Victoza® (liraglutide) Injection

Warnings

Do not drive if you face a hypoglycaemic condition or handle projects which require prompt alertness.

Do not use too much alcohol with the medication course.

Children (especially those under ten years of age) are at more risk of hypoglycemia. Therefore, blood sugar levels should be monitored regularly.

You should recognize signs and symptoms of acute pancreatitis and should seek immediate medical attention if symptoms develop.

You should know the potential risk of dehydration with gastro-intestinal side-effects and should take precautions to avoid fluid depletion

You should be able to recognize the symptoms of cholelithiasis and cholecystitis. Symptoms include fever, jaundice (which indicates raised bilirubin levels presents as yellowish discoloration of skin and sclera), pain in the right adjacent area of the stomach and nausea.

Your healthcare provider will watch for the following signs and symptoms to pick up any neoplastic growth at the earliest as thyroid-related cancers are a significant concern with the use of Victoza.

Usage

Your doctor will usually instruct you to inject this medication under the skin once a day in the thigh, abdomen, or upper arm.

Separately inject liraglutide and insulin if you are also taking insulin. It is not advisable to mix them. Medications may be injected in the same area of the body, but they should not be injected next to each other.

Depending on your medical condition and response to treatment, the dosage will vary. Initially, your doctor will prescribe a low dose to decrease your risk of stomach/abdominal side effects, and gradually increase the dose. To reduce the chance of side effects, ask your doctor if the low dose of liraglutide should be restarted if more than 3 days have passed since your last dose. Make sure you follow your doctor’s instructions.

Check this product visually for particles or discoloration before using. Do not use the liquid if either of these conditions exists. Make sure the injection site is clean before injecting each dose. To avoid problem areas under the skin, it is important to change the injection site every day.

Get the most benefit from this medication by using it regularly. Keep it at the same time each day to make it easier to remember. Follow your doctor’s medication treatment plan, meal plan, and exercise program carefully.

Even if the needle is changed, do not share your pen device. You may give other people a serious infection, or get a serious infection from them. Learn how to store and discard medical supplies safely.

You should tell your doctor if your condition lasts or gets worse (for example, your blood sugar remains high or increases).

Before Taking Victoza

You should tell your doctor or pharmacist if you are allergic to liraglutide; or if you have any other allergies. There is a possibility that this product contains inactive ingredients that can cause allergic reactions. Talk to your pharmacist for more details.

It is important to inform your doctor or pharmacist about your medical history, including kidney disease, pancreatic disease, gallbladder disease, stomach/intestinal disorder (gastroparesis), and mental/mood disorders (such as depression, suicide thoughts).

When your blood sugar is extremely low or high, you may experience blurred vision, dizziness, or drowsiness. Until you are sure you can perform such activities safely, do not drive, operate machinery, or do anything else that requires alertness or clear vision.

Drinking alcohol while taking this medication can increase your risk of low blood sugar.

You may have difficulties controlling your blood sugar when your body is stressed (such as when you have a fever, an infection, an injury, or surgery). A change in your treatment plan, medications, or blood sugar tests may be required if you are experiencing increased stress.

Ensure that all products you use (including prescription and nonprescription drugs) are disclosed to your doctor or dentist before surgery.

When this drug is used by children, they may be at a greater risk for low blood sugar.

Pregnant women should only use this medication when clearly necessary. Diabetes may be caused or worsened by pregnancy. Manage your blood sugar during pregnancy with the help of your doctor. During pregnancy, your doctor may change your diabetes treatment. Different treatments have different risks and benefits.

There is no information on whether this medication passes into breast milk. Breastfeeding should be discussed with your doctor.

If you have any questions, contact your pharmacist or physician.

Common Side Effects

You may experience any of the following side effects while taking Victoza. There may be other side effects not listed here. For more information about Victoza’s potential side effects, speak with your doctor or pharmacist.

• Headache,
• Dizziness,
• Vomiting,
• Upset stomach,
• Irritability,
• Appetite loss,
• Diarrhea,
• Constipation,
• Symptoms of a cold (stuffy nose, sneezing, sinus pain, sore throat),
• Anxiety,
• Feeling tired,
• Skin rash,
• An upper respiratory tract infection
• Injection site redness or rash.

Severe Side Effects

Victoza can cause serious side effects, but they aren’t common. If you experience serious side effects, contact your doctor immediately. The first thing you should do if you think you’re experiencing a medical emergency is to dial 911.

Symptoms of serious side effects include:

• Gallbladder disease. You may experience stomach pain, nausea, vomiting, fever, diarrhea, and jaundice (yellowing of the skin and whites of your eyes).
• Kidney problems. As a result of dehydration, this can occur. There can be a number of symptoms, including urinating less frequently than usual, swelling in your lower legs and feet, drowsiness, confusion, shortness of breath, nausea, and a headache.

