Patient Medication Information: uses, side effects, how to take - Eperzan

What is EPERZAN™ used for?

EPERZAN™ is used along with diet and exercise to lower blood glucose (sugar) in adult patients with type 2 diabetes mellitus:

as monotherapy in patients inadequately controlled by diet, exercise and when metformin is inappropriate due to contraindications or intolerance.
in combination with one of the following therapeutic options in patients who have not achieved adequate glycemic control:
- metformin, when diet and exercise plus maximal tolerated dose of metformin do not achieve adequate glycemic control
- metformin and sulfonylurea, when diet and exercise plus dual therapy with metformin and sulfonylurea do not achieve adequate glycemic control

Serious Warnings and Precautions

Thyroid C-cell tumors have been observed in rodent studies with glucagon-like peptide-1 (GLP-1) receptor agonists at clinically relevant exposures. We cannot confirm whether or not EPERZAN™ causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans.

EPERZAN™ is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

basal insulin with oral antidiabetic therapies, when diet and exercise plus basal insulin with oral antidiabetic therapies do not achieve adequate glycemic control.
It is not known if EPERZAN™ can be used with mealtime insulin.
EPERZAN™ is not a substitute for insulin. EPERZAN™ should not be used in type 1 diabetes (formerly known as insulin-dependent diabetes mellitus or IDDM) or diabetic ketoacidosis.
EPERZAN™ has not been studied in children under 18 years of age.

How does EPERZAN™ work?

EPERZAN™ belongs to a class of medicines called GLP-1 receptor agonists. EPERZAN™ is an injectable medicine used to lower blood sugar in adults with type 2 diabetes mellitus.

What are the ingredients in EPERZAN™?

Medicinal ingredient: albiglutide

Non-medicinal ingredients: mannitol, polysorbate 80, sodium phosphate monobasic monohydrate, sodium phosphate dibasic anhydrous, trehalose dihydrate, water for injection

EPERZAN™ comes in the following dosage form:

EPERZAN™ is supplied as a prefilled, single use pen for self injection. Each pen contains a white to yellow powder and a colourless liquid in separate compartments. A needle is provided with each pen.

EPERZAN™ is available in 30 mg/0.5 mL (after reconstitution) and 50 mg/0.5 mL (after reconstitution) strengths.

Do not use EPERZAN™ if:

you are allergic to albiglutide or any other ingredient in the injection (see What are the ingredients in EPERZAN™? for a complete list of ingredients).
you or a member of your family has ever had medullary thyroid cancer.
you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). This is a disease where people have tumours in more than one gland in their body.
you are pregnant or breastfeeding. EPERZAN™ may harm your unborn baby.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take EPERZAN™. Talk about any health conditions or problems you may have, including if you:

have type 1 diabetes
have ever had diabetic ketoacidosis (increased ketones in the blood or urine)
have ever had an allergic reaction to EPERZAN™
or a member of your family has or has had medullary thyroid carcinoma, or if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
are pregnant or plan to have a baby. EPERZAN™ may harm your unborn baby. Tell your doctor if you become pregnant while taking EPERZAN™. If you are pregnant, stop using EPERZAN™.
are breastfeeding or plan to breastfeed. It is not known if EPERZAN™ passes into your breast milk. You and your doctor should decide if you will take EPERZAN™ or breastfeed.
have a high heart rate (fast pulse)
have a condition called heart block
have any heart disease, such as angina, heart rhythm disturbances or congestive heart failure; or if you have ever had a myocardial infarction (heart attack)
have kidney problems
have liver problems
have inflammation of your pancreas (pancreatitis)
have severe stomach or intestinal problems
have severe vomiting and/or diarrhea and/or dehydration

Other warnings you should know about:

