BYETTA- exenatide injection

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

exenatide (UNII: 9P1872D4OL) (exenatide - UNII:9P1872D4OL)

Inapatikana kutoka:

AstraZeneca Pharmaceuticals LP

INN (Jina la Kimataifa):

exenatide

Tungo:

exenatide 250 ug in 1 mL

Njia ya uendeshaji:

SUBCUTANEOUS

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

BYETTA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies (14)] . Limitations of Use BYETTA is contraindicated in patients with: Risk Summary Limited data with BYETTA in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage. There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see Clinical Considerations). Based on animal reproduction studies, there may be risks to the fetus from exposure to BYETTA during pregnancy. BYETTA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal reproduction studies identified increased adverse fetal and neonatal outcomes from exposure to exenatide during pregnancy and lactation in association with maternal effects. In mice, exenatide administered during gestation and lactation caused increased neonatal deaths at systemic exposure 3-times the human exposure resulting from the maximum recommended human dose (MRHD) of 20 mcg/day for BYETTA (see Data) . The estimated background risk of major birth defects is 6-10% in women with pre-gestational diabetes with an HbA1c >7 and has been reported to be as high as 20-25% in women with HbA1c >10. The estimated background risk of miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Clinical Considerations Disease-associated maternal and/or embryofetal risk Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery, and delivery complications. Poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia related morbidity. Data Animal Data In studies evaluating reproduction and development in pregnant mice and rabbits, maternal animals were administered exenatide, the active ingredient in BYETTA, by subcutaneous injection twice a day. In pregnant mice given 6, 68, 460, or 760 mcg/kg/day exenatide during fetal organogenesis, skeletal variations associated with slowed fetal growth, including changes in number of rib pairs or vertebral ossifications sites, and wavy ribs were observed at 760 mcg/kg/day, a dose that produced maternal toxicity and yielded systemic exposure 390-times the human exposure resulting from the MRHD of BYETTA based on AUC comparison. In pregnant rabbits given 0.2, 2, 22, 156, or 260 mcg/kg/day exenatide during fetal organogenesis, irregular fetal skeletal ossifications were observed at 2 mcg/kg/day, a dose yielding systemic exposure up to 12-times the human exposure from the MRHD of BYETTA based on AUC comparison. In maternal mice given 6, 68, or 760 mcg/kg/day exenatide from gestation day 6 through lactation day 20 (weaning), an increased number of neonatal deaths was observed on postpartum days 2 to 4 in dams given 6 mcg/kg/day, a dose yielding a systemic exposure 3-times the human exposure from the MRHD of BYETTA based on AUC comparison. Risk Summary There is no information regarding the presence of BYETTA, in human milk, the effects of BYETTA on the breastfed infant, or the effects of BYETTA on milk production. Exenatide was present in the milk of lactating mice. However, due to species-specific differences in lactation physiology, the clinical relevance of these data is not clear (see Data) . The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for BYETTA and any potential adverse effects on the breastfed child from BYETTA or from the underlying maternal condition. Data In lactating mice subcutaneously injected twice a day with exenatide, the concentration of exenatide in milk was up to 2.5% of the concentration in maternal plasma. The Safety and effectiveness of BYETTA have not been established in pediatric patients. Effectiveness of BYETTA was not demonstrated in a randomized, double-blind, placebo-controlled study conducted in 120 pediatric patients (78 received BYETTA and 42 received placebo) aged 10 to 17 years with type 2 diabetes mellitus. Population pharmacokinetic analysis of patients ranging from 22 to 73 years of age suggests that age does not influence the pharmacokinetic properties of exenatide [see Clinical Pharmacology (12.3)] . BYETTA was studied in 282 patients 65 years of age or older and in 16 patients 75 years of age or older. No differences in safety or effectiveness were observed between these patients and younger patients. