PATIENT INFORMATION. (methotrexate) injection, for subcutaneous use

Transcription

1 What is Rasuv? PATIENT INFORMATION RASUVO (ruh-soo-vh) (methtrexate) injectin, fr subcutaneus use Rasuv is a single-dse manually-triggered aut-injectr cntaining a prescriptin medicine, methtrexate. Methtrexate is used t: treat certain adults with severe, active rheumatid arthritis (RA), and children with active plyarticular juvenile idipathic arthritis (pjia), after treatment with ther medicines including nn-steridal anti-inflammatry (NSAIDS) have been used and did nt wrk well. cntrl the symptms f severe, resistant, disabling psriasis in adults when ther types f treatment have been used and did nt wrk well. Rasuv is available in dses f 7.5, 10, 12.5, 15, 17.5, 20, 22.5, 25, 27.5 and 30 mg. Yur dctr will prescribe a different way t take methtrexate if yu need t take methtrexate by muth r in sme ther way. Yur dctr may als change yur prescriptin if yur dse des nt match the available Rasuv dses, such as dses f less than 7.5 mg, mre than 30 mg, r dses in between the available Rasuv dses. Rasuv shuld nt be used fr the treatment f cancer. Rasuv shuld nt be used fr the treatment f children with psriasis. What is the mst imprtant infrmatin I shuld knw abut Rasuv? Rasuv can cause serius side effects that can lead t death, including: 1. Organ system txicity. Peple wh use methtrexate fr the treatment f cancer, psriasis, r rheumatid arthritis, have an increased risk f death frm rgan txicity. Types f rgan txicity can include: gastrintestinal bne marrw liver immune system nerve lung kidneys skin Yur dctr will d bld tests and ther types f tests befre yu take and while yu are taking Rasuv t check fr signs and symptms f rgan txicity. Call yur dctr right away if yu have any f the fllwing symptms f rgan txicity: vmiting diarrhea muth sres fever cnfusin weakness neck stiffness paralysis irritability sleepiness prblems with crdinatin dry cugh

2 temprary blindness seizures headache back pain 2. Wmen wh are pregnant are at increased risk fr death f the baby and birth defects. Wmen wh are pregnant r wh plan t becme pregnant must nt take Rasuv. A pregnancy test shuld be perfrmed befre starting Rasuv. Cntraceptin shuld be used by bth females and males while taking Rasuv. Pregnancy shuld be avided if either partner is receiving Rasuv: fr a minimum f 3 mnths after treatment with Rasuv fr males. during and fr at least 1 menstrual cycle after treatment with Rasuv fr females. Wh shuld nt take Rasuv? D nt take Rasuv if yu: are pregnant r planning t becme pregnant. See What is the mst imprtant infrmatin I shuld knw abut Rasuv? are breastfeeding. Rasuv can pass int yur breast milk and may harm yur baby. D nt breastfeed while taking Rasuv. Talk t yur dctr abut the best way t feed yur baby if yu take Rasuv. have alchl prblems (alchlism) have liver prblems have prblems fighting infectin (immundeficiency syndrme) have been tld yu have (r think yu have) a bld disrder such as lw levels f white bld cells, red bld cells (anemia), r platelets. have had an allergy t methtrexate r any f the ingredients in Rasuv. See the end f this leaflet fr a cmplete list f ingredients in Rasuv. Talk t yur dctr befre taking this medicine if yu have any f these cnditins. What shuld I tell my dctr befre taking Rasuv? Befre yu take Rasuv, tell yur dctr if yu have any ther medical cnditins. Tell yur dctr abut all f the medicines yu take, including prescriptin, ver-the-cunter medicines, vitamins, and herbal supplements. Rasuv may affect hw ther medicines wrk, and ther medicines may affect hw Rasuv wrks causing side effects. Ask yur dctr r pharmacist fr a list f medicines if yu are nt sure. Knw the medicines yu take. Keep a list f them t shw yur dctr and pharmacist when yu get a new medicine. truble breathing severe skin rash infectin