See “Serious Warnings and Precautions” black box.
Heart rate increase and PR interval prolongation. EPERZAN™ may increase heart rate and could cause changes known as PR prolongation, which are detected by electrocardiogram (ECG) tracings. Increased heart rate is the same as a faster pulse. Rarely, drugs with these effects can cause changes in heart rhythm that could result in dizziness, palpitations (a feeling of rapid, pounding, or irregular heart beat), fainting or death. These heart rhythm changes are more likely if you have heart disease, or if you are taking certain other drugs. It is important to follow your doctor's advice about the dose of EPERZAN™ or about any special tests that you may need.
Inflammation of your pancreas (pancreatitis). Stop using EPERZAN™ 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 pain from your abdomen to your back.
It is not known if EPERZAN™ can be used in people who have had pancreatitis.
Gastrointestinal disorders. EPERZAN™ is not recommended for use in people with severe stomach or intestinal problems.
Low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use EPERZAN™ with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin.
Serious allergic reactions. Stop using EPERZAN™ and get medical help right away if you have any symptoms of a serious allergic reaction including itching, rash, or difficulty breathing.
Kidney problems (kidney failure). In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration) which may cause kidney problems to get worse.
Liver problems. The use of EPERZAN™ in patients with hepatic impairment has not been studied.

Talk to your healthcare provider about any side effect that bothers you or does not go away. These are not all the possible side effects of EPERZAN™.

The following may interact with EPERZAN™:

Before using EPERZAN™, talk to your healthcare provider about low blood sugar and how to manage it. Tell your healthcare provider if you are taking other medicines to treat diabetes including insulin or sulfonylureas. You may get hypoglycemia (low blood sugar) when using EPERZAN™ with other medicines for diabetes.

The following list includes some, but not all, of the drugs that may increase the risk of heart rhythm problems while receiving EPERZAN™:

Drugs to treat hypertension
Drugs to treat heart failure
Drugs to treat HIV infection
Drugs to treat attention deficit-hyperactivity disorder
Drugs to suppress appetite/cause weight loss
Decongestants
Drugs to treat asthma

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

How to take EPERZAN™:

EPERZAN™ is injected under the skin (subcutaneously) of your stomach (abdomen), thigh, or upper arm. Do not inject EPERZAN™ into a vein or muscle. Change (rotate) your injection site with each weekly injection. Do not use the same site for each injection.
EPERZAN™ should be injected within 8 hours after mixing your medicine.
EPERZAN™ should be injected right after you attach the needle.
Always use a new needle for each injection
Do not share your EPERZAN™ pen or needles with another person. You may give another person an infection or get an infection from them.
See the Instructions for Use. They describe the right way to mix and use your pen. Follow the Instructions for Use carefully. Failure to follow the steps in the correct order may result in damage to the pen.
If you also give yourself insulin injections in addition to EPERZAN™, never mix insulin and EPERZAN™ together, rather give yourself 2 separate injections. You may give both injections in the same body area (for example, your stomach area), but you should not give the injections right next to each other.
Keep pens and needles out of the reach of children

Usual dose:

Use EPERZAN™ exactly as prescribed. Do not change your dose or stop EPERZAN™ without talking to your doctor.

EPERZAN™ is injected one time on the same day each week, at any time of the day. You can take EPERZAN™ with or without food. The recommended dose of EPERZAN™ is 30 mg once per week, administered subcutaneously. The dose may be increased to 50 mg once-weekly based on your glycemic response.
Your healthcare provider will teach you how to mix and inject EPERZAN™ before you use it for the first time. If you have questions or do not understand the Instructions for Use, talk to your healthcare provider or pharmacist.
Your doctor should start you on a diet and exercise program when you start taking EPERZAN™. Stay on this program while you are taking EPERZAN™.
Your dose of EPERZAN™ and other diabetes medicines may need to change because of: change in level of physical activity or exercise, weight gain or loss, increased stress, illness, change in diet, or because of other medicines you take.

Overdose:

If you think you have taken too much EPERZAN™, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose: If you miss a dose of EPERZAN™, take it as soon as possible within 3 days after the missed dose. You can then take your next dose at your usual weekly time. If it has been longer than 3 days after the missed dose, wait and take EPERZAN™ at your next usual weekly time. Do not take an extra dose of EPERZAN™ to make up for your missed dose.

Do not take 2 doses of EPERZAN™ within 3 days of each other.

What are possible side effects from using EPERZAN™?