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection in the elderly based on renal function. BYETTA is not recommended for use in patients with end-stage renal disease or severe renal impairment (creatinine clearance <30 mL/min) and should be used with caution in patients with renal transplantation. In patients with end-stage renal disease receiving dialysis, single doses of BYETTA 5 mcg were not well-tolerated due to gastrointestinal side effects. No dosage adjustment of BYETTA is required in patients with mild renal impairment (creatinine clearance 50-80 mL/min). Caution should be applied when initiating or escalating doses of BYETTA from 5 to 10 mcg in patients with moderate renal impairment (creatinine clearance 30-50 mL/min) [see Clinical Pharmacology (12.3)] . No pharmacokinetic study has been performed in patients with a diagnosis of acute or chronic hepatic impairment. Because exenatide is cleared primarily by the kidney, hepatic dysfunction is not expected to affect blood concentrations of exenatide [see Clinical Pharmacology (12.3)] . INSTRUCTIONS FOR USE BYETTA® (bye-A-tuh) (exenatide) injection for subcutaneous use 250 mcg/mL, 1.2 mL   Do not share your BYETTA Pen with other people, even if the needle has been changed. You may give other people a serious infection or get a serious infection from them.   Section 1 Read this section completely before you begin. Then, move on to Section 2–Getting Started.   WHAT YOU NEED TO KNOW ABOUT YOUR BYETTA PEN   INSTRUCTIONS FOR USE   Read these instructions carefully BEFORE using your BYETTA Pen. For complete dosing and safety information, also read the BYETTA Medication Guide that comes with the BYETTA Pen carton.   It is important that you use your pen correctly. Failure to follow these instructions completely may result in a wrong dose, a broken pen or an infection.   These instructions do not take the place of talking with your healthcare provider about your medical condition or your treatment. If you are having problems using your BYETTA Pen, call toll free 1-800-236-9933.   IMPORTANT INFORMATION ABOUT YOUR BYETTA PEN   ABOUT PEN NEEDLES   What kinds of needles can be used with my BYETTA Pen?   Do I use a new needle for each injection?   How do I throw away my needles? Put your used needles in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles and syringes in your household trash. If you do not have a FDA-cleared sharps disposal container, you may use a household container that is: 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.   Do not share your BYETTA Pen with other people, even if the needle has been changed. You may give other people a serious infection or get a serious infection from them.   STORING YOUR BYETTA PEN   How do I store my BYETTA Pen?   Keep your pen and needles out of the reach of children.   How long can I use a BYETTA Pen?   Date of First Use                                         Date to Throw Away Pen                                  How do I clean my BYETTA Pen?   See the complete BYETTA Medication Guide that comes with BYETTA. For more information, call toll free 1-800-236-9933.   Section 2 Read and follow the directions in this section only after you've read Section 1—What You Need To Know About Your BYETTA Pen. GETTING STARTED   Set up your new pen just before you use it the first time. For routine use, do not repeat this one-time-only new pen setup. If you do, you will run out of BYETTA before 30 days of use.     ONE-TIME-ONLY NEW PEN SETUP   STEP A Check the Pen Note: Small air bubbles in the cartridge are normal.   STEP B Attach the Needle   STEP C Dial the Dose   Note: If you cannot turn the dose knob away from you to the , see Commonly Asked Questions, number 7, in Section 4 of these Instructions for Use.   STEP D Prepare the Pen PUSH & HOLD   Note: If you do not see liquid after 4 times, see Commonly Asked Questions, number 3, in Section 4 of these Instructions for Use.   