3 Hw shuld I take Rasuv? Read the Instructins fr Use that cme with Rasuv. Take Rasuv exactly as yur dctr tells yu t take it. Inject Rasuv nly 1 time each week. D nt take Rasuv every day. Taking Rasuv every day may cause death frm txicity. Yur dctr will shw yu r yur caregiver hw t inject Rasuv. Yu shuld nt inject Rasuv until yu have been trained n the right way t use it. Check Rasuv befre yu inject it. Rasuv shuld be yellw t brwn in clr and shuld nt have any lumps r particles in it. Rasuv shuld be injected under the skin f the abdmen r thigh. D nt inject Rasuv within 2 inches f the belly buttn (navel) Use a different site each time yu inject. This may help t decrease any reactins at the injectin site. D nt inject Rasuv in the arms r any ther areas f the bdy. D nt inject Rasuv in areas where the skin is tender, bruised, red, scaly, hard, r has scars r stretch marks. If yu are nt sure if Rasuv was injected, r if yu have hard time giving the injectin, d nt inject anther dse. Call yur pharmacist r dctr right away. If yu inject t much Rasuv, call yur dctr r g t the nearest hspital emergency rm right away. What shuld I avid while taking Rasuv? D nt drink alchl while taking Rasuv. Drinking alchl can increase yur chances f getting serius side effects. Rasuv can cause dizziness and tiredness. D nt drive a car, perate machinery, r d anything that needs yu t be alert until yu knw hw Rasuv affects yu. Certain vaccinatins shuld be avided while taking Rasuv. Talk t yur dctr befre yu r members f yur husehld receive any vaccines. What are the pssible side effects f Rasuv? Rasuv may cause serius side effects, including: See What is the mst imprtant infrmatin I shuld knw abut Rasuv? fertility prblems. Methtrexate, the active ingredient in Rasuv, may affect yur ability t have a baby. Males may have a decreased sperm cunt, and females may have changes t their menstrual cycle. This can happen while taking Rasuv and fr a shrt perid f time after yu stp. certain cancers. Sme peple wh have taken methtrexate have had a certain type f cancer called Nn-Hdgkin s lymphma and ther tumrs. Yur dctr may tell yu t stp taking Rasuv if this happens. tissue and bne prblems. Taking methtrexate while having radiatin therapy may increase the risk f yur tissue r bne nt receiving enugh bld. This may lead t death f the tissue r bne.

4 Cmmn side effects f Rasuv include: nausea stmach pain indigestin (dyspepsia) muth sres rash stuffy r runny nse and sre thrat diarrhea abnrmal liver functin tests vmiting headache brnchitis lw red, white, and platelet bld cell cunt hair lss dizziness sensitivity t light burning skin lesins lung prblems Tell yur dctr if yu have any side effect that bthers yu r that des nt g away. These are nt all the pssible side effects f Rasuv. Fr mre infrmatin, ask yur dctr r pharmacist. Call yu dctr fr medical advice abut side effects. Yu may reprt side effects t FDA at FDA Hw shuld I dispse f Rasuv? D nt thrw away in the husehld trash. Put used Rasuv in a FDAcleared sharps dispsal cntainer right away after use. If yu d nt have a FDA-cleared sharps dispsal cntainer, yu may use a husehld cntainer that is: made f a heavy-duty plastic can be clsed with a tight-fitting, puncture-resistant lid, withut sharps being able t cme ut upright stable during use leak-resistant prperly labeled t warn f hazardus waste inside the cntainer When yur sharps dispsal cntainer is almst full, yu will need t fllw yur cmmunity guidelines fr the right way t dispse f yur sharps dispsal cntainer. There may be state r lcal laws abut hw yu shuld thrw away used needles and syringes. Fr mre infrmatin abut the safe sharps dispsal, and fr specific infrmatin abut sharps dispsal in the state that yu live in, g t the FDA s website at: D nt dispse f yur used sharps dispsal cntainer in yur husehld trash unless yur cmmunity guidelines permit this. D nt recycle yur used sharps dispsal cntainer. Safely dispse f Rasuv that is ut f date r is n lnger needed. Hw shuld I stre Rasuv? Stre Rasuv at rm temperature between 68 F t 77 F (20 C t 25 C) D nt freeze Keep Rasuv ut f the light.