These are not all the possible side effects you may feel when taking EPERZAN™. If you experience any side effects not listed here, contact your healthcare professional. Please also see Warnings and Precautions.

Very common (≥ 1 in 10):

low blood sugar (hypoglycemia) when used in combination with other diabetes medicines, especially a sulfonylurea medicine or insulin. The dose of the sulfonylurea medicine or insulin may need to be lowered while using EPERZAN™
diarrhea
nausea
rash, redness, or itching of the skin where you have injected EPERZAN™
infection of the upper airways

Common (≥ 1 in 100 and < 1 in 10):

chest infection (pneumonia)
hypoglycaemia (when albiglutide is used as monotherapy or in combination with metformin or pioglitazone)
irregular heartbeat (atrial fibrillation/flutter)
being sick (vomiting)
constipation
indigestion
heartburn (gastroesophageal reflux)

Uncommon (≥ 1 in 1,000 and < 1 in 100):

appendicitis
pancreatitis (an inflamed pancreas)

Rare (< 1 in 1,000): hypersensitivity reaction

Serious side effects and what to do about them

Symptom / effect	Talk to your healthcare professional	Stop taking drug and get immediate medical help
Only if severe	In all cases
COMMON Pneumonia,symptoms such as increased cough with increase in mucus (sputum) production, fever that may be accompanied by shaking chills, shortness of breath, sharp or stabbing chest pain during deep breaths, and increased rapid breathing		√
Atrial fibrillation/ flutter, irregular heart rate, palpitations, fatigue or shortness of breath			√
UNCOMMON Severe hypoglycemia; disorientation, loss of consciousness, or seizures	√
Pancreatitis; severe pain in your stomach area (abdomen) that does not go away (with or without vomiting) or nausea			√
Severe form of allergic reaction (anaphylactic reaction) with symptoms of breathing problems, swelling of throat and face, and fast heart beat. You should seek immediate medical attention			√
Appendicitis		√
Thyroid tumour / lump in the neck, difficulty in swallowing difficulty in breathing or persistent hoarseness		√

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

Reporting Side Effects

You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.

3 ways to report:

Online at MedEffect;
By calling 1-866-234-2345 (toll-free);
By completing a Patienter Side Effect Reporting Form and sending it by:
- Fax to 1-866-678-6789 (toll-free), or
- Mail to: Canada Vigilance Program
  Health Canada, Postal Locator 0701E Ottawa, ON
  K1A 0K9
  Postage paid labels and the Patienter Side Effect Reporting Form are available at MedEffect.

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

Store pens in the original carton until use.
Refrigerate at 2°C to 8°C. Do not freeze.
You may store pens at room temperature not to exceed 30°C for no more than 4 weeks. If storing for more than 4 weeks, keep refrigerated at 2°C to 8°C.
Once the needle is attached, inject immediately. Do not store with needle attached.
Do not use EPERZAN™ if it has been frozen.
Do not keep medicine that is out of date or that you no longer need.
Keep EPERZAN™ out of the reach of children.
Dispose of EPERZAN™ as instructed in the Instructions for Use.

If you want more information about EPERZAN™:

Talk to your healthcare professional
Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (http://hc-sc.gc.ca/index-eng.php); the manufacturer’s website http://www.gsk.ca, or by calling 1-800-387-7374.

EPERZAN is a trademark of Glaxo Group Limited, used under license by GlaxoSmithKline Inc.

Last Revised FEB-12-2016

INSTRUCTIONS FOR USE

^PrEPERZAN™ (albiglutide) powder for solution for injection ANTIDIABETIC AGENT 30 mg/0.5 mL after reconstitution

Read all the instructions and follow the steps below to mix the medicine and prepare the pen for injection.

Failure to follow Steps A to C in the correct order may result in damage to your pen.

What is Unique About This Pen

This medication is injected once per week.
The pen has the medicine powder in one compartment and the water in another compartment. You will need to mix them together by twisting the pen, then wait for 15 minutes for the medicine and water to fully mix.

CAUTION:

Do not allow the pen to freeze. Discard it if frozen.

If stored in refrigerator, allow to sit at room temperature for 15 minutes before starting Step A.