STEP E Complete New Pen Setup   Note: If you cannot turn the dose knob, see Commonly Asked Questions, number 7, in Section 4 of Instructions for Use. Section 3 Now that you have done the one-time-only new pen setup, follow Section 3 for all of your injections.   ROUTINE USE STEP 1 Check the Pen Note: Small air bubbles will not harm you or affect your dose.   STEP 2 Attach the Needle   STEP 3 Dial the Dose   Note: If you cannot turn the dose knob away from you to the , see Commonly Asked Questions, number 7, in Section 4 of these Instructions for Use.   STEP 4 Inject the Dose PUSH & HOLD   Note: If you see several drops of BYETTA leaking from the needle after the injection, you may not have received a complete dose. See Commonly Asked Questions, number 4, in Section 4 of these Instructions for Use.   STEP 5 Reset the Pen Note: If you cannot turn the dose knob, or if your pen leaks, your full dose has not been delivered. See Commonly Asked Questions, numbers 4 and 7, in Section 4 of these Instructions for Use.   STEP 6 Remove and Dispose of the Needle   STEP 7 Store Pen for Next Dose Section 4 COMMONLY ASKED QUESTIONS 1. Do I need to do the One-Time-Only New Pen Setup before every dose?   2. Why are there air bubbles in the cartridge?   3. What should I do if BYETTA does not come out of the needle tip after four tries during One-Time-Only New Pen Setup?   4. Why do I see BYETTA leaking from my needle after I have finished my injection?   It is normal for a single drop to remain on the tip of your needle after your injection is complete. If you see more than one drop:   5. How can I tell when the injection is complete?   The injection is complete when: and and   If you hear a click sound from your BYETTA Pen, ignore it. You must follow all the steps listed above to make sure your injection is complete. 6. Where should I inject BYETTA? Inject BYETTA into your abdomen, thigh, or upper arm using the injection method explained to you by your healthcare provider.   7. What if I cannot pull, turn, or push the dose knob?   Check the symbol in the dose window. Follow the steps next to the matching symbol.   If is in the dose window:   If is in the dose window and the dose knob will not turn: If and part of are in the dose window and the dose knob cannot be pushed in:   If part of and part of are in the dose window and the dose knob cannot be pushed in:     If is in the dose window and the dose knob will not turn:     See the complete BYETTA Medication Guide that comes with BYETTA. For more information, call toll free 1-800-236-9933.   Distributed by: AstraZeneca Pharmaceuticals LP Wilmington, DE 19850     BYETTA® is a registered trademark of the AstraZeneca group of companies. This Instructions for Use has been approved by the U.S. Food and Drug Administration.   Revised: December 2022 INSTRUCTIONS FOR USE BYETTA® (bye-A-tuh) (exenatide) injection for subcutaneous use 250 mcg/mL, 2.4 mL   Do not share your BYETTA Pen with other people, even if the needle has been changed. You may give other people a serious infection or get a serious infection from them.   Section 1 Read this section completely before you begin. Then, move on to Section 2−Getting Started.   WHAT YOU NEED TO KNOW ABOUT YOUR BYETTA PEN   PEN INSTRUCTIONS FOR USE   Read these instructions carefully BEFORE using your BYETTA Pen . For complete dosing and safety information, also read the BYETTA Medication Guide that comes with the BYETTA Pen carton.   It is important that you use your pen correctly. Failure to follow these instructions completely may result in a wrong dose, a broken pen or an infection.   These instructions do not take the place of talking with your healthcare provider about your medical condition or your treatment. If you are having problems using your BYETTA Pen, call toll free 1-800-236-9933.   IMPORTANT INFORMATION ABOUT YOUR BYETTA PEN ABOUT PEN NEEDLES   What kinds of needles can be used with my BYETTA Pen? Do I use a new needle for each injection? How do I throw away my needles? Put your used needles in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles and syringes in your household trash. If you do not have a FDA-cleared sharps disposal container, you may use a household container that is: 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. Do not share your BYETTA Pen with other people, even if the needle has been changed. You may give other people a serious infection or get a serious infection from them.   