MEDICATION GUIDE Boniva (bon-ee-va) (ibandronate) Injection for intravenous use

Transcription

1 MEDICATION GUIDE Bniva (bn-ee-va) (ibandrnate) Injectin fr intravenus use Read the Medicatin Guide that cmes with BONIVA befre yu start taking it and each time yu get a refill. There may be new infrmatin. This Medicatin Guide des nt take the place f talking with yur dctr abut yur medical cnditin r treatment. Talk t yur dctr if yu have any questins abut BONIVA. What is the mst imprtant infrmatin I shuld knw abut BONIVA? BONIVA Injectin is given in yur vein (intravenusly) and nly given by a healthcare prvider. D nt give BONIVA Injectin t yurself. BONIVA may cause serius side effects including: 1. Lw calcium levels in yur bld (hypcalcemia) 2. Severe allergic reactin (anaphylactic reactin) 3. Severe kidney prblems 4. Severe jaw bne prblems (stenecrsis) 5. Bne, jint r muscle pain 6. Unusual thigh bne fractures 1. Lw calcium levels in yur bld (hypcalcemia). BONIVA may lwer the calcium levels in yur bld. If yu have lw bld calcium befre yu start taking BONIVA, it may get wrse during treatment. Yur lw bld calcium must be treated befre yu receive BONIVA. Mst peple with lw bld calcium levels d nt have symptms, but sme peple may have symptms. Call yur dctr right away if yu have symptms f lw bld calcium such as: Spasms, twitches, r cramps in yur muscles Numbness r tingling in yur fingers, tes, r arund yur muth Yur dctr may prescribe calcium and vitamin D t help prevent lw calcium levels in yur bld, while yu receive BONIVA. Take calcium and vitamin D as yur dctr tells yu t. 2. Severe allergic reactins. Sme peple wh received BONIVA Injectin had severe allergic reactins (anaphylactic reactins) that led t death. Get medical help right away if yu have any f the symptms f a serius allergic reactin such as: Swelling f yur face, lips, muth r tngue Truble breathing Wheezing Severe itching Skin rash, redness r swelling Dizziness r fainting Fast heartbeat r punding in yur chest Sweating 18

2 3. Severe kidney prblems. Severe kidney prblems, including kidney failure, may happen when yu receive BONIVA. Yur dctr shuld d bld tests t check yur kidneys befre yu receive each dse f BONIVA. 4. Severe jaw bne prblems (stenecrsis). Severe jaw bne prblems may happen when yu receive BONIVA. Yur dctr may examine yur muth befre yu start BONIVA. Yur dctr may tell yu t see yur dentist befre yu start BONIVA. It is imprtant fr yu t practice gd muth care during treatment with BONIVA. 5. Bne, jint, r muscle pain. Sme peple wh receive BONIVA develp severe bne, jint, r muscle pain. 6. Unusual thigh bne fractures. Sme peple have develped unusual fractures in their thigh bne. Symptms f a fracture may include new r unusual pain in yur hip, grin, r thigh. Call yur dctr right away if yu have any f these side effects. What is BONIVA? BONIVA is a prescriptin medicine used t treat steprsis in wmen after menpause. BONIVA helps increase bne mass and helps reduce the chance f having a spinal fracture (break). It is nt knwn hw lng BONIVA wrks fr the treatment f steprsis. Yu shuld see yur dctr regularly t determine if BONIVA is still right fr yu. It is nt knwn if BONIVA is safe and effective in children. Wh shuld nt receive BONIVA? D nt receive BONIVA if yu: Have lw levels f calcium in yur bld Are allergic t ibandrnate sdium r any f the ingredients in BONIVA. See the end f this leaflet fr a cmplete list f ingredients in BONIVA. What shuld I tell my healthcare prvider befre receiving BONIVA? Befre yu receive BONIVA, tell yur dctr if yu: Have lw bld calcium Plan t have dental surgery r teeth remved Have kidney prblems r ther prblems that may affect yur kidneys Have been tld yu have truble absrbing minerals in yur stmach r intestines (malabsrptin syndrme) Are pregnant r plan t becme pregnant. It is nt knwn if BONIVA can harm yur unbrn baby. Are breast-feeding r plan t breast-feed. It is nt knwn if BONIVA passes int yur milk and may harm yur baby. Tell yur dctr and dentist abut all the medicines yu take, including prescriptin and nn-prescriptin medicines, vitamins and herbal supplements. 19