Do not reuse needles, recap needles or remove needles from the pen after injection. Safely dispose of the pen and needle right away after injecting (see Step C).

Before You Begin: Wash Your Hands, Gather & Inspect Materials

Wash your hands.
Take a pen and new needle out of the box and check the label on your pen to make sure it is your prescribed dose of medicine.
Gather a clean empty cup to hold the pen while the medicine mixes, a clock/timer to measure the time while the medication mixes and a container for pen disposal as directed by your healthcare provider. These items are not provided in the pack.
mixed.
be

STEP A

Inspect Your Pen and Mix Your Medicine

Inspect Your Pen

Make sure that you have all of the supplies listed above (pen, needle, cup, timer, disposal container).
Check the expiration date on the pen. Do not use if expired.

Check that the pen has a [1] in the number window. DO NOT use if the [1] is not showing.

If the pen is expired, or the [1] is not in the number window, return the pen to your pharmacist for disposal.

Twist Pen to Mix Your Medicine

Hold the pen body with the clear cartridge pointing up so that you can see the [1] in the number window.
With your other hand, twist the clear cartridge in the direction of the arrow until you feel/hear the pen “click” into place and you see the [2] in the number window. This will mix the medicine powder and liquid in the clear cartridge.

Slowly and gently rock the pen side to side 5 times, with the clear cartridge pointing up, to mix the drug (like a windshield wiper). DO NOT shake the pen hard to avoid foaming which may affect your dose.

Wait for Medicine to Dissolve

Place the pen into the clean, empty cup with the clear cartridge pointing up.
Set the clock/timer for 15 minutes.

You must wait 15 minutes for the medicine to dissolve

before continuing to Step B.

The reconstituted pen can be stored for no more than 8 hours before continuing to Step B. Once the needle is attached the pen must be used immediately.

STEP B

Attach the Needle and Prepare Pen for Injection

After the 15 minute wait, wash your hands and finish the rest of the steps right away.

Inspect Your Dissolved Medicine

Again, slowly and gently rock the pen side to side 5 times to re-mix the medicine (like a windshield wiper). DO NOT shake the pen hard to avoid foaming which may affect your dose.

Look through the viewing window to check that the liquid in the cartridge is clear and free of solid particles.

The liquid will have a yellow colour and there will be large air bubbles on top of the liquid.

Attach the Needle

Peel the tab from the outer needle cap.

Hold the pen with the clear cartridge pointing up and push the needle straight down onto the clear cartridge until you hear a “click” and feel the needle “snap” down into place – This means the needle is attached.

Tap for Air Bubbles

With the needle point up, gently tap the clear cartridge 2-3 times with your finger to bring large air bubbles to the top.

Small bubbles are okay and do not need to rise to the top.

Twist Pen to Prime the Needle

Slowly twist the clear cartridge several times in the direction of the arrow (clockwise) until you feel/hear the pen “click” and you see the [3] in the number window. This removes the large air bubbles from the clear cartridge. The injection button will also pop out from the bottom of the pen.

STEP C

Remove Both Needle Caps and Inject Your Medicine

Remove Needle Caps

Carefully remove the outer needle cap, then the inner needle cap. A few drops of liquid may come out of the needle. This is normal.

Step 1: Remove Outer Needle Cap

Step 2: Remove Inner Needle Cap

Inject the Medicine

Insert the needle into the skin on your abdomen, thigh or upper arm and inject as shown to you by your healthcare provider.

With your thumb, press the injection button slowly and steadily to inject your medicine. The slower you press, the easier the injection will feel.
Keep the injection button pressed down until you hear a “click”. After hearing the click, continue holding your thumb down on the button and then slowly count to 5 to deliver the full dose of the medicine.

After hearing the click and then slowly counting to 5, pull the needle out of your skin.

Dispose the Pen

Do not recap the needle or remove the needle from the pen.
Do not dispose of the used pen in the household waste. Dispose the pen as your healthcare provider has instructed, such as in a sharps container.