STORING YOUR BYETTA PEN   How do I store my BYETTA Pen?   Keep your pen and needles out of the reach of children. How long can I use a BYETTA Pen?   Date of First Use                                         Date to Throw Away Pen                                    How do I clean my BYETTA Pen?     See the complete BYETTA Medication Guide that comes with BYETTA. For more information, call toll free 1-800-236-9933. Section 2 Read and follow the directions in this section only after you've read Section 1—What You Need To Know About Your BYETTA Pen .   GETTING STARTED   Set up your new pen just before you use it the first time. For routine use, do not repeat this one-time-only new pen setup. If you do, you will run out of BYETTA before 30 days of use.   ONE-TIME-ONLY NEW PEN SETUP   STEP A Check the Pen Note: Small air bubbles in the cartridge are normal.   STEP B Attach the Needle   STEP C Dial the Dose   Note: If you cannot turn the dose knob away from you to the , see Commonly Asked Questions, number 7, in Section 4 of these Instructions for Use.   STEP D Prepare the Pen PUSH & HOLD   Note: If you do not see liquid after 4 times, see Commonly Asked Questions, number 3, in Section 4 of these Instructions for Use.   STEP E Complete New Pen Setup    Note: If you cannot turn the dose knob, see Commonly Asked Questions, number 7, in Section 4 of these Instructions for Use.  Section 3 Now that you have done the one-time-only new pen setup, follow Section 3 for all of your injections.   ROUTINE USE STEP 1 Check the Pen Note: Small air bubbles will not harm you or affect your dose.   STEP 2 Attach the Needle   STEP 3 Dial the Dose   Note: If you cannot turn the dose knob away from you to the , see Commonly Asked Questions, number 7, in Section 4 of these Instructions for Use.   STEP 4 Inject the Dose PUSH & HOLD   Note: If you see several drops of BYETTA leaking from the needle after the injection, you may not have received a complete dose. See Commonly Asked Questions, number 4, in Section 4 of these Instructions for Use.   STEP 5 Reset the Pen Note: If you cannot turn the dose knob, or if your pen leaks, your full dose has not been delivered. See Commonly Asked Questions, numbers 4 and 7, in Section 4 of these Instructions for Use.   STEP 6 Remove and Dispose of the Needle   STEP 7 Store Pen for Next Dose     Section 4 COMMONLY ASKED QUESTIONS   1. Do I need to do the One-Time-Only New Pen Setup before every dose?   2. Why are there air bubbles in the cartridge?   3. What should I do if BYETTA does not come out of the needle tip after four tries during One-Time-Only New Pen Setup?   4. Why do I see BYETTA leaking from my needle after I have finished my injection?   It is normal for a single drop to remain on the tip of your needle after your injection is complete. If you see more than one drop:   5. How can I tell when the injection is complete?   The injection is complete when: and and   If you hear a click sound from your BYETTA Pen, ignore it. You must follow all the steps listed above to make sure your injection is complete. 6. Where should I inject BYETTA? Inject BYETTA into your abdomen, thigh, or upper arm using the injection method explained to you by your healthcare provider.   7. What if I cannot pull, turn, or push the dose knob?   Check the symbol in the dose window. Follow the steps next to the matching symbol.   If is in the dose window:   If is in the dose window and the dose knob will not turn:  If and part of are in the dose window and the dose knob cannot be pushed in:   If part of and part of are in the dose window and the dose knob cannot be pushed in: If is in the dose window and the dose knob will not turn:   See the complete BYETTA Medication Guide that comes with BYETTA. For more information, call toll free 1-800-236-9933.     Distributed by: AstraZeneca Pharmaceuticals LP Wilmington, DE 19850       BYETTA® is a registered trademark of the AstraZeneca group of companies. This Instructions for Use has been approved by the U.S. Food and Drug Administration Revised: December 2022