5 Keep Rasuv and all medicines ut f the reach f children. General infrmatin abut the safe and effective use f Rasuv. Methtrexate is smetimes prescribed fr purpses ther than thse listed in Patient Infrmatin leaflet. D nt use Rasuv fr a cnditin fr which it was nt prescribed. D nt give Rasuv t ther peple, even if they have the same symptms that yu have. It may harm them. This Patient Infrmatin leaflet summarizes the mst imprtant infrmatin abut Rasuv. If yu wuld like mre infrmatin, talk t yur dctr. Yu can ask yur dctr r pharmacist fr infrmatin abut Rasuv that is written fr health prfessinals. Fr mre infrmatin, please cntact Medac Pharma, Inc. at ur number What are the ingredients in Rasuv? Active ingredient: methtrexate Inactive ingredients: sdium chlride, sdium hydrxide and water fr injectin, USP, and if necessary hydrchlric acid, USP. This Patient Infrmatin has been apprved by the U.S. Fd and Drug Administratin. Manufactured fr: Medac Pharma, Inc. 29 N Wacker Drive, Suite 704 Chicag, IL Issued: 07/2014

6 Read this Instructins fr Use befre using Rasuv (ruh-soo-vh) (methtrexate) injectin, fr subcutaneus use Fllw these instructins each time yu use Rasuv. Parts f yur Rasuv aut-injectr Yellw injectin buttn Handling area Transparent cntrl zne Yellw cap (Figure A) (Figure B) a) Pre-filled aut-injectr with cap befre injectin b) Pre-filled aut-injectr after cap remval befre injectin c) Pre-filled aut-injectr after injectin Prepare t Use Rasuv Wash yur hands well with sap and warm water.

7 Select a clean, well-lit, flat wrk surface, such as a table. Place the Rasuv cartn cntaining the aut-injectr n yur flat wrk surface. Be sure that the dse, either 7.5, 10, 12.5, 15, 17.5, 20, 22.5, 25, 27.5 r 30 mg, stated n the cartn is the same as the dse prescribed by yur dctr. Check the expiratin date n the label. D nt use if expired. Remve ne Rasuv aut-injectr frm the packaging. If the Rasuv appears t be damaged d nt use it. Use anther Rasuv. In additin t Rasuv, yu will need the fllwing items: ne alchl swab and ne cttn ball r gauze and small adhesive bandage strip, if desired. Check the Liquid (Figure C) Lk at the transparent cntrl zne (see Figure C). The prefilled syringe is visible within the transparent cntrl zne. Examine the cntents f the syringe carefully. If the syringe is cracked r brken, d nt use it. Use anther aut-injectr. The liquid shuld be clear and yellw t brwn in clr and shuld nt have any lumps r particles in it. D nt use Rasuv if the liquid is cludy, disclred r cntains particles. Yu may see an air bubble. This is nrmal. If yu are nt able t see r t check the Rasuv aut-injectr crrectly prir t injectin, ask a caretaker fr assistance. D nt remve the yellw cap frm the aut-injectr until yu are ready t use Rasuv. Chse an Injectin Site Rasuv shuld be injected int the stmach (abdmen) r the upper thigh. D nt inject Rasuv within 2 inches f the belly buttn (navel) (see Figure D). D nt inject Rasuv in the arms r any ther areas f the bdy.

8 D nt inject Rasuv in areas where the skin is tender, bruised, red, scaly, hard, r has scars r stretch marks. Use a different site each time yu inject. This may help t decrease any reactins at the injectin site. Wipe the area with an alchl swab (see Figure E). Allw the skin t dry and d nt tuch this area again befre giving Rasuv. D nt fan r blw n the clean area. (Figure D) (Figure E) Give yur Injectin STEP 1: Remve the Yellw Cap (see Figure F) Hld the Rasuv aut-injectr with ne hand in the handling area.

