Medication Guide SIGNIFOR [sig-na-for] (pasireotide) Injection

Transcription

1 Medicatin Guide SIGNIFOR [sig-na-fr] (pasiretide) Injectin Read this Medicatin Guide befre yu start using SIGNIFOR and each time yu get a refill. There may be new infrmatin. This infrmatin des nt take the place f talking t yur dctr abut yur medical cnditin r yur treatment. What is the mst imprtant infrmatin I shuld knw abut SIGNIFOR? SIGNIFOR can cause serius side effects, including: Lw crtisl levels in yur bld (hypcrtislism). Tell yur dctr right away if yu have any signs and symptms f hypcrtislism. Signs and symptms f hypcrtislism may include: weakness fatigue lss f appetite nausea vmiting lw bld pressure lw level f sdium in yur bld lw bld sugar If yu get hypcrtislism while taking SIGNIFOR, yur dctr may change yur dse r ask yu t stp taking it. High bld sugar (hyperglycemia). Yur dctr shuld check yur bld sugar level befre yu start taking SIGNIFOR and while yu take it. Signs and symptms f hyperglycemia may include: excessive thirst high urine utput increased appetite with weight lss tiredness If yu get hyperglycemia while taking SIGNIFOR, yur dctr may give yu anther medicine t take t lwer yur bld sugar. Yur dctr may als change yur dse f SIGNIFOR r ask yu t stp taking it.

2 What is SIGNIFOR? SIGNIFOR is a prescriptin medicine used t treat Cushing s disease in adults wh cannt have surgery r have failed surgery. It is nt knwn if SIGNIFOR is safe and effective in children. What shuld I tell my dctr befre using SIGNIFOR? Befre yu take SIGNIFOR, tell yur dctr if yu: have r have had high bld sugar (hyperglycemia) have diabetes have r have had heart prblems have a histry f lw levels f ptassium r magnesium in yur bld have r have had liver prblems have r have had gallstnes have any ther medical cnditins are pregnant r plan t becme pregnant. SIGNIFOR may harm yur unbrn baby. are breastfeeding r plan t breastfeed. It is nt knwn if SIGNIFOR passes int yur breast milk. Yu and yur dctr shuld decide if yu will take SIGNIFOR r breastfeed. Yu shuld nt d bth. Tell yur dctr abut all the medicines yu take, including prescriptin and nnprescriptin medicines, vitamins, and herbal supplements. Taking SIGNIFOR with certain ther medicines can affect each ther and cause side effects. Especially tell yur dctr if yu take: medicines t cntrl yur heart beat (anti-arrhythmics) medicines that can affect the electrical system f yur heart (QT prlngatin) medicines t cntrl yur bld pressure (such as beta-blckers r calcium channel blckers) medicines t cntrl the electrlyte (such as ptassium r magnesium) levels in yur bld cyclsprine (Gengraf, Neral, Restasis, Sandimmune ) brmcriptine (Cyclset, Parldel ) Ask yur dctr fr a list f these medicines, if yu are nt sure. Knw the medicines yu take. Keep a list f them t shw t yur dctr and pharmacist when yu get a new medicine.

3 Hw shuld I use SIGNIFOR? Read the Instructins fr Use at the end f this Medicatin Guide fr infrmatin abut the right way t use SIGNIFOR. Use SIGNIFOR exactly as yur dctr tells yu t. Yur dctr may change yur dse if needed. Befre yu use SIGNIFOR fr the first time, yur dctr shuld d a bld test t check yur bld sugar levels and yur liver tests. Befre yu use SIGNIFOR fr the first time, yur dctr shuld d a test t check yur heart (electrcardigram) and yur gallbladder (ultrasund). SIGNIFOR shuld be clear and clrless. Befre yu inject yur dse, check t make sure that SIGNIFOR is clear and clrless, and des nt have any clumps r particles in it. SIGNIFOR is given as an injectin int the fat just under yur skin (subcutaneus injectin). D nt inject SIGNIFOR int skin that is red r irritated. The recmmended injectin sites fr SIGNIFOR are the tp f yur thigh r stmach area (abdmen). Change (rtate) yur injectin site with each dse. D nt inject SIGNIFOR int the exact same spt fr each injectin. Yur dctr shuld shw yu hw t prepare and give yur dse f SIGNIFOR befre yu use it fr the first time. Yu shuld nt inject SIGNIFOR until yur dctr has shwn yu hw t use it the right way. If yu take t much SIGNIFOR, tell yur dctr right away. What are the pssible side effects f SIGNIFOR? SIGNIFOR may cause serius side effects, including: See What is the mst imprtant infrmatin I shuld knw abut SIGNIFOR? slw heart rate (bradycardia). SIGNIFOR can cause yur heart t beat slwer, which may cause yu t feel weak, dizzy r even faint. Peple wh have, r have had, heart prblems are at higher risk fr bradycardia. prblems with the electrical system f yur heart (QT interval prlngatin) which can put yu at risk fr abnrmal heart beats, dizziness and fainting spells that can be very serius. Call yur dctr right away if yu experience such spells. elevatin f yur liver tests. Yur dctr shuld d bld tests t mnitr yur liver tests while yu use SIGNIFOR. gallstnes (chlelithiasis). Yur dctr shuld d an ultrasund t check fr gallstnes befre yu start using SIGNIFOR and while yu use it. The mst cmmn side effects f SIGNIFOR include: diarrhea nausea high bld sugar headache abdminal pain