Other serious side effects, include:

• Pancreatitis (severe abdominal pain that spreads to your back, nausea and vomiting, fast heart rate).
• Severe allergic reaction (itching; rapid heartbeat; dizziness; trouble breathing or swallowing; swelling of your face, lips, tongue, or throat). See more in Allergic Reactions tab.
• Possible risk of thyroid cancer ( swollen neck, difficulty swallowing, hoarse voice, feeling short of breath)

Allergic Reactions

Victoza can cause an allergic reaction in some people, as with most drugs. The number of people who have experienced an allergic reaction to Victoza is unknown. Mild allergic reactions can cause the following symptoms:

• A rash on the skin
• An itchy feeling
• Flushing (warmth and redness of the skin)

There is a possibility of a more severe allergic reaction, but it is rare. A severe allergic reaction can cause the following symptoms:

• Inflammation under your skin, usually in your eyelids, lips, hands, or feet
• You may experience swelling in your tongue, mouth, or throat
• Inability to breathe or speak

Victoza can cause severe allergic reactions, so you should contact your doctor right away. In case of a medical emergency or if your symptoms seem life-threatening, call 911.

The active ingredient in Victoza is liraglutide. The inactive ingredients are disodium phosphate dihydrate, propylene glycol, phenol and water for injection.

Dosing

Adult Dosage

For one week, administer Victoza at a dose of 0.6 mg daily. As a starting dose, 0.6 mg is intended to reduce gastrointestinal symptoms during initial titration, and is not effective for glycemic control in adults. Increase the dose to 1.2 mg per day after one week at 0.6 mg per day.

After at least one week of treatment with the 1.2 mg daily dose, increase the dose to 1.8 mg daily if additional glycemic control is required.

Pediatric Dosage

Starting dose of Victoza should be 0.6 mg per day. If additional glycemic control is required after one week at 0.6 mg daily, the dose can be increased to 1.2 mg daily.

After one week of treatment with the 1.2 mg daily dose, increase the dose to 1.8 mg daily if additional glycemic control is required.

Consider dose reduction of the insulin secretagogue to reduce the risk of hypoglycemia.

Drug Interactions

You may experience serious side effects if there is a drug interaction between your medications. Drug interactions are not covered in this document. Provide your doctor and pharmacist with a list of all the products you use (including prescription and nonprescription drugs and herbal products). Without your doctor’s approval, do not start, stop, or change the dosage of any medicines.

You may be able to prevent the fast/pounding heartbeat associated with hypoglycemia by taking beta-blocker medications (such as metoprolol, propranolol, glaucoma eye drops such as timolol). These drugs do not affect dizziness, hunger, or sweating, which are other symptoms of low blood sugar.

Blood sugar can be affected by many drugs, making it harder to control. In addition to corticosteroids (such as prednisone), psychiatric medicines (such as olanzapine), and quinolone antibiotics (such as ciprofloxacin), there are a variety of other medications that are prescribed. Share your blood sugar results with your doctor on a regular basis as directed. In case of high or low blood sugar symptoms, tell your doctor right away (see also Side Effects). The medication, exercise program, or diet you are taking for diabetes may need to be adjusted by your doctor.

Liraglutide-containing products should not be used together with this medication (such as Saxenda).

Pregnancy

As of now, there is no data available to inform whether drugs can cause major birth defects or miscarriages. There may be risks to the fetus during pregnancy based on animal reproduction studies.

Patients with diabetes mellitus should consider switching to insulin if pregnancy occurs or they wish to become pregnant while taking this drug.

Due to the potential harm to a fetus from weight loss, the use of this drug during pregnancy is contraindicated for weight loss.

Breastfeeding

It has been shown that this drug is excreted into rat milk at a concentration of approximately 50% of maternal plasma levels. During gestation and lactation, this drug reduced postnatal weight gain in rats. Reduced food consumption by the mother may have contributed to this finding.

The drug should not be used and a decision should be made about discontinuing breastfeeding or discontinuing the drug, taking into consideration how important the drug is to the mother.

Storage

Before use

Store your new, unused Victoza pen in the refrigerator at 36ºF to 46ºF (2ºC to 8ºC).  Do not freeze Victoza or use Victoza if it has been frozen. Do not store Victoza near the refrigerator cooling element.

Pen in use

Store your Victoza pen for 30 days either at 59ºF to 86ºF (15ºC to 30ºC), or in a refrigerator at 36ºF to 46ºF (2°C to 8°C). When carrying the pen away from home, store the pen at a temperature between 59ºF to 86ºF (15ºC to 30ºC) and keep it dry.

If Victoza has been exposed to temperatures above 86ºF (30ºC), it should be thrown away. Protect your Victoza pen from heat and sunlight. Keep the pen cap on when your Victoza pen is not in use.

Use your Victoza pen within 30 days after the first day it is stored outside the refrigerator. After these 30 days, throw away your Victoza pen even if some medicine is left in the pen. Do not use Victoza after the expiration date printed on the carton

Do not store the Victoza pen with the needle attached. Always safely remove and safely throw away the needle after each injection. This may help prevent contamination, infection and leakage. It also helps to make sure that you get the correct dose of Victoza. See the Patient Instructions for Use for information about how to dispose of used pen needles and used Victoza pens.