Liraglutide Solution for injection

What is this medicine?

LIRAGLUTIDE (LIR a GLOO tide) is used to improve blood sugar control in adults with type 2 diabetes. This medicine may be used with other oral diabetes medicines.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• endocrine tumors (MEN 2) or if someone in your family had these tumors

• gallstones

• high cholesterol

• history of alcohol abuse problem

• history of pancreatitis

• kidney disease or if you are on dialysis

• liver disease

• previous swelling of the tongue, face, or lips with difficulty breathing, difficulty swallowing, hoarseness, or tightening of the throat

• stomach problems

• suicidal thoughts, plans, or attempt; a previous suicide attempt by you or a family member

• thyroid cancer or if someone in your family had thyroid cancer

• an unusual or allergic reaction to liraglutide, medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This medicine is for injection under the skin of your upper leg, stomach area, or upper arm. You will be taught how to prepare and give this medicine. Use exactly as directed. Take your medicine at regular intervals. Do not take it more often than directed.

It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or healthcare provider to get one.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you've taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

• acetaminophen

• atorvastatin

• birth control pills

• digoxin

• griseofulvin

• lisinopril

Many medications may cause changes in blood sugar, these include:

• alcohol containing beverages

• aspirin and aspirin-like drugs

• chloramphenicol

• chromium

• diuretics

• female hormones, such as estrogens or progestins, birth control pills

• heart medicines

• isoniazid

• male hormones or anabolic steroids

• medications for weight loss

• medicines for allergies, asthma, cold, or cough

• medicines for mental problems

• medicines called MAO inhibitors - Nardil, Parnate, Marplan, Eldepryl

• niacin

• NSAIDS, such as ibuprofen

• pentamidine

• phenytoin

• probenecid

• quinolone antibiotics such as ciprofloxacin, levofloxacin, ofloxacin

• some herbal dietary supplements

• steroid medicines such as prednisone or cortisone

• thyroid hormones

Some medications can hide the warning symptoms of low blood sugar (hypoglycemia). You may need to monitor your blood sugar more closely if you are taking one of these medications. These include:

• beta-blockers, often used for high blood pressure or heart problems (examples include atenolol, metoprolol, propranolol)

• clonidine

• guanethidine

• reserpine

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checks on your progress.

A test called the HbA1C (A1C) will be monitored. This is a simple blood test. It measures your blood sugar control over the last 2 to 3 months. You will receive this test every 3 to 6 months.

Learn how to check your blood sugar. Learn the symptoms of low and high blood sugar and how to manage them.

Always carry a quick-source of sugar with you in case you have symptoms of low blood sugar. Examples include hard sugar candy or glucose tablets. Make sure others know that you can choke if you eat or drink when you develop serious symptoms of low blood sugar, such as seizures or unconsciousness. They must get medical help at once.

Tell your doctor or health care professional if you have high blood sugar. You might need to change the dose of your medicine. If you are sick or exercising more than usual, you might need to change the dose of your medicine.

Do not skip meals. Ask your doctor or health care professional if you should avoid alcohol. Many nonprescription cough and cold products contain sugar or alcohol. These can affect blood sugar.

Liraglutide pens and cartridges should never be shared. Even if the needle is changed, sharing may result in passing of viruses like hepatitis or HIV.

Wear a medical ID bracelet or chain, and carry a card that describes your disease and details of your medicine and dosage times.

Patients and their families should watch out for worsening depression or thoughts of suicide. Also watch out for sudden changes in feelings such as feeling anxious, agitated, panicky, irritable, hostile, aggressive, impulsive, severely restless, overly excited and hyperactive, or not being able to sleep. If this happens, especially at the beginning of treatment or after a change in dose, call your health care professional.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• fever, chills

• loss of appetite

• signs and symptoms of low blood sugar such as feeling anxious, confusion, dizziness, increased hunger, unusually weak or tired, sweating, shakiness, cold, irritable, headache, blurred vision, fast heartbeat, loss of consciousness

• trouble passing urine or change in the amount of urine

• unusual stomach pain or upset

• vomiting

Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome.):

• constipation

• diarrhea

• fatigue

• headache

• nausea

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store unopened pen in a refrigerator between 2 and 8 degrees C (36 and 46 degrees F). Do not freeze or use if the medicine has been frozen. Protect from light and excessive heat. After you first use the pen, it can be stored at room temperature between 15 and 30 degrees C (59 and 86 degrees F) or in a refrigerator. Throw away your used pen after 30 days or after the expiration date, whichever comes first.

Do not store your pen with the needle attached. If the needle is left on, medicine may leak from the pen.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Liraglutide Solution for injection [Weight Management]

What is this medicine?

LIRAGLUTIDE (LIR a GLOO tide) is used with a reduced calorie diet and exercise to help you lose weight.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• endocrine tumors (MEN 2) or if someone in your family had these tumors

• gallstones

• high cholesterol

• history of alcohol abuse problem

• history of pancreatitis

• kidney disease or if you are on dialysis

• liver disease

• previous swelling of the tongue, face, or lips with difficulty breathing, difficulty swallowing, hoarseness, or tightening of the throat

• stomach problems

• suicidal thoughts, plans, or attempt; a previous suicide attempt by you or a family member

• thyroid cancer or if someone in your family had thyroid cancer

• an unusual or allergic reaction to liraglutide, medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This medicine is for injection under the skin of your upper leg, stomach area, or upper arm. You will be taught how to prepare and give this medicine. Use exactly as directed. Take your medicine at regular intervals. Do not take it more often than directed.

It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or healthcare provider to get one.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you've taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses. If you miss your dose for 3 days or more, call your doctor or health care professional to talk about how to restart this medicine.

What may interact with this medicine?

• acetaminophen

• atorvastatin

• birth control pills

• digoxin

• griseofulvin

• lisinopril

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checks on your progress. This medicine is intended to be used in addition to a healthy diet and appropriate exercise. The best results are achieved this way. Do not increase or in any way change your dose without consulting your doctor or health care professional.

This medicine may affect blood sugar levels. If you have diabetes, check with your doctor or health care professional before you change your diet or the dose of your diabetic medicine.

Patients and their families should watch out for worsening depression or thoughts of suicide. Also watch out for sudden changes in feelings such as feeling anxious, agitated, panicky, irritable, hostile, aggressive, impulsive, severely restless, overly excited and hyperactive, or not being able to sleep. If this happens, especially at the beginning of treatment or after a change in dose, call your health care professional.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• fever, chills

• loss of appetite

• signs and symptoms of low blood sugar such as feeling anxious, confusion, dizziness, increased hunger, unusually weak or tired, sweating, shakiness, cold, irritable, headache, blurred vision, fast heartbeat, loss of consciousness

• trouble passing urine or change in the amount of urine

• unusual stomach pain or upset

• vomiting

Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome.):

• constipation

• diarrhea

• fatigue

• headache

• nausea

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store unopened pen in a refrigerator between 2 and 8 degrees C (36 and 46 degrees F). Do not freeze or use if the medicine has been frozen. Protect from light and excessive heat. After you first use the pen, it can be stored at room temperature between 15 and 30 degrees C (59 and 86 degrees F) or in a refrigerator. Throw away your used pen after 30 days or after the expiration date, whichever comes first.

Do not store your pen with the needle attached. If the needle is left on, medicine may leak from the pen.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.