Insulin-degludec-liraglutide Injectable Solution

INSULIN DEGLUDEC; LIRAGLUTIDE (IN su lin de GLOO dek; LIR a GLOO tide) is a combination of 2 medicines used to treat type 2 diabetes. This medicine lowers blood sugar. Treatment is combined with a balanced diet and exercise.

This drug can cause serious side effects. See which side effects you should report to your doctor right away.

Know how to use your medication, and learn what might happen if you miss a dose.

Talk to your healthcare provider if you have any of these conditions.

Know what to watch for and get tips for reducing your risks while taking this drug.

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 high blood sugar such as dizziness, dry mouth, dry skin, fruity breath, nausea, stomach pain, increased hunger or thirst, increased urination
• 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
• increase or decrease in fatty tissue under the skin due to overuse of a particular injection site
• itching, burning, swelling, or rash at site where injected
• nausea

• acetaminophen
• atorvastatin
• birth control pills
• digoxin
• griseofulvin
• lisinopril

Many medications may cause an increase or decrease in blood sugar, these include:

• alcohol containing beverages
• aspirin and aspirin-like drugs
• certain medicines for HIV like indinavir, lopinavir; ritonavir, nelfinavir, ritonavir, saquinavir
• diuretics
• female hormones, like estrogens or progestins and birth control pills
• heart medicines
• isoniazid
• medicines for allergies, asthma, cold, or cough
• medicines for mental problems
• medicines called MAO Inhibitors like Nardil, Parnate, Marplan, Eldepryl
• niacin
• octreotide
• pentamidine
• quinolone antibiotics like ciprofloxacin, levofloxacin, ofloxacin
• some herbal dietary supplements
• steroid medicines like prednisone or cortisone
• sulfasalazine
• sulfamethoxazole; trimethoprim
• thyroid medicine

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

• beta-blockers such as atenolol, metoprolol, propranolol
• clonidine
• guanethidine
• reserpine

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.

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

• endocrine tumors (MEN 2) or if someone in your family had these tumors
• episodes of hypoglycemia
• gallbladder disease
• 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
• thyroid cancer or if someone in your family had thyroid cancer
• an unusual or allergic reaction to insulin, liraglutide, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

It is important not to miss a dose. Your health care professional or doctor should discuss a plan for missed doses with you. If you do miss a dose, follow their plan. Do not take double doses.

Visit your health care professional or doctor 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.

Insulin; liraglutide pens 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.

Keep out of the reach of children.

Store unopened pens in a refrigerator between 2 and 8 degrees C (36 and 46 degrees F.) Do not store in the freezer or directly adjacent to the refrigerator cooling element. Do not use the pen if it has been frozen. After first use, the pen can be stored for 21 days at controlled room temperature of 15 to 30 degrees C (59 to 86 degrees F) or in a refrigerator 2 to 8 degrees C (36 to 46 degrees F). Do not expose to excessive heat or direct light. Do not use past the expiration date or 21 days after the pen is first in use.

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