9 Use yur ther hand t pull the yellw cap straight ff (see Figure F). D nt twist the cap. If yu are unable t remve the cap, ask a caretaker fr assistance. Cautin! (Figure F) D nt tuch the needle end with yur hands r fingers. This culd inject the medicine int yur hand. T avid any injury, never insert yur fingers in the pening f the prtect tube cvering the needle. D nt replace the cap after it has been remved. After the cap is remved Rasuv must be used withut delay r dispsed f safely. D nt press the yellw injectin buttn until yu are ready t inject Rasuv. STEP 2: Prepare the Injectin Pinch a pad f skin surrunding the cleaned injectin site with yur thumb and frefinger f yur free hand by gently squeezing. Patients with rheumatid arthritis wh are unable t pinch the skin can inject directly int the thigh withut pinching if needed. Hld the skin pinched until Rasuv is remved frm the skin after the injectin. Psitin the uncapped transparent end f the Rasuv aut-injectr perpendicular (at a 90 degree angle) t the skin (see Figure G). Withut pressing the buttn, push Rasuv firmly nt yur skin until yu feel the stp pint in rder t unlck the yellw injectin buttn (see Figure G). If yu are unable t push Rasuv t the stp-pint, ask a caretaker fr assistance.

10 (Figure G) STEP 3: Inject Rasuv While still hlding Rasuv firmly against the skin, press the yellw injectin buttn with yur thumb (see Figure H). Yu will hear a click which indicates the start f the injectin. Hld Rasuv against the skin until all f the medicine is injected. This can take up t 5 secnds (slwly cunt 1, 2, 3, 4, 5). T avid an incmplete injectin, d nt remve the Rasuv frm the skin befre the end f the injectin. Lk at the transparent cntrl zne while yu are injecting t make sure that the entire dse is injected. When the mvement stps, the injectin is cmpleted. If yu have prblems with yur hearing, slwly cunt t 5 secnds frm the mment yu have pressed the buttn. It is nt necessary t keep the buttn f the Rasuv pressed dwn with yur thumb after the injectin has begun. Figure H After cmpleting the injectin, remve Rasuv frm the injectin site by pulling straight up (perpendicular t the skin). The prtective needle shield autmatically mves int place and lcks ver the needle.

11 Put a small adhesive bandage strip ver the injectin site, if desired. STEP 4: Check the Transparent Cntrl Zne Check visually t make sure that there is n liquid left in the syringe inside the transparent cntrl zne. If there is liquid left, nt all f the medicine has been injected crrectly. Cnsult yur dctr r health care prfessinal immediately. D nt use anther Rasuv, unless advised by yur dctr. STEP 5: Dispse f Rasuv Each Rasuv can be used nly 1 time. D nt thrw away in the husehld trash. Put used Rasuv in a FDAcleared sharps dispsal cntainer right away after use. If yu d nt have a FDA-cleared sharps dispsal cntainer, yu may use a husehld cntainer that is: made f a heavy-duty plastic can be clsed with a tight-fitting, puncture-resistant lid, withut sharps being able t cme ut upright and stable during use leak-resistant prperly labeled t warn f hazardus waste inside the cntainer When yur sharps dispsal cntainer is almst full, yu will need t fllw yur cmmunity guidelines fr the right way t dispse f yur sharps dispsal cntainer. There may be state r lcal laws abut hw yu shuld thrw away used needles and syringes. Fr mre infrmatin abut the safe sharps dispsal, and fr specific infrmatin abut sharps dispsal in the state that yu live in, g t the FDA s website at: D nt dispse f yur used sharps dispsal cntainer in yur husehld trash unless yur cmmunity guidelines permit this. D nt recycle yur used sharps dispsal cntainer. Safely dispse f Rasuv that is ut f date r n lnger needed. Hw shuld I stre Rasuv? Stre Rasuv at rm temperature between 68 F t 77 F (20 C t 25 C). D nt freeze. Keep Rasuv ut f the light. Always keep yur Rasuv ut f the reach f children. This Instructins fr Use has been apprved by the U.S. Fd and Drug Administratin.

12 Manufactured fr: Medac Pharma Inc. 29 N Wacker Drive, Suite 704 Chicag, IL /2014