Bidhaa muhtasari:

BYETTA (exenatide) 250 mcg/mL is a clear, colorless solution supplied as:

Idhini hali ya:

New Drug Application

Taarifa za kipeperushi

AstraZeneca Pharmaceuticals LP
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MEDICATION GUIDE
BYETTA® (bye-A-tuh)
(exenatide)
injection, for subcutaneous use
Read this Medication Guide and the Instructions for Use that comes
with BYETTA before you start
using it and each time you get a refill. There may be new information.
This Medication Guide does not
take the place of talking with your healthcare provider about your
medical condition or your treatment. If
you have questions about BYETTA after reading this information, ask
your healthcare provider or
pharmacist.
What is the most important information I should know about BYETTA?
•
Do not share your BYETTA Pen with other people, even if the needle has
been changed. You may
give other people a serious infection or get a serious infection from
them.
•
Serious side effects can happen in people who take BYETTA, including
inflammation of the
pancreas (pancreatitis) which may be severe and lead to death. Stop
using BYETTA and call your
healthcare provider right away if you have severe pain in your stomach
area (abdomen) that will
not go away, with or without vomiting. You may feel the pain from your
abdomen to your back.
These may be symptoms of pancreatitis.
What is BYETTA?
•
BYETTA is an injectable prescription medicine that may improve blood
sugar (glucose) control in
adults with type 2 diabetes mellitus, when used with a diet and
exercise program.
•
BYETTA is not insulin.
•
BYETTA is not a substitute for insulin.
•
The use of BYETTA with short acting insulin is not recommended.
•
The use of BYETTA with rapid acting insulin is not recommended.
•
BYETTA is not for people with type 1 diabetes or people with diabetic
ketoacidosis.
•
It is not known if BYETTA can be used in people who have had
pancreatitis.
•
It is not known if BYETTA is safe and effective in children.
•
BYETTA should not be used in people who have severe kidney problems.
Who should not use BYETTA?
Do not use BYETTA if:
•
you have had a severe allergic reaction to exenatide or any of the
other ingredients in BYET

Tabia za bidhaa

BYETTA- EXENATIDE INJECTION
ASTRAZENECA PHARMACEUTICALS LP
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BYETTA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR BYETTA.
BYETTA® (EXENATIDE) INJECTION, FOR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 2005
RECENT MAJOR CHANGES
Warnings and Precautions, Acute Gallbladder Disease (5.9) 06/2022
INDICATIONS AND USAGE
BYETTA (exenatide) is a glucagon-like peptide-1 (GLP-1) receptor
agonist indicated as an adjunct to diet
and exercise to improve glycemic control in adults with type 2
diabetes mellitus. (1, 14)
Limitations of Use
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DOSAGE AND ADMINISTRATION
•
•
DOSAGE FORMS AND STRENGTHS
BYETTA injection is supplied as 250 mcg/mL exenatide in: (3)
•
•
CONTRAINDICATIONS
•
•
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
•
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Should not be used for the treatment of type 1 diabetes. (1)
Has not been studied in patients with a history of pancreatitis.
Consider other antidiabetic therapies in
patients with a history of pancreatitis. (1)
Inject subcutaneously within 60 minutes prior to morning and evening
meals (or before the two main
meals of the day, approximately 6 hours or more apart). (2.1)
Initiate at 5 mcg per dose twice daily; increase to 10 mcg twice daily
after 1 month based on clinical
response. (2.1)
5 mcg per dose, 60 doses, 1.2 mL single-patient-use prefilled pen
10 mcg per dose, 60 doses, 2.4 mL single-patient-use prefilled pen
History of severe hypersensitivity to exenatide or any of the
excipients in BYETTA. (4)
History of drug-induced immune-mediated thrombocytopenia from
exenatide products. (4)
Never share a BYETTA pen between patients, even if the needle is
changed. (5.1)
Acute Pancreatitis: Postmarketing reports with exenatide, including
fatal and non-fatal hemorrhagic or
necrotizing pancreatitis. Discontinue BYETTA promptly. BYETTA should
not be restarted. Consider
other antidiabetic therapies in patients with a history of
pancreatitis. (5.2)
Hypoglycemia wit