^PrEPERZAN™ (albiglutide) powder for solution for injection ANTIDIABETIC AGENT 30 mg/0.5 mL after reconstitution

Frequently Asked Questions

Medication Dosing

How often should I take my medicine?

Take once a week, on the same day each week. You can administer your medicine at any time of day, with or without meals.

What if I need to take my medicine on a different day of the week?

If you need to change the day of the week that you take your medicine, you may take your next dose of medicine from 4 to 10 days after the last dose.

What if I forget to take the medicine on the day I’m supposed to?

Take your next dose of medicine within 3 days after your usual day, then return to your usual day for your next dose. If you miss more than 3 days after your usual day, wait until your next regularly scheduled weekly dose.

Storage

When and how should I store my EPERZAN™ Pen?

Store your pens in the original carton until use. Refrigerate at 2°C to 8°C. You may store your pens at room temperature (not to exceed 30°C) for no more than 4 weeks.
If a box of pens will be stored for more than 4 weeks, keep it refrigerated at 2°C to 8°C. DO NOT FREEZE. If the liquid in the pen is frozen, do not use the pen, use another pen.
Keep away from dust, dirt and liquids and out of the reach of children.

Number Window

Are the Numbers 1, 2 & 3 how I select my dose of medicine?

No, you do not have to select your dose. The numbers are to help you prepare and administer your medicine.
- Number 1 – The pen is ready to be mixed. Medicine powder and water are in separate compartments in the clear cartridge. If you don’t see a number 1 in the window, return the pen to your pharmacist for disposal.
- Number 2 – Medicine powder and water are mixed. After you gently rock the pen 5 times, wait 15 minutes. Then gently rock the pen again 5 times, and attach needle.
- Number 3 – Large air bubble are removed, the injection button pops out, and the pen is ready for injection.

What if I do not hear the “CLICK” when the 2 or 3 are moved into the Number Window?

If you do not hear a “click” when 2 or 3 are moved into the number window, you may not have the number fully centered in the window. Twist clear cartridge slightly in the direction of the arrow to complete the “click” and center the number in the window. Do not turn the clear cartridge in the opposite direction from the arrows.

Step A - Inspect Your Pen and Mix Your Medicine

What if I do not wait 15 minutes after turning the pen to the Number 2?

Waiting the full 15 minutes ensures that the medicine powder and water are properly mixed, even though it may visually appear to be mixed sooner than that. If you do not wait the full 15 minutes the drug may not be properly mixed with the water. This can result in particles floating in the clear cartridge, an ineffective dose and/or a blocked needle.

What if I leave my pen for more than 15 minutes after turning the pen to the Number 2 in Step A?

As long as the needle has not been attached, the pen can be used for up to 8 hours from the time Step A was started. If it has been more than 8 hours since the medicine was mixed in Step A, discard pen and use another pen.

Step B - Attach the Needle and Prepare Pen for Injection

What if I do not attach the needle at Step B?

If the needle is not attached in Step B, and you go to Step C to turn the pen from Position 2 to 3, this can damage the pen.
Do not attach the needle at Step A. Some of the medicine may be lost during mixing. Return the pen to your pharmacist for disposal.

What if I leave my pen with the needle attached at Step B, and come back later to finish Step C?

This can cause your needle to block, you should continue from Step B to Step C right away.

Step C - Remove Both Needle Caps and Inject Your Medicine

After I turn the pen to Number 3 (Step C), there are still some small air bubbles remaining. Can I still use the pen?

Yes, if you see small air bubbles that don’t rise to the top, it is normal and you will receive the correct dose of your medicine. The small air bubbles will not harm you.

Can I inject the medicine into my arm?

Yes, the upper arm can be used as one of the injection sites.

After I administer my medicine, there is some liquid still visible in the clear cartridge.

This is normal. If you have heard/felt the injection button “click” and slowly counted to 5 before pulling the needle out of your skin, you have received the correct dose of your medicine.

Please verify you are using the correct dosage.

These instructions are for:

30 mg

EPERZAN is a trademark of Glaxo Group Limited, used under license by GlaxoSmithKline Inc.

GlaxoSmithKline Inc. Mississauga, Ontario L5N 6L4