5 and 10 micrograms injection in prefilled pen 
exenatide

1. What Byetta is and what it is used for

Byetta contains the active substance exenatide. It is an injectable drug used to improve blood sugar control in adults with type 2 diabetes (non-insulin-dependent).

Byetta is used with other diabetes medicines, such as metformin, sulphonylureas, thiazolidinediones, and basic or long-acting insulin. You are now being prescribed Byetta as an additional medicine, in order to better control your blood sugar level. Continue to follow the diet and exercise program you received.

You have diabetes because your body does not produce enough insulin to control your blood sugar level or because your body cannot use insulin properly. The medicine in Byetta helps your body increase insulin production when blood sugar levels are high.

2. What you need to know before using Byetta

Do not use Byetta:

  • if you are allergic to exenatide or any of the other ingredients of this medicine (listed in section 6).

Warnings and cautions

Before using Byetta, talk to your doctor, pharmacist, or diabetes nurse about the following:

  • Use this medicine with a sulphonylurea, as hypoglycemia (too low blood sugar) may occur. If you are not sure if any of your other medicines contain a sulphonylurea, ask your doctor, pharmacist, or diabetes nurse.
  • If you have type 1 diabetes or diabetic ketoacidosis (a dangerous condition that can occur in diabetes ), then you should not use this medicine.
  • How to inject this medicine. It should be injected under the skin and not into a vein or muscle.
  • If you have severe problems with slow stomach emptying or digestion because the use of this medicine is not recommended. The active substance in this medicine delays the emptying of the stomach, which causes the food to pass more slowly through the stomach.
  • If you have had inflammation of the pancreas ( pancreatitis ) (see section 4).
  • If you lose weight too fast (more than 1.5 kg a week), talk to your doctor about this as it can cause problems, such as gallstones.
  • If you suffer from severe kidney disease or if you are receiving dialysis treatment, then the use of this medicine is not recommended. There is little experience with this medicine in patients with kidney problems.

Byetta is not insulin and should therefore not be used as a replacement for insulin.

Children and young people

Do not give this medicine to children and adolescents under 18 years of age as there is no experience with this medicine in this age group.

Other drugs and Byetta

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines in particular:

  • medicines used to treat type 2 diabetes that acts as Byetta (eg liraglutide and depot- exenatide), as the use of these medicines with Byetta is not recommended;
  • drugs used to thin the blood ( anticoagulants ), e.g. warfarin, as you will need further monitoring of altered INR values ​​(measures of blood coagulation capacity) during the start of treatment with this medicine.

If you are taking any tablets, ask your doctor if you should change the time you take them as this medicine delays the emptying of the stomach, which can affect medicines that are supposed to pass through the stomach quickly, e.g.

  • enteric tablets or capsules, e.g. Medicines that reduce stomach acid ( proton pump inhibitors ) that should not be left in the stomach for too long may need to be taken one hour before, or four hours after, this medicine.
  • Some antibiotics may need to be taken one hour before your Byetta‑ injection .
  • Tablets to be taken with food should preferably be taken with a meal as this medicine is not administered.

Swap with food

This medicine can be taken at the earliest 60 minutes (1 hour) before the meal and until the meal (see section 3. “How to use Byetta”). Do not take this medicine after a meal.

Pregnancy and breastfeeding

It is not known if this medicine can harm your fetus. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine, as it should not be used during pregnancy.

It is not known if exenatide passes into breast milk. This medicine should not be used if you are breast-feeding.

Driving and using machines

If you use this medicine together with a sulphonylurea or insulin, hypoglycemia (too low blood sugar) may occur. Hypoglycemia may impair the ability to concentrate. Keep this in mind in all situations where you may put yourself and others at risk (eg while driving or using machines).

Byetta contains metacresol

Meta cresol may cause allergic reactions

Byetta contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per dose, ie essentially ‘ sodium-free’. is almost “sodium-free”.

3. How to use Byetta

Always use this medicine exactly as your doctor, pharmacist, or diabetes nurse has told you. If you are not sure, talk to your doctor, pharmacist, or diabetes nurse.

Byetta is available in two strengths: Byetta 5 micrograms and Byetta 10 micrograms. Your doctor may initially choose to give you Byetta 5 micrograms twice a day. After taking Byetta 5 micrograms twice a day for 30 days, your doctor may increase the dose of Byetta to 10 micrograms twice a day.

If you are over 70 years of age or have kidney problems, it may take longer than 30 days for your body to get used to a 5 microgram Byetta dose, and therefore your doctor may not increase dose one.