3 Knw the medicines yu take. Keep a list f them and shw it t yur healthcare prvider and pharmacist each time yu get a new medicine. Hw shuld I receive BONIVA? BONIVA Injectin is given 1 time every 3 mnths by a healthcare prvider. If yu miss a dse f BONIVA, call yur dctr r healthcare prvider t schedule yur next dse. What are the pssible side effects f BONIVA? BONIVA may cause serius side effects. See What is the mst imprtant infrmatin I shuld knw abut BONIVA? The mst cmmn side effects f BONIVA include: Pain in yur bnes, jints r muscles Back pain Abdminal pain Flu-like symptms may happen within 3 days after yu receive BONIVA. Symptms include: fever chills bne, jint, r muscle pain fatigue If yu have flu-like symptms, they shuld get better within 24 t 48 hurs. Sme peple have pain r a sre that will nt heal in their muth r jaw while they receive BONIVA. Tell yur dctr r dentist if yu have muth r jaw 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 BONIVA. 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 BONIVA if I need t pick it up frm a pharmacy? Stre BONIVA Injectin at rm temperature between 68 F and 77 F (20 C and 25 C). Keep BONIVA Injectin and all medicines ut f the reach f children. General infrmatin abut the safe and effective use f BONIVA. Medicines are smetimes prescribed fr purpses ther than thse listed in a Medicatin Guide. D nt use BONIVA fr a cnditin fr which it was nt prescribed. D nt give BONIVA t ther peple, even if they have the same symptms yu have. It may harm them. This Medicatin Guide summarizes the mst imprtant infrmatin abut BONIVA. If yu wuld like mre infrmatin, talk with yur dctr. Yu can ask yur dctr r pharmacist fr infrmatin abut BONIVA that is written fr health prfessinals. What are the ingredients in BONIVA? Active ingredient: ibandrnate sdium 20

4 Inactive ingredients: sdium chlride, glacial acetic acid, sdium acetate and water This Medicatin Guide has been apprved by the U.S. Fd and Drug Administratin. Revised: April Genentech, Inc. All rights reserved. 21

5 TERUMO Surshield Safety Winged Infusin Set Instructins fr Use: IV Administratin Aseptic technique, prper skin preparatin and cntinued prtectin f the site are essential. Observe Universal Precautins n all patients. Cautin: Keep hands behind the needle at all times during use and dispsal. Instructins fr Device Assembly 1. Open the package. 2. Remve the rubber cap frm the tip f the syringe cntaining the BONIVA Injectin and the prtective SV cap frm hub at the end f the tubing ppsite the butterfly needle. 3. Insert the tip f the syringe int the hub and twist as firm pressure is applied t assure a tight cnnectin. 4. Prceed with priming and cnfirm that administratin fluid cmes frm the needle. Venipuncture and Administratin 1. Flip the safety shield back away frm the needle twards the tubing. Grasp wings securely. 2. Remve the needle prtectr. Cautin: Care shuld be taken nt t tuch the needle. 3. Perfrm venipuncture and cnfirm prper psitining f the needle in the vein. 4. Carefully allw wings t return t starting psitin and cnfrm t the shape f the skin. 5. Further secure the psitin f the winged infusin set per facility prtcl. After Use 1. Remve tape, if present, frm wings. 2. Flip the safety shield frward tward the needle. Grasp a wing and the safety shield between yur thumb and index finger. Cmpletely remve the needle frm the puncture site and apply digital pressure t the site using a sterile gauze pad held in the ppsite hand (Fig. 1). 3. With the wing and shield between yur thumb and index finger pinch tgether (r press the safety shield against a hard surface such as a bedside table) until an audible click is heard (Fig. 2). 4. Visually cnfirm activatin f the safety feature (Fig. 3). 5. Dispse f used needles and materials fllwing the plicies and prcedures f yur facility, as well as federal and lcal regulatins fr Sharps Dispsal. Registered Trademark. Surshield is a trademark f TERUMO CORPORATION. 22