for cablivi and any potential adverse effects on the breastfed child from cablivi, or from the underlying maternal condition. the safety and effectiveness of cablivi in pediatric patients have not been established. clinical studies of cablivi did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. no formal studies with cablivi have been conducted in patients with severe acute or chronic hepatic impairment and no data regarding the use of cablivi in these populations are available. due to a potential increased risk of bleeding, use of cablivi in patients with severe hepatic impairment requires close monitoring for bleeding [see warnings and precautions (5.1)] . - make sure that the name cablivi appears on the carton and vial label. - for each injection, one cablivi carton is needed. only use the vial one time. - only use the supplies that are provided in the carton to prepare your prescribed dose. - do not use cablivi after the expiration date on the carton. - do not reuse any of the supplies. after your injection, throw away (dispose of) the used vial with any remaining cablivi liquid in it. throw away (dispose of) the used vial with the adapter attached and the syringe with the needle attached in a fda-cleared sharps disposal container. see "step 13: throw away (dispose of) the used syringe and vial" at the end of this instructions for use for more disposal information. - store cablivi in the refrigerator between 36°f to 46°f (2°c to 8°c). - use the mixed cablivi solution immediately. the mixed cablivi solution can be stored for up to 4 hours in the refrigerator at 36°f to 46°f (2°c to 8°c). - if needed, unopened cablivi vials may be stored at room temperature (up to 30°c or 86°f) in the original carton for a single period of up to two months. write the date removed from the refrigerator in the space provided on the carton. - do not return cablivi to the refrigerator after it has been stored at room temperature. - do not freeze cablivi. - keep cablivi in the carton that it came in to protect it from light. - keep cablivi and all medicines out of the reach of children. - 1 vial of cablivi - 1 prefilled syringe containing 1 ml sterile water for injection, usp (diluent for cablivi) - 1 sterile vial adapter - 1 sterile needle - 2 alcohol swabs - fda-cleared sharps disposal container. see "step 13: throw away (dispose of) the used syringe" at the end of this instructions for use for more disposal information. - cotton balls - wash your hands well with soap and water. - prepare a clean flat surface. - check to make sure the carton contains all of the items needed to prepare a dose. - check the expiration date (see figure a) . do not use cablivi if the date has passed. - do not use cablivi if the packaging or any supplies inside of the carton are damaged in any way. - place all the supplies in the carton on the clean flat surface. - if the carton was not stored at room temperature, allow the vial and the syringe to reach room temperature by holding them in your hands for 10 seconds (see figure b) . do not use any other way to warm up the vial and syringe. - remove the green plastic flip-off cap from the metal cap of the vial (see figure c) . do not use the vial if the green plastic cap is missing. - clean the exposed rubber stopper using one alcohol swab to wipe it and allow it to dry for a few seconds (see figure d) . - after cleaning the rubber stopper, do not touch it or allow it to touch any surface. - take the vial adapter and remove the paper cover (see figure e) . leave the vial adapter in its opened plastic packaging for now. do not touch the adapter itself. - place the adapter over the vial, while keeping the adapter in its plastic packaging. - press down firmly on the adapter until it snaps into place, with the adapter spike pushing through the vial stopper (see figure f) . do not remove the adapter from the vial once attached. - keep the adapter in its plastic packaging. - pick up the syringe. - while holding the syringe with one hand, break off the white plastic cap by snapping at the perforation of the cap with your other hand (see figure g) . - do not use the syringe if the white plastic cap is missing, loose, or damaged. - do not touch the syringe tip or allow it to come into contact with any surfaces. - lay the syringe on the clean flat surface. - remove the plastic packaging from the adapter attached to the vial by holding the vial with one hand, pressing the sides of the adapter packaging with your other hand, and then lifting the packaging upwards (see figure h) . - be sure that the adapter does not detach from the vial. - hold the adapter with the attached vial with one hand. place the tip of the syringe on the connector part of the vial adapter using the other hand. - gently lock the syringe into the vial adapter by turning it clockwise until it cannot twist any further (see figure