An injection with your pre-filled pen gives you a dose. Do not change dose one unless your doctor tells you to.

This medicine should be injected no earlier than 60 minutes (1 hour) before the morning or evening meal or before the two main meals of the day, between which there should be at least 6 hours. Do not take this medicine after a meal.

This medicine should be injected under the skin ( subcutaneous injection ) in the upper leg (thigh), abdomen, or upper arm. If you are using Byetta and one insulin, you will need to make two separate injections.

You do not need to measure your blood sugar daily to set a dose of Byetta. However, if you are also taking a sulphonylurea or insulin, your doctor may ask you to check your blood sugar level to adjust the dose of your sulphonylurea or insulin . If you are taking insulin, your doctor will tell you how to lower your insulin dose and recommend that you check your blood sugar more often to avoid hyperglycemia (high blood sugar) and diabetic ketoacidosis (a complication of diabetes that occurs when the body cannot break down glucose because there is not enough a lot of insulin).

See instructions for using the Byetta pen in the enclosed operating instructions.

Your doctor or nurse must teach you how to inject Byetta before using it for the first time.

Becton, Dickinson, and Company (BDs) needles are suitable for use with the Byetta pen. Needles not included.

Insert a new needle before each injection and discard it immediately after each use. This medicine has been prescribed for you. Do not share the Byetta pen with anyone else.

If you use more Byetta than you should 

If you have taken more of this medicine than you should, talk to a doctor or go to a hospital immediately. Too much of this medicine may cause nausea, vomiting, dizziness, or symptoms of low blood sugar (see section 4).

If you forget to use Byetta

If you forget to take a dose of this medicine, skip that dose and use the next dose at the prescribed time. Do not use an extra dose or increased dose at the next dose to compensate for a missed dose.

If you stop using Byetta

If you feel that you should stop taking this medicine, talk to your doctor first. If you stop using this medicine, it may affect your blood sugar levels.

If you have any further questions on the use of this product, ask your doctor, pharmacist, or diabetes nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Severe allergic reactions ( anaphylaxis ) have been reported rarely (may affect up to 1 in 1,000 patients).

You should contact your doctor immediately if you experience symptoms such as:

  • swelling of the face, tongue, or throat ( angioedema )
  • rash, itching, and rapid swelling of the tissues of the throat, face, mouth, or throat
  • difficulty swallowing
  • hives and difficulty breathing.

Cases of inflammation of the pancreas ( pancreatitis ) have been reported (frequency) of the patients receiving this drug. Pancreatitis can be a serious, potentially life-threatening medical condition.

  • Tell your doctor if you have had pancreatitis, gallstones, alcohol problems, or very high triglyceride levels. These medical conditions may increase the risk of getting pancreatitis or getting it again, regardless of whether you are taking this medicine or not.
  • Stop taking this medicine and call your doctor immediately if you experience severe and persistent stomach pain, with or without vomiting, because you may have suffered from inflammation of the pancreas ( pancreatitis ).

Very common side effects (may affect more than 1 in 10 people):

  • nausea (most common at the beginning of treatment with this medicine, but decreases with time in most patients)
  • vomiting
  • diarrhea
  • hypoglycemia.

When this medicine is used in combination with medicines containing a sulphonylurea or insulin, it is very common for mild or moderate hypoglycemia (too low blood sugar) to occur. The dose of sulphonylurea or insulin may need to be reduced when you use this medicine. Signs and symptoms of low blood sugar can include headaches, drowsiness, weakness, dizziness, confusion, irritation, hunger, palpitations, sweating, and trembling / irritability. Your doctor should tell you how to treat low blood sugar.

Common side effects (may affect up to 1 in 10 people):

  • dizziness
  • headache
  • trembling / irritability
  • constipation
  • abdominal pain
  • bloating
  • indigestion
  • itching (with or without rash)
  • weather voltage
  • increased sweating
  • impotence
  • heartburn
  • decreased appetite.

This medicine can reduce your appetite and the amount of food you eat as well as your weight.

Tell your doctor if you lose weight too fast (more than 1.5 kg a week) as it can cause problems, such as gallstones.

Uncommon side effects (may affect up to 1 in 100 people):

  • impaired renal function
  • dehydration, generally associated with nausea, vomiting and/or diarrhea
  • taste change
  • belching
  • injection site reactions ( redness )
  • somnolence
  • hair loss
  • weight loss.

Rare side effects (may affect up to 1 in 1,000 patients):

  • intestinal obstruction (blockage in the intestine).