4 fatigue diabetes mellitus injectin site reactins cmmn cld hair lss weakness fluid retentin Abnrmal bld test result fr glycsylated hemglbin (the level f glycsylated hemglbin indicates the average bld sugar level ver the previus mnths) 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 SIGNIFOR. Fr mre infrmatin, ask yur dctr r pharmacist. Call yur dctr fr medical advice abut side effects. Yu may reprt side effects t FDA at FDA Hw shuld I stre SIGNIFOR? Stre SIGNIFOR at 68 F t 77 F (20 C t 25 C). Keep SIGNIFOR ut f the light. Keep SIGNIFOR and all medicines ut f the reach f children. General infrmatin abut the safe and effective use f SIGNIFOR. Medicines are smetimes prescribed fr purpses ther than thse listed in a Medicatin Guide. D nt use SIGNIFOR fr a cnditin fr which it was nt prescribed. D nt give SIGNIFOR t ther peple, even if they have the same symptms that yu have. It may harm them. This Medicatin Guide summarizes the mst imprtant infrmatin abut SIGNIFOR. If yu wuld like mre infrmatin, talk t yur dctr. Yu can ask yur pharmacist r dctr fr infrmatin abut SIGNIFOR that is written fr health prfessinals. Fr mre infrmatin g t r call What are the ingredients in SIGNIFOR? Active ingredient: Pasiretide Inactive ingredients: Mannitl, tartaric acid, sdium hydrxide and water fr injectin. T March 2018

5 Instructins fr Use SIGNIFOR [sig-na-fr] (pasiretide) Injectin Supplies yu will need t give yur SIGNIFOR injectin: 1 SIGNIFOR ampule (See Figure A) 1 sterile syringe (See Figure B) 1 lng sterile needle (See Figure B) This needle is used t draw up yur SIGNIFOR frm the ampule. Yu shuld nly use this needle if yur dctr r nurse tells yu t. 1 shrt sterile needle (See Figure B) Alchl wipes 1 cttn ball r gauze A sharps dispsal cntainer r ther clseable, puncture resistant dispsal cntainer Figure A Figure B Getting started: Step 1: Wash yur hands well with sap and water and dry them. Step 2: Take 1 SIGNIFOR ampule ut f the bx. Step 3: Lk at the SIGNIFOR ampule. Check that the ampule is nt cracked r brken and that the liquid medicine in the ampule is clear and clrless. D nt use SIGNIFOR if the ampule is cracked r brken r if the liquid lks cludy r cntains particles. Take the whle bx back t the pharmacy and get a new ne. Ampules shuld be pened just prir t administratin and any unused prtin discarded.

6 Step 4: Check the dse and expiratin date printed n the ampule (See Figure C). Preparing yur SIGNIFOR dse: Figure C Step 5: Hld the SIGNIFOR ampule at the bttm with 1 hand. With yur ther hand, tap the tp f the SIGNIFOR ampule with yur finger t make sure there is n liquid in the tp f the ampule when yu pen it (See Figure D). Figure D Step 6: Hld the ampule with 1 hand. With yur ther hand, hld the tp f the ampule and pull it sideways until the tp snaps ff at the line marked n the ampule neck (See Figure E). Put the ampule upright n a clean and flat surface. Figure E

7 Step 7: Open the sterile needle package. Place the needle n the tp f the syringe. Push dwn n the needle and twist it clckwise until it is tight (See Figure F). If yu have been tld t use 1 lng and 1 shrt needle, yu shuld use the lng needle fr this step. Figure F Step 8: Pull the needle cver straight ff the sterile needle (See Figure G). Figure G Step 9: Put the needle int the ampule making sure yu d nt tuch the utside f the ampule and pull up n the plunger t draw up all f the SIGNIFOR liquid int the syringe (See Figure H). If yu have been tld t use 1 lng and 1 shrt needle, yu shuld nw take the lng needle ff f the syringe and put n the shrt ne. Figure H

8 Step 10: Hld the syringe upright in 1 hand between 2 fingers with yur thumb at the bttm f the plunger. With yur ther hand, tap the syringe with yur finger t get rid f air bubbles (See Figure I). Figure I Step 11: Push up n the plunger until yu see a drp f liquid n the tip f the needle (See Figure J). D nt let the needle tuch anything. Yu are nw ready t inject yur dse f SIGNIFOR. Figure J Injecting yur SIGNIFOR dse: Step 12: Chse yur injectin site and wipe the site with an alchl wipe (See Figure K). Let the site dry. Figure K

9 Step 13: With 1 hand, gently pinch the skin at the injectin site yu have chsen and wiped with an alchl wipe. With yur ther hand, pick up the syringe and hld it like a pencil. Insert the needle int the pinched skin at a 45 degree angle using a quick dart like mtin (See Figure L). D nt let g f the skin. Figure L Step 14: Gently press the plunger all the way dwn, until the syringe is empty (See Figure M). Figure M Step 15: When the syringe is empty, slwly let g f the skin and gently pull the needle ut f the skin (See Figure N). Figure N Step 16: Place a cttn ball r gauze ver the injectin site and press fr abut 5 secnds. D nt massage the injectin site. If there is bleeding, cver it with a bandage. After injecting yur SIGNIFOR dse: Put yur used needles and syringes in a FDA-cleared sharps dispsal cntainer right away after use. D nt thrw away (dispse f) lse needles and syringes in yur husehld trash. If yu d nt have a FDA-cleared sharps dispsal cntainer, yu may use a husehld cntainer that is:

10 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, and 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 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. This Medicatin Guide and Instructins fr Use has been apprved by the U.S. Fd and Drug Administratin. Distributed by: Nvartis Pharmaceuticals Crpratin East Hanver, NJ T March 2018