i) . - place the vial upright on the flat surface with the syringe pointing downwards. - slowly push the syringe plunger down until the syringe is empty (see figure j) . do not remove the syringe from the vial adapter. - with the syringe still connected to the vial adapter, gently swirl the vial, with syringe attached, until the powder is dissolved in the vial (see figure k) . do not shake the vial. - allow the vial with the attached syringe to stand on the flat surface for 2 minutes at room temperature to allow the powder to completely dissolve (see figure l) . the plunger may rise up by itself again, this is normal. - check the solution in the vial for particles, cloudiness, or clumps. all powder must be fully dissolved and the solution must be clear. do not use the medicine if you see particles, cloudiness, or clumps. use a new carton of cablivi or call your healthcare provider. - slowly press the syringe plunger fully down. - keep the syringe on the vial and turn the vial, adapter and syringe upside down. - slowly pull the plunger down to withdraw all of the solution from the vial into the syringe (see figure m) . do not shake it. - after drawing up the solution into the syringe, turn the vial, adapter and syringe back to the starting position and place on the flat surface (see figure n) . - detach the filled syringe from the adapter by holding the vial and adapter in one hand and gently twisting the syringe counter-clockwise with the other hand (see figure o) . - throw away the vial and the attached adapter into a sharps disposal container. - do not touch the syringe tip or allow it to touch the clean flat surface. place the syringe on the clean flat surface. - open the needle package by using both thumbs to pull apart the packaging (see figure p) . - remove the needle from the package. - attach the needle with the needle cap to the syringe by turning clockwise until it cannot twist any further (see figure q) . do not remove the needle cap. - pull back the needle safety shield (see figure r) . - select an injection site on your stomach (abdomen) (see figure s) . avoid the 2-inch area around your belly button (navel). it is important to avoid injecting in the same site on your abdomen that you used for a previous injection on consecutive days. - clean your injection site with an alcohol swab (see figure t) . let your skin dry. - carefully remove the needle cap from the needle and throw it away in a sharps disposal container (see figure u) . make sure the needle does not touch anything before the injection. - hold the syringe at eye level with the needle pointing upwards. - check to see if there are any air bubbles. if there are any air bubbles, remove them by tapping the side of the syringe with your finger until they rise towards the tip (see figure v) . - then, slowly push the plunger up until a small amount of liquid drips from the needle (see figure w) . - gently use one hand to pinch the skin that has been cleaned between your thumb and forefinger, making a fold (see figure x) . - hold the pinch during the entire injection. - use your other hand to insert the needle all the way into your skin fold at a 45 to 90-degree angle (see figure y) . - push down on the plunger of the syringe until all of the solution is injected into your skin. - pull out the needle at the same angle you inserted it. do not rub your injection site. - right after your injection, move the needle safety shield over the needle until it clicks into place to activate the shield (see figure z) . - in case you are bleeding at the injection site, place a cotton ball over the skin right away. press gently on the cotton ball until the bleeding has stopped. if bleeding does not stop, call your healthcare provider. - if your injection site becomes red or sore, call your healthcare provider right away. - throw away the syringe with the needle and the vial with the adapter in a fda-cleared sharps disposal container right away after use. do not throw away (dispose of) loose needles and syringes with your household trash. - if you do not have a fda-cleared sharps disposal container, you may use a household container that is: made of a heavy-duty plastic, can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, upright and stable during use, leak-resistant, and properly labeled to warn of hazardous waste inside the container. - made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. - 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 in which you live, go to the fda's website at: http://www.fda.gov/safesharpsdisposal. - do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. do not recycle your used sharps disposal container. manufactured by: ablynx n.v. technologiepark 21 9052 ghent (zwijnaarde), belgium a sanofi company u.s. license no. 2085 distributed by: genzyme corporation cambridge, ma 02141 a sanofi company issued: april 2023