Has been reported (occurs in an unknown number of users):

In addition, some other side effects are reported:

  • bleeding or easier than normal to get bruises due to low levels of platelets.
  • Altered INR values ​​(measures of blood coagulation capacity ) have been reported with concomitant use of warfarin.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Byetta

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiration date is the last day of the specified month.

Store in a refrigerator (2 ° C – 8 ° C). Store the pen currently in use at a maximum of 25 ° C for 30 days. Discard a used pen after 30 days even if there is some medicine left in the pen.

Put the cap back on the pen as this medicine is light sensitive. Do not freeze. Discard the Byetta pen if it has frozen.

Do not use this medicine if you see particles in the solution or if it is cloudy or colored.

Do not store the pen with the needle attached. If the needle remains, medicines may leak from the pen, or air bubbles may form in the ampoule.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is exenatide.
  • Two pre-filled pens are provided. One gives you a dose of 5 micrograms and the other of 10 micrograms.
  • One dose of Byetta 5 micrograms solution for injection ( injection ) contains 5 micrograms of exenatide in 20 microliters.
  • One dose of Byetta 10 micrograms solution for injection ( injection ) contains 10 micrograms of exenatide in 40 microliters.
  • One milliliter (ml) solution for injection contains 0.25 milligrams (mg) of exenatide.
  • The other ingredients are metacresol (44 micrograms per dose in Byetta 5 micrograms solution for injection and 88 micrograms per dose in Byetta 10 micrograms solution for injection ), mannitol, concentrated acetic acid, sodium acetate trihydrate, and water for injections (see section 2).

What the medicine looks like and the contents of the pack

Byetta is a clear and colorless liquid ( injection ) and is contained in an ampoule in the pen. When the pen is empty, you can no longer use it. One pen contains 60 doses, which is enough for two doses a day for 30 days.

Byetta is available in pack sizes of 1 and 3 pre-filled pens. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Manufacturer

AstraZeneca AB

Global External Sourcing (GES)

AstraZeneca UK Limited

Silk Road Business Park,

Macclesfield, Cheshire, SK10 2NA

UK

Swords Laboratories T / A Lawrence Laboratories

Unit 12 Distribution Center, Shannon Industrial Estate, Shannon, Co. Clare

Ireland

Contact the representative of the marketing authorization holder to find out more about this medicine:

Belgium / Belgique / BelgienAstraZeneca SA / NVTel: +32 2 370 48 11
LithuaniaUAB AstraZeneca LietuvaTel: +370 5 2660550
BulgariaAstrology Bulgaria BODYTel: +359 24455000 Luxembourg / LuxemburgAstraZeneca SA / NVTel: +32 2 370 48 11
Czech RepublicAstraZeneca Czech Republic sroTel: +420 222 807 111 HungaryAstraZeneca Kft.Tel .: +36 1 883 6500
DenmarkAstraZeneca A / STel: +45 43 66 64 62 MaltaAssociated Drug Co. Ltd.Tel: +356 2277 8000
GermanyAstraZeneca GmbHTel: +49 41 03 7080
The NetherlandsAstraZeneca BVTel: +31 79 363 2222
EestiAstraZenecaTel: +372 6549 600 NorwayAstraZeneca ASTel: +47 21 00 64 00
GreeceAstraZeneca AE:Ηλ: +30 210 6871500 AustriaAstraZeneca Österreich GmbHTel: +43 1 711 31 0
SpainAstraZeneca Pharmacéutica Spain, SATel: +34 91 301 91 00 PolandAstraZeneca Pharma Poland Sp. z ooTel .: +48 22 245 73 00
FranceAstraZenecaTel: +33 1 41 29 40 00
PortugalAstraZeneca Pharmaceutical Products, Lda.Tel: +351 21 434 61 00
CroatiaAstraZeneca dooTel: +385 1 4628 000
RomaniaAstraZeneca Pharma SRLTel: +40 21 317 60 41
IrelandAstraZeneca Pharmaceuticals (Ireland) LtdTel: +353 1609 7100
SloveniaAstraZeneca UK LimitedTel: +386 1 51 35 600
IcelandVistor hf.Phone: + 354 535 7000 Slovak RepublicAstraZeneca AB, ozTel: +421 2 5737 7777
ItalyAstraZeneca SpATel: +39 02 9801 1 Finland / FinlandAstraZeneca OyPuh / Tel: +358 10 23 010
ΚύπροςAlexander the Great:Ηλ: +357 22490305
LatviaSIA AstraZeneca LatvijaTel: +371 67377100 United KingdomAstraZeneca UK LtdTel: +44 1582 836 836

Muhammad